Use of a modified informed consent process among vulnerable patients: a descriptive study.

PubMed

Sudore, Rebecca L; Landefeld, C Seth; Williams, Brie A; Barnes, Deborah E; Lindquist, Karla; Schillinger, Dean

2006-08-01

Little is known about patient characteristics associated with comprehension of consent information, and whether modifications to the consent process can promote understanding. To describe a modified research consent process, and determine whether literacy and demographic characteristics are associated with understanding consent information. Descriptive study of a modified consent process: consent form (written at a sixth-grade level) read to participants, combined with 7 comprehension questions and targeted education, repeated until comprehension achieved (teach-to-goal). Two hundred and four ethnically diverse subjects, aged > or = 50, consenting for a trial to improve the forms used for advance directives. Number of passes through the consent process required to achieve complete comprehension. Literacy assessed in English and Spanish with the Short Form Test of Functional Health Literacy in Adults (scores 0 to 36). Participants had a mean age of 61 years and 40% had limited literacy (s-TOHFLA<23). Only 28% of subjects answered all comprehension questions correctly on the first pass. After adjustment, lower literacy (P=.04) and being black (P=.03) were associated with requiring more passes through the consent process. Not speaking English as a primary language was associated with requiring more passes through the consent process in bivariate analyses (P<.01), but not in multivariable analyses (P>.05). After the second pass, most subjects (80%) answered all questions correctly. With a teach-to-goal strategy, 98% of participants who engaged in the consent process achieved complete comprehension. Lower literacy and minority status are important determinants of understanding consent information. Using a modified consent process, little additional education was required to achieve complete comprehension, regardless of literacy or language barriers.

Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia

PubMed Central

Vučemilo, Luka; Borovečki, Ana

2015-01-01

Background High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. Methods 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. Results The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10–19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Conclusions Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation. PMID:26376183

Clinical records anonymisation and text extraction (CRATE): an open-source software system.

PubMed

Cardinal, Rudolf N

2017-04-26

Electronic medical records contain information of value for research, but contain identifiable and often highly sensitive confidential information. Patient-identifiable information cannot in general be shared outside clinical care teams without explicit consent, but anonymisation/de-identification allows research uses of clinical data without explicit consent. This article presents CRATE (Clinical Records Anonymisation and Text Extraction), an open-source software system with separable functions: (1) it anonymises or de-identifies arbitrary relational databases, with sensitivity and precision similar to previous comparable systems; (2) it uses public secure cryptographic methods to map patient identifiers to research identifiers (pseudonyms); (3) it connects relational databases to external tools for natural language processing; (4) it provides a web front end for research and administrative functions; and (5) it supports a specific model through which patients may consent to be contacted about research. Creation and management of a research database from sensitive clinical records with secure pseudonym generation, full-text indexing, and a consent-to-contact process is possible and practical using entirely free and open-source software.

Macao Report: Informed Consent in a Multilingual and Multicultural Region, a Bioethical Challenge.

PubMed

Raposo, Vera Lúcia

2018-07-01

Complying with the requirements of informed consent for medical procedures can sometimes be problematic, even when the hospitals are located in countries that are uniform in their language and cultural values. However, when hospitals are located in countries with diverse linguistic and ethnic communities, it becomes particularly challenging. This article examines how Macao, with four predominant languages-Mandarin, Portuguese, Cantonese and English-and two very strong cultures, Western and Chinese, strives to meet the challenges of informed consent. The situation is made even more complicated by a healthcare delivery in Macao that is mostly guided by Chinese ethical and cultural perspectives, whereas its law is inspired by the Western model.

The Language of Love?--Verbal versus Implied Consent at First Heterosexual Intercourse: Implications for Contraceptive Use

ERIC Educational Resources Information Center

Higgins, Jenny A.; Trussell, James; Moore, Nelwyn B.; Davidson, J. Kenneth, Sr.

2010-01-01

Background: Little is known about how young people communicate about initiating intercourse. Purpose: This study was designed to gauge the prevalence of implied versus verbal consent at first intercourse in a U.S. college population, assess effects of consent type on contraceptive use, and explore the influences of gender, race and other factors.…

[Quality of information in the process of informed consent for anesthesia].

PubMed

Guillén-Perales, José; Luna-Maldonado, Aurelio; Fernández-Prada, María; Guillén-Solvas, José Francisco; Bueno-Cavanillas, Aurora

2013-11-01

To assess the quality of the information that patients receive in the informed consent document signed prior to surgery. Cross-sectional study of a sample of cancer patients admitted for surgery at the University Hospital San Cecilio of Granada in 2011. After checking the inclusion criteria and obtaining their consent, demographic data were collected and procedure data, and a questionnaire «ad hoc» to assess the quality and comprehensiveness of the information provided in the informed consent. 150 patients were studied. The majority (109 over 150) said they had received sufficient information, in appropriate language, and had the opportunity to ask questions, but only 44.7% correctly answered three or more issues related to anesthesia. University education level, knowledge of the intervention, information about the anesthesia problems and appropriate language were associated. Although systematic informed consent was performed, half of the patients did not comprehend the anesthesia risks. Variables primarily related to the information received were associated with the quality of the response, but not with patient characteristics. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness.

PubMed

Gobat, Nina H; Gal, Micaela; Francis, Nick A; Hood, Kerenza; Watkins, Angela; Turner, Jill; Moore, Ronald; Webb, Steve A R; Butler, Christopher C; Nichol, Alistair

2015-12-29

A rigorous research response is required to inform clinical and public health decision-making during an epi/pandemic. However, the ethical conduct of such research, which often involves critically ill patients, may be complicated by the diminished capacity to consent and an imperative to initiate trial therapies within short time frames. Alternative approaches to taking prospective informed consent may therefore be used. We aimed to rapidly review evidence on key stakeholder (patients, their proxy decision-makers, clinicians and regulators) views concerning the acceptability of various approaches for obtaining consent relevant to pandemic-related acute illness research. We conducted a rapid evidence review, using the Internet, database and hand-searching for English language empirical publications from 1996 to 2014 on stakeholder opinions of consent models (prospective informed, third-party, deferred, or waived) used in acute illness research. We excluded research on consent to treatment, screening, or other such procedures, non-emergency research and secondary studies. Papers were categorised, and data summarised using narrative synthesis. We screened 689 citations, reviewed 104 full-text articles and included 52. Just one paper related specifically to pandemic research. In other emergency research contexts potential research participants, clinicians and research staff found third-party, deferred, and waived consent to be acceptable as a means to feasibly conduct such research. Acceptability to potential participants was motivated by altruism, trust in the medical community, and perceived value in medical research and decreased as the perceived risks associated with participation increased. Discrepancies were observed in the acceptability of the concept and application or experience of alternative consent models. Patients accepted clinicians acting as proxy-decision makers, with preference for two decision makers as invasiveness of interventions increased. Research regulators were more cautious when approving studies conducted with alternative consent models; however, their views were generally under-represented. Third-party, deferred, and waived consent models are broadly acceptable to potential participants, clinicians and/or researchers for emergency research. Further consultation with key stakeholders, particularly with regulators, and studies focused specifically on epi/pandemic research, are required. We highlight gaps and recommendations to inform set-up and protocol development for pandemic research and institutional review board processes. CRD42014014000.

Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level.

PubMed

Kim, Eun Jin; Kim, Su Hyun

2015-06-01

This study evaluated the effect of a simplified informed consent form for clinical trials on the understanding and efficacy of informed consent information across health literacy levels. A total of 150 participants were randomly assigned to one of two groups and provided with either standard or simplified consent forms for a cancer clinical trial. The features of the simplified informed consent form included plain language, short sentences, diagrams, pictures, and bullet points. Levels of objective and subjective understanding were significantly higher in participants provided with simplified informed consent forms relative to those provided with standard informed consent forms. The interaction effects between type of consent form and health literacy level on objective and subjective understanding were nonsignificant. Simplified informed consent was effective in enhancing participant's subjective and objective understanding regardless of health literacy. © The Author(s) 2015.

Patients' understanding of telemedicine terms required for informed consent when translated into Kiswahili.

PubMed

Odhiambo, Rachael; Mars, Maurice

2018-05-03

In Africa, where access to specialist medical services is often limited, telemedicine, the use of information and communication technologies for the provision of healthcare at a distance, can contribute towards enhancing access to healthcare. Informed consent is considered the cornerstone of ethical practice, especially when technology and techniques are considered new and or unproven. It is advised that informed consent should be gained in the patient's mother tongue. However, many African languages have not kept pace with technology and lack the words and terms needed to describe computing and technical terms. Additionally, even when present, patients may not understand these words and terms. This affects the validity of informed consent given. Forty relevant computer terms and words used when explaining telemedicine during the consent process were selected and translated into Kiswahili. Patients at the outpatient department of the Kilifi County Hospital in Kenya participated. The study consisted of two phases. In the first, 50 people were asked whether they understood the translated words and terms and were able to explain their meaning. In the second (n = 42) they were asked to explain the meaning of the translated word, the original English word, and those words that could not be translated. Of the 40 terms, 14 could not be translated (35%). A total of 92 people attending the Kilifi County Hospital participated. Their average age was 31.2 ± 10.6 y, 70.7% were female and 55.4% were from rural areas. More than half of the respondents did not understand videoconference, store and forward, digital photograph, wireless, World Wide Web, antivirus or email in either language. No-one understood the words telemedicine, firewall, encryption, decryption and tele-diagnosis. Currently it is unlikely that valid informed consent can be obtained for a telemedicine encounter in Kiswahili. Innovative solutions are required to overcome the barrier of languages failing to keep pace with technology and their effect on consent.

Vulnerable Subjects: Why Does Informed Consent Matter?

PubMed

Goodwin, Michele

2016-09-01

This special issue of the Journal Law, Medicine & Ethics takes up the concern of informed consent, particularly in times of controversy. The dominant moral dilemmas that frame traditional bioethical concerns address medical experimentation on vulnerable subjects; physicians assisting their patients in suicide or euthanasia; scarce resource allocation and medical futility; human trials to develop drugs; organ and tissue donation; cloning; xenotransplantation; abortion; human enhancement; mandatory vaccination; and much more. The term "bioethics" provides a lens, language, and guideposts to the study of medical ethics. It is worth noting, however, that medical experimentation is neither new nor exclusive to one country. Authors in this issue address thorny subjects that span borders and patients: from matters dealing with children and vaccination to the language and perception of consent. © 2016 American Society of Law, Medicine & Ethics.

Recruitment of ethnic minorities into cancer clinical trials: experience from the front lines.

PubMed

Symonds, R P; Lord, K; Mitchell, A J; Raghavan, D

2012-09-25

Throughout the world there are problems recruiting ethnic minority patients into cancer clinical trials. A major barrier to trial entry may be distrust of research and the medical system. This may be compounded by the regulatory framework governing research with an emphasis on written consent, closed questions and consent documentation, as well as fiscal issues. The Leicester UK experience is that trial accrual is better if British South Asian patients are approached by a senior doctor rather than someone of perceived lesser hierarchical status and a greater partnership between the hospital and General Practitioner may increase trial participation of this particular ethnic minority. In Los Angeles, USA, trial recruitment was improved by a greater utilisation of Hispanic staff and a Spanish language-based education programme. Involvement of community leaders is essential. While adhering to national, legal and ethnical standards, information sheets and consent, it helps if forms can be tailored towards the local ethnic minority population. Written translations are often of limited value in the recruitment of patients with no or limited knowledge of English. In some cultural settings, tape-recorded verbal consent (following approval presentations) may be an acceptable substitute for written consent, and appropriate legislative changes should be considered to facilitate this option. Approaches should be tailored to specific minority populations, taking consideration of their unique characteristics and with input from their community leadership.

Determination of mental competency, a neurological perspective.

PubMed

Kirshner, Howard S

2013-06-01

This article discusses the evaluation of the capacity of a person to make informed decisions about financial matters, independent living, and informed consent for medical treatment and research. Determination of capacity is a function for which most physicians have little training. The determination of competency for a general medical patient may be assessed by a combination of a bedside mental status examination such as the MMSE and a questionnaire such as the Aid To Capacity Evaluation (ACE 1999). For patients with focal neurological deficits such as aphasia, further evaluation of specific cognitive and language functions is needed; Alexander (Arch Neurol 45:23-6, 1988) suggested 7 specific functions to be assessed. Finally, in dementing illnesses, evaluation by the MMSE and a questionnaire such as the CCTI, or Capacity to Consent to Treatment Instrument (Marson et al. Arch Neurol 52:949-54, 1995) is needed. Dementia includes several separate syndromes of neurodegenerative disease, and in many of these conditions, focal deficits such as aphasia may necessitate a more thorough neuropsychological evaluation.

Organ Donation in Switzerland - An Analysis of Factors Associated with Consent Rate

PubMed Central

Keel, Isabelle; Immer, Franz F.; Jüni, Peter

2014-01-01

Background and Aim Switzerland has a low post mortem organ donation rate. Here we examine variables that are associated with the consent of the deceased’s next of kin (NOK) for organ donation, which is a prerequisite for donation in Switzerland. Methods and Analysis During one year, we registered information from NOK of all deceased patients in Swiss intensive care units, who were approached for consent to organ donation. We collected data on patient demographics, characteristics of NOK, factors related to the request process and to the clinical setting. We analyzed the association of collected predictors with consent rate using univariable logistic regression models; predictors with p-values <0.2 were selected for a multivariable logistic regression. Results Of 266 NOK approached for consent, consent was given in 137 (51.5%) cases. In multivariable analysis, we found associations of consent rates with Swiss nationality (OR 3.09, 95% CI: 1.46–6.54) and German language area (OR 0.31, 95% CI: 0.14–0.73). Consent rates tended to be higher if a parent was present during the request (OR 1.76, 95% CI: 0.93–3.33) and if the request was done before brain death was formally declared (OR 1.87, 95% CI: 0.90–3.87). Conclusion Establishing an atmosphere of trust between the medical staff putting forward a request and the NOK, allowing sufficient time for the NOK to consider donation, and respecting personal values and cultural differences, could be of importance for increasing donation rates. Additional measures are needed to address the pronounced differences in consent rates between language regions. PMID:25208215

A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting.

PubMed

Addissie, Adamu; Davey, Gail; Newport, Melanie J; Addissie, Thomas; MacGregor, Hayley; Feleke, Yeweyenhareg; Farsides, Bobbie

2014-05-02

Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia. Mixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health researchers and regulators including ethics committee members in Ethiopian health research institutions and universities. In their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity (48.1%), inadequate information (34%), language barriers (28.2%), cultural differences (27.4%), undue expectations (26.6%) and power imbalances (20.7%). About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test (pilot) phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed. The study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders to address these gaps. Exploring further the feasibility and applicability of REA is recommended.

A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting

PubMed Central

2014-01-01

Background Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia. Methods Mixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health researchers and regulators including ethics committee members in Ethiopian health research institutions and universities. Results In their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity (48.1%), inadequate information (34%), language barriers (28.2%), cultural differences (27.4%), undue expectations (26.6%) and power imbalances (20.7%). About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test (pilot) phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed. Conclusion The study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders to address these gaps. Exploring further the feasibility and applicability of REA is recommended. PMID:24885049

Resting-State Functional MR Imaging for Determining Language Laterality in Intractable Epilepsy.

PubMed

DeSalvo, Matthew N; Tanaka, Naoaki; Douw, Linda; Leveroni, Catherine L; Buchbinder, Bradley R; Greve, Douglas N; Stufflebeam, Steven M

2016-10-01

Purpose To measure the accuracy of resting-state functional magnetic resonance (MR) imaging in determining hemispheric language dominance in patients with medically intractable focal epilepsies against the results of an intracarotid amobarbital procedure (IAP). Materials and Methods This study was approved by the institutional review board, and all subjects gave signed informed consent. Data in 23 patients with medically intractable focal epilepsy were retrospectively analyzed. All 23 patients were candidates for epilepsy surgery and underwent both IAP and resting-state functional MR imaging as part of presurgical evaluation. Language dominance was determined from functional MR imaging data by calculating a laterality index (LI) after using independent component analysis. The accuracy of this method was assessed against that of IAP by using a variety of thresholds. Sensitivity and specificity were calculated by using leave-one-out cross validation. Spatial maps of language components were qualitatively compared among each hemispheric language dominance group. Results Measurement of hemispheric language dominance with resting-state functional MR imaging was highly concordant with IAP results, with up to 96% (22 of 23) accuracy, 96% (22 of 23) sensitivity, and 96% (22 of 23) specificity. Composite language component maps in patients with typical language laterality consistently included classic language areas such as the inferior frontal gyrus, the posterior superior temporal gyrus, and the inferior parietal lobule, while those of patients with atypical language laterality also included non-classical language areas such as the superior and middle frontal gyri, the insula, and the occipital cortex. Conclusion Resting-state functional MR imaging can be used to measure language laterality in patients with medically intractable focal epilepsy. (©) RSNA, 2016 Online supplemental material is available for this article.

Resting-State Functional MR Imaging for Determining Language Laterality in Intractable Epilepsy

PubMed Central

Tanaka, Naoaki; Douw, Linda; Leveroni, Catherine L.; Buchbinder, Bradley R.; Greve, Douglas N.; Stufflebeam, Steven M.

2016-01-01

Purpose To measure the accuracy of resting-state functional magnetic resonance (MR) imaging in determining hemispheric language dominance in patients with medically intractable focal epilepsies against the results of an intracarotid amobarbital procedure (IAP). Materials and Methods This study was approved by the institutional review board, and all subjects gave signed informed consent. Data in 23 patients with medically intractable focal epilepsy were retrospectively analyzed. All 23 patients were candidates for epilepsy surgery and underwent both IAP and resting-state functional MR imaging as part of presurgical evaluation. Language dominance was determined from functional MR imaging data by calculating a laterality index (LI) after using independent component analysis. The accuracy of this method was assessed against that of IAP by using a variety of thresholds. Sensitivity and specificity were calculated by using leave-one-out cross validation. Spatial maps of language components were qualitatively compared among each hemispheric language dominance group. Results Measurement of hemispheric language dominance with resting-state functional MR imaging was highly concordant with IAP results, with up to 96% (22 of 23) accuracy, 96% (22 of 23) sensitivity, and 96% (22 of 23) specificity. Composite language component maps in patients with typical language laterality consistently included classic language areas such as the inferior frontal gyrus, the posterior superior temporal gyrus, and the inferior parietal lobule, while those of patients with atypical language laterality also included non-classical language areas such as the superior and middle frontal gyri, the insula, and the occipital cortex. Conclusion Resting-state functional MR imaging can be used to measure language laterality in patients with medically intractable focal epilepsy. © RSNA, 2016 Online supplemental material is available for this article. PMID:27467465

How US institutional review boards decide when researchers need to translate studies

PubMed Central

Klitzman, Robert

2013-01-01

Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards (IRBs) and research ethics committees’ (RECs) about the need for researchers to translate consent forms and other study materials. Sixty US IRBs (every fourth one in the list of the top 240 institutions by The National Institutes of Health funding) were contacted, and leaders (eg, chairs) from 34 (response rate=57%) and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals—what, when and how to translate (eg, for how many or what proportion of potential subjects), why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy (through informed consent) and justice (to ensure fair distribution of benefits and burdens of research) against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions. PMID:23475805

How US institutional review boards decide when researchers need to translate studies.

PubMed

Klitzman, Robert

2014-03-01

Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards (IRBs) and research ethics committees' (RECs) about the need for researchers to translate consent forms and other study materials. Sixty US IRBs (every fourth one in the list of the top 240 institutions by The National Institutes of Health funding) were contacted, and leaders (eg, chairs) from 34 (response rate=57%) and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals-what, when and how to translate (eg, for how many or what proportion of potential subjects), why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy (through informed consent) and justice (to ensure fair distribution of benefits and burdens of research) against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions.

Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment trial

PubMed Central

Denning, Eileen; Sharma, Shweta; Smolskis, Mary; Touloumi, Giota; Walker, Sarah; Babiker, Abdel; Clewett, Megan; Emanuel, Ezekiel; Florence, Eric; Papadopoulos, Antonios; Sánchez, Adriana; Tavel, Jorge; Grady, Christine

2014-01-01

Objectives Efforts are needed to improve informed consent of participants in research. The Strategic Timing of AntiRetroviral Therapy (START) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants. Methods Interested START sites were randomised to use either the standard consent form or the concise consent form for all of the site’s participants. Results A total of 4473 HIV-positive participants at 154 sites worldwide took part in the Informed Consent Substudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment. Conclusions These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world. PMID:25711320

Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial.

PubMed

Denning, E; Sharma, S; Smolskis, M; Touloumi, G; Walker, S; Babiker, A; Clewett, M; Emanuel, E; Florence, E; Papadopoulos, A; Sánchez, A; Tavel, J; Grady, C

2015-04-01

Efforts are needed to improve informed consent of participants in research. The Strategic Timing of AntiRetroviral Therapy (START) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants. Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site's participants. A total of 4473 HIV-positive participants at 154 sites world-wide took part in the Informed Consent Substudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment. These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world. © 2015 British HIV Association.

Digitised audio questionnaire for assessment of informed consent comprehension in a low-literacy African research population: development and psychometric evaluation

PubMed Central

Afolabi, Muhammed O; Bojang, Kalifa; D'Alessandro, Umberto; Ota, Martin O C; Imoukhuede, Egeruan B; Ravinetto, Raffaella; Larson, Heidi J; McGrath, Nuala; Chandramohan, Daniel

2014-01-01

Objective To develop and psychometrically evaluate an audio digitised tool for assessment of comprehension of informed consent among low-literacy Gambian research participants. Setting We conducted this study in the Gambia where a high illiteracy rate and absence of standardised writing formats of local languages pose major challenges for research participants to comprehend consent information. We developed a 34-item questionnaire to assess participants’ comprehension of key elements of informed consent. The questionnaire was face validated and content validated by experienced researchers. To bypass the challenge of a lack of standardised writing formats, we audiorecorded the questionnaire in three major Gambian languages: Mandinka, Wolof and Fula. The questionnaire was further developed into an audio computer-assisted interview format. Participants The digitised questionnaire was administered to 250 participants enrolled in two clinical trials in the urban and rural areas of the Gambia. One week after first administration, the questionnaire was readministered to half of the participants who were randomly selected. Participants were eligible if enrolled in the parent trials and could speak any of the three major Gambian languages. Outcome measure The primary outcome measure was reliability and validity of the questionnaire. Results Item reduction by factor analysis showed that 21 of the question items have strong factor loadings. These were retained along with five other items which were fundamental components of informed consent. The 26-item questionnaire has high internal consistency with a Cronbach's α of 0.73–0.79 and an intraclass correlation coefficient of 0.94 (95% CI 0.923 to 0.954). Hypotheses testing also showed that the questionnaire has a positive correlation with a similar questionnaire and discriminates between participants with and without education. Conclusions We have developed a reliable and valid measure of comprehension of informed consent information for the Gambian context, which might be easily adapted to similar settings. This is a major step towards engendering comprehension of informed consent information among low-literacy participants. PMID:24961716

Digitised audio questionnaire for assessment of informed consent comprehension in a low-literacy African research population: development and psychometric evaluation.

PubMed

Afolabi, Muhammed O; Bojang, Kalifa; D'Alessandro, Umberto; Ota, Martin O C; Imoukhuede, Egeruan B; Ravinetto, Raffaella; Larson, Heidi J; McGrath, Nuala; Chandramohan, Daniel

2014-06-24

To develop and psychometrically evaluate an audio digitised tool for assessment of comprehension of informed consent among low-literacy Gambian research participants. We conducted this study in the Gambia where a high illiteracy rate and absence of standardised writing formats of local languages pose major challenges for research participants to comprehend consent information. We developed a 34-item questionnaire to assess participants' comprehension of key elements of informed consent. The questionnaire was face validated and content validated by experienced researchers. To bypass the challenge of a lack of standardised writing formats, we audiorecorded the questionnaire in three major Gambian languages: Mandinka, Wolof and Fula. The questionnaire was further developed into an audio computer-assisted interview format. The digitised questionnaire was administered to 250 participants enrolled in two clinical trials in the urban and rural areas of the Gambia. One week after first administration, the questionnaire was readministered to half of the participants who were randomly selected. Participants were eligible if enrolled in the parent trials and could speak any of the three major Gambian languages. The primary outcome measure was reliability and validity of the questionnaire. Item reduction by factor analysis showed that 21 of the question items have strong factor loadings. These were retained along with five other items which were fundamental components of informed consent. The 26-item questionnaire has high internal consistency with a Cronbach's α of 0.73-0.79 and an intraclass correlation coefficient of 0.94 (95% CI 0.923 to 0.954). Hypotheses testing also showed that the questionnaire has a positive correlation with a similar questionnaire and discriminates between participants with and without education. We have developed a reliable and valid measure of comprehension of informed consent information for the Gambian context, which might be easily adapted to similar settings. This is a major step towards engendering comprehension of informed consent information among low-literacy participants. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Contents and readability of currently used surgical/procedure informed consent forms in Nigerian tertiary health institutions.

PubMed

Ezeome, E R; Chuke, P I; Ezeome, I V

2011-01-01

Surgical informed consent forms should have evidence that their use will enhance a shared decision-making which is the fundamental objective of informed consent in clinical practice. In the absence of any guideline in Nigeria on the content and language of informed consent forms, we sort to examine the surgical and procedure consent forms used by Federal tertiary health institutions in Nigeria, to know whether they fulfill the basic elements of informed consent. The surgical and procedure informed consent forms of 33 tertiary health institutions in Nigeria were assessed for their readability and contents. Adequacy of their content was evaluated based on provision for 28 content items identified as necessary information to be provided in a good consent form. The potential of the forms to be comprehended were assessed with Flesch readability formula. The contents of majority of the forms were scant. None of the forms made provision for documentation of the patient's permission for blood transfusion, tissue disposal, awareness of the risks of not undergoing the prescribed treatment, and the risk of anesthesia. Risk disclosures were only mentioned in specific terms in 11.4% of the forms. Less than 10% of the forms made provisions for an interpreter, signature of anesthetists, alternative to the procedure to be mentioned, and answering of the patient's questions. The Flesch reading ease scores of the forms ranged from 34.1 (Difficult) to 67.5 (Standard), with a mean score of 55.2 (Fairly difficult level). Field evaluation of the forms show that they shall be partly understood by 13- to 15-year-old patients with basic education but are best understood by literate adult patients. The content of majority of the informed consent forms used in Nigerian tertiary health institutions are poor and their readability scores are not better than those used in developed parts of the world. Health Institutions in Nigeria should revise their informed consent forms to improve their contents and do a usability trial on the sample forms before deployment in order to ensure that they are comprehensible for their patient population.

78 FR 45068 - Commission's Rules of Practice and Procedure; Practice Before the Commission, Parties to...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-26

... amendments. Section 502.42--Bureau of Enforcement Section 502.42 is amended to simplify the language... proceeding. (e) If an attorney wishes to withdraw from representing a party, and written consent is not... simplification of the issues by consent of the parties or by the use of alternative means of dispute resolution...

Informed consent in a multicultural cancer patient population: implications for nursing practice.

PubMed

Barnes, D M; Davis, A J; Moran, T; Portillo, C J; Koenig, B A

1998-09-01

Obtaining informed consent, an ethical obligation of nurses and other health care providers, occurs routinely when patients make health care decisions. The values underlying informed consent (promotion of patients' well-being and respect for their self-determination) are embedded in the dominant American culture. Nurses who apply the USA's cultural values of informed consent when caring for patients who come from other cultures encounter some ethical dilemmas. This descriptive study, conducted with Latino, Chinese and Anglo-American cancer patients in a large, public, west-coast clinic, describes constraints on the informed consent process in a multicultural setting, including language barriers, the clinical environment, control in decision making, and conflicting desired health outcomes for health care providers and patients, and suggests some implications for nursing practice.

Access to special care dentistry, part 3. Consent and capacity.

PubMed

Dougall, A; Fiske, J

2008-07-26

This article considers what is meant by informed consent and the implications of the Mental Capacity Act in obtaining consent from vulnerable adults. It explores a number of conditions which impact on this task, namely dyslexia, literacy problems and learning disability. The focus on encouraging and facilitating autonomy and the use of the appropriate level of language in the consent giving process ensures that consent is valid. The use of appropriate methods to facilitate communication with individuals in order to be able to assess capacity and ensure that any treatment options that are chosen on their behalf are in their best interests are outlined. The use of physical intervention in special care dentistry in order to provide dental care safely for both the patient and the dental team is also considered.

Culturally Competent Informed-Consent Process to Evaluate a Social Policy for Older Persons With Low Literacy: The Mexican Case

PubMed Central

Aguila, Emma; Weidmer, Beverly A.; Illingworth, Alfonso Rivera; Martinez, Homero

2017-01-01

The informed-consent process seeks to provide complete information to participants about a research project and to protect personal information they may disclose. In this article, we present an informed-consent process that we piloted and improved to obtain consent from older adults in Yucatan, Mexico. Respondents had limited fluency in Spanish, spoke the local Mayan language, and had some physical limitations due to their age. We describe how we adapted the informed-consent process to comply with U.S. and Mexican regulations, while simplifying the forms and providing them in Spanish and Mayan. We present the challenges and lessons learned when dealing with low-literacy older populations, some with diminished autonomy, in a bilingual context and a binational approach to the legal framework. PMID:28824826

Women lose suit over involuntary sterilizations (California).

PubMed

1978-10-01

Federal Judge Jesse W. Curtis dismissed a suit brought by 10 Mexican-American women, who charged that between 1971-1974 they were sterilized without their voluntary and informed consent by physicians at the USC-Los Angeles County General Medical Center. Judge Curtis considered the case a communications breakdown between doctor and patient based on the patients' limited ability to speak English. Many women testified that they were pressured by hospital staff to consent to sterilization while they were in labor. Subsequent regulations passed by the California health department prohibit obtaining sterilization consent from a woman in labor or 24 hours postpartum. It further requires the consent form be written in the patient's preferred language. 8 of the plaintiffs had signed consent forms; 2 of the plaintiffs' husbands had signed. In the future, doctors must fully explain the procedure and its effects.

Patient predictors of colposcopy comprehension of consent among English- and Spanish-speaking women.

PubMed

Krankl, Julia Tatum; Shaykevich, Shimon; Lipsitz, Stuart; Lehmann, Lisa Soleymani

2011-01-01

patients with limited English proficiency may be at increased risk for diminished understanding of clinical procedures. This study sought to assess patient predictors of comprehension of colposcopy information during informed consent and to assess differences in understanding between English and Spanish speakers. between June and August 2007, English- and Spanish-speaking colposcopy patients at two Boston hospitals were surveyed to assess their understanding of the purpose, risks, benefits, alternatives, and nature of colposcopy. Patient demographic information was collected. there were 183 women who consented to participate in the study. We obtained complete data on 111 English speakers and 38 Spanish speakers. English speakers were more likely to have a higher education, greater household income, and private insurance. Subjects correctly answered an average of 7.91 ± 2.16 (72%) of 11 colposcopy survey questions. English speakers answered more questions correctly than Spanish speakers (8.50 ± 1.92 [77%] vs 6.21 ± 1.93 [56%]; p < .001). Using linear regression to adjust for confounding variables, we found that language was not significantly associated with greater understanding (p = .46). Rather, education was the most significant predictor of colposcopy knowledge (p < .001). many colposcopy patients did not understand the procedure well enough to give informed consent. The observed differences in colposcopy comprehension based on language were a proxy for differences in education. Education, not language, predicted subjects' understanding of colposcopy. These results demonstrate the need for greater attention to patients' educational background to ensure adequate understanding of clinical information. 2011 Jacobs Institute of Women's Health. Published by Elsevier Inc.

Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: an empirical study.

PubMed

Chima, Sylvester C

2013-01-01

Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent. The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa. The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while internists, GPs and obstetricians/gynaecologists scored highest. Comparative ICAS scores showed that professional nurses scored significantly lower than doctors (p ≤ 0.001). This study shows that though doctors had general knowledge of informed consent requirements, execution in practice was inadequate, with deficiency in knowledge of basic local laws and regulations. Remedying identified deficiencies may require a 'corps' of interpreters in local hospitals to assist doctors in dealing with language difficulties, and continuing education in medical law and ethics to improve informed consent practices and overall quality of healthcare service delivery.

Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: An empirical study

PubMed Central

2013-01-01

Background Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent. Methods The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa. Results The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while internists, GPs and obstetricians/gynaecologists scored highest. Comparative ICAS scores showed that professional nurses scored significantly lower than doctors (p ≤ 0.001). Conclusions This study shows that though doctors had general knowledge of informed consent requirements, execution in practice was inadequate, with deficiency in knowledge of basic local laws and regulations. Remedying identified deficiencies may require a 'corps' of interpreters in local hospitals to assist doctors in dealing with language difficulties, and continuing education in medical law and ethics to improve informed consent practices and overall quality of healthcare service delivery. PMID:24564932

Automated Detection of Privacy Sensitive Conditions in C-CDAs: Security Labeling Services at the Department of Veterans Affairs

PubMed Central

Bouhaddou, Omar; Davis, Mike; Donahue, Margaret; Mallia, Anthony; Griffin, Stephania; Teal, Jennifer; Nebeker, Jonathan

2016-01-01

Care coordination across healthcare organizations depends upon health information exchange. Various policies and laws govern permissible exchange, particularly when the information includes privacy sensitive conditions. The Department of Veterans Affairs (VA) privacy policy has required either blanket consent or manual sensitivity review prior to exchanging any health information. The VA experience has been an expensive, administratively demanding burden on staffand Veterans alike, particularly for patients without privacy sensitive conditions. Until recently, automatic sensitivity determination has not been feasible. This paper proposes a policy-driven algorithmic approach (Security Labeling Service or SLS) to health information exchange that automatically detects the presence or absence of specific privacy sensitive conditions and then, to only require a Veteran signed consent for release when actually present. The SLS was applied successfully to a sample of real patient Consolidated-Clinical Document Architecture(C-CDA) documents. The SLS identified standard terminology codes by both parsing structured entries and analyzing textual information using Natural Language Processing (NLP). PMID:28269828

Automated Detection of Privacy Sensitive Conditions in C-CDAs: Security Labeling Services at the Department of Veterans Affairs.

PubMed

Bouhaddou, Omar; Davis, Mike; Donahue, Margaret; Mallia, Anthony; Griffin, Stephania; Teal, Jennifer; Nebeker, Jonathan

2016-01-01

Care coordination across healthcare organizations depends upon health information exchange. Various policies and laws govern permissible exchange, particularly when the information includes privacy sensitive conditions. The Department of Veterans Affairs (VA) privacy policy has required either blanket consent or manual sensitivity review prior to exchanging any health information. The VA experience has been an expensive, administratively demanding burden on staffand Veterans alike, particularly for patients without privacy sensitive conditions. Until recently, automatic sensitivity determination has not been feasible. This paper proposes a policy-driven algorithmic approach (Security Labeling Service or SLS) to health information exchange that automatically detects the presence or absence of specific privacy sensitive conditions and then, to only require a Veteran signed consent for release when actually present. The SLS was applied successfully to a sample of real patient Consolidated-Clinical Document Architecture(C-CDA) documents. The SLS identified standard terminology codes by both parsing structured entries and analyzing textual information using Natural Language Processing (NLP).

The Frequency of Reporting Ethical Issues in Human Subject Articles Published in Iranian Medical Journals: 2009-2013.

PubMed

Astaneh, Behrooz; Khani, Parisa

2017-11-10

Researchers should strictly consider the participants' rights. They are required to document such protections as an ethical approval of the study proposal, the obtaining "informed consent", the authors' "conflict of interests", and the source of "financial support" in the published articles. The purpose of this study was to assess the frequency of reporting ethical issues in human subject articles published in Iranian medical journals during 2009-2013. In this cross-sectional study, we randomly reviewed 1460 human subject articles published in Iranian medical journals during 2009-2013 in two Persian and English language groups. Data collection was carried out by assessing articles, focusing on the documentation "ethics committee approval", patients' "informed consent", "financial support", "confidentiality", and "conflict of interest". Of 1460 evaluated articles, 443 (30.3%) reported "ethics committee approval", 686 (47.0%) reported "informed consent", 594 (40.7%) reported "financial support", and 341 (23.4%) reported "conflict of interest". 13% of the articles referred to patients' confidentiality in their text. There was a significant association between these ethical documentations and the year of publication. Articles published in English language journals reported "ethics committee approval", "financial support", and "conflict of interest" significantly more than Persian language journals, but the frequency of "informed consent" was similar. Ethical documentation rate in Iranian medical journals is not up to the expected standards of reputable journals which might be related to a lack of awareness and the education of the authors and the journal's editors. Precise reporting of ethical considerations in medical articles by authors are recommended. It is suggested journals and policymakers pay more attention to reporting this issue while providing standard guidelines in this regard.

Table ronde "linguistique et sociologie du langage" (A Round Table Discussion "Linguistics and Sociology of Language")

ERIC Educational Resources Information Center

Bourdieu, Pierre; And Others

1977-01-01

A panel discussion on sociology and language which leads one to think that a relationship between linguistics and sociolinguistics could be effected if linguists would consent to move toward a situation in which linguistics and sociolinguistics would establish a definite bond with sociology. (Text is in French.) (AMH)

"Operating on a Basis of Student Consent": Peter Medway's Work in "Finding a Language"

ERIC Educational Resources Information Center

Burgess, Tony

2015-01-01

Written nearly 40 years ago, Peter Medway's "Finding a Language" continues to be an arresting read, which offers a powerful vision of what might be possible in education. In this brief introduction, I set the work in context, referring to ideas that Pete engaged with and recalling a little of the times.

Assessing physician-parent communication during emergency medical procedures in children: an observational study in a low-literacy Latino patient population.

PubMed

Dahl, Aaron; Sinha, Madhumita; Rosenberg, David I; Tran, Melissa; Valdez, André

2015-05-01

Effective physician-patient communication is critical to the clinical decision-making process. We studied parental recall of information provided during an informed consent discussion process before performance of emergency medical procedures in a pediatric emergency department of an inner-city hospital with a large bilingual population. Fifty-five parent/child dyads undergoing emergency medical procedures were surveyed prospectively in English/Spanish postprocedure for recall of informed consent information. Exact logistic regression was used to predict the ability to name a risk, benefit, and alternative to the procedure based on a parent's language, education, and acculturation. Among English-speaking parents, there tended to be higher proportions that could name a risk, benefit, or alternative. Our regression models showed overall that the parents with more than a high school education tended to have nearly 5 times higher odds of being able to name a risk. A gap in communication may exist between physicians and patients (or parents of patients) during the consent-taking process, and this gap may be impacted by socio-demographic factors such as language and education level.

Language Policy and the Manufacturing of Consent for Foreign Intervention in Colombia (La política lingüística y la fabricación del consentimiento para la intervención extranjera en Colombia)

ERIC Educational Resources Information Center

Valencia, Marlon

2013-01-01

The present paper provides a critical analysis of Colombia's National Program of Bilingualism focusing on the ideologies behind it, how it facilitates the manufacturing of Colombian citizens' consent for foreign intervention through free trade agreements, and the progressive dismantling of public education. The program is analyzed with a critical…

[Episodic breathlessness: translation and consenting of the international definition using the Delphi method].

PubMed

Simon, S T; Weingärtner, V; Voltz, R; Bausewein, C

2014-10-01

Similar to pain, refractory breathlessness can occur episodically. Episodic Breathlessness is a distressing symptom in patients with advanced life-limiting disease. The lack of a universal definition impedes symptom understanding in clinical practice and effective management, respectively. The aim of the study was to formally consent a German translation of the English definition and terminology of episodic breathlessness. A web-based Delphi survey was conducted with German breathlessness experts (breathlessness working group of Germany's National Guideline (S3) for Palliative Care). Drafts of German-language definitions und terminology were assessed using structured questionnaires by binary rating or rankings, respectively. Optional comments were analysed by content analysis. Consensus was defined by ≥ 70% agreement among participants. In two resulting Delphi-rounds 8/16 (50%) und 11/16 (69%) experts, 30-59 years of age, 50%/55% female, participated. After the second round, consensus was reached for the symptom's description "Atemnotattacke" (73%) and a German-language definition (90%). The terms "vorhersehbar" vs. "unvorhersehbar" were directly consented for the categorization (88%). The formally consented German definition and terminology of episodic breathlessness enable clearer symptom understanding and provide a precise basis for education and research on the symptom and its management also in Germany. Effective management options are warranted to improve quality of life of suffering patients and their relatives. © Georg Thieme Verlag KG Stuttgart · New York.

Seeking consent for research with indigenous communities: a systematic review.

PubMed

Fitzpatrick, Emily F M; Martiniuk, Alexandra L C; D'Antoine, Heather; Oscar, June; Carter, Maureen; Elliott, Elizabeth J

2016-10-22

When conducting research with Indigenous populations consent should be sought from both individual participants and the local community. We aimed to search and summarise the literature about methods for seeking consent for research with Indigenous populations. A systematic literature search was conducted for articles that describe or evaluate the process of seeking informed consent for research with Indigenous participants. Guidelines for ethical research and for seeking consent with Indigenous people are also included in our review. Of 1447 articles found 1391 were excluded (duplicates, irrelevant, not in English); 56 were relevant and included. Articles were categorised into original research that evaluated the consent process (n = 5) or publications detailing the process of seeking consent (n = 13) and guidelines for ethical research (n = 38). Guidelines were categorised into international (n = 8); national (n = 20) and state/regional/local guidelines (n = 10). In five studies based in Australia, Canada and The United States of America the consent process with Indigenous people was objectively evaluated. In 13 other studies interpreters, voice recording, videos, pictures, flipcharts and "plain language" forms were used to assist in seeking consent but these processes were not evaluated. Some Indigenous organisations provide examples of community-designed resources for seeking consent and describe methods of community engagement, but none are evaluated. International, national and local ethical guidelines stress the importance of upholding Indigenous values but fail to specify methods for engaging communities or obtaining individual consent. In the 'Grey literature' concerns about the consent process are identified but no solutions are offered. Consultation with Indigenous communities is needed to determine how consent should be sought from the community and the individual, and how to evaluate this process.

Doctors' perspectives of informed consent for non-emergency surgical procedures: a qualitative interview study.

PubMed

Wood, Fiona; Martin, Sean Michael; Carson-Stevens, Andrew; Elwyn, Glyn; Precious, Elizabeth; Kinnersley, Paul

2016-06-01

The need to involve patients more in decisions about their care, the ethical imperative and concerns about ligation and complaints has highlighted the issue of informed consent and how it is obtained. In order for a patient to make an informed decision about their treatment, they need appropriate discussion of the risks and benefits of the treatment. To explore doctors' perspectives of gaining informed consent for routine surgical procedures. Qualitative study using semi-structured interviews selected by purposive sampling. Data were analysed thematically. Twenty doctors in two teaching hospitals in the UK. Doctors described that while consent could be taken over a series of consultations, it was common for consent to be taken immediately prior to surgery. Juniors were often taking consent when they were unfamiliar with the procedure. Doctors used a range of communication techniques to inform patients about the procedure and its risks including quantifying risks, personalizing risk, simplification of language and use of drawings. Barriers to effective consent taking were reported to be shortage of time, clinician inexperience and patients' reluctance to be involved. Current consent processes do not appear to be ideal for many doctors. In particular, junior doctors are often not confident taking consent for surgical procedures and require more support to undertake this task. This might include written information for junior staff, observation by senior colleagues when undertaking the task and ward-based communication skills teaching on consent taking. © 2014 John Wiley & Sons Ltd.

Reading Level and Comprehension of Research Consent Forms: An Integrative Review.

PubMed

Foe, Gabriella; Larson, Elaine L

2016-02-01

Consent forms continue to be at a higher reading level than the recommended sixth to eighth grade, making it difficult for participants to comprehend information before enrolling in research. To assess and address the extent of the problem regarding the level of literacy of consent forms and update previously published reports, we conducted an integrative literature review of English language research published between January 1, 2000, and December 31, 2013; 35 descriptive and eight intervention studies met inclusion criteria. Results confirmed that developing forms at eighth-grade level was attainable though not practiced. It was found that risks of participation was the section most poorly understood. There was also a lack of consensus regarding the most effective method to increase comprehension. Further research using standardized tools is needed to determine the best approach for improving consent forms and processes. © The Author(s) 2016.

Protecting Adolescents' Right to Seek Treatment for Sexually Transmitted Diseases without Parental Consent: The Arizona Experience with Senate Bill 1309

PubMed Central

Goodwin, Kimberly D.; Taylor, Melanie M.; Brown, Erin C. Fuse; Winscott, Michelle; Scanlon, Megan; Hodge, James G.; Mickey, Tom; England, Bob

2012-01-01

In 2010, Senate Bill 1309 included language to repeal an existing Arizona law that enables minors younger than 18 years of age to seek diagnosis and treatment of sexually transmitted diseases (STDs) without parental consent. Numerous implications were identified that would have stemmed from parental consent provisions originally proffered in Senate Bill 1309. These implications included diminished access to essential health services among minors, exacerbated existing health disparities, increased health-care spending costs, and thwarted efforts to curb the spread of STDs. Lastly, minors would have been deprived of existing privacy protections concerning their STD-related medical information. This case study describes how collaborative advocacy efforts resulted in the successful amendment of Senate Bill 1309 to avert the negative sexual and reproductive health outcomes among adolescents stemming from the potential repeal of their existing legal right to seek STD treatment without parental consent. PMID:22547855

Protecting adolescents' right to seek treatment for sexually transmitted diseases without parental consent: the Arizona experience with Senate Bill 1309.

PubMed

Goodwin, Kimberly D; Taylor, Melanie M; Brown, Erin C Fuse; Winscott, Michelle; Scanlon, Megan; Hodge, James G; Mickey, Tom; England, Bob

2012-01-01

In 2010, Senate Bill 1309 included language to repeal an existing Arizona law that enables minors younger than 18 years of age to seek diagnosis and treatment of sexually transmitted diseases (STDs) without parental consent. Numerous implications were identified that would have stemmed from parental consent provisions originally proffered in Senate Bill 1309. These implications included diminished access to essential health services among minors, exacerbated existing health disparities, increased health-care spending costs, and thwarted efforts to curb the spread of STDs. Lastly, minors would have been deprived of existing privacy protections concerning their STD-related medical information. This case study describes how collaborative advocacy efforts resulted in the successful amendment of Senate Bill 1309 to avert the negative sexual and reproductive health outcomes among adolescents stemming from the potential repeal of their existing legal right to seek STD treatment without parental consent.

Procedures of recruiting, obtaining informed consent, and compensating research participants in Qatar: findings from a qualitative investigation.

PubMed

Killawi, Amal; Khidir, Amal; Elnashar, Maha; Abdelrahim, Huda; Hammoud, Maya; Elliott, Heather; Thurston, Michelle; Asad, Humna; Al-Khal, Abdul Latif; Fetters, Michael D

2014-02-04

Very few researchers have reported on procedures of recruiting, obtaining informed consent, and compensating participants in health research in the Arabian Gulf Region. Empirical research can inform the debate about whether to adjust these procedures for culturally diverse settings. Our objective was to delineate procedures related to recruiting, obtaining informed consent, and compensating health research participants in the extremely high-density multicultural setting of Qatar. During a multistage mixed methods project, field observations and qualitative interviews were conducted in a general medicine clinic of a major medical center in Qatar. Participants were chosen based on gender, age, literacy, and preferred language, i.e., Arabic, English, Hindi and Urdu. Qualitative analysis identified themes about recruitment, informed consent, compensation, and other research procedures. A total of 153 individuals were approached and 84 enrolled; the latter showed a diverse age range (18 to 75 years); varied language representation: Arabic (n = 24), English (n = 20), Hindi (n = 20), and Urdu (n = 20); and balanced gender distribution: women (n = 43) and men (n = 41). Primary reasons for 30 declinations included concern about interview length and recording. The study achieved a 74% participation rate. Qualitative analytics revealed key themes about hesitation to participate, decisions about participation with family members as well as discussions with them as "incidental research participants", the informed consent process, privacy and gender rules of the interview environment, reactions to member checking and compensation, and motivation for participating. Vulnerability emerged as a recurring issue throughout the process among a minority of participants. This study from Qatar is the first to provide empirical data on recruitment, informed consent, compensation and other research procedures in a general adult population in the Middle East and Arabian Gulf. This investigation illustrates how potential research participants perceive research participation. Fundamentally, Western ethical research principles were applicable, but required flexibility and culturally informed adaptations.

Alternatives to project-specific consent for access to personal information for health research: Insights from a public dialogue

PubMed Central

Willison, Donald J; Swinton, Marilyn; Schwartz, Lisa; Abelson, Julia; Charles, Cathy; Northrup, David; Cheng, Ji; Thabane, Lehana

2008-01-01

Background The role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues. Methods We conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly. Results Broad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research. Conclusion Because no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research. PMID:19019239

Challenges and strategies for conducting sensitive research with an Arab American population.

PubMed

Timraz, Shahrazad M; Alhasanat, Dalia I; Albdour, Maha M; Lewin, Linda; Giurgescu, Carmen; Kavanaugh, Karen

2017-02-01

Recruiting minority groups such as Arab Americans (Ar-Am) for research studies has been challenging. To date no studies were found that explicitly addressed challenges to recruit Ar-Am for sensitive research. The purpose of this article is to present the challenges across three pilot studies that involved Ar-Am samples and the strategies that were implemented to overcome these challenges. The challenges faced with conducting studies with Ar-Am included difficulty for participants to express emotions, influence of male/female authority to consent for the study, lack of trust to disclose sensitive information, language barrier, and slow recruitment. Having bilingual female recruiters of Arabic descent, engaging the women's family members in the consent process, and addressing the sensitive topics in culturally appropriate language were effective strategies to overcome these challenges. These strategies might be helpful for other researchers who recruit Ar-Am for sensitive research. Copyright © 2016 Elsevier Inc. All rights reserved.

Developing a simplified consent form for biobanking.

PubMed

Beskow, Laura M; Friedman, Joëlle Y; Hardy, N Chantelle; Lin, Li; Weinfurt, Kevin P

2010-10-08

Consent forms have lengthened over time and become harder for participants to understand. We sought to demonstrate the feasibility of creating a simplified consent form for biobanking that comprises the minimum information necessary to meet ethical and regulatory requirements. We then gathered preliminary data concerning its content from hypothetical biobank participants. We followed basic principles of plain-language writing and incorporated into a 2-page form (not including the signature page) those elements of information required by federal regulations and recommended by best practice guidelines for biobanking. We then recruited diabetes patients from community-based practices and randomized half (n = 56) to read the 2-page form, first on paper and then a second time on a tablet computer. Participants were encouraged to use "More information" buttons on the electronic version whenever they had questions or desired further information. These buttons led to a series of "Frequently Asked Questions" (FAQs) that contained additional detailed information. Participants were asked to identify specific sentences in the FAQs they thought would be important if they were considering taking part in a biorepository. On average, participants identified 7 FAQ sentences as important (mean 6.6, SD 14.7, range: 0-71). No one sentence was highlighted by a majority of participants; further, 34 (60.7%) participants did not highlight any FAQ sentences. Our preliminary findings suggest that our 2-page form contains the information that most prospective participants identify as important. Combining simplified forms with supplemental material for those participants who desire more information could help minimize consent form length and complexity, allowing the most substantively material information to be better highlighted and enabling potential participants to read the form and ask questions more effectively.

College students and sexual consent: unique insights.

PubMed

Jozkowski, Kristen N; Peterson, Zoë D

2013-01-01

Sexual assault continues to be a salient health concern, especially among college women. Because assault is often defined in terms of consent, prevention efforts hinge on promoting the definition and the obtainment of consent as a mechanism to reduce assault. Despite the focus on consent promotion, research specifically examining consent in general and among college students specifically is limited. College students (n = 185) were recruited to participate in an open-ended survey in which they were asked to report how they indicated consent and interpreted their partners' consent to engage in a range of sexual behaviors. Content analysis was utilized to qualitatively analyze responses. In the current study, data were assessed for emerging themes across all items. In examining participants' responses, four distinct themes emerged: (a) endorsement of the traditional sexual script; (b) women are responsible for performing oral sex; (c) men's consent to sex can be aggressive; and (d) men utilize deception to obtain consent to sex. Findings suggest that men are conceptualized as sexual initiators and women as sexual gatekeepers, and that men's sexual pleasure is primary whereas women's experience of pleasure is secondary. Findings articulate the need for more pointed research aimed at assessing sexual consent among college students.

Policies of Academic Medical Centers for Disclosing Conflicts of Interest to Potential Research Participants

PubMed Central

Weinfurt, Kevin P.; Dinan, Michaela A.; Allsbrook, Jennifer S.; Friedman, Joëlle Y.; Hall, Mark A.; Schulman, Kevin A.; Sugarman, Jeremy

2007-01-01

Many professional organizations and governmental bodies recommend disclosing financial conflicts of interest to potential research participants. Three possible goals of such disclosures are to inform the decision making of potential research participants, to protect against liability, and to deter conflicts of interest. We reviewed US academic medical centers' policies regarding the disclosure of conflicts of interest in research. Forty-eight percent mentioned disclosing conflicts to potential research participants. Of those, 58% included verbatim language that could be used in informed consent documents. Considerable variability exists concerning the specific information that should be disclosed. Most of the institutions' policies are consistent with the goal of protection from legal liability. PMID:16436571

Facilitating enrollment in a Cancer Registry through modified consent procedures: a pilot study.

PubMed

Mazanec, Susan; Daly, Barbara; Meropol, Neal J; Step, Mary

2012-12-01

Research registries are increasingly important in medical research and are essential to the mission of cancer centers. However, designing enrollment and data collection procedures that are consistent with ethical norms and regulatory requirements yet are efficient and cost effective is a major challenge. Current standard consent forms can be a barrier to enrollment because of their length, multiple components, and technical language. We pilot tested an IRB-approved registry booklet and simplified one-page, tiered consent form, allowing for choice of extent of participation. The booklet was mailed to patients with breast cancer as part of their routine information packet prior to the first clinic appointment. A research nurse met with 27 patients at initial treatment to review the booklet, answer questions, obtain informed consent, and collect quality of life data. The consent rate was 78% with 21 patients enrolling in the study. Twelve of the 21 patients (57%) did not read the booklet prior to the visit. The 9 patients (43%) who had read the booklet prior to arrival found it easy to understand. The multi-stage, simplified consent process and data collection were acceptable to these patients and readily integrated into clinical operations. An easy-to-read registry booklet may be an effective guide for discussion, but in-person consent procedures and further testing of the approach are required.

Informed consent in paediatric critical care research--a South African perspective.

PubMed

Morrow, Brenda M; Argent, Andrew C; Kling, Sharon

2015-09-09

Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa. Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both child participant and parent. Where appropriate, alternatives to prospective informed consent should be considered to ensure that important paediatric critical care research can be undertaken in South Africa, whilst being cognisant of research risk. This document could provide a basis for debate on consent options in paediatric critical care research and contribute to efforts to advocate for South African law reform.

Completion of hand-written surgical consent forms is frequently suboptimal and could be improved by using electronically generated, procedure-specific forms.

PubMed

St John, E R; Scott, A J; Irvine, T E; Pakzad, F; Leff, D R; Layer, G T

2017-08-01

Completion of hand-written consent forms for surgical procedures may suffer from missing or inaccurate information, poor legibility and high variability. We audited the completion of hand-written consent forms and trialled a web-based application to generate modifiable, procedure-specific consent forms. The investigation comprised two phases at separate UK hospitals. In phase one, the completion of individual responses in hand-written consent forms for a variety of procedures were prospectively audited. Responses were categorised into three domains (patient details, procedure details and patient sign-off) that were considered "failed" if a contained element was not correct and legible. Phase two was confined to a breast surgical unit where hand-written consent forms were assessed as for phase one and interrogated for missing complications by two independent experts. An electronic consent platform was introduced and electronically-produced consent forms assessed. In phase one, 99 hand-written consent forms were assessed and the domain failure rates were: patient details 10%; procedure details 30%; and patient sign-off 27%. Laparoscopic cholecystectomy was the most common procedure (7/99) but there was significant variability in the documentation of complications: 12 in total, a median of 6 and a range of 2-9. In phase two, 44% (27/61) of hand-written forms were missing essential complications. There were no domain failures amongst 29 electronically-produced consent forms and no variability in the documentation of potential complications. Completion of hand-written consent forms suffers from wide variation and is frequently suboptimal. Electronically-produced, procedure-specific consent forms can improve the quality and consistency of consent documentation. Copyright © 2015 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

Obtaining subjects' consent to publish identifying personal information: current practices and identifying potential issues.

