Science.gov

Sample records for industry informed consent

  1. Informed Consent

    MedlinePlus

    ... ask during informed consent? Can I change my mind after I’ve signed the consent? What if I don’t want the treatment that’s being offered? How is informed consent for a clinical trial or research study different from consent for standard treatment? How is ...

  2. [Informed consent].

    PubMed

    Medina Castellano, Carmen Delia

    2009-10-01

    At present times, numerous complaints claiming defects produced at some point in the process of obtaining informed consent are filed in courts of justice; in these complaints there is an underlying comment element which is the roles that health professionals have in these processes. In obtaining this consent, one can see this more as a means to obtain judicial protection for professional practices rather than this process being a respectful exercise for the dignity and freedom which health service patients have. This article reflects on two basic rights related to informed consent: adequately obtaining this consent and the need to protect those people who lack, either partially or totally, the capacity to make this decision by themselves. Afterwards, the author makes some considerations about the necessity to obtain informed consent for nursing practices and treatment.

  3. Informed consent.

    PubMed

    Sacchini, D; Pennacchini, M

    2010-01-01

    Informed consent (IC) in clinical experimentation is a process by which a subject voluntarily and freely confirms his/her willingness to participate in a trial, after having been informed of all involved aspects. IC is a concept enough recent within medical tradition. Unquestionably, Nuremberg trials (1945-1947) influenced thought about consent in Medicine. When the idea of IC evolved, discussion for appropriate guidelines moved increasingly from a narrow focus on the physician's/researcher's obligation. IC shall be obtained in writing and documented before a subject is enrolled into clinical investigation. , Particularly in the case of medical devices, it is necessary an adequate information to the patient on possible incidents occurring following placing of devices.

  4. Informed consent.

    PubMed

    Steevenson, Grania

    2006-08-01

    Disclosure of information prior to consent is a very complex area of medical ethics. On the surface it would seem to be quite clear cut, but on closer inspection the scope for 'grey areas' is vast. In practice, however, it could be argued that the number of cases that result in complaint or litigation is comparatively small. However, this does not mean that wrong decisions or unethical scenarios do not occur. It would seem that in clinical practice these ethical grey areas concerning patients' full knowledge of their condition or treatment are quite common. One of the barometers for how much disclosure should be given prior to consent could be the feedback obtained from the patients. Are they asking relevant questions pertinent to their condition and do they show a good understanding of the options available? This should be seen as a positive trait and should be welcomed by the healthcare professionals. Ultimately it gives patients greater autonomy and the healthcare professional can expand and build on the patient's knowledge as well as allay fears perhaps based on wrongly held information. Greater communication with the patient would help the healthcare professional pitch their explanations at the right level. Every case and scenario is different and unique and deserves to be treated as such. Studies have shown that most patients can understand their medical condition and treatment provided communication has been thorough (Gillon 1996). It is in the patients' best interests to feel comfortable with the level of disclosure offered to them. It can only foster greater trust and respect between them and the healthcare profession which has to be mutually beneficial to both parties.

  5. [Informed consent].

    PubMed

    López-Sáez, Asunción; López, de Teruel; Siso Martín, Juan

    2003-11-01

    Once the stage of health paternalism, exercised so many times under the pretext of the principle of benevolence, has been overcome, treatment relationships level off, they become symmetrical and balanced and in this climate of a "therapeutic alliance", both parties, the patient and the health professional, have to merge their capabilities and their limitations. The health professional can not impose general character operational methods to follow to a patient nor interventions, even though clinically correct, against a patient's will; but neither does a patient have the right to obtain treatment in accordance with his desires if these are found to be in disagreement with concrete clinical recommendations for the case dealt with according to the health professional's criteria. We can summarize what has just been stated in two basic principles: 1. The health professional is not obliged to follow the requests of a patient if he/she does not consider these clinically appropriate, but in order to follow a different treatment method, the health professional must have the consent of the patient. 2. In any case, if a patient opposes a treatment being applied to him/her, except in the few legally recognized exceptions, the health professional can try to persuade a patient to accept recommended treatment, but never can carry out treatment against the patient's will.

  6. Informed consent in gerontology.

    PubMed

    Glock, Rosana Soibelmann; Goldim, Jose Roberto

    2003-01-01

    The aim of this study was to assess the use and adequacy of informed consent in research involving the elderly in Brazil. Using a reading index, we observed that in 83% of informed consent forms, the text was considered difficult, and demanded a higher schooling level than that presented by the subjects. Whereas 100% of the investigators considered the text in informed consent forms accessible, 75% of the subjects considered it hard to understand. This difference was statistically significant. 94% percent of the elderly participating in research protocols made the decision to participate in the study before reading the term of consent. More attention should be given both to the writing of informed consent forms and to the entire informed consent process, which in gerontology research, should be reviewed at each encounter with study participants.

  7. 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

  8. Informed Consent (Clinical Trials)

    MedlinePlus

    ... Credit: National Cancer Institute Informed consent is a process through which you learn details about the trial before deciding whether to take part. This includes learning about the trial’s purpose and possible risks and ...

  9. Informed consent and research

    PubMed Central

    Mandal, Jharna; Parija, Subhash Chandra

    2014-01-01

    Informed consent is the central doctrine to any research based on the principles of autonomy and self-determination. For it to be genuine and effective, it should be in simple regional language catering to the cultural and psychological and social requisites of the participant. The information entailed in the consent form must be true, should cover all the relevant aspects, and no fact should be hidden however seemingly important or unimportant. Every research volunteer puts his or her health and life at risk for the sake of science, and this must be respected at all times during the research. PMID:25250226

  10. Informed consent in clinical research.

    PubMed

    Pick, Andrew; Berry, Shelley; Gilbert, Kayleigh; McCaul, James

    Since increasing numbers of patients are asked to take part in clinical trials, nurses need to be aware of the principles of valid, informed consent. This article explores consent, which aims to protect the rights, safety and wellbeing of patients. In particular, the history of consent in research and the elements involved in obtaining informed consent from potential participants in research studies are discussed.

  11. Informed Consent for Braces

    PubMed Central

    Trehan, Mridula; Rathore, Nidhi; Rathee, Pooja; Agarwal, Deepesh; Mathur, Nikunj

    2014-01-01

    ABSTRACT The influence of law on the orthodontic profession has greatly increased in the last few decades. Dental law has emerged today as a full-fedged specialty dealing with a variety of areas, like professional negligence, doctor-patient contracts, consumer protection laws, ethics, general and special health legislations and practice regulatory mechanisms. This article highlights the concept of informed consent which is based on the premise that each individual has a right to make decisions concerning his health, disease and treatment. How to cite this article: Jharwal V, Trehan M, Rathore N, Rathee P, Agarwal D, Mathur N. Informed Consent for Braces. Int J Clin Pediatr Dent 2014;7(2):105-108. PMID:25356009

  12. Some limits of informed consent.

    PubMed

    O'Neill, O

    2003-02-01

    Many accounts of informed consent in medical ethics claim that it is valuable because it supports individual autonomy. Unfortunately there are many distinct conceptions of individual autonomy, and their ethical importance varies. A better reason for taking informed consent seriously is that it provides assurance that patients and others are neither deceived nor coerced. Present debates about the relative importance of generic and specific consent (particularly in the use of human tissues for research and in secondary studies) do not address this issue squarely. Consent is a propositional attitude, so intransitive: complete, wholly specific consent is an illusion. Since the point of consent procedures is to limit deception and coercion, they should be designed to give patients and others control over the amount of information they receive and opportunity to rescind consent already given.

  13. [Informed consent in emergency medicine].

    PubMed

    Ersoy, Nermin; Ozcan Senses, Müesser; Aydin Er, Rahime

    2010-01-01

    Informed consent is a prerequisite for the ethical and legal validity of the emergency intervention in emergency medicine, since it protects the fiduciary relationship between the physician and patient; the principle of honesty that grounds this relationship; the principle of autonomy that necessitates right of self-determination; and the principle of respect for persons. Informed consent in emergency medicine, which is supposed to include the nature, benefits and risks of emergency medical intervention, differentiates with respect to definite groups of patients: (1) conscious patients, (2) unconscious patients, and (3) children and mature minors. In addition, informed consent differentiates between medical, psychological and even social circumstances of the patients, referred to as valid consent, expressed-explicit consent, blanket consent, presumed consent, tacit consent, proxy consent, and parental consent. There are a few exceptions in which emergency medical intervention is administered without informed consent. In addition to the exceptions of life-saving interventions, when a patient can not decide for herself/himself, intervention of the physician in the best interest of the patient or children is based on the "therapeutic privilege" of the physician. As an ethically defensible right, since therapeutic privilege may open a door to hard paternalistic approaches, in those situations, emergency physicians should be cautious not to violate a patient's autonomy.