PubMed

Yoshida, Akiko; Dowa, Yuri; Murakami, Hiromi; Kosugi, Shinji

2013-11-25

In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed have not yet been fully examined. This study was conducted to identify potential issues surrounding consent to publish identifying personal information. Content analysis was carried out on instructions for authors and consent forms developed by academic journals in four fields (as classified by Journal Citation Reports): medicine general and internal, genetics and heredity, pediatrics, and psychiatry. An online questionnaire survey of editors working for journals that require the submission of consent forms was also conducted. Instructions for authors were reviewed for 491 academic journals (132 for medicine general and internal, 147 for genetics and heredity, 100 for pediatrics, and 112 for psychiatry). Approximately 40% (203: 74 for medicine general and internal, 31 for genetics and heredity, 58 for pediatrics, and 40 for psychiatry) stated that subject consent was necessary. The submission of consent forms was required by 30% (154) of the journals studied, and 10% (50) provided their own consent forms for authors to use. Two journals mentioned that the possible effects of publication on subjects should be considered. Many journal consent forms mentioned the difficulties in ensuring complete anonymity of subjects, but few addressed the study objective, the subjects' right to refuse consent and the withdrawal of consent. The main reason for requiring the submission of consent forms was to confirm that consent had been obtained. Approximately 40% of journals required subject consent to be obtained. However, differences were observed depending on the fields. Specific considerations were not always documented. There is a need to address issues around the study objective, subjects' right to refuse consent and the withdrawal of consent. Whether responsibility for ensuring that the consent form has been signed lies with publishers also needs to be discussed.

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

Building and evaluating an ontology-based tool for reasoning about consent permission

PubMed Central

Grando, Adela; Schwab, Richard

2013-01-01

Given the lack of mechanisms for specifying, sharing and checking the compliance of consent permissions, we focus on building and testing novel approaches to address this gap. In our previous work, we introduced a “permission ontology” to capture in a precise, machine-interpretable form informed consent permissions in research studies. Here we explain how we built and evaluated a framework for specifying subject’s permissions and checking researcher’s resource request in compliance with those permissions. The framework is proposed as an extension of an existing policy engine based on the eXtensible Access Control Markup Language (XACML), incorporating ontology-based reasoning. The framework is evaluated in the context of the UCSD Moores Cancer Center biorepository, modeling permissions from an informed consent and a HIPAA form. The resulting permission ontology and mechanisms to check subject’s permission are implementation and institution independent, and therefore offer the potential to be reusable in other biorepositories and data warehouses. PMID:24551354

A universal exchange language for healthcare.

PubMed

Robson, Barry; Caruso, Thomas P

2013-01-01

We have defined a Universal Exchange Language (UEL) for healthcare that takes a green field approach to the development of a novel "XML-like" language. We consider here what given a free hand might mean: a UEL that incorporates an advanced mathematical foundation that uses Dirac's notation and algebra. For consented and public information, it allows probabilistic inference from UEL semantic web triplet tags. But also it is possible to use similar thinking to maximize the security and analytic characteristics of private health data by disaggregating or "shredding" it. Both are scalable to millions of records that could be spread across the Internet.

Using Google AdWords for international multilingual recruitment to health research websites.

PubMed

Gross, Margaret S; Liu, Nancy H; Contreras, Omar; Muñoz, Ricardo F; Leykin, Yan

2014-01-20

Google AdWords, the placement of sponsored links in Google search results, is a potent method of recruitment to Internet-based health studies and interventions. However, the performance of Google AdWords varies considerably depending on the language and the location of the target audience. Our goal was to describe differences in AdWords performance when recruiting participants to the same study conducted in four languages and to determine whether AdWords campaigns can be optimized in order to increase recruitment while decreasing costs. Google AdWords were used to recruit participants to the Mood Screener, a multilingual online depression screening tool available in English, Russian, Spanish, and Chinese. Two distinct recruitment periods are described: (1) "Unmanaged", a 6-month period in which ads were allowed to run using only the AdWords tool itself, with no human intervention, and (2) "Managed", a separate 7-week period during which we systematically sought to optimize our recruitment campaigns. During 6 months of unmanaged recruitment, our ads were shown over 1.3 million times, resulting in over 60,000 site visits. The average click-through rate (ratio of ads clicked to ads displayed) varied from 1.86% for Chinese ads to 8.48% for Russian ads, as did the average cost-per-click (from US $0.20 for Chinese ads to US $0.50 for English ads). Although Chinese speakers' click-through rate was lowest, their rate of consenting to participate was the highest, at 3.62%, with English speakers exhibiting the lowest consent rate (0.97%). The conversion cost (cost to recruit a consenting participant) varied from US $10.80 for Russian speakers to US $51.88 for English speakers. During the 7 weeks of "managed" recruitment, we attempted to improve AdWords' performance in regards to the consent rate and cost by systematically deleting underperforming ads and adjusting keywords. We were able to increase the number of people who consent after coming to the site by 91.8% while also decreasing per-consent cost by 23.3%. Our results illustrate the need to linguistically and culturally adapt Google AdWords campaigns and to manage them carefully to ensure the most cost-effective results.

What English Language Learners Have to Say about NCLB Testing

ERIC Educational Resources Information Center

Yee, Mary

2015-01-01

This study constitutes the secondary analysis of data collected as part of classroom instruction in a prior practitioner inquiry study. Consequently, IRB approval, parental consent, and participant assent for the present study were obtained after the conclusion of the original study.

Obtaining subjects’ consent to publish identifying personal information: current practices and identifying potential issues

PubMed Central

2013-01-01

Background In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed have not yet been fully examined. This study was conducted to identify potential issues surrounding consent to publish identifying personal information. Methods Content analysis was carried out on instructions for authors and consent forms developed by academic journals in four fields (as classified by Journal Citation Reports): medicine general and internal, genetics and heredity, pediatrics, and psychiatry. An online questionnaire survey of editors working for journals that require the submission of consent forms was also conducted. Results Instructions for authors were reviewed for 491 academic journals (132 for medicine general and internal, 147 for genetics and heredity, 100 for pediatrics, and 112 for psychiatry). Approximately 40% (203: 74 for medicine general and internal, 31 for genetics and heredity, 58 for pediatrics, and 40 for psychiatry) stated that subject consent was necessary. The submission of consent forms was required by 30% (154) of the journals studied, and 10% (50) provided their own consent forms for authors to use. Two journals mentioned that the possible effects of publication on subjects should be considered. Many journal consent forms mentioned the difficulties in ensuring complete anonymity of subjects, but few addressed the study objective, the subjects’ right to refuse consent and the withdrawal of consent. The main reason for requiring the submission of consent forms was to confirm that consent had been obtained. Conclusion Approximately 40% of journals required subject consent to be obtained. However, differences were observed depending on the fields. Specific considerations were not always documented. There is a need to address issues around the study objective, subjects’ right to refuse consent and the withdrawal of consent. Whether responsibility for ensuring that the consent form has been signed lies with publishers also needs to be discussed. PMID:24267590

The acceptability of conducting data linkage research without obtaining consent: lay people's views and justifications.

PubMed

Xafis, Vicki

2015-11-17

A key ethical issue arising in data linkage research relates to consent requirements. Patients' consent preferences in the context of health research have been explored but their consent preferences regarding data linkage specifically have been under-explored. In addition, the views on data linkage are often those of patient groups. As a result, little is known about lay people's views and their preferences about consent requirements in the context of data linkage. This study explores lay people's views and justifications regarding the acceptability of conducting data linkage research without obtaining consent. A qualitative study explored lay people's views regarding consent requirements in data linkage via four hypothetical data linkage scenarios of increasing complexity. Prior to considering the scenarios, participants were provided with information regarding best practice data linkage processes via discussion and a diagrammatic representation of the process. Lay people were able to understand the intricate processes involved in data linkage and the key protections afforded within a short amount of time. They were supportive of data linkage research and, on the whole, believed it should be conducted without consent provided a data linkage organization de-identifies the data used so that researchers do not handle identifiable data. Many thought that de-identified data holds a different status to identifiable data and should be used without specific consent in research that aims to benefit society. In weighing up conflicting values and interests, participants shifted consent preferences before arriving at their final consent preference for each scenario and provided justifications for their choices. They considered the protection of people's information, societal benefits, and the nature and constraints of research and recognized that these need to be balanced. With some exposure to the features of data linkage, lay people have the capacity to understand the processes sufficiently in order to consider ethical issues associated with consent preferences. Shifts in views reveal the complexity of such decisions. While privacy protection remained an important consideration for most participants, adequate protection measures adopted in best practice data linkage were viewed by most as protection enough for data linkage to proceed without specific individual consent.

Using iterative learning to improve understanding during the informed consent process in a South African psychiatric genomics study.

PubMed

Campbell, Megan M; Susser, Ezra; Mall, Sumaya; Mqulwana, Sibonile G; Mndini, Michael M; Ntola, Odwa A; Nagdee, Mohamed; Zingela, Zukiswa; Van Wyk, Stephanus; Stein, Dan J

2017-01-01

Obtaining informed consent is a great challenge in global health research. There is a need for tools that can screen for and improve potential research participants' understanding of the research study at the time of recruitment. Limited empirical research has been conducted in low and middle income countries, evaluating informed consent processes in genomics research. We sought to investigate the quality of informed consent obtained in a South African psychiatric genomics study. A Xhosa language version of the University of California, San Diego Brief Assessment of Capacity to Consent Questionnaire (UBACC) was used to screen for capacity to consent and improve understanding through iterative learning in a sample of 528 Xhosa people with schizophrenia and 528 controls. We address two questions: firstly, whether research participants' understanding of the research study improved through iterative learning; and secondly, what were predictors for better understanding of the research study at the initial screening? During screening 290 (55%) cases and 172 (33%) controls scored below the 14.5 cut-off for acceptable understanding of the research study elements, however after iterative learning only 38 (7%) cases and 13 (2.5%) controls continued to score below this cut-off. Significant variables associated with increased understanding of the consent included the psychiatric nurse recruiter conducting the consent screening, higher participant level of education, and being a control. The UBACC proved an effective tool to improve understanding of research study elements during consent, for both cases and controls. The tool holds utility for complex studies such as those involving genomics, where iterative learning can be used to make significant improvements in understanding of research study elements. The UBACC may be particularly important in groups with severe mental illness and lower education levels. Study recruiters play a significant role in managing the quality of the informed consent process.

Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review.

PubMed

Schenker, Yael; Fernandez, Alicia; Sudore, Rebecca; Schillinger, Dean

2011-01-01

Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. . To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources. A systematic literature search of English-language articles in MEDLINE (1949-2008) and EMBASE (1974-2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection. Randomized controlled trials and controlled trials with nonrandom allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction. Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis. Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations. Many studies failed to include adequate description of the study population, and outcome measures varied widely. . A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: A Systematic Review

PubMed Central

Schenker, Yael; Fernandez, Alicia; Sudore, Rebecca; Schillinger, Dean

2017-01-01

Background Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. Purpose To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources A systematic literature search of English-language articles in MEDLINE (1949–2008) and EMBASE (1974–2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection Randomized controlled trials and controlled trials with non-random allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations Many studies failed to include adequate description of the study population, and outcome measures varied widely. Conclusions A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations. PMID:20357225

16 CFR 312.5 - Parental consent.

Code of Federal Regulations, 2014 CFR

2014-01-01

... available technology, to ensure that the person providing consent is the child's parent. (2) Existing... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... children, including consent to any material change in the collection, use, or disclosure practices to which...

16 CFR 312.5 - Parental consent.

Code of Federal Regulations, 2013 CFR

2013-01-01

... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

16 CFR 312.5 - Parental consent.

Code of Federal Regulations, 2012 CFR

2012-01-01

... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

16 CFR 312.5 - Parental consent.

Code of Federal Regulations, 2011 CFR

2011-01-01

... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

16 CFR 312.5 - Parental consent.

Code of Federal Regulations, 2010 CFR

2010-01-01

... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

The importance of purpose: moving beyond consent in the societal use of personal health information.

PubMed

Grande, David; Mitra, Nandita; Shah, Anand; Wan, Fei; Asch, David A

2014-12-16

Adoption of electronic health record systems has increased the availability of patient-level electronic health information. To examine public support for secondary uses of electronic health information under different consent arrangements. National experimental survey to examine perceptions of uses of electronic health information according to patient consent (obtained vs. not obtained), use (research vs. marketing), and framing of the findings (abstract description without results vs. specific results). Nationally representative survey. 3064 African American, Hispanic, and non-Hispanic white persons (response rate, 65%). Appropriateness of health information use described in vignettes on a scale of 1 (not at all appropriate) to 10 (very appropriate). Mean ratings ranged from a low of 3.81 for a marketing use when consent was not obtained and specific results were presented to a high of 7.06 for a research use when consent was obtained and specific results were presented. Participants rated scenarios in which consent was obtained as more appropriate than when consent was not obtained (difference, 1.01 [95% CI, 0.69 to 1.34]; P<0.001). Participants rated scenarios in which the use was marketing as less appropriate than when the use was research (difference, -2.03 [CI, -2.27 to -1.78]; P<0.001). Unconsented research uses were rated as more appropriate than consented marketing uses (5.65 vs. 4.52; difference, 1.13 [CI, 0.87 to 1.39]). Participants rated hypothetical scenarios. Results could be vulnerable to nonresponse bias despite the high response rate. Although approaches to health information sharing emphasize consent, public opinion also emphasizes purpose, which suggests a need to focus more attention on the social value of information use. National Human Genome Research Institute.

Satisfying the needs of Japanese cancer patients: a comparative study of detailed and standard informed consent documents.

PubMed

Sato, Keiko; Watanabe, Toru; Katsumata, Noriyuki; Sato, Tosiya; Ohashi, Yasuo

2014-02-01

Simplified informed consent forms have been successful in improving patient satisfaction and decreasing patient anxiety. However, unsolved problems remain about whether these documents improve comprehension and satisfaction of patients with standard literacy skills. s To investigate whether a detailed consent form explaining the key elements of informed consent, in comparison to a standard consent form, would increase the comprehension and satisfaction of adult cancer patients. Patients who were eligible for the National Surgical Adjuvant Study of Breast Cancer (protocol 01(N-SAS/BC-01)) were randomly selected to receive one of the following four versions: detailed document with graphics, detailed document without graphics, standard document with graphics, and standard document without graphics. The forms were written in plain language from the patients' point of view. A total of 85 patients were administered questionnaires via interview to assess levels of comprehension, satisfaction, and anxiety. Patients demonstrated a strong understanding of information regarding treatment and research. Patient comprehension did not differ significantly between the detailed document arms and the standard document arms. Patient satisfaction level increased according to the amount of information presented in the consent form; most patients preferred the detailed document with graphics. Anxiety and accrual rates in the parent study were not affected by informed consent procedures. Findings were limited to adults who had standard literacy skills and may not be generalizable to a population with lower literacy. Informed consent can be a significant experience for a population with standard literacy skills, as long as the document is easily comprehensible. Such information should be provided in a format that corresponds with patient needs, education levels, and preferences.

The Picture Talk Project: Starting a Conversation with Community Leaders on Research with Remote Aboriginal Communities of Australia.

PubMed

Fitzpatrick, E F M; Macdonald, G; Martiniuk, A L C; D'Antoine, H; Oscar, J; Carter, M; Lawford, T; Elliott, E J

2017-05-11

Researchers are required to seek consent from Indigenous communities prior to conducting research but there is inadequate information about how Indigenous people understand and become fully engaged with this consent process. Few studies evaluate the preference or understanding of the consent process for research with Indigenous populations. Lack of informed consent can impact on research findings. The Picture Talk Project was initiated with senior Aboriginal leaders of the Fitzroy Valley community situated in the far north of Western Australia. Aboriginal people were interviewed about their understanding and experiences of research and consent processes. Transcripts were analysed using NVivo10 software with an integrated method of inductive and deductive coding and based in grounded theory. Local Aboriginal interpreters validated coding. Major themes were defined and supporting quotes sourced. Interviews with Aboriginal leaders (n = 20) were facilitated by a local Aboriginal Community Navigator who could interpret if necessary and provide cultural guidance. Participants were from all four major local language groups of the Fitzroy Valley; aged 31 years and above; and half were male. Themes emerging from these discussions included Research-finding knowledge; Being respectful of Aboriginal people, Working on country, and Being flexible with time; Working together with good communication; Reciprocity-two-way learning; and Reaching consent. The project revealed how much more there is to be learned about how research with remote Aboriginal communities should be conducted such that it is both culturally respectful and, importantly, meaningful for participants. We identify important elements in community consultation about research and seeking consent.

The use of Spanish language skills by physicians and nurses: policy implications for teaching and testing.

PubMed

Diamond, Lisa C; Tuot, Delphine S; Karliner, Leah S

2012-01-01

Language barriers present a substantial communication challenge in the hospital setting. To describe how clinicians with various levels of Spanish language proficiency work with interpreters or their own Spanish skills in common clinical scenarios. Survey of physicians and nurses who report ever speaking Spanish with patients on a general medicine hospital floor. Spanish proficiency rated on a 5-point scale, self-reported use of specific strategies (own Spanish skills, professional or ad-hoc interpreters) to overcome the language barrier. Sixty-eight physicians and 65 nurses participated. Physicians with low-level Spanish proficiency reported frequent use of ad-hoc interpreters for all information-based scenarios, except pre-rounding in the morning when most reported using their own Spanish skills. For difficult conversations and procedural consent, most used professional interpreters. Comparatively, physicians with medium proficiency reported higher rates of using their own Spanish skills for information-based scenarios, lower rates of professional interpreter use, and little use of ad-hoc interpreters. They rarely used their own Spanish skills or ad-hoc interpreters for difficult conversations. Physicians with high-level Spanish proficiency almost uniformly reported using their own Spanish skills. The majority (82%) of nurses had low-level Spanish proficiency, and frequently worked with professional interpreters for educating patients, but more often used ad hoc interpreters and their own Spanish skills for information-based scenarios, including medication administration. Physicians and nurses with limited Spanish proficiency use these skills, even in important clinical circumstances in the hospital. Health-care organizations should evaluate clinicians' non-English language proficiency and set policies about use of language skills in clinical care.

Active choice but not too active: Public perspectives on biobank consent models

PubMed Central

Simon, Christian M.; L’Heureux, Jamie; Murray, Jeffrey C.; Winokur, Patricia; Weiner, George; Newbury, Elizabeth; Shinkunas, Laura; Zimmerman, Bridget

2013-01-01

Purpose Despite important recent work, US public attitudes toward specific biobank consent models are not well understood. Public opinion data can help shape efforts to develop ethically sound and publicly trusted mechanisms for informing and consenting prospective biobank donors. The purpose of this study was to explore public perspectives toward a range of consent models currently being used or considered for use among comprehensive US biobanks. Methods The study used an exploratory mixed-methods design, using focus groups and telephone surveys. Eligible participants were English-speaking residents in the catchment area of a comprehensive biobank being developed at the University of Iowa. Results Forty-eight participants in seven focus groups and 751 survey participants were recruited. Biobanks were unfamiliar to almost all study participants but were seen as valuable resources. Most focus group (63%) and survey (67%) participants preferred a prospective opt-in over an opt-out consent approach. Broad, research-unspecific consent was preferred over categorical and study-specific consent models for purposes of approving future research use. Conclusion Many individuals may want to make an active and informed choice at the point of being approached for biobank participation but are prepared to consent broadly to future research use and to forego additional choices as a result. PMID:21555942

32 CFR 935.40 - Criminal offenses.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., device, or any matter containing obscene language, that tends to corrupt morals; (e) Make any obscene or...) Lodge or sleep in any place without the consent of the person in legal possession of that place; (p... firearm, whether operated by air, gas, spring, or otherwise, or explosive device, including fireworks...

32 CFR 935.40 - Criminal offenses.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., device, or any matter containing obscene language, that tends to corrupt morals; (e) Make any obscene or...) Lodge or sleep in any place without the consent of the person in legal possession of that place; (p... firearm, whether operated by air, gas, spring, or otherwise, or explosive device, including fireworks...

The Accommodation of Some Historic Determinants in a Culturally Pluralistic Society.

ERIC Educational Resources Information Center

Olivier, S. F.

Ways in which pluralistic communities can exist in peace and harmony through consent rather than force are discussed. Historical and sociological determinants, which should be considered when coexistence is sought, are politics, color, religion, nationalism, national aspirations, language, employment, and educational systems. Problems which arise…

The changing face of informed surgical consent.

PubMed

Oosthuizen, J C; Burns, P; Timon, C

2012-03-01

To determine whether procedure-specific brochures improve patients' pre-operative knowledge, to determine the amount of information expected by patients during the consenting process, and to determine whether the recently proposed 'Request for Treatment' consenting process is viable on a large scale. A prospective, questionnaire-based study of 100 patients admitted for selected, elective surgical procedures. In total, 99 per cent of patients were satisfied with the information received in the out-patient department, regarding the proposed procedure. However, 38 per cent were unable to correctly state the nature of the surgery or specific procedure they were scheduled to undergo. Although the vast majority of patients were able to state the intended benefits to be gained from the procedure, only 54 per cent were able to list at least one potential complication, and 80 per cent indicated that they wished to be informed about all potential complications, even if these occurred in less than 1 per cent of cases. The introduction of procedure-specific brochures improved patients' pre-operative knowledge. Although the failings of current consenting practice are clear, the Request for Treatment consenting process would not appear to be a viable alternative because of the large number of patients unable to accurately recall the nature of the proposed surgery or potential complications, following consent counselling.

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Informed consent. 441.257 Section 441.257 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations § 441.257 Informed consent. (a) Informing...

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Informed consent. 441.257 Section 441.257 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations § 441.257 Informed consent. (a) Informing...

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Informed consent. 441.257 Section 441.257 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations § 441.257 Informed consent. (a) Informing...

Using Google AdWords for International Multilingual Recruitment to Health Research Websites

PubMed Central

Gross, Margaret S; Liu, Nancy H; Contreras, Omar; Muñoz, Ricardo F

2014-01-01

Background Google AdWords, the placement of sponsored links in Google search results, is a potent method of recruitment to Internet-based health studies and interventions. However, the performance of Google AdWords varies considerably depending on the language and the location of the target audience. Objective Our goal was to describe differences in AdWords performance when recruiting participants to the same study conducted in four languages and to determine whether AdWords campaigns can be optimized in order to increase recruitment while decreasing costs. Methods Google AdWords were used to recruit participants to the Mood Screener, a multilingual online depression screening tool available in English, Russian, Spanish, and Chinese. Two distinct recruitment periods are described: (1) “Unmanaged”, a 6-month period in which ads were allowed to run using only the AdWords tool itself, with no human intervention, and (2) “Managed”, a separate 7-week period during which we systematically sought to optimize our recruitment campaigns. Results During 6 months of unmanaged recruitment, our ads were shown over 1.3 million times, resulting in over 60,000 site visits. The average click-through rate (ratio of ads clicked to ads displayed) varied from 1.86% for Chinese ads to 8.48% for Russian ads, as did the average cost-per-click (from US $0.20 for Chinese ads to US $0.50 for English ads). Although Chinese speakers’ click-through rate was lowest, their rate of consenting to participate was the highest, at 3.62%, with English speakers exhibiting the lowest consent rate (0.97%). The conversion cost (cost to recruit a consenting participant) varied from US $10.80 for Russian speakers to US $51.88 for English speakers. During the 7 weeks of “managed” recruitment, we attempted to improve AdWords’ performance in regards to the consent rate and cost by systematically deleting underperforming ads and adjusting keywords. We were able to increase the number of people who consent after coming to the site by 91.8% while also decreasing per-consent cost by 23.3%. Conclusions Our results illustrate the need to linguistically and culturally adapt Google AdWords campaigns and to manage them carefully to ensure the most cost-effective results. PMID:24446166

12 CFR 347.119 - Specific consent.

Code of Federal Regulations, 2010 CFR

2010-01-01

... processing procedure. (d) Specific consent. Direct or indirect investments in or activities of foreign... control such organization as a result of a foreign investment; or (ii) A bank would be establishing a... foreign country. (1) Applicable law or practice in the foreign country where the foreign organization or...

Medical records and privacy: empirical effects of legislation.

PubMed

McCarthy, D B; Shatin, D; Drinkard, C R; Kleinman, J H; Gardner, J S

1999-04-01

To determine the effects of state legislation requiring patient informed consent prior to medical record abstraction by external researchers for a specific study. Informed consent responses obtained from November 1997 through April 1998 from members of a Minnesota-based IPA model health plan. Descriptive case study of consent to gain access to medical records for a pharmaco-epidemiologic study of seizures associated with use of a pain medication that was conducted as part of the FDA's post-marketing safety surveillance program to evaluate adverse events associated with approved drugs. The informed consent process approved by an institutional review board consisted of three phases: (1) a letter from the health plan's medical director requesting participation, (2) a second mailing to nonrespondents, and (3) a follow-up telephone call to nonrespondents. Of 140 Minnesota health plan members asked to participate in the medical records study, 52 percent (73) responded and 19 percent (26) returned a signed consent form authorizing access to their records for the study. For 132 study subjects enrolled in five other health plans in states where study-specific consent was not required, health care providers granted access to patient medical records for 93 percent (123) of the members. Legislation requiring patient informed consent to gain access to medical records for a specific research study was associated with low participation and increased time to complete that observational study. Efforts to protect patient privacy may come into conflict with the ability to produce timely and valid research to safeguard and improve public health.

Improving consent in patients undergoing surgery for fractured neck of femur.

PubMed

Thiruchandran, Gajendiran; McKean, Andrew R; Rudran, Branavan; Imam, Mohamed A; Yeong, Keefai; Hassan, Abdel

2018-05-02

Background Neck of femur fractures and their subsequent operative fixation are associated with high rates of perioperative morbidity and mortality. Consenting in this setting is suboptimal with the Montgomery court ruling changing the perspective of consent. This quality improvement project assessed the adequacy of consenting against British Orthopaedic Association-endorsed guidance and implemented a series of changes to improve the documentation of risks associated with surgery for fractured neck of femur. Methods Seventy consecutive patients who underwent any operative fixation of a neck of femur fracture were included over a 6-month period at a single centre. Patients unable to consent or without electronic notes were excluded. Consent forms were analysed and the documented potential risks or complications associated with surgery were compared to British Orthopaedic Association-endorsed guidance. A series of changes (using the plan, do study, act (PDSA) approach) was implemented to improve the adequacy of consent. Results Documentation of four out of 12 potential risks or complications was recorded in <50% of cases for patients with intracapsular fractures (n=35), and documentation of seven out of 12 potential risks or complications was recorded in <50% of cases for patients with extracapsular fractures (n=35). Re-audit following raising awareness and attaching consent guidance showed 100% documentation of potential risks or complications in patients with intracapsular and extracapsular fractures (n=70). A neck of femur fracture-specific consent form has been implemented which will hopefully lead to sustained improvement. Conclusions Consenting patients with fractured neck of femur for surgery in the authors' unit was suboptimal when compared to British Orthopaedic Association-endorsed consent guidance. This project has shown that ensuring such guidance is readily available has improved the adequacy of consent. The authors hope that introduction of a neck of femur fracture-specific consent form within their unit will lead to sustained adequate documentation of risks associated with surgery.

Law on consent and confidentiality in India: a need for clarity.

PubMed

Mathiharan, Karunakaran

2014-01-01

The concept of informed consent specific to medical research and treatment is still alien to many medical researchers and practitioners and to millions of Indians. The doctor-patient relationship in India is governed more by trust where the doctor is the authoritative person. Therefore, the benefit of informed consent does not reach all patients in day-to-day medical practice. To complicate the issue, the Indian law is not specific about the age at which a person can give valid consent. The Indian Penal Code is silent about the legal validity of consent given by persons between 12 and 18 years of age. Similarly, the age at which the 'Right to Confidentiality' begins is yet to be defined either by the statute or by the courts. Hence, there is a need for a clear statutory provision to remove the anomalies and ambiguities regarding the age of consent to undergo invasive therapeutic or investigative procedures, participate in clinical trials, as well as define the age at which a person's right to medical confidentiality begins.

The Importance of Purpose: Moving beyond Consent in the Societal Use of Personal Health Information

PubMed Central

Grande, David; Mitra, Nandita; Shah, Anand; Wan, Fei; Asch, David A.

2015-01-01

Background Adoption of electronic health record systems has increased the availability of patient-level electronic health information. Objective Examine public support for secondary uses of electronic health information under different consent arrangements. Design National experimental survey to examine perceptions of uses of electronic health information when varying along three dimensions: patient consent (obtained vs. not obtained), use (research vs. marketing), and framing of the findings (abstract description without results vs. specific results). Setting Nationally representative survey. Participants 3,064 African American, Hispanic, and non-Hispanic White individuals representing a response rate of 65%. Measurements Appropriateness of health information use described in vignettes on a 1-10 scale (1=not at all appropriate; 10=very appropriate). Results Mean ratings ranged from a low of 3.81 for a marketing use when consent was not obtained and specific results were presented to a high of 7.06 for a research use when consent was obtained and specific results were presented. Participants rated scenarios where consent was obtained as more appropriate compared to when consent was not obtained (+1.01; 95% CI 0.69, 1.34, P<0.001). Participants rated scenarios where the use was marketing as less appropriate compared to when the use was research (−2.03; 95% CI −2.27, −1.78, P<0.001). Unconsented research uses were seen as more appropriate than consented marketing uses (5.65 vs. 4.52; difference = 1.13; 95% CI 0.87, 1.39).. Limitations Participants rated hypothetical scenarios and results could be vulnerable to non-response bias despite the high response rate. Conclusions Although approaches to health information sharing emphasize consent, public opinion also emphasizes purpose suggesting a need to focus more attention on the social value of information use. Primary Funding Source National Human Genome Research Institute PMID:25506854

Enhancing informed consent for research and treatment.

PubMed

Dunn, L B; Jeste, D V

2001-06-01

Increased scrutiny of informed consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding of informed consent. A number of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible "predictors" of understanding of consent, such as subject characteristics, psychiatric symptoms, and cognitive impairment. Deficits in patients' understanding of informed consent may be partially related to poorly conceived, written, or organized informed consent materials; these deficits may be remediable with educational interventions. We find that effective interventions include corrected feedback, multiple learning trials, and more organized or simplified consent forms. Educational levels of patients generally correlate with levels of understanding. Even among individuals with psychiatric illness or cognitive impairment, deficits in understanding can be remedied with certain educational interventions. A variety of interventions can enhance understanding of informed consent.

76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

...://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm , is intended to assist... , http://www.hhs.gov/ohrp/newsroom/rfc/index.html , or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm . III. Request for Comments OHRP and FDA are making their joint draft...

Guidance: Revised Model CERCLA Section 122(g)(4) De Minimis Contributor CD and AOC and New Model ATP Provisions for De Minimis Settlements

EPA Pesticide Factsheets

Cover memorandum and four attachments containing model language for de minimis settlement consent decrees and/or administrative orders and ability to pay provisions in de minimis settlements for ability to pay and non-ability to pay parties.

Gender differences in heterosexual college students' conceptualizations and indicators of sexual consent: implications for contemporary sexual assault prevention education.

PubMed

Jozkowski, Kristen N; Peterson, Zoë D; Sanders, Stephanie A; Dennis, Barbara; Reece, Michael

2014-01-01

Because sexual assault is often defined in terms of nonconsent, many prevention efforts focus on promoting the clear communication of consent as a mechanism to reduce assault. Yet little research has specifically examined how sexual consent is being conceptualized by heterosexual college students. In this study, 185 Midwestern U.S. college students provided responses to open-ended questions addressing how they define, communicate, and interpret sexual consent and nonconsent. The study aimed to assess how college students define and communicate consent, with particular attention to gender differences in consent. Results indicated no gender differences in defining consent. However, there were significant differences in how men and women indicated their own consent and nonconsent, with women reporting more verbal strategies than men and men reporting more nonverbal strategies than women, and in how they interpreted their partner's consent and nonconsent, with men relying more on nonverbal indicators of consent than women. Such gender differences may help to explain some misunderstandings or misinterpretations of consent or agreement to engage in sexual activity, which could partially contribute to the occurrence of acquaintance rape; thus, a better understanding of consent has important implications for developing sexual assault prevention initiatives.

Assessing capacity to consent to treatment with cholinesterase inhibitors in dementia using a specific and standardized version of the MacArthur Competence Assessment Tool (MacCAT-T).

PubMed

Mueller, Tanja; Haberstroh, Julia; Knebel, Maren; Oswald, Frank; Kaspar, Roman; Kemper, Christoph J; Halder-Sinn, Petra; Schroeder, Johannes; Pantel, Johannes

2017-02-01

The use of assessment tools has been shown to improve the inter-rater reliability of capacity assessments. However, instrument-based capacity assessments of people with dementia face challenges. In dementia research, measuring capacity with instruments like the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) mostly employ hypothetical treatment vignettes that can overwhelm the abstraction capabilities of people with dementia and are thus not always suitable for this target group. The primary aim of this study was to provide a standardized real informed consent paradigm that enables the dementia-specific properties of capacity to consent to treatment in people with dementia to be identified in a real informed consent process that is both externally valid and ethically justifiable. The sample consisted of 53 people with mild to moderate dementia and a group of 133 people without cognitive impairment. Rather than using a hypothetical treatment vignette, we used a standardized version of the MacCAT-T to assess capacity to consent to treatment with cholinesterase inhibitors in people with dementia. Inter-rater reliability, item statistics, and psychometric properties were also investigated. Intraclass correlations (ICCs) (0.951-0.990) indicated high inter-rater reliability of the standardized real informed consent paradigm. In the dementia group, performance on different items of the MacCAT-T varied. Most people with dementia were able to express a treatment choice, and were aware of the need to take a tablet. Further information on the course of the disorder and the benefits and risks of the treatment were less understood, as was comparative reasoning regarding treatment alternatives. The standardized real informed consent paradigm enabled us to detect dementia-specific characteristics of patients' capacity to consent to treatment with cholinesterase inhibitors. In order to determine suitable enhanced consent procedures for this treatment, we recommend the consideration of MacCAT-T results on an item level. People with dementia seem to understand only basic information. Our data indicate that one useful strategy to enhance capacity to consent is to reduce attention and memory demands as far as possible.

Patient representatives' views on patient information in clinical cancer trials.

PubMed

Dellson, Pia; Nilbert, Mef; Carlsson, Christina

2016-02-01

Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis. Two major themes emerged: emotional responses and cognitive responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development of future simplified and more attractive informed consent forms. The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials.

Can Broad Consent be Informed Consent?

PubMed Central

Sheehan, Mark

2011-01-01

In biobanks, a broader model of consent is often used and justified by a range of different strategies that make reference to the potential benefits brought by the research it will facilitate combined with the low level of risk involved (provided adequate measures are in place to protect privacy and confidentiality) or a questioning of the centrality of the notion of informed consent. Against this, it has been suggested that the lack of specific information about particular uses of the samples means that such consent cannot be fully autonomous and so is unethical. My answer to the title question is a definite ‘yes’. Broad consent can be informed consent and is justified by appeal to the principle of respect for autonomy. Indeed, I will suggest that the distinction between the various kinds of consent is not a distinction between kinds of consent but between the kinds of choice a person makes. When an individual makes a choice (of any kind) it is important that they do so according to the standards of informed consent and consistent with the choice that they are making. PMID:22102849

Keywords to Recruit Spanish- and English-Speaking Participants: Evidence From an Online Postpartum Depression Randomized Controlled Trial

PubMed Central

Kelman, Alex R; Muñoz, Ricardo F

2014-01-01

Background One of the advantages of Internet-based research is the ability to efficiently recruit large, diverse samples of international participants. Currently, there is a dearth of information on the behind-the-scenes process to setting up successful online recruitment tools. Objective The objective of the study was to examine the comparative impact of Spanish- and English-language keywords for a Google AdWords campaign to recruit pregnant women to an Internet intervention and to describe the characteristics of those who enrolled in the trial. Methods Spanish- and English-language Google AdWords campaigns were created to advertise and recruit pregnant women to a Web-based randomized controlled trial for the prevention of postpartum depression, the Mothers and Babies/Mamás y Bebés Internet Project. Search engine users who clicked on the ads in response to keyword queries (eg, pregnancy, depression and pregnancy) were directed to the fully automated study website. Data on the performance of keywords associated with each Google ad reflect Web user queries from February 2009 to June 2012. Demographic information, self-reported depression symptom scores, major depressive episode status, and Internet use data were collected from enrolled participants before randomization in the intervention study. Results The Google ads received high exposure (12,983,196 impressions) and interest (176,295 clicks) from a global sample of Web users; 6745 pregnant women consented to participate and 2575 completed enrollment in the intervention study. Keywords that were descriptive of pregnancy and distress or pregnancy and health resulted in higher consent and enrollment rates (ie, high-performing ads). In both languages, broad keywords (eg, pregnancy) had the highest exposure, more consented participants, and greatest cost per consent (up to US $25.77 per consent). The online ads recruited a predominantly Spanish-speaking sample from Latin America of Mestizo racial identity. The English-speaking sample was also diverse with most participants residing in regions of Asia and Africa. Spanish-speaking participants were significantly more likely to be of Latino ethnic background, not married, completed fewer years of formal education, and were more likely to have accessed the Internet for depression information (P<.001). Conclusions The Internet is an effective method for reaching an international sample of pregnant women interested in online interventions to manage changes in their mood during the perinatal period. To increase efficiency, Internet advertisements need to be monitored and tailored to reflect the target population’s conceptualization of health issues being studied. Trial Registration ClinicalTrials.gov NCT00816725; http://clinicaltrials.gov/show/NCT00816725 (Archived by WebCite at http://www.webcitation.org/6LumonjZP). PMID:24407163

3D printing of patient-specific anatomy: A tool to improve patient consent and enhance imaging interpretation by trainees.

PubMed

Liew, Yaoren; Beveridge, Erin; Demetriades, Andreas K; Hughes, Mark A

2015-01-01

We report the use of three-dimensional or 3D printed, patient-specific anatomy as a tool to improve informed patient consent and patient understanding in a case of posterior lumbar fixation. Next, we discuss its utility as an educational tool to enhance imaging interpretation by neurosurgery trainees.

Linguistic and Cultural Challenges in Communication and Translation in US-Sponsored HIV Prevention Research in Emerging Economies

PubMed Central

2015-01-01

Linguistic and cultural differences can impede comprehension among potential research participants during the informed consent process, but how researchers and IRBs respond to these challenges in practice is unclear. We conducted in-depth interviews with 15 researchers, research ethics committee (REC) chairs and members from 8 different countries with emerging economies, involved in HIV-related research sponsored by HIV Prevention Trials Network (HPTN), regarding the ethical and regulatory challenges they face in this regard. In the interviews, problems with translating study materials often arose as major concerns. Four sets of challenges were identified concerning linguistic and cultural translations of informed consent documents and other study materials, related to the: (1) context, (2) process, (3) content and (4) translation of these documents. Host country contextual issues included low literacy rates, education (e.g., documents may need to be written below 5th grade reading level), and experiences with research, and different views of written documentation. Certain terms and concepts may not exist in other languages, or have additional connotations that back translations do not always reveal. Challenges arise because of not only the content of word-for-word, literal translation, but the linguistic form of the language, such as tone (e.g., appropriate forms of politeness vs. legalese, seen as harsh), syntax, manner of questions posed, and the concept of the consent); and the contexts of use affect meaning. Problems also emerged in bilateral communications – US IRBs may misunderstand local practices, or communicate insufficiently the reasons for their decisions to foreign RECs. In sum, these data highlight several challenges that have received little, if any, attention in past literature on translation of informed consent and study materials, and have crucial implications for improving practice, education, research and policy, suggesting several strategies, including needs for broader open-source multilingual lexicons, and more awareness of the complexities involved. PMID:26225759

Linguistic and Cultural Challenges in Communication and Translation in US-Sponsored HIV Prevention Research in Emerging Economies.

PubMed

Hanrahan, Donna; Sexton, Patrina; Hui, Katrina; Teitcher, Jennifer; Sugarman, Jeremy; London, Alex John; Barnes, Mark; Purpura, James; Klitzman, Robert

2015-01-01

Linguistic and cultural differences can impede comprehension among potential research participants during the informed consent process, but how researchers and IRBs respond to these challenges in practice is unclear. We conducted in-depth interviews with 15 researchers, research ethics committee (REC) chairs and members from 8 different countries with emerging economies, involved in HIV-related research sponsored by HIV Prevention Trials Network (HPTN), regarding the ethical and regulatory challenges they face in this regard. In the interviews, problems with translating study materials often arose as major concerns. Four sets of challenges were identified concerning linguistic and cultural translations of informed consent documents and other study materials, related to the: (1) context, (2) process, (3) content and (4) translation of these documents. Host country contextual issues included low literacy rates, education (e.g., documents may need to be written below 5th grade reading level), and experiences with research, and different views of written documentation. Certain terms and concepts may not exist in other languages, or have additional connotations that back translations do not always reveal. Challenges arise because of not only the content of word-for-word, literal translation, but the linguistic form of the language, such as tone (e.g., appropriate forms of politeness vs. legalese, seen as harsh), syntax, manner of questions posed, and the concept of the consent); and the contexts of use affect meaning. Problems also emerged in bilateral communications--US IRBs may misunderstand local practices, or communicate insufficiently the reasons for their decisions to foreign RECs. In sum, these data highlight several challenges that have received little, if any, attention in past literature on translation of informed consent and study materials, and have crucial implications for improving practice, education, research and policy, suggesting several strategies, including needs for broader open-source multilingual lexicons, and more awareness of the complexities involved.

7 CFR 3015.205 - General provisions for grants and cooperative agreements with institutions of higher education...

Code of Federal Regulations, 2013 CFR

2013-01-01

... informed consent shall include any exculpatory language through which the subject is made to waiver, or to... or similar action has been duly adopted or passed as an official act of its governing body... General, through any authorized representative, access to and the right to examine all records, books...

7 CFR 3015.205 - General provisions for grants and cooperative agreements with institutions of higher education...

Code of Federal Regulations, 2012 CFR

2012-01-01

... informed consent shall include any exculpatory language through which the subject is made to waiver, or to... or similar action has been duly adopted or passed as an official act of its governing body... General, through any authorized representative, access to and the right to examine all records, books...

Return of results in translational iPS cell research: considerations for donor informed consent

PubMed Central

2013-01-01

Efforts have emerged internationally to recruit donors with specific disease indications and to derive induced pluripotent cell lines. These disease-specific induced pluripotent stem cell lines have the potential to accelerate translational goals such as drug discovery and testing. One consideration for donor recruitment and informed consent is the possibility that research will result in findings that are clinically relevant to the cell donor. Management protocols for such findings should be developed a priori and disclosed during the informed consent process. The California Institute for Regenerative Medicine has developed recommendations for informing donors in sponsored research. These recommendations include obtaining consent to recontact tissue donors for a range of scientific, medical and ethical considerations. This article reviews the basis for these recommendations and suggests conditions that may be appropriate when reporting findings to donors. PMID:23336317

Creating a Controlled Vocabulary for the Ethics of Human Research: Towards a Biomedical Ethics Ontology

PubMed Central

Koepsell, David; Arp, Robert; Fostel, Jennifer; Smith, Barry

2009-01-01

Ontologies describe reality in specific domains in ways that can bridge various disciplines and languages. They allow easier access and integration of information that is collected by different groups. Ontologies are currently used in the biomedical sciences, geography, and law. A Biomedical Ethics Ontology (BMEO) would benefit members of ethics committees who deal with protocols and consent forms spanning numerous fields of inquiry. There already exists the Ontology for Biomedical Investigations (OBI); the proposed BMEO would interoperate with OBI, creating a powerful information tool. We define a domain ontology and begin to construct a BMEO, focused on the process of evaluating human research protocols. Finally, we show how our BMEO can have practical applications for ethics committees. This paper describes ongoing research and a strategy for its broader continuation and cooperation. PMID:19374479

Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk.

PubMed

Rogers, C G; Tyson, J E; Kennedy, K A; Broyles, R S; Hickman, J F

1998-04-01

The objective of this study was to assess a modified consent procedure allowed under federal regulations and developed for studies, particularly clinical trials, that are judged by the Institutional Review Board to reduce or have no effect on patient risk. This was a randomized trial of a conventional consent procedure that required parental signature to give consent (opting in) after a comprehensive disclosure of the rights of participants in research versus a modified consent procedure that required parental signature to refuse consent (opting out) after specific disclosures appropriate when risk is not increased. Consent was sought for a trial of primary follow-up care for disadvantaged infants at high risk, a trial judged by our Institutional Review Board to increase access to care for both groups. A blinded assessor interviewed mothers within 24 hours of the consent decision. Among the 44 mothers interviewed, the modified consent group scored higher than the conventional consent group in recall and understanding of study purpose and methods (47% vs 30%; p < 0.02). Other comparisons provided no evidence that the modified consent procedure was less desirable. Virtually all mothers reported satisfaction. The modified approach may improve communication and facilitate studies judged by the Institutional Review Board to be risk-neutral or risk-reducing. Further evaluation of a modified consent procedure for such studies is warranted.

Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study

PubMed Central

Festinger, David S.; Marlowe, Douglas B.; Croft, Jason R.; Dugosh, Karen L.; Arabia, Patricia L.; Benasutti, Kathleen M.

2011-01-01

Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, we randomly assigned 31 drug court clients participating in a clinical research trial to a standard consent procedure or to the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1-week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the standard group (65% vs. 42%; p < .01). Similar findings were observed for specific categories of consent information, including study purpose and design, risks and benefits, and human subject protections. Effect sizes were all large (d = 0.89 to 1.25). Findings suggest that motivation plays a key role in recall of consent information and should be considered in the development of future interventions. PMID:19331486

Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior

PubMed Central

Shaer, Orit; Okerlund, Johanna; Westendorf, Lauren; Ball, Madeleine; Nov, Oded

2016-01-01

Background Social media, mobile and wearable technology, and connected devices have significantly expanded the opportunities for conducting biomedical research online. Electronic consent to collecting such data, however, poses new challenges when contrasted to traditional consent processes. It reduces the participant-researcher dialogue but provides an opportunity for the consent deliberation process to move from solitary to social settings. In this research, we propose that social annotations, embedded in the consent form, can help prospective participants deliberate on the research and the organization behind it in ways that traditional consent forms cannot. Furthermore, we examine the role of the comments’ valence on prospective participants’ beliefs and behavior. Objective This study focuses specifically on the influence of annotations’ valence on participants’ perceptions and behaviors surrounding online consent for biomedical research. We hope to shed light on how social annotation can be incorporated into digitally mediated consent forms responsibly and effectively. Methods In this controlled between-subjects experiment, participants were presented with an online consent form for a personal genomics study that contained social annotations embedded in its margins. Individuals were randomly assigned to view the consent form with positive-, negative-, or mixed-valence comments beside the text of the consent form. We compared participants’ perceptions of being informed and having understood the material, their trust in the organization seeking the consent, and their actual consent across conditions. Results We find that comment valence has a marginally significant main effect on participants’ perception of being informed (F2=2.40, P=.07); specifically, participants in the positive condition (mean 4.17, SD 0.94) felt less informed than those in the mixed condition (mean 4.50, SD 0.69, P=.09). Comment valence also had a marginal main effect on the extent to which participants reported trusting the organization (F2=2.566, P=.08). Participants in the negative condition (mean 3.59, SD 1.14) were marginally less trusting than participants exposed to the positive condition (mean 4.02, SD 0.90, P=.06). Finally, we found that consent rate did not differ across comment valence conditions; however, participants who spent less time studying the consent form were more likely to consent when they were exposed to positive-valence comments. Conclusions This work explores the effects of adding a computer-mediated social dimension, which inherently contains human emotions and opinions, to the consent deliberation process. We proposed that augmenting the consent deliberation process to incorporate multiple voices can enable individuals to capitalize on the knowledge of others, which brings to light questions, problems, and concerns they may not have considered on their own. We found that consent forms containing positive valence annotations are likely to lead participants to feel less informed and simultaneously more trusting of the organization seeking consent. In certain cases where participants spent little time considering the content of the consent form, participants exposed to positive valence annotations were even more likely to consent to the study. We suggest that these findings represent important considerations for the design of future electronic informed consent mechanisms. PMID:27439320

Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior.

PubMed

Balestra, Martina; Shaer, Orit; Okerlund, Johanna; Westendorf, Lauren; Ball, Madeleine; Nov, Oded

2016-07-20

Social media, mobile and wearable technology, and connected devices have significantly expanded the opportunities for conducting biomedical research online. Electronic consent to collecting such data, however, poses new challenges when contrasted to traditional consent processes. It reduces the participant-researcher dialogue but provides an opportunity for the consent deliberation process to move from solitary to social settings. In this research, we propose that social annotations, embedded in the consent form, can help prospective participants deliberate on the research and the organization behind it in ways that traditional consent forms cannot. Furthermore, we examine the role of the comments' valence on prospective participants' beliefs and behavior. This study focuses specifically on the influence of annotations' valence on participants' perceptions and behaviors surrounding online consent for biomedical research. We hope to shed light on how social annotation can be incorporated into digitally mediated consent forms responsibly and effectively. In this controlled between-subjects experiment, participants were presented with an online consent form for a personal genomics study that contained social annotations embedded in its margins. Individuals were randomly assigned to view the consent form with positive-, negative-, or mixed-valence comments beside the text of the consent form. We compared participants' perceptions of being informed and having understood the material, their trust in the organization seeking the consent, and their actual consent across conditions. We find that comment valence has a marginally significant main effect on participants' perception of being informed (F2=2.40, P=.07); specifically, participants in the positive condition (mean 4.17, SD 0.94) felt less informed than those in the mixed condition (mean 4.50, SD 0.69, P=.09). Comment valence also had a marginal main effect on the extent to which participants reported trusting the organization (F2=2.566, P=.08). Participants in the negative condition (mean 3.59, SD 1.14) were marginally less trusting than participants exposed to the positive condition (mean 4.02, SD 0.90, P=.06). Finally, we found that consent rate did not differ across comment valence conditions; however, participants who spent less time studying the consent form were more likely to consent when they were exposed to positive-valence comments. This work explores the effects of adding a computer-mediated social dimension, which inherently contains human emotions and opinions, to the consent deliberation process. We proposed that augmenting the consent deliberation process to incorporate multiple voices can enable individuals to capitalize on the knowledge of others, which brings to light questions, problems, and concerns they may not have considered on their own. We found that consent forms containing positive valence annotations are likely to lead participants to feel less informed and simultaneously more trusting of the organization seeking consent. In certain cases where participants spent little time considering the content of the consent form, participants exposed to positive valence annotations were even more likely to consent to the study. We suggest that these findings represent important considerations for the design of future electronic informed consent mechanisms.

The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol.

PubMed

Perrenoud, Beatrice; Velonaki, Venetia-Sofia; Bodenmann, Patrick; Ramelet, Anne-Sylvie

2015-10-01

The aim of this systematic review is to establish the best available evidence of the effectiveness of health literacy interventions on the informed consent process for health care users. The specific review question is:What is the effectiveness of health literacy interventions on health care users' informed consent to health procedures processes? Informed consent is a fundamental principal in the health care context which nowadays includes the patient's capacity to judge and to be involved in the decision making concerning their care that ensures that the care received reflects their goals, preferences and values. The importance of obtaining a valid consent before any medical procedure is well-established. In a US court case in 1914, it was stated that it is the right of any adult with the capability of making decisions concerning his own body, and that any surgical operation without the patient's consent could be considered as an assault. In another US court case, the court stated that it is a doctor's duty to make a reasonable disclosure to his patient of the nature, probable consequences and dangers of the proposed treatment to the patient. The application of the doctrine of informed consent as a legal procedure may slightly differ from country to country or from state to state, and may have different forms even within the same country. For example in the UK, consent can be written, verbal or non-verbal/implied, and a written consent form is not the actual consent itself but merely serves as evidence that consent has been given. If the elements of voluntariness, appropriate information and capacity have not been satisfied, a signed informed consent form will not make the consent valid. Nowadays it is widely accepted that prior to the application of any medical procedure, its benefits, risks and alternatives must have been explained to the patient, and the competent patient should have voluntarily and understandingly consented. Hence, the informed consent refers both to the health professional's obligation of information disclosure to the patient and to the quality of the patient's understanding and decision making. In other words, it does not refer to the single moment of the agreement, but to the whole complex process of gaining information, deciding and consenting. Several factors may restrict informed consent, including the patient's competence, provision of limited information, ineffective communication between patients and professionals, the hospital environment itself and privacy problems.According to the World Health Organization (WHO), people are increasingly urged to make choices for themselves or for their family members in regards to health care use. However, at the same time, inadequate or problematic health literacy skills have been reported in approximately half of the adult population in eight European countries. "Health literacy is linked to literacy and entails people's knowledge, motivation and competences to access, understand, appraise and apply health information in order to make judgments and take decisions in everyday life concerning health care, disease prevention and health promotion to maintain or improve quality of life during the life course". There are many instruments measuring either health literacy in general or some dimensions of health literacy (e.g. numeracy), health literacy related to specific issues (e.g. nutrition, diabetes) or health literacy of specific populations (e.g. adolescents). The diversity of existing instruments, which includes diversity in terms of scoring and ranges, makes the comparison of the results of different studies difficult. Index thresholds and ranges for different levels of health literacy for most tools were set based either on that of other well established health literacy instruments used in the same study, or on experts' assessments of the required health literacy scores. Adequate health literacy could be considered as the capacity of successfully completing most tasks required to function in the health care setting.Low or inadequate health literacy has been found to have several adverse effects on health and health care use: reduced ability to take medications properly and to interpret labels and health messages, poorer overall health status and higher risk of mortality in seniors, increased emergency department and hospital use, and decreased use of preventive interventions.Most studies examining the relationship between health literacy and informed consent conclude that patients with low health literacy are less likely to participate in decision making concerning their health care. According to a recent literature review, health care users' literacy, together with other factors, were found to be important determinants of a patient's capacity to provide fully informed consent. According to this review, 21 to 86% of the patients were able to recall the potential risks and complications of their medical procedure. This percentage may be even lower because most of the included studies referred to self-reported recall, which may be a flawed measure. According to the literature, much of the written material related to the informed consent is too difficult for health care users to understand. In addition, in their study, McCarthy et al. observed that during consultations, physicians spoke and used significantly more complex language than their patients, which may result in inappropriate communication for the patients, mainly for those with limited literacy. The situations described above may raise a number of critical legal and ethical problems. Health professionals, who shape the conditions of interactions with the patient, are responsible for adapting appropriate interventions, such as communication approaches that take into account patients' health literacy. These interventions could have a major contribution to the improvement of the informed consent process.Sheridan et al. conducted a systematic review on interventions designed to reduce the effects of limited health literacy in general. Some of the outcomes of the included studies were comprehension and behavioral intent, outcomes which could be strongly related to the informed consent process. Without making any distinction of the studies referring to the informed consent process, they conclude that several health literacy interventions, for example, adding video to narrative, could improve an individual's comprehension. Schenker et al. conducted a systematic review on the interventions to improve patient comprehension of medical and surgical procedures, including articles published until 2008. One of their conclusions was that, in most studies, while particular attention is needed for interventions provided to patients with limited literacy, the literacy of the patients was not addressed or assessed.Since then, many articles on health literacy and informed consent have been published. According to a recent review on best practices and new models of health literacy for informed consent, which includes papers published from 2004 to 2014, over half of the collected articles were published since 2010. This review, which is limited to literature within the US and its territories, and does not focus on the evaluation of the recommended practices in the literature, concludes that different tactics for simplifying written documents and clarifying verbal exchanges, and the use of multimedia formats and computerized exchanges might ameliorate constraints to health literate communications required for informed consent.Studies have evaluated the effectiveness of health literacy interventions which aim to improve the informed consent process. Improvement of the informed consent process may refer not only to the patients' comprehension but also, for example, to the recall of the information provided, to their intention to ask for clarifications, or to their satisfaction with the procedure. Interventions described and tested in the literature focus on the improvement of the print material, the process (e.g. the communication of the appropriate information) or both. Davis et al. conducted a randomized controlled trial to compare two polio vaccine pamphlets written at a sixth grade level - an international standardized pamphlet and an easy-to-read pamphlet - for the comprehension and preference among parents. Although the parents in the intervention group (N=304) achieved significantly higher comprehension than the control group (N=306) (65% vs 60%, p<0.005), the authors concluded that simplifying written material increases appeal but not the comprehension to an adequate level without use of instructional graphics. Similarly, Lorenzen et al. found that a reader friendly informed consent document to surgical procedures was more commonly read by the health care users as compared to the original consent document; however, no difference was found in terms of the participants' capacity to describe the procedure in their own words. Kang et al. evaluated recall and comprehension of orthodontic informed consent among pairs of children and their parents (N=90) applying three different informed consent procedures. According to this study, a combination of improving the readability of consent materials and the informed consent process (audio and visual cues) led to better recall for the patients and better recall and comprehension for their parents compared to an improved readability form or the usual informed consent form. Smith et al. used a randomized controlled trial to compare a decision aid (booklet and DVD) specifically designed for adults with low literacy skills (N=357) with a standard information booklet (N=173) on screening for bowel cancer. They found that the proportion of participants making an informed choice was 22% higher in the intervention group than in the control group (34% vs 12%, P<0.001). Matsuyama et al. (ABSTRACT TRUNCATED)

The writing of informed consent in accessible language: difficulties.