  14. Informed consent in medical research.

    PubMed

    Evans, John Grimley; Beck, Peter

    2002-01-01

    That people should only be enrolled in medical research if they have given free and informed consent is now an unquestioned principle of research ethics. It is however a recent innovation. Prior to the prominence given to consent to participation in research in the condemnation of German doctors arraigned at Nuremberg in 1945, informed consent had appeared in American litigation, but only as an issue in clinical malpractice suits. Informed consent as an ethical requirement in medical research had arisen in some earlier European contexts. Despite the Nuremberg judgement, informed consent by participants in research was not widely recognised as ethically mandatory until the early 1970s. This delay seems to have been due in part to scepticism about the practicability of truly informed consent, but medical paternalism and the circumstances surrounding military research during the Cold War period may have contributed.

  15. Do informed consent documents matter?

    PubMed

    Resnik, David B

    2009-03-01

    This commentary argues that, despite extensive critiques of informed consent documents, there are several ethical and legal reasons for investigators and IRB members to take these documents seriously.

  16. Human Subjects and Informed Consent.

    ERIC Educational Resources Information Center

    Smith, Arthur A.

    1988-01-01

    The doctrine of informed consent has been enumerated to protect the rights of human subjects involved in biomedical research. The elements of informed consent are summarized along with the changes of emphasis that have evolved. The issue of liability and means for minimizing its impact are discussed. (Author/MLW)

  17. Human Subjects and Informed Consent.

    ERIC Educational Resources Information Center

    Smith, Arthur A.

    1988-01-01

    The doctrine of informed consent has been enumerated to protect the rights of human subjects involved in biomedical research. The elements of informed consent are summarized along with the changes of emphasis that have evolved. The issue of liability and means for minimizing its impact are discussed. (Author/MLW)

  18. Informed consent for clinical photography.

    PubMed

    Johns, Martin K

    2002-06-01

    The question of (informed) consent to medical photography has long been a vexed one. This paper briefly considers key landmarks in the debate, and examines in detail the evolution of the Addenbrooke's NHS Trust policy Photography and Video Recordings of Patients: Confidentiality and Consent, Copyright and Storage. The impact of the 1998 Data Protection Act, the Department of Health's Model Policy on Consent, and the implications of wider access to digital photography are discussed together with their integration into the Addenbrooke's policy.

  19. Proposing modesty for informed consent.

    PubMed

    Burgess, Michael M

    2007-12-01

    The extension of informed consent into social science research has met with considerable opposition. The history and concept of informed consent, however, is based on a substantive ethical notion of the research relationship as informed and voluntary that is appropriate for social science research relationships. Yet social science research might sometimes be different from health research in ways that justify a different approach to informed consent and research relationships. Social science research tends to have a lower magnitude of risk, usually does not need to disrupt the therapeutic assumption common in health research contexts or when researchers are health professionals, and recruitment is sometimes incremental and reflects a building of trust and development of the research participant's role. These differences may sometimes justify novel approaches to the research relationship and require case-by-case evaluation to determine their relevance to establishing the informed and voluntary nature of the relationship through the use of informed consent procedures. Ultimately, respect for research participants requires social research into practices that can support or replace informed consent. The institutional role of informed consent and the goal of informed and voluntary research participation serve modest but important roles in health and social research. Their proper role in health and social research requires flexibility and experimentation, but does not justify abdication of informed consent or the notion of informed and voluntary participation.

  20. Informed consent: information or knowledge?

    PubMed

    Berger, Ken

    2003-01-01

    A fiduciary relationship should be nurtured between patient and physician. This requires effective communication throughout all aspects of care - especially pertaining to treatment decisions. In the context of illness as experienced by the patient a unique set of circumstances is presented. However, communication in an illness context is fraught with problems. The patient is vulnerable and the situation may be overwhelming. Voluminous amounts of information are available to patients from a host of health care providers, family members, support groups, advocacy centers, books, journals, and the internet. Often conflicting and confusion, frequently complex, this information may be of greater burden than benefit. Some information is of high validity and reliability while other information is of dubious reliability. The emotional freight of bad news may further inhibit understanding. An overload of information may pose an obstacle in decision-making. To facilitate the transformation of information into knowledge, the health care provider must act on some occasions as a filter, on other occasions as a conduit, and on still other occasions simply as a reservoir. The evolution of patient rights to receive or refuse treatment, the right to know or not to know calls for a change in processing of overwhelming information in our modem era. In this paper we will discuss the difference between information and knowledge. How can health care providers ensure they have given their patients all necessary and sufficient information to make an autonomous decision? How can they facilitate the transformation of information into knowledge? The effect of knowledge to consent allows a more focused, relevant and modern approach to choice in health care.

  1. [Informed consent in valvular diseases].

    PubMed

    Ito, Toshiaki

    2014-09-01

    Informed consent has two aspects. First, we must give patients sufficient, precise information on the nature of their disease, natural history, possible choices of treatment, and risks of the treatment to help them make their own decisions. The estimated risks should be based on a database, not on personal impressions or limited experience. In choosing the type of prosthetic valve in young or middle-aged patients, unbiased information based on guidelines should be presented. The second aspect of informed consent is its role as a contract for providing medical service. Estimated in-hospital mortality and major morbidities should be clarified in percentages on the consent form as confirmation of understanding.

  2. Informed Consent: Reality or Illusion?

    ERIC Educational Resources Information Center

    Janik, Carol J.; And Others

    The goal of this study was to produce an improved medical consent form. This form was designed to record the informed consent discussion between doctor and patient which should include an explanation of what procedure will be performed, by whom, why, the risks, and the alternatives. Patients, doctors, and hospitals may all benefit from the use of…

  3. Do Informed Consent Documents Matter?

    PubMed Central

    Resnik, David B.

    2009-01-01

    This commentary argues that, despite extensive critiques of informed consent documents, there are several ethical and legal reasons for investigators and IRB members to take these documents seriously. PMID:18977313

  4. Clinical research before informed consent.

    PubMed

    Miller, Franklin G

    2014-06-01

    Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.

  5. 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

  6. 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

  7. Informed consent in pediatric research.

    PubMed

    Leibson, Tom; Koren, Gideon

    2015-02-01

    Pediatric drug research is gradually becoming more and more accepted as the norm for assessing whether a drug is safe and efficacious for infants and children. The process of informed consent and assent for these trials presents a major challenge. The aim of this review is to map historical, ethical and legal aspects relevant to the challenges of informed consent in the setting of pediatric drug research. The impact of age, level of maturity and life circumstances on the process of obtaining informed consent as well as the relations between consent and assent are discussed. There appears to be a lack of regulatory clarity in the area of pediatric clinical trials; while numerous statements have been made regarding children's rights to autonomy and their ability to care for themselves and for younger ones, the ever changing status of adolescence is still difficult to translate to informed consent. This may delay scientific and clinical advancement for children who are at the very junction of being independent and not needing parental permission. Obtaining consent and assent for pediatric clinical trials is a delicate matter, as both parent and child need to agree to participate. The appropriate transfer of information to guardians and the children, especially concerning potential risks and benefits, is at the heart of informed consent, as it serves to protect both patient and physician. As many adults lack health literacy, one must ensure that guardians receive relevant information at a level and in forms they can understand regarding the trials their children are asked to participate in.

  8. Informed Consent for Case Reports

    PubMed Central

    Levine, Stephen B.; Stagno, Susan J.

    2001-01-01

    A new international standard of editorial policy calls for written informed consent by the subject of every case report. Although this appears to be ethically appealing, the authors posit that in some situations, requesting informed consent may be unethical, can harm patients, and may erode the use of case reports as a valuable teaching method in psychiatry and psychotherapy. The authors discuss concerns regarding this new policy for mental health publication based on issues of transference, countertransference, best interest of the patient, and practicality. PMID:11402083

  9. Informed consent and moral integrity.

    PubMed Central

    Gillett, G R

    1989-01-01

    Informed consent is required for any medical procedure although the situations in which it is given are beset by uncertainties and indeterminacies. These make medicolegal scrutiny of such situations very difficult. Although some people find the decision in the Sidaway case incomprehensible because of its continuing regard for a 'professional practice standard' in informed consent, I will argue that an important fact in many cases is the moral integrity of the doctor concerned and the pattern of his practice. This may provide the only morally principled and legally accessible evidence enabling a correct decision to be made in a difficult case. Although the epistemological significance of a professional practice standard is thereby defended the 'prudent patient standard' for what counts as consent is left intact. PMID:2795625

  10. Mindsets, informed consent, and research.

    PubMed

    Jansen, Lynn A

    2014-01-01

    Study after study shows that subjects regularly overestimate the likelihood of gaining therapeutic benefit from a clinical trial. But more study is needed on why that mistake is common, and what it says about informed consent. Subjects may think about research differently at different phases in their participation.

  11. Informed consent in the nuclear medicine setting.

    PubMed

    Rosenthal, M Sara

    2011-03-01

    In the nuclear medicine setting, the task of obtaining informed consent for procedures that require it is frequently left to the nuclear medicine technologist. Unfortunately, a patient's signature on a consent form does not mean the patient has given informed consent, or what legal scholars call valid consent. On completion of this scholarly bioethics article, the reader will understand the troubled history that led to informed consent as social and regulatory policy. Additionally, the reader will discover the meaning of "informed consent," which includes 3 critical components: disclosure, decision-making capacity, and voluntariness. Finally, this article will discuss which nuclear medicine procedures require informed consent, how to assess whether patients have given informed consent, what to do when the patient refuses a procedure, and what to do when informed consent is unachievable.

  12. Identity change and informed consent.

    PubMed

    Witt, Karsten

    2017-03-20

    In this paper, I focus on a kind of medical intervention that is at the same time fascinating and disturbing: identity-changing interventions. My guiding question is how such interventions can be ethically justified within the bounds of contemporary bioethical mainstream that places great weight on the patient's informed consent. The answer that is standardly given today is that patients should be informed about the identity effects, thus suggesting that changes in identity can be treated like 'normal' side effects. In the paper, I argue that this approach is seriously lacking because it misses important complexities going along with decisions involving identity changes and consequently runs into mistakes. As a remedy I propose a new approach, the 'perspective-sensitive account', which avoids these mistakes and thus provides the conceptual resources to systematically reflect on and give a valid consent to identity-changing interventions.

  13. Ensuring Subjects' Understanding of Informed Consent.

    ERIC Educational Resources Information Center

    Smith, Deborah L.; And Others

    1995-01-01

    A discussion of informed consent by human subjects in experimentation presents background on the consent issue, including federal requirements; lists factors that may affect a subject's ability to understand the consent document; and offers suggestions for preparing consent forms to ensure the subject's better comprehension. (Author/MSE)

  14. Ensuring Subjects' Understanding of Informed Consent.

    ERIC Educational Resources Information Center

    Smith, Deborah L.; And Others

    1995-01-01

    A discussion of informed consent by human subjects in experimentation presents background on the consent issue, including federal requirements; lists factors that may affect a subject's ability to understand the consent document; and offers suggestions for preparing consent forms to ensure the subject's better comprehension. (Author/MSE)

  15. On Taylor's justification of medical informed consent.

    PubMed

    Varelius, Jukka

    2012-05-01

    In contemporary Western biomedical ethics, informed consent practices are commonly justified in terms of the intrinsic value of patient autonomy. James Stacey Taylor maintains that this conception of the moral grounding of medical informed consent is mistaken. On the basis of his reasoning to that effect, Taylor argues that medical informed consent is justified by the instrumental value of personal autonomy. In this article, I examine whether Taylor's justification of medical informed consent is plausible.

  16. 42 CFR 441.257 - Informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Sterilizations § 441.257 Informed consent. (a) Informing the individual. For purposes of this subpart, an individual has given informed consent only if— (1) The person who obtained consent for the sterilization... procedure at any time before the sterilization without affecting the right to future care or treatment and...

  17. [The origin of informed consent].

    PubMed

    Mallardi, V

    2005-10-01

    The principle of informed consent, aimed at the lawfulness of health assistance, tends to reflect the concept of autonomy and of decisional autodetermination of the person requiring and requesting medical and/or surgical interventions. This legal formula, over the last few years, has gained not only considerable space but also importance in the doctrinal elaboration and approaches, as well as juridical interpretations, thereby influencing the everyday activities of the medical profession. Informed consent is still the object of continuous explorations, not only asfar as concerns the already confirmed theoretical profile but, instead, the ambiguous practical and consequential aspect. Analysing how the concept and role of consensus was born and developed with the more adequate and reasonable excursions to make it valid and obtain it, it is impossible not to take into consideration, on the one hand, the very ancient philosophical origins and, on the other, the fact that it was conditioned by religion with the moral aspects and the accelerated deontological evolution with pathways parallel to the needs and the progress offered by new forms of treatment and novel biotechnological applications. The principle of consent is a relatively new condition. In fact, already in the times of not only the Egyptian civilisation, but also the Greek and Roman, documents have been found which show how the doctor's intervention had, in some way, first to be approved by the patient. Plato (law IV) had already foreseen the problems, the procedures and the modes of information which are, in synthesis, at the root of the principles of the present formula of informed consent and correlated the practice of the information and consensus with the quality and social position of the patient. The only guarantee that the patient might have, derived from a fundamental principle of medicine of all times: "in disease, focus on two aims, to improve and not to cause damage". A figure can be recognised

  18. Interactive Informed Consent: Randomized Comparison with Paper Consents

    PubMed Central

    Rowbotham, Michael C.; Astin, John; Greene, Kaitlin; Cummings, Steven R.

    2013-01-01

    Informed consent is the cornerstone of human research subject protection. Many subjects sign consent documents without understanding the study purpose, procedures, risks, benefits, and their rights. Proof of comprehension is not required and rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing and reading about the study and the consent form at the subject’s own pace with testing and immediate feedback. This prospective randomized study compared the IRB-approved paper ICF for an actual clinical research study with an interactive presentation of the same study and its associated consent form using an iPad device in two populations: clinical research professionals, and patients drawn from a variety of outpatient practice settings. Of the 90 participants, 69 completed the online test and survey questions the day after the session (maximum 36 hours post-session). Among research professionals (n = 14), there was a trend (p  = .07) in the direction of iPad subjects testing better on the online test (mean correct  =  77%) compared with paper subjects (mean correct  =  57%). Among patients (n = 55), iPad subjects had significantly higher test scores than standard paper consent subjects (mean correct  =  75% vs 58%, p < .001). For all subjects, the total time spent reviewing the paper consent was 13.2 minutes, significantly less than the average of 22.7 minutes total on the three components to be reviewed using the iPad (introductory video, consent form, interactive quiz). Overall satisfaction and overall enjoyment slightly favored the interactive iPad presentation. This study demonstrates that combining an introductory video, standard consent language, and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks. PMID:23484041

  19. Infants, Children, and Informed Consent*

    PubMed Central

    Campbell, A. G. M.

    1974-01-01

    Obtaining informed consent for non-therapeutic experimentation on infants and children has ethical and legal implications that cause great controversy. There is some danger that worthy research will be inhibited if current ethical codes are interpreted too strictly, yet infants, children, and other vulnerable groups clearly must be protected from exploitation as research subjects. It is suggested that permission from parents coupled with integrity of the investigator will remain the child's best protection, but several additional protective mechanisms are available and should be used. Some guidelines for non-therapeutic research are suggested which should not only provide adequate protection for infants and young children involved in research projects, but allow investigators reasonable freedom to prosecute worthy research vital to continued improvements in child care. PMID:4413853

  20. Ethics, informed consent, and assisted reproduction.

    PubMed

    Macklin, R

    1995-09-01

    Informed consent to treatment is an ethical requirement often misunderstood or not fully appreciated by physicians. The purpose of obtaining informed consent is to ensure that patients know what doctors propose to do and freely grant their permission. Although the purpose of informed consent and the standards by which it is to be employed are the same in all areas of medical practice, special problems arise in assisted reproduction. Voluntary, informed consent is an instance of a reproductive right that should be recognized by the international medical community, and not limited to Western and European countries.

  1. Empty ethics: the problem with informed consent.

    PubMed

    Corrigan, Oonagh

    2003-11-01

    Informed consent is increasingly heralded as an ethical panacea, a tool to counter autocratic and paternalistic medical practices. Debate about the implementation of informed consent is constricted and polarised, centring on the right of individuals to be fully informed and to freely choose versus an autocratic, paternalistic practice that negates individual choice. A bioethical framework, based on a principle-led form of reductive/deductive reasoning, dominates the current model of informed consent. Such a model tends to abstract the process of consent from its clinical and social setting. By fleshing out the social process involved whe patients and healthy volunteer subjects consent to take part in clinical drug trials, this paper attempts to address the problem arising from the current 'empty ethics' model. My arguments are substantiated by qualitative interview data drawn from a study I conducted on the process of consent as experienced by participants in clinical drug trials.