PubMed

Fernandes, Nurimar C

2015-06-01

In order to assess the adequacy of informed consent terminology of research projects developed at the Clementino Fraga Filho University Hospital (Federal University of Rio de Janeiro) , we conducted a review study on the terminology found in 55 projects (2008-20013) . Such projects belonged to different medical specialties and were all registered in the hospital's Ethics in Research Committee. Patients had difficulty in understanding the meanings of 76 medical terms and expressions; only 12 of them could be replaced. On the other hand, the present study reached the conclusion that, in most cases, the writing with scientific terms is essential in items such as justification/objectives and procedures, being insurmountable obstacles to the participants of this research and patients' understanding.

Linguistic Strategies for Improving Informed Consent in Clinical Trials Among Low Health Literacy Patients.

PubMed

Krieger, Janice L; Neil, Jordan M; Strekalova, Yulia A; Sarge, Melanie A

2017-03-01

Improving informed consent to participate in randomized clinical trials (RCTs) is a key challenge in cancer communication. The current study examines strategies for enhancing randomization comprehension among patients with diverse levels of health literacy and identifies cognitive and affective predictors of intentions to participate in cancer RCTs. Using a post-test-only experimental design, cancer patients (n = 500) were randomly assigned to receive one of three message conditions for explaining randomization (ie, plain language condition, gambling metaphor, benign metaphor) or a control message. All statistical tests were two-sided. Health literacy was a statistically significant moderator of randomization comprehension (P = .03). Among participants with the lowest levels of health literacy, the benign metaphor resulted in greater comprehension of randomization as compared with plain language (P = .04) and control (P = .004) messages. Among participants with the highest levels of health literacy, the gambling metaphor resulted in greater randomization comprehension as compared with the benign metaphor (P = .04). A serial mediation model showed a statistically significant negative indirect effect of comprehension on behavioral intention through personal relevance of RCTs and anxiety associated with participation in RCTs (P < .001). The effectiveness of metaphors for explaining randomization depends on health literacy, with a benign metaphor being particularly effective for patients at the lower end of the health literacy spectrum. The theoretical model demonstrates the cognitive and affective predictors of behavioral intention to participate in cancer RCTs and offers guidance on how future research should employ communication strategies to improve the informed consent processes. © The Author 2016. Published by Oxford University Press.

Linguistic Strategies for Improving Informed Consent in Clinical Trials Among Low Health Literacy Patients

PubMed Central

Neil, Jordan M.; Strekalova, Yulia A.; Sarge, Melanie A.

2017-01-01

Abstract Background: Improving informed consent to participate in randomized clinical trials (RCTs) is a key challenge in cancer communication. The current study examines strategies for enhancing randomization comprehension among patients with diverse levels of health literacy and identifies cognitive and affective predictors of intentions to participate in cancer RCTs. Methods: Using a post-test-only experimental design, cancer patients (n = 500) were randomly assigned to receive one of three message conditions for explaining randomization (ie, plain language condition, gambling metaphor, benign metaphor) or a control message. All statistical tests were two-sided. Results: Health literacy was a statistically significant moderator of randomization comprehension (P = .03). Among participants with the lowest levels of health literacy, the benign metaphor resulted in greater comprehension of randomization as compared with plain language (P = .04) and control (P = .004) messages. Among participants with the highest levels of health literacy, the gambling metaphor resulted in greater randomization comprehension as compared with the benign metaphor (P = .04). A serial mediation model showed a statistically significant negative indirect effect of comprehension on behavioral intention through personal relevance of RCTs and anxiety associated with participation in RCTs (P < .001). Conclusions: The effectiveness of metaphors for explaining randomization depends on health literacy, with a benign metaphor being particularly effective for patients at the lower end of the health literacy spectrum. The theoretical model demonstrates the cognitive and affective predictors of behavioral intention to participate in cancer RCTs and offers guidance on how future research should employ communication strategies to improve the informed consent processes. PMID:27794035

Pastoral power and gynaecological examinations: a Foucauldian critique of clinician accounts of patient-centred consent.

PubMed

Cook, Catherine; Brunton, Margaret

2015-05-01

Invasive non-sedated clinical procedures such as gynaecological examinations are normalised; however, there is limited research highlighting the relational and technical skills required for clinicians to ensure patients' continued consent. A considerable body of research emphasises that women dislike examinations, leading to their non-compliance or a delayed follow up for gynaecological and sexual health problems. However, medical research focuses on 'problem' women; the role of clinicians receives limited appraisal. This article draws on interviews with sexual health clinicians in New Zealand, from metropolitan and provincial locations. The gynaecological care of women in New Zealand attained international notoriety with the 1988 publication of Judge Cartwright's inquiry into ethical shortcomings in cervical cancer research at the National Women's Hospital. Judge Cartwright's recommendations included patient-centred care in order to ensure informed consent had been received for clinical procedures and research participation. This article's critical analysis is that, although clinicians' language draws on humanistic notions of patient-centredness, Foucault's notion of secularised pastoral power enables a more nuanced appreciation of the ethical work undertaken by clinicians when carrying out speculum examinations. The analysis highlights both the web of power relations present during examination practices and the strategies clinicians use to negotiate women's continued consent; which is significant because consent is usually conceptualised as an event, rather than an unfolding, unstable process. © 2015 The Authors. Sociology of Health & Illness © 2015 Foundation for the Sociology of Health & Illness/John Wiley & Sons Ltd.

Public Preferences Regarding Informed Consent Models for Participation in Population-based Genomic Research

PubMed Central

Platt, Jodyn; Bollinger, Juli; Dvoskin, Rachel; Kardia, Sharon LR; Kaufman, David

2013-01-01

Purpose Some large population biobanks that house biospecimens and health information for research seek broad consent from participants, while others re-consent for specific new studies. Understanding research participants’ attitudes and preferences about broad and narrow consent may improve recruitment, retention, and public support. Methods An online survey was conducted among a representative sample of 4,659 US adults to examine relationships between consent preferences and demographic factors, beliefs about privacy, the value of research, and the perceived trustworthiness of researchers. Results Participants preferred broad consent (52%) over study-by-study consent models (48%). Higher preferences for study-by-study consent observed among Black non-Hispanic respondents, and respondents with lower income and education were explained by differences in the prevalence of one or more beliefs about the study. Respondents with fears about research and those that would feel respected if asked for permission for each research use preferred study-by-study consent. Preference for broad consent was related to the desire not to be bothered with multiple requests and the belief that the study could lead to improved treatments, cures, and lives saved. Conclusion These data suggest that support for broad consent is contingent on sufficient information about data use. Work with research participants and community leaders to understand, respond to, and influence opinions about a given, ongoing study may improve uptake of broad consent. PMID:23660530

Readability of patient information and consent documents in rheumatological studies.

PubMed

Hamnes, Bente; van Eijk-Hustings, Yvonne; Primdahl, Jette

2016-07-16

Before participation in medical research an informed consent must be obtained. This study investigates whether the readability of patient information and consent documents (PICDs) corresponds to the average educational level of participants in rheumatological studies in the Netherlands, Denmark, and Norway. 24 PICDs from studies were collected and readability was assessed independently using the Gunning's Fog Index (FOG) and Simple Measure of Gobbledygook (SMOG) grading. The mean score for the FOG and SMOG grades were 14.2 (9.0-19.0) and 14.2 (12-17) respectively. The mean FOG and SMOG grades were 12.7 and 13.3 in the Dutch studies, 15.0 and 14.9 in the Danish studies, and 14.6 and 14.3 in the Norwegian studies, respectively. Out of the 2865 participants, more than 57 % had a lower educational level than the highest readability score calculated in the individual study. As the readability level of the PICDs did not match the participants' educational level, consent may not have been valid, as the participants may have had a limited understanding of what they agreed to participate in. There should be more focus on the readability of PICDs. National guidelines for how to write clear and unambiguous PICDs in simple and easily understandable language could increase the focus on the readability of PICD.

Delegating Informed Consent.

PubMed

Koch, Valerie Gutmann

2017-11-01

Ten years ago, Megan Shinal sought the care of neurosurgeon Steven Toms for the surgical treatment of a recurrent nonmalignant tumor in the pituitary region of her brain. In their twenty-minute meeting, Shinal did not make a final decision about which surgical approach she wished to pursue. Subsequently, she spoke with Tom's physician assistant once by phone and once in person, when she signed the consent form, which did not appear to designate which surgical approach she had chosen. During the operation-a total resection-Toms perforated Shinal's carotid artery, resulting in hemorrhage, stroke, brain injury, and partial blindness. The jury found that Toms had fulfilled his informed-consent obligations prior to performing the resection; however, in June 2017, the Supreme Court of Pennsylvania overturned the decision, relying on the Pennsylvania Medical Care Availability and Reduction of Error Act. The court found that the language of the act is unambiguous in its requirement that "a physician's duty to provide information to a patient sufficient to obtain her informed consent is non-delegable." Presumably, this rule of nondelegation applies beyond the surgical theater to other major treatment decisions. And it is unclear whether it applies to other professionals in a subordinate position to the treating physician, such as residents and fellows. © 2017 The Hastings Center.

Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents.

PubMed

Knopf, Amelia S; Gilbert, Amy Lewis; Zimet, Gregory D; Kapogiannis, Bill G; Hosek, Sybil G; Fortenberry, J Dennis; Ott, Mary A

2017-01-01

Biomedical HIV prevention research with minors is complicated by the requirement of parental consent, which may disclose sensitive information to parents. We examine the experience of principal investigators (PIs) and study personnel who faced this complex ethical issue in the first biomedical HIV prevention study that allowed minors to self-consent for enrollment. We conducted in-depth interviews with PIs and study personnel from 13 medical trial sites in cities across the United States. Data were analyzed using a conventional content analysis. Participants experienced moral conflict as they struggled to fulfill conflicting duties in this trial involving minor adolescents with multiple vulnerabilities. Our participants experienced conflict between the two types of duties-protective and scientific-previously identified by Merritt. Protective duties were owed to the child, the parents, and the institution, and participants expressed tension between the actions that would protect these subgroups and the actions necessary to fulfill their scientific duties. Moral conflict was resolved in a variety of ways, including reflecting on the protocol's alignment with federal regulations, modifying consent language, considering each individual for enrollment carefully, and accepting institutional review board (IRB) decisions. Potential solutions for future studies are discussed, and include flexible protocol consent procedures and centralized IRB reviews.

USING FORMATIVE RESEARCH TO DEVELOP A CONTEXT-SPECIFIC APPROACH TO INFORMED CONSENT FOR CLINICAL TRIALS

PubMed Central

Corneli, Amy L.; Bentley, Margaret E.; Sorenson, James R.; Henderson, Gail E.; van der Horst, Charles; Moses, Agnes; Nkhoma, Jacqueline; Tenthani, Lyson; Ahmed, Yusuf; Heilig, Charles M.; Jamieson, Denise J.

2009-01-01

Participant understanding is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturally appropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-to-child transmission of HIV during breastfeeding, formative research was conducted to explore the community’s understanding of medical research as well as how to explain research through local terms and meanings. Contextual analogies and other approaches were identified to explain consent information. Guided by theory, strategies for developing culturally appropriate interventions, and recommendations from the literature, we demonstrate how the formative data were used to develop culturally appropriate counseling cards specifically for the trial in Malawi. With appropriate contextual modifications, the steps outlined here could be applied in other clinical trials conducted elsewhere, as well as in other types of research. PMID:19385837

Dentist-patient communication in the multilingual dental setting.

PubMed

Goldsmith, C; Slack-Smith, L; Davies, G

2005-12-01

Communication between dentists and patients can be exceptionally challenging when the patient and the dentist do not speak the same language, as is frequently the case in multicultural Australia. The aim of this study was to describe the issues involved in dealing with limited-English speaking patients in order to formulate recommendations on how to improve dental communication. A cross sectional study was performed using a postal survey to Australian Dental Association member dental practitioners in Western Australia. Responses were collated and data analysis was performed using SPSS 11.5 for Windows. Most respondents encounter language-related communication barriers weekly or monthly, and the most satisfactory method of communication is informal interpreters. Despite reporting satisfaction working with professional chairside interpreters or dental staff interpreters, most respondents did not use them. The most common alternative communication methods were diagrams and models. Endodontics and periodontics provided the greatest challenge in communication. Informed consent was reportedly compromised due to language barriers by 29 per cent of respondents. Recommendations to improve communication included access to interpretation services, dentist technique/attitude to communication and patient preparedness for English-speaking encounters. Many respondents do not utilize the preferential communication methods, creating a potential compromise to both informed consent and the patients' best interests. The use of professional interpreters is recommended, and discussion should be supplemented with means of non-verbal communication. Dentists require access to lists of multilingual dentists and greater awareness of interpretation services to improve multilingual dentist-patient communication.

Development and Pilot Testing of a Video-Assisted Informed Consent Process

PubMed Central

Sonne, Susan C.; Andrews, Jeannette O.; Gentilin, Stephanie M.; Oppenheimer, Stephanie; Obeid, Jihad; Brady, Kathleen; Wolf, Sharon; Davis, Randal; Magruder, Kathryn

2013-01-01

The informed consent process for research has come under scrutiny, as consent documents are increasingly long and difficult to understand. Innovations are needed to improve comprehension in order to make the consent process truly informed. We report on the development and pilot testing of video clips that could be used during the consent process to better explain research procedures to potential participants. Based on input from researchers and community partners, 15 videos of common research procedures/concepts were produced. The utility of the videos was then tested by embedding them in mock informed consent documents that were presented via an online electronic consent system designed for delivery via iPad. Three mock consents were developed, each containing five videos. All participants (n=61) read both a paper version and the video-assisted iPad version of the same mock consent and were randomized to which format they reviewed first. Participants were given a competency quiz that posed specific questions about the information in the consent after reviewing the first consent document to which they were exposed. Most participants (78.7%) preferred the video-assisted format compared to paper (12.9%). Nearly all (96.7%) reported that the videos improved their understanding of the procedures described in the consent document; however, comprehension of material did not significantly differ by consent format. Results suggest videos may be helpful in providing participants with information about study procedures in a way that is easy to understand. Additional testing of video consents for complex protocols and with subjects of lower literacy is warranted. PMID:23747986

Development and pilot testing of a video-assisted informed consent process.

PubMed

Sonne, Susan C; Andrews, Jeannette O; Gentilin, Stephanie M; Oppenheimer, Stephanie; Obeid, Jihad; Brady, Kathleen; Wolf, Sharon; Davis, Randal; Magruder, Kathryn

2013-09-01

The informed consent process for research has come under scrutiny, as consent documents are increasingly long and difficult to understand. Innovations are needed to improve comprehension in order to make the consent process truly informed. We report on the development and pilot testing of video clips that could be used during the consent process to better explain research procedures to potential participants. Based on input from researchers and community partners, 15 videos of common research procedures/concepts were produced. The utility of the videos was then tested by embedding them in mock-informed consent documents that were presented via an online electronic consent system designed for delivery via iPad. Three mock consents were developed, each containing five videos. All participants (n = 61) read both a paper version and the video-assisted iPad version of the same mock consent and were randomized to which format they reviewed first. Participants were given a competency quiz that posed specific questions about the information in the consent after reviewing the first consent document to which they were exposed. Most participants (78.7%) preferred the video-assisted format compared to paper (12.9%). Nearly all (96.7%) reported that the videos improved their understanding of the procedures described in the consent document; however, the comprehension of material did not significantly differ by consent format. Results suggest videos may be helpful in providing participants with information about study procedures in a way that is easy to understand. Additional testing of video consents for complex protocols and with subjects of lower literacy is warranted. Copyright © 2013 Elsevier Inc. All rights reserved.

Beyond informed consent.

PubMed Central

Bhutta, Zulfiqar A.

2004-01-01

Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. The emphasis in most externally sponsored research projects in developing countries is on laborious documentation of several mechanical aspects of the research process rather than on assuring true comprehension and voluntary participation. The onus for the oversight of this process is often left to overworked and ill-equipped local ethics review committees. Current guidelines and processes for obtaining informed consent should be reviewed with the specific aim of developing culturally appropriate methods of sharing information about the research project and obtaining and documenting consent that is truly informed. Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings. PMID:15643799

Patient perceptions and recall of consent for regional anaesthesia compared with consent for surgery.

PubMed

Zarnegar, Roxaneh; Brown, Matthew R D; Henley, Matthew; Tidman, Victoria; Pathmanathan, Ahilan

2015-11-01

In Britain, consent for surgery is documented using a Department of Health form signed by the surgeon and the patient. In contrast, anaesthetic procedures have no formalised consent process. Evidence on the process of consent for regional anaesthesia, and patient perceptions of this, is scarce outside obstetric practice. We aimed to determine patient recall and perceptions of consent for interscalene brachial plexus block and compared this to surgical consent for shoulder arthroplasty. Prospective observational survey. A specialist musculoskeletal centre, UK. Forty-six patients (female:male 30:16, mean age 61 years) undergoing shoulder arthroplasty with interscalene brachial plexus block. Recall and understanding of consent for regional anaesthesia and surgery was examined using a semi-structured questionnaire 1-2 days after arthroplasty. Surgical consent forms and discussions recorded by the anaesthetist were examined in participants' medical notes to compare against the level of recall. Analysis to determine statistical significance was conducted using McNemar's test. Recall of surgical risks was overall significantly better than recall of brachial plexus block risks. Compared to their recollections of surgical risk, patients remembered fewer specific risks for brachial plexus block (p < 0.001). There were more patients unable to recall any risks when questioned about brachial plexus block than about their surgery (p < 0.05). One-third of patients did not regard the consent discussion about regional anaesthesia as important as consent for surgery and over one-quarter had not recognised the preoperative discussion about the brachial plexus block as a consent process similar to that conducted for surgery. Fundamental misunderstandings about the consent process are prevalent. Future work in this area should seek to investigate how documentation of the consent process and patients' understanding of consent for regional anaesthesia can be improved. © The Royal Society of Medicine.

78 FR 41803 - Notice of Lodging of Proposed Amendment to Consent Decree Under the Clean Water Act

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-11

... original 2012 consent decree, the Metropolitan St. Louis Sewer District (``MSD'') agreed to undertake... specific combined sewer overflow control measures. MSD still is in the process of complying with the 2012...

Consent Processes for Mobile App Mediated Research: Systematic Review.

PubMed

Moore, Sarah; Tassé, Anne-Marie; Thorogood, Adrian; Winship, Ingrid; Zawati, Ma'n; Doerr, Megan

2017-08-30

Since the launch of ResearchKit on the iOS platform in March 2015 and ResearchStack on the Android platform in June 2016, many academic and commercial institutions around the world have adapted these frameworks to develop mobile app-based research studies. These studies cover a wide variety of subject areas including melanoma, cardiomyopathy, and autism. Additionally, these app-based studies target a variety of participant populations, including children and pregnant women. The aim of this review was to document the variety of self-administered remote informed consent processes used in app-based research studies available between May and September 2016. Remote consent is defined as any consenting process with zero in-person steps, when a participant is able to join a study without ever seeing a member of the research team. This type of review has not been previously conducted. The research community would benefit from a rigorous interrogation of the types of consent taken as part of the seismic shift to entirely mobile meditated research studies. This review examines both the process of information giving and specific content shared, with special attention to data privacy, aggregation, and sharing. Consistency across some elements of the app-based consent processes was found; for example, informing participants about how data will be curated from the phone. Variations in other elements were identified; for example, where specific information is shared and the level of detail disclosed. Additionally, several novel elements present in eConsent not typically seen in traditional consent for research were highlighted. This review advocates the importance of participant informedness in a novel and largely unregulated research setting. ©Sarah Moore, Anne-Marie Tassé, Adrian Thorogood, Ingrid Winship, Ma'n Zawati, Megan Doerr. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 30.08.2017.

Consent Processes for Mobile App Mediated Research: Systematic Review

PubMed Central

Tassé, Anne-Marie; Thorogood, Adrian; Winship, Ingrid; Zawati, Ma'n; Doerr, Megan

2017-01-01

Background Since the launch of ResearchKit on the iOS platform in March 2015 and ResearchStack on the Android platform in June 2016, many academic and commercial institutions around the world have adapted these frameworks to develop mobile app-based research studies. These studies cover a wide variety of subject areas including melanoma, cardiomyopathy, and autism. Additionally, these app-based studies target a variety of participant populations, including children and pregnant women. Objective The aim of this review was to document the variety of self-administered remote informed consent processes used in app-based research studies available between May and September 2016. Remote consent is defined as any consenting process with zero in-person steps, when a participant is able to join a study without ever seeing a member of the research team. This type of review has not been previously conducted. The research community would benefit from a rigorous interrogation of the types of consent taken as part of the seismic shift to entirely mobile meditated research studies. Methods This review examines both the process of information giving and specific content shared, with special attention to data privacy, aggregation, and sharing. Results Consistency across some elements of the app-based consent processes was found; for example, informing participants about how data will be curated from the phone. Variations in other elements were identified; for example, where specific information is shared and the level of detail disclosed. Additionally, several novel elements present in eConsent not typically seen in traditional consent for research were highlighted. Conclusions This review advocates the importance of participant informedness in a novel and largely unregulated research setting. PMID:28855147

Biobanking research on oncological residual material: a framework between the rights of the individual and the interest of society

PubMed Central

2013-01-01

Background The tissue biobanking of specific biological residual materials, which constitutes a useful resource for medical/scientific research, has raised some ethical issues, such as the need to define which kind of consent is applicable for biological residual materials biobanks. Discussion Biobank research cannot be conducted without considering arguments for obtaining the donors’ consent: in this paper we discuss to what extent consent in biobank research on oncological residual materials has to be required, and what type of consent would be appropriate in this context, considering the ethical principles of donation, solidarity, protection of the donors’ rights and the requirements of scientific progress. Regarding the relationship between informed consent and tissue collection, storage and research, we have focused on two possible choices related to the treatment of data and samples in the biobank: irreversible and reversible anonymization of the samples, distinguishing between biobank research on residual materials for which obtaining consent is necessary and justified, and biobank research for which it is not. The procedures involve different approaches and possible solutions that we will seek to define. The consent for clinical research reported in the Helsinki Declaration regards research involving human beings and for this reason it is subordinate to specific and detailed information on the research projects. Summary An important ethical aspect in regard to the role of Biobanks is encouraging sample donation. For donors, seeing human samples being kept rather than discarded, and seeing them become useful for research highlights the importance of the human body and improves the attitude towards donation. This process might also facilitate the giving of informed consent more willingly, and with greater trust. PMID:23547565

Fitting Square Pegs into round Holes: Doing Qualitative Nursing Research in a Quantitative World.

PubMed

Newton, Lorelei; Kimpson, Sally

2014-09-01

The authors, as doctoral candidates and registered nurses, took on a qualitative research project investigating nursing practice in a research-intensive organization. Their aims were to explore and describe how nurses in the ambulatory care setting assist patients and families, including how nursing practice was carried out, constraints to practice, and the influence of the interprofessional milieu. Their first finding, in part because of the qualitative research design used, concerned the potential impact of the organizational ethics review process on the project. The authors discuss how the language, definition of risk, and notion of informed consent articulated in the organizational review process influenced both the research timeline and (potentially) the study itself. While not dismissing the value of ethics review, they explore the tension of overlaying generic criteria for quantitative research, specifically randomized controlled trials, on nursing research from other traditions. Copyright© by Ingram School of Nursing, McGill University.

Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

PubMed

Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles

2017-08-01

Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28%) had no identifiable data collected from any research participants. Overall, only three trials (9%) indicated that a waiver of consent had been granted by a research ethics committee. When considering the combined requirement of research ethics review and informed consent (or a waiver), only one in three studies were compliant. Conclusion The ethical conduct and reporting of key ethical protections in stepped wedge trials, namely, research ethics review and informed consent, are inadequate. We recommend that stepped wedge trials be classified as research and reviewed and approved by a research ethics committee. We also recommend that researchers appropriately identify research participants (which may include health professionals), seek informed consent or appeal to an ethics committee for a waiver of consent, and include explicit details of research ethics approval and informed consent in the trial report.

Imaging Depression in Adults With ASD

DTIC Science & Technology

2015-10-30

immunologic bias in autism spectrum disorder (ASD) confers greater risk for co-occurring depression than severity of ASD. If depression severity is associated...other healthcare professionals or caregivers with an interest in autism spectrum disorders , open to the public. No subject has consented to and enrolled...nationally known researchers in two areas: sign language linguistics and the study of social communication among individuals with autism spectrum disorders

How are we communicating about clinical trials?: an assessment of the content and readability of recruitment resources.

PubMed

Friedman, Daniela B; Kim, Sei-Hill; Tanner, Andrea; Bergeron, Caroline D; Foster, Caroline; General, Kevin

2014-07-01

Clinical trials (CTs) are important for advancing public health and medical research, however, CT recruitment is challenging. The high reading level of CT information and the technical language of providers or researchers can serve as barriers to recruitment. Prior studies on the informed consent process found that consent documents often contain complicated terms. Limited research has examined resources specifically used to recruit individuals into CTs. The purpose of this study was to examine the content and readability of CT recruitment education resources in one U.S. state. Convenience sampling was employed for the collection of CT recruitment materials. A codebook was developed based on previous content analyses and emergent themes from statewide focus groups about CTs. A total of 127 materials were collected and analyzed (37.8% print; 62.2% Web). Most content was focused on treatment-related CTs (60.6%). Inclusion criteria related to specific disease conditions (88.9%) and age (73.6%) were described most often. Only 30% of resources had an explicit call to action. Overall mean readability level was Grade 11.7. Web-based materials were significantly more likely to be written at a higher grade level than print materials (p ≤ .0001). Readability also differed significantly according to resource distributor/creator, CT type, person quoted, and presence or absence of inclusion criteria and an explicit call to action. Our study provides insight into the content and difficulty level of recruitment materials intended to provide initial information about a CT. Future studies should examine individuals' comprehension of recruitment materials and how participation intentions are associated with recruitment messages. Copyright © 2014 Elsevier Inc. All rights reserved.

Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing.

PubMed

Afolabi, Muhammed Olanrewaju; Bojang, Kalifa; D'Alessandro, Umberto; Imoukhuede, Egeruan Babatunde; Ravinetto, Raffaella M; Larson, Heidi Jane; McGrath, Nuala; Chandramohan, Daniel

2014-04-05

International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information. This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia. We developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants' comprehension of the study information was measured by using a validated digitised audio questionnaire. The majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants' 'recall' and 'understanding' between first and second visits were statistically significant (F (1,41)=25.38, p<0.00001 and (F (1, 41) = 31.61, p<0.00001 respectively. Our locally developed multimedia tool was acceptable and easy to administer among low literacy participants in The Gambia. It also proved to be effective in delivering and sustaining comprehension of study information across a diverse group of participants. Additional research is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings.

The ethical use of existing samples for genome research.

PubMed

Bathe, Oliver F; McGuire, Amy L

2009-10-01

Modern biobanking efforts consist of prospective collections of tissues linked to clinical data for patients who have given informed consent for the research use of their specimens and data, including their DNA. In such efforts, patient autonomy and privacy are well respected because of the prospective nature of the informed consent process. However, one of the richest sources of tissue for research continues to be the millions of archived samples collected by pathology departments during normal clinical care or for research purposes without specific consent for future research or genetic analysis. Because specific consent was not obtained a priori, issues related to individual privacy and autonomy are much more complicated. A framework for accessing these existing samples and related clinical data for research is presented. Archival tissues may be accessed only when there is a reasonable likelihood of generating beneficial and scientifically valid information. To minimize risks, databases containing information related to the tissue and to clinical data should be coded, no personally identifying phenotypic information should be included, and access should be restricted to bona fide researchers for legitimate research purposes. These precautions, if implemented appropriately, should ensure that the research use of archival tissue and data are no more than minimal risk. A waiver of the requirement for informed consent would then be justified if reconsent is shown to be impracticable. A waiver of consent should not be granted, however, if there is a significant risk to privacy, if the proposed research use is inconsistent with the original consent (where there is one), or if the potential harm from a privacy breach is considerable.

Informed consent in direct-to-consumer personal genome testing: the outline of a model between specific and generic consent.

PubMed

Bunnik, Eline M; Janssens, A Cecile J W; Schermer, Maartje H N

2014-09-01

Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place--and a need--for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. © 2012 John Wiley & Sons Ltd.

Enhancing the informed consent process for critical care research: strategies from a thromboprophylaxis trial.

PubMed

Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Fleury, Suzie; Krause, Katie; McArdle, Tracey; Skrobik, Yoanna; Cook, Deborah J

2013-12-01

Critically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers. To present strategies that may optimise the process of obtaining informed consent from substitute decision-makers for participation of critically ill patients in trials. We use examples from a randomised trial of heparin thromboprophylaxis in the intensive care unit (PROTECT, clinicaltrials.gov NCT00182143). 3764 patients were randomised, with an informed consent rate of 82%; 90% of consents were obtained from substitute decision-makers. North American PROTECT research coordinators attended three meetings to discuss enrolment: (1) Trial start-up (January 2006); (2) Near trial closure (January 2010); and (3) Post-publication (April 2011). Data were derived from slide presentations, field notes from break-out groups and plenary discussions, then analysed inductively. We derived three phases for the informed consent process: (1) Preparation for the Consent Encounter; (2) The Consent Encounter; and (3) Follow-up to the Consent Encounter. Specific strategies emerged for each phase: Phase 1 (four strategies); Phase 2 (six strategies); and Phase 3 (three strategies). We identified 13 strategies that may improve the process of obtaining informed consent from substitute decision-makers and be generalisable to other settings and studies. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

Patient Education and Informed Consent for Preimplantation Genetic Diagnosis: Health Literacy for Genetics and Assisted Reproductive Technology

PubMed Central

McGowan, Michelle L.; Burant, Chris; Moran, Rocio; Farrell, Ruth

2013-01-01

Introduction Innovative applications of genetic testing have emerged within the field of assisted reproductive technology through preimplantation genetic diagnosis (PGD). As in all forms of genetic testing, adequate genetic counseling and informed consent are critical. Despite the growing recognition of the role of informed consent in genetic testing, there is little data available about how this process occurs in the setting of PGD. Methods A cross sectional study of IVF clinics offering PGD in the U.S. was conducted to assess patient education and informed consent practices. Descriptive data were collected with a self-administered survey instrument. Results More than half of the clinics offering PGD required genetic counseling prior to PGD (56%). Genetic counseling was typically performed by certified genetic counselors (84 %). Less than half (37%) of the clinics required a separate informed consent process for genetic testing of embryonic cells. At a majority of those clinics requiring a separate informed consent for genetic testing (54%), informed consent for PGD and genetic testing took place as a single event before beginning IVF procedures. Conclusions The results suggest that patient education and informed consent practices for PGD have yet to be standardized. These findings warrant the establishment of professional guidelines for patient education and informed consent specific to embryonic genetic testing. PMID:19652605

The Department of Veterans Affairs, Department of Defense, and Kaiser Permanente Nationwide Health Information Network Exchange in San Diego: Patient Selection, Consent, and Identity Matching

PubMed Central

Bouhaddou, Omar; Bennett, Jamie; Cromwell, Tim; Nixon, Graham; Teal, Jennifer; Davis, Mike; Smith, Robert; Fischetti, Linda; Parker, David; Gillen, Zachary; Mattison, John

2011-01-01

The Nationwide Health Information Network allow for the secure exchange of Electronic Health Records over the Internet. The Department of Veterans Affairs, Department of Defense, and Kaiser Permanente, participated in an implementation of the NwHIN specifications in San Diego, California. This paper focuses primarily on patient involvement. Specifically, it describes how the shared patients were identified, were invited to participate and to provide consent for disclosing parts of their medical record, and were matched across organizations. A total 1,144 were identified as shared patients. Invitation letters containing consent forms were mailed and resulted in 42% participation. Invalid consent forms were a significant issue (25%). Initially, the identity matching algorithms yielded low success rate (5%). However, elimination of certain traits and abbreviations and probabilistic algorithms have significantly increased matching rate. Access to information from external sources better informs providers, improves decisions and efficiency, and helps meet the meaningful use criteria. PMID:22195064

The Department of Veterans Affairs, Department of Defense, and Kaiser Permanente Nationwide Health Information Network exchange in San Diego: patient selection, consent, and identity matching.

PubMed

Bouhaddou, Omar; Bennett, Jamie; Cromwell, Tim; Nixon, Graham; Teal, Jennifer; Davis, Mike; Smith, Robert; Fischetti, Linda; Parker, David; Gillen, Zachary; Mattison, John

2011-01-01

The Nationwide Health Information Network allow for the secure exchange of Electronic Health Records over the Internet. The Department of Veterans Affairs, Department of Defense, and Kaiser Permanente, participated in an implementation of the NwHIN specifications in San Diego, California. This paper focuses primarily on patient involvement. Specifically, it describes how the shared patients were identified, were invited to participate and to provide consent for disclosing parts of their medical record, and were matched across organizations. A total 1,144 were identified as shared patients. Invitation letters containing consent forms were mailed and resulted in 42% participation. Invalid consent forms were a significant issue (25%). Initially, the identity matching algorithms yielded low success rate (5%). However, elimination of certain traits and abbreviations and probabilistic algorithms have significantly increased matching rate. Access to information from external sources better informs providers, improves decisions and efficiency, and helps meet the meaningful use criteria.

Asking the difficult questions: message strategies used by organ procurement coordinators in requesting familial consent to organ donation.

PubMed

Anker, Ashley E; Feeley, Thomas Hugh

2011-07-01

The present study provides an in-depth examination of the messages used by organ procurement coordinators (OPCs) in shaping familial requests for organ donation. OPCs (N = 102), recruited from a national sample of 16 organ procurement organizations, participated in a structured interview designed to uncover the communication strategies used in obtaining familial consent for donation. Analysis of interviews indicates OPCs' messages cover 4 domain areas. Specifically, OPCs report use of messages intended to (a) provide education, (b) discuss the benefits to donation, (c) learn about potential donor families, and (d) persuade families to engage in donation. Within the 4 domain areas, OPCs report use of 15 specific messages (e.g., "positively framing the donor," "social proof," "discuss the benefit of donation to grieving") in requesting consent. The present study provides a detailed examination of strategies and offers recommendations for using message strategies to explore the effectiveness of the consent process from the perspective of OPCs in approaching donor families.

Enhancing HIV Vaccine Trial Consent Preparedness Among Street Drug Users

PubMed Central

Fisher, Celia B.

2011-01-01

This research used open-ended and true-false questions to assess the preparedness of 96 ethnically diverse, economically and socially marginalized adult street drug users to consent to participate in HIV vaccine trials (HVT). Specific areas of consent vulnerability included misconceptions about: (1) the recuperative value and risk of vaccines in general; (2) the presence of the HIV virus within the vaccine and the possibility of contracting or transmitting HIV as a consequence of participation; (3) inclusion criteria and experimental blinds; and (4) distrust in the medical and research establishments. A brief HVT lesson administered to 30 participants was effective in correcting specific HVT knowledge misperceptions and increasing certain, but not all areas of HVT trust. Assessment of post-lesson responses to ethics-relevant questions provides information on respondents' attitudes toward AIDS safe behavior, research risks and benefits, monetary compensation, and willingness to participate. Implications for enhancing informed consent for HVT involving active drug users are discussed. PMID:20569151

Obstetrics and gynaecology residents' knowledge of the informed consent process and its practice in their training institutions.

PubMed

Okonta, P I

2015-01-01

The ethical principle of autonomy as expressed in the practice of informed consent is a core tenet of clinical practice and good patient physician relationship. The aim was to identify specific gaps in the knowledge of trainee obstetricians and gynecologists in Nigeria about the informed consent process and its content. It also sought to describe the practice of informed consent in their respective institutions. A survey of Residents in obstetrics and gynecology attending the revision course of the Faculty of obstetrics and gynecology of the national postgraduate medical college was done to determine their knowledge of the informed consent process and its practice in their institutions. None of the residents was able to give responses that contained all five conditions for informed consent to be valid. Furthermore, only 3 (2.22%) Residents mentioned that the name of the surgeon to perform the surgery should be part of the information provided to patients during the informed consent process. Similarly, only 8 (5.93%) mentioned that consequences of not having the surgery should be part of the informed consent process. The concept of the 'emancipated minor' being competent to give consent was known by 38% of the residents. Although Residents in obstetrics and gynecology in Nigeria have some knowledge of the informed consent process, this knowledge is deficient in key areas such as competence to give consent, content and scope of information to be disclosed to patients for surgery. There is a need to teach residents the rudiments of informed consent and bioethics in general.

Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

PubMed

Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

2018-02-01

Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

Interpreter services in an inner city teaching hospital: a 6-year experience.

PubMed

Khwaja, Nadeem; Sharma, Saroj; Wong, Julian; Murray, David; Ghosh, Jonathan; Murphy, Michael O; Halka, Anastassi T; Walker, Michael G

2006-11-01

Being able to communicate effectively with patients is essential not only from a medicolegal standpoint but more importantly from clinical governance perspectives. Issues such as informed consent and patient choice within the NHS are currently being highlighted; for these to be available to patients, their language requirements are paramount. An audit was performed by the Linkworkers office at the Central Manchester & Manchester Children's Hospital NHS (CMMC) Trust on the total number of attendances and refusals per language in the period 1998-2003. In the CMMC Trust, Urdu/Punjabi, Bengali, Cantonese, Somali, Arabic and French represent the majority of the workload, comprising almost 80% of cases in 2003. In the same year, an increase in demand for languages of Eastern European countries became evident. Finding interpreters for these languages even via agencies can be extremely difficult. If the current trend continues, requirement for these services will increase exponentially. For this demand to be met adequately these issues must be kept at the forefront of NHS planning.

[The doctrine of free and informed consent: its ethical and legal foundations and its applications in research and practice of psychiatry].

PubMed

Grunberg, F

1990-06-01

This article briefly examines the ethical and legal foundations for the doctrine of informed consent in medical research and practice. The doctrine is based upon the importance of respecting the individual's autonomy and his right to self-determination. The article also reviews the development of the doctrine of informed consent based on its recent application. The authors cite the Nuremburg Code and the Helsinki Declarations and particularly the media denunication of several scandals in the United States during the late 1960s, when Henri Beecher's name figured prominently. The effects of informed consent in psychiatry are examined specifically, as well as the consequences for psychiatric research, on subjects who are able to give their consent, as well as those who are unable to do so. As for its effects on clinical practice, the paper discusses the right of the hospitalized patient to refuse treatment, and informed consent and the risks for patients treated with neuroleptics of developing tardive dyskinesia. The authors conclude that in psychotherapy the concept of informed consent cannot be taken for granted.

Open consent, biobanking and data protection law: can open consent be 'informed' under the forthcoming data protection regulation?

PubMed

Hallinan, Dara; Friedewald, Michael

2015-01-01

This article focuses on whether a certain form of consent used by biobanks--open consent--is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent--in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context--exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of 'data'. The authors argue that these assumptions are difficult to apply to genetic data and accordingly a different approach to consent might be preferable. Such an approach might be more open consent friendly.

Informed consent in the context of pharmacogenomic research: ethical considerations.

PubMed

Howard, H C; Joly, Y; Avard, D; Laplante, N; Phillips, M; Tardif, J C

2011-06-01

Although the scientific research surrounding pharmacogenomics (PGx) has been relatively plentiful, the ethical research concerning this discipline has developed rather conservatively. Following investigation of the ethical, legal and social issues (ELSI) of PGx research, as well as consulting with key stakeholders, we identified six outstanding ethical issues raised by the informed consent process in PGx research: (1) scope of consent; (2) consent to 'add-on' studies; (3) protection of personal information; (4) commercialization; (5) data sharing; and (6) potential risks stemming from population-based research. In discussing these six areas as well as offering specific considerations, this article offers a solid base from which future practical guidelines for informed consent in PGx research can be constructed. As such, this effort works toward filling the ELSI gap and provides ethical support to the numerous PGx projects undertaken by researchers every year.

To ‘Get by’ or ‘get help’? A qualitative study of physicians’ challenges and dilemmas when patients have limited English proficiency

PubMed Central

Parsons, Janet A; Baker, Natalie A; Smith-Gorvie, Telisha; Hudak, Pamela L

2014-01-01

Objective Encounters between patients and physicians who do not speak the same language are relatively common in Canada, particularly in urban settings; this trend is increasing worldwide. Language discordance has important effects on health outcomes, including mortality. This study sought to explore physicians’ experiences of care provision in situations of language discordance in depth. Design Qualitative study based on individual interviews. Interview guides elicited physicians’ perspectives on how they determined whether communication could proceed unaided. A descriptive qualitative approach was adopted, entailing inductive thematic analysis. Participants 22 physicians experienced in treating patients in situations of language discordance were recruited from the emergency and internal medicine departments of an urban tertiary-care hospital. Setting Large, inner-city teaching hospital in Toronto, Canada, one of the most linguistically diverse cities internationally. Results Determining when to ‘get by’ or ‘get help’ in order to facilitate communication was described as a fluid and variable process. Deciding which strategy to use depended on three inter-related factors: time/time constraints, acuity of situation and ease of use/availability of translation aids. Participants reported at times feeling conflicted about their decisions, portraying some of these clinical encounters as a ‘troubling space’ in which they experienced one or more dilemmas related to real versus ideal practice, responsibility and informed consent. Conclusions In situations of language discordance, a physician's decision to ‘get by’ (vs ‘get help’) rests on a judgement of whether communication can be considered ‘good enough’ to proceed and depends on the circumstances of the specific encounter. The tension set up between what is ‘ideal’ and what is practically possible can be experienced as a dilemma by physicians. The study's findings have implications for practice and policy not only in Canada but in other multilingual settings, and indicate that physicians require greater support. PMID:24902724

10 CFR 850.36 - Medical consent.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Medical consent. 850.36 Section 850.36 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Specific Program Requirements § 850.36 Medical... medical surveillance program established in § 850.34 at least one week before the first medical evaluation...

10 CFR 850.36 - Medical consent.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Medical consent. 850.36 Section 850.36 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Specific Program Requirements § 850.36 Medical... medical surveillance program established in § 850.34 at least one week before the first medical evaluation...

10 CFR 850.36 - Medical consent.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Medical consent. 850.36 Section 850.36 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Specific Program Requirements § 850.36 Medical... medical surveillance program established in § 850.34 at least one week before the first medical evaluation...

10 CFR 850.36 - Medical consent.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Medical consent. 850.36 Section 850.36 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Specific Program Requirements § 850.36 Medical... medical surveillance program established in § 850.34 at least one week before the first medical evaluation...

10 CFR 850.36 - Medical consent.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Medical consent. 850.36 Section 850.36 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Specific Program Requirements § 850.36 Medical... medical surveillance program established in § 850.34 at least one week before the first medical evaluation...

"The angel of the house" in the realm of ART: feminist approach to oocyte and spare embryo donation for research.

PubMed

Alichniewicz, Anna; Michalowska, Monika

2014-02-01

The spectacular progress in assisted reproduction technology that has been witnessed for the past thirty years resulted in emerging new ethical dilemmas as well as the revision of some perennial ones. The paper aims at a feminist approach to oocyte and spare embryo donation for research. First, referring to different concepts of autonomy and informed consent, we discuss whether the decision to donate oocyte/embryo can truly be an autonomous choice of a female patient. Secondly, we argue the commonly adopted language of gift is misleading and that calling for altruism could put female patients at risk of exploitation. Finally, we point out that the presence of gender stereotypes in the procreative area casts doubt whether even a more robust notion of informed consent manages to overcome this risk.

A randomized study of a method for optimizing adolescent assent to biomedical research.

PubMed

Annett, Robert D; Brody, Janet L; Scherer, David G; Turner, Charles W; Dalen, Jeanne; Raissy, Hengameh

2017-01-01

Voluntary consent/assent with adolescents invited to participate in research raises challenging problems. No studies to date have attempted to manipulate autonomy in relation to assent/consent processes. This study evaluated the effects of an autonomy-enhanced individualized assent/consent procedure embedded within a randomized pediatric asthma clinical trial. Families were randomly assigned to remain together or separated during a consent/assent process; the latter we characterize as an autonomy-enhanced assent/consent procedure. We hypothesized that separating adolescents from their parents would improve adolescent assent by increasing knowledge and appreciation of the clinical trial and willingness to participate. Sixty-four adolescent-parent dyads completed procedures. The together versus separate randomization made no difference in adolescent or parent willingness to participate. However, significant differences were found in both parent and adolescent knowledge of the asthma clinical trial based on the assent/consent procedure and adolescent age. The separate assent/consent procedure improved knowledge of study risks and benefits for older adolescents and their parents but not for the younger youth or their parents. Regardless of the assent/consent process, younger adolescents had lower comprehension of information associated with the study medication and research risks and benefits, but not study procedures or their research rights and privileges. The use of an autonomy-enhanced assent/consent procedure for adolescents may improve their and their parent's informed assent/consent without impacting research participation decisions. Traditional assent/consent procedures may result in a "diffusion of responsibility" effect between parents and older adolescents, specifically in attending to key information associated with study risks and benefits.

Perception on Informed Consent Regarding Nursing Care Practices in a Tertiary Care Center.

PubMed

Paudel, B; Shrestha, G K

Background Consent for care procedures is mandatory after receipt of adequate information. It maintains patient's rights and autonomy to make thoughtful decisions. Poor communication often leads to poor health quality. Objective To assess hospitalized patients' perception on informed consent regarding nursing care practices in a tertiary care center. Method This is a descriptive cross-sectional study among 113 admitted patients conducted in February 2012 at Dhulikhel Hospital, Nepal. Patients of various wards were selected using purposive non-probability sampling with at least 3 days of hospitalization. Close ended structured questionnaire was used to assess patients' perception on three different areas of informed consent (information giving, opportunity to make decision and taking prior consent). Result Among the participants 71.6% perceived positively regarding informed consent towards nursing care practices with a mean score of 3.32 ± 1.28. Patients' perception on various areas of informed consent viz. information giving, opportunities to make specific decision and taking prior consent were all positive with mean values of 3.43±1.12, 2.88±1.23, 3.65±1.49 respectively. Comparison of mean perception of informed consent with various variables revealed insignificant correlation (p-value >0.05) for age, educational level and previous hospitalization while it was significant (p-value < 0.05) for communication skills of nurses. Conclusion Majority of patients have positive perception on informed consent towards nursing care practices. Communication skills of nurses affect the perception of patients' regardless of age, education level and past experiences.

[Schizophrenia and informed consent to research].

PubMed

Fovet, T; Amad, A; Thomas, P; Jardri, R

2015-10-01

Informed consent to research remains a complex issue, while sometimes staying difficult to obtain, even in the general population. This problem may be maximized with patients suffering from schizophrenia. This paper summarizes available data in the literature about informed consent for research involving patients suffering from schizophrenia. Medline and Google Scholar searches were conducted using the following MESH terms: schizophrenia, informed consent and research. Studies using dedicated standardized scales (e.g. MacCAT-CR) revealed a decrease in the capacity to consent of patients with schizophrenia when compared with healthy individuals. Keeping in mind that schizophrenia is an heterogeneous disorder, patients with the lowest insight as well as those with the most severe cognitive symptoms appeared more impaired in their capacity to consent. Such a poor capacity to understand and consent to trials was shown linked with alterations in decision-making. For these specific patients, interventions may be set up to increase their capacity to consent. Various strategies were proposed: enhanced consent forms, extended discussion, test/feedback method or multimedia interventions. Among them, interventions relying on communication and the growing field of information technologies (e.g. web-based tools) seem promising. Finally, associations grouping families and patients (like the French Association UNAFAM) may facilitate the involvement of patients in research programs with safer conditions. Patients suffering from schizophrenia appear able to consent to research programs when suitable interventions are proposed. Further studies are now needed to optimize and individualize such interventions. Copyright © 2014 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India.

PubMed

Joglekar, Neelam S; Deshpande, Swapna S; Sahay, Seema; Ghate, Manisha V; Bollinger, Robert C; Mehendale, Sanjay M

2013-03-01

Optimum comprehension of informed consent by research participants is essential yet challenging. This study explored correlates of lower comprehension of informed consent among 1334 participants of a cohort study aimed at estimating HIV incidence in Pune, India. As part of the informed consent process, a structured comprehension tool was administered to study participants. Participants scoring ≥90% were categorised into the 'optimal comprehension group', whilst those scoring 80-89% were categorised into the 'lower comprehension group'. Data were analysed to identify sociodemographic and behavioural correlates of lower consent comprehension. The mean ± SD comprehension score was 94.4 ± 5.00%. Information pertaining to study-related risks was not comprehended by 61.7% of participants. HIV-negative men (adjusted OR [AOR] = 4.36, 95% CI 1.71-11.05) or HIV-negative women (AOR = 13.54, 95% CI 6.42-28.55), illiteracy (AOR= 1.65, 95% CI 1.19-2.30), those with a history of multiple partners (AOR = 1.73, 95% CI 1.12-2.66) and those never using condoms (AOR = 1.35, 95% CI 1.01-1.82) were more likely to have lower consent comprehension. We recommend exploration of domains of lower consent comprehension using a validated consent comprehension tool. Improved education in these specific domains would optimise consent comprehension among research participants.

A systematic literature review of individuals' perspectives on broad consent and data sharing in the United States.

PubMed

Garrison, Nanibaa' A; Sathe, Nila A; Antommaria, Armand H Matheny; Holm, Ingrid A; Sanderson, Saskia C; Smith, Maureen E; McPheeters, Melissa L; Clayton, Ellen W

2016-07-01

In 2011, an Advanced Notice of Proposed Rulemaking proposed that de-identified human data and specimens be included in biobanks only if patients provide consent. The National Institutes of Health Genomic Data Sharing policy went into effect in 2015, requiring broad consent from almost all research participants. We conducted a systematic literature review of attitudes toward biobanking, broad consent, and data sharing. Bibliographic databases included MEDLINE, Web of Science, EthxWeb, and GenETHX. Study screening was conducted using DistillerSR. The final 48 studies included surveys (n = 23), focus groups (n = 8), mixed methods (n = 14), interviews (n = 1), and consent form analyses (n = 2). Study quality was characterized as good (n = 19), fair (n = 27), and poor (n = 2). Although many participants objected, broad consent was often preferred over tiered or study-specific consent, particularly when broad consent was the only option, samples were de-identified, logistics of biobanks were communicated, and privacy was addressed. Willingness for data to be shared was high, but it was lower among individuals from under-represented minorities, individuals with privacy and confidentiality concerns, and when pharmaceutical companies had access to data. Additional research is needed to understand factors affecting willingness to give broad consent for biobank research and data sharing in order to address concerns to enhance acceptability.Genet Med 18 7, 663-671.

Participation in clinical research: perspectives of adult patients and parents of pediatric patients undergoing hematopoietic stem cell transplantation.

PubMed

Keusch, Florian; Rao, Rohini; Chang, Lawrence; Lepkowski, James; Reddy, Pavan; Choi, Sung Won

2014-10-01

Despite major improvements over the past several decades, many patients undergoing hematopoietic stem cell transplantations (HSCT) continue to suffer from significant treatment-related morbidity and mortality. Clinical research studies (trials) have been integral to advancing the standard of care in HSCT. However, 1 of the biggest challenges with clinical trials is the low participation rate. Although barriers to participation in cancer clinical trials have been previously explored, studies specific to HSCT are lacking. The current study was undertaken to examine the knowledge, attitudes, and perceptions of HSCT patients regarding clinical trials. As members of focus groups, participants responded to open-ended questions that assessed factors influencing decision-making about HSCT clinical trials. Suggestions for improvements in the recruitment process were also solicited among participants. Seventeen adult HSCT patients and 6 parents of pediatric HSCT patients participated in the study. The median age was 56 years (range, 18 to 70) and 44 years (range, 28 to 54) for adult patients and parents, respectively. Participants universally indicated that too much information was provided within the informed consents and they were intimidated by the medical and legal language. Despite the large amount of information provided to them at the time of study enrollment, the participants had limited knowledge retention and recall of study details. Nevertheless, participants reported overall positive experiences with clinical trial participation and many would readily choose to participate again. A common concern among participants was the uncertainty of study outcome and general lack of feedback about results at the end of the study. Participants suggested that investigators provide more condensed and easier to understand informed consents and follow-up of study findings. These findings could be used to help guide the development of improved consent documents and enhanced participation in research studies, thereby affecting the future design of HSCT research protocols. Copyright © 2014 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Children, biobanks and the scope of parental consent

PubMed Central

Hens, Kristien; Cassiman, Jean-Jacques; Nys, Herman; Dierickx, Kris

2011-01-01

The use of stored tissue samples from children for genetic research raises specific ethical questions that are not all analogous to those raised when adult participants are concerned. These include issues with regard to consent, as it is typically a parent who consents to the use of samples from children. In this paper, we discuss the scope of parental consent. This scope has a temporal dimension and one related to the content of consent. It is not questioned that the temporal scope of parental consent is limited and that young adults have the right to decide on the fate of their samples when they reach the age of maturity. With regard to the content of consent, the question remains whether parents are allowed to give full broad consent to any possible future research on the samples of their children. We argue that they should not be allowed to do so, based on two premises. First, it is generally acknowledged that children have a right to express their own values and that they should be given the opportunity to develop their own autonomy as they grow older. Second, research and science are not completely value-free and some types of research may be more sensitive than other types. Children should be given the opportunity to express their values also in this respect. PMID:21386873

Efficacy of a Procedure-Specific Education Module on Informed Consent in Plastic Surgery.

PubMed

Brandel, Michael G; Reid, Christopher M; Parmeshwar, Nisha; Dobke, Marek K; Gosman, Amanda A

2017-05-01

Truly informed consent is an elusive goal, seldom attained in medical or surgical practice. Patients often do not fully understand procedures and therapies they undergo or the associated sequelae. Historically, informed consent and patient education have been limited to physician discussions, sometimes with the addition of simple visual aids. More recently, there is a growing body of decision aids available, including interactive multimedia patient educational modules that review preoperative through postoperative care, risks, benefits, alternatives, different surgical options, as well as commonly asked questions. We hypothesized that the addition of a Web-based educational tool would positively impact attainment of informed consent and satisfaction in plastic surgery patients. We performed a prospective randomized controlled study comparing patients who presented in consultation for breast reconstruction, breast reduction, and abdominoplasty. Patients received standard patient education along with a procedure-specific (study) or general patient safety (control) Web-based educational module. Informed consent was measured using a surgical-focused, modified version of the Shared Decision-making 25 index tool. Patient demographic information as well as surrogate markers of familiarity with technology were recorded preoperatively and postoperatively. Comparisons were made between study and control groups, procedure subgroups, and preoperative and postoperative time points. Demographic factors and consent variables were compared among experimental and procedure groups. Data were collected from 65 patients preoperatively and 48 patients postoperatively. Thirty patients competed both surveys. Overall, no differences in patient characteristics or familiarity with technology were observed between experimental groups. Demographic characteristics were also similar between groups. No meaningful differences were identified in comparisons between experimental groups on either cross-sectional or longitudinal analyses. Nearly all patient responses were consistent with being well informed and satisfied with the educational process. Overall, patients undergoing plastic surgery procedures are adequately informed and have a high degree of satisfaction regarding their patient education. The addition of a Web-based informed consent tool did not make a demonstrable difference in informed consent.

Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China

PubMed Central

Wen, Gaiyan; Liu, Xinchun; Huang, Lihua; Shu, Jingxian; Xu, Nana; Chen, Ruifang; Huang, Zhijun; Yang, Guoping; Wang, Xiaomin; Xiang, Yuxia; Lu, Yao; Yuan, Hong

2016-01-01

Purpose To explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs. Methods The length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared. Results Among the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02–4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P < 0.05). Conclusion The ICFs used in China were difficult to read for most participants. These forms had poor description of alternatives to participation, and failed to provide a high degree of information disclosure, including an explanation of informed consent, follow-up processing of the data/sample, inclusion/exclusion criteria, double blinding, and unpredictable risks. International ICFs had better readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China. PMID:27701471

Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China.

PubMed

Wen, Gaiyan; Liu, Xinchun; Huang, Lihua; Shu, Jingxian; Xu, Nana; Chen, Ruifang; Huang, Zhijun; Yang, Guoping; Wang, Xiaomin; Xiang, Yuxia; Lu, Yao; Yuan, Hong

2016-01-01

To explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs. The length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared. Among the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02-4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P < 0.05). The ICFs used in China were difficult to read for most participants. These forms had poor description of alternatives to participation, and failed to provide a high degree of information disclosure, including an explanation of informed consent, follow-up processing of the data/sample, inclusion/exclusion criteria, double blinding, and unpredictable risks. International ICFs had better readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China.

Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing

PubMed Central

Afolabi, Muhammed Olanrewaju; Bojang, Kalifa; D’Alessandro, Umberto; Imoukhuede, Egeruan Babatunde; Ravinetto, Raffaella M; Larson, Heidi Jane; McGrath, Nuala; Chandramohan, Daniel

2014-01-01

Background International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information. Objectives This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia. Methods We developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants’ comprehension of the study information was measured by using a validated digitised audio questionnaire. Results The majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants’ ‘recall’ and ‘understanding’ between first and second visits were statistically significant (F (1,41)=25.38, p<0.00001 and (F (1, 41) = 31.61, p<0.00001 respectively. Conclusions Our locally developed multimedia tool was acceptable and easy to administer among low literacy participants in The Gambia. It also proved to be effective in delivering and sustaining comprehension of study information across a diverse group of participants. Additional research is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings. PMID:25133065

Assessing chronic stroke survivors with aphasia sheds light on prevalence of spatial neglect

PubMed Central

Hreha, Kimberly; Mulry, Claire; Gross, Melissa; Jedziniak, Tarah; Gramas, Natanya; Ohevshalom, Leora; Sheridan, Alisha; Szabo, Gretchen; Davison, Christina; Barrett, A. M.

2016-01-01

Background Stroke is a chronic disease. Standardized assessment is essential in order to determine areas for treatment. Individuals with aphasia are often excluded from research, because it is believed that their language impairments may impact their ability to provide informed consent. Thus, right spatial neglect could be under-diagnosed. Objective This study was developed to (1) determine the frequency of spatial neglect in chronic left-brain stroke survivors with aphasia, (2) determine the clinical utility of an aphasia-friendly consent form, and (3) determine any differences between neglect and no-neglect groups regarding activities of daily living (ADL) performance and community independence. Methods Forty-six people were consented at community center. Three were screen failures secondary to the exclusion criteria. A novel, aphasia-friendly consent form was developed to facilitate participation of individuals with aphasia. This enabled 93% or 40 out of the 43 recruited participants to be included in this study. The Behavioral Inattention Test-conventional and the Catherine Bergego Scale via Kessler Foundation Neglect Assessment Process (CBS via KF-NAP) were utilized to determine neglect. The Life Space Questionnaire was used to determine community mobility and independence. The Barthel Index (BI) was used for objective clarification of performance in ADL. Results Successful use of the consent form resulted in determination that five out of 40 (12.5%) met criteria for spatial neglect; (on the CBS via KF-NAP). The neglect group had lower scores on the Life Space, suggesting less community mobility and independence, however, it was not statistically significant (p = 0.16). Differences in BI scores were also not significant (p = .013) but the neglect group did have reduced independence. Conclusions This study demonstrates the need to administer functional neglect assessments in left-brain stroke and to include individuals with aphasia in research. PMID:27322860

Assessing chronic stroke survivors with aphasia sheds light on prevalence of spatial neglect.

PubMed

Hreha, Kimberly; Mulry, Claire; Gross, Melissa; Jedziniak, Tarah; Gramas, Natanya; Ohevshalom, Leora; Sheridan, Alisha; Szabo, Gretchen; Davison, Christina; Barrett, A M

2017-03-01

Stroke is a chronic disease. Standardized assessment is essential in order to determine areas for treatment. Individuals with aphasia are often excluded from research, because it is believed that their language impairments may impact their ability to provide informed consent. Thus, right spatial neglect could be under-diagnosed. This study was developed to (1) determine the frequency of spatial neglect in chronic left-brain stroke survivors with aphasia, (2) determine the clinical utility of an aphasia-friendly consent form, and (3) determine any differences between neglect and no-neglect groups regarding activities of daily living (ADL) performance and community independence. Forty-six people were consented at community center. Three were screen failures secondary to the exclusion criteria. A novel, aphasia-friendly consent form was developed to facilitate participation of individuals with aphasia. This enabled 93% or 40 out of the 43 recruited participants to be included in this study. The Behavioral Inattention Test-conventional and the Catherine Bergego Scale via Kessler Foundation Neglect Assessment Process (CBS via KF-NAP) were utilized to determine neglect. The Life Space Questionnaire was used to determine community mobility and independence. The Barthel Index (BI) was used for objective clarification of performance in ADL. Successful use of the consent form resulted in determination that five out of 40 (12.5%) met criteria for spatial neglect; (on the CBS via KF-NAP). The neglect group had lower scores on the Life Space, suggesting less community mobility and independence, however, it was not statistically significant (p = 0.16). Differences in BI scores were also not significant (p = .013) but the neglect group did have reduced independence. This study demonstrates the need to administer functional neglect assessments in left-brain stroke and to include individuals with aphasia in research.

Establishing and adhering to sexual consent: the association between reading magazines and college students' sexual consent negotiation.

PubMed

Hust, Stacey J T; Marett, Emily Garrigues; Ren, Chunbo; Adams, Paula M; Willoughby, Jessica F; Lei, Ming; Ran, Weina; Norman, Cassie

2014-01-01

Content analyses have cataloged the sexual scripts present in magazines largely because of their perceived value to readers and their potential role as sex educators. Although it is generally agreed that magazines have the potential to influence sexual attitudes and behavioral intentions, the effects of this medium are not as frequently researched as are other forms of media. The current study tested whether exposure to magazines was associated with intentions related to sexual consent negotiation. A survey of 313 college students indicated that exposure to men's magazines was significantly associated with lower intentions to seek sexual consent and lower intentions to adhere to decisions about sexual consent. In contrast, exposure to women's magazines was significantly associated with greater intentions to refuse unwanted sexual activity. Overall, the findings of this study further reinforce the critical need for responsible and realistic portrayals of sex in entertainment media, specifically magazines.

Chemically dependent physicians and informed consent disclosure.

PubMed

Ackerman, T F

1996-01-01

Developments in law, professional guidelines, and public attitudes support informed consent disclosure by physicians who have been treated for chemical dependency. This view is built on the apparent materiality of the risk of relapse to informed treatment decisions by patients. Several considerations undercut this position. The probability is remote that a patient will be injured by a recovering physician who suffers an undetected relapse while being properly monitored. Monitoring by impaired physicians programs provides a more sensitive and specific mechanism for detecting relapsed physicians. Moreover, compromise of the privacy and employment rights of recovering physicians by consent disclosure is not justified if programs provide rigorous monitoring that protects the welfare of patients. Finally, required consent disclosure will reduce referrals of chemically dependent physicians to impaired physicians programs, thereby increasing the danger to patients. Limiting demands for required consent disclosure necessitates effective operation of impaired physicians programs.

77 FR 26438 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-04

...EPA is taking direct final action to approve State Implementation Plan (SIP) revisions submitted by the Maryland Department of the Environment (MDE) pertaining to the GenOn Chalk Point Generating Station (Chalk Point). These revisions approve specific provisions of a 2011 Consent Decree between MDE and GenOn to reduce particulate matter (PM), sulfur oxides (SOX), and nitrogen oxides (NOX) from Chalk Point. These revisions also remove the 1978 and 1979 Consent Orders for the Chalk Point generating station from the Maryland SIP as those Consent Orders have been superseded by the 2011 Consent Decree. EPA is approving these SIP revisions because the reductions of PM, SOX, and NOX are beneficial for reducing ambient levels of the PM, sulfur dioxide (SO2), nitrogen dioxide (NO2) and ozone. They also reduce visible emissions from Chalk Point. This action is being taken under the Clean Air Act (CAA).

Culturally diverse attitudes and beliefs of students majoring in speech-language pathology.

PubMed

Franca, Maria Claudia; Smith, Linda McCabe; Nichols, Jane Luanne; Balan, Dianna Santos

Academic education in speech-language pathology should prepare students to provide professional services that mirror current knowledge, skills, and scope of practice in a pluralistic society. This study seeks to examine the impact of speech-language pathology (SLP) students prior multicultural experiences and previous formal education on attitudes and beliefs toward language diversity. A survey to investigate SLP students attitudes toward language diversity was applied. After the research study and instructions to complete the consent form questionnaire was presented by a research assistant, an announcement was given by a graduate student who speaks English as a second language with an accent. The participants then completed a questionnaire containing questions related to attitudes about the presentation of the announcement in particular and toward language diversity in general. Responses suggested a relationship between self-reported cultural bias and ability to concentrate on speech with an accent, and the extent of interaction with individuals from a cultural and linguistic diverse (CLD) background. Additional outcomes revealed that cultural bias may be predicted by factors related to amount of CLD exposure. Results of this study indicated critical areas that need to be considered when developing curricula in speech-language pathology programs. The results will be useful in determining procedures applicable in larger investigations, and encourage future research on attitudes and beliefs toward aspects of cultural diversity.

[The Willingness to Consent to the Linkage of Primary and Secondary Data: An Analysis Based on a Survey of Patients with Primary Breast Cancer in Northrhine Westfalia].

PubMed

Scholten, N; Pfaff, H; Raabe, N; Kowalski, C

2017-03-01

Introduction: By linking data it is possible to merge, for example, survey data with routine data from statutory health insurance (GKV), to gain benefit from the advantages of both. As personal data is involved, it is necessary to obtain consent. Previous studies show that willingness to release this kind of data for scientific research is limited. This fact restricts the number of participants and can cause selection bias. The aim of our study was to analyze willingness to consent to the linkage of survey data with statutory health insurance data in patients with primary breast cancer. Associations between approval and socio-demographic characteristics were explored. Method: In the annual survey of patients with primary breast cancer in certified breast centers in North Rhine-Westphalia, all included patients were questioned concerning their willingness to consent to data linkage. We distinguished between patients insured by AOK Rhineland/Hamburg and all other patients: based on cooperation with AOK Rhineland/Hamburg, we obtained consent to actually link the data for all patients insured there. All other patients were questioned in terms of their insurance and their willingness to consent in general. Results: A total of 2,387 questionnaires were returned, giving a return rate of 49.3%. For the AOK Rhineland/Hamburg-insured patients, the consent rate was at 89.6%. At 75.7%, positive attitudes towards data linkage turned out to be a bit lower for patients with other insurers. Under the assumption that all non-responders disapprove data linkage, still 38.1% of patients showed a positive attitude towards data linkage. As a result of the multivariable model, insurance status (private vs. statutory) and first language turned out to be the only significant factors influencing the response. The consent of patients insured by AOK Rhineland/Hamburg is not significantly influenced by any of the measured socio-demographic factors. Conclusion: Currently, there is not much knowledge on the acceptance of data linkage in patients suffering from an acute illness. Although our results are restricted to breast cancer patients, they are able to uncover problems and chances concerning data linkage. © Georg Thieme Verlag KG Stuttgart · New York.

Consent, Refusal, and Waivers in Patient-Centered Dysphagia Care: Using Law, Ethics, and Evidence to Guide Clinical Practice.

PubMed

Horner, Jennifer; Modayil, Maria; Chapman, Laura Roche; Dinh, An

2016-11-01

When patients refuse medical or rehabilitation procedures, waivers of liability have been used to bar future lawsuits. The purpose of this tutorial is to review the myriad issues surrounding consent, refusal, and waivers. The larger goal is to invigorate clinical practice by providing clinicians with knowledge of ethics and law. This tutorial is for educational purposes only and does not constitute legal advice. The authors use a hypothetical case of a "noncompliant" individual under the care of an interdisciplinary neurorehabilitation team to illuminate the ethical and legal features of the patient-practitioner relationship; the elements of clinical decision-making capacity; the duty of disclosure and the right of informed consent or informed refusal; and the relationship among noncompliance, defensive practices, and iatrogenic harm. We explore the legal question of whether waivers of liability in the medical context are enforceable or unenforceable as a matter of public policy. Speech-language pathologists, among other health care providers, have fiduciary and other ethical and legal obligations to patients. Because waivers try to shift liability for substandard care from health care providers to patients, courts usually find waivers of liability in the medical context unenforceable as a matter of public policy.

Informed consent in surgical trials.

PubMed

Etchells, E

1999-12-01

All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. To protect vulnerable persons, an incapable person should not be enrolled in most clinical trials. The only exception is if the study can only be conducted on incapable persons. If the willing research participant is incapable, consent must be obtained from others through a process called substitute (or proxy) consent. Disclosure refers to the provision of relevant information to the patient and its comprehension by the patient. Most surgical trials carry more than minimal risks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.

Consent for third molar tooth extractions in Australia and New Zealand: a review of current practice.

PubMed

Badenoch-Jones, E K; Lynham, A J; Loessner, D

2016-06-01

Informed consent is the legal requirement to educate a patient about a proposed medical treatment or procedure so that he or she can make informed decisions. The purpose of the study was to examine the current practice for obtaining informed consent for third molar tooth extractions (wisdom teeth) by oral and maxillofacial surgeons in Australia and New Zealand. An online survey was sent to 180 consultant oral and maxillofacial surgeons in Australia and New Zealand. Surgeons were asked to answer (yes/no) whether they routinely warned of a specific risk of third molar tooth extraction in their written consent. Seventy-one replies were received (39%). The only risks that surgeons agreed should be routinely included in written consent were a general warning of infection (not alveolar osteitis), inferior alveolar nerve damage (temporary and permanent) and lingual nerve damage (temporary and permanent). There is significant variability among Australian and New Zealand oral and maxillofacial surgeons regarding risk disclosure for third molar tooth extractions. We aim to improve consistency in consent for third molar extractions by developing an evidence-based consent form. © 2016 Australian Dental Association.

42 CFR Appendix to Subpart F of... - Required Consent Form

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Required Consent Form Appendix to Subpart F of Part 441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations Pt. 441, Subpt. F, App....

42 CFR Appendix to Subpart F of... - Required Consent Form

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Required Consent Form Appendix to Subpart F of Part 441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations Pt. 441, Subpt. F, App....

42 CFR Appendix to Subpart F of... - Required Consent Form

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Required Consent Form Appendix to Subpart F of Part 441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations Pt. 441, Subpt. F, App....

42 CFR Appendix to Subpart F of... - Required Consent Form

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Required Consent Form Appendix to Subpart F of Part 441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations Pt. 441, Subpt. F, App....

42 CFR Appendix to Subpart F of... - Required Consent Form

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Required Consent Form Appendix to Subpart F of Part 441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations Pt. 441, Subpt. F, App....

"Let's get the best quality research we can": public awareness and acceptance of consent to use existing data in health research: a systematic review and qualitative study.

PubMed

Hill, Elizabeth M; Turner, Emma L; Martin, Richard M; Donovan, Jenny L

2013-06-04

Opt-in consent is usually required for research, but is known to introduce selection bias. This is a particular problem for large scale epidemiological studies using only pre-collected health data. Most previous studies have shown that members of the public value opt-in consent and can perceive research without consent as an invasion of privacy. Past research has suggested that people are generally unaware of research processes and existing safeguards, and that education may increase the acceptability of research without prior informed consent, but this recommendation has not been formally evaluated. Our objectives were to determine the range of public opinion about the use of existing medical data for research and to explore views about consent to a secondary review of medical records for research. We also investigated the effect of the provision of detailed information about the potential effect of selection bias on public acceptability of the use of data for research. We carried out a systematic review of existing literature on public attitudes to secondary use of existing health records identified by searching PubMed (1966-present), Embase (1974-present) and reference lists of identified studies to provide a general overview, followed by a qualitative focus group study with 19 older men recruited from rural and suburban primary care practices in the UK to explore key issues in detail. The systematic review identified twenty-seven relevant papers and the findings suggested that males and older people were more likely to consent to a review of their medical data. Many studies noted participants' lack of knowledge about research processes and existing safeguards and this was reflected in the focus groups. Focus group participants became more accepting of the use of pre-collected medical data without consent after being given information about selection bias and research processes. All participants were keen to contribute to NHS-related research but some were concerned about data-sharing for commercial gain and the potential misuse of information. Increasing public education about research and specific targeted information provision could promote trust in research processes and safeguards, which in turn could increase the acceptability of research without specific consent where the need for consent would lead to biased findings and impede research necessary to improve public health.

National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: a systematic review.

PubMed

Barchi, Francis; Little, Madison T

2016-10-22

Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks. An extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country. A second review documented active trials listed in the WHO International Clinical Trials Registry Platform as of January 2015 in which HBS collection was specified in the protocol. Findings were combined to determine the extent to which countries that are study sites for HBS-related research are supported by regulatory guidance language on the collection, use, ownership and storage of biospecimens. Of the 49 SSA countries, 29 had some form of national ethics guidance, yet only 17 provided language relating to HBS-related research, with specific guidance on consent (14), ownership (6), reuse (10), storage (9), and export/import/transfer (13). Ten countries accounted for 84 % of the active clinical trials involving the collection of HBS in SSA. All except one of these countries were found to have some national guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven of the ten offered any language specific to HBS. Despite the fact that the bulk of registered clinical trials in SSA involving HBS, as well as existing and proposed sites for biorepositories under the H3Africa Initiative, are currently situated in countries with the most complete ethics and regulatory guidance, variability in the regulations themselves may create challenges for planned and future pan-African collaborations and may require legislative action at the national level to revise. Countries in SSA that still lack regulatory guidance on HBS will require extensive health system strengthening in ethics governance before they can be full participants in the modern research enterprise.

"I didn't have anything to decide, I wanted to help my kids" - An interview-based study of consent procedures for sampling human biological material for genetic research in rural Pakistan.

PubMed

Kongsholm, Nana Cecilie Halmsted; Lassen, Jesper; Sandøe, Peter

2018-05-03

Individual, comprehensive, and written informed consent is broadly considered an ethical obligation in research involving the sampling of human material. In developing countries, however, local conditions, such as widespread illiteracy, low levels of education, and hierarchical social structures complicate compliance with these standards. As a result, researchers may modify the consent process to secure participation. To evaluate the ethical status of such modified consent strategies it is necessary to assess the extent to which local practices accord with the values underlying informed consent. Over a two-week period in April 2014 we conducted semi-structured interviews with researchers from a genetic research institute in rural Pakistan and families who had given blood samples for their research. Interviews with researchers focused on the institute's requirements for consent, and the researchers' strategies for and experiences with obtaining consent in the field. Interviews with donors focused on their motivation for donating samples, their experience of consent and donation, and what factors were central in their decisions to give consent. Researchers often reported modifications to consent procedures suited to the local context, standardly employing oral and elder consent, and tailoring information to the social education level of donor families. Central themes in donors' accounts of their decision to consent were the hope of getting something out of their participation and their remarkably high levels of trust in the researchers. Several donor accounts indicated a degree of confusion about participation and diagnosis, resulting in misconceived expectations of therapeutic benefits. We argue that while building and maintaining trusting relationships in research is important - not least in developing countries - strategies that serve this endeavor should be supplemented with efforts to ensure proper provision and understanding of relevant information, specifically about the nature of research and measures for individual consent and opt-out.

Patient preferences toward an interactive e-consent application for research using electronic health records.

PubMed

Harle, Christopher A; Golembiewski, Elizabeth H; Rahmanian, Kiarash P; Krieger, Janice L; Hagmajer, Dorothy; Mainous, Arch G; Moseley, Ray E

2017-12-19

The purpose of this study was to assess patient perceptions of using an interactive electronic consent (e-consent) application when deciding whether or not to grant broad consent for research use of their identifiable electronic health record (EHR) information. For this qualitative study, we conducted a series of 42 think-aloud interviews with 32 adults. Interview transcripts were coded and analyzed using a modified grounded theory approach. We identified themes related to patient preferences, reservations, and mixed attitudes toward consenting electronically; low- and high-information-seeking behavior; and an emphasis on reassuring information, such as data protections and prohibitions against sharing data with pharmaceutical companies. Participants expressed interest in the types of information contained in their EHRs, safeguards protecting EHR data, and specifics on studies that might use their EHR data. This study supports the potential value of interactive e-consent applications that allow patients to customize their consent experience. This study also highlights that some people have concerns about e-consent platforms and desire more detailed information about administrative processes and safeguards that protect EHR data used in research. This study contributes new insights on how e-consent applications could be designed to ensure that patients' information needs are met when seeking consent for research use of health record information. Also, this study offers a potential electronic approach to meeting the new Common Rule requirement that consent documents contain a "concise and focused" presentation of key information followed by more details. © The Author(s) 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

A Randomized Study of a Method for Optimizing Adolescent Assent to Biomedical Research

PubMed Central

Annett, Robert D.; Brody, Janet L.; Scherer, David G.; Turner, Charles W.; Dalen, Jeanne; Raissy, Hengameh

2018-01-01

Purpose Voluntary consent/assent with adolescents invited to participate in research raises challenging problems. No studies to date have attempted to manipulate autonomy in relation to assent/consent processes. This study evaluated the effects of an autonomy-enhanced individualized assent/consent procedure embedded within a randomized pediatric asthma clinical trial. Methods Families were randomly assigned to remain together or separated during a consent/assent process, the latter we characterize as an autonomy-enhanced assent/consent procedure. We hypothesized that separating adolescents from their parents would improve adolescent assent by increasing knowledge and appreciation of the clinical trial and willingness to participate. Results 64 adolescent-parent dyads completed procedures. The together versus separate randomization made no difference in adolescent or parent willingness to participate. However, significant differences were found in both parent and adolescent knowledge of the asthma clinical trial based on the assent/consent procedure and adolescent age. The separate assent/consent procedure improved knowledge of study risks and benefits for older adolescents and their parents but not for the younger youth or their parents. Regardless of the assent/consent process, younger adolescents had lower comprehension of information associated with the study medication and research risks and benefits, but not study procedures or their research rights and privileges. Conclusions The use of an autonomy-enhanced assent/consent procedure for adolescents may improve their and their parent’s informed assent/consent without impacting research participation decisions. Traditional assent/consent procedures may result in a “diffusion of responsibility” effect between parents and older adolescents, specifically in attending to key information associated with study risks and benefits. PMID:28949898

A computer-based education intervention to enhance surrogates' informed consent for genomics research.

PubMed

Shelton, Ann K; Freeman, Bradley D; Fish, Anne F; Bachman, Jean A; Richardson, Lloyd I

2015-03-01

Many research studies conducted today in critical care have a genomics component. Patients' surrogates asked to authorize participation in genomics research for a loved one in the intensive care unit may not be prepared to make informed decisions about a patient's participation in the research. To examine the effectiveness of a new, computer-based education module on surrogates' understanding of the process of informed consent for genomics research. A pilot study was conducted with visitors in the waiting rooms of 2 intensive care units in a Midwestern tertiary care medical center. Visitors were randomly assigned to the experimental (education module plus a sample genomics consent form; n = 65) or the control (sample genomics consent form only; n = 69) group. Participants later completed a test on informed genomics consent. Understanding the process of informed consent was greater (P = .001) in the experimental group than in the control group. Specifically, compared with the control group, the experimental group had a greater understanding of 8 of 13 elements of informed consent: intended benefits of research (P = .02), definition of surrogate consenter (P= .001), withdrawal from the study (P = .001), explanation of risk (P = .002), purpose of the institutional review board (P = .001), definition of substituted judgment (P = .03), compensation for harm (P = .001), and alternative treatments (P = .004). Computer-based education modules may be an important addition to conventional approaches for obtaining informed consent in the intensive care unit. Preparing patients' family members who may consider serving as surrogate consenters is critical to facilitating genomics research in critical care. ©2015 American Association of Critical-Care Nurses.

Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia.

PubMed

Mboizi, Robert B; Afolabi, Muhammed O; Okoye, Michael; Kampmann, Beate; Roca, Anna; Idoko, Olubukola T

2017-09-02

Communicating essential research information to low literacy research participants in Africa is highly challenging, since this population is vulnerable to poor comprehension of consent information. Several supportive materials have been developed to aid participant comprehension in these settings. Within the framework of a pneumococcal vaccine trial in The Gambia, we evaluated the recall and decay of consent information during the trial which used an audio-visual tool called 'Speaking Book', to foster comprehension among parents of participating infants. The Speaking Book was developed in the 2 most widely spoken local languages. Four-hundred and 9 parents of trial infants gave consent to participate in this nested study and were included in the baseline assessment of their knowledge about trial participation. An additional assessment was conducted approximately 90 d later, following completion of the clinical trial protocol. All parents received a Speaking Book at the start of the trial. Trial knowledge was already high at the baseline assessment with no differences related to socio-economic status or education. Knowledge of key trial information was retained at the completion of the study follow-up. The Speaking Book (SB) was well received by the study participants. We hypothesize that the SB may have contributed to the retention of information over the trial follow-up. Further studies evaluating the impact of this innovative tool are thus warranted.

Qualitative studies using in-depth interviews with older people from multiple language groups: methodological systematic review.

PubMed

Fryer, Caroline; Mackintosh, Shylie; Stanley, Mandy; Crichton, Jonathan

2012-01-01

This paper is a report of a methodological review of language appropriate practice in qualitative research, when language groups were not determined prior to participant recruitment. When older people from multiple language groups participate in research using in-depth interviews, additional challenges are posed for the trustworthiness of findings. This raises the question of how such challenges are addressed. The Cumulative Index to Nursing and Allied Health Literature, Scopus, Embase, Web of Science, Ageline, PsycINFO, Sociological abstracts, Google Scholar and Allied and Complementary Medicine databases were systematically searched for the period 1840 to September 2009. The combined search terms of 'ethnic', 'cultural', 'aged', 'health' and 'qualitative' were used. In this methodological review, studies were independently appraised by two authors using a quality appraisal tool developed for the review, based on a protocol from the McMaster University Occupational Therapy Evidence-Based Practice Research Group. Nine studies were included. Consideration of language diversity within research process was poor for all studies. The role of language assistants was largely absent from study methods. Only one study reported using participants' preferred languages for informed consent. More examples are needed of how to conduct rigorous in-depth interviews with older people from multiple language groups, when languages are not determined before recruitment. This will require both researchers and funding bodies to recognize the importance to contemporary healthcare of including linguistically diverse people in participant samples. © 2011 The Authors. Journal of Advanced Nursing © 2011 Blackwell Publishing Ltd.

Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India

PubMed Central

Joglekar, Neelam S.; Deshpande, Swapna S.; Sahay, Seema; Ghate, Manisha V.; Bollinger, Robert C.; Mehendale, Sanjay M.

2013-01-01

Background Optimum comprehension of informed consent by research participants is essential yet challenging. This study explored correlates of lower comprehension of informed consent among 1334 participants of a cohort study aimed at estimating HIV incidence in Pune, India. Methods As part of the informed consent process, a structured comprehension tool was administered to study participants. Participants scoring ≥90% were categorised into the ‘optimal comprehension group’, whilst those scoring 80–89% were categorised into the ‘lower comprehension group’. Data were analysed to identify sociodemographic and behavioural correlates of lower consent comprehension. Results The mean ± SD comprehension score was 94.4 ± 5.00%. Information pertaining to study-related risks was not comprehended by 61.7% of participants. HIV-negative men (adjusted OR [AOR] = 4.36, 95% CI 1.71–11.05) or HIV-negative women (AOR = 13.54, 95% CI 6.42–28.55), illiteracy (AOR= 1.65, 95% CI 1.19–2.30), those with a history of multiple partners (AOR = 1.73, 95% CI 1.12–2.66) and those never using condoms (AOR = 1.35, 95% CI 1.01–1.82) were more likely to have lower consent comprehension. Conclusions We recommend exploration of domains of lower consent comprehension using a validated consent comprehension tool. Improved education in these specific domains would optimise consent comprehension among research participants. PMID:24029848

Comprehensibility of patient consent forms for radiation therapy of cervical cancer.

PubMed

MacDougall, Deborah Skinner; Connor, Ulla M; Johnstone, Peter A S

2012-06-01

The construct of Health Literacy (HL) deals with patients' capacity to understand their health-related instructions, consent forms, and other documents. A significant challenge of providing healthcare to patients with low HL is the complex nature of the disease process, and of requisite treatments. In radiation oncology specifically, the delivery of ionizing radiation is difficult enough to describe; describing radiation toxicity in terms of the underlying physics and biology is daunting. A multimodal analysis of a small sample of patient consent forms was undertaken in order to address this issue more closely, and identify the extent to which such literature contributes to the challenges faced by patients with low HL. Members of national cooperative group panels dealing with gynecologic cancer were asked to submit copies of consent forms provided to patients with stage II cervical cancer. Four such forms were submitted and reviewed by a single person with expertise in linguistics using standard tools. Three of the four consents scored within the lower portion of the "adequate" range. One consent was not suitable. Consent readability ranged from grades 12.18 to 16.13; this means that they required at least a high school education to interpret, and in two cases required post-graduate coursework. There is significant room for improvement in consent form design and structure. When considering cultural and socioeconomic appropriateness of patient consent forms, input of staff with expertise in linguistics should be sought. Copyright © 2012 Elsevier Inc. All rights reserved.

Alternatives for randomization in lifestyle intervention studies in cancer patients were not better than conventional randomization.

PubMed

Velthuis, Miranda J; May, Anne M; Monninkhof, Evelyn M; van der Wall, Elsken; Peeters, Petra H M

2012-03-01

Assessing effects of lifestyle interventions in cancer patients has some specific challenges. Although randomization is urgently needed for evidence-based knowledge, sometimes it is difficult to apply conventional randomization (i.e., consent preceding randomization and intervention) in daily settings. Randomization before seeking consent was proposed by Zelen, and additional modifications were proposed since. We discuss four alternatives for conventional randomization: single and double randomized consent design, two-stage randomized consent design, and the design with consent to postponed information. We considered these designs when designing a study to assess the impact of physical activity on cancer-related fatigue and quality of life. We tested the modified Zelen design with consent to postponed information in a pilot. The design was chosen to prevent drop out of participants in the control group because of disappointment about the allocation. The result was a low overall participation rate most likely because of perceived lack of information by eligible patients and a relatively high dropout in the intervention group. We conclude that the alternatives were not better than conventional randomization. Copyright © 2012 Elsevier Inc. All rights reserved.

Representations of ECT in English-Language Film and Television in the New Millennium.

PubMed

Matthews, Avery Madeleine; Rosenquist, Peter B; McCall, William Vaughn

2016-09-01

The aim of the study was to survey the media landscape to determine whether visual depictions of electroconvulsive therapy (ECT) are becoming more or less medically accurate in the new millennium. English-language film and television shows depicting ECT were analyzed for patient demographics, administrator roles, indication, consent, anesthesia, paralytics, bite block, lead placement, electroencephalogram, and outcome. Thirty-nine ECT scenes were viewed, and just 3 included all 5 essential tools of modern ECT: anesthesia, paralytic, electrodes, electroencephalogram, and a bite block. Media depictions of ECT do not reflect current practice. Too often, ECT is portrayed as a torture technique rather than an evidenced-based therapy, and even in a therapeutic setting, it is too often shown with outdated techniques.

A dialectical perspective on informed consent to treatment: an examination of radiologists' dilemmas and negotiations.

PubMed

Olufowote, James Olumide

2011-06-01

Informed consent to treatment (ICT), designed to honor patient autonomy, has been an important subject of inquiry in many disciplines. To foreground the dynamic and dilemmatic tendencies of ICT practice implied by previous inquiries, I advanced relational dialectics theory into the realm of physicians' experiences with ICT. On performing a dialectical analysis of transcripts from focus group discussions with radiologists, I found them experiencing four primary tensions: (a) between simple and complex ICT; (b) between radiologist and patient control; (c) between standardized and idiosyncratic practice (involving struggles between documentation and conversational process, and between vague and detailed language use); and (d) between withholding and disclosing alternatives. Moreover, I drew on concepts from relational dialectics theory to capture the various ways radiologists negotiate these dialectics. I conclude with practical applications for physician and patient training and interprofessional coordination.

Dynamic Consent: a potential solution to some of the challenges of modern biomedical research.

PubMed

Budin-Ljøsne, Isabelle; Teare, Harriet J A; Kaye, Jane; Beck, Stephan; Bentzen, Heidi Beate; Caenazzo, Luciana; Collett, Clive; D'Abramo, Flavio; Felzmann, Heike; Finlay, Teresa; Javaid, Muhammad Kassim; Jones, Erica; Katić, Višnja; Simpson, Amy; Mascalzoni, Deborah

2017-01-25

Innovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment. An interdisciplinary workshop jointly organised by the University of Oxford and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach. Dynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies. Dynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures.

Intervention Research with Youths at Elevated Risk for Suicide: Meeting the Ethical and Regulatory Challenges of Informed Consent and Assent

ERIC Educational Resources Information Center

King, Cheryl A.; Kramer, Anne C.

2008-01-01

Intervention research with youths at elevated risk for suicidal behavior and suicide--a vulnerable and high risk population--presents investigators with numerous ethical challenges. This report specifically addresses those challenges involving the informed consent and assent process with parents/guardians and youths. The challenges are delineated…

Attitudes of the Japanese public and doctors towards use of archived information and samples without informed consent: preliminary findings based on focus group interviews.

PubMed

Asai, Atsushi; Ohnishi, Motoki; Nishigaki, Etsuyo; Sekimoto, Miho; Fukuhara, Shunichi; Fukui, Tsuguya

2002-01-09

The purpose of this study is to explore laypersons' attitudes toward the use of archived (existing) materials such as medical records and biological samples and to compare them with the attitudes of physicians who are involved in medical research. Three focus group interviews were conducted, in which seven Japanese male members of the general public, seven female members of the general public and seven physicians participated. It was revealed that the lay public expressed diverse attitudes towards the use of archived information and samples without informed consent. Protecting a subject's privacy, maintaining confidentiality, and communicating the outcomes of studies to research subjects were regarded as essential preconditions if researchers were to have access to archived information and samples used for research without the specific informed consent of the subjects who provided the material. Although participating physicians thought that some kind of prior permission from subjects was desirable, they pointed out the difficulties involved in obtaining individual informed consent in each case. The present preliminary study indicates that the lay public and medical professionals may have different attitudes towards the use of archived information and samples without specific informed consent. This hypothesis, however, is derived from our focus groups interviews, and requires validation through research using a larger sample.

Interpreter Services in An Inner City Teaching Hospital: A 6-Year Experience

PubMed Central

Khwaja, Nadeem; Sharma, Saroj; Wong, Julian; Murray, David; Ghosh, Jonathan; Murphy, Michael O; Halka, Anastassi T; Walker, Michael G

2006-01-01

INTRODUCTION Being able to communicate effectively with patients is essential not only from a medicolegal standpoint but more importantly from clinical governance perspectives. Issues such as informed consent and patient choice within the NHS are currently being highlighted; for these to be available to patients, their language requirements are paramount. PATIENTS AND METHODS An audit was performed by the Linkworkers office at the Central Manchester & Manchester Children's Hospital NHS (CMMC) Trust on the total number of attendances and refusals per language in the period 1998–2003. RESULTS In the CMMC Trust, Urdu/Punjabi, Bengali, Cantonese, Somali, Arabic and French represent the majority of the workload, comprising almost 80% of cases in 2003. In the same year, an increase in demand for languages of Eastern European countries became evident. Finding interpreters for these languages even via agencies can be extremely difficult. CONCLUSIONS If the current trend continues, requirement for these services will increase exponentially. For this demand to be met adequately these issues must be kept at the forefront of NHS planning. PMID:17132317

A qualitative study of participants' views on re-consent in a longitudinal biobank.

PubMed

Dixon-Woods, Mary; Kocman, David; Brewster, Liz; Willars, Janet; Laurie, Graeme; Tarrant, Carolyn

2017-03-23

Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or "biobanks" over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank. We conducted a qualitative study involving interviews with 24 people who were participating in a longitudinal biobank. Their views were elicited using a semi-structured interview schedule and scenarios based on a hypothetical biobank. Data analysis was based on the constant comparative method. What participants identified as requiring new consent was not a straightforward matter predictable by algorithms about the scope of the consent, but instead was contingent. They assessed whether proposed new research implied a fundamental alteration in the underlying character of the biobank and whether specific projects were within the scope of the original consent. What mattered most to them was that the cooperative bargain into which they had entered was maintained in good faith. They saw re-consent as one important safeguard in this bargain. In determining what required re-consent, they deployed two logics. First, they used a logic of boundaries, where they sought to detect any possible rupture with their existing framework of cooperation. Second, they used a logic of risk, where they assessed proposed research for any potential threats for them personally or the research endeavour. When they judged that a need for re-consent had been activated, participants saw the process as way of re-actualising and renewing the cooperative bargain. Participants' perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two logics used by research volunteers, and avoid rigidity. Agility may be favoured by tiered consent combined with strong oversight mechanisms; this approach requires evaluation.

Public preferences on written informed consent for low‐risk pragmatic clinical trials in Spain

PubMed Central

Carcas, Antonio J.; Carné, Xavier; Wendler, David

2017-01-01

Aims Pragmatic randomized clinical trials (pRCTs) collect data that have the potential to improve medical care significantly. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the US public endorses written consent for low‐risk pRCTs. The present study was designed to assess whether this view is specific to the US. Methods The study took the form of a cross‐sectional, probability‐based survey, with a 2 × 2 factorial design, assessing support for written informed consent vs. verbal consent or general notification for two low‐risk pRCTs in hypertension, one comparing two drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. The primary outcome measures were respondents' personal preference and hypothetical recommendation to a research ethics committee regarding the use of written informed consent vs. the alternatives. Results A total of 2008 adults sampled from a probability‐based online panel responded to the web‐based survey conducted in May 2016 (response rate: 61%). Overall, 77% of respondents endorsed written consent. In both scenarios, the alternative of general notification received significantly more support (28.7–37.1%) than the alternative of verbal consent (12.7–14.0%) (P = 0.001). Forty per cent of respondents preferred and/or recommended general notification rather than written consent. Conclusions The results suggested that, rather than attempting to waive written consent, current pRCTs should focus on developing ways to implement written consent that provide sufficient information without undermining recruitment or increasing selection bias. The finding that around 40% of respondents endorsed general notification over written consent raises the possibility that, with educational efforts, the majority of Spaniards might accept general notification for low‐risk pRCTs. PMID:28419518

Benign Breast Disease: Toward Molecular Prediction of Breast Cancer Risk

DTIC Science & Technology

2004-06-01

stored in groups according to immunostain (i.e., all of the number 3 slides together, the number 4 slides, and so on) to match the stain in bar coded...standoff between the DOD and Wayne State on consent form language around institutional coverage for any "research- related risks". Dr. Beitens from the...Sponsoring this Study Clinic will not be jeopardized. This work has been, and continues to be, sponsored by several groups including the Confidentiality

Cardiac imaging modalities with ionizing radiation: the role of informed consent.

PubMed

Paterick, Timothy E; Jan, M Fuad; Paterick, Zachary R; Tajik, A Jamil; Gerber, Thomas C

2012-06-01

Informed consent ideally results in patient autonomy and rational health care decisions. Frequently, patients face complex medical decisions that require a delicate balancing of anticipated benefits and potential risks, which is the concept of informed consent. This balancing process requires an understanding of available medical evidence and alternative medical options, and input from experienced physicians. The informed consent doctrine places a positive obligation on physicians to partner with patients as they try to make the best decision for their specific medical situation. The high prevalence and mortality related to heart disease in our society has led to increased cardiac imaging with modalities that use ionizing radiation. This paper reviews how physicians can meet the ideals of informed consent when considering cardiac imaging with ionizing radiation, given the limited evidence for risks and benefits. The goal is an informed patient making rational choices based on available medical information. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

[Acute scrotal pain in childhood: legal pitfalls].

PubMed

Bader, Pia; Hugemann, Christoph; Frohneberg, Detlef

2017-12-01

Acute scrotal pain in childhood is an emergency.Sudden scrotal pain may be caused by a variety of diseases. Therefore, it is important to carefully consider the specific medical history and possible differential diagnoses in each case for fast and decisive action (e. g. in case of testicular torsion). As minors lack the capacity for consent, it is absolutely necessary to obtain consent from their legal guardian. However, obtaining consent in the available time frame can cause organisational challenges in an acute emergency, which may lead to situations in the daily routine where a therapeutic decision needs to be taken (including surgery) without legal security based on consent by the guardian. In some cases, the child's consent also needs to be taken into account, depending on its age and development.For the physician and surgeon in charge, the legal evaluation of the case at hand and therewith the obtainment of legal security are of great significance. © Georg Thieme Verlag KG Stuttgart · New York.

Pushing up daisies: implicit and explicit language in oncologist-patient communication about death.

PubMed

Rodriguez, Keri L; Gambino, Frank J; Butow, Phyllis; Hagerty, Rebecca; Arnold, Robert M

2007-02-01

Although there are guidelines regarding how conversations with patients about prognosis in life-limiting illness should occur, there are little data about what doctors actually say. This study was designed to qualitatively analyze the language that oncologists and cancer patients use when talking about death. We recruited 29 adults who had incurable forms of cancer, were scheduled for a first-time visit with one of six oncologists affiliated with a teaching hospital in Australia, and consented to having their visit audiotaped and transcribed. Using content analytic techniques, we coded various features of language usage. Of the 29 visits, 23 (79.3%) included prognostic utterances about treatment-related and disease-related outcomes. In 12 (52.2%) of these 23 visits, explicit language about death ("terminal," variations of "death") was used. It was most commonly used by the oncologist after the physical examination, but it was sometimes used by patients or their kin, usually before the examination and involving emotional questioning about the patient's future. In all 23 (100%) visits, implicit language (euphemistic or indirect talk) was used in discussing death and focused on an anticipated life span (mentioned in 87.0% of visits), estimated time frame (69.6%), or projected survival (47.8%). Instead of using the word "death," most participants used some alternative phrase, including implicit language. Although oncologists are more likely than patients and their kin to use explicit language in discussing death, the oncologists tend to couple it with implicit language, possibly to mitigate the message effects.

Assessment of children's capacity to consent for research: a descriptive qualitative study of researchers' practices.

PubMed

Gibson, Barbara E; Stasiulis, Elaine; Gutfreund, Shawna; McDonald, Maria; Dade, Lauren

2011-08-01

In Canadian jurisdictions without specific legislation pertaining to research consent, the onus is placed on researchers to determine whether a child is capable of independently consenting to participate in a research study. Little, however, is known about how child health researchers are approaching consent and capacity assessment in practice. The aim of this study was to explore and describe researchers' current practices. The study used a qualitative descriptive design consisting of 14 face-to-face interviews with child health researchers and research assistants in Southern Ontario. Transcribed interviews were analysed for common themes. Procedures for assessing capacity varied considerably from the use of age cutoffs to in-depth engagement with each child. Three key issues emerged from the accounts: (1) requirements that consent be provided by a single person thwarted researchers' abilities to support family decision-making; (2) little practical distinction was made between assessing if a child was capable, versus determining if study information had been adequately explained by the researcher; and (3) participants' perceived that review boards' requirements may conflict with what they considered ethical consent practices. The results suggest that researchers' consent and capacity knowledge and skills vary considerably. Perceived discrepancies between ethical practice and ethics boards' requirements suggest the need for dialogue, education and possibly ethics board reforms. Furthermore we propose, where appropriate, a 'family decision-making' model that allows parents and their children to consent together, thereby shifting the focus from separate assent and consent procedures to approaches that appropriately engage the child and family.

A Troubled Past? Reassessing Ethics in the History of Tissue Culture.

PubMed

Wilson, Duncan

2016-09-01

Recent books, articles and plays about the 'immortal' HeLa cell line have prompted renewed interest in the history of tissue culture methods that were first employed in 1907 and became common experimental tools during the twentieth century. Many of these sources claim tissue cultures like HeLa had a "troubled past" because medical researchers did not seek informed consent before using tissues in research, contravening a long held desire for self-determination on the part of patients and the public. In this article, I argue these claims are unfair and misleading. No professional guidelines required informed consent for tissue culture during the early and mid twentieth century, and popular sources expressed no concern at the widespread use of human tissues in research. When calls for informed consent did emerge in the 1970s and 1980s, moreover, they reflected specific political changes and often emanated from medical researchers themselves. I conclude by arguing that more balanced histories of tissue culture can make a decisive contribution to public debates today: by refuting a false dichotomy between science and its publics, and showing how ethical concepts such as informed consent arise from a historically specific engagement between professional and social groups.

Informed Consent for Interventional Radiology Procedures: A Survey Detailing Current European Practice

DOE Office of Scientific and Technical Information (OSTI.GOV)

O'Dwyer, H.M.; Lyon, S.M.; Fotheringham, T.

Purpose: Official recommendations for obtaining informed consent for interventional radiology procedures are that the patient gives their consent to the operator more than 24 hr prior to the procedure. This has significant implications for interventional radiology practice. The purpose of this study was to identify the proportion of European interventional radiologists who conform to these guidelines. Methods: A questionnaire was designed consisting of 12 questions on current working practice and opinions regarding informed consent. These questions related to where, when and by whom consent was obtained from the patient. Questions also related to the use of formal consent forms andmore » written patient information leaflets. Respondents were asked whether they felt patients received adequate explanation regarding indications for intervention,the procedure, alternative treatment options and complications. The questionnaire was distributed to 786 European interventional radiologists who were members of interventional societies. The anonymous replies were then entered into a database and analyzed. Results: Two hundred and fifty-four (32.3%) questionnaires were returned. Institutions were classified as academic (56.7%),non-academic (40.5%) or private (2.8%). Depending on the procedure,in a significant proportion of patients consent was obtained in the outpatient department (22%), on the ward (65%) and in the radiology day case ward (25%), but in over half (56%) of patients consent or re-consent was obtained in the interventional suite. Fifty percent of respondents indicated that they obtain consent more than 24 hr before some procedures, in 42.9% consent is obtained on the morning of the procedure and 48.8% indicated that in some patients consent is obtained immediately before the procedure. We found that junior medical staff obtained consent in 58% of cases. Eighty-two percent of respondents do not use specific consent forms and 61% have patient information leaflets. The majority of respondents were satisfied with their level of explanation regarding indications for treatment (69.3%) and the procedure (78.7%). Fifty-nine percent felt patients understood alternative treatment options. Only 37.8% of radiologists document possible complications in the patient's chart. Comments from respondents indicated that there is insufficient time for radiologists to obtain consent in all patients. Suggestions to improve current local policies included developing the role of radiology nursing staff and the use of radiology outpatient clinics. Conclusions: More than 50% of respondents are unhappy with their policies for obtaining informed consent. Interventional societies have a role to play in advocating formal consent guidelines.« less

Young people's views about consenting to data linkage: findings from the PEARL qualitative study.

PubMed

Audrey, Suzanne; Brown, Lindsey; Campbell, Rona; Boyd, Andy; Macleod, John

2016-03-21

Electronic administrative data exist in several domains which, if linked, are potentially useful for research. However, benefits from data linkage should be considered alongside risks such as the threat to privacy. Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study. The Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. Qualitative research was incorporated in the PEARL study to examine participants' views about data linkage and inform approaches to information sharing. This paper focusses on issues of consent. Digitally recorded interviews were conducted with 55 participants aged 17-19 years. Terms and processes relating to consent, anonymization and data linkage were explained to interviewees. Scenarios were used to prompt consideration of linking different sources of data, and whether consent should be requested. Interview recordings were fully transcribed. Thematic analysis was undertaken using the Framework approach. Participant views on data linkage appeared to be most influenced by: considerations around the social sensitivity of the research question, and; the possibility of tangible health benefits in the public interest. Some participants appeared unsure about the effectiveness of anonymization, or did not always view effective anonymization as making consent unnecessary. This was related to notions of ownership of personal information and etiquette around asking permission for secondary use. Despite different consent procedures being explained, participants tended to equate consent with 'opt-in' consent through which participants are 'asked' if their data can be used for a specific study. Participants raising similar concerns came to differing conclusions about whether consent was needed. Views changed when presented with different scenarios, and were sometimes inconsistent. Findings from this study question the validity of 'informed consent' as a cornerstone of good governance, and the extent to which potential research participants understand different types of consent and what they are consenting, or not consenting, to. Pragmatic, imaginative and flexible approaches are needed if research using data linkage is to successfully realise its potential for public good without undermining public trust in the research process.

A visual approach to providing prognostic information to parents of children with retinoblastoma.

PubMed

Panton, Rachel L; Downie, Robert; Truong, Tran; Mackeen, Leslie; Kabene, Stefane; Yi, Qi-Long; Chan, Helen S L; Gallie, Brenda L

2009-03-01

Parents must rapidly assimilate complex information when a child is diagnosed with cancer. Education correlates with the ability to process and use medical information. Graphic tools aid reasoning and communicate complex ideas with precision and efficiency. We developed a graphic tool, DePICT (Disease-specific electronic Patient Illustrated Clinical Timeline), to visually display entire retinoblastoma treatment courses from real-time clinical data. We report retrospective evaluation of the effectiveness of DePICT to communicate risk and complexity of treatment to parents. We assembled DePICT graphics from multiple children on cards representing each stage of intraocular retinoblastoma. Forty-four parents completed a 14-item questionnaire to evaluate the understanding of retinoblastoma treatment and outcomes acquired from DePICT. As a proposed tool for informed consent, DePICT effectively communicated knowledge of complex medical treatment and risks, regardless of the education level. We identified multiple potential factors affecting parent comprehension of treatment complexity and risk. These include language proficiency (p=0.005) and age-related experience, as younger parents had higher education (p=0.021) but lower comprehension scores (p=0.011), regardless of first language. Provision of information at diagnosis concerning long-term treatment complexity helps parents of children with cancer. DePICT effectively transfers knowledge of treatments, risks, and prognosis in a manner that offsets parental educational disadvantages.

Student-patient communication during physical examination.

PubMed

Cleland, Jennifer; de la Croix, Anne; Cotton, Philip; Coull, Sharon; Skelton, John

2013-04-01

Communication during the physical examination has been understudied. Explicit, evidence-based guidance is not available as to the most effective content or process of communication while performing physical examination, or indeed how to teach this to medical students. The objective of this exploratory study was to explore how medical students communicate with patients when performing a physical examination in the absence of formal teaching on how to communicate in this situation. We recorded 15 senior UK medical students as they performed physical examinations with real patients in general practice situations. The transcriptions were analysed for linguistic functions to identify the use of different categories of utterances. Student utterances fell into four categories: minimising language; using positive evaluative language; repeating the patient; and stating intentions or explanations and requesting consent. Students would often preface an explanation or action by phrases showing 'togetherness', by using 'we' rather than 'you'. They also used linguistic 'hedges' to minimise the impact of an utterance. Senior medical students speak very little during the physical examination. When they do, they use a taxonomy of utterances that reflects those reported in doctor-patient interactions. Identifying how medical students communicate when carrying out the physical examination is the first step in planning how to best teach specific communication skills. Further work is needed to identify how best to explore communication during physical examination, and how this is taught and learned. © Blackwell Publishing Ltd 2013.

Assessing capacity to consent for research in cognitively impaired older patients

PubMed Central

Gilbert, Thomas; Bosquet, Antoine; Thomas-Antérion, Catherine; Bonnefoy, Marc; Le Saux, Olivia

2017-01-01

Background The number of clinical trials including older patients, and particularly patients with cognitive impairment, is increasing. While statutory provisions exist to make sure that the capacity to consent is assessed systematically for each patient, many gray areas remain with regard to how this assessment is made or should be made in the routine practice of clinical research. Objectives The aim of this review was to draw up an inventory of assessment tools evaluating older patients’ capacity to consent specifically applicable to clinical research, which could be used in routine practice. Methods Two authors independently searched PubMed, Cochrane, and Google Scholar data-bases between November 2015 and January 2016. The search was actualized in April 2017. We used keywords (MeSH terms and text words) referring to informed consent, capacity to consent, consent for research, research ethics, cognitive impairment, vulnerable older patients, and assessment tools. Existing reviews were also considered. Results Among the numerous existing tools for assessing capacity to consent, 14 seemed potentially suited for clinical research and six were evaluated in older patients. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) was the most frequently cited. Conclusion The MacCAT-CR is currently the most used and the best validated questionnaire. However, it appears difficult to use and time-consuming. A more recent tool, the University of California Brief Assessment of Capacity to Consent (UBACC), seems interesting for routine practice because of its simplicity, relevance, and applicability in older patients. PMID:29026293

Consent to medical research of vulnerable subjects from the French point of view: the example of consent in research in the case of Alzheimer disease.

PubMed

Duguet, Anne-Marie; Boyer-Beviere, Bénédicte

2011-12-01

The consent to research is the expression of autonomy. Some groups are vulnerable and cannot give free consent because their conditions limit their decision making or because they are unable to consent themselves (minor, incompetent adults). International standards and recommendations for medical research protect vulnerable subjects (article 17 of the Helsinki declaration, guidelines 9 and 13 of the CIOMS, article 17 of the Oviedo Convention). French Law protects mostly three categories of vulnerable people: minors, adults with a legal representative, and the people living in sanitary and social establishments. Specific protection is given as well to pregnant women, detainees and persons with psychiatric disorders in involuntary commitment. From the example of research with Alzheimer patients the authors show the original provisions of French legislation to involve in medical research incompetent patients with or without legal protection. Clinical research on Alzheimer's disease poses challenges as never before to research ethics. In fact, the development of the disease progressively reduces the patient's ability to make choices: the latter is no longer capable, but is not totally incapacitated. Several solutions are offered for a "proxy" consent or authorisation.

Unconstitutionality of abortion laws affirmed.

PubMed

1979-08-01

A federal appeals court has affirmed lower court rulings that substantial portions of the Illinois' 1975 Abortion Act and 1977 Abortion Parental Consent Act are unconstitutional. The 7th Court adopted an April 12, 1978 district court opinion that invalidated several sections of the Illinois 1975 abortion statute, including parental and spousal consent requirements and provisions requiring that a woman be informed of the "physical competency" of the fetus at the time the abortion was to be performed. The appeals court specifically addressed the statute's provision making a liveborn fetus resulting from an abortion a ward of the state, unless the abortion was performed to save the woman's life. Regarding the 1977 Parental Consent Act, the 7th Circuit reaffirmed its August 1978 ruling that it is unconstitutional to require an unmarried minor to have the consent of both parents or, if they refused consent, a circuit court judge before undergoing an abortion. The appeals court also agreed with the lower court's November 2nd ruling that the Act's requirement of a 48-hour delay between the time the minor gives her consent and the performance of an abortion violated the equal protection clause of the 14th amendment.

International Guidelines for Privacy in Genomic Biobanking (or the Unexpected Virtue of Pluralism).

PubMed

Thorogood, Adrian; Zawati, Ma'n H

2015-01-01

This article reviews international privacy norms governing human genomic biobanks and databases, and how they address issues related to consent, secondary use, de- identification, access, security, and governance. A range of international instruments were identified, varying in substance - e.g., human rights, data protection, research ethics, biobanks, and genetics - and legal character. Some norms detail processes for broad consent, namely, that even where potential participants cannot consent to specific users and uses, they should be given clear information on access policies, procedures, and governance structures. Some also give guidance about the conditions under which secondary use of data and samples without consent is appropriate, e.g., where consent is impracticable. International norms exhibit a confusing range of terminology relating to de-identification. They also continue to rely heavily on consent and anonymity as the basis for privacy protection, though governance is becoming more prominent. It may not be fatal that such a plurality of norms apply to biobanking; what is essential is that governance be built on shared values, our common interest in the success of genomic research, and practical tools that incentivize responsible, global sharing. © 2015 American Society of Law, Medicine & Ethics, Inc.