  2. Informed consent for medical photographs

    PubMed Central

    Cunniff, Christopher; Byrne, Janice L.B.; Hudgins, Louanne M.; Moeschler, John B.; Olney, Ann Haskins; Pauli, Richard M.; Seaver, Lauri H.; Stevens, Cathy A.; Figone, Christopher

    2000-01-01

    Patient images are used for many purposes in medical practice. They are placed in the medical record as an adjunct to clinical care, displayed to colleagues, students and other audiences in educational settings, and published in medical journals or other media as part of medical research. In each case it is not only prudent, but necessary for the patients’ protection and interest that appropriate consent be obtained. While medical journals invariably require written consent for photographs that may identify the patient, the format of the photograph consent form is usually not specified, nor is it always clear which images require consent. With the proliferation of published images on the Internet it has become particularly important to obtain permission for all uses that will be made of medical images, including worldwide distribution through various electronic media. PMID:11339658

  3. Medical ghostwriting and informed consent.

    PubMed

    Almassi, Ben

    2014-11-01

    Ghostwriting in its various forms has received critical scrutiny from medical ethicists, journal editors, and science studies scholars trying to explain where ghostwriting goes wrong and ascertain how to counter it. Recent analyses have characterized ghostwriting as plagiarism or fraud, and have urged that it be deterred through stricter compliance with journal submission requirements, conflict of interest disclosures, author-institutional censure, legal remedies, and journals' refusal to publish commercially sponsored articles. As a supplement to such efforts, this paper offers a critical assessment of medical ghostwriting as contrary to good patient care, on the grounds that it contradicts established general principles guiding clinical ethics. Specifically, I argue that ghostwriting undermines trust relationships between authors and their readers, and between these readers and their trusting patients, and in so doing contradicts the duty of respect for patient autonomy by obstructing informed consent. For this reason, complicity in ghostwriting practices should be understood as a violation of the professional ethical duties of physicians and other healthcare workers.

  4. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written...

  5. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The...

  6. 28 CFR 549.52 - Informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

  7. 28 CFR 549.52 - Informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

  8. 28 CFR 549.52 - Informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

  9. 28 CFR 549.52 - Informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

  10. 28 CFR 549.52 - Informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

  11. Dynamic axes of informed consent in Japan.

    PubMed

    Specker Sullivan, Laura

    2017-02-01

    Scholarship in cross-cultural bioethics routinely frames Japanese informed consent in contrast to informed consent in North America. This contrastive analysis foregrounds cancer diagnosis disclosure and physician paternalism as unique aspects of Japanese informed consent that deviate from American practices. Drawing on in-depth interviews with 15 Japanese medical professionals obtained during fieldwork in Japan from 2013 to 15, this article complicates the informed consent discourse beyond East-West comparisons premised on Anglo-American ethical frameworks. It expands professional perspectives to include nurses, medical social workers, clinical psychologists, and ethicists and it addresses informed consent for a broad range of conditions in addition to cancer. The results suggest that division of affective labor is an under-theorized dimension of informed consent that is perceived as at odds with principled demands for universal informed consent. These practical tensions are conceptualized as cultural differences, with Japan identified in terms of omakase as practical and supportive and the United States identified in terms of jiko kettei as principled and self-determining. These results have implications for the methodology of cross-cultural bioethics as well as for theories and practices of informed consent in both Japan and the United States. I conclude that responsible cross-cultural work in bioethics must begin from the ground up, incorporating all relevant stakeholder perspectives, attitudes, and experiences.

  12. 76 FR 256 - Informed Consent Elements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ... materials submitted with the comments. We also consulted with our internal experts on informed consent... as a ``basic'' element of informed consent under Sec. 50.25(a), a new paragraph (c) has been added... basis of the new element--required only for applicable clinical trials--as compared with existing...

  13. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written...

  14. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written...

  15. 21 CFR 640.61 - Informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written...

  16. Collective informed consent and decision power.

    PubMed

    Varelius, Jukka

    2009-03-01

    It has been suggested that, in addition to individual level decision-making, informed consent procedures could be used in collective decision-making too. One of the main criticisms directed at this suggestion concerns decision-making power. It is maintained that consent is a veto power concept and that, as such, it is not appropriate for collective decision-making. This paper examines this objection to collective informed consent. It argues that veto power informed consent can have some uses in the collective level and that when it is not appropriate the decision power a concerned party ought to have in connection with an arrangement should be made relative to the interest she has at stake in it. It concludes that the objection examined does not undermine collective informed consent.

  17. Informed Consent to Treatment in Psychiatry

    PubMed Central

    Neilson, Grainne; Chaimowitz, Gary

    2015-01-01

    Summary Patients have a right to be informed and actively involved in their health care. Fundamental to a person’s dignity and autonomy is the right to make decisions about their psychiatric treatment, including their right to refuse unwanted treatments, providing that the refusal is a capable one. It is important that psychiatrists have an awareness of the ethical underpinnings of consent and the legislated requirements related to consent, including precedent cases. Consent may change over time and for different conditions and circumstances. Consent must be an ongoing process.

  18. Informed consent in rheumatology care practice.

    PubMed

    Marques Filho, José

    2011-01-01

    Informed consent is a mandatory document in human subject research protocols. Its principles have been recently established in the history of Medicine, and the first official document to establish the need for an informed consent from the research subject was the Nuremberg Code (1947). All following documents confirmed that the informed consent is mandatory in human subject research. However, the informed consent, which represents patients' autonomy or self-determination regarding their relationship with their physicians, took a while to be included in medical care practice and medical deontology codes. The convenience of using the informed consent in medical practice is widely discussed today, especially in rheumatology. Our opinion is that the obligation of a signed informed consent provided by the patient for every medical procedure is neither reasonable nor practical. It should be used for more invasive or risky therapeutic procedures. We understand that the informed consent does not guarantee that the patient has been fully informed, which is an essential condition for the current rheumatological practice. Its adoption in routine medical care practice would make medical intervention bureaucratic, and, thus, quite different from the Hippocratic view, which considered the trustful physician-patient relationship fundamental for an adequate medical care practice.

  19. Informed Consent for Reconstructive Pelvic Surgery.

    PubMed

    Alam, Pakeeza; Iglesia, Cheryl B

    2016-03-01

    Informed consent is the process in which a patient makes a decision about a surgical procedure or medical intervention after adequate information is relayed by the physician and understood by the patient. This process is critical for reconstructive pelvic surgeries, particularly with the advent of vaginal mesh procedures. In this article, we review the principles of informed consent, the pros and cons of different approaches in reconstructive pelvic surgery, the current legal issues surrounding mesh use for vaginal surgery, and tips on how to incorporate this information when consenting patients for pelvic floor surgery. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Use of informed consent with therapeutic paradox.

    PubMed

    Farkas, M M

    1992-01-01

    Debate persists in the literature and among clinicians about the ethical appropriateness of paradoxical interventions. It has been suggested that informed consent with therapeutic paradox would alleviate ethical concerns of deception, manipulation, harm to the client, and withholding of information from the client in therapy. The purpose of this study was to explore health care consumer reactions to the benefits and risks of therapeutic paradox as stated in a consent for treatment form. The study explored the responses of 32 medical patients to a hypothetical consent for treatment form for therapeutic paradox. Data were collected in a brief semistructured interview after subjects read the hypothetical consent form. Utilizing a case study, the investigator then offered an example of a successful paradoxical intervention and additional subject comments were solicited. Content analysis of the responses was made. Health care consumers had mixed responses to the consent form. While the consent form served as an obstacle for some consumers, many were willing to sign the consent form and accept treatment even though they had internal reservations and questions. Appropriateness of the consent form format is discussed.

  1. Informed consent comprehension in African research settings.

    PubMed

    Afolabi, Muhammed O; Okebe, Joseph U; McGrath, Nuala; Larson, Heidi J; Bojang, Kalifa; Chandramohan, Daniel

    2014-06-01

    Previous reviews on participants' comprehension of informed consent information have focused on developed countries. Experience has shown that ethical standards developed on Western values may not be appropriate for African settings where research concepts are unfamiliar. We undertook this review to describe how informed consent comprehension is defined and measured in African research settings. We conducted a comprehensive search involving five electronic databases: Medline, Embase, Global Health, EthxWeb and Bioethics Literature Database (BELIT). We also examined African Index Medicus and Google Scholar for relevant publications on informed consent comprehension in clinical studies conducted in sub-Saharan Africa. 29 studies satisfied the inclusion criteria; meta-analysis was possible in 21 studies. We further conducted a direct comparison of participants' comprehension on domains of informed consent in all eligible studies. Comprehension of key concepts of informed consent varies considerably from country to country and depends on the nature and complexity of the study. Meta-analysis showed that 47% of a total of 1633 participants across four studies demonstrated comprehension about randomisation (95% CI 13.9-80.9%). Similarly, 48% of 3946 participants in six studies had understanding about placebo (95% CI 19.0-77.5%), while only 30% of 753 participants in five studies understood the concept of therapeutic misconception (95% CI 4.6-66.7%). Measurement tools for informed consent comprehension were developed with little or no validation. Assessment of comprehension was carried out at variable times after disclosure of study information. No uniform definition of informed consent comprehension exists to form the basis for development of an appropriate tool to measure comprehension in African participants. Comprehension of key concepts of informed consent is poor among study participants across Africa. There is a vital need to develop a uniform definition for

  2. Physicians and the minefield surrounding informed consent.

    PubMed

    Capen, K

    1996-08-15

    Most of the legal cases that follow the informed-consent standard set in recent court cases have involved surgical procedures. However, issues concerning a pregnant British Columbia mother who contracted chicken pox and whose child was subsequently born with severe medical complications demonstrate the complexity of medical decision making and the inadequacy of established legal requirements, especially when consent has dimensions beyond technical considerations usually associated with medical procedures. The problem physicians face, says lawyer Karen Capen, is to find a way to balance a range of professional responsibilities and the overriding fiduciary obligation to patients in matters associated with informed decision making and consent.