Patients´ Rights and the National Health Service in Britain, 1960s–1980s

PubMed Central

2012-01-01

The language of rights has long permeated discussions about health care in Britain, but during the latter half of the 20th century, patients’ rights achieved a level of unprecedented prominence. By the end of the 1980s, the language of entitlement appeared to have spread into many areas of the National Health Service: consent to treatment, access to information, and the ability to complain were all legally established patients’ rights. Patient organizations played a critical role in both realizing these rights and in popularizing the discourse of rights in health care in Britain. “Rights talk,” however, was not without its drawbacks, as it was unclear what kinds of rights were being exercised and whether these were held by patients, consumers, or citizens. PMID:22994184

Participants’ perceptions and understanding of a malaria clinical trial in Bangladesh

PubMed Central

2014-01-01

Background Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects’ understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial. Methods In this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh. Results Of 16 participants, the vast majority (81%) were illiterate. All subjects had a ‘therapeutic misconception’ i.e. the trial was perceived to be conducted primarily for the benefit of individual patients when in fact the main objective was to provide information to inform public health policy. From the patients’ perspective, getting well from their illness was their major concern. Poor actual understanding of trial specific procedures was reported despite participants’ satisfaction with treatment and nursing care. Conclusion There is frequently a degree of overlap between research and provision of clinical care in malaria research studies. Patients may be motivated to participate to research without a good understanding of the principal objectives of the study despite a lengthy consent process. The findings suggest that use of a standard consent form following the current ICH-GCP guidelines does not result in achieving fully informed consent and the process should be revised, simplified and adapted to individual trial settings. PMID:24893933

Participants' perceptions and understanding of a malaria clinical trial in Bangladesh.

PubMed

Das, Debashish; Cheah, Phaik Yeong; Akter, Fateha; Paul, Dulal; Islam, Akhterul; Sayeed, Abdullah A; Samad, Rasheda; Rahman, Ridwanur; Hossain, Amir; Dondorp, Arjen; Day, Nicholas P; White, Nicholas J; Hasan, Mahtabuddin; Ghose, Aniruddha; Ashley, Elizabeth A; Faiz, Abul

2014-06-04

Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects' understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial. In this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh. Of 16 participants, the vast majority (81%) were illiterate. All subjects had a 'therapeutic misconception' i.e. the trial was perceived to be conducted primarily for the benefit of individual patients when in fact the main objective was to provide information to inform public health policy. From the patients' perspective, getting well from their illness was their major concern. Poor actual understanding of trial specific procedures was reported despite participants' satisfaction with treatment and nursing care. There is frequently a degree of overlap between research and provision of clinical care in malaria research studies. Patients may be motivated to participate to research without a good understanding of the principal objectives of the study despite a lengthy consent process. The findings suggest that use of a standard consent form following the current ICH-GCP guidelines does not result in achieving fully informed consent and the process should be revised, simplified and adapted to individual trial settings.

Minors' capacity to refuse treatment: a reply to Gilmore and Herring.

PubMed

Cave, Emma; Wallbank, Julie

2012-01-01

Re R and Re W allow a parent to consent to treatment a competent minor refuses, but the cases have not been tested post-Human Rights Act 1998. Gilmore and Herring offer a means by which they might be distinguished or sidelined. They interpret Gillick to say that in order to consent a minor need only have a full understanding of the particular treatment. They argue that the minors in Re R and Re W were refusing all treatment which requires a separate assessment of capacity-an assessment which was not made. We fear that this distinction would not be workable in clinical practice and argue that their interpretation of Gillick is flawed. From a clinician's point of view, competence cannot always be judged in relation to a specific treatment, but instead must relate to the decision. We show that a decision can incorporate more than one treatment, and more than one decision might be made about one treatment. A minor's understanding of a specific treatment is not always sufficient to demonstrate competence to make a decision. The result is that whilst there might be situations when a parent and a minor both have the power to consent to a particular treatment, they will not share concurrent powers in relation to the same decision. Consequently, a challenge to Re R and Re W, if forthcoming, would need to take a different form. We emphasise the necessity to minimise the dichotomy between legal consent and how consent works in medical practice.

Civil Law Legal Assistance; Lawyer’s Study Guide

DTIC Science & Technology

1998-05-01

from bigamy and incest . D. The void/voidable distinction. The grounds relating to annulment apply to voidable marriages — marriages with such defects...differences, uses neutral language [" son lives with father every other weekend"] rather than "loaded words" with win-lose implications [i.e., "custody...mutual consent" What if mom disagrees to Wednesday night supper with dad? What if dad disagrees with mom having the children on the 4th of July? What

40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

Code of Federal Regulations, 2010 CFR

2010-07-01

... 80-05-7 Bisphenol A 51 FR 33047, 9/18/86 April 6, 1993 84-65-1 Anthraquinone 52 FR 21018, 6/4/87 Aug... consent orders for which the testing reimbursement period has passed. 799.18 Section 799.18 Protection of...) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS General Provisions § 799.18...

40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

Code of Federal Regulations, 2014 CFR

2014-07-01

... 80-05-7 Bisphenol A 51 FR 33047, 9/18/86 April 6, 1993 84-65-1 Anthraquinone 52 FR 21018, 6/4/87 Aug... consent orders for which the testing reimbursement period has passed. 799.18 Section 799.18 Protection of...) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS General Provisions § 799.18...

40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

Code of Federal Regulations, 2013 CFR

2013-07-01

... 80-05-7 Bisphenol A 51 FR 33047, 9/18/86 April 6, 1993 84-65-1 Anthraquinone 52 FR 21018, 6/4/87 Aug... consent orders for which the testing reimbursement period has passed. 799.18 Section 799.18 Protection of...) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS General Provisions § 799.18...

40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

Code of Federal Regulations, 2012 CFR

2012-07-01

... 80-05-7 Bisphenol A 51 FR 33047, 9/18/86 April 6, 1993 84-65-1 Anthraquinone 52 FR 21018, 6/4/87 Aug... consent orders for which the testing reimbursement period has passed. 799.18 Section 799.18 Protection of...) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS General Provisions § 799.18...

40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

Code of Federal Regulations, 2011 CFR

2011-07-01

... 80-05-7 Bisphenol A 51 FR 33047, 9/18/86 April 6, 1993 84-65-1 Anthraquinone 52 FR 21018, 6/4/87 Aug... consent orders for which the testing reimbursement period has passed. 799.18 Section 799.18 Protection of...) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS General Provisions § 799.18...

Towards a standardized informed consent procedure for live donor nephrectomy: What do surgeons tell their donors?

PubMed

Kortram, Kirsten; Ijzermans, Jan N M; Dor, Frank J M F

2016-08-01

Living kidney donors comprise a unique group of "patients", undergoing an operation for the benefit of others. The informed consent process is therefore valued differently. Although this is a team effort, the surgeon is responsible for performing the donor nephrectomy, and often the one held accountable, should adverse events occur. Although there is some consensus on how the informed consent procedure should be arranged, practices vary. The aim of this study was to evaluate the surgical informed consent procedure for live donor nephrectomy, with special regards to disclosure of complications. A web-based survey was sent to all kidney transplant surgeons (n = 50) in eight transplant centers with questions regarding the local procedure and disclosure of specific details. Response rate was 98% (n = 49), of which 32 (65%) were involved in living donor education; overall, transplant- (50%), vascular- (31%), and abdominal surgeons (13%), and urologists (6%) performed donor nephrectomies in the eight centers. Informed consent procedures varied, ranging from assumed to signed consent. Bleeding was the only complication every surgeon mentioned. Risk of death was always mentioned by 16 surgeons (50%), sometimes by 13 (41%), three surgeons (9%) never disclosed this disastrous complication. Reported mortality rates ranged from 0.003% to 0.1%. Mentioning frequencies for all other complications varied. Important complications are not always disclosed during the surgical informed consent process for live donor nephrectomy. Informed consent procedures vary. To optimally prepare living kidney donors for the procedure, a standardized informed consent procedure for live donor nephrectomy is highly recommended. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Challenges of Obtaining Informed Consent in Emergency Ward: A Qualitative Study in One Iranian Hospital

PubMed Central

Davoudi, Nayyereh; Nayeri, Nahid Dehghan; Zokaei, Mohammad Saeed; Fazeli, Nematallah

2017-01-01

Background and Objective: Regarding the fact that emergency ward has unique characteristics, whose uniqueness affects informed consent processes by creating specific challenges. Hence, it seems necessary to identify the process and challenges of informed consent in the emergency ward through a qualitative study to understand actual patients’ and health care providers’ experiences, beliefs, values, and feelings about the informed consent in the emergency ward. Through such studies, new insight can be gained on the process of informed consent and its challenges with the hope that the resulting knowledge will enable the promotion of ethical, legal as well as effective health services to the patients in the emergency ward. Method: In this qualitative study, research field was one of the emergency wards of educational and public hospitals in Iran. Field work and participant observation were carried out for 515 hours from June 2014 to March 2016. Also, conversations and semi-structured interviews based on the observations were conducted. The participants of the study were nurses and physicians working in the emergency ward, as well as patients and their attendants who were involved in the process of obtaining informed consent. Results: Three main categories were extracted from the data: a sense of frustration; reverse protection; and culture of paternalism in consent process. Conclusion: Findings of this study can be utilized in correcting the structures and processes of obtaining informed consent together with promotion of patients' ethical and legal care in emergency ward. In this way, the approaches in consent process will be changed from paternalistic approach to patient-centered care which concomitantly protects patient’s autonomy. PMID:29399235

Readability of informed consent forms in clinical trials conducted in a skin research center

PubMed Central

Samadi, Aniseh; Asghari, Fariba

2016-01-01

Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch–Kincaid reading ease score, Flesch–Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23–14.09) using the Flesch–Kincaid formula and 14.64 ± 1.22 (12.67–18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11th grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590

Research protocol for the Picture Talk Project: a qualitative study on research and consent with remote Australian Aboriginal communities

PubMed Central

Fitzpatrick, Emily F M; Carter, Maureen; Oscar, June; Lawford, Tom; Martiniuk, Alexandra L C; D’Antoine, Heather A; Elliott, Elizabeth J

2017-01-01

Introduction Research with Indigenous populations is not always designed with cultural sensitivity. Few publications evaluate or describe in detail seeking consent for research with Indigenous participants. When potential participants are not engaged in a culturally respectful manner, participation rates and research quality can be adversely affected. It is unethical to proceed with research without truly informed consent. Methods and analysis We describe a culturally appropriate research protocol that is invited by Aboriginal communities of the Fitzroy Valley in Western Australia. The Picture Talk Project is a research partnership with local Aboriginal leaders who are also chief investigators. We will interview Aboriginal leaders about research, community engagement and the consent process and hold focus groups with Aboriginal community members about individual consent. Cultural protocols will be applied to recruit and conduct research with participants. Transcripts will be analysed using NVivo10 qualitative software and themes synthesised to highlight the key issues raised by the community about the research process. This protocol will guide future research with the Aboriginal communities of the Fitzroy Valley and may inform the approach to research with other Indigenous communities of Australia or the world. It must be noted that no community is the same and all research requires local consultation and input. To conduct culturally sensitive research, respected local people from the community who have knowledge of cultural protocol and language are engaged to guide each step of the research process from the project design to the delivery of results. Ethics and dissemination Ethics approval was granted by the University of Sydney Human Research Ethics Committee (No. 2012/348, reference:14760), the Western Australia Country Health Service Ethics Committee (No. 2012:15), the Western Australian Aboriginal Health Ethics Committee and reviewed by the Kimberley Aboriginal Health Planning Forum Research Sub-Committee (No. 2012–008). Results will be disseminated through peer review articles, a local Fitzroy Valley report and conference presentations. PMID:29288181

National Comparative Audit of Blood Transfusion: report on the 2014 audit of patient information and consent.

PubMed

Booth, C; Grant-Casey, J; Lowe, D; Court, E L; Allard, S

2017-11-28

The aim of this study was to assess current practices around obtaining consent for blood transfusion and provision of patient information in hospitals across the UK and identify areas for improvement. Recommendations from the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) (2011) state that valid consent should be obtained for blood transfusion and documented in clinical records. A standardised source of information should be available to patients. Practices in relation to this have historically been inconsistent. The consent process was studied in hospitals across the UK over a 3-month period in 2014 by means of an audit of case notes and simultaneous surveys of patients and staff. In total, 2784 transfusion episodes were reviewed across 164 hospital sites. 85% of sites had a policy on consent for transfusion. Consent was documented in 43% of case notes. 68% of patients recalled being given information on benefits of transfusion, 38% on risks and 8% on alternatives and 28% reported receiving an information leaflet. In total, 85% of staff stated they had explained the reason for transfusion, but only 65% had documented this. 41% of staff had received training specifically on transfusion consent in the last 2 years. There is a need to improve clinical practice in obtaining valid consent for transfusion in line with existing national guidelines and local Trust policies, with emphasis on documentation within clinical records. Provision of patient information is an area particularly highlighted for action, and transfusion training for clinicians should be strengthened. © 2017 British Blood Transfusion Society.

Specific Language Impairments in Children.

ERIC Educational Resources Information Center

Watkins, Ruth V., Ed.; Rice, Mabel L., Ed.

The fourth volume in a series on communication and language intervention focuses on specific language impairments in children, and contains papers presented at a 1992 conference. Papers include the following: "Specific Language Impairments in Children: An Introduction" (Ruth V. Watkins); "Studies of Genetics of Specific Language Impairment" (J.…

Law & Order, CSI, and NCIS: The Association Between Exposure to Crime Drama Franchises, Rape Myth Acceptance, and Sexual Consent Negotiation Among College Students.

PubMed

Hust, Stacey J T; Marett, Emily Garrigues; Lei, Ming; Ren, Chunbo; Ran, Weina

2015-01-01

Previous research has identified that exposure to the crime drama genre lowers rape myth acceptance and increases sexual assault prevention behaviors such as bystander intervention. However, recent content analyses have revealed marked differences in the portrayal of sexual violence within the top three crime drama franchises. Using a survey of 313 college freshmen, this study explores the influence of exposure to the three most popular crime drama franchises: Law & Order, CSI, and NCIS. Findings indicate that exposure to the Law & Order franchise is associated with decreased rape myth acceptance and increased intentions to adhere to expressions of sexual consent and refuse unwanted sexual activity; whereas exposure to the CSI franchise is associated with decreased intentions to seek consent and decreased intentions to adhere to expressions of sexual consent. Exposure to the NCIS franchise was associated with decreased intentions to refuse unwanted sexual activity. These results indicate that exposure to the specific content of each crime drama franchise may have differential results on sexual consent negotiation behaviors.

Do surgeons and patients discuss what they document on consent forms?

PubMed

Hall, Daniel E; Hanusa, Barbara H; Fine, Michael J; Arnold, Robert M

2015-07-01

Previous studies of surgeon behavior report that surgeons rarely meet basic standards of informed consent, raising concerns that current practice requires urgent remediation. We wondered if the Veterans Affairs Healthcare System's recent implementation of standardized, procedure-specific consent forms might produce a better practice of informed consent than has been reported previously. Our goal was to determine how the discussions shared between surgeons and patients correspond to the VA's standardized consent forms. We enrolled a prospective cohort of patients presenting for possible cholecystectomy or inguinal herniorrhaphy and the surgical providers for those patients. Audio recordings captured the clinical encounter(s) culminating in a decision to have surgery. Each patient's informed consent was documented using a standardized, computer-generated form. We abstracted and compared the information documented with the information discussed. Of 75 consecutively enrolled patients, 37 eventually decided to have surgery and signed the standardized consent form. Patients and providers discussed 37% (95% confidence interval, 0.07-0.67) and 33% (95% confidence interval, 0.21-0.43) of the information found on the cholecystectomy and herniorrhaphy consent forms, respectively. However, the patient-provider discussions frequently included relevant details nowhere documented on the standardized forms, culminating in discussions that included a median 27.5 information items for cholecystectomy and 20 items for herniorrhaphy. Fully, 80% of cholecystectomy discussions and 76% of herniorrhaphy discussions mentioned at least one risk, benefit or alternative, indication for, and description of the procedure. The patients and providers observed here collaborated in a detailed process of informed consent that challenges the initial reports suggesting the need to remediate surgeon's practice of informed consent. However, because the discrepancy between the information documented and discussed exposes legal and ethical liability, there is an opportunity to improve the iMed system so that it better reflects what surgeons discuss and more frequently includes all the information patients need. Published by Elsevier Inc.

Phonological deficits in specific language impairment and developmental dyslexia: towards a multidimensional model

PubMed Central

Ramus, Franck; Marshall, Chloe R.; Rosen, Stuart

2013-01-01

An on-going debate surrounds the relationship between specific language impairment and developmental dyslexia, in particular with respect to their phonological abilities. Are these distinct disorders? To what extent do they overlap? Which cognitive and linguistic profiles correspond to specific language impairment, dyslexia and comorbid cases? At least three different models have been proposed: the severity model, the additional deficit model and the component model. We address this issue by comparing children with specific language impairment only, those with dyslexia-only, those with specific language impairment and dyslexia and those with no impairment, using a broad test battery of language skills. We find that specific language impairment and dyslexia do not always co-occur, and that some children with specific language impairment do not have a phonological deficit. Using factor analysis, we find that language abilities across the four groups of children have at least three independent sources of variance: one for non-phonological language skills and two for distinct sets of phonological abilities (which we term phonological skills versus phonological representations). Furthermore, children with specific language impairment and dyslexia show partly distinct profiles of phonological deficit along these two dimensions. We conclude that a multiple-component model of language abilities best explains the relationship between specific language impairment and dyslexia and the different profiles of impairment that are observed. PMID:23413264

A booklet on participants' rights to improve consent for clinical research: a randomized trial.

PubMed

Benatar, Jocelyne R; Mortimer, John; Stretton, Matthew; Stewart, Ralph A H

2012-01-01

Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire. Information related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). A booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials.

A Booklet on Participants’ Rights to Improve Consent for Clinical Research: A Randomized Trial

PubMed Central

Benatar, Jocelyne R.; Mortimer, John; Stretton, Matthew; Stewart, Ralph A. H.

2012-01-01

Objective Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. Methods 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants’ rights. A booklet designed to provide information on participants’ rights which used simple language was developed to replace this information in current ICF’s Readability of each component of ICF’s and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant’s rights was assessed by questionnaire. Results Information related to participants’ rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). Conclusions A booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials. PMID:23094034

Development of a tiered and binned genetic counseling model for informed consent in the era of multiplex testing for cancer susceptibility.

PubMed

Bradbury, Angela R; Patrick-Miller, Linda; Long, Jessica; Powers, Jacquelyn; Stopfer, Jill; Forman, Andrea; Rybak, Christina; Mattie, Kristin; Brandt, Amanda; Chambers, Rachelle; Chung, Wendy K; Churpek, Jane; Daly, Mary B; Digiovanni, Laura; Farengo-Clark, Dana; Fetzer, Dominique; Ganschow, Pamela; Grana, Generosa; Gulden, Cassandra; Hall, Michael; Kohler, Lynne; Maxwell, Kara; Merrill, Shana; Montgomery, Susan; Mueller, Rebecca; Nielsen, Sarah; Olopade, Olufunmilayo; Rainey, Kimberly; Seelaus, Christina; Nathanson, Katherine L; Domchek, Susan M

2015-06-01

Multiplex genetic testing, including both moderate- and high-penetrance genes for cancer susceptibility, is associated with greater uncertainty than traditional testing, presenting challenges to informed consent and genetic counseling. We sought to develop a new model for informed consent and genetic counseling for four ongoing studies. Drawing from professional guidelines, literature, conceptual frameworks, and clinical experience, a multidisciplinary group developed a tiered-binned genetic counseling approach proposed to facilitate informed consent and improve outcomes of cancer susceptibility multiplex testing. In this model, tier 1 "indispensable" information is presented to all patients. More specific tier 2 information is provided to support variable informational needs among diverse patient populations. Clinically relevant information is "binned" into groups to minimize information overload, support informed decision making, and facilitate adaptive responses to testing. Seven essential elements of informed consent are provided to address the unique limitations, risks, and uncertainties of multiplex testing. A tiered-binned model for informed consent and genetic counseling has the potential to address the challenges of multiplex testing for cancer susceptibility and to support informed decision making and adaptive responses to testing. Future prospective studies including patient-reported outcomes are needed to inform how to best incorporate multiplex testing for cancer susceptibility into clinical practice.Genet Med 17 6, 485-492.

Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research.

PubMed

Hein, Irma M; De Vries, Martine C; Troost, Pieter W; Meynen, Gerben; Van Goudoever, Johannes B; Lindauer, Ramón J L

2015-11-09

For many decades, the debate on children's competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children's competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children's competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives. Although assessment of children's competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad. Previous research outcomes showed that children's medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children's competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated.

[Physicians and professionalism. Patients and information].

PubMed

Carvallo, Aurelio

2005-02-01

In the present time, the advances in sciences brought by technology are worshiped. This contributes to dehumanize human relationships. Medical profession is a commitment to oneself, society and social justice. Scientific and humanist formation must coexist during the training of new physicians. The main objective of medical profession is the relationship with patients. Patients have acquired increasing autonomy and a deliberative relationship is the closest to the ideal medical action. The relationship must be based in autonomy, beneficence, lack of maleficence and justice. The patient must receive all the information about his ailment and the diagnostic and therapeutic alternatives in a clear and intelligible language. This will allow to obtain a fully conscious informed consent from the patient. Asking for this consent, gives the patient the opportunity to practice his responsibility and to decide the best for him in a friendly and confident environment. In the middle of science and technology, a close contact with ethics and humanism will allow a better understanding of the integrity of subjects, specially when they are ill.

The radiology informed consent form: recommendations from the European Society of Cardiology position paper.

PubMed

Carpeggiani, Clara; Picano, Eugenio

2016-06-01

Every radiological and nuclear medicine examination confers a definite long-term risk of cancer, but most patients undergoing such examinations receive no or inaccurate information about radiation dose and corresponding risk related to the dose received. Informed consent is a procedure to support (not substitute) the physician/patient dialogue and relationship, facilitating a free, informed and aware expression of the patient's will in the principle of patient autonomy. Physicians are responsible for providing patients with all the information on risks, benefits and alternatives useful to the patient to make the decision. In current radiological practice the information on the radiation dose and long-term cancer risks is difficult to find and not easy to understand. The form using plain language should spell-out the type of examination, the effective dose (mSv), the effective dose expressed in number of chest radiographs and the risk of cancer. The current practice clashes against the guidelines and the law.

Disclosure of Individual Surgeon's Performance Rates During Informed Consent

PubMed Central

Burger, Ingrid; Schill, Kathryn; Goodman, Steven

2007-01-01

Objective: The purpose of the paper is to examine the ethical arguments for and against disclosing surgeon-specific performance rates to patients during informed consent, and to examine the challenges that generating and using performance rates entail. Methods: Ethical, legal, and statistical theory is explored to approach the question of whether, when, and how surgeons should disclosure their personal performance rates to patients. The main ethical question addressed is what type of information surgeons owe their patients during informed consent. This question comprises 3 related, ethically relevant considerations that are explored in detail: 1) Does surgeon-specific performance information enhance patient decision-making? 2) Do patients want this type of information? 3) How do the potential benefits of disclosure balance against the risks? Results: Calculating individual performance measures requires tradeoffs and involves inherent uncertainty. There is a lack of evidence regarding whether patients want this information, whether it facilitates their decision-making for surgery, and how it is best communicated to them. Disclosure of personal performance rates during informed consent has the potential benefits of enhancing patient autonomy, improving patient decision-making, and improving quality of care. The major risks of disclosure include inaccurate and misleading performance rates, avoidance of high-risk cases, unjust damage to surgeon's reputations, and jeopardized patient trust. Conclusion: At this time, we think that, for most conditions, surgical procedures, and outcomes, the accuracy of surgeon- and patient-specific performance rates is illusory, obviating the ethical obligation to communicate them as part of the informed consent process. Nonetheless, the surgical profession has the duty to develop information systems that allow for performance to be evaluated to a high degree of accuracy. In the meantime, patients should be informed of the quantity of procedures their surgeons have performed, providing an idea of the surgeon's experience and qualitative idea of potential risk. PMID:17414595

The cultural specifity of research ethics—or why ethical debate in France is different

PubMed Central

Maio, G

2002-01-01

In the search for a globally binding ethical minimal consensus in dealing with research on human beings the awareness of the cultural specificity of such questions will be of central importance. France provides a good example of such cultural specificities. Three basic structures of French discussion on research ethics can be enumerated: first the particular weight placed on therapeutic benefit, second a particular accentuation on freedom and voluntarism, and third its lesser attention to the aspect of ability to give consent. The weak emphasis on the ability to give consent is rooted as much in the traditionally paternalistically imbued physician-patient relationship as in the French legal system, in which the doctrine of consent is not given the fundamental position of importance found in the Anglo-Saxon countries. As an important Roman country, a different accentuation in the ethical discussion on research on humans can be recognised, a discussion in which for a long time the right of self determination was less of a criterion for decision than the teleology of medical action. It is precisely this aspect of latent cultural influence in ethical convictions which is of decisive importance for future discussion on research on humans. PMID:12042397

Emerging issues in paediatric health research consent forms in Canada: working towards best practices.

PubMed

Dove, Edward S; Avard, Denise; Black, Lee; Knoppers, Bartha M

2013-01-30

Obtaining a research participant's voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008-2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child's assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child's psychological and social perspective; (3) whether a child's ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child's perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed. The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study. The analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics.

Ethical Issues in Conducting Research With Deaf Populations

PubMed Central

Schlehofer, Deirdre; Thew, Denise

2013-01-01

Deaf American Sign Language (ASL) users represent a small population at risk for marginalization from research and surveillance activities resulting from cultural, language, and ethical challenges. The Deaf community’s view of deafness as a cultural identity, rather than a disability, contradicts the medical community’s perception of deafness as a disease or deficiency in need of correction or elimination. These differences continue to have significant cultural and social implications within the Deaf community, resulting in mistrust of research opportunities. Two particularly contentious ethical topics for the Deaf community are the absence of community representation in genetic research and the lack of accessible informed consents and research materials. This article outlines a series of innovative strategies and solutions to these issues, including the importance of community representation and collaboration with researchers studying deaf populations. PMID:24134363

Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials.

PubMed

Kimberly, Michael B; Hoehn, K Sarah; Feudtner, Chris; Nelson, Robert M; Schreiner, Mark

2006-05-01

To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols. Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs. Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180-1425; study 2, $0-500; and study 3, $0-100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified > or =1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants. In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.

77 FR 12588 - Long Fence & Home, LLLP; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

... homeowners can realize by replacing their windows, including the home's geographic location, size, insulation... window of a specific composition in a building having a specific level of insulation in a specific region..., energy savings, energy [[Page 12590

Abortion.

PubMed

1993-05-01

The Alan Guttmacher Institute's State Reproductive Health Monitor "Legislative Proposals and Actions" provides US legislative information on abortion. The listing contains information on pending bills: the state, the identifying legislative number, the sponsor, the committee, the date the bill was introduced, a description of the bill, and when available the bill's status. The bills cover: 1) clinic licensing, e.g., requiring outpatient health care facilities in which abortions are performed, to have malpractice liability insurance; 2) comprehensive statues, which require parental notification before minor may obtain abortions, mandate abortion counseling to all women 24 hours before the abortion can be performed and prohibit disciplining or discharging a state employee for refusing to provide abortion counseling; 3) fetal personhood and rights, e.g. providing that life is vested in each person at fertilization; 4) fetal research and remains; 5) gender of fetus, which regulate abortions relative to sex selection in pregnancies; 6) harassment regulation; 7) informed consent and waiting periods detailing the risks and alternatives to abortion, and the 24-hour waiting period; 8) insurance coverage, e.g., eliminating language banning the coverage of abortions for state workers, and prohibiting disclosure by a health insurance carrier to the employer of a claimant that the claimant had a surgical abortion; 9) legality of abortion, urging Congress to reject he Freedom of Choice Act; 10) parental consent and notification; 11) postviability requirements; 12) public funding; 13) reporting requirements; 14) reproductive rights, and 15) spousal and paternal consent and notification.

Barriers and facilitators to uptake of the school-based HPV vaccination programme in an ethnically diverse group of young women.

PubMed

Batista Ferrer, Harriet; Trotter, Caroline L; Hickman, Matthew; Audrey, Suzanne

2016-09-01

To identify the barriers and facilitators to uptake of the HPV vaccine in an ethnically diverse group of young women in the south west of England. Three school-based vaccination sessions were observed. Twenty-three young women aged 12 to 13 years, and six key informants, were interviewed between October 2012 and July 2013. Data were analysed using thematic analysis and the Framework method for data management. The priority given to preventing cervical cancer in this age group influenced whether young women received the HPV vaccine. Access could be affected by differing levels of commitment by school staff, school nurses, parents and young women to ensure parental consent forms were returned. Beliefs and values, particularly relevant to minority ethnic groups, in relation to adolescent sexual activity may affect uptake. Literacy and language difficulties undermine informed consent and may prevent vaccination. The school-based HPV vaccination programme successfully reaches the majority of young women. However, responsibility for key aspects remain unresolved which can affect delivery and prevent uptake for some groups. A multi-faceted approach, targeting appropriate levels of the socio-ecological model, is required to address procedures for consent and cultural and literacy barriers faced by minority ethnic groups, increase uptake and reduce inequalities. © The Author 2015. Published by Oxford University Press on behalf of Faculty of Public Health.

Email-Based Informed Consent: Innovative Method for Reaching Large Numbers of Subjects for Data Mining Research

NASA Technical Reports Server (NTRS)

Lee, Lesley R.; Mason, Sara S.; Babiak-Vazquez, Adriana; Ray, Stacie L.; Van Baalen, Mary

2015-01-01

Since the 2010 NASA authorization to make the Life Sciences Data Archive (LSDA) and Lifetime Surveillance of Astronaut Health (LSAH) data archives more accessible by the research and operational communities, demand for data has greatly increased. Correspondingly, both the number and scope of requests have increased, from 142 requests fulfilled in 2011 to 224 in 2014, and with some datasets comprising up to 1 million data points. To meet the demand, the LSAH and LSDA Repositories project was launched, which allows active and retired astronauts to authorize full, partial, or no access to their data for research without individual, study-specific informed consent. A one-on-one personal informed consent briefing is required to fully communicate the implications of the several tiers of consent. Due to the need for personal contact to conduct Repositories consent meetings, the rate of consenting has not kept up with demand for individualized, possibly attributable data. As a result, other methods had to be implemented to allow the release of large datasets, such as release of only de-identified data. However the compilation of large, de-identified data sets places a significant resource burden on LSAH and LSDA and may result in diminished scientific usefulness of the dataset. As a result, LSAH and LSDA worked with the JSC Institutional Review Board Chair, Astronaut Office physicians, and NASA Office of General Counsel personnel to develop a "Remote Consenting" process for retrospective data mining studies. This is particularly useful since the majority of the astronaut cohort is retired from the agency and living outside the Houston area. Originally planned as a method to send informed consent briefing slides and consent forms only by mail, Remote Consenting has evolved into a means to accept crewmember decisions on individual studies via their method of choice: email or paper copy by mail. To date, 100 emails have been sent to request participation in eight HRP-funded studies. The development of the Remote Consent process, the laws allowing transmission of consent via electronic means, total metrics to date, and remaining challenges (e.g., response issues, use of International Partner data, biospecimens/genetic data) for the research use of LSAH/LSDA data will be described.

A critique of the regulation of data science in healthcare research in the European Union.

PubMed

Rumbold, John M M; Pierscionek, Barbara K

2017-04-08

The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions (albeit with a supranational legal framework), which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification. Consequently, there is a balancing act between this risk and retaining sufficient utility of the data. Anonymising methods need to take into account the circumstances of data sharing to enable an appropriate balance in all cases. There are ethical and policy advantages to exceeding the legal requirements and thereby securing the social licence for research. This process would require the examination and comparison of data protection laws across the trading bloc to produce an ethico-legal framework compatible with the requirements of all member states. Seven EU jurisdictions are given consideration in this critique.

Language-Independent and Language-Specific Aspects of Early Literacy: An Evaluation of the Common Underlying Proficiency Model.

PubMed

Goodrich, J Marc; Lonigan, Christopher J

2017-08-01

According to the common underlying proficiency model (Cummins, 1981), as children acquire academic knowledge and skills in their first language, they also acquire language-independent information about those skills that can be applied when learning a second language. The purpose of this study was to evaluate the relevance of the common underlying proficiency model for the early literacy skills of Spanish-speaking language-minority children using confirmatory factor analysis. Eight hundred fifty-eight Spanish-speaking language-minority preschoolers (mean age = 60.83 months, 50.2% female) participated in this study. Results indicated that bifactor models that consisted of language-independent as well as language-specific early literacy factors provided the best fits to the data for children's phonological awareness and print knowledge skills. Correlated factors models that only included skills specific to Spanish and English provided the best fits to the data for children's oral language skills. Children's language-independent early literacy skills were significantly related across constructs and to language-specific aspects of early literacy. Language-specific aspects of early literacy skills were significantly related within but not across languages. These findings suggest that language-minority preschoolers have a common underlying proficiency for code-related skills but not language-related skills that may allow them to transfer knowledge across languages.

Exercise to Counteract Loss of Bone and Muscle During Androgen Deprivation Therapy in Men with Prostate Cancer

DTIC Science & Technology

2009-08-01

finishers in the current study on age and body mass index . This will enable us to evaluate BMD and body composition changes in response to exercise in men...support from the Clinical Nutrition Research Unit (CNRU) • prepare data forms • prepare data base • train research staff Final approval of the protocol...the local IRB on 19 Feb 2008. In the past year, the consent form underwent minor changes to update standard language used by the local IRB (approved

Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico.

PubMed

Verástegui, Emma L

2006-12-13

A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important. To gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale. Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8th grade. The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients.

Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico

PubMed Central

Verástegui, Emma L

2006-01-01

Background A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important. Methods To gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale. Results Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8TH Grade. Conclusion The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients. PMID:17166274

Abnormal Functional Lateralization and Activity of Language Brain Areas in Typical Specific Language Impairment (Developmental Dysphasia)

ERIC Educational Resources Information Center

de Guibert, Clement; Maumet, Camille; Jannin, Pierre; Ferre, Jean-Christophe; Treguier, Catherine; Barillot, Christian; Le Rumeur, Elisabeth; Allaire, Catherine; Biraben, Arnaud

2011-01-01

Atypical functional lateralization and specialization for language have been proposed to account for developmental language disorders, yet results from functional neuroimaging studies are sparse and inconsistent. This functional magnetic resonance imaging study compared children with a specific subtype of specific language impairment affecting…

Compiler writing system detail design specification. Volume 1: Language specification

NASA Technical Reports Server (NTRS)

Arthur, W. J.

1974-01-01

Construction within the Meta language for both language and target machine specification is reported. The elements of the function language as a meaning and syntax are presented, and the structure of the target language is described which represents the target dependent object text representation of applications programs.

Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned

PubMed Central

Ramo, Danielle E.; Rodriguez, Theresa M.S.; Chavez, Kathryn; Sommer, Markus J.; Prochaska, Judith J.

2014-01-01

Further understanding is needed of the functionalities and efficiency of social media for health intervention research recruitment. Facebook was examined as a mechanism to recruit young adults for a smoking cessation intervention. An ad campaign targeting young adult smokers tested specific messaging based on market theory and successful strategies used to recruit smokers in previous clinical trials (i.e. informative, call to action, scarcity, social norms), previously successful ads, and general messaging. Images were selected to target smokers (e.g., lit cigarette), appeal to the target age, vary demographically, and vary graphically (cartoon, photo, logo). Facebook’s Ads Manager was used over 7 weeks (6/10/13 – 7/29/13), targeted by age (18–25), location (U.S.), and language (English), and employed multiple ad types (newsfeed, standard, promoted posts, sponsored stories) and keywords. Ads linked to the online screening survey or study Facebook page. The 36 different ads generated 3,198,373 impressions, 5,895 unique clicks, at an overall cost of $2,024 ($0.34/click). Images of smoking and newsfeed ads had the greatest reach and clicks at the lowest cost. Of 5,895 unique clicks, 586 (10%) were study eligible and 230 (39%) consented. Advertising costs averaged $8.80 per eligible, consented participant. The final study sample (n=79) was largely Caucasian (77%) and male (69%), averaging 11 cigarettes/day (SD=8.3) and 2.7 years smoking (SD=0.7). Facebook is a useful, cost-effective recruitment source for young adult smokers. Ads posted via newsfeed posts were particularly successful, likely because they were viewable via mobile phone. Efforts to engage more ethnic minorities, young women, and smokers motivated to quit are needed. PMID:25045624

Understanding variations in secondary findings reporting practices across U.S. genome sequencing laboratories.

PubMed

Ackerman, Sara L; Koenig, Barbara A

2018-01-01

Increasingly used for clinical purposes, genome and exome sequencing can generate clinically relevant information that is not directly related to the reason for testing (incidental or secondary findings). Debates about the ethical implications of secondary findings were sparked by the American College of Medical Genetics (ACMG) 2013 policy statement, which recommended that laboratories report pathogenic alterations in 56 genes. Although wide variation in laboratories' secondary findings policies has been reported, little is known about its causes. We interviewed 18 laboratory directors and genetic counselors at 10 U.S. laboratories to investigate the motivations and interests shaping secondary findings reporting policies for clinical exome sequencing. Analysis of interview transcripts and laboratory documents was informed by sociological theories of standardization. Laboratories varied widely in terms of the types of secondary findings reported, consent-form language, and choices offered to patients. In explaining their adaptation of the ACMG report, our participants weighed genetic information's clinical, moral, professional, and commercial value in an attempt to maximize benefits for patients and families, minimize the costs of sequencing and analysis, adhere to professional norms, attract customers, and contend with the uncertain clinical implications of much of the genetic information generated. Nearly all laboratories in our study voluntarily adopted ACMG's recommendations, but their actual practices varied considerably and were informed by laboratory-specific judgments about clinical utility and patient benefit. Our findings offer a compelling example of standardization as a complex process that rarely leads simply to uniformity of practice. As laboratories take on a more prominent role in decisions about the return of genetic information, strategies are needed to inform patients, families, and clinicians about the differences between laboratories' practices and ensure that the consent process prompts a discussion of the value of additional genetic information for patients and their families.

Facebook Recruitment of Young Adult Smokers for a Cessation Trial: Methods, Metrics, and Lessons Learned.

PubMed

Ramo, Danielle E; Rodriguez, Theresa M S; Chavez, Kathryn; Sommer, Markus J; Prochaska, Judith J

2014-04-01

Further understanding is needed of the functionalities and efficiency of social media for health intervention research recruitment. Facebook was examined as a mechanism to recruit young adults for a smoking cessation intervention. An ad campaign targeting young adult smokers tested specific messaging based on market theory and successful strategies used to recruit smokers in previous clinical trials (i.e. informative, call to action, scarcity, social norms), previously successful ads, and general messaging. Images were selected to target smokers (e.g., lit cigarette), appeal to the target age, vary demographically, and vary graphically (cartoon, photo, logo). Facebook's Ads Manager was used over 7 weeks (6/10/13 - 7/29/13), targeted by age (18-25), location (U.S.), and language (English), and employed multiple ad types (newsfeed, standard, promoted posts, sponsored stories) and keywords. Ads linked to the online screening survey or study Facebook page. The 36 different ads generated 3,198,373 impressions, 5,895 unique clicks, at an overall cost of $2,024 ($0.34/click). Images of smoking and newsfeed ads had the greatest reach and clicks at the lowest cost. Of 5,895 unique clicks, 586 (10%) were study eligible and 230 (39%) consented. Advertising costs averaged $8.80 per eligible, consented participant. The final study sample (n=79) was largely Caucasian (77%) and male (69%), averaging 11 cigarettes/day (SD=8.3) and 2.7 years smoking (SD=0.7). Facebook is a useful, cost-effective recruitment source for young adult smokers. Ads posted via newsfeed posts were particularly successful, likely because they were viewable via mobile phone. Efforts to engage more ethnic minorities, young women, and smokers motivated to quit are needed.

Lack of Comprehension of Common Prostate Cancer Terms in an Underserved Population

PubMed Central

Kilbridge, Kerry L.; Fraser, Gertrude; Krahn, Murray; Nelson, Elizabeth M.; Conaway, Mark; Bashore, Randall; Wolf, Andrew; Barry, Michael J.; Gong, Debra A.; Nease, Robert F.; Connors, Alfred F.

2009-01-01

Purpose To assess the comprehension of common medical terms used in prostate cancer in patient education materials to obtain informed consent, and to measure outcomes after prostate cancer treatment. We address this issue among underserved, African-American men because of the increased cancer incidence and mortality observed in this population. Patients and Methods We reviewed patient education materials and prostate-specific quality-of-life instruments to identify technical terms describing sexual, urinary, and bowel function. Understanding of these terms was assessed in face-to-face interviews of 105, mostly African-American men, age ≥ 40, from two low-income clinics. Comprehension was evaluated using semiqualitative methods coded by two independent investigators. Demographics were collected and literacy was measured. Results Fewer than 50% of patients understood the terms “erection” or “impotent.” Only 5% of patients understood the term “incontinence” and 25% understood the term “bowel habits.” More patients recognized word roots than related terms or compound words (eg, “rectum” v “rectal urgency,” “intercourse” v “vaginal intercourse”). Comprehension of terms from all domains was statistically significantly correlated with reading level (P < .001). Median literacy level was fourth to sixth grade. Prostate cancer knowledge was poor. Many patients had difficulty locating key anatomic structures. Conclusion Limited comprehension of prostate cancer terms and low literacy create barriers to obtaining informed consent for treatment and to measuring prostate cancer outcomes accurately in our study population. In addition, the level of prostate cancer knowledge was poor. These results highlight the need for prostate cancer education efforts and outcomes measurements that consider literacy and use nonmedical language. PMID:19307512

The ethics of managing affective and emotional states to improve informed consent: autonomy, comprehension, and voluntariness.

PubMed

Braude, Hillel; Kimmelman, Jonathan

2012-03-01

Over the past several decades the 'affective revolution' in cognitive psychology has emphasized the critical role affect and emotion play in human decision-making. Drawing on this affective literature, various commentators have recently proposed strategies for managing therapeutic expectation that use contextual, symbolic, or emotive interventions in the consent process to convey information or enhance comprehension. In this paper, we examine whether affective consent interventions that target affect and emotion can be reconciled with widely accepted standards for autonomous action. More specifically, the ethics of affective consent interventions is assessed in terms of key elements of autonomy, comprehension and voluntariness. While there may appear to be a moral obligation to manage the affective environment to ensure valid informed consent, in circumstances where volunteers may be prone to problematic therapeutic expectancy, this moral obligation needs to be weighed against the potential risks of human instrumentalization. At this point in time we do not have enough information to be able to justify clearly the programmatic manipulation of human subjects' affective states. The lack of knowledge about affective interventions requires corresponding caution in its ethical justification. © 2010 Blackwell Publishing Ltd.

Hypothetical contractarianism and the disclosure requirement problem in informed consent.

PubMed

Cust, Kenneth F T

1991-01-01

Two of the more deeply problematic issues surrounding the doctrine of informed consent are providing a justification for the practice of informed consent and providing an account of the nature and amount of information that must be disclosed in order for informed consent to take place. This paper is concerned with the latter problem, the problem of disclosure requirements, but it deals with this problem in a novel way; it approaches the problem by asking what fully informed and fully rational agents would agree to under certain hypothetical conditions. In general terms I juxtapose the hypothetical contractarianism found in Rawls' A Theory of Justice with that found in Gauthier's Morals By Agreement and ask what their respective hypothetical contractors would agree to with respect to choosing a particular standard of disclosure to govern the practice of informed consent. In more specific terms a contrast is made between what a Rawlsian agent behind a veil of ignorance would choose as compared to what, in Gauthier's terms, an ideal actor making an Archimedean choice would choose. The idea of an Archimedean point, and the subsequent choice made from that point, although technically identified by Rawls, originated with Archimedes of Syracuse.

Dynamic consent: a patient interface for twenty-first century research networks

PubMed Central

Kaye, Jane; Whitley, Edgar A; Lund, David; Morrison, Michael; Teare, Harriet; Melham, Karen

2015-01-01

Biomedical research is being transformed through the application of information technologies that allow ever greater amounts of data to be shared on an unprecedented scale. However, the methods for involving participants have not kept pace with changes in research capability. In an era when information is shared digitally at the global level, mechanisms of informed consent remain static, paper-based and organised around national boundaries and legal frameworks. Dynamic consent (DC) is both a specific project and a wider concept that offers a new approach to consent; one designed to meet the needs of the twenty-first century research landscape. At the heart of DC is a personalised, digital communication interface that connects researchers and participants, placing participants at the heart of decision making. The interface facilitates two-way communication to stimulate a more engaged, informed and scientifically literate participant population where individuals can tailor and manage their own consent preferences. The technical architecture of DC includes components that can securely encrypt sensitive data and allow participant consent preferences to travel with their data and samples when they are shared with third parties. In addition to improving transparency and public trust, this system benefits researchers by streamlining recruitment and enabling more efficient participant recontact. DC has mainly been developed in biobanking contexts, but it also has potential application in other domains for a variety of purposes. PMID:24801761

Informed consent for and regulation of critical care research.

PubMed

Lemaire, François

2008-12-01

Critical care is a special area in which research needs to take place, because of the severity of the diseases which are treated there, but it is also a place where research faces a lot of hurdles and difficulties. The main cause of difficulties is the consent issue, as most patients cannot consent for themselves. Recently, all national legislations in the countries of the European Union have been modified to include the provisions of directive 2001/20. This review article provides a summary of the recent literature concerning the issue of consent for clinical care research such as how the surrogate consent reflects the view of the patient and how time consuming and inaccurate can be the consultation of a community before the start of a trial with a waiver of consent. Another hurdle to research is the rigidity of our legislations concerning clinical research, especially the absence of a simplified way for low or no-risk research. This article shows how this situation is potentially deleterious and how it could ultimately forbid low-risk research. Critical research remains a domain in which research on patients is difficult and controversial. Regulation can be difficult to implement, largely inadequate or uselessly complicated. Intensive care physicians need to keep pressure on politicians and lawmakers to constantly explain the necessity and specificities of critical care research.

Development of the Precision Link Biobank at Boston Children's Hospital: Challenges and Opportunities.

PubMed

Bourgeois, Florence T; Avillach, Paul; Kong, Sek Won; Heinz, Michelle M; Tran, Tram A; Chakrabarty, Ramkrishna; Bickel, Jonathan; Sliz, Piotr; Borglund, Erin M; Kornetsky, Susan; Mandl, Kenneth D

2017-12-15

Increasingly, biobanks are being developed to support organized collections of biological specimens and associated clinical information on broadly consented, diverse patient populations. We describe the implementation of a pediatric biobank, comprised of a fully-informed patient cohort linking specimens to phenotypic data derived from electronic health records (EHR). The Biobank was launched after multiple stakeholders' input and implemented initially in a pilot phase before hospital-wide expansion in 2016. In-person informed consent is obtained from all participants enrolling in the Biobank and provides permission to: (1) access EHR data for research; (2) collect and use residual specimens produced as by-products of routine care; and (3) share de-identified data and specimens outside of the institution. Participants are recruited throughout the hospital, across diverse clinical settings. We have enrolled 4900 patients to date, and 41% of these have an associated blood sample for DNA processing. Current efforts are focused on aligning the Biobank with other ongoing research efforts at our institution and extending our electronic consenting system to support remote enrollment. A number of pediatric-specific challenges and opportunities is reviewed, including the need to re-consent patients when they reach 18 years of age, the ability to enroll family members accompanying patients and alignment with disease-specific research efforts at our institution and other pediatric centers to increase cohort sizes, particularly for rare diseases.

Development of the Precision Link Biobank at Boston Children’s Hospital: Challenges and Opportunities

PubMed Central

Avillach, Paul; Kong, Sek Won; Heinz, Michelle M.; Tran, Tram A.; Chakrabarty, Ramkrishna; Bickel, Jonathan; Sliz, Piotr; Borglund, Erin M.; Kornetsky, Susan; Mandl, Kenneth D.

2017-01-01

Increasingly, biobanks are being developed to support organized collections of biological specimens and associated clinical information on broadly consented, diverse patient populations. We describe the implementation of a pediatric biobank, comprised of a fully-informed patient cohort linking specimens to phenotypic data derived from electronic health records (EHR). The Biobank was launched after multiple stakeholders’ input and implemented initially in a pilot phase before hospital-wide expansion in 2016. In-person informed consent is obtained from all participants enrolling in the Biobank and provides permission to: (1) access EHR data for research; (2) collect and use residual specimens produced as by-products of routine care; and (3) share de-identified data and specimens outside of the institution. Participants are recruited throughout the hospital, across diverse clinical settings. We have enrolled 4900 patients to date, and 41% of these have an associated blood sample for DNA processing. Current efforts are focused on aligning the Biobank with other ongoing research efforts at our institution and extending our electronic consenting system to support remote enrollment. A number of pediatric-specific challenges and opportunities is reviewed, including the need to re-consent patients when they reach 18 years of age, the ability to enroll family members accompanying patients and alignment with disease-specific research efforts at our institution and other pediatric centers to increase cohort sizes, particularly for rare diseases. PMID:29244735

Informed Consent Decision-Making in Deep Brain Stimulation.

PubMed

Mandarelli, Gabriele; Moretti, Germana; Pasquini, Massimo; Nicolò, Giuseppe; Ferracuti, Stefano

2018-05-11

Deep brain stimulation (DBS) has proved useful for several movement disorders (Parkinson’s disease, essential tremor, dystonia), in which first and/or second line pharmacological treatments were inefficacious. Initial evidence of DBS efficacy exists for refractory obsessive-compulsive disorder, treatment-resistant major depressive disorder, and impulse control disorders. Ethical concerns have been raised about the use of an invasive surgical approach involving the central nervous system in patients with possible impairment in cognitive functioning and decision-making capacity. Most of the disorders in which DBS has been used might present with alterations in memory, attention, and executive functioning, which may have an impact on the mental capacity to give informed consent to neurosurgery. Depression, anxiety, and compulsivity are also common in DBS candidate disorders, and could also be associated with an impaired capacity to consent to treatment or clinical research. Despite these issues, there is limited empirical knowledge on the decision-making levels of these patients. The possible informed consent issues of DBS will be discussed by focusing on the specific treatable diseases.

Multimedia in the informed consent process for endoscopic sinus surgery: A randomized control trial.

PubMed

Siu, Jennifer M; Rotenberg, Brian W; Franklin, Jason H; Sowerby, Leigh J

2016-06-01

To determine patient recall of specific risks associated with endoscopic sinus surgery and whether an adjunct multimedia education module is an effective patient tool in enhancing the standard informed consent process. Prospective, randomized, controlled trial. Fifty consecutive adult patients scheduled for endoscopic sinus surgery at a rhinology clinic of a tertiary care hospital were recruited for this study. Informed consent was studied by comparing the number of risks recalled when patients had a verbal discussion in conjunction with a 6-minute interactive module or the verbal discussion alone. Early recall was measured immediately following the informed consent process, and delayed recall was measured 3 to 4 weeks after patient preference details were also collected. Early risk recall in the multimedia group was significantly higher than the control group (P = .0036); however, there was no difference between the groups in delayed risk recall. Seventy-six percent of participants expressed interest in viewing the multimedia module if available online between the preoperative and procedural day. Sixty-eight percent of patients preferred having the multimedia module as an adjunct to the informed consent process as opposed to the multimedia consent process alone. There is an early improvement in overall risk recall in patients who complete an interactive multimedia module, with a clear patient preference for this method. Here we emphasize the well-known challenges of patient education and demonstrate the effectiveness of integrating technology into clinical practice in order to enhance the informed consent process. 1b Laryngoscope, 126:1273-1278, 2016. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

Perceptions of potential donors in the Swedish public towards information and consent procedures in relation to use of human tissue samples in biobanks: a population-based study.

PubMed

Kettis-Lindblad, Asa; Ring, Lena; Viberth, Eva; Hansson, Mats G

2007-01-01

To assess the Swedish public's preferences for information and consent procedures when being asked for permission to use previously collected tissue samples for new research studies. Cross-sectional study employing postal questionnaires to a random sample of the Swedish general public (n = 6,000) in October 2002-February 2003. The response rate was 49% (n = 2,928). This paper includes only respondents who reportedly would approve of samples being taken and stored (n = 2,122). When potential tissue sample donors in the general public have to strike a balance between the values at stake, i.e. the autonomy of the donor versus the research value, most (72%) prefer general consent, i.e. where consent is asked for at the outset only. They want the research ethics committee (REC) alone to decide on the use of stored samples, and they would allow storage as long as the sample is useful for research. The minority of respondents who were in favour of specific consent were more likely to be young, well educated, have negative experiences of healthcare and low trust in healthcare authorities. The majority of the Swedish general public prefer general consent, and are thus willing to delegate some decisions to the RECs. However, preferences for information and consent procedures depend on the context, e.g. the risks for the donor and the purpose of the research. If feasible, procedures should be differentiated according to the preferences of individual donors, thus protecting the interests of both the minority and the majority.

Risk communication and informed consent in the medical tourism industry: a thematic content analysis of Canadian broker websites.

PubMed

Penney, Kali; Snyder, Jeremy; Crooks, Valorie A; Johnston, Rory

2011-09-26

Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the risks and benefits of undergoing surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns. An exhaustive online search using multiple search engines and keywords was performed to compile a comprehensive directory of English-language Canadian medical tourism brokerage websites. These websites were examined using thematic content analysis, which included identifying informational themes, generating frequency counts of these themes, and comparing trends in these counts to the established literature. Seventeen websites were identified for inclusion in this study. It was found that Canadian medical tourism broker websites varied widely in scope, content, professionalism and depth of information. Three themes emerged from the thematic content analysis: training and accreditation, risk communication, and business dimensions. Third party accreditation bodies of debatable regulatory value were regularly mentioned on the reviewed websites, and discussion of surgical risk was absent on 47% of the websites reviewed, with limited discussion of risk on the remaining ones. Terminology describing brokers' roles was somewhat inconsistent across the websites. Finally, brokers' roles in follow up care, their prices, and the speed of surgery were the most commonly included business dimensions on the reviewed websites. Canadian medical tourism brokers currently lack a common standard of care and accreditation, and are widely lacking in providing adequate risk communication for potential medical tourists. This has implications for the informed consent and consequent safety of Canadian medical tourists.

Risk communication and informed consent in the medical tourism industry: A thematic content analysis of canadian broker websites

PubMed Central

2011-01-01

Background Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the risks and benefits of undergoing surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns. Methods An exhaustive online search using multiple search engines and keywords was performed to compile a comprehensive directory of English-language Canadian medical tourism brokerage websites. These websites were examined using thematic content analysis, which included identifying informational themes, generating frequency counts of these themes, and comparing trends in these counts to the established literature. Results Seventeen websites were identified for inclusion in this study. It was found that Canadian medical tourism broker websites varied widely in scope, content, professionalism and depth of information. Three themes emerged from the thematic content analysis: training and accreditation, risk communication, and business dimensions. Third party accreditation bodies of debatable regulatory value were regularly mentioned on the reviewed websites, and discussion of surgical risk was absent on 47% of the websites reviewed, with limited discussion of risk on the remaining ones. Terminology describing brokers' roles was somewhat inconsistent across the websites. Finally, brokers' roles in follow up care, their prices, and the speed of surgery were the most commonly included business dimensions on the reviewed websites. Conclusion Canadian medical tourism brokers currently lack a common standard of care and accreditation, and are widely lacking in providing adequate risk communication for potential medical tourists. This has implications for the informed consent and consequent safety of Canadian medical tourists. PMID:21943392

Health information exchange policies of 11 diverse health systems and the associated impact on volume of exchange.

PubMed

Downing, N Lance; Adler-Milstein, Julia; Palma, Jonathan P; Lane, Steven; Eisenberg, Matthew; Sharp, Christopher; Longhurst, Christopher A

2017-01-01

Provider organizations increasingly have the ability to exchange patient health information electronically. Organizational health information exchange (HIE) policy decisions can impact the extent to which external information is readily available to providers, but this relationship has not been well studied. Our objective was to examine the relationship between electronic exchange of patient health information across organizations and organizational HIE policy decisions. We focused on 2 key decisions: whether to automatically search for information from other organizations and whether to require HIE-specific patient consent. We conducted a retrospective time series analysis of the effect of automatic querying and the patient consent requirement on the monthly volume of clinical summaries exchanged. We could not assess degree of use or usefulness of summaries, organizational decision-making processes, or generalizability to other vendors. Between 2013 and 2015, clinical summary exchange volume increased by 1349% across 11 organizations. Nine of the 11 systems were set up to enable auto-querying, and auto-querying was associated with a significant increase in the monthly rate of exchange (P = .006 for change in trend). Seven of the 11 organizations did not require patient consent specifically for HIE, and these organizations experienced a greater increase in volume of exchange over time compared to organizations that required consent. Automatic querying and limited consent requirements are organizational HIE policy decisions that impact the volume of exchange, and ultimately the information available to providers to support optimal care. Future efforts to ensure effective HIE may need to explicitly address these factors. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association.

Loss of Language in Early Development of Autism and Specific Language Impairment

ERIC Educational Resources Information Center

Pickles, Andrew; Simonoff, Emily; Conti-Ramsden, Gina; Falcaro, Milena; Simkin, Zoe; Charman, Tony; Chandler, Susie; Loucas, Tom; Baird, Gillian

2009-01-01

Background: Several authors have highlighted areas of overlap in symptoms and impairment among children with autism spectrum disorder (ASD) and children with specific language impairment (SLI). By contrast, loss of language and broadly defined regression have been reported as relatively specific to autism. We compare the incidence of language loss…

Working memory and sentence comprehension of Hong Kong Chinese children with specific language impairment.

PubMed

Siu, Elaine; Man, David W K

2006-09-01

Children with Specific Language Impairment present with delayed language development, but do not have a history of hearing impairment, mental deficiency, or associated social or behavioral problems. Non-word repetition was suggested as an index to reflect the capacity of phonological working memory. There is a paucity of such studies among Hong Kong Chinese children. This preliminary study aimed to examine the relationship between phonological working memory and Specific Language Impairment, through the processes of non-word repetition and sentence comprehension, of children with Specific Language Impairment and pre-school children with normal language development. Both groups of children were screened by a standardized language test. A list of Cantonese (the commonest dialect used in Hong Kong) multisyllabic nonsense utterances and a set of 18 sentences were developed for this study. t-tests and Pearson correlation were used to study the relationship between non-word repetition, working memory and specific language impairment. Twenty-three pre-school children with Specific Language Impairment (mean age = 68.30 months; SD = 6.90) and another 23 pre-school children (mean age = 67.30 months; SD = 6.16) participated in the study. Significant difference performance was found between the Specific Language Impairment group and normal language group in the multisyllabic nonsense utterances repetition task and the sentence comprehension task. Length effect was noted in Specific Language Impairment group children, which is consistent with the findings of other literature. In addition, correlations were also observed between the number of nonsense utterances repeated and the number of elements comprehended. Cantonese multisyllabic nonsense utterances might be worth further developing as a screening tool for the early detection of children with Specific Language Impairment.

The Formal Semantics of PVS

NASA Technical Reports Server (NTRS)

Owre, Sam; Shankar, Natarajan

1999-01-01

A specification language is a medium for expressing what is computed rather than how it is computed. Specification languages share some features with programming languages but are also different in several important ways. For our purpose, a specification language is a logic within which the behavior of computational systems can be formalized. Although a specification can be used to simulate the behavior of such systems, we mainly use specifications to state and prove system properties with mechanical assistance. We present the formal semantics of the specification language of SRI's Prototype Verification System (PVS). This specification language is based on the simply typed lambda calculus. The novelty in PVS is that it contains very expressive language features whose static analysis (e.g., typechecking) requires the assistance of a theorem prover. The formal semantics illuminates several of the design considerations underlying PVS, the interaction between theorem proving and typechecking.

Ovarian Cancer: Deaf and Hearing Women’s Knowledge Before and After an Educational Video

PubMed Central

Jensen, Lindsay G.; Nakaji, Melanie; Harry, Kadie M.; Gallegos, Nick; Malcarne, Vanessa L.; Sadler, Georgia Robins

2013-01-01

Members of the Deaf community report language and cultural barriers to accessing health information and care. This study evaluated whether an ovarian cancer education video in American Sign Language with English captioning and voiceover could close the anticipated knowledge gap between Deaf and hearing women’s cancer knowledge. Consented Deaf (n = 55) and hearing (n = 52) women’s General, Ovarian, and Total Cancer Knowledge were assessed before and after viewing the video. At baseline, hearing women demonstrated significantly higher General, Ovarian, and Total Cancer Knowledge scores than Deaf women. By the post-test, all of Deaf women’s knowledge scores had increased, closing the baseline gap. However, hearing women’s post-video knowledge had also increased, thereby creating a new knowledge gap. The ovarian cancer education video offers an effective method to increase ovarian and general cancer knowledge for Deaf and hearing women. PMID:23975658

Research-Related Injury Compensation Policies of U.S. Research Institutions

PubMed Central

Resnik, David B.; Parasidis, Efthimios; Carroll, Kelly; Evans, Jennifer M.; Pike, Elizabeth R.; Kissling, Grace E.

2014-01-01

Federal research regulations require participants to be informed about whether medical care or compensation for injury is available in more than minimal risk studies and prohibit language in informed consent documents that waives, or appears to waive, legal rights. The objectives of this study were to compare data collected in 2000 and 2012 to identify significant changes in types of institutional compensation policies at U.S. research institutions, and assess the relationship between institutional characteristics and different types of policies. We found that research-related injury compensation policies did not change substantially during the time period. A significant percentage of policies contain language that can be reasonably interpreted as waiving, or appearing to waive, legal rights. Level of funding, public vs. private status, and institutional involvement in clinical research were associated with different types of policies. The lack of substantial change in compensation policies supports arguments for a national policy. PMID:24649739

Differential Language Markers of Pathology in Autism, Pervasive Developmental Disorder Not Otherwise Specified and Specific Language Impairment

ERIC Educational Resources Information Center

Demouy, Julie; Plaza, Monique; Xavier, Jean; Ringeval, Fabien; Chetouani, Mohamed; Perisse, Didier; Chauvin, Dominique; Viaux, Sylvie; Golse, Bernard; Cohen, David; Robel, Laurence

2011-01-01

Language impairment is a common core feature in Pervasive Developmental Disorders (PDD) and Specific Language Impairment (SLI). Many studies have tried to define the specific language profiles of these disorders, some claiming the existence of overlaps, and others conceiving of them as separate categories. Fewer have sought to determine whether…

Emerging issues in paediatric health research consent forms in Canada: working towards best practices

PubMed Central

2013-01-01

Background Obtaining a research participant’s voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Methods Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008–2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child’s assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child’s psychological and social perspective; (3) whether a child’s ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child’s perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed. Results The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study. Conclusions The analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics. PMID:23363554

Tools reference manual for a Requirements Specification Language (RSL), version 2.0

NASA Technical Reports Server (NTRS)

Fisher, Gene L.; Cohen, Gerald C.

1993-01-01

This report describes a general-purpose Requirements Specification Language, RSL. The purpose of RSL is to specify precisely the external structure of a mechanized system and to define requirements that the system must meet. A system can be comprised of a mixture of hardware, software, and human processing elements. RSL is a hybrid of features found in several popular requirements specification languages, such as SADT (Structured Analysis and Design Technique), PSL (Problem Statement Language), and RMF (Requirements Modeling Framework). While languages such as these have useful features for structuring a specification, they generally lack formality. To overcome the deficiencies of informal requirements languages, RSL has constructs for formal mathematical specification. These constructs are similar to those found in formal specification languages such as EHDM (Enhanced Hierarchical Development Methodology), Larch, and OBJ3.

Reasons for resubmission of research projects to the research ethics committee of a university hospital in São Paulo, Brazil.

PubMed

Bueno, Mariana; Brevidelli, Maria Meimei; Cocarelli, Thaís; Santos, Gianni Mara Silva dos; Ferraz, Maria Auxiliadora; Mion, Décio

2009-01-01

It is important to know the reasons for resubmitting research projects to the Research Ethics Committee in order to help researchers to prepare their research projects, informed consent forms and needed research documentation. To verify the reasons for resubmitting projects that were previously rejected by the Ethics Committee. This is a cross-sectional study that evaluated research projects involving human beings. Research projects were submitted in 2007 to the Research Ethics Committee of the Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo. One thousand two hundred and fifty six research projects were submitted to the ethics committee and the average time for evaluating the research projects and related documents until a final decision was reached was 49.95 days. From the total, 399 projects were reviewed in 2 or more meetings until a final decision was reached. Of these, 392 research projects were included in the study; 35 projects were subsequently excluded for involving animals. Among the research projects included, 42.5% concerned research with new drugs, vaccines and diagnostic tests, 48.5% consisted of undergraduate students' research projects, 68.9% of the research had no sponsorship, and 97.5% were eventually approved. The main reasons for returning the projects to the researchers were the use of inadequate language and/or difficulty of understanding the informed consent form (32.2%), lack of information about the protocol at the informed consent form (25.8%), as well as doubts regarding methodological and statistical issues of the protocol (77.1%). Other reasons for returning the research projects involved lack of, inaccuracy on or incomplete documentation, need of clarification or approval for participation of external entities on the research, lack of information on financial support. Among the research projects that were returned to the researchers for additional clarification, the main reasons were inadequacies or doubts about the terms used in the informed consent form as well as lack of information regarding the research at the informed consent form and methodological and statistical issues regarding the protocol.

Recruiting women smokers: the engineering of consent.

PubMed

Brandt, A M

1996-01-01

A range of social forces contributed to the effective recruitment of women to cigarette smoking in the crucial period between 1900 and 1940. Cigarette advertisers and public relations experts recognized the significance of women's changing roles and the rising culture of consumption, and worked to create specific meanings for the cigarette to make it appeal to women. The cigarette was a flexible symbol, with a remarkably elastic set of meanings; for women, it represented rebellious independence, glamour, seduction, and sexual allure, and served as a symbol for both feminists and flappers. The industry, with the help of advertisers and public relations experts, effectively engineered consent for women as smokers. The "engineering of consent" has a role to play in smoking cessation, since negative meanings for the cigarette can be engineered as well.

On the Difficulties of Concurrent-System Design, Illustrated with a 2×2 Switch Case Study

NASA Astrophysics Data System (ADS)

Daylight, Edgar G.; Shukla, Sandeep K.

While various specification languages for concurrent-system design exist today, it is often not clear which specification language is more suitable than another for a particular case study. To address this problem, we study four different specification languages for the same 2×2 Switch case study: TLA + , Bluespec, Statecharts, and the Algebra of Communicating Processes (ACP). By slightly altering the design intent of the Switch, we obtain more complicated behaviors of the Switch. For each design intent, we investigate how each specification, in each of the specification languages, captures the corresponding behavior. By using three different criteria, we judge each specification and specification language. For our case study, however, all four specification languages perform poorly in at least two criteria! Hence, this paper illustrates, on a seemingly simple case study, some of the prevailing difficulties of concurrent-system design.

Postal consent for upper gastrointestinal endoscopy.

PubMed

Shepherd, H A; Bowman, D; Hancock, B; Anglin, J; Hewett, D

2000-01-01

Standards for good practice in clinical risk management issued by the Clinical Negligence Scheme for Trusts indicate that "appropriate information is provided to patients on the risks and benefits of proposed treatment, and of the alternatives available before a signature on a consent form is sought". To investigate the practicability and patient acceptability of a postal information and consent booklet for patients undergoing outpatient gastroscopy. Information about gastroscopy procedure, personalised appointment details, and a carbonised consent form were compiled into a single booklet. This was mailed to patients well in advance of their endoscopic procedure. Patient satisfaction for this new process was assessed by questionnaire. 275 patients received a patient information booklet. Of these, 150 (54.5%) returned the consent form by post when they confirmed their attendance; 141 (94%) had signed the form, and the other nine requested further information. Of the remaining 125 booklets sent out, 115 (92%) forms were brought back on the day of the investigation having been previously signed. The remaining 10 (8%) required further information before signing the form. An audit of 168 patients was used to test reaction to the booklet and the idea of filling in the form before coming to hospital; 155 patients (92. 2%) reported the information given in the booklet to be "very useful", and all reported it to be "clear and understandable". A specifically designed patient information booklet with integral consent form is accepted by patients, and improves the level of understanding prior to the investigation being carried out.

Informed Consent: Does Anyone Really Understand What Is Contained In The Medical Record?

PubMed

Fenton, S H; Manion, F; Hsieh, K; Harris, M

2015-01-01

Despite efforts to provide standard definitions of terms such as "medical record", "computer-based patient record", "electronic medical record" and "electronic health record", the terms are still used interchangeably. Initiatives like data and information governance, research biorepositories, and learning health systems require availability and reuse of data, as well as common understandings of the scope for specific purposes. Lacking widely shared definitions, utilization of the afore-mentioned terms in research informed consent documents calls to question whether all participants in the research process - patients, information technology and regulatory staff, and the investigative team - fully understand what data and information they are asking to obtain and agreeing to share. This descriptive study explored the terminology used in research informed consent documents when describing patient data and information, asking the question "Does the use of the term "medical record" in the context of a research informed consent document accurately represent the scope of the data involved?" Informed consent document templates found on 17 Institutional Review Board (IRB) websites with Clinical and Translational Science Awards (CTSA) were searched for terms that appeared to be describing the data resources to be accessed. The National Library of Medicine's (NLM) Terminology Services was searched for definitions provided by key standards groups that deposit terminologies with the NLM. The results suggest research consent documents are using outdated terms to describe patient information, health care terminology systems need to consider the context of research for use cases, and that there is significant work to be done to assure the HIPAA Omnibus Rule is applied to contemporary activities such as biorepositories and learning health systems. "Medical record", a term used extensively in research informed consent documents, is ambiguous and does not serve us well in the context of contemporary information management and governance.

Language translation, doman specific languages and ANTLR

NASA Technical Reports Server (NTRS)

Craymer, Loring; Parr, Terence

2002-01-01

We will discuss the features of ANTLR that make it an attractive tool for rapid developement of domain specific language translators and present some practical examples of its use: extraction of information from the Cassini Command Language specification, the processing of structured binary data, and IVL--an English-like language for generating VRML scene graph, which is used in configuring the jGuru.com server.

Informed Consent in Genome-Scale Research: What Do Prospective Participants Think?

PubMed Central

Trinidad, Susan Brown; Fullerton, Stephanie M.; Bares, Julie M.; Jarvik, Gail P.; Larson, Eric B.; Burke, Wylie

2012-01-01

Background To promote effective genome-scale research, genomic and clinical data for large population samples must be collected, stored, and shared. Methods We conducted focus groups with 45 members of a Seattle-based integrated healthcare delivery system to learn about their views and expectations for informed consent in genome-scale studies. Results Participants viewed information about study purpose, aims, and how and by whom study data could be used to be at least as important as information about risks and possible harms. They generally supported a tiered consent approach for specific issues, including research purpose, data sharing, and access to individual research results. Participants expressed a continuum of opinions with respect to the acceptability of broad consent, ranging from completely acceptable to completely unacceptable. Older participants were more likely to view the consent process in relational – rather than contractual – terms, compared with younger participants. The majority of participants endorsed seeking study subjects’ permission regarding material changes in study purpose and data sharing. Conclusions Although this study sample was limited in terms of racial and socioeconomic diversity, our results suggest a strong positive interest in genomic research on the part of at least some prospective participants and indicate a need for increased public engagement, as well as strategies for ongoing communication with study participants. PMID:23493836

Parental views on informed consent for expanded newborn screening.

PubMed

Moody, Louise; Choudhry, Kubra

2013-09-01

An increasing array of rare inherited conditions can be detected as part of the universal newborn screening programme. The introduction and evaluation of these service developments require consideration of the ethical issues involved and appropriate mechanisms for informing parents and gaining consent if required. Exploration of parental views is needed to inform the debate and specifically consider whether more flexible protocols are needed to fit with the public perception of new developments in this context. This study has been undertaken to explore perceptions and attitudes of parents and future parents to an expanded newborn screening programme in the United Kingdom and the necessary information provision and consent processes. A mixed methods study involving focus groups (n = 29) and a web-survey (n = 142) undertaken with parents and future parents. Parents want guaranteed information provision with clear decision-making powers and an awareness of the choices available to them. The difference between existing screening provision and expanded screening was not considered to be significant enough by participants to warrant formal written, informed consent for expanded screening. It is argued that the ethical review processes need to be more flexible towards the provision of information and consent processes for service developments in newborn screening. © 2011 John Wiley & Sons Ltd.

77 FR 26474 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-04

...EPA proposes to approve State Implementation Plan (SIP) revisions submitted by the Maryland Department of the Environment (MDE). These revisions approve specific provisions of a 2011 Consent Decree between MDE and GenOn to reduce particulate matter (PM), sulfur oxides (SOX), and nitrogen oxides (NOX) from the GenOn Chalk Point generating station (Chalk Point). These revisions also remove the 1978 and 1979 Consent Orders for the Chalk Point generating station from the Maryland SIP as those Consent Orders have been superseded by the 2011 Consent Decree. In the Final Rules section of this Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.

Beyond Morphosyntax in Developing Bilinguals and "Specific" Language Impairment

ERIC Educational Resources Information Center

Kohnert, Kathryn; Ebert, Kerry Danahy

2010-01-01

In the Keynote Article, "The Interface Between Bilingual Development and Specific Language Impairment," Johanne Paradis considers issues and evidence at the intersection of children learning two languages and primary or specific language impairment (SLI). The review focuses on morphosyntactic evidence and the fit of this evidence with maturational…

Specific Language or Working Memory Impairments: A Small Scale Observational Study

ERIC Educational Resources Information Center

Archibald, Lisa M. D.; Joanisse, Marc; Edmunds, Alan

2011-01-01

Study of the developmental relationship between language and working memory skills has only just begun, despite the prominent role of their interdependency in some theoretical accounts of developmental language impairments. Recently, Archibald and Joanisse (2009) identified children with specific language impairment (SLI), or specific working…

Dyslexia and Specific Language Impairment: The Role of Phonology and Auditory Processing

ERIC Educational Resources Information Center

Fraser, Jill; Goswami, Usha; Conti-Ramsden, Gina

2010-01-01

We explore potential similarities between developmental dyslexia (specific reading disability [SRD]) and specific language impairment (SLI) in terms of phonological skills, underlying auditory processing abilities, and nonphonological language skills. Children aged 9 to 11 years with reading and/or language difficulties were recruited and compared…

Preference for language in early infancy: the human language bias is not speech specific.

PubMed

Krentz, Ursula C; Corina, David P

2008-01-01

Fundamental to infants' acquisition of their native language is an inherent interest in the language spoken around them over non-linguistic environmental sounds. The following studies explored whether the bias for linguistic signals in hearing infants is specific to speech, or reflects a general bias for all human language, spoken and signed. Results indicate that 6-month-old infants prefer an unfamiliar, visual-gestural language (American Sign Language) over non-linguistic pantomime, but 10-month-olds do not. These data provide evidence against a speech-specific bias in early infancy and provide insights into those properties of human languages that may underlie this language-general attentional bias.

Audio-visual presentation of information for informed consent for participation in clinical trials.

PubMed

Synnot, Anneliese; Ryan, Rebecca; Prictor, Megan; Fetherstonhaugh, Deirdre; Parker, Barbara

2014-05-09

Informed consent is a critical component of clinical research. Different methods of presenting information to potential participants of clinical trials may improve the informed consent process. Audio-visual interventions (presented, for example, on the Internet or on DVD) are one such method. We updated a 2008 review of the effects of these interventions for informed consent for trial participation. To assess the effects of audio-visual information interventions regarding informed consent compared with standard information or placebo audio-visual interventions regarding informed consent for potential clinical trial participants, in terms of their understanding, satisfaction, willingness to participate, and anxiety or other psychological distress. We searched: the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, issue 6, 2012; MEDLINE (OvidSP) (1946 to 13 June 2012); EMBASE (OvidSP) (1947 to 12 June 2012); PsycINFO (OvidSP) (1806 to June week 1 2012); CINAHL (EbscoHOST) (1981 to 27 June 2012); Current Contents (OvidSP) (1993 Week 27 to 2012 Week 26); and ERIC (Proquest) (searched 27 June 2012). We also searched reference lists of included studies and relevant review articles, and contacted study authors and experts. There were no language restrictions. We included randomised and quasi-randomised controlled trials comparing audio-visual information alone, or in conjunction with standard forms of information provision (such as written or verbal information), with standard forms of information provision or placebo audio-visual information, in the informed consent process for clinical trials. Trials involved individuals or their guardians asked to consider participating in a real or hypothetical clinical study. (In the earlier version of this review we only included studies evaluating informed consent interventions for real studies). Two authors independently assessed studies for inclusion and extracted data. We synthesised the findings using meta-analysis, where possible, and narrative synthesis of results. We assessed the risk of bias of individual studies and considered the impact of the quality of the overall evidence on the strength of the results. We included 16 studies involving data from 1884 participants. Nine studies included participants considering real clinical trials, and eight included participants considering hypothetical clinical trials, with one including both. All studies were conducted in high-income countries.There is still much uncertainty about the effect of audio-visual informed consent interventions on a range of patient outcomes. However, when considered across comparisons, we found low to very low quality evidence that such interventions may slightly improve knowledge or understanding of the parent trial, but may make little or no difference to rate of participation or willingness to participate. Audio-visual presentation of informed consent may improve participant satisfaction with the consent information provided. However its effect on satisfaction with other aspects of the process is not clear. There is insufficient evidence to draw conclusions about anxiety arising from audio-visual informed consent. We found conflicting, very low quality evidence about whether audio-visual interventions took more or less time to administer. No study measured researcher satisfaction with the informed consent process, nor ease of use.The evidence from real clinical trials was rated as low quality for most outcomes, and for hypothetical studies, very low. We note, however, that this was in large part due to poor study reporting, the hypothetical nature of some studies and low participant numbers, rather than inconsistent results between studies or confirmed poor trial quality. We do not believe that any studies were funded by organisations with a vested interest in the results. The value of audio-visual interventions as a tool for helping to enhance the informed consent process for people considering participating in clinical trials remains largely unclear, although trends are emerging with regard to improvements in knowledge and satisfaction. Many relevant outcomes have not been evaluated in randomised trials. Triallists should continue to explore innovative methods of providing information to potential trial participants during the informed consent process, mindful of the range of outcomes that the intervention should be designed to achieve, and balancing the resource implications of intervention development and delivery against the purported benefits of any intervention.More trials, adhering to CONSORT standards, and conducted in settings and populations underserved in this review, i.e. low- and middle-income countries and people with low literacy, would strengthen the results of this review and broaden its applicability. Assessing process measures, such as time taken to administer the intervention and researcher satisfaction, would inform the implementation of audio-visual consent materials.

Language Diversity & Practice in Higher Education: Can Discipline-Specific Language Instruction Improve Economics Learning Outcomes?

ERIC Educational Resources Information Center

Nguyen, Trien; Trimarchi, Angela; Williams, Julia

2012-01-01

In the field of second language acquisition, discipline-specific language instruction is becoming widely known as Content and Language Integrated Learning. This method includes any activity that involves teaching a subject in a second language for the purpose of teaching both the subject content and the language. Research has shown that this two…

Sample selection may bias the outcome of an adolescent mental health survey: results from a five-year follow-up of 4171 adolescents.

PubMed

Kekkonen, V; Kivimäki, P; Valtonen, H; Hintikka, J; Tolmunen, T; Lehto, S M; Laukkanen, E

2015-02-01

The representativeness of the data is one of the main issues in evaluating the significance of research findings. Dropping out is common in adolescent mental health research, and may distort the results. Nevertheless, very little is known about the types of systematic bias that may affect studies in a) the informed consent phase and b) later in follow-up phases. The authors addressed this gap in knowledge in a five-year follow-up study on a sample of adolescents aged 13-18 years. The data were collected using self-report questionnaires. The baseline sample consisted of 4171 adolescents, 1827 (43.8%) of whom gave consent to be contacted for a follow-up survey, but only 797 (19.1%) participated in the follow-up. Binary logistic regression models were used to explain the participation. Young age, female gender, a high number of hobbies, good performance at school in the native language and general subjects, family disintegration such as divorce, high parental employment, and symptoms of depression and anxiety were associated with both consent and participation. However, the effect of mental health aspects was smaller than the effect of age and gender. This study confirmed the possibility of systematic selection bias by adolescents' sociodemographic characteristics. The representativeness of the study sample might have been improved by more intense recruitment strategies. Copyright © 2014 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Practical Communication Guidance to Improve Phase I Informed Consent Conversations and Decision-Making in Pediatric Oncology

PubMed Central

Johnson, Liza-Marie; Leek, Angela C.; Drotar, Dennis; Noll, Robert B.; Rheingold, Susan R.; Kodish, Eric D.; Baker, Justin N.

2015-01-01

Background It can be difficult to explain pediatric Phase I oncology trials to families of children with refractory cancer. Parents may misunderstand the information presented to them, and physicians may assume that certain topics are covered in the informed consent document and need not be discussed. Communication models can help to ensure effective discussions. Methods Suggestions for improving the informed consent process were first solicited from Phase I study clinicians via questionnaire. Eight parents who had enrolled their child on a Phase I pediatric oncology trial were recruited for an advisory group designed to assess the clinicians’ suggestions and make additional recommendations for improving informed consent for pediatric Phase I trials. Results A Phase I Communication Model was designed to incorporate the suggestions of clinicians and families. It focuses on education of parents/families about Phase I trials at specific time points during a child’s illness, but specifically at the point of relapse. We also present an informative Phase I fact sheet that can be distributed to families. Conclusions Families who will be offered information about a Phase I clinical trial can first receive a standardized fact sheet explaining the general purpose of these early-phase clinical trials. Parental understanding may be further enhanced when oncologists address key themes, beginning at diagnosis and continuing through important decision points during the child’s illness. This model should be prospectively evaluated. PMID:25873253

Comparison of Spontaneously Elicited Language Patterns in Specific Language Impairment and High-Functioning Autism.

PubMed

Craig, Megan; Trauner, Doris

2018-02-01

We aimed to characterize differences in the use of language in children with specific language impairment and high-functioning autism by analyzing verbal responses on standardized tests. The overall goal was to provide clinicians with additional tools with which to aid in distinguishing the two neurodevelopmental disorders. This study included 16 children with specific language impairment, 28 children with high-functioning autism, and 52 typically developing participants between the ages of six and 14. Groups were matched for age, and specific language impairment and high-functioning autism groups were matched on verbal and performance IQ. Responses from standardized tests were examined for response length, grammatical errors, filler words, perseverations, revisions (repeated attempts to begin or continue a sentence), off-topic attention shifts (lapses in attention to the task), and rambling. Data were analyzed using parametric and nonparametric methods. Specific language impairment responses were longer and contained more filler words than did those of the other two groups, whereas high-functioning autism responses exhibited more grammatical errors, off-topic attention shifts, and rambling. Specific language impairment and high-functioning autism responses showed higher rates of perseveration compared with controls. There were no significant differences in revisions among the three groups. Differences in language patterns of participants with specific language impairment and high-functioning autism may be useful to the clinician in helping to differentiate isolated language impairment from high-functioning autism. The results also support the conclusion that the two conditions are separable, and each exhibits a different pattern of language dysfunction. Copyright © 2017 Elsevier Inc. All rights reserved.

Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Gillies, Katie; Entwistle, Vikki; Treweek, Shaun P; Fraser, Cynthia; Williamson, Paula R; Campbell, Marion K

2015-10-27

The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to recognise any potential risks or benefits associated with the research. A number of interventions have been put forward to improve this process. Outcomes reported in trials of interventions to improve the informed consent process for decisions about trial participation tend to focus on the 'understanding' of trial information. However, the operationalization of understanding as a concept, the tools used to measure it and the timing of the measurements are heterogeneous. A lack of clarity exists regarding which outcomes matter (to whom) and why. This inconsistency between studies results in difficulties when making comparisons across studies as evidenced in two recent systematic reviews of informed consent interventions. As such, no optimal method for measuring the impact of these interventions aimed at improving informed consent for RCTs has been identified. The project will adopt and adapt methodology previously developed and used in projects developing core outcome sets for assessment of clinical treatments. Specifically, the work will consist of three stages: 1) A systematic methodology review of existing outcome measures of trial informed consent interventions; 2) Interviews with key stakeholders to explore additional outcomes relevant for trial participation decisions; and 3) A Delphi study to refine the core outcome set for evaluation of trial informed consent interventions. All stages will include the stakeholders involved in the various aspects of RCT consent: users (that is, patients), developers (that is, trialists), deliverers (focusing on research nurses) and authorisers (that is, ethics committees). A final consensus meeting including all stakeholders will be held to review outcomes. The ELICIT study aims to develop a core outcome set for the evaluation of interventions intended to improve informed consent for RCTs for use in future RCTs and reviews, thereby improving the reliability and consistency of research in this area.

Attitude towards informed consent practice in a developing country: a community-based assessment of the role of educational status.

PubMed

Agu, Kenneth Amaechi; Obi, Emmanuel Ikechukwu; Eze, Boniface Ikenna; Okenwa, Wilfred Okwudili

2014-10-22

It has been reported by some studies that the desire to be involved in decisions concerning one's healthcare especially with regard to obtaining informed consent is related to educational status. The purpose of this study, therefore, is to assess the influence of educational status on attitude towards informed consent practice in three south-eastern Nigerian communities. Responses from consenting adult participants from three randomly selected communities in Enugu State, southeast Nigeria were obtained using self-/interviewer-administered questionnaire. There were 2545 respondents (1508 males and 1037 females) with an age range of 18 to 65 years. More than 70% were aged 40 years and below and 28.4% were married. More than 70% of the respondents irrespective of educational status will not leave all decisions about their healthcare to the doctor. A lower proportion of those with no formal education (18.5%) will leave this entire decision-making process in the hands of the doctor compared to those with tertiary education (21.9%). On being informed of all that could go wrong with a procedure, 61.5% of those with no formal education would consider the doctor unsafe and incompetent while 64.2% of those with tertiary education would feel confident about the doctor. More than 85% of those with tertiary education would prefer consent to be obtained by the doctor who will carry out the procedure as against 33.8% of those with no formal education. Approximately 70% of those who had tertiary education indicated that informed consent was necessary for procedures on children, while the greater number of those with primary (64.4%) and no formal education (76.4%) indicated that informed consent was not necessary for procedures on children. Inability to understand the information was the most frequent specific response among those without formal education on why they would leave all the decisions to the doctor. The study showed that knowledge of the informed consent practice increased with level of educational attainment but most of the participants irrespective of educational status would want to be involved in decisions about their healthcare. This knowledge will be helpful to healthcare providers in obtaining informed consent.

Internal Versus External DSLs for Trace Analysis: Extended Abstract

NASA Technical Reports Server (NTRS)

Barringer, Howard; Havelund, Klaus

2011-01-01

This tutorial explores the design and implementation issues arising in the development of domain-specific languages for trace analysis. It introduces the audience to the general concepts underlying such special-purpose languages building upon the authors' own experiences in developing both external domain specific languages and systems, such as EAGLE, HAWK, RULER and LOGSCOPE, and the more recent internal domain-specific language and system TRACECONTRACT within the SCALA language.

Languages for Specific Academic Purposes or Languages for General Academic Purposes? A Critical Reappraisal of a Key Issue for Language Provision in Higher Education

ERIC Educational Resources Information Center

Krekeler, Christian

2013-01-01

The debate about the subject specificity of university language tuition has been going on for decades; it has mostly been discussed in the context of English for Academic Purposes. This paper considers the case for disciplinary specificity with regard to languages other than English. Few, if any, developed curricula, syllabuses, suitable textbooks…

Ethics and the psychiatry journal editor: responsibilities and dilemmas.

PubMed

Greenberg, David; D Strous, Rael

2014-01-01

An array of potential ethical stumbling blocks awaits the editors of scientific journals. There are issues of particular relevance to mental health journals, and others unique to local journals with a relatively small circulation and low impact factor. The blind review system, conflict of interests, redundant publication, fraud and plagiarism, guest and ghost authorship and ghost writing, advertising, language and stigma, patient consent, and "rigging" the Impact Factor are all issues of importance. It is critical that editors are aware and informed of these important issues, and have an accessible forum for evaluating problems as they arise.

Understanding and retention of trial-related information among participants in a clinical trial after completing the informed consent process.

PubMed

Mexas, Fernanda; Efron, Anne; Luiz, Ronir Raggio; Cailleaux-Cezar, Michelle; Chaisson, Richard E; Conde, Marcus B

2014-02-01

for assessing the level of understanding of trial-related information during the informed consent (IC) process in developing countries are lacking. To assess the understanding and retention of trial-related information presented in the IC process by administering an informed consent assessment instrument (ICAI) to participants in a clinical trial for a new tuberculosis (TB) regimen being conducted in Rio de Janeiro (Brazil). Methods The format of the ICAI was based on the language and structure of the United States National Cancer Institute's IC comprehension checklist. The ICAI was designed to assess points of the RioMAR study IC process that addressed the principles of research ethics requested by Brazilian Regulatory Authority: autonomy, beneficence, non-maleficence, and justice. Briefly, (1) Is the respondent participating in a clinical trial? (2) Are two different treatments being evaluated? (3) Is the treatment arm chosen by chance? (4) Is an HIV test required? (5) Are liver function tests required? (6) Can participants leave the study at any time? (7) Are the risks and benefits of taking part in the study clear? (8) May pregnant women participate in the study? (9) Can one of the study drugs reduce the effectiveness of contraceptives? (10) Are patients paid to participate in the study? The ICAI was applied at two time points: immediately after enrollment in the clinical trial and 2 months later. A total of 61 patients who enrolled in the RioMAR study participated in this study. The percentage of correct answers to all questions was 82% at the time of the first ICAI; 31 participants (51%) did not recall that an HIV test was required (question 4) and 43 (70%) did not know that they could leave the study (question 6). Other individual questions were answered correctly by at least 76% of participants. There was no association between incorrect answers and age, gender, monthly family income, neighborhood, or level of education (p > 0.07). When the responses to the first and the second ICAI questions were compared, 15% or more of participants had conflicting answers to 5 of the 10 questions. The ICAI uses dichotomous responses, leading to a 50% chance of guessing the correct answers. Two questions were asked only of women. Finally, only 6 of the 10 questions on the current version of the ICAI apply to most trials; others are trial-specific. The ICAI may be adapted to an individual trial and may prove to be a useful tool following a consent discussion to identify issues not fully understood by the research participants, thus prompting study staff to re-explain topics, possibly in a more elementary manner.

An exploratory study of relational, persuasive, and nonverbal communication in requests for tissue donation.

PubMed

Siminoff, Laura A; Traino, Heather M; Gordon, Nahida H

2011-10-01

This study explores the effects of tissue requesters' relational, persuasive, and nonverbal communication on families' final donation decisions. One thousand sixteen (N = 1,016) requests for tissue donation were audiotaped and analyzed using the Siminoff Communication Content and Affect Program, a computer application specifically designed to code and assist with the quantitative analysis of communication data. This study supports the important role of communication strategies in health-related decision making. Families were more likely to consent to tissue donation when confirmational messages (e.g., messages that expressed validation or acceptance) or persuasive tactics such as credibility, altruism, or esteem were used during donation discussions. Consent was also more likely when family members exhibited nonverbal immediacy or disclosed private information about themselves or the patient. The results of a hierarchical log-linear regression revealed that the use of relational communication during requests directly predicted family consent. The results provide information about surrogate decision making in end-of-life situations and may be used to guide future practice in obtaining family consent to tissue donation.

The Meta-Nudge - A Response to the Claim That the Use of Nudges During the Informed Consent Process is Unavoidable.

PubMed

Gelfand, Scott D

2016-10-01

Richard Thaler and Cass Sunstein, in Nudge: Improving Decisions About Health, Wealth, and Happiness, assert that rejecting the use nudges is 'pointless' because '[i]n many cases, some kind of nudge is inevitable'. Schlomo Cohen makes a similar claim. He asserts that in certain situations surgeons cannot avoid nudging patients either toward or away from consenting to surgical interventions. Cohen concludes that in these situations (assuming surgeons believe that surgery is the best option for their patients), nudging patients toward consenting to surgical interventions is (at the very least) uncriticizable or morally permissible. I call this argument: The Unavoidability Argument. In this essay, I will respond to Cohen's use of the unavoidability argument in support of using nudges during the process of informed consent. Specifically, I argue that many so-called 'unavoidable nudges' are, in fact, avoidable. Although my argument is directed toward Cohen's use of the unavoidability argument, it is applicable to the unavoidability argument more generally. © 2016 John Wiley & Sons Ltd.

An Exploratory Study of Relational, Persuasive, and Nonverbal Communication in Requests for Tissue Donation

PubMed Central

SIMINOFF, LAURA A.; TRAINO, HEATHER M.; GORDON, NAHIDA H.

2011-01-01

This study explores the effects of tissue requesters’ relational, persuasive, and nonverbal communication on families’ final donation decisions. One thousand sixteen (N=1,016) requests for tissue donation were audiotaped and analyzed using the Siminoff Communication Content and Affect Program, a computer application specifically designed to code and assist with the quantitative analysis of communication data. This study supports the important role of communication strategies in health-related decision making. Families were more likely to consent to tissue donation when confirmational messages (e.g., messages that expressed validation or acceptance) or persuasive tactics such as credibility, altruism, or esteem were used during donation discussions. Consent was also more likely when family members exhibited nonverbal immediacy or disclosed private information about themselves or the patient. The results of a hierarchical log-linear regression revealed that the use of relational communication during requests directly predicted family consent. The results provide information about surrogate decision making in end-of-life situations and may be used to guide future practice in obtaining family consent to tissue donation. PMID:21512935

Efficient Method of Achieving Agreements between Individuals and Organizations about RFID Privacy

NASA Astrophysics Data System (ADS)

Cha, Shi-Cho

This work presents novel technical and legal approaches that address privacy concerns for personal data in RFID systems. In recent years, to minimize the conflict between convenience and the privacy risk of RFID systems, organizations have been requested to disclose their policies regarding RFID activities, obtain customer consent, and adopt appropriate mechanisms to enforce these policies. However, current research on RFID typically focuses on enforcement mechanisms to protect personal data stored in RFID tags and prevent organizations from tracking user activity through information emitted by specific RFID tags. A missing piece is how organizations can obtain customers' consent efficiently and flexibly. This study recommends that organizations obtain licenses automatically or semi-automatically before collecting personal data via RFID technologies rather than deal with written consents. Such digitalized and standard licenses can be checked automatically to ensure that collection and use of personal data is based on user consent. While individuals can easily control who has licenses and license content, the proposed framework provides an efficient and flexible way to overcome the deficiencies in current privacy protection technologies for RFID systems.

Real-Time Language Processing in School-Age Children with Specific Language Impairment

ERIC Educational Resources Information Center

Montgomery, James W.

2006-01-01

Background:School-age children with specific language impairment (SLI) exhibit slower real-time (i.e. immediate) language processing relative to same-age peers and younger, language-matched peers. Results of the few studies that have been done seem to indicate that the slower language processing of children with SLI is due to inefficient…

Concurrent and Construct Validity of Oral Language Measures with School-Age Children with Specific Language Impairment

ERIC Educational Resources Information Center

Hoffman, LaVae M.; Loeb, Diane Frome; Brandel, Jayne; Gillam, Ronald B.

2011-01-01

Purpose: This study investigated the psychometric properties of 2 oral language measures that are commonly used for diagnostic purposes with school-age children who have language impairments. Method: Two hundred sixteen children with specific language impairment were assessed with the Test of Language Development--Primary, Third Edition (TOLD-P:3;…

Componential Skills in Second Language Development of Bilingual Children with Specific Language Impairment

ERIC Educational Resources Information Center

Verhoeven, Ludo; Steenge, Judit; van Leeuwe, Jan; van Balkom, Hans

2017-01-01

In this study, we investigated which componential skills can be distinguished in the second language (L2) development of 140 bilingual children with specific language impairment in the Netherlands, aged 6-11 years, divided into 3 age groups. L2 development was assessed by means of spoken language tasks representing different language skills…

The Relationship between Mathematics and Language: Academic Implications for Children with Specific Language Impairment and English Language Learners

ERIC Educational Resources Information Center

Alt, Mary; Arizmendi, Genesis D.; Beal, Carole R.

2014-01-01

Purpose: The present study examined the relationship between mathematics and language to better understand the nature of the deficit and the academic implications associated with specific language impairment (SLI) and academic implications for English language learners (ELLs). Method: School-age children (N = 61; 20 SLI, 20 ELL, 21 native…

Sentence Repetition in Deaf Children with Specific Language Impairment in British Sign Language

ERIC Educational Resources Information Center

Marshall, Chloë; Mason, Kathryn; Rowley, Katherine; Herman, Rosalind; Atkinson, Joanna; Woll, Bencie; Morgan, Gary

2015-01-01

Children with specific language impairment (SLI) perform poorly on sentence repetition tasks across different spoken languages, but until now, this methodology has not been investigated in children who have SLI in a signed language. Users of a natural sign language encode different sentence meanings through their choice of signs and by altering…

Designing Specification Languages for Process Control Systems: Lessons Learned and Steps to the Future

NASA Technical Reports Server (NTRS)

Leveson, Nancy G.; Heimdahl, Mats P. E.; Reese, Jon Damon

1999-01-01

Previously, we defined a blackbox formal system modeling language called RSML (Requirements State Machine Language). The language was developed over several years while specifying the system requirements for a collision avoidance system for commercial passenger aircraft. During the language development, we received continual feedback and evaluation by FAA employees and industry representatives, which helped us to produce a specification language that is easily learned and used by application experts. Since the completion of the PSML project, we have continued our research on specification languages. This research is part of a larger effort to investigate the more general problem of providing tools to assist in developing embedded systems. Our latest experimental toolset is called SpecTRM (Specification Tools and Requirements Methodology), and the formal specification language is SpecTRM-RL (SpecTRM Requirements Language). This paper describes what we have learned from our use of RSML and how those lessons were applied to the design of SpecTRM-RL. We discuss our goals for SpecTRM-RL and the design features that support each of these goals.

Domain-Specific Treatment Effects in Children with Language and/or Working Memory Impairments: A Pilot Study

ERIC Educational Resources Information Center

Wener, Sarah E; Archibald, Lisa MD

2011-01-01

This pilot study with an n-of-1 design examined whether children with a specific language impairment without working memory impairment (SLI), a specific working memory impairment without language impairment (SWMI), or mixed language and working memory impairments (L&WMI) may respond differently to treatment targeting verbal or visuospatial…

Hebrew Language Assessment Measure for Preschool Children: A Comparison between Typically Developing Children and Children with Specific Language Impairment

ERIC Educational Resources Information Center

Katzenberger, Irit; Meilijson, Sara

2014-01-01

The Katzenberger Hebrew Language Assessment for Preschool Children (henceforth: the KHLA) is the first comprehensive, standardized language assessment tool developed in Hebrew specifically for older preschoolers (4;0-5;11 years). The KHLA is a norm-referenced, Hebrew specific assessment, based on well-established psycholinguistic principles, as…

Measuring Language-Specific Phonetic Settings

ERIC Educational Resources Information Center

Mennen, Ineke; Scobbie, James M.; de Leeuw, Esther; Schaeffler, Sonja; Schaeffler, Felix

2010-01-01

While it is well known that languages have different phonemes and phonologies, there is growing interest in the idea that languages may also differ in their "phonetic setting". The term "phonetic setting" refers to a tendency to make the vocal apparatus employ a language-specific habitual configuration. For example, languages may differ in their…

Child research in South Africa: How do the new regulations help?

PubMed

Strode, Ann Elaine; Slack, Catherine May

2015-11-01

Child research is governed by legal norms in the National Health Act (2003) and the Regulations. There is increasing harmony between the two on many issues, including the conditions under which children should be enrolled in research. The most striking disjuncture in the ethical-legal framework remains the allowable consent strategy for child research, where the law requires mandatory parental or legal guardian consent for all child research, while ethical guidelines afford research stakeholders the discretion to implement exceptions to this approach in specific justifiable circumstances.

Child research in South Africa: How do the new regulations help?

PubMed Central

Strode, AE; Slack, CM

2018-01-01

Child research is governed by legal norms in the National Health Act (2003) and the Regulations. There is increasing harmony between the two on many issues, including the conditions under which children should be enrolled in research. The most striking disjuncture in the ethical-legal framework remains the allowable consent strategy for child research, where the law requires mandatory parental or legal guardian consent for all child research, while ethical guidelines afford research stakeholders the discretion to implement exceptions to this approach in specific justifiable circumstances. PMID:26632311

Sensitivity and Specificity of French Language and Processing Measures for the Identification of Primary Language Impairment at Age 5

ERIC Educational Resources Information Center

Thordardottir, Elin; Kehayia, Eva; Mazer, Barbara; Lessard, Nicole; Majnemer, Annette; Sutton, Ann; Trudeau, Natacha; Chilingaryan, Gevorg

2011-01-01

Purpose: Research on the diagnostic accuracy of different language measures has focused primarily on English. This study examined the sensitivity and specificity of a range of measures of language knowledge and language processing for the identification of primary language impairment (PLI) in French-speaking children. Because of the lack of…

Potential negative consequences of non-consented switch of inhaled medications and devices in asthma patients.

PubMed

Björnsdóttir, U S; Gizurarson, S; Sabale, U

2013-09-01

Asthma requires individually tailored and careful management to control and prevent symptoms and exacerbations. Selection of the most appropriate treatment is dependent on both the choice of drugs and inhaler device; however, financial pressures may result in patients being switched to alternative medications and devices in an attempt to reduce costs. This review aimed to examine the published literature in order to ascertain whether switching a patient's asthma medications or device negatively impacts clinical and economic outcomes. A literature search of MEDLINE (2001-13 September 2011) was conducted to identify English-language articles focused on the direct impact of switching medications and inhaler devices and switching from fixed-dose combination to monocomponent therapy via separate inhalers in patients with asthma; the indirect impacts of switching were also assessed. Evidence showed that non-consented switching of medications and inhalers in patients with asthma can be associated with a range of negative outcomes, at both individual and organisational levels. Factors that reduce adherence may lead to compromised symptom control resulting in increased healthcare resource utilisation and poorer patient quality of life. The consequences of a non-consented switch should be weighed carefully against arguments supporting an inhaler switch without the patient's consent for non-medical/budgetary reasons, such as potential reductions in initial acquisition costs, which may be associated with subsequent additional healthcare needs. Given the increasing pressure for reduced costs and efficient allocation of limited healthcare resources, an additional investment in ensuring high medication adherence may lead to greater savings due to a potentially decreased demand for healthcare services. In contrast, savings achieved in acquisition costs may result in a greater net loss due to increased healthcare consumption caused by decreased asthma control. © 2013 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd.

Abnormal functional lateralization and activity of language brain areas in typical specific language impairment (developmental dysphasia)

PubMed Central

De Guibert, Clément; Maumet, Camille; Jannin, Pierre; Ferré, Jean-Christophe; Tréguier, Catherine; Barillot, Christian; Le Rumeur, Elisabeth; Allaire, Catherine; Biraben, Arnaud

2011-01-01

Atypical functional lateralization and specialization for language have been proposed to account for developmental language disorders, yet results from functional neuroimaging studies are sparse and inconsistent. This functional magnetic resonance imaging study compared children with a specific subtype of specific language impairment affecting structural language (n=21), to a matched group of typically-developing children using a panel of four language tasks neither requiring reading nor metalinguistic skills, including two auditory lexico-semantic tasks (category fluency and responsive naming) and two visual phonological tasks based on picture naming. Data processing involved normalizing the data with respect to a matched pairs pediatric template, groups and between-groups analysis, and laterality indexes assessment within regions of interest using single and combined task analysis. Children with specific language impairment exhibited a significant lack of left lateralization in all core language regions (inferior frontal gyrus-opercularis, inferior frontal gyrus-triangularis, supramarginal gyrus, superior temporal gyrus), across single or combined task analysis, but no difference of lateralization for the rest of the brain. Between-group comparisons revealed a left hypoactivation of Wernicke’s area at the posterior superior temporal/supramarginal junction during the responsive naming task, and a right hyperactivation encompassing the anterior insula with adjacent inferior frontal gyrus and the head of the caudate nucleus during the first phonological task. This study thus provides evidence that this specific subtype of specific language impairment is associated with atypical lateralization and functioning of core language areas. PMID:21719430

Does simultaneous bilingualism aggravate children's specific language problems?

PubMed

Korkman, Marit; Stenroos, Maria; Mickos, Annika; Westman, Martin; Ekholm, Pia; Byring, Roger

2012-09-01

There is little data on whether or not a bilingual upbringing may aggravate specific language problems in children. This study analysed whether there was an interaction of such problems and simultaneous bilingualism. Participants were 5- to 7-year-old children with specific language problems (LANG group, N = 56) or who were typically developing (CONTR group, N = 60). Seventy-three children were Swedish-Finnish bilingual and 43 were Swedish-speaking monolingual. Assessments (in Swedish) included tests of expressive language, comprehension, repetition and verbal memory. Per definition, the LANG group had lower scores than the CONTR group on all language tests. The bilingual group had lower scores than the monolingual group only on a test of body part naming. Importantly, the interaction of group (LANG or CONTR) and bilingualism was not significant on any of the language scores. Simultaneous bilingualism does not aggravate specific language problems but may result in a slower development of vocabulary both in children with and without specific language problems. Considering also advantages, a bilingual upbringing is an option also for children with specific language problems. In assessment, tests of vocabulary may be sensitive to bilingualism, instead tests assessing comprehension, syntax and nonword repetition may provide less biased methods. © 2012 The Author(s)/Acta Paediatrica © 2012 Foundation Acta Paediatrica.

Relation between language, audio-vocal psycholinguistic abilities and P300 in children having specific language impairment.

PubMed

Shaheen, Elham Ahmed; Shohdy, Sahar Saad; Abd Al Raouf, Mahmoud; Mohamed El Abd, Shereen; Abd Elhamid, Asmss

2011-09-01

Specific language impairment is a relatively common developmental condition in which a child fails to develop language at the typical rate despite normal general intellectual abilities, adequate exposure to language, and in the absence of hearing impairments, or neurological or psychiatric disorders. There is much controversy about the extent to which the auditory processing deficits are important in the genesis specific language impairment. The objective of this paper is to assess the higher cortical functions in children with specific language impairment, through assessing neurophysiological changes in order to correlate the results with the clinical picture of the patients to choose the proper rehabilitation training program. This study was carried out on 40 children diagnosed to have specific language impairment and 20 normal children as a control group. All children were subjected to the assessment protocol applied in Kasr El-Aini hospital. They were also subjected to a language test (receptive, expressive and total language items), the audio-vocal items of Illinois test of psycholinguistic (auditory reception, auditory association, verbal expression, grammatical closure, auditory sequential memory and sound blending) as well as audiological assessment that included peripheral audiological and P300 amplitude and latency assessment. The results revealed a highly significant difference in P300 amplitude and latency between specific language impairment group and control group. There is also strong correlations between P300 latency and the grammatical closure, auditory sequential memory and sound blending, while significant correlation between the P300 amplitude and auditory association and verbal expression. Children with specific language impairment, in spite of the normal peripheral hearing, have evidence of cognitive and central auditory processing defects as evidenced by P300 auditory event related potential in the form of prolonged latency which indicate a slow rate of processing and defective memory as evidenced by small amplitude. These findings affect cognitive and language development in specific language impairment children and should be considered during planning the intervention program. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Requirements Specification Language (RSL) and supporting tools

NASA Technical Reports Server (NTRS)

Frincke, Deborah; Wolber, Dave; Fisher, Gene; Cohen, Gerald C.

1992-01-01

This document describes a general purpose Requirement Specification Language (RSL). RSL is a hybrid of features found in several popular requirement specification languages. The purpose of RSL is to describe precisely the external structure of a system comprised of hardware, software, and human processing elements. To overcome the deficiencies of informal specification languages, RSL includes facilities for mathematical specification. Two RSL interface tools are described. The Browser view contains a complete document with all details of the objects and operations. The Dataflow view is a specialized, operation-centered depiction of a specification that shows how specified operations relate in terms of inputs and outputs.

Oral Language and Narrative Skills in Children with Specific Language Impairment with and without Literacy Delay: A Three-Year Longitudinal Study

ERIC Educational Resources Information Center

Vandewalle, Ellen; Boets, Bart; Boons, Tinne; Ghesquiere, Pol; Zink, Inge

2012-01-01

This longitudinal study compared the development of oral language and more specifically narrative skills (storytelling and story retelling) in children with specific language impairment (SLI) with and without literacy delay. Therefore, 18 children with SLI and 18 matched controls with normal literacy were followed from the last year of…

How Language Is Embodied in Bilinguals and Children with Specific Language Impairment

PubMed Central

Adams, Ashley M.

2016-01-01

This manuscript explores the role of embodied views of language comprehension and production in bilingualism and specific language impairment. Reconceptualizing popular models of bilingual language processing, the embodied theory is first extended to this area. Issues such as semantic grounding in a second language and potential differences between early and late acquisition of a second language are discussed. Predictions are made about how this theory informs novel ways of thinking about teaching a second language. Secondly, the comorbidity of speech, language, and motor impairments and how embodiment theory informs the discussion of the etiology of these impairments is examined. A hypothesis is presented suggesting that what is often referred to as specific language impairment may not be so specific due to widespread subclinical motor deficits in this population. Predictions are made about how weaknesses and instabilities in speech motor control, even at a subclinical level, may disrupt the neural network that connects acoustic input, articulatory motor plans, and semantics. Finally, I make predictions about how this information informs clinical practice for professionals such as speech language pathologists and occupational and physical therapists. These new hypotheses are placed within the larger framework of the body of work pertaining to semantic grounding, action-based language acquisition, and action-perception links that underlie language learning and conceptual grounding. PMID:27582716

25 CFR 39.137 - May schools operate a language development program without a specific appropriation from Congress?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 1 2010-04-01 2010-04-01 false May schools operate a language development program... Formula Language Development Programs § 39.137 May schools operate a language development program without a specific appropriation from Congress? Yes, a school may operate a language development program...

Autistic Symptomatology and Language Ability in Autism Spectrum Disorder and Specific Language Impairment

ERIC Educational Resources Information Center

Loucas, Tom; Charman, Tony; Pickles, Andrew; Simonoff, Emily; Chandler, Susie; Meldrum, David; Baird, Gillian

2008-01-01

Background: Autism spectrum disorders (ASD) and specific language impairment (SLI) are common developmental disorders characterised by deficits in language and communication. The nature of the relationship between them continues to be a matter of debate. This study investigates whether the co-occurrence of ASD and language impairment is associated…

Cognitive Predictors of Language Development in Children with Specific Language Impairment (SLI)

ERIC Educational Resources Information Center

van Daal, John; Verhoeven, Ludo; van Balkom, Hans

2009-01-01

Background: Language development is generally viewed as a multifactorial process. There are increasing indications that this similarly holds for the problematic language development process. Aims: A population of 97 young Dutch children with specific language impairment (SLI) was followed over a 2-year period to provide additional evidence for the…

Cerebellum, Language, and Cognition in Autism and Specific Language Impairment

ERIC Educational Resources Information Center

Hodge, Steven M.; Makris, Nikos; Kennedy, David N.; Caviness, Verne S., Jr.; Howard, James; McGrath, Lauren; Steele, Shelly; Frazier, Jean A.; Tager-Flusberg, Helen; Harris, Gordon J.

2010-01-01

We performed cerebellum segmentation and parcellation on magnetic resonance images from right-handed boys, aged 6-13 years, including 22 boys with autism [16 with language impairment (ALI)], 9 boys with Specific Language Impairment (SLI), and 11 normal controls. Language-impaired groups had reversed asymmetry relative to unimpaired groups in…

A Read-Aloud for Foreign Languages: Becoming a Language Master (Read It Aloud).

ERIC Educational Resources Information Center

Richardson, Judy S.

1998-01-01

Describes the use of some read-alouds from Alexandre Dumas'"The Count of Monte Cristo" which helped to demonstrate some principles of learning foreign languages. Describes briefly the read aloud selection, discusses some specific activities that relate to foreign language learning, and discusses specific language arts activities. (SR)

The Use of Descriptive Data from Bilingual Children to Inform Theories of Specific Language Impairment

ERIC Educational Resources Information Center

Weismer, Susan Ellis; Kaushanskaya, Margarita

2010-01-01

In her Keynote Article, Paradis reviews evidence from bilingual language development to assess the claims of two opposing theoretical views of language disorders. Specifically, she examines the evidence for similarities in language profiles of typically developing (TD) sequential bilingual (second language [L2]) children and monolingual children…

Social Valence in Children with Specific Language Impairment during Imitation-Based and Conversation-Based Language Intervention.