  3. A linguistic model of informed consent.

    PubMed

    Marta, J

    1996-02-01

    The current disclosure model of informed consent ignores the linguistic complexity of any act of communication, and the increased risk of difficulties in the special circumstances of informed consent. This article explores, through linguistic analysis, the specificity of informed consent as a speech act, a communication act, and a form of dialogue, following on the theories of J.L. Austin, Roman Jakobson, and Mikhail Bakhtin, respectively. In the proposed model, informed consent is a performative speech act resulting from a series of communication acts which together constitute a dialogic, polyphonic, heteroglossial discourse. It is an act of speech that results in action being taken after a conversation has happened where distinct individuals, multiple voices, and multiple perspectives have been respected, and convention observed and recognized. It is more meaningful and more ethical for both patient and physician, in all their human facets including their interconnectedness.

  4. [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.

  5. Is Consent Based on Trust Morally Inferior to Consent Based on Information?

    PubMed

    Kongsholm, Nana Cecilie Halmsted; Kappel, Klemens

    2017-02-27

    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.

  6. Do the Patients Read the Informed Consent?

    PubMed Central

    Özhan, Mehmet Özgür; Süzer, Mehmet Anıl; Çomak, İlker; Çaparlar, Ceyda Özhan; Aydın, Gözde Bumin; Eşkin, Mehmet Burak; Atik, Bülent; Ergin, Atilla; Çekmen, Nedim; Kurt, Ercan

    2014-01-01

    Background: Informed consent is a process which consists of informing the patient about the medical interventions planned to be applied to the patient’s body and making the patient active in the decision making process. Aims: The aim of this study was to evaluate whether the patients read the informed consent document or not and if not, to determine why they did not read it. This was achieved via a questionnaire administered at the pre-anaesthetic visit to assess the perception of patients to the informed consent process. Study Design: Survey study. Methods: The patients were given a questionnaire after signing the informed consent document at the pre-anaesthetic visit. We studied whether the patients read the informed consent document or not and asked for their reasons if they did not. Results: A total of 522 patients were included during the two month study (mean age: 38.1 years; 63.8% male, 36.2% female). Overall, 54.8% of patients reported that they did not read the informed consent. Among them, 50.3% did not care about it because they thought they would have the operation anyway, 13.4% did not have enough time to read it, 11.9% found it difficult to understand, 5.9% could not read because they had no glasses with them, and 5.2% found it frightening and gave up reading. Inpatients, older patients and patients with co-morbidities were less likely to read the informed consent document than outpatients, and younger and healthy patients (p<0.05). Also, 57.9% of parents whose children would be operated on had read the document. Conclusion: This study shows that the majority of our patients did not understand the importance of the informed consent. It is therefore concluded that informed consent documents should be rearranged to be easily read and should be supported with visual elements such as illustrations or video presentations, as informed consent is a process rather than just simply signing a form. PMID:25207184

  7. [Informed consent in clinical practice: persistent doubts].

    PubMed

    Kottow, Miguel

    2016-11-01

    Informed consent is the core aspect of the patient-physician relationship. Since its beginnings, clinical bioethics was opposed to the authoritarian paternalism characteristic of medicine since the 19th century. The informed consent was developed to provide patients with sufficient information to allow autonomous decisions when faced with medical diagnostic and therapeutic alternatives. In spite of bioethics’ effort to perfect informed consent, the discipline has been unable to avoid informed consent from becoming an impersonal and administrative procedure. Even though the major goal of this procedure is to provide sufficient information to allow patients an objective weighting of benefits and risks of medical practice, the uncertainties of medicine make full disclosure unattainable. Collecting more information finally leads to indecision and ultimate trust in medical advice. The clinical encounter is fundamentally a fiduciary relationship, and bioethics ought to accept that its main objective is to strengthen the trust bond that is essential to the clinical encounter. This goal may become incompatible with the quest for unlimited autonomy. Patients often will only require information as long as they distrust that medical institutions and their professionals are considering their interests and needs. The main proposal of this article is to temper bioethics’ insistence on autonomy, and accept that patients essentially seek to be protected and cared for. Informed consent ought to relent its efforts at full autonomy to the benefit of trustworthiness in medicine, and trust in clinical practice.

  8. The limits of informed consent.

    PubMed

    1975-09-01

    The patient, a 59-year-old man, was referred to a psychiatric hospital with what appeared initially to be the signs and symptoms of mental disorder. In hospital a lesion of the brain was diagnosed and surgery was proposed to relieve the condition. The patient, however, during this and subsequent admissions to hospital, refused operation. His refusal to consent was regarded as valid as he seemed to have good insight into his condition. Finally, under section 26 of the Mental Health Act, he was treated surgically. Unfortunately the patient died six weeks later of intracranial haemorrhage. Three comments are made on this case - two by psychiatrists, Dr K Davison and Dr Ashley Robin, the other by a professor of Christian ethics, Professor F C Blackie. Both psychiatrists argue that when a patient's mind is affected by mental or organic illness to the degree that 'he cannot bring a rational and conscious mind' to the question of his treatment then the doctor, in consultation with the relatives, making clear to them the likely course of events if an operation is not performed, must take whatever is the proper course of action, in this case surgery. In this view, such an operation performed immediately the diagnosis was confirmed might not have been so complicated. Professor Blackie, commending 'the attempt to regard the patient as a responsible human being' with a 'moral right to be consulted on all aspects of treatment', questions in this patient the limits to which the appeal to reason was carried. He concludes that 'in this situation the advice and consent of the family must weigh more heavily than the statements of the patient'.

  9. Informed consent: an international researchers' perspective.

    PubMed

    Rivera, Roberto; Borasky, David; Rice, Robert; Carayon, Florence; Wong, Emelita

    2007-01-01

    We reported 164 researchers' recommendations for information that should be included in the informed consent process. These recommendations were obtained during training workshops conducted in Africa, Europe, and the United States. The 8 elements of informed consent of the US Code of Federal Regulations were used to identify 95 items of information ("points"), most related to benefits and research description. Limited consensus was found among the 3 workshops: of the 95 points, only 27 (28%) were identified as useful by all groups. These points serve as a springboard for identifying information applicable in different geographic areas and indicate the need for involving a variety of individuals and stakeholders, with different research and cultural perspectives, in the development of informed consent, particularly for research undertaken in international settings.

  10. Medical informed consent: general considerations for physicians.

    PubMed

    Paterick, Timothy J; Carson, Geoff V; Allen, Marjorie C; Paterick, Timothy E

    2008-03-01

    Medical informed consent is essential to the physician's ability to diagnose and treat patients as well as the patient's right to accept or reject clinical evaluation, treatment, or both. Medical informed consent should be an exchange of ideas that buttresses the patient-physician relationship. The consent process should be the foundation of the fiduciary relationship between a patient and a physician. Physicians must recognize that informed medical choice is an educational process and has the potential to affect the patient-physician alliance to their mutual benefit. Physicians must give patients equality in the covenant by educating them to make informed choices. When physicians and patients take medical informed consent seriously, the patient-physician relationship becomes a true partnership with shared decision-making authority and responsibility for outcomes. Physicians need to understand informed medical consent from an ethical foundation, as codified by statutory law in many states, and from a generalized common-law perspective requiring medical practice consistent with the standard of care. It is fundamental to the patient-physician relationship that each partner understands and accepts the degree of autonomy the patient desires in the decision-making process.

  11. Written Informed Consent: Closing the Door to Clinical Research. and Another Look at Informed Consent.

    ERIC Educational Resources Information Center

    Noble, Mary Anne; Oberst, Marilyn T.

    1985-01-01

    Two viewpoints on written informed consent are presented: Written informed consent should not be required unless research goes beyond the bounds of normal practice and poses danger or discomfort to the patient; and the principles of autonomy and individual rights must be applied at least as stringently to research as to practice. (CT)

  12. [Parental Information and Consent in Neonatology].