ERIC Educational Resources Information Center

Haley, Katarina L.; And Others

1994-01-01

Fifteen preschool children with specific language impairment engaged in typical language intervention activities during conversation-based and imitation-based language programs. A higher number of positive social valence ratings; higher frequency of smiling, laughing, and engagement; and higher rate of verbal initiations were noted within…

Cognitive Approach to Assessing Pragmatic Language Comprehension in Children with Specific Language Impairment

ERIC Educational Resources Information Center

Ryder, Nuala; Leinonen, Eeva; Schulz, Joerg

2008-01-01

Background: Pragmatic language impairment in children with specific language impairment has proved difficult to assess, and the nature of their abilities to comprehend pragmatic meaning has not been fully investigated. Aims: To develop both a cognitive approach to pragmatic language assessment based on Relevance Theory and an assessment tool for…

Passive Consent for Clinical Research in the Age of HIPAA

PubMed Central

Littenberg, Benjamin; MacLean, Charles D

2006-01-01

BACKGROUND Federal laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA) of 1996, intended primarily to protect individuals, have been described as significant barriers to the use of clinical registries and other population-based tools for health care research. Although these regulations allow for the waiver or alteration of usual consent procedures when the research meets certain specific criteria, waivers and alterations are rarely used in health care research. METHODS The Vermont Diabetes Information System is a multistate randomized trial of a quality improvement intervention that uses a novel alteration of informed consent to help ensure that the study sample is representative of the target population. Patients are notified by mail that they are eligible for the study and that they may opt out of the study, if they desire, by calling a toll-free number. RESULTS Seven thousand five hundred and fifty-eight patients were invited to participate. Two hundred and ten (2.8%) opted out. Three patients (0.04%) filed complaints, all of which were addressed satisfactorily. CONCLUSIONS Health Insurance Portability and Accountability Act and other federal regulations raise challenges to the use of clinical registries in research, but modifications to the consent process, including passive consent methods, are useful tools to overcome these challenges. It is possible to recruit a broad and representative population under current law while maintaining appropriate protections for research subjects. PMID:16637821

Therapeutic misconception: hope, trust and misconception in paediatric research.

PubMed

Woods, Simon; Hagger, Lynn E; McCormack, Pauline

2014-03-01

Although the therapeutic misconception (TM) has been well described over a period of approximately 20 years, there has been disagreement about its implications for informed consent to research. In this paper we review some of the history and debate over the ethical implications of TM but also bring a new perspective to those debates. Drawing upon our experience of working in the context of translational research for rare childhood diseases such as Duchenne muscular dystrophy, we consider the ethical and legal implications of the TM for parental consent to research. In this situation, it is potentially the parent who is vulnerable to TM. In our analysis we not only consider the context of informed consent for research but also the wider environment in which the value of research is promoted, more broadly through the media but also more specifically through the communication strategies of patient organizations. All dissemination about developments in research for health runs the risk of portraying an overly optimistic view of the promise of biotechnological solutions and has the potential to encourage a 'collective' TM. In this paper we consider the challenge that TM presents to parents as well as explore the ethical and legal responsibilities of researchers to ensure an appropriately informed consent: compatible with a hopeful disposition of parents who consent for the their children whilst avoiding a blind and misleading optimism.

Factors influencing young adults' attitudes and knowledge of late-life sexuality among older women.

PubMed

Allen, Rebecca S; Petro, Kathryn N; Phillips, Laura L

2009-03-01

Although sexuality is valued throughout the lifespan, older women's sexual expression can be influenced by physical, mental and social factors, including attitudes and stereotypes held by younger generations. By gaining an understanding of what influences negative attitudes toward sexuality and beliefs about sexual consent capacity, the stigma associated with sexuality in late life may be reduced. Using vignette methodology in an online survey, we examined older women's health and young adults' (N = 606; mean age = 18.86, SD = 1.42, range 17-36) general knowledge and attitudes toward aging and sexuality, personal sexual behavior, religious beliefs and perceived closeness with an older adult on attitudes towards sexual behavior and perceptions of consent capacity among older women. The health status of older women proved important in determining young adults' acceptance and perception of sexual consent capacity regarding late-life heterosexual/autoerotic and homosexual behaviors. Specifically, young adults expressed lower acceptance and more doubt regarding capacity to consent to sexual expression when the older woman was described as cognitively impaired. Additionally, young adults' personal attitudes toward late-life sexuality, but not knowledge, predicted acceptance toward sexual expression and belief in sexual consent capacity. Attention toward the influence of older women's cognitive health and young adults' attitudes toward late-life sexuality may prove beneficial in designing interventions to decrease the stigma associated with sexual activity in later life.

Comprehension of Randomization and Uncertainty in Cancer Clinical Trials Decision Making Among Rural, Appalachian Patients.

PubMed

Krieger, Janice L; Palmer-Wackerly, Angela; Dailey, Phokeng M; Krok-Schoen, Jessica L; Schoenberg, Nancy E; Paskett, Electra D

2015-12-01

Comprehension of randomization is a vital, but understudied, component of informed consent to participate in cancer randomized clinical trials (RCTs). This study examines patient comprehension of the randomization process as well as sources of ongoing uncertainty that may inhibit a patient's ability to provide informed consent to participate in RCTs. Cancer patients living in rural Appalachia who were offered an opportunity to participate in a cancer treatment RCT completed in-depth interviews and a brief survey. No systematic differences in randomization comprehension between patients who consented and those who declined participation in a cancer RCT were detected. Comprehension is conceptually distinct from uncertainty, with patients who had both high and low comprehension experiencing randomization-related uncertainty. Uncertainty about randomization was found to have cognitive and affective dimensions. Not all patients enrolling in RCTs have a sufficient understanding of the randomization process to provide informed consent. Healthcare providers need to be aware of the different types of randomization-related uncertainty. Efforts to improve informed consent to participate in RCTs should focus on having patients teach back their understanding of randomization. This practice could yield valuable information about the patient's cognitive and affective understanding of randomization as well as opportunities to correct misperceptions. Education about RCTs should reflect patient expectations of individualized care by explaining how all treatments being compared are appropriate to the specifics of a patient's disease.

TMS uncovers details about sub-regional language-specific processing networks in early bilinguals.

PubMed

Hämäläinen, Sini; Mäkelä, Niko; Sairanen, Viljami; Lehtonen, Minna; Kujala, Teija; Leminen, Alina

2018-05-01

Despite numerous functional neuroimaging and intraoperative electrical cortical mapping studies aimed at investigating the cortical organisation of native (L1) and second (L2) language processing, the neural underpinnings of bilingualism remain elusive. We investigated whether the neural network engaged in speech production over the bilateral posterior inferior frontal gyrus (pIFG) is the same (i.e., shared) or different (i.e., language-specific) for the two languages of bilingual speakers. Navigated transcranial magnetic stimulation (TMS) was applied over the left and right posterior inferior gyrus (pIFG), while early simultaneous bilinguals performed a picture naming task with their native languages. An ex-Gaussian distribution was fitted to the naming latencies and the resulting parameters were compared between languages and across stimulation conditions. The results showed that although the naming performance in general was highly comparable between the languages, TMS produced a language-specific effect when the pulses were delivered to the left pIFG at 200 ms poststimulus. We argue that this result causally demonstrates, for the first time, that even within common language-processing areas, there are distinct language-specific neural populations for the different languages in early simultaneous bilinguals. Copyright © 2018 Elsevier Inc. All rights reserved.

Simplicity and Specificity in Language: Domain-General Biases Have Domain-Specific Effects

PubMed Central

Culbertson, Jennifer; Kirby, Simon

2016-01-01

The extent to which the linguistic system—its architecture, the representations it operates on, the constraints it is subject to—is specific to language has broad implications for cognitive science and its relation to evolutionary biology. Importantly, a given property of the linguistic system can be “specific” to the domain of language in several ways. For example, if the property evolved by natural selection under the pressure of the linguistic function it serves then the property is domain-specific in the sense that its design is tailored for language. Equally though, if that property evolved to serve a different function or if that property is domain-general, it may nevertheless interact with the linguistic system in a way that is unique. This gives a second sense in which a property can be thought of as specific to language. An evolutionary approach to the language faculty might at first blush appear to favor domain-specificity in the first sense, with individual properties of the language faculty being specifically linguistic adaptations. However, we argue that interactions between learning, culture, and biological evolution mean any domain-specific adaptations that evolve will take the form of weak biases rather than hard constraints. Turning to the latter sense of domain-specificity, we highlight a very general bias, simplicity, which operates widely in cognition and yet interacts with linguistic representations in domain-specific ways. PMID:26793132

Compositional Abstraction and Refinement for Aspects (CARA)

DTIC Science & Technology

2004-03-01

tight. 5 5 The SAL Language Manual by Leonardo de Moura, Sam Owre, and N. Shankar. Avail- able as [9]. The heart of the SAL system is its language , also...called SAL. The SAL language provides an attractive language for writing specifications, and it is also suitable as a target for translating...key part of the SAL framework is a language for describing transition systems. This language serves as a specification language and as the target for

Language-specific memory for everyday arithmetic facts in Chinese-English bilinguals.

PubMed

Chen, Yalin; Yanke, Jill; Campbell, Jamie I D

2016-04-01

The role of language in memory for arithmetic facts remains controversial. Here, we examined transfer of memory training for evidence that bilinguals may acquire language-specific memory stores for everyday arithmetic facts. Chinese-English bilingual adults (n = 32) were trained on different subsets of simple addition and multiplication problems. Each operation was trained in one language or the other. The subsequent test phase included all problems with addition and multiplication alternating across trials in two blocks, one in each language. Averaging over training language, the response time (RT) gains for trained problems relative to untrained problems were greater in the trained language than in the untrained language. Subsequent analysis showed that English training produced larger RT gains for trained problems relative to untrained problems in English at test relative to the untrained Chinese language. In contrast, there was no evidence with Chinese training that problem-specific RT gains differed between Chinese and the untrained English language. We propose that training in Chinese promoted a translation strategy for English arithmetic (particularly multiplication) that produced strong cross-language generalization of practice, whereas training in English strengthened relatively weak, English-language arithmetic memories and produced little generalization to Chinese (i.e., English training did not induce an English translation strategy for Chinese language trials). The results support the existence of language-specific strengthening of memory for everyday arithmetic facts.

Trip-specific training enhances recovery after large postural disturbances for which there is NO expectation.

PubMed

Oludare, Simisola O; Pater, Mackenzie L; Rosenblatt, Noah J; Grabiner, Mark D

2018-03-01

Informed consent usually provides foreknowledge of experimental methods that can potentially increase expectation of stimuli and, therefore, influence the response. We determined the effects of increased expectation and trip-specific training on the recovery response following a treadmill-delivered, trip-specific disturbance. To deliver unexpected disturbances, subjects were deceived during the informed consent process. The primary hypothesis was that the recovery response following an expected postural disturbance would be characterized by trunk kinematics that have been shown to decrease the likelihood of a fall, compared to following an unexpected postural disturbance. We further hypothesized that following an unexpected postural disturbance, the recovery response of the subjects who had completed a trip-specific training protocol would be more biomechanically favorable to recovery compared to those of subjects who had not received the training. Young adults were randomized into Untrained or Trained groups. During the informed consent process, the purpose of the study was explained to subjects in both groups as being to determine the effect of trip-specific training on postural sway while performing an attention-demanding task. Untrained subjects completed two trials during which they minimized their postural sway. During the second trial, an unexpected disturbance was delivered while they performed the attention-demanding task. Trained subjects performed a pre-training postural sway trial, followed by the delivery of a series of expected, training disturbances. Finally, an unexpected disturbance was delivered while they minimized postural sway and performed the attention-demanding task. Expectation significantly improved trunk kinematics (p < .05). In addition, participation in the trip-specific training protocol following the unexpected disturbance the trunk kinematics of the Trained subjects were more biomechanically favorable to recovery than those of the Untrained subjects (p < .01). Improved trunk kinematics following trip-specific training may be independent of the extent to which the disturbance is expected. Copyright © 2018 Elsevier B.V. All rights reserved.

Influence of Phonology on Morpho-Syntax in Romance Languages in Children with Specific Language Impairment (SLI)

ERIC Educational Resources Information Center

Aguilar-Mediavilla, Eva; Sanz-Torrent, Monica; Serra-Raventos, Miquel

2007-01-01

Background: The profiles of children with Specific Language Impairment (SLI) differ greatly according to the language they speak. The Surface Hypothesis attempts to explain these differences through the theory that children with SLI will incorrectly produce elements in their language with low phonological weights or that are produced in a…

Predictors of Growth or Attrition of the First Language in Latino Children with Specific Language Impairment

ERIC Educational Resources Information Center

Simon-Cereijido, Gabriela; Gutierrez-Clellen, Vera F.; Sweet, Monica

2013-01-01

We investigated the factors that may help understand the differential rates of language development in the home language (i.e., Spanish) of Latino preschoolers with specific language impairment. Children were randomly assigned to either bilingual or English-only small group interventions and followed from preschool to kindergarten. Predictors of…

Language in Autism and Specific Language Impairment: Where Are the Links?

ERIC Educational Resources Information Center

Williams, David; Botting, Nicola; Boucher, Jill

2008-01-01

It has been suggested that language impairment in autism is behaviorally, neurobiologically, and etiologically related to specific language impairment (SLI). In this article, the authors review evidence at each level and argue that the vast majority of data does not support the view that language impairment in autism can be explained in terms of…

Lipreading Ability and Its Cognitive Correlates in Typically Developing Children and Children with Specific Language Impairment

ERIC Educational Resources Information Center

Heikkilä, Jenni; Lonka, Eila; Ahola, Sanna; Meronen, Auli; Tiippana, Kaisa

2017-01-01

Purpose: Lipreading and its cognitive correlates were studied in school-age children with typical language development and delayed language development due to specific language impairment (SLI). Method: Forty-two children with typical language development and 20 children with SLI were tested by using a word-level lipreading test and an extensive…

A Case of Specific Language Impairment in a Deaf Signer of American Sign Language

ERIC Educational Resources Information Center

Quinto-Pozos, David; Singleton, Jenny L.; Hauser, Peter C.

2017-01-01

This article describes the case of a deaf native signer of American Sign Language (ASL) with a specific language impairment (SLI). School records documented normal cognitive development but atypical language development. Data include school records; interviews with the child, his mother, and school professionals; ASL and English evaluations; and a…

Imitative Production of Regular Past Tense -Ed by English-Speaking Children with Specific Language Impairment

ERIC Educational Resources Information Center

Dalal, Rinky Harish; Loeb, Diane Frome

2005-01-01

Background: Language intervention procedures often involve the speech-language pathologist highlighting or making more salient forms that are problematic for the child with a language impairment. According to limited processing accounts of specific language impairment (SLI), one way to increase the saliency of a form is to manipulate its sentence…

Investigation of Language and Motor skills in Serbian Speaking Children with Specific Language Impairment and in Typically Developing Children

ERIC Educational Resources Information Center

Vukovic, Mile; Vukovic, Irena; Stojanovik, Vesna

2010-01-01

Specific language impairment (SLI) is usually defined as a developmental language disorder which does not result from a hearing loss, autism, neurological and emotional difficulties, severe social deprivation, low non-verbal abilities. Children affected with SLI typically have difficulties with the acquisition of different aspects of language and…

Developing a Non-Language Related Span Test for the Use in Language-Specific and Cross-Language Studies

ERIC Educational Resources Information Center

Shahnazari-Dorcheh, Mohammadtaghi; Roshan, Saeed

2012-01-01

Due to the lack of span test for the use in language-specific and cross-language studies, this study provides L1 and L2 researchers with a reliable language-independent span test (math span test) for the measurement of working memory capacity. It also describes the development, validation, and scoring method of this test. This test included 70…

The Acquisition of Tense in English: Distinguishing Child Second Language from First Language and Specific Language Impairment

ERIC Educational Resources Information Center

Paradis, Johanne; Rice, Mabel L.; Crago, Martha; Marquis, Janet

2008-01-01

This study reports on a comparison of the use and knowledge of tense-marking morphemes in English by first language (L1), second language (L2), and specific language impairment (SLI) children. The objective of our research was to ascertain whether the L2 children's tense acquisition patterns were similar or dissimilar to those of the L1 and SLI…

48 CFR 552.270-14 - Changes.

Code of Federal Regulations, 2012 CFR

2012-10-01

... following: (1) Specifications (including drawings and designs). (2) Work or services. (3) Facilities or space layout. (4) Amount of space, provided the Lessor consents to the change. (b) If any such change...

48 CFR 552.270-14 - Changes.

Code of Federal Regulations, 2013 CFR

2013-10-01

... following: (1) Specifications (including drawings and designs). (2) Work or services. (3) Facilities or space layout. (4) Amount of space, provided the Lessor consents to the change. (b) If any such change...

48 CFR 552.270-14 - Changes.

Code of Federal Regulations, 2010 CFR

2010-10-01

... following: (1) Specifications (including drawings and designs). (2) Work or services. (3) Facilities or space layout. (4) Amount of space, provided the Lessor consents to the change. (b) If any such change...

48 CFR 552.270-14 - Changes.

Code of Federal Regulations, 2014 CFR

2014-10-01

... following: (1) Specifications (including drawings and designs). (2) Work or services. (3) Facilities or space layout. (4) Amount of space, provided the Lessor consents to the change. (b) If any such change...

48 CFR 552.270-14 - Changes.

Code of Federal Regulations, 2011 CFR

2011-10-01

... following: (1) Specifications (including drawings and designs). (2) Work or services. (3) Facilities or space layout. (4) Amount of space, provided the Lessor consents to the change. (b) If any such change...

SSL: A software specification language

NASA Technical Reports Server (NTRS)

Austin, S. L.; Buckles, B. P.; Ryan, J. P.

1976-01-01

SSL (Software Specification Language) is a new formalism for the definition of specifications for software systems. The language provides a linear format for the representation of the information normally displayed in a two-dimensional module inter-dependency diagram. In comparing SSL to FORTRAN or ALGOL, it is found to be largely complementary to the algorithmic (procedural) languages. SSL is capable of representing explicitly module interconnections and global data flow, information which is deeply imbedded in the algorithmic languages. On the other hand, SSL is not designed to depict the control flow within modules. The SSL level of software design explicitly depicts intermodule data flow as a functional specification.

Governing the postmortem procurement of human body material for research.

PubMed

Van Assche, Kristof; Capitaine, Laura; Pennings, Guido; Sterckx, Sigrid

2015-03-01

Human body material removed post mortem is a particularly valuable resource for research. Considering the efforts that are currently being made to study the biochemical processes and possible genetic causes that underlie cancer and cardiovascular and neurodegenerative diseases, it is likely that this type of research will continue to gain in importance. However, post mortem procurement of human body material for research raises specific ethical concerns, more in particular with regard to the consent of the research participant. In this paper, we attempt to determine which consent regime should govern the post mortem procurement of body material for research. In order to do so, we assess the various arguments that could be put forward in support of a duty to make body material available for research purposes after death. We argue that this duty does in practice not support conscription but is sufficiently strong to defend a policy of presumed rather than explicit consent.

Avoiding malpractice suits through the use of informed consent.

PubMed

Annas, G J

1976-03-01

The doctrine of informed consent is based on a long tradition of promoting self-autonomy and rational decision-making. The amount of information required to be disclosed by the doctor to the patient is that which permits the patient to decide for himself whether or not to undergo the recommended treatment. It includes information about risks of death or serious bodily harm, probability of success, problems of recuperation, and alternative modes of treatment. Disclosing such information contributes to the doctor-patient relationship and therefore makes recourse to malpractice litigation in the face of an unsatisfactory or untoward result less likely. Attempts to abolish the doctrine are potentially counterproductive and could lead to widespread mistrust of the medical profession on the part of a society that increasingly demands more information in all areas. Physicians will best serve both themselves and their patients by fully disclosing all relevant information before asking patients to consent to specific therapies.

Developing genetic privacy legislation: the South Carolina experience.

PubMed

Edwards, J G; Young, S R; Brooks, K A; Aiken, J H; Patterson, E D; Pritchett, S T

1998-01-01

The availability of presymptomatic and predisposition genetic testing has spawned the need for legislation prohibiting health insurance discrimination on the basis of genetic information. The federal effort, the Health Insurance Portability and Accountability Act (HIPAA) of 1996, falls short by protecting only those who access insurance through group plans. A committee of University of South Carolina professionals convened in 1996 to develop legislation in support of genetic privacy for the state of South Carolina. The legislation prevents health insurance companies from denying coverage or setting insurance rates on the basis of genetic information. It also protects the privacy of genetic information and prohibits performance of genetic tests without specific informed consent. In preparing the bill, genetic privacy laws from other states were reviewed, and a modified version of the Virginia law adopted. The South Carolina Committee for the Protection of Genetic Privacy version went a step further by including enforcement language and excluding Virginia's sunset clause. The definition of genetic information encompassed genetic test results, and importantly, includes family history of genetic disease. Our experience in navigating through the state legislature and working through opposition from the health insurance lobby is detailed herein.

Important Constructs in Literacy Learning across Disciplines

ERIC Educational Resources Information Center

Foorman, Barbara R.; Arndt, Elissa J.; Crawford, Elizabeth C.

2011-01-01

Currently students who struggle with language and literacy learning are classified with various labels in different states--language learning disabilities, dyslexia, specific language impairment, and specific learning disability--in spite of having similar diagnostic profiles. Drawing on the research on comprehension of written language, we…

Standard Specification for Language Laboratory.

ERIC Educational Resources Information Center

North Carolina State Dept. of Administration, Raleigh.

This specification covers the components of electronic and electromechanical equipment, nonelectronic materials for the teacher-student positions, and other items of a miscellaneous nature to provide for a complete and workable language laboratory facility. Language laboratory facilities covered by this specification are of two types: (1)…

Declarative language design for interactive visualization.

PubMed

Heer, Jeffrey; Bostock, Michael

2010-01-01

We investigate the design of declarative, domain-specific languages for constructing interactive visualizations. By separating specification from execution, declarative languages can simplify development, enable unobtrusive optimization, and support retargeting across platforms. We describe the design of the Protovis specification language and its implementation within an object-oriented, statically-typed programming language (Java). We demonstrate how to support rich visualizations without requiring a toolkit-specific data model and extend Protovis to enable declarative specification of animated transitions. To support cross-platform deployment, we introduce rendering and event-handling infrastructures decoupled from the runtime platform, letting designers retarget visualization specifications (e.g., from desktop to mobile phone) with reduced effort. We also explore optimizations such as runtime compilation of visualization specifications, parallelized execution, and hardware-accelerated rendering. We present benchmark studies measuring the performance gains provided by these optimizations and compare performance to existing Java-based visualization tools, demonstrating scalability improvements exceeding an order of magnitude.

Phonological Processing Deficits in Specific Reading Disability and Specific Language Impairment: Same or Different?

ERIC Educational Resources Information Center

McArthur, Genevieve; Castles, Anne

2013-01-01

The aim of this study was to determine if phonological processing deficits in specific reading disability (SRD) and specific language impairment (SLI) are the same or different. In four separate analyses, a different combination of reading and spoken language measures was used to divide 73 children into three subgroups: poor readers with average…

Patient and public attitudes towards informed consent models and levels of awareness of Electronic Health Records in the UK

PubMed Central

Riordan, Fiona; Papoutsi, Chrysanthi; Reed, Julie E.; Marston, Cicely; Bell, Derek; Majeed, Azeem

2015-01-01

Background The development of Electronic Health Records (EHRs) forms an integral part of the information strategy for the National Health Service (NHS) in the UK, with the aim of facilitating health information exchange for patient care and secondary use, including research and healthcare planning. Implementing EHR systems requires an understanding of patient expectations for consent mechanisms and consideration of public awareness towards information sharing as might be made possible through integrated EHRs across primary and secondary health providers. Objectives To explore levels of public awareness about EHRs and to examine attitudes towards different consent models with respect to sharing identifiable and de-identified records for healthcare provision, research and planning. Methods A cross-sectional questionnaire survey was administered to adult patients and members of the public in primary and secondary care clinics in West London, UK in 2011. In total, 5331 individuals participated in the survey, and 3157 were included in the final analysis. Results The majority (91%) of respondents expected to be explicitly asked for consent for their identifiable records to be accessed for health provision, research or planning. Half the respondents (49%) did not expect to be asked for consent before their de-identified records were accessed. Compared with White British respondents, those from all other ethnic groups were more likely to anticipate their permission would be obtained before their de-identified records were used. Of the study population, 59% reported already being aware of EHRs before the survey. Older respondents and individuals with complex patterns of interaction with healthcare services were more likely to report prior awareness of EHRs. Individuals self-identifying as belonging to ethnic groups other than White British, and those with lower educational qualifications were less likely to report being aware of EHRs than White British respondents and respondents with degree-level education, respectively. Those who reported being aware of EHRs were less likely to say they expected explicit consent to be sought before use of their de-identified record. Conclusions A large number of patients remain unaware of EHRs, while preference for implicit consent is stronger among those who report previous awareness. Differences in awareness levels and consent expectations between groups with different socio-demographic characteristics suggest that public education and information campaigns should target specific groups to increase public awareness and ensure meaningful informed consent mechanisms. PMID:25649841

Feasibility of an Assessment Tool for Children's Competence to Consent to Predictive Genetic Testing: a Pilot Study.

PubMed

Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Christiaans, Imke; Grisso, Thomas; van Goudoever, Johannes B; Lindauer, Ramón J L

2015-12-01

Knowledge on children's capacities to consent to medical treatment is limited. Also, age limits for asking children's consent vary considerably between countries. Decision-making on predictive genetic testing (PGT) is especially complicated, considering the ongoing ethical debate. In order to examine just age limits for alleged competence to consent in children, we evaluated feasibility of a standardized assessment tool, and investigated cutoff ages for children's competence to consent to PGT. We performed a pilot study, including 17 pediatric outpatients between 6 and 18 years at risk for an autosomal dominantly inherited cardiac disease, eligible for predictive genetic testing. The reference standard for competence was established by experts trained in the relevant criteria for competent decision-making. The MacArthur Competence Assessment Tool for Treatment (MacCAT-T) served as index test. Data analysis included raw agreement between competence classifications, difference in mean ages between children judged competent and judged incompetent, and estimation of cutoff ages for judgments of competence. Twelve (71 %) children were considered competent by the reference standard, and 16 (94 %) by the MacCAT-T, with an overall agreement of 76 %. The expert judgments disagreed in most cases, while the MacCAT-T judgments agreed in 65 %. Mean age of children judged incompetent was 9.3 years and of children judged competent 12.1 years (p = .035). With 90 % sensitivity, children younger than 10.0 years were judged incompetent, with 90 % specificity children older than 11.8 years were judged competent. Feasibility of the MacCAT-T in children is confirmed. Initial findings on age cutoffs are indicative for children between the age of 12 and 18 to be judged competent for involvement in the informed consent process. Future research on appropriate age-limits for children's alleged competence to consent is needed.

Non-Word Repetition in Adolescents with Specific Language Impairment and Autism Plus Language Impairments: A Qualitative Analysis

ERIC Educational Resources Information Center

Riches, N. G.; Loucas, T.; Baird, G.; Charman, T.; Simonoff, E.

2011-01-01

Non-word repetition (NWR) was investigated in adolescents with typical development, Specific Language Impairment (SLI) and Autism Plus language Impairment (ALI) (n = 17, 13, 16, and mean age 14;4, 15;4, 14;8 respectively). The study evaluated the hypothesis that poor NWR performance in both groups indicates an overlapping language phenotype…

Developmental Associations between Working Memory and Language in Children with Specific Language Impairment: A Longitudinal Study

ERIC Educational Resources Information Center

Vugs, Brigitte; Hendriks, Marc; Cuperus, Juliane; Knoors, Harry; Verhoeven, Ludo

2017-01-01

Purpose: This longitudinal study examined differences in the development of working memory (WM) between children with specific language impairment (SLI) and typically developing (TD) children. Further, it explored to what extent language at ages 7-8 years could be predicted by measures of language and/or WM at ages 4-5 years. Method: Thirty…

The generativist-interactionist debate over specific language impairment: psycholinguistics at a crossroads.

PubMed

Shanker, Stuart

2002-01-01

Certain defining problems in psychology force us to clarify both the origins and the limits of a paradigm that has long governed our thinking in a particular area of research. The current debate over the nature and causes of specific language impairment is proving to be just such an issue. In particular, the existence of the KE family, 15 of whose 37 members suffer from specific language impairment, has raised far-reaching questions about the conceptual foundations of our current views about language deficits and, indeed, about language development in general.

Social and Behavioral Correlates of Preschoolers with Specific Language Impairment

ERIC Educational Resources Information Center

McCabe, Paul C.

2005-01-01

The relationship between specific subtypes of speech language impairment (SLI) and concomitant social competence and behavioral adjustment was investigated. Teachers and parents completed behavior ratings of SLI preschoolers enrolled in a language-based intervention program and preschoolers without language impairment, including the Parent-Child…

Legal and ethical aspects of deliberate G-induced loss of consciousness experiments.

PubMed

Euretig, J G

1991-07-01

Informed consent is both a legal and accepted ethical prerequisite to nontherapeutic human experimentation. The informed consent obtained from the subject in G-LOC experimentation is in the same form as the risk disclosures used in high-G acceleration experiments. However, in high acceleration protocols G-LOC is a potential risk while in G-LOC experiments it is the result. The case law embodies three modern evidentiary standards (the "professional," "material fact," and "possible risks" tests) employed by common law courts when deciding whether the risk disclosures are sufficient to elicit the informed consent of the subject. Each standard is applied against the disclosures in the G-LOC protocol to determine if the elements of the requirement are met. The risk disclosures are wanting in specific identification under the three tests. The deficiency is the failure to inform the subject that G-LOC may result in a pathologic state of unconsciousness about which little is known. Without complete disclosure of this lacking state of medical knowledge, it is questionable whether informed consent can be given. If subjected to judicial scrutiny, the disclosures stated in the G-LOC protocol used in government sponsored research will probably be found deficient.

Individual rights over public good? The future of anthropometric monitoring of school children in the fight against obesity.

PubMed

Stubbs, Joanne M; Achat, Helen M

2009-02-02

Available evidence indicates that rates of childhood overweight and obesity have been increasing over the past two decades, but inconsistencies between study methods moderate the strength of this evidence. Concomitant health problems and associated costs make it imperative that primary prevention initiatives are introduced to combat the obesity epidemic. Fundamental to informed action is anthropometric monitoring, which if properly implemented will identify changes over time in specific populations to inform policies, practices and services aimed at prevention and treatment. Sample representativeness is essential for valid trend and prevalence data, but efforts to obtain population-based anthropometric data from school children with the required written parental consent have been thwarted by low participation rates. Notable improvements in participation rates when utilising opt-out consent, in which participation is assumed unless otherwise indicated, are evident from local as well as international studies. Opt-out consent can facilitate anthropometric monitoring, delivering a more informed, best-value-for-money response to the obesity epidemic. Health and education ethics committees need to acknowledge the benefits of opt-out consent for "low-risk" anthropometric measurement, which ultimately upholds the individual's rights.

77 FR 12591 - THV Holdings LLC; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

... homeowners can realize by replacing their windows, including the home's geographic location, size, insulation... having a specific level of insulation in a specific region). The performance standard imposed under this... consumption, energy savings, energy costs, heating and cooling costs, U-factor, solar heat gain coefficient, R...

77 FR 12584 - Gorell Enterprises, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

... location, size, insulation package, and existing windows. Consumers who replace single or double-paned wood... a building having a specific level of insulation in a specific region). The performance standard... consumption, energy savings, energy costs, heating and cooling costs, U-factor, solar heat gain coefficient, R...

Component Models for Semantic Web Languages

NASA Astrophysics Data System (ADS)

Henriksson, Jakob; Aßmann, Uwe

Intelligent applications and agents on the Semantic Web typically need to be specified with, or interact with specifications written in, many different kinds of formal languages. Such languages include ontology languages, data and metadata query languages, as well as transformation languages. As learnt from years of experience in development of complex software systems, languages need to support some form of component-based development. Components enable higher software quality, better understanding and reusability of already developed artifacts. Any component approach contains an underlying component model, a description detailing what valid components are and how components can interact. With the multitude of languages developed for the Semantic Web, what are their underlying component models? Do we need to develop one for each language, or is a more general and reusable approach achievable? We present a language-driven component model specification approach. This means that a component model can be (automatically) generated from a given base language (actually, its specification, e.g. its grammar). As a consequence, we can provide components for different languages and simplify the development of software artifacts used on the Semantic Web.

Discriminating languages in bilingual contexts: the impact of orthographic markedness

PubMed Central

Casaponsa, Aina; Carreiras, Manuel; Duñabeitia, Jon A.

2014-01-01

Does language-specific orthography help language detection and lexical access in naturalistic bilingual contexts? This study investigates how L2 orthotactic properties influence bilingual language detection in bilingual societies and the extent to which it modulates lexical access and single word processing. Language specificity of naturalistically learnt L2 words was manipulated by including bigram combinations that could be either L2 language-specific or common in the two languages known by bilinguals. A group of balanced bilinguals and a group of highly proficient but unbalanced bilinguals who grew up in a bilingual society were tested, together with a group of monolinguals (for control purposes). All the participants completed a speeded language detection task and a progressive demasking task. Results showed that the use of the information of orthotactic rules across languages depends on the task demands at hand, and on participants' proficiency in the second language. The influence of language orthotactic rules during language detection, lexical access and word identification are discussed according to the most prominent models of bilingual word recognition. PMID:24860536

Ensuring Cross-Cultural Equivalence in Translation of Research Consents and Clinical Documents

PubMed Central

Lee, Cheng-Chih; Li, Denise; Arai, Shoshana; Puntillo, Kathleen

2010-01-01

The aim of this article is to describe a formal process used to translate research study materials from English into traditional Chinese characters. This process may be useful for translating documents for use by both research participants and clinical patients. A modified Brislin model was used as the systematic translation process. Four bilingual translators were involved, and a Flaherty 3-point scale was used to evaluate the translated documents. The linguistic discrepancies that arise in the process of ensuring cross-cultural congruency or equivalency between the two languages are presented to promote the development of patient-accessible cross-cultural documents. PMID:18948451

Abortion and informed consent requirements.

PubMed

Kapp, M B

1982-09-01

Supreme Court decisions have liberalized a woman's right to decide whether to obtain an abortion. Some state and local governments have tried to circumvent these decisions by enacting requirements designed to discourage abortions by, among other things, dictating to physicians an elaborate litany of specific information that must be communicated to a patient as a necessary precondition of her informed consent for an abortion. This article discusses the legal status of such requirements, their implications for the professional autonomy of physicians, and the role of the medical profession in challenging these restrictions, on its own behalf and in concert with its patients.

The new EU General Data Protection Regulation: what the radiologist should know.

PubMed

2017-06-01

The European Society of Radiology (ESR) informs its membership and its associated Institutional Members about the new General Data Protection Regulation (GDPR) of the European Union (EU,) which will apply from 25 May 2018. Radiologists and radiology departments should be prepared to comply with several new rules for the protection of imaging data. Although the new GDPR applies to all domains of the public and private sectors, some specific derogations are defined for data concerning health, aiming at protecting the rights of data subjects and confidentiality of their personal health data, whilst preserving the benefits of processing data, including digital images for research and public health purposes. Specific new obligations which healthcare providers (including radiologists/radiology departments) should prepare for include data access for patients, rules for data processing including explicit consent of the data subject in the absence of derogations, or technical and organisational safeguards. National health authorities can define exceptions and derogations from certain obligations by means of national law. They will also define sanctions in the form of penalties or fines that may be applicable for organisations of the public and private sector that fail to comply with the rules of the GDPR. • Explicit consent prior to data processing will be necessary. • Explicit consent prior to communication of imaging data will be necessary. • Providing patient access to their personal data, including portability, will be required. • Certain derogations and exceptions exist for healthcare and research. • Additional specific rules may be defined by national law.

One Approach to Teaching the Specific Language Disabled Adult Language Arts.

ERIC Educational Resources Information Center

Peterson, Binnie L.

1981-01-01

One approach never before used in adult language arts instruction--the Slingerland Simultaneous Multisensory Technique--has been found useful for specific language disabled adults in multisensory programs at Anchorage Community College. The Slingerland method builds from single sight, sound, and feel of letters through combinations, encoding,…

Speech-Language Evaluation and Rehabilitation Treatment in Floating-Harbor Syndrome: A Case Study

ERIC Educational Resources Information Center

Angelillo, Nicola; Di Costanzo, Brigida; Barillari, Umberto

2010-01-01

Floating-Harbor syndrome is a rare congenital disorder characterized by specific facial features, short stature associated with significantly delayed bone age and language impairment. Although language delay is a cardinal manifestation of this syndrome, few reports describe the specific language difficulties of these patients, particularly the…

Using Tasks to Assess Spanish Language Learning

ERIC Educational Resources Information Center

Herrera Mosquera, Leonardo

2012-01-01

The methodology of Task-based teaching (TBT) has been positively regarded by many researchers and language teachers around the world. Yet, this language teaching methodology has been mainly implemented in English as a second language (ESL) classrooms and in English for specific purpose (ESP) courses; and more specifically with advanced-level…

The Potential of Studying Specific Language Impairment in Bilinguals for Linguistic Research on Specific Language Impairment in Monolinguals

ERIC Educational Resources Information Center

Rothweiler, Monika

2010-01-01

In her Keynote Article, Paradis discusses the role of the interface between bilingual development and specific language impairment (SLI) on two different levels. On the level of theoretical explanations of SLI, Paradis asks how domain general versus domain-specific perspectives on SLI can account for bilingual SLI, as well as what bilingual SLI…

Writing Motivation of Students with Specific Language Impairments

ERIC Educational Resources Information Center

Brouwer, Kyle Lee

2010-01-01

This study was designed to compare the writing motivation of students with specific language impairments with their non-disabled peers. Due to the cognitive and linguistic demands of the writing process, students with language impairments face unique difficulties during the writing process. It was hypothesized that students with specific language…

Medical Spanish: A Functional Approach.

ERIC Educational Resources Information Center

Hendrickson, James M.

A functional approach to language teaching begins with knowing how students intend to use the foreign language for specific purposes and in specific situations. Instructors of medical Spanish can begin by determining the specific language functions that their students must be able to express when communicating with Hispanic patients, by means of a…

Closing the Gap Between Specification and Programming: VDM++ and SCALA

NASA Technical Reports Server (NTRS)

Havelund, Klaus

2011-01-01

We argue that a modern programming language such as Scala offers a level of succinctness, which makes it suitable for program and systems specification as well as for high-level programming. We illustrate this by comparing the language with the Vdm++ specification language. The comparison also identifies areas where Scala perhaps could be improved, inspired by Vdm++. We furthermore illustrate Scala's potential as a specification language by augmenting it with a combination of parameterized state machines and temporal logic, defined as a library, thereby forming an expressive but simple runtime verification framework.

Improving Domain-specific Machine Translation by Constraining the Language Model

DTIC Science & Technology

2012-07-01

performance. To make up for the lack of parallel training data, one assumption is that more monolingual target language data should be used in building the...target language model. Prior work on domain-specific MT has focused on training target language models with monolingual 2 domain-specific data...showed that the using a large dictionary extracted from medical domain documents in a statistical MT system to generalize the training data significantly

Language Impairments in the Development of Sign: Do They Reside in a Specific Modality or Are They Modality-Independent Deficits?

ERIC Educational Resources Information Center

Woll, Bencie; Morgan, Gary

2012-01-01

Various theories of developmental language impairments have sought to explain these impairments in modality-specific ways--for example, that the language deficits in SLI or Down syndrome arise from impairments in auditory processing. Studies of signers with language impairments, especially those who are bilingual in a spoken language as well as a…

Identifying Specific Language Impairment in Deaf Children Acquiring British Sign Language: Implications for Theory and Practice

ERIC Educational Resources Information Center

Mason, Kathryn; Rowley, Katherine; Marshall, Chloe R.; Atkinson, Joanna R.; Herman, Rosalind; Woll, Bencie; Morgan, Gary

2010-01-01

This paper presents the first ever group study of specific language impairment (SLI) in users of sign language. A group of 50 children were referred to the study by teachers and speech and language therapists. Individuals who fitted pre-determined criteria for SLI were then systematically assessed. Here, we describe in detail the performance of 13…

Guidance and Ethical Considerations for Undertaking Transgender Health Research and Institutional Review Boards Adjudicating this Research

PubMed Central

Adams, Noah; Pearce, Ruth; Veale, Jaimie; Radix, Asa; Castro, Danielle; Sarkar, Amrita; Thom, Kai Cheng

2017-01-01

Abstract The purpose of this review is to create a set of provisional criteria for Institutional Review Boards (IRBs) to refer to when assessing the ethical orientation of transgender health research proposals. We began by searching for literature on this topic using databases and the reference lists of key articles, resulting in a preliminary set of criteria. We then collaborated to develop the following nine guidelines: (1) Whenever possible, research should be grounded, from inception to dissemination, in a meaningful collaboration with community stakeholders; (2) language and framing of transgender health research should be non-stigmatizing; (3) research should be disseminated back to the community; (4) the diversity of the transgender and gender diverse (TGGD) community should be accurately reflected and sensitively reflected; (5) informed consent must be meaningful, without coercion or undue influence; (6) the protection of participant confidentiality should be paramount; (7) alternative consent procedures should be considered for TGGD minors; (8) research should align with current professional standards that refute conversion, reorientation, or reparative therapy; and (9) IRBs should guard against the temptation to avoid, limit, or delay research on this subject. PMID:29098202

Relations among Language Exposure, Phonological Memory, and Language Development in Spanish-English Bilingually-Developing Two-Year-Olds

PubMed Central

Parra, Marisol; Hoff, Erika; Core, Cynthia

2010-01-01

The relation of phonological memory to language experience and development was investigated in 41 Spanish-English bilingual first language learners. The children’s relative exposure to English and Spanish and phonological memory for English-like and Spanish-like nonwords were assessed at 22 months; their productive vocabulary and grammar in both languages were assessed at 25 months. Phonological memory for English- and Spanish-like nonwords were highly correlated, and each was related to vocabulary and grammar in both languages, suggesting a language-general component to phonological memory skill. In addition, there was evidence of language-specific benefits of language exposure to phonological memory skill and of language-specific benefits of phonological memory skill to language development. PMID:20828710

Do children with autism have a theory of mind? A non-verbal test of autism vs. specific language impairment.

PubMed

Colle, Livia; Baron-Cohen, Simon; Hill, Jacqueline

2007-04-01

Children with autism have delays in the development of theory of mind. However, the sub-group of children with autism who have little or no language have gone untested since false belief tests (FB) typically involve language. FB understanding has been reported to be intact in children with specific language impairment (SLI). This raises the possibility that a non-verbal FB test would distinguish children with autism vs. children with SLI. The present study tested two predictions: (1) FB understanding is to some extent independent of language ability; and (2) Children with autism with low language levels show specific impairment in theory of mind. Results confirmed both predictions. Results are discussed in terms of the role of language in the development of mindreading.

Quantitative and qualitative analysis of study-related patient information sheets in randomised neuro-oncology phase III-trials.

PubMed

Reinert, Christiane; Kremmler, Lukas; Burock, Susen; Bogdahn, Ulrich; Wick, Wolfgang; Gleiter, Christoph H; Koller, Michael; Hau, Peter

2014-01-01

In randomised controlled trials (RCTs), patient informed consent documents are an essential cornerstone of the study flow. However, these documents are often oversized in format and content. Clinical experience suggests that study information sheets are often not used as an aid to decision-making due to their complexity. We analysed nine patient informed consent documents from clinical neuro-oncological phase III-studies running at a German Brain Tumour Centre with the objective to investigate the quality of these documents. Text length, formal layout, readability, application of ethical and legal requirements, scientific evidence and social aspects were used as rating categories. Results were assessed quantitatively by two independents investigators and were depicted using net diagrams. All patient informed consent documents were of insufficient quality in all categories except that ethical and legal requirements were fulfilled. Notably, graduate levels were required to read and understand five of nine consent documents. Quality deficits were consistent between the individual study information texts. Irrespective of formal aspects, a document that is intended to inform and motivate patients to participate in a study needs to be well-structured and understandable. We therefore strongly mandate to re-design patient informed consent documents in a patient-friendly way. Specifically, standardised components with a scientific foundation should be provided that could be retrieved at various times, adapted to the mode of treatment and the patient's knowledge, and could weigh information dependent of the stage of treatment decision. Copyright © 2013 Elsevier Ltd. All rights reserved.

Clinical research involving minors in international and serbian regulations.

PubMed

Planojević, Nina; Zivojinović, Dragica

2013-07-01

Participation in clinical trials can be useful for the health of a person, in who it is conducted, but it does not have to be - it can even be harmful. Therefore, primary motive to accept such risk is humanity and human wish to contribute to the progress of medicine; this is expressed by personal consent. The consent, however, can be an expression of personal humanity, and for this, it is not logical that someone can give consent on behalf of someone else, as it is done by a legally authorized representative on behalf of a minor. Therefore, authors raise 3 questions: What are the reasons to consider representative's consent acceptable? How should a model of regulations look like in order to provide the most complete possible protection to a minor? Is actual regulation of minors' position within international and Serbian law, analyzed here by authors for their specific solutions, acceptable? Representative's consent is acceptable only for therapeutic research, because these can bring benefits to everyone's health, including a minor in which those are conducted - this is an acceptable (secondary) motive of participation in the research. Expression of humanity on other's behalf, typical for non-therapeutic research, is not acceptable; this makes ban of minors' participation in non-therapeutic research more appropriate regulation model. International regulations are not in accordance to results presented in the paper for allowing participation of minors both in therapeutic and non-therapeutic research. Serbian regulation is closer to the most acceptable regulation model.

Automated benchmark generation based upon a specification language

NASA Technical Reports Server (NTRS)

Rajan, N.; Feteih, S. E.; Saito, J.

1984-01-01

The problem of validating and verifying digital flight control system (DFCS) software is addressed in this paper. A new specification language DIVERS is proposed, and is the keystone of the approach. This language consists of keywords where each keyword represents an element in the block diagram of a DFCS. DIVERS has a dictionary which contains all the keywords a DFCS designer might need. Translator programs convert the system specifications into an executable, high-level language program. The features of translators are discussed and are elucidated by examples. This language is used to describe a typical flight software module.

Spoken Word Recognition in Adolescents with Autism Spectrum Disorders and Specific Language Impairment

ERIC Educational Resources Information Center

Loucas, Tom; Riches, Nick; Baird, Gillian; Pickles, Andrew; Simonoff, Emily; Chandler, Susie; Charman, Tony

2013-01-01

Spoken word recognition, during gating, appears intact in specific language impairment (SLI). This study used gating to investigate the process in adolescents with autism spectrum disorders plus language impairment (ALI). Adolescents with ALI, SLI, and typical language development (TLD), matched on nonverbal IQ listened to gated words that varied…

Txt Lang: Texting, Textism Use and Literacy Abilities in Adolescents with and without Specific Language Impairment

ERIC Educational Resources Information Center

Durkin, K.; Conti-Ramsden, G.; Walker, A. J.

2011-01-01

The present study examined text messaging in adolescence, in particular relationships among textism use, language and literacy skills. Forty-seven typically developing (TD) 17-year-olds and 47 adolescents of the same age with specific language impairment (SLI) participated. Participants completed standardised assessments of cognitive, language and…

Predictors of Second Language Acquisition in Latino Children with Specific Language Impairment

ERIC Educational Resources Information Center

Gutierrez-Clellen, Vera; Simon-Cereijido, Gabriela; Sweet, Monica

2012-01-01

Purpose: This study evaluated the extent to which the language of intervention, the child's development in Spanish, and the effects of English vocabulary, use, proficiency, and exposure predict differences in the rates of acquisition of English in Latino children with specific language impairment (SLI). Method: In this randomized controlled trial,…

The Role of Technology in Teaching Languages for Specific Purposes Courses

ERIC Educational Resources Information Center

Arno-Macia, Elisabet

2012-01-01

Within the integration of technology into language education, special attention needs to be paid to languages for specific purposes (LSP), drawing on developments in computer-assisted language learning and applied linguistics, on the one hand, and on the pervasive use of technology in academic and professional communication, on the other. From a…

Assessing Language Proficiency Levels: Oral Proficiency Testing, Pre- and Post-Soviet Study.

ERIC Educational Resources Information Center

Baker, Robert L.

The importance of assessing language proficiency levels and the relationship of this priority to the teaching of Russian at the university level are discussed. Serious concerns about the value of language-specific proficiency guidelines are raised, and an argument is presented suggesting that language-specific guidelines may lead to undue emphasis…

Memory Functioning and Mental Verbs Acquisition in Children with Specific Language Impairment

ERIC Educational Resources Information Center

Spanoudis, George C.; Natsopoulos, Demetrios

2011-01-01

Memory and language operate in synergy. Recent literature stresses the importance of memory functioning in interpreting language deficits. Two groups of 50 children each, ages 8-12 were studied. The first group included children with specific language impairment, while the participants in the second group were typically developing children. The…

Grammatical Language Impairment and the Specificity of Cognitive Domains: Relations between Auditory and Language Abilities

ERIC Educational Resources Information Center

van der Lely, Heather K. J.; Rosen, Stuart; Adlard, Alan

2004-01-01

Grammatical-specific language impairment (G-SLI) in children, arguably, provides evidence for the existence of a specialised grammatical sub-system in the brain, necessary for normal language development. Some researchers challenge this, claiming that domain-general, low-level auditory deficits, particular to rapid processing, cause phonological…

Auditory Perception and Word Recognition in Cantonese-Chinese Speaking Children with and without Specific Language Impairment

ERIC Educational Resources Information Center

Kidd, Joanna C.; Shum, Kathy K.; Wong, Anita M.-Y.; Ho, Connie S.-H.

2017-01-01

Auditory processing and spoken word recognition difficulties have been observed in Specific Language Impairment (SLI), raising the possibility that auditory perceptual deficits disrupt word recognition and, in turn, phonological processing and oral language. In this study, fifty-seven kindergarten children with SLI and fifty-three language-typical…

Dynamic Temporal Processing of Nonspeech Acoustic Information by Children with Specific Language Impairment.

ERIC Educational Resources Information Center

Visto, Jane C.; And Others

1996-01-01

Ten children (ages 12-16) with specific language impairments (SLI) and controls matched for chronological or language age were tested with measures of complex sound localization involving the precedence effect phenomenon. SLI children exhibited tracking skills similar to language-age matched controls, indicating impairment in their ability to use…

Expressive versus Receptive Language Skills in Specific Reading Disorder

ERIC Educational Resources Information Center

Stojanovik, Vesna; Riddell, Patricia

2008-01-01

Despite ample research into the language skills of children with specific reading disorder no studies so far have investigated whether there may be a difference between expressive and receptive language skills in this population. Yet, neuro-anatomical models would predict that children who have specific reading disorder which is not associated…

78 FR 24777 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

... modified, without complying with Best Available Control Technology (``BACT'') requirements for sulfur.... Specifically, the Complaint alleges that the Defendants modified various units at the Columbia, Edgewater, and...

Is Word-Problem Solving a Form of Text Comprehension?

PubMed Central

Fuchs, Lynn S.; Fuchs, Douglas; Compton, Donald L.; Hamlett, Carol L.; Wang, Amber Y.

2015-01-01

This study’s hypotheses were that (a) word-problem (WP) solving is a form of text comprehension that involves language comprehension processes, working memory, and reasoning, but (b) WP solving differs from other forms of text comprehension by requiring WP-specific language comprehension as well as general language comprehension. At the start of the 2nd grade, children (n = 206; on average, 7 years, 6 months) were assessed on general language comprehension, working memory, nonlinguistic reasoning, processing speed (a control variable), and foundational skill (arithmetic for WPs; word reading for text comprehension). In spring, they were assessed on WP-specific language comprehension, WPs, and text comprehension. Path analytic mediation analysis indicated that effects of general language comprehension on text comprehension were entirely direct, whereas effects of general language comprehension on WPs were partially mediated by WP-specific language. By contrast, effects of working memory and reasoning operated in parallel ways for both outcomes. PMID:25866461

A Quasi-Universal Nonword Repetition Task as a Diagnostic Tool for Bilingual Children Learning Dutch as a Second Language

ERIC Educational Resources Information Center

Boerma, Tessel; Chiat, Shula; Leseman, Paul; Timmermeister, Mona; Wijnen, Frank; Blom, Elma

2015-01-01

Purpose: This study evaluated a newly developed quasi-universal nonword repetition task (Q-U NWRT) as a diagnostic tool for bilingual children with language impairment (LI) who have Dutch as a 2nd language. The Q-U NWRT was designed to be minimally influenced by knowledge of 1 specific language in contrast to a language-specific NWRT with which it…

Theoretical foundations for information representation and constraint specification

NASA Technical Reports Server (NTRS)

Menzel, Christopher P.; Mayer, Richard J.

1991-01-01

Research accomplished at the Knowledge Based Systems Laboratory of the Department of Industrial Engineering at Texas A&M University is described. Outlined here are the theoretical foundations necessary to construct a Neutral Information Representation Scheme (NIRS), which will allow for automated data transfer and translation between model languages, procedural programming languages, database languages, transaction and process languages, and knowledge representation and reasoning control languages for information system specification.

The European Language Portfolio and Languages for Specific Purposes: A Project to Develop "Can Do" Descriptors Focused on Students' Interests and Motivation

ERIC Educational Resources Information Center

Gori, Federica

2014-01-01

Projects related to the European Language Portfolio (ELP) carried out at the Language Centre of the University of Trieste are concerned to examine whether and to what extent "can do" descriptors can be extended to courses in Languages for Specific Purposes. The project reported in this article had two aims. The first was to explore what…

Does the road go up the mountain? Fictive motion between linguistic conventions and cognitive motivations.

PubMed

Stosic, Dejan; Fagard, Benjamin; Sarda, Laure; Colin, Camille

2015-09-01

Fictive motion (FM) characterizes the use of dynamic expressions to describe static scenes. This phenomenon is crucial in terms of cognitive motivations for language use; several explanations have been proposed to account for it, among which mental simulation (Talmy in Toward a cognitive semantics, vol 1. MIT Press, Cambridge, 2000) and visual scanning (Matlock in Studies in linguistic motivation. Mouton de Gruyter, Berlin and New York, pp 221-248, 2004a). The aims of this paper were to test these competing explanations and identify language-specific constraints. To do this, we compared the linguistic strategies for expressing several types of static configurations in four languages, French, Italian, German and Serbian, with an experimental set-up (59 participants). The experiment yielded significant differences for motion-affordance versus no motion-affordance, for all four languages. Significant differences between languages included mean frequency of FM expressions. In order to refine the picture, and more specifically to disentangle the respective roles of language-specific conventions and language-independent (i.e. possibly cognitive) motivations, we completed our study with a corpus approach (besides the four initial languages, we added English and Polish). The corpus study showed low frequency of FM across languages, but a higher frequency and translation ratio for some FM types--among which those best accounted for by enactive perception. The importance of enactive perception could thus explain both the universality of FM and the fact that language-specific conventions appear mainly in very specific contexts--the ones furthest from enaction.

Decreasing the Burden of Side Effects Through Positive Message Framing: an Experimental Proof-of-Concept Study.

PubMed

Wilhelm, Marcel; Rief, Winfried; Doering, Bettina K

2018-05-21

Informing patients about treatment side effects increases the occurrence and intensity of side effects. Since the obligatory informed consent procedure in drug treatments requires transparency and nocebo research suggests that the informed consent of a drug leads to an increased occurrence of the mentioned side effects, the aim of this proof of concept study was to determine the effect of two different framings of informed consent on the occurrence, intensity, and perceived threat of side effects. Healthy male participants (n = 80) were randomized to one of two framing groups. The positive framing group was informed that the common side effect dizziness was a sign that the drug had started to work, while the neutral framing group was told that dizziness is an unpleasant but well-known side effect. Side effects were measured after the administration of metoprolol, an antihypertensive agent. Post hoc moderator analyses investigated the effect of pre-existing negative beliefs about the general harm of medication on the framing manipulation. Metoprolol-specific drug-attributed side effects were rated significantly less threatening in the positive framing group. The between-group effect size (Cohen's d) was small (d = 0.38, p = 0.049). Exploratory post hoc moderator analyses suggest that participants who believed that medication is a source of harmful effects benefited from positive framing, compared to neutral framing of drug-attributed side effects. Positive framing was partially effective in decreasing specific side effect measures, particularly among participants with a tendency to believe that medicine is harmful. Informed consent procedures should therefore be personalized, focusing on patients with negative treatment beliefs.

Solidify, An LLVM pass to compile LLVM IR into Solidity

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kothapalli, Abhiram

The software currently compiles LLVM IR into Solidity (Ethereum’s dominant programming language) using LLVM’s pass library. Specifically, his compiler allows us to convert an arbitrary DSL into Solidity. We focus specifically on converting Domain Specific Languages into Solidity due to their ease of use, and provable properties. By creating a toolchain to compile lightweight domain-specific languages into Ethereum's dominant language, Solidity, we allow non-specialists to effectively develop safe and useful smart contracts. For example lawyers from a certain firm can have a proprietary DSL that codifies basic laws safely converted to Solidity to be securely executed on the blockchain. Inmore » another example, a simple provenance tracking language can be compiled and securely executed on the blockchain.« less

The evolution of the Faculty of Language from a Chomskyan perspective: bridging linguistics and biology.

PubMed

Longa, Victor Manuel

2013-01-01

While language was traditionally considered a purely cultural trait, the advent of Noam Chomsky's Generative Grammar in the second half of the twentieth century dramatically challenged that view. According to that theory, language is an innate feature, part of the human biological endowment. If language is indeed innate, it had to biologically evolve. This review has two main objectives: firstly, it characterizes from a Chomskyan perspective the evolutionary processes by which language could have come into being. Secondly, it proposes a new method for interpreting the archaeological record that radically differs from the usual types of evidence Paleoanthropology has concentrated on when dealing with language evolution: while archaeological remains have usually been regarded from the view of the behavior they could be associated with, the paper will consider archaeological remains from the view of the computational processes and capabilities at work for their production. This computational approach, illustrated with a computational analysis of prehistoric geometric engravings, will be used to challenge the usual generative thinking on language evolution, based on the high specificity of language. The paper argues that the biological machinery of language is neither specifically linguistic nor specifically human, although language itself can still be considered a species-specific innate trait. From such a view, language would be one of the consequences of a slight modification operated on an ancestral architecture shared with vertebrates.

Long-range correlations and burstiness in written texts: Universal and language-specific aspects

NASA Astrophysics Data System (ADS)

Constantoudis, Vassilios; Kalimeri, Maria; Diakonos, Fotis; Karamanos, Konstantinos; Papadimitriou, Constantinos; Chatzigeorgiou, Manolis; Papageorgiou, Harris

2016-08-01

Recently, methods from the statistical physics of complex systems have been applied successfully to identify universal features in the long-range correlations (LRCs) of written texts. However, in real texts, these universal features are being intermingled with language-specific influences. This paper aims at the characterization and further understanding of the interplay between universal and language-specific effects on the LRCs in texts. To this end, we apply the language-sensitive mapping of written texts to word-length series (wls) and analyse large parallel (of same content) corpora from 10 languages classified to four families (Romanic, Germanic, Greek and Uralic). The autocorrelation functions of the wls reveal tiny but persistent LRCs decaying at large scales following a power-law with a language-independent exponent ˜0.60-0.65. The impact of language is displayed in the amplitude of correlations where a relative standard deviation >40% among the analyzed languages is observed. The classification to language families seems to play a significant role since, the Finnish and Germanic languages exhibit more correlations than the Greek and Roman families. To reveal the origins of the LRCs, we focus on the long words and perform burst and correlation analysis in their positions along the corpora. We find that the universal features are linked more to the correlations of the inter-long word distances while the language-specific aspects are related more to their distributions.

Subtlety of Ambient-Language Effects in Babbling: A Study of English- and Chinese-Learning Infants at 8, 10, and 12 Months

PubMed Central

Lee, Chia-Cheng; Jhang, Yuna; Chen, Li-mei; Relyea, George; Oller, D. Kimbrough

2016-01-01

Prior research on ambient-language effects in babbling has often suggested infants produce language-specific phonological features within the first year. These results have been questioned in research failing to find such effects and challenging the positive findings on methodological grounds. We studied English- and Chinese-learning infants at 8, 10, and 12 months and found listeners could not detect ambient-language effects in the vast majority of infant utterances, but only in items deemed to be words or to contain canonical syllables that may have made them sound like words with language-specific shapes. Thus, the present research suggests the earliest ambient-language effects may be found in emerging lexical items or in utterances influenced by language-specific features of lexical items. Even the ambient-language effects for infant canonical syllables and words were very small compared with ambient-language effects for meaningless but phonotactically well-formed syllable sequences spoken by adult native speakers of English and Chinese. PMID:28496393

Social media in adolescent health literacy education: a pilot study.

PubMed

Tse, Carrie Kw; Bridges, Susan M; Srinivasan, Divya Parthasarathy; Cheng, Brenda Ss

2015-03-09

While health literacy has gained notice on a global stage, the initial focus on seeking associations with medical conditions may have overlooked its impact across generations. Adolescent health literacy, specifically in dentistry, is an underexplored area despite the significance of this formative stage on an individual's approach to healthy lifestyles and behaviors. The aim is to conduct a pilot study to evaluate the efficacy of three major social media outlets - Twitter, Facebook, and YouTube - in supporting adolescents' oral health literacy (OHL) education. A random sample of 22 adolescents (aged 14-16 years) from an English-medium international school in Hong Kong provided informed consent. Sociodemographic information, including English language background, social media usage, and dental experience were collected via a questionnaire. A pre- and post-test of OHL (REALD-30) was administered by two trained, calibrated examiners. Following pre-test, participants were randomly assigned to one of three social media outlets: Twitter, Facebook, or YouTube. Participants received alerts posted daily for 5 consecutive days requiring online accessing of modified and original OHL education materials. One-way ANOVA ( analysis of variance) was used to compare the mean difference between the pre- and the post-test results among the three social media. No associations were found between the social media allocated and participants' sociodemographics, including English language background, social media usage, and dental experience. Of the three social media, significant differences in literacy assessment scores were evident for participants who received oral health education messages via Facebook (P=.02) and YouTube (P=.005). Based on the results of the pilot study, Facebook and YouTube may be more efficient media outlets for OHL promotion and education among adolescent school children when compared to Twitter. Further analyses with a larger study group is warranted.

Modality-specific processing precedes amodal linguistic processing during L2 sign language acquisition: A longitudinal study.

PubMed

Williams, Joshua T; Darcy, Isabelle; Newman, Sharlene D

2016-02-01

The present study tracked activation pattern differences in response to sign language processing by late hearing second language learners of American Sign Language. Learners were scanned before the start of their language courses. They were scanned again after their first semester of instruction and their second, for a total of 10 months of instruction. The study aimed to characterize modality-specific to modality-general processing throughout the acquisition of sign language. Results indicated that before the acquisition of sign language, neural substrates related to modality-specific processing were present. After approximately 45 h of instruction, the learners transitioned into processing signs on a phonological basis (e.g., supramarginal gyrus, putamen). After one more semester of input, learners transitioned once more to a lexico-semantic processing stage (e.g., left inferior frontal gyrus) at which language control mechanisms (e.g., left caudate, cingulate gyrus) were activated. During these transitional steps right hemispheric recruitment was observed, with increasing left-lateralization, which is similar to other native signers and L2 learners of spoken language; however, specialization for sign language processing with activation in the inferior parietal lobule (i.e., angular gyrus), even for late learners, was observed. As such, the present study is the first to track L2 acquisition of sign language learners in order to characterize modality-independent and modality-specific mechanisms for bilingual language processing. Copyright © 2015 Elsevier Ltd. All rights reserved.

The Romani Minority, Coercive Sterilization, and Languages of Denial in the Czech Lands

PubMed Central

2017-01-01

Abstract Sterilizations of Romani women in socialist Czechoslovakia, either carried out without proper consent, or coerced through substantial financial incentive, were first reported in 1978. Yet these practices did not end with the fall of communism, and it took until 2005 for this to be officially acknowledged by the Czech government. This article draws on published and unpublished documents, as well as oral history interviews, to trace the history of efforts to expose such practices, ‘come to terms’ with their existence, and change social attitudes in relation to the Romani minority in the Czech lands. These exposures have uncovered instances of denial, and have also offered up a variety of ways of understanding the mental and social mechanisms that might have enabled silences, refusals or disavowals with regard to human rights abuses. Under Communism, dissidents associated with Charter 77 elaborated these through the philosophical concepts of phenomenology; after the transition to democracy, a more psychological and therapeutic language came to the fore. I argue that the Czech case suggests that the historiography of denial and disavowal could be enriched by looking beyond the framework of psychoanalysis: by taking into account how historical actors, sometimes with opposing worldviews, have comprehended these processes within the languages of their own culture and period. PMID:29695946

[Multilingualism and child psychiatry: on differential diagnoses of language disorder, specific learning disorder, and selective mutism].

PubMed

Tamiya, Satoshi

2014-01-01

Multilingualism poses unique psychiatric problems, especially in the field of child psychiatry. The author discusses several linguistic and transcultural issues in relation to Language Disorder, Specific Learning Disorder and Selective Mutism. Linguistic characteristics of multiple language development, including so-called profile effects and code-switching, need to be understood for differential diagnosis. It is also emphasized that Language Disorder in a bilingual person is not different or worse than that in a monolingual person. Second language proficiency, cultural background and transfer from the first language all need to be considered in an evaluation for Specific Learning Disorder. Selective Mutism has to be differentiated from the silent period observed in the normal successive bilingual development. The author concludes the review by remarking on some caveats around methods of language evaluation in a multilingual person.

Language-Specific Developmental Differences in Speech Production: A Cross-Language Acoustic Study

ERIC Educational Resources Information Center

Li, Fangfang

2012-01-01

Speech productions of 40 English- and 40 Japanese-speaking children (aged 2-5) were examined and compared with the speech produced by 20 adult speakers (10 speakers per language). Participants were recorded while repeating words that began with "s" and "sh" sounds. Clear language-specific patterns in adults' speech were found,…

Markers for Persistent Specific Expressive Language Delay in 3-4-Year-Olds

ERIC Educational Resources Information Center

Everitt, Andrea; Hannaford, Philip; Conti-Ramsden, Gina

2013-01-01

Background: Identifying 3-4-year-olds who are most at risk of persisting language difficulties, and possibly specific language impairment (SLI), is difficult due to the natural variation of language in young children. In older children, markers for SLI have been identified that differentiate between children with and without SLI. It is not known…

Taxometric Analyses of Specific Language Impairment in 6-Year-Old Children

ERIC Educational Resources Information Center

Dollaghan, Christine A.

2011-01-01

Purpose: To determine whether language scores at age 6 years suggest that specific language impairments (SLIs) distribute in a categorical or in a dimensional fashion. Method: A taxometric analysis of language scores from 601 six-year-old children who were free of neonatal risk factors was performed. From among 4 candidate indicators of SLI, 2…

Past Tense Production in Children with and without Specific Language Impairment across Germanic Languages: A Meta-Analysis

ERIC Educational Resources Information Center

Krok, Windi C.; Leonard, Laurence B.

2015-01-01

Purpose: This study examined the extent to which children with specific language impairment (SLI) across Germanic languages differ from their typically developing (TD) peers in the use of past tense morphology. Method: A systematic literature search identified empirical studies examining regular and/or irregular past tense production by English…

The Faculty of Language: What's Special about It?

ERIC Educational Resources Information Center

Pinker, S.; Jackendoff, R.

2005-01-01

We examine the question of which aspects of language are uniquely human and uniquely linguistic in light of recent suggestions by Hauser, Chomsky, and Fitch that the only such aspect is syntactic recursion, the rest of language being either specific to humans but not to language (e.g. words and concepts) or not specific to humans (e.g. speech…

Analysis of Culture-Specific Items and Translation Strategies Applied in Translating Jalal Al-Ahmad's "By the Pen"

ERIC Educational Resources Information Center

Daghoughi, Shekoufeh; Hashemian, Mahmood

2016-01-01

Due to differences across languages, meanings and concepts vary across different languages, too. The most obvious points of difference between languages appear in their literature and their culture-specific items (CSIs), which lead to complexities when transferring meanings and concepts from one language into another. To overcome the complexities…

Interaction of Language Processing and Motor Skill in Children with Specific Language Impairment

ERIC Educational Resources Information Center

DiDonato Brumbach, Andrea C.; Goffman, Lisa

2014-01-01

Purpose: To examine how language production interacts with speech motor and gross and fine motor skill in children with specific language impairment (SLI). Method: Eleven children with SLI and 12 age-matched peers (4-6 years) produced structurally primed sentences containing particles and prepositions. Utterances were analyzed for errors and for…

A Preliminary Comparison of Reading Subtypes in a Clinical Sample of Children with Specific Language Impairment

ERIC Educational Resources Information Center

Werfel, Krystal L.; Krimm, Hannah

2017-01-01

Purpose: The purpose of this preliminary study was to (a) compare the pattern of reading subtypes among a clinical sample of children with specific language impairment (SLI) and children with typical language and (b) evaluate phonological and nonphonological language deficits within each reading impairment subtype. Method: Participants were 32…

The Prevalence of Autistic Spectrum Disorders in Adolescents with a History of Specific Language Impairment (SLI)

ERIC Educational Resources Information Center

Conti-Ramsden, Gina; Simkin, Zoe; Botting, Nicola

2006-01-01

Background: Traditionally, autism and specific language impairment (SLI) have been regarded as distinct disorders but, more recently, evidence has been put forward for a closer link between them: a common set of language problems, in particular receptive language difficulties and the existence of intermediate cases including pragmatic language…

Identification of Specific Language Impairment in Bilingual Children: I. Assessment in English

ERIC Educational Resources Information Center

Gillam, Ronald B.; Peña, Elizabeth D.; Bedore, Lisa M.; Bohman, Thomas M.; Mendez-Perez, Anita

2013-01-01

Purpose: This study was designed to derive cut scores for English testing for use in identifying specific language impairment (SLI) in bilingual children who were learning English as a second language. Method: In a 1-gate design, 167 children received comprehensive language assessments in English and Spanish during their first-grade year. The…

Using Principles of Learning to Inform Language Therapy Design for Children with Specific Language Impairment

ERIC Educational Resources Information Center

Alt, Mary; Meyers, Christina; Ancharski, Alexandra

2012-01-01

Background: Language treatment for children with specific language impairment (SLI) often takes months to achieve moderate results. Interventions often do not incorporate the principles that are known to affect learning in unimpaired learners. Aims: To outline some key findings about learning in typical populations and to suggest a model of how…

Specific Language Impairment (SLI) and Reading Development in Early School Years

ERIC Educational Resources Information Center

Isoaho, Pia; Kauppila, Timo; Launonen, Kaisa

2016-01-01

Specific language impairment (SLI) is a condition that affects children's emerging language skills. Many different language skills can be affected in SLI, but not all individuals with SLI have the same set of difficulties. As a result, SLI is a highly heterogeneous condition. The ability to read and understand written text is a higher function of…

Language-General and Language-Specific Influences on Children's Acquisition of Argument Structure: A Comparison of French and English

ERIC Educational Resources Information Center

Naigles, Letitia R.; Lehrer, Nadine

2002-01-01

This research investigates language-general and language-specific properties of the acquisition of argument structure. Ten French preschoolers enacted forty sentences containing motion verbs; sixteen sentences were ungrammatical in that the syntactic frame was incompatible with the standard argument structure for the verb (e.g. *"Le tigre va le…

Language Teachers' Target Language Project: Language for Specific Purposes of Language Teaching

ERIC Educational Resources Information Center

Korenev, Alexey; Westbrook, Carolyn; Merry, Yvonne; Ershova, Tatiana

2016-01-01

The Language Teachers' Target Language project (LTTL) aims to describe language teachers' target language use domain (Bachman & Palmer 2010) and to develop a language test for future teachers of English. The team comprises four researchers from Moscow State University (MSU) and Southampton Solent University.

25 CFR 39.137 - May schools operate a language development program without a specific appropriation from Congress?

Code of Federal Regulations, 2012 CFR

2012-04-01

... a specific appropriation from Congress? Yes, a school may operate a language development program... 25 Indians 1 2012-04-01 2011-04-01 true May schools operate a language development program without a specific appropriation from Congress? 39.137 Section 39.137 Indians BUREAU OF INDIAN AFFAIRS...

25 CFR 39.137 - May schools operate a language development program without a specific appropriation from Congress?

Code of Federal Regulations, 2013 CFR

2013-04-01

... a specific appropriation from Congress? Yes, a school may operate a language development program... 25 Indians 1 2013-04-01 2013-04-01 false May schools operate a language development program without a specific appropriation from Congress? 39.137 Section 39.137 Indians BUREAU OF INDIAN AFFAIRS...

25 CFR 39.137 - May schools operate a language development program without a specific appropriation from Congress?

Code of Federal Regulations, 2011 CFR

2011-04-01

... a specific appropriation from Congress? Yes, a school may operate a language development program... 25 Indians 1 2011-04-01 2011-04-01 false May schools operate a language development program without a specific appropriation from Congress? 39.137 Section 39.137 Indians BUREAU OF INDIAN AFFAIRS...

25 CFR 39.137 - May schools operate a language development program without a specific appropriation from Congress?

Code of Federal Regulations, 2014 CFR

2014-04-01

... a specific appropriation from Congress? Yes, a school may operate a language development program... 25 Indians 1 2014-04-01 2014-04-01 false May schools operate a language development program without a specific appropriation from Congress? 39.137 Section 39.137 Indians BUREAU OF INDIAN AFFAIRS...

Analogical reasoning in children with specific language impairment: Evidence from a scene analogy task.

PubMed

Krzemien, Magali; Jemel, Boutheina; Maillart, Christelle

2017-01-01

Analogical reasoning is a human ability that maps systems of relations. It develops along with relational knowledge, working memory and executive functions such as inhibition. It also maintains a mutual influence on language development. Some authors have taken a greater interest in the analogical reasoning ability of children with language disorders, specifically those with specific language impairment (SLI). These children apparently have weaker analogical reasoning abilities than their aged-matched peers without language disorders. Following cognitive theories of language acquisition, this deficit could be one of the causes of language disorders in SLI, especially those concerning productivity. To confirm this deficit and its link to language disorders, we use a scene analogy task to evaluate the analogical performance of SLI children and compare them to controls of the same age and linguistic abilities. Results show that children with SLI perform worse than age-matched peers, but similar to language-matched peers. They are more influenced by increased task difficulty. The association between language disorders and analogical reasoning in SLI can be confirmed. The hypothesis of limited processing capacity in SLI is also being considered.

Randomization to Standard and Concise Informed Consent Forms: Development of Evidence-Based Consent Practices

PubMed Central

Enama, Mary E.; Hu, Zonghui; Gordon, Ingelise; Costner, Pamela; Ledgerwood, Julie E.; Grady, Christine

2012-01-01

Background Consent to participate in research is an important component of the conduct of ethical clinical trials. Current consent practices are largely policy-driven. This study was conducted to assess comprehension of study information and satisfaction with the consent form between subjects randomized to concise or to standard informed consent forms as one approach to developing evidence-based consent practices. Methods Participants (N=111) who enrolled into two Phase I investigational influenza vaccine protocols (VRC 306 and VRC 307) at the NIH Clinical Center were randomized to one of two IRB-approved consents; either a standard or concise form. Concise consents had an average of 63% fewer words. All other aspects of the consent process were the same. Questionnaires about the study and the consent process were completed at enrollment and at the last visit in both studies. Results Subjects using concise consent forms scored as well as those using standard length consents in measures of comprehension (7 versus 7, p=0.79 and 20 versus 21, p=0.13), however, the trend was for the concise consent group to report feeling better informed. Both groups thought the length and detail of the consent form was appropriate. Conclusions Randomization of study subjects to different length IRB-approved consents forms as one method for developing evidence-based consent practices, resulted in no differences in study comprehension or satisfaction with the consent form. A concise consent form may be used ethically in the context of a consent process conducted by well-trained staff with opportunities for discussion and education throughout the study. PMID:22542645

Is Consent Based on Trust Morally Inferior to Consent Based on Information?

PubMed

Kongsholm, Nana Cecilie Halmsted; Kappel, Klemens

2017-07-01

Informed consent is considered by many to be a moral imperative in medical research. However, it is increasingly acknowledged that in many actual instances of consent to participation in medical research, participants do not employ the provided information in their decision to consent, but rather consent based on the trust they hold in the researcher or research enterprise. In this article we explore whether trust-based consent is morally inferior to information-based consent. We analyse the moral values essential to valid consent - autonomy, voluntariness, non-manipulation, and non-exploitation - and assess whether these values are less protected and promoted by consent based on trust than they are by consent based on information. We find that this is not the case, and thus conclude that trust-based consent if not morally inferior to information-based consent. © 2017 John Wiley & Sons Ltd.

King's Health Partners' Prostate Cancer Biobank (KHP PCaBB).

PubMed

Saifuddin, S R; Devlies, W; Santaolalla, A; Cahill, F; George, G; Enting, D; Rudman, S; Cathcart, P; Challacombe, B; Dasgupta, P; Galustian, C; Chandra, A; Chowdhury, S; Gillett, C; Van Hemelrijck, M

2017-11-22

The KHP PCaBB was established in 2013 and recruits donors from the Urology or Oncology Departments at Guy's Hospital in London (UK). Prostate cancer patients may be approached to give their consent for biobanking at any point in their treatment pathway, which allows residual material from their earlier diagnosis to be transferred and used by the Biobank. Currently, patients are specifically asked to donate samples of blood and surplus prostate tissue as well as permitting access to their clinical and pathological data that continues to be added throughout the course of their disease. Between 2013 and 2015, 549 prostate cancer patients gave their consent to the biobank and, the tissue repository collected 489 blood samples, 120 frozen prostate tissue samples and 1064 formalin fixed paraffin embedded diagnostic blocks.Prostate cancer has become a chronic disease in a large proportion of men, with many men receiving multiple subsequent treatments, and their treatment trajectory often spanning over decades. Therefore, this resource aims to provide an ideal research platform to explore potential variations in treatment response as well as disease markers in the different risk categories for prostate cancer.A recent audit of the KHP PCaBB revealed that between 2013 and 2015, 1796 patients were diagnosed with prostate cancer at King's Health Partners (KHP), out of which 549 (30.6%) gave their consent to KHP PCaBB. Comparisons between demographic and clinical characteristics of patients who had consented compared to the total patient population revealed that the KHP PCaBB is demographically representative of the total prostate cancer patient population seen in Guy's and St Thomas' NHS Foundation Trust (GSTT). We observed no differences in distribution of ethnicity (p = 0.507) and socioeconomic status (p = 0.097). Some differences were observed in clinical characteristics, specifically with treatment type - which differed significantly between the patients who had given consent and total patient population.The KHP PCaBB has thereby amassed a rich data and tissue repository that is largely reflective of both the demographic and clinical diversity within the total prostate cancer patient population seen at KHP, making it an ideal platform for prostate cancer research.

Patient and public attitudes towards informed consent models and levels of awareness of Electronic Health Records in the UK.

PubMed

Riordan, Fiona; Papoutsi, Chrysanthi; Reed, Julie E; Marston, Cicely; Bell, Derek; Majeed, Azeem

2015-04-01

The development of Electronic Health Records (EHRs) forms an integral part of the information strategy for the National Health Service (NHS) in the UK, with the aim of facilitating health information exchange for patient care and secondary use, including research and healthcare planning. Implementing EHR systems requires an understanding of patient expectations for consent mechanisms and consideration of public awareness towards information sharing as might be made possible through integrated EHRs across primary and secondary health providers. To explore levels of public awareness about EHRs and to examine attitudes towards different consent models with respect to sharing identifiable and de-identified records for healthcare provision, research and planning. A cross-sectional questionnaire survey was administered to adult patients and members of the public in primary and secondary care clinics in West London, UK in 2011. In total, 5331 individuals participated in the survey, and 3157 were included in the final analysis. The majority (91%) of respondents expected to be explicitly asked for consent for their identifiable records to be accessed for health provision, research or planning. Half the respondents (49%) did not expect to be asked for consent before their de-identified records were accessed. Compared with White British respondents, those from all other ethnic groups were more likely to anticipate their permission would be obtained before their de-identified records were used. Of the study population, 59% reported already being aware of EHRs before the survey. Older respondents and individuals with complex patterns of interaction with healthcare services were more likely to report prior awareness of EHRs. Individuals self-identifying as belonging to ethnic groups other than White British, and those with lower educational qualifications were less likely to report being aware of EHRs than White British respondents and respondents with degree-level education, respectively. Those who reported being aware of EHRs were less likely to say they expected explicit consent to be sought before use of their de-identified record. A large number of patients remain unaware of EHRs, while preference for implicit consent is stronger among those who report previous awareness. Differences in awareness levels and consent expectations between groups with different socio-demographic characteristics suggest that public education and information campaigns should target specific groups to increase public awareness and ensure meaningful informed consent mechanisms. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Is recursion language-specific? Evidence of recursive mechanisms in the structure of intentional action.

PubMed

Vicari, Giuseppe; Adenzato, Mauro

2014-05-01

In their 2002 seminal paper Hauser, Chomsky and Fitch hypothesize that recursion is the only human-specific and language-specific mechanism of the faculty of language. While debate focused primarily on the meaning of recursion in the hypothesis and on the human-specific and syntax-specific character of recursion, the present work focuses on the claim that recursion is language-specific. We argue that there are recursive structures in the domain of motor intentionality by way of extending John R. Searle's analysis of intentional action. We then discuss evidence from cognitive science and neuroscience supporting the claim that motor-intentional recursion is language-independent and suggest some explanatory hypotheses: (1) linguistic recursion is embodied in sensory-motor processing; (2) linguistic and motor-intentional recursions are distinct and mutually independent mechanisms. Finally, we propose some reflections about the epistemic status of HCF as presenting an empirically falsifiable hypothesis, and on the possibility of testing recursion in different cognitive domains. Copyright © 2014 Elsevier Inc. All rights reserved.

NASA software specification and evaluation system design, part 1

NASA Technical Reports Server (NTRS)

1976-01-01

The research to develop methods for reducing the effort expended in software and verification is reported. The development of a formal software requirements methodology, a formal specifications language, a programming language, a language preprocessor, and code analysis tools are discussed.

A Quasi-Universal Nonword Repetition Task as a Diagnostic Tool for Bilingual Children Learning Dutch as a Second Language.

PubMed

Boerma, Tessel; Chiat, Shula; Leseman, Paul; Timmermeister, Mona; Wijnen, Frank; Blom, Elma

2015-12-01

This study evaluated a newly developed quasi-universal nonword repetition task (Q-U NWRT) as a diagnostic tool for bilingual children with language impairment (LI) who have Dutch as a 2nd language. The Q-U NWRT was designed to be minimally influenced by knowledge of 1 specific language in contrast to a language-specific NWRT with which it was compared. One hundred twenty monolingual and bilingual children with and without LI participated (30 per group). A mixed-design analysis of variance was used to investigate the effects of LI and bilingualism on the NWRTs. Receiver operating characteristic analyses were conducted to evaluate the instruments' diagnostic value. Large negative effects of LI were found on both NWRTs, whereas negative effects of bilingualism only occurred on the language-specific NWRT. Both instruments had high clinical accuracy in the monolingual group, but only the Q-U NWRT had high clinical accuracy in the bilingual group. This study indicates that the Q-U NWRT is a promising diagnostic tool to help identify LI in bilingual children learning Dutch as a 2nd language. The instrument was clinically accurate in both a monolingual and bilingual group of children and seems better able to disentangle LI from language disadvantage than more language-specific measures.

Brain responses in 4-month-old infants are already language specific.

PubMed

Friederici, Angela D; Friedrich, Manuela; Christophe, Anne

2007-07-17

Language is the most important faculty that distinguishes humans from other animals. Infants learn their native language fast and effortlessly during the first years of life, as a function of the linguistic input in their environment. Behavioral studies reported the discrimination of melodic contours [1] and stress patterns [2, 3] in 1-4-month-olds. Behavioral [4, 5] and brain measures [6-8] have shown language-independent discrimination of phonetic contrasts at that age. Language-specific discrimination, however, has been reported for phonetic contrasts only for 6-12-month-olds [9-12]. Here we demonstrate language-specific discrimination of stress patterns in 4-month-old German and French infants by using electrophysiological brain measures. We compare the processing of disyllabic words differing in their rhythmic structure, mimicking German words being stressed on the first syllable, e.g., pápa/daddy[13], and French ones being stressed on the second syllable, e.g., papá/daddy. Event-related brain potentials reveal that experience with German and French differentially affects the brain responses of 4-month-old infants, with each language group displaying a processing advantage for the rhythmic structure typical in its native language. These data indicate language-specific neural representations of word forms in the infant brain as early as 4 months of age.

The PlusCal Algorithm Language

NASA Astrophysics Data System (ADS)

Lamport, Leslie

Algorithms are different from programs and should not be described with programming languages. The only simple alternative to programming languages has been pseudo-code. PlusCal is an algorithm language that can be used right now to replace pseudo-code, for both sequential and concurrent algorithms. It is based on the TLA + specification language, and a PlusCal algorithm is automatically translated to a TLA + specification that can be checked with the TLC model checker and reasoned about formally.

Imitation of Body Postures and Hand Movements in Children with Specific Language Impairment

ERIC Educational Resources Information Center

Marton, Klara

2009-01-01

Within the domain-general theory of language impairment, this study examined body posture and hand movement imitation in children with specific language impairment (SLI) and in their age-matched peers. Participants included 40 children with SLI (5 years 3 months to 6 years 10 months of age) and 40 children with typical language development (5…

The Roles of Cognitive and Language Abilities in Predicting Decoding and Reading Comprehension: Comparisons of Dyslexia and Specific Language Impairment

ERIC Educational Resources Information Center

Lauterbach, Alexandra A.; Park, Yujeong; Lombardino, Linda J.

2017-01-01

This study aimed to (a) explore the roles of cognitive and language variables in predicting reading abilities of two groups of individuals with reading disabilities (i.e., dyslexia and specific language impairment) and (b) examine which variable(s) is the most predictive in differentiating two groups. Inclusion/exclusion criteria applied to…

A Developmental Shift from Similar to Language-Specific Strategies in Verb Acquisition: A Comparison of English, Spanish, and Japanese

ERIC Educational Resources Information Center

Maguire, Mandy J.; Hirsh-Pasek, Kathy; Golinkoff, Roberta Michnick; Imai, Mutsumi; Haryu, Etsuko; Vanegas, Sandra; Okada, Hiroyuki; Pulverman, Rachel; Sanchez-Davis, Brenda

2010-01-01

The world's languages draw on a common set of event components for their verb systems. Yet, these components are differentially distributed across languages. At what age do children begin to use language-specific patterns to narrow possible verb meanings? English-, Japanese-, and Spanish-speaking adults, toddlers, and preschoolers were shown…

Educational and Interpersonal Uses of Home Computers by Adolescents with and without Specific Language Impairment

ERIC Educational Resources Information Center

Durkin, Kevin; Conti-Ramsden, Gina; Walker, Allan; Simkin, Zoe

2009-01-01

Many uses of new media entail processing language content, yet little is known about the relationship between language ability and media use in young people. This study compares educational versus interpersonal uses of home computers in adolescents with and without a history of specific language impairment (SLI). Participants were 55 17-year-olds…

Grammatical Tense Deficits in Children with Specific Language Impairment (SLI) and Nonspecific Language Impairment: Relationships with Nonverbal IQ over Time

ERIC Educational Resources Information Center

Rice, Mabel L.; Tomblin, J. Bruce; Hoffman, Lesa; Richman, W. Allen; Marquis, Janet

2004-01-01

The relationship between children's language acquisition and their nonverbal intelligence has a long tradition of scientific inquiry. Current attention focuses on the use of nonverbal IQ level as an exclusionary criterion in the definition of specific language impairment (SLI). Grammatical tense deficits are known as a clinical marker of SLI, but…

Screening for Specific Language Impairment in Preschool Children: Evaluating a Screening Procedure Including the Token Test

ERIC Educational Resources Information Center

Willinger, Ulrike; Schmoeger, Michaela; Deckert, Matthias; Eisenwort, Brigitte; Loader, Benjamin; Hofmair, Annemarie; Auff, Eduard

2017-01-01

Specific language impairment (SLI) comprises impairments in receptive and/or expressive language. Aim of this study was to evaluate a screening for SLI. 61 children with SLI (SLI-children, age-range 4-6 years) and 61 matched typically developing controls were tested for receptive language ability (Token Test-TT) and for intelligence (Wechsler…

Conflict resolution abilities in children with Specific Language Impairment.

PubMed

Paula, Erica Macêdo de; Befi-Lopes, Debora Maria

2013-01-01

To investigate the conflict resolution abilities of children with Specific Language Impairment, and to verify whether the time of speech-language therapy correlates to the performance on the conflict resolution task. Participants included 20 children with Specific Language Impairment (Research Group) and 40 children with normal language development (Control Group), with ages ranging from 7 years to 8 years and 11 months. To assess the conflict resolution abilities, five hypothetical contexts of conflict were presented. The strategies used by the children were classified and scored by the following levels: level 0 (solutions that do not match the other levels), level 1 (physical solutions), level 2 (unilateral solutions), level 3 (cooperative solutions), and level 4 (mutual solutions). Statistical analysis showed group effect for the variable total score. There was a difference between the groups for modal development level, with higher level of modal development observed in the Control Group. There was no correlation between the period of speech-language therapy attendance and the total score. Children with Specific Language Impairment present difficulties in solving problems, in view of the fact that they mainly use physical and unilateral strategies. There was no correlation between the time of speech-language therapy and performance in the task.

Development and pilot testing of an informed consent video for patients with limb trauma prior to debridement surgery using a modified Delphi technique.

PubMed

Lin, Yen-Ko; Chen, Chao-Wen; Lee, Wei-Che; Lin, Tsung-Ying; Kuo, Liang-Chi; Lin, Chia-Ju; Shi, Leiyu; Tien, Yin-Chun; Cheng, Yuan-Chia

2017-11-29

Ensuring adequate informed consent for surgery in a trauma setting is challenging. We developed and pilot tested an educational video containing information regarding the informed consent process for surgery in trauma patients and a knowledge measure instrument and evaluated whether the audiovisual presentation improved the patients' knowledge regarding their procedure and aftercare and their satisfaction with the informed consent process. A modified Delphi technique in which a panel of experts participated in successive rounds of shared scoring of items to forecast outcomes was applied to reach a consensus among the experts. The resulting consensus was used to develop the video content and questions for measuring the understanding of the informed consent for debridement surgery in limb trauma patients. The expert panel included experienced patients. The participants in this pilot study were enrolled as a convenience sample of adult trauma patients scheduled to receive surgery. The modified Delphi technique comprised three rounds over a 4-month period. The items given higher scores by the experts in several categories were chosen for the subsequent rounds until consensus was reached. The experts reached a consensus on each item after the three-round process. The final knowledge measure comprising 10 questions was developed and validated. Thirty eligible trauma patients presenting to the Emergency Department (ED) were approached and completed the questionnaires in this pilot study. The participants exhibited significantly higher mean knowledge and satisfaction scores after watching the educational video than before watching the video. Our process is promising for developing procedure-specific informed consent and audiovisual aids in medical and surgical specialties. The educational video was developed using a scientific method that integrated the opinions of different stakeholders, particularly patients. This video is a useful tool for improving the knowledge and satisfaction of trauma patients in the ED. The modified Delphi technique is an effective method for collecting experts' opinions and reaching a consensus on the content of educational materials for informed consent. Institutions should prioritize patient-centered health care and develop a structured informed consent process to improve the quality of care. The ClinicalTrials.gov Identifier is NCT01338480 . The date of registration was April 18, 2011 (retrospectively registered).

Diagnostic Accuracy of Repetition Tasks for the Identification of Specific Language Impairment (SLI) in Bilingual Children: Evidence from Russian and Hebrew

ERIC Educational Resources Information Center

Armon-Lotem, Sharon; Meir, Natalia

2016-01-01

Background: Previous research demonstrates that repetition tasks are valuable tools for diagnosing specific language impairment (SLI) in monolingual children in English and a variety of other languages, with non-word repetition (NWR) and sentence repetition (SRep) yielding high levels of sensitivity and specificity. Yet, only a few studies have…

Constructing an ethical framework for embryo donation to research: is it time for a restricted consent policy?

PubMed

Ehrich, Kathryn; Farsides, Bobbie; Williams, Clare; Scott, Rosamund

2011-06-01

An Ethics & Policy Workshop was held with 20 invited UK stakeholders to consider whether embryo donors should be able to restrict the future use of human embryonic stem cells (hESCs) created from their embryos. Participants cited tensions between pure altruism and a more reciprocal basis for donation; and between basic research (in which genetic material would never form part of another living being) and treatment applications. Two restriction models were suggested to acknowledge specific ethical issues raised by hESCs' use in research and treatments: (1) a two tier system: hESCs with unrestricted consent could go to the UK Stem Cell Bank; those with restricted consent could be used in individual labs which could guarantee to honour the restrictions, and Bank deposit would not be required. (2) a three category system: restrictions could include (i) basic hESC research; (ii) hESC research and treatment; no gamete derivation (iii) 'unrestricted' hESC research and treatment.

Placebo Effects and Informed Consent.

PubMed

Alfano, Mark

2015-01-01

The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. Obtaining informed consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice.

The Legal Implications of Report Back in Household Exposure Studies

PubMed Central

Goho, Shaun A.

2016-01-01

Background: Scientists conducting research into household air or dust pollution must decide whether, when, and how to disclose to study participants their individual results. A variety of considerations factor into this decision, but one factor that has not received attention until now is the possibility that study participants’ receipt of their results might create legal duties under environmental, property, landlord–tenant, or other laws. Objectives: This article examines relevant laws and regulations and explores the scope of participants’ legal duties and the resulting legal and ethical consequences for researchers. Participants could be required in some situations to disclose the presence of certain chemicals when selling or renting their homes or to frequent visitors. The article discusses hypothetical case studies involving the reporting back of results regarding lead, polychlorinated biphenyls, and phthalates. Discussion: The potential legal duties of study participants have both ethical and legal implications for researchers. Issues include whether the legal consequences for participants should affect the decision whether to report back individual results, how researchers should disclose the legal risks to participants during the informed consent process, and whether researchers would be liable to study participants for legal or economic harm arising from reporting study results to them. The review provides recommendations for language that researchers could use in the informed consent process to disclose the legal risks. Conclusions: Researchers should still report back to participants who want to see their results, but they should disclose the risks of obtaining the information as part of the informed consent process. Citation: Goho SA. 2016. The legal implications of report back in household exposure studies. Environ Health Perspect 124:1662–1670; http://dx.doi.org/10.1289/EHP187 PMID:27153111

The Legal Implications of Report Back in Household Exposure Studies.

PubMed

Goho, Shaun A

2016-11-01

Scientists conducting research into household air or dust pollution must decide whether, when, and how to disclose to study participants their individual results. A variety of considerations factor into this decision, but one factor that has not received attention until now is the possibility that study participants' receipt of their results might create legal duties under environmental, property, landlord-tenant, or other laws. This article examines relevant laws and regulations and explores the scope of participants' legal duties and the resulting legal and ethical consequences for researchers. Participants could be required in some situations to disclose the presence of certain chemicals when selling or renting their homes or to frequent visitors. The article discusses hypothetical case studies involving the reporting back of results regarding lead, polychlorinated biphenyls, and phthalates. The potential legal duties of study participants have both ethical and legal implications for researchers. Issues include whether the legal consequences for participants should affect the decision whether to report back individual results, how researchers should disclose the legal risks to participants during the informed consent process, and whether researchers would be liable to study participants for legal or economic harm arising from reporting study results to them. The review provides recommendations for language that researchers could use in the informed consent process to disclose the legal risks. Researchers should still report back to participants who want to see their results, but they should disclose the risks of obtaining the information as part of the informed consent process. Citation: Goho SA. 2016. The legal implications of report back in household exposure studies. Environ Health Perspect 124:1662-1670; http://dx.doi.org/10.1289/EHP187.

The under reporting of recruitment strategies in research with children with life-threatening illnesses: A systematic review

PubMed Central

Hudson, Briony F; Oostendorp, Linda JM; Candy, Bridget; Vickerstaff, Victoria; Jones, Louise; Lakhanpaul, Monica; Bluebond-Langner, Myra; Stone, Paddy

2016-01-01

Background: Researchers report difficulties in conducting research with children and young people with life-limiting conditions or life-threatening illnesses and their families. Recruitment is challenged by barriers including ethical, logistical and clinical considerations. Aim: To explore how children and young people (aged 0–25 years) with life-limiting conditions or life-threatening illnesses and their families were identified, invited and consented to research published in the last 5 years. Design: Systematic review. Data sources: MEDLINE, PsycINFO, Web of Science, Sciences Citation Index and SCOPUS were searched for original English language research published between 2009 and 2014, recruiting children and young people with life-limiting conditions or life-threatening illness and their families. Results: A total of 215 studies – 152 qualitative, 54 quantitative and 9 mixed methods – were included. Limited recruitment information but a range of strategies and difficulties were provided. The proportion of eligible participants from those screened could not be calculated in 80% of studies. Recruitment rates could not be calculated in 77%. A total of 31% of studies recruited less than 50% of eligible participants. Reasons given for non-invitation included missing clinical or contact data, or clinician judgements of participant unsuitability. Reasons for non-participation included lack of interest and participants’ perceptions of potential burdens. Conclusion: All stages of recruitment were under reported. Transparency in reporting of participant identification, invitation and consent is needed to enable researchers to understand research implications, bias risk and to whom results apply. Research is needed to explore why consenting participants decide to take part or not and their experiences of research recruitment. PMID:27609607

Returning to Paid Employment after Stroke: The Psychosocial Outcomes In StrokE (POISE) Cohort Study

PubMed Central

Hackett, Maree L.; Glozier, Nick; Jan, Stephen; Lindley, Richard

2012-01-01

Objectives To determine which early modifiable factors are associated with younger stroke survivors' ability to return to paid work in a cohort study with 12-months of follow-up conducted in 20 stroke units in the Stroke Services NSW clinical network. Participants Were aged >17 and <65 years, recent (within 28 days) stroke, able to speak English sufficiently to respond to study questions, and able to provide written informed consent. Participants with language or cognitive impairment were eligible to participate if their proxy provided consent and completed assessments on the participants' behalf. The main outcome measure was return to paid work during the 12 months following stroke. Results Of 441 consented participants (average age 52 years, 68% male, 83% with ischemic stroke), 218 were in paid full-time and 53 in paid part-time work immediately before their stroke, of whom 202 (75%) returned to paid part- or full-time work within 12 months. Being male, female without a prior activity restricting illness, younger, independent in activities of daily living (ADL) at 28 days after stroke, and having private health insurance was associated with return to paid work, following adjustment for other illnesses and a history of depression before stroke (C statistic 0·81). Work stress and post stroke depression showed no such independent association. Conclusions Given that independence in ADL is the strongest predictor of return to paid work within 12 months of stroke, these data reinforce the importance of reducing stroke-related disability and increasing independence for younger stroke survivors. Trial Registration Australian New Zealand Clinical Trials Registry ANZCTRN 12608000459325 PMID:22848610

Neurocomputational Consequences of Evolutionary Connectivity Changes in Perisylvian Language Cortex.

PubMed

Schomers, Malte R; Garagnani, Max; Pulvermüller, Friedemann

2017-03-15

The human brain sets itself apart from that of its primate relatives by specific neuroanatomical features, especially the strong linkage of left perisylvian language areas (frontal and temporal cortex) by way of the arcuate fasciculus (AF). AF connectivity has been shown to correlate with verbal working memory-a specifically human trait providing the foundation for language abilities-but a mechanistic explanation of any related causal link between anatomical structure and cognitive function is still missing. Here, we provide a possible explanation and link, by using neurocomputational simulations in neuroanatomically structured models of the perisylvian language cortex. We compare networks mimicking key features of cortical connectivity in monkeys and humans, specifically the presence of relatively stronger higher-order "jumping links" between nonadjacent perisylvian cortical areas in the latter, and demonstrate that the emergence of working memory for syllables and word forms is a functional consequence of this structural evolutionary change. We also show that a mere increase of learning time is not sufficient, but that this specific structural feature, which entails higher connectivity degree of relevant areas and shorter sensorimotor path length, is crucial. These results offer a better understanding of specifically human anatomical features underlying the language faculty and their evolutionary selection advantage. SIGNIFICANCE STATEMENT Why do humans have superior language abilities compared to primates? Recently, a uniquely human neuroanatomical feature has been demonstrated in the strength of the arcuate fasciculus (AF), a fiber pathway interlinking the left-hemispheric language areas. Although AF anatomy has been related to linguistic skills, an explanation of how this fiber bundle may support language abilities is still missing. We use neuroanatomically structured computational models to investigate the consequences of evolutionary changes in language area connectivity and demonstrate that the human-specific higher connectivity degree and comparatively shorter sensorimotor path length implicated by the AF entail emergence of verbal working memory, a prerequisite for language learning. These results offer a better understanding of specifically human anatomical features for language and their evolutionary selection advantage. Copyright © 2017 Schomers et al.

The relationship between mathematics and language: academic implications for children with specific language impairment and English language learners.

PubMed

Alt, Mary; Arizmendi, Genesis D; Beal, Carole R

2014-07-01

The present study examined the relationship between mathematics and language to better understand the nature of the deficit and the academic implications associated with specific language impairment (SLI) and academic implications for English language learners (ELLs). School-age children (N = 61; 20 SLI, 20 ELL, 21 native monolingual English [NE]) were assessed using a norm-referenced mathematics instrument and 3 experimental computer-based mathematics games that varied in language demands. Group means were compared with analyses of variance. The ELL group was less accurate than the NE group only when tasks were language heavy. In contrast, the group with SLI was less accurate than the groups with NE and ELLs on language-heavy tasks and some language-light tasks. Specifically, the group with SLI was less accurate on tasks that involved comparing numerical symbols and using visual working memory for patterns. However, there were no group differences between children with SLI and peers without SLI on language-light mathematics tasks that involved visual working memory for numerical symbols. Mathematical difficulties of children who are ELLs appear to be related to the language demands of mathematics tasks. In contrast, children with SLI appear to have difficulty with mathematics tasks because of linguistic as well as nonlinguistic processing constraints.

42 CFR 486.346 - Condition: Organ preparation and transport.

Code of Federal Regulations, 2010 CFR

2010-10-01

... with the identification number, specific contents, and donor's blood type. ... complete documentation of donor information to the transplant center with the organ, including donor evaluation, the complete record of the donor's management, documentation of consent, documentation of the...

Impact of an educational video as a consent tool on knowledge about cure research among patients and caregivers at HIV clinics in South Africa.

PubMed

Hendricks, Melany; Nair, Gonasagrie; Staunton, Ciara; Pather, Michael; Garrett, Nigel; Baadjies, Dianno; Kidd, Martin; Moodley, Keymanthri

2018-04-01

Despite increasing access to antiretroviral therapy in low- and middle-income countries, only 54% of eligible individuals were receiving treatment in Africa by 2015. Recent developments in HIV cure research have been encouraging. However, the complex science and procedures of cure research render the informed consent process challenging. This study evaluates the impact of a video tool on educating participants about HIV cure. A questionnaire assessing the content of the video was administered to adults recruited from two clinics in South Africa. Patients and their care partners, who provided voluntary informed consent, were included in the study. The questionnaire was administered in each participant's home language before, immediately after and at 3 months after viewing the video, in an uncontrolled quasi-experimental 'one group pre-test-post-test' design. Scoring was carried out according to a predetermined scoring grid, with a maximum score of 22. A total of 88 participants, median age 32.0 years and 86% female, were enrolled and completed the pre- and post-video questionnaires. Twenty-nine (33%) completed the follow-up questionnaire 3 months later to assess retention of knowledge. Sixty-three (72%) participants had a known HIV-positive status. A significant increase (10.1 vs 15.1, P =0.001) in knowledge about HIV and HIV cure immediately after viewing the video was noted. No statistically significant difference in knowledge between HIV-positive and -negative patients was noted at baseline. After 3 months, a decrease in performance participation (14 vs 13.5, P =0.19) was noted. However, knowledge scores achieved after 3 months remained significantly higher than scores at baseline (13.5 vs 9.5, P <0.01). This research showed that a video intervention improved participants' knowledge related to HIV, HIV cure research and ethics, and the improvement was sustained over 3 months. Video intervention may be a useful tool to add to the consent process when dealing with complex medical research questions.

Saudi views on consenting for research on medical records and leftover tissue samples

PubMed Central

2010-01-01

Background Consenting for retrospective medical records-based research (MR) and leftover tissue-based research (TR) continues to be controversial. Our objective was to survey Saudis attending outpatient clinics at a tertiary care hospital on their personal preference and perceptions of norm and current practice in relation to consenting for MR and TR. Methods We surveyed 528 Saudis attending clinics at a tertiary care hospital in Saudi Arabia to explore their preferences and perceptions of norm and current practice. The respondents selected one of 7 options from each of 6 questionnaires. Results Respondents' mean (SD) age was 33 (11) years, 42% were males, 56% were patients, 84% had ≥ secondary school education, and 10% had previously volunteered for research. Respectively, 40% and 49% perceived that the norm is to conduct MR and TR without consent and 38% and 37% with general or proposal-specific consent; the rest objected to such research. There was significant difference in the distribution of choices according to health status (patients vs. companions) for MR (adjusted Kruskal-Wallis test P = 0.03) but not to age group, gender, education level, or previous participation in research (unadjusted P = 0.02 - 0.59). The distributions of perceptions of current practice and norm were similar (unadjusted Marginal Homogeneity test P = 0.44 for MR and P = 0.89 for TR), whereas the distributions of preferences and perceptions of norm were different (adjusted P = 0.09 for MR and P = 0.02 for TR). The distributions of perceptions of norm, preferences, and perceptions of current practice for MR were significantly different from those of TR (adjusted P < 0.009 for all). Conclusions We conclude that: 1) there is a considerable diversity among Saudi views regarding consenting for retrospective research which may be related to health status, 2) the distribution of perceptions of norm was similar to the distribution of perceptions of current practice but different from that of preferences, and 3) MR and TR are perceived differently in regard to consenting. PMID:20955580

Reference manual for a Requirements Specification Language (RSL), version 2.0

NASA Technical Reports Server (NTRS)

Fisher, Gene L.; Cohen, Gerald C.

1993-01-01

This report is a Reference Manual for a general-purpose Requirements Specification Language, RSL. The purpose of RSL is to specify precisely the external structure of a mechanized system and to define requirements that the system must meet. A system can be comprised of a mixture of hardware, software, and human processing elements. RSL is a hybrid of features found in several popular requirements specification languages and includes constructs for formal mathematical specification.

Informed consent for clinical trials of deep brain stimulation in psychiatric disease: challenges and implications for trial design.

PubMed

Lipsman, Nir; Giacobbe, Peter; Bernstein, Mark; Lozano, Andres M

2012-02-01

Advances in neuromodulation and an improved understanding of the anatomy and circuitry of psychopathology have led to a resurgence of interest in surgery for psychiatric disease. Clinical trials exploring deep brain stimulation (DBS), a focally targeted, adjustable and reversible form of neurosurgery, are being developed to address the use of this technology in highly selected patient populations. Psychiatric patients deemed eligible for surgical intervention, such as DBS, typically meet stringent inclusion criteria, including demonstrated severity, chronicity and a failure of conventional therapy. Although a humanitarian device exemption by the US Food and Drug Administration exists for its use in obsessive-compulsive disorder, DBS remains a largely experimental treatment in the psychiatric context, with its use currently limited to clinical trials and investigative studies. The combination of a patient population at the limits of conventional therapy and a novel technology in a new indication poses interesting challenges to the informed consent process as it relates to clinical trial enrollment. These challenges can be divided into those that relate to the patient, their disease and the technology, with each illustrating how traditional conceptualisations of research consent may be inadequate in the surgical psychiatry context. With specific reference to risk analysis, patient autonomy, voluntariness and the duty of the clinician-researcher, this paper will discuss the unique challenges that clinical trials of surgery for refractory psychiatric disease present to the consent process. Recommendations are also made for an ethical approach to clinical trial consent acquisition in this unique patient population.

T.D. v. New York State Office of Mental Health.

PubMed

1995-02-28

The New York Supreme Court for New York County determined that a state regulation allowing substituted consent to research on mentally ill individuals by a spouse, parent, adult child or sibling, guardian, or authorized committee did not apply to nonfederally funded research. The court was asked by a group of involuntary state mental patients to decide on the validity of state regulations concerning participation in potentially high risk experimentation without consent. The patients, who were incapable of giving informed consent, claimed that their right to refuse treatment based on autonomy, privacy, due process, and equal protection was violated by provisions allowing substituted consent by third party decision makers. The court interpreted federal regulations on research and state regulations on public health and mental health as they applied to both federally funded and nonfederally funded, possibly therapeutic and nontherapeutic, research using non-FDA approved psychotropic drugs that could cause stroke, heart attack, convulsions, hallucinations, or death. The court found first, that the state mental health regulations covered the care, treatment, and rehabilitation of the mentally ill generally; second, that the state public health regulations specifically governed research on human subjects; and third, that the federal regulations controlled federally funded research unless state or local law provides additional protection. But in this case the state public health regulations did not apply to the federally funded research due to an exemption by the state legislature, but did apply to the nonfederally funded research, because not all the federal requirements had been met. The state mental health regulation on substituted consent was enacted without authority and thus was found to be invalid.

Clinical Research Involving Minors in International and Serbian Regulations

PubMed Central

PLANOJEVIĆ, Nina; ŽIVOJINOVIĆ, Dragica

2013-01-01

Background: Participation in clinical trials can be useful for the health of a person, in who it is conducted, but it does not have to be – it can even be harmful. Therefore, primary motive to accept such risk is humanity and human wish to contribute to the progress of medicine; this is expressed by personal consent. The consent, however, can be an expression of personal humanity, and for this, it is not logical that someone can give consent on behalf of someone else, as it is done by a legally authorized representative on behalf of a minor. Therefore, authors raise 3 questions: What are the reasons to consider representative’s consent acceptable? How should a model of regulations look like in order to provide the most complete possible protection to a minor? Is actual regulation of minors’ position within international and Serbian law, analyzed here by authors for their specific solutions, acceptable? Representative’s consent is acceptable only for therapeutic research, because these can bring benefits to everyone’s health, including a minor in which those are conducted – this is an acceptable (secondary) motive of participation in the research. Expression of humanity on other’s behalf, typical for non-therapeutic research, is not acceptable; this makes ban of minors’ participation in non-therapeutic research more appropriate regulation model. International regulations are not in accordance to results presented in the paper for allowing participation of minors both in therapeutic and non-therapeutic research. Serbian regulation is closer to the most acceptable regulation model. PMID:24455493

Individual characteristics of language learners in lesson planning for specific purposes

NASA Astrophysics Data System (ADS)

Ivleva, N. V.

2016-04-01

This paper provides a summary of internationally recognized methods and approaches in teaching foreign languages with the focus on teaching foreign languages for specific purposes. It also covers the idea of mastering a foreign language through knowing speech units which are necessary for individual language learners in the professional area with due regard to criteria provided by the author. The criteria were developed on the basis of the theory on adaptation of complex systems and also observation in the teaching process.

Language and the Law.

ERIC Educational Resources Information Center

Gibbons, John

1999-01-01

Discusses the language of law and its general interest to the field of applied linguistics. Specific focus is on legal language, the problems and remedies of legal communication (e.g., language and disadvantage before the law, improving legal communication) the legislation of language (e.g., language rights, language crimes), and forensic…

Speech Perception and Phonological Short-Term Memory Capacity in Language Impairment: Preliminary Evidence from Adolescents with Specific Language Impairment (SLI) and Autism Spectrum Disorders (ASD)

ERIC Educational Resources Information Center

Loucas, Tom; Riches, Nick Greatorex; Charman, Tony; Pickles, Andrew; Simonoff, Emily; Chandler, Susie; Baird, Gillian

2010-01-01

Background: The cognitive bases of language impairment in specific language impairment (SLI) and autism spectrum disorders (ASD) were investigated in a novel non-word comparison task which manipulated phonological short-term memory (PSTM) and speech perception, both implicated in poor non-word repetition. Aims: This study aimed to investigate the…

Compiler writing system detail design specification. Volume 2: Component specification

NASA Technical Reports Server (NTRS)

Arthur, W. J.

1974-01-01

The logic modules and data structures composing the Meta-translator module are desribed. This module is responsible for the actual generation of the executable language compiler as a function of the input Meta-language. Machine definitions are also processed and are placed as encoded data on the compiler library data file. The transformation of intermediate language in target language object text is described.

Detecting Potential Synchronization Constraint Deadlocks from Formal System Specifications

DTIC Science & Technology

1992-03-01

family of languages, consisting of the Larch Shared Language and a series of Larch interface languages, specific to particular programming languages...specify sequential (non- concurrent) programs , and explicitly does not include the ability to specify atomic actions (Guttag, 1985). Larch is therefore...synchronized communication between two such agents is ronsidered as a single action. The transitions in CCS trees are labelled to show how they are

Do Children with Autism Have a Theory of Mind? A Non-Verbal Test of Autism vs. Specific Language Impairment

ERIC Educational Resources Information Center

Colle, Livia; Baron-Cohen, Simon; Hill, Jacqueline

2007-01-01

Children with autism have delays in the development of theory of mind. However, the sub-group of children with autism who have little or no language have gone untested since false belief tests (FB) typically involve language. FB understanding has been reported to be intact in children with specific language impairment (SLI). This raises the…