    PubMed

    Ehlen, M; Budde, A

    2015-06-01

    Careful analysis of current adjudication reveals increasing demand of adequate record-keeping as well as meticulously documented informed consent forms regarding all aspects of medicine. Although standardized informed consent forms or explicit guidelines for obtaining procedural consent already exist in surgical disciplines there is strong evidence that, however, in neonatology (and paediatric intensive care) these processes are still incomplete and qualitatively insufficiently implemented. Therefore the author discussed all existing information prescriptions with the legal department and quality management of a large German clinic group especially in terms of relevant legislation, recent case law and specialist literature in order to obtain potential for improvement. Based on the results of this audit of expert opinions improved recommendations could be implemented in the daily practise of a department of neonatology and paediatric intensive care on a tertiary level.

  13. Within and beyond the communal turn to informed consent in industry-sponsored pharmacogenetics research: merits and challenges of community advisory boards.

    PubMed

    Soofi, Hojjat; van Leeuwen, Evert

    2016-10-01

    The one-size-fits-all paradigm of drug development fails to address inter-individual variability in drug response. Pharmacogenetics research aims at studying the role of genotypic differences in drug response. Recently, the pharmaceutical industry has shown interest to embed pharmacogenetics studies in the process of drug development. Nevertheless, population-based and commercial aspects of such future-oriented studies pose challenges for individually based informed consent (IC). As an exemplar of the communal turn to IC procedures, community advisory boards (CABs) have been integrated into different types of medical research. CABs hold the promise of organizing the relationship between participants and researchers in a more reciprocal and participatory way, offering possible means of overcoming the lapses of individualistic IC. However, the involvement of CABs with pharmacogenetics research might be rife with difficulties, uncertainties, and challenges. The current study first reviews the existing literature to discuss added values and challenges of relying on CABs as a supplement to individually based IC. Then, the particular moral and regulatory landscape of pharmacogenetics research will be delineated to argue that community engagement is both necessary and promising beyond the communal turn to IC processes. Three main features of the landscape include (1) new supportive stances that some regulatory bodies have adopted toward pharmacogenetics research, (2) the motivation of the industry to draw reception and trust from the subpopulations, and (3) the important role of the society in generating and embedding pharmacogenetics knowledge. Finally, some points to consider will be discussed to contextualize relying on CABs within this landscape.

  14. Informed consent and the psychiatric patient.

    PubMed Central

    Dyer, A R; Bloch, S

    1987-01-01

    Informed consent is reviewed as it applies to psychiatric patients. Although new legislation, such as the Mental Health Act 1983, provides a useful safeguard for the protection of the civil rights of patients, it could actually reduce their humane care unless applied with sensitivity for the nature of their unique difficulties. In order to guard against this possibility, we suggest that legal requirements should be considered in light of the ethical principles which underlie them. Three principles are considered: those of autonomy (freedom); beneficence (paternalism); and the fiduciary principle (partnership). Psychotherapy is offered as a model for informed consent, which might be generalised to other clinical situations. PMID:3572986

  15. [Human rights and informed consent].

    PubMed

    Navarro-Reynoso, Francisco P; Argüelles-Mier, Miguel; Cicero-Sabido, Raúl

    2004-01-01

    The right to information is a right that all human beings have; it is unrenounceable and confers to the human being the Rights to the Political Constitution of the United States of Mexico, the Universal Declaration of Human Rights, the Declaration of Geneva, and the Code of Behavior for Health Personnel. Information given to a sick person should suffice so that he/she can make a decision on management and treatment. Information is related directly with medical ethics and is obligatory not only for health workers but for all professionals in general.

  16. Informed consent in Malaysia: an overview.

    PubMed

    Che Ngah, Anisah

    2005-01-01

    The right of a person to control his body is a concept that has long been recognized in Malaysia under the law of torts. The purpose of requiring informed consent is to preserve that right in medical decision-making. Informed Consent is a relatively new concept in medical litigation cases. However in the late 1990's, it has become one of the important claims under negligence made against the doctor for failure to disclose relevant information to patients in respect of the treatment proposed. Whether Malaysia has begun to recognize patient's right to decision-making is yet to be seen. Furthermore the social-cultural relationship between doctors and patients had to be considered. In this respect, the researcher had conducted interviews with doctors and patients to gauge their reaction towards a shared process of decision-making, which is the central issue in the doctrine of informed consent. Findings suggest that in society where primary health care is the main thrust to achieve health for all, the possibility of recognition of the rights of patients to receive information before making decisions about treatment appears remote. The findings also underscore the importance of incorporating aspects of informed consent as part of providing quality service to patients.

  17. 28 CFR 512.16 - Informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Informed consent. 512.16 Section 512.16 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE GENERAL MANAGEMENT AND ADMINISTRATION... the subject indicates an intent to commit future criminal conduct or harm himself/herself or someone...

  18. 28 CFR 512.16 - Informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Informed consent. 512.16 Section 512.16 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE GENERAL MANAGEMENT AND ADMINISTRATION... the subject indicates an intent to commit future criminal conduct or harm himself/herself or someone...

  19. 28 CFR 512.16 - Informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Informed consent. 512.16 Section 512.16 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE GENERAL MANAGEMENT AND ADMINISTRATION... the subject indicates an intent to commit future criminal conduct or harm himself/herself or someone...

  20. 28 CFR 512.16 - Informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Informed consent. 512.16 Section 512.16 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE GENERAL MANAGEMENT AND ADMINISTRATION... the subject indicates an intent to commit future criminal conduct or harm himself/herself or someone...

  1. Learning Ethics through Everyday Problems: Informed Consent

    ERIC Educational Resources Information Center

    Verdu, Fernando; Frances, Francesc; Castello, Ana

    2012-01-01

    The teaching of bioethics and its importance in clinical relationships is to a certain extent complicated when we address students of medicine, young people who are more used to dealing with and solving strictly clinical problems. Informed Consent is one of the aspects of professional practice that is generally and widely accepted in Western…

  2. Learning Ethics through Everyday Problems: Informed Consent

    ERIC Educational Resources Information Center

    Verdu, Fernando; Frances, Francesc; Castello, Ana

    2012-01-01

    The teaching of bioethics and its importance in clinical relationships is to a certain extent complicated when we address students of medicine, young people who are more used to dealing with and solving strictly clinical problems. Informed Consent is one of the aspects of professional practice that is generally and widely accepted in Western…

  3. Informed consent: what does it mean?

    PubMed Central

    Kirby, M D

    1983-01-01

    The editorial in the September 1982 issue of this journal and many articles before and since have addressed the problem of informed consent. Is it possible? Is it a useful concept? Is there anything new to be said about it? In this article the basic rationale of the rule (patient autonomy) is explained and the extent of the rule explored. Various exceptions have been offered by the law and an attempt is made to catalogue the chief of these. A number of specially vulnerable groups are then identified, the most important, and vexed, being children. How can informed consent be secured in the case of young patients? Finally, a few problems are mentioned in an attempt to get this subject back to reality. The appeal to the principle primum non nocere may be medical paternalism in disguise. Informed consent is the competing principle that reminds us of the primacy of human autonomy. A pointer is given to the future: even the use of sound recordings to explain medical procedures and to activate informed consent so that it may become a reality and not just a lawyer's myth, should be considered. PMID:6876100

  4. Informed Consent and the "Medical Student Psychiatrist."

    ERIC Educational Resources Information Center

    Cohen, Daniel L.; And Others

    1990-01-01

    Responses to a 1986 questionnaire by 91 departments of clinical psychiatry in U.S. medical schools revealed that a substantial proportion (29.3 percent) were not fully compliant with established guidelines requiring informed consent from patients before allowing students to participate in their psychiatric assessment and care. (Author/DB)

  5. Limning the Semantic Frontier of Informed Consent.

    PubMed

    Washington, Harriet A

    2016-09-01

    It is the researcher's responsibility to provide accurate, complete, and unbiased verbal and written information yet, as this essay discusses, challenges to meaningful research consent abound in the communication between researcher and subject. This discussion of these challenges is far from exhaustive, but it will flag some of the potholes that researchers must anticipate on the sometimes rocky road to eliciting meaningful consent. These include, but are not limited to, inadequate scientific literacy, poorly written consent forms, and even the deployment of scientific terms and seductive acronyms like CURE and MIRACL. Studies with acronyms, for example, enroll five times as many patients as those without, are more likely to be published by prestigious journals, and have higher Jadad methodologic quality scores although they are no more likely to conclude with positive findings. Other barriers to researcher-subject communication include: widely differing beliefs and customs, semiotics, socioeconomic status, iatrophobia, and dramatically different histories of treatment in the medical-research arena.

  6. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

    PubMed Central

    Borello, Alessandro; Passera, Roberto; Surace, Alessandra; Marola, Silvia; Buccelli, Claudio; Niola, Massimo; Di Lorenzo, Pierpaolo; Amato, Maurizio; Di Domenico, Lorenza; Solej, Mario; Martino, Valter

    2016-01-01

    Abstract Background Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. Methods This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. Results Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. Conclusions Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding. PMID:28352847

  7. Informed consent, anticipatory regulation and ethnographic practice.

    PubMed

    Murphy, Elizabeth; Dingwall, Robert

    2007-12-01

    In this paper we examine the application of informed consent to ethnographic research in health care settings. We do not quarrel with either the principle of informed consent or its translation into the requirement that research should only be carried out with consenting participants. However, we do challenge the identification of informed consent with the particular set of bureaucratic practices of ethical review which currently operate in Canada, the US and elsewhere. We argue that these anticipatory regulatory regimes threaten the significant contribution of ethnographic research to the creation of more efficient, more effective, more equitable and more humane health care systems. Informed consent in ethnographic research is neither achievable nor demonstrable in the terms set by anticipatory regulatory regimes that take clinical research or biomedical experimentation as their paradigm cases. This is because of differences in the practices of ethnographic and biomedical research which we discuss. These include the extended periods of time ethnographers spend in the research setting, the emergent nature of ethnographic research focus and design, the nature and positioning of risk in ethnographic research, the power relationships between researchers and participants, and the public and semi-public nature of the settings normally studied. Anticipatory regulatory regimes are inimical to ethnographic research and risk undermining the contribution of systematic inquiry to understanding whether institutions do what they claim to do, fairly and civilly and with an appropriate mobilisation of resources. We do not suggest that we should simply ignore ethics or leave matters to the individual consciences of researchers. Rather, we need to develop and strengthen professional models of regulation which emphasise education, training and mutual accountability. We conclude the paper with a number of suggestions about how such professional models might be implemented.

  8. The nocebo effect of informed consent.

    PubMed

    Cohen, Shlomo

    2014-03-01

    The nocebo effect, the mirror-phenomenon to the placebo effect, is when the expectation of a negative outcome precipitates the corresponding symptom or leads to its exacerbation. One of the basic ethical duties in health care is to obtain informed consent from patients before treatment; however, the disclosure of information regarding potential complications or side effects that this involves may precipitate a nocebo effect. While dilemmas between the principles of respect for patient autonomy and of nonmaleficence are recognized in medical ethics, there has not yet been an ethical discussion focused on the potential dilemma raised by the nocebo effect of informed consent (NEIC). This dilemma is especially pernicious, since it involves a direct causality of harm by the caregiver that is unparalleled by other potential harmful effects of information disclosure. This paper articulates the dilemma of the NEIC and offers a seminal ethical analysis.

  9. Some observations on informed consent in non-therapeutic research.

    PubMed

    Garnham, J C

    1975-09-01

    The quality of the consent obtained from 41 volunteer subjects in eight experiments is evaluated. Five subjects (all physicians) gave informed consent; 22 subjects gave partially informed consent; and 14 subjects merely gave consent. It is argued that 'informed' consent is obtainable only from medically trained people, and that lip service to this concept in laymen should cease. The concept of medical competence should instead be introduced and a personal medical referee appointed to adjudicate on behalf of the volunteer.

  10. Informed consent to HIV cure research.

    PubMed

    Bromwich, Danielle; Millum, Joseph R

    2017-02-01

    Trials with highly unfavourable risk-benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants' motivations for enrolling in potentially high risk research with no prospect of direct benefit; and third, participants' understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies.

  11. Is informed consent effective in trauma patients?

    PubMed

    Bhangu, A; Hood, E; Datta, A; Mangaleshkar, S

    2008-11-01

    Informed consent in the modern era is a common and important topic both for the well-informed patient and to prevent unnecessary litigation. However, the effectiveness of informed consent in trauma patients is an under-researched area. This paper aims to assess the differences in patient recall of the consent process and desire for information by performing a comparative analysis between orthopaedic trauma and elective patients. Information from 41 consecutive elective operations and 40 consecutive trauma operations was collected on the first post-operative day. 100% of elective patients and 90% of trauma patients knew what operation they had received (p = 0.06). Overall recall of complications was poor, but was significantly lower in trauma patients compared with elective patients (62% vs 22%, p<0.001). 30% of trauma patients desired more information about their operation compared to 12% of elective patients (p = 0.049), although only 35% of trauma patients wanted written as well as verbal explanations, compared to 85% of elective patients p<0.001). Overall 100% of elective and 90% of trauma patients were happy with the consent process (p = 0.06). Subset analysis of neck of femur compared to other trauma patients showed that the above factors were not significantly different between the two groups. Recall of complications in the trauma patients is significantly lower than in elective patients, although both groups scored poorly overall. Repeated verbal explanations should be reinforced with the option of additional information leaflets for trauma operations. Further research into the usefulness of DVDs for commonly performed operations is warranted, although official internet resources may be more cost-effective.

  12. Informed Consent, Deaf Culture, and Cochlear Implants.

    PubMed

    Pass, Lauren; Graber, Abraham D

    2015-01-01

    While cochlear implantation is now considered routine in many parts of the world, the debate over how to ethically implement this technology continues. One's stance on implantation often hinges on one's understanding of deafness. On one end of the spectrum are those who see cochlear implants as a much needed cure for an otherwise intractable disability. On the other end of the spectrum are those who view the Deaf as members of a thriving culture and see the cochlear implant as an attempt to eliminate this culture. Rather than take a stance in this debate, we will argue that the informed consent process for cochlear implantation must include access to Deaf perspectives. Deaf individuals know best what it is like to be a member of the Deaf community; the reasonable person would put significant weight on the testimony of Deaf individuals when considering whether to undergo cochlear implantation. The reasonable person standard determines what information careproviders must present as part of the informed consent process; thus, informed consent for cochlear implantation requires access to the testimony of Deaf individuals.

  13. Informed consent in Texas: theory and practice.

    PubMed

    Cherry, Mark J; Engelhardt, H Tristram

    2004-04-01

    The legal basis of informed consent in Texas may on first examination suggest an unqualified affirmation of persons as the source of authority over themselves. This view of individuals in the practice of informed consent tends to present persons outside of any social context in general and outside of their families in particular. The actual functioning of law and medical practice in Texas, however, is far more complex. This study begins with a brief overview of the roots of Texas law and public policy regarding informed consent. This surface account is then contrasted with examples drawn from the actual functioning of Texas law: Texas legislation regarding out-of-hospital do-not-resuscitate (DNR) orders. As a default approach to medical decision-making when patients lose decisional capacity and have failed to appoint a formal proxy or establish their wishes, this law establishes a defeasible presumption in favor of what the law characterizes as "qualified relatives" who can function as decision-makers for those terminal family members who lose decisional capacity. The study shows how, in the face of a general affirmation of the autonomy of individuals as if they were morally and socially isolated agents, space is nevertheless made for families to choose on behalf of their own members. The result is a multi-tier public morality, one affirming individuals as morally authoritative and the other recognizing the decisional standing of families.

  14. Informed consent: Do not be afraid.

    PubMed

    Sprumont, Dominique

    2017-04-01

    Informed consent is the cornerstone of the doctor-patient relationship. At least this is how it is presented in theory. In practice, doctors struggle with their obligation to inform their patient before obtaining their approval prior to a medical intervention. In Taiwan, the culture is often mentioned to justify the doctor's reluctance to speak openly with their patient. Invoking the importance of the family in the society, doctors tend to rely less on their patients and more on their relatives to make important decisions. Yet, the cultural argument for not seeking the patients' informed consent sounds more like a mere excuse than the real cause of the difficulties doctors face today in obtaining their patients' consent. This paper argues that today the doctors in Taiwan are mostly governed by the same fear that was the rule in the USA and Europe until the 1980s. It may be time for changing the paradigm, admitting that patients are able to handle even the most dramatic diagnosis. It seems also important to get away from the sterile opposition of doctor's paternalism versus patient's autonomy and to introduce a true partnership between doctors and patients. Copyright © 2015. Published by Elsevier B.V.

  15. Ensuring that informed consent is really an informed consent: Role of videography

    PubMed Central

    Ghooi, Ravindra B.

    2014-01-01

    The voluntary consent of a subject participating in research is fundamental to the principle of autonomy. This consent must be free from any coercion, intimidation, falsehood, physical, psychological, or economic pressure. It is in the interest of the subject, the investigator and the sponsor to ensure that informed consent processes conform to the guidelines and regulations, both in the letter and spirit. However, ignorance on the part of investigating team causes deviation from these norms. Videography of the entire process has been suggested as a means to ensure the compliance, and draft rules for the same published. The present article examines how best videography can be introduced in the informed consent procedure without violating other protective mechanisms. PMID:24551579

  16. [Information provided in writing for "informed consent" in clinical trials].

    PubMed

    Sella, A

    1999-05-02

    The Helsinki Declaration contains recommendations guiding physicians who conduct clinical trials. One is that the requirement for informed consent is essential for approval of a trial. An important component of the informed consent doctrine is that all data required for the participant's decision must be provided. We analyze data of a therapeutic trial, and define 12 data components outlined in, or directly derived from the Helsinki Declaration. 61 instances of informed consent for therapeutic clinical trials from various fields of medicine, from 1994 to 1997, were analyzed. In each the presence of the 12 components was evaluated. The data demonstrated that there were only 5 components cited in most cases of informed consent: trial objectives, methods, treatment plan, risks, and the option of withdrawing. Benefit to the participant was mentioned in half the cases, while only limited information was provided about other components such as life-threatening and unpredictable risks, and alternative treatment. Examples of informed consent from 1997 showed statistical improvement since 1994 in the data concerning trial objectives, methods, risks and alternative therapy. Informed consent documents of international multicenter trials compared with local trials showed statistical improvement in the data components of the trial objectives, methods, and risks, including those of potentially life-threatening and unpredictable risks, and alternative therapy. Analysis of informed consent showed that not all components required for a comprehensive decision regarding participation in a clinical trial are included. These data emphasize the need to design a structured informed consent protocol in which all the required data components are specifically outlined for potential participants.

  17. Changes in the Concept of Informed Consent in Medical Encounters.

    ERIC Educational Resources Information Center

    Hollander, Rachelle D.

    1984-01-01

    Recent changes in the conceptualization of informed consent in medical encounters are reviewed to help provide a better understanding of the concept itself and of some difficulties in philosophical justifications for the requirement of informed consent. (Author/MLW)

  18. 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.

  19. Communication and informed consent in elderly people.

    PubMed

    Giampieri, M

    2012-02-01

    Physician-patient relationship is the key-point for an optimal management of any medical procedure. Before performing any diagnostic or therapeutic procedure, clinical communication with patients is necessary. It should regard the nature and purpose of a proposed procedure including potential risks and benefits. During physician-patient communication, alternatives, as well as the risks and benefits of not receiving or undergoing a procedure should also be disclosed. Thus, a complete physician-patient clinical communication is the basis of "shared decision-making" and plays a clinical-therapeutic role in the informed consent process in order to improve patient care. Informed consent is a delicate process of communication between a patient and physician necessary for patient authorization for any medical intervention. The success of achieving good informed consent procedure depends on the strength of the relationship between the doctor and the patient. For this reason, the traditional paternalistic relationship, in which decisions were made by the doctor, is no longer appropriate. Therefore, the use of a model which allows for a greater patient involvement in the decision making process is fundamental. This approach allows for a clearer impact on patient values. The aspects of the procedure related to these values, combined with the technical and scientific considerations of the doctor, are the basis of a shared decision making process, in which the patient is actively involved. Therefore, an informed consent is not simply the acquisition of the patient's signature, but a real process based on the dialogue between doctor and patient. This dialogue is particularly delicate in some circumstances, such as geriatric medicine and anesthesiology. Seeking consent is part of a respectful relationship with an older person. Adults are almost always considered capable of making personal healthcare decisions. Older adults should also be considered capable of handling their own

  20. [Scientific drug safety information for patients' consent].

    PubMed

    Suzuki-Nishimura, Tamiko

    2011-01-01

    One of the important roles of pharmacists is to continue their contributions to new drug discovery and development. However, it seems to be very difficult to obtain patient satisfaction with new drugs. Because new medicines have both benefit and risk, there should be many systems to maximize the safety and efficacy of the drugs. In clinical trials, the rights, safety and welfare of human subjects under the investigator's care must be protected. Good Clinical Practice is a harmonized ICH-guideline, and the safety information of an investigational product is explained to patients who voluntarily enter the clinical trials. Since safety information about investigational products is still limited, subjects are informed about the results of animal experiments and those of finished clinical trials. The sponsor of clinical trials should be responsible for the on-going safety evaluation of the investigational products. When additional safety information is collected in the clinical trials, the written informed consent form should be appropriately revised. During the review process, quality, safety and efficacy of new drugs are evaluated and judged based on the scientific risk-benefit balance. The safety information collected in clinical trials is reflected in the decision-making process written in the review reports. All-case investigation should be also performed until data from a certain number of patients has been accumulated in order to collect early safety and efficacy data. Important messages written in review reports for drug safety and patient consent are explained. Risk communication will improve the application of patients' consent for new drugs.

  1. 10 CFR 745.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Documentation of informed consent. 745.117 Section 745.117 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.117 Documentation of informed consent. (a... embodies the elements of informed consent required by § 745.116. This form may be read to the subject...

  2. 10 CFR 745.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Documentation of informed consent. 745.117 Section 745.117 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of...

  3. A Case for Obtaining Informed Consent from Young Children.

    ERIC Educational Resources Information Center

    Hughes, Teresa; Helling, Mary Kay

    A discussion of informed consent in research on children focuses on the history of informed consent and problems of obtaining informed consent from young children. It is argued that, in the past, researchers and research monitors have assumed that parents will act in the best interests of children participating in research and protect them from…

  4. Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents

    PubMed Central

    Munung, Nchangwi Syntia; Marshall, Patricia; Campbell, Megan; Littler, Katherine; Masiye, Francis; Ouwe-Missi-Oukem-Boyer, Odile; Seeley, Janet; Stein, D J; Tindana, Paulina; de Vries, Jantina

    2016-01-01

    Background The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. Methods A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of test results. Results Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. Conclusion H3Africa research makes use of three consent models—specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa. PMID:26644426

  5. Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents.

    PubMed

    Munung, Nchangwi Syntia; Marshall, Patricia; Campbell, Megan; Littler, Katherine; Masiye, Francis; Ouwe-Missi-Oukem-Boyer, Odile; Seeley, Janet; Stein, D J; Tindana, Paulina; de Vries, Jantina

    2016-02-01

    The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of test results. Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. H3Africa research makes use of three consent models-specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  6. Informed consent: Enforcing pharmaceutical companies' obligations abroad.

    PubMed

    Lee, Stacey B

    2010-06-15

    The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the "right to health." This article concludes that by building on the federal appellate court's ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections.

  7. 49 CFR 11.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Documentation of informed consent. 11.117 Section 11.117 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.117... following: (1) A written consent document that embodies the elements of informed consent required by §...

  8. 38 CFR 16.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... consent. 16.117 Section 16.117 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.117 Documentation of informed consent. (a) Except as provided in paragraph... elements of informed consent required by § 16.116. This form may be read to the subject or the...

  9. Informed consent: protection or obstacle? Some emerging issues.

    PubMed

    Ellenberg, S S

    1997-12-01

    There is widespread consensus on the need for informed consent procedures in medical research. Nevertheless, aspects of the informed consent process remain controversial, and innovative approaches to research may raise new issues and concerns. The randomized consent design for clinical trials, proposed by Zelen (N Engl J Med 1979; 300:1242-1245), permitted physicians to randomize patients without consent, then obtain informed consent from only those patients randomized to the experimental (as opposed to the standard treatment) arm. More recently, the proposal has been made to allow waiver of informed consent for study of patients in emergency circumstances who may be temporarily incapable of providing such consent, and for whom no family member is immediately available to give a "proxy" consent (Biros M.H. et al. JAMA 1995; 273:1283-1287). The medical community and federal regulatory policy have responded differently to these proposals.

  10. [Informed consent. Historical background and current problems].

    PubMed

    Jensen, A B

    1990-11-26

    At present, informed consent is essential before patients can participate in clinical trials. The fact that a doctor asks the patient for informed consent is an expression of respect for the patient's right to make decisions about his own body. The request is made in recognition of the fact that optimal treatment can only be ensured by means of clinically controlled trials. The need for regulation of research arose at the beginning of the present century when pharmacological development accelerated. The Nürenberg Declaration was elaborated after the second world war and, subsequently, the Helsinki Declarations I and II. In these, directives are established for clinical research and for the rights of participants. A number of conditions make it difficult to fulfill these intentions. It may be difficult to ensure that the patient has adequate basic knowledge. The patient may feel that he is in a state of dependence on the doctor which influences his possibility to choose freely. Confidence between doctor and patient may be undermined if the patient is requested to participate in randomization for choice of treatment. Doctors know too little about how valid information can be ensured.

  11. [The informed consent in international clinical trials including developing countries].

    PubMed

    Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

    2008-01-01

    The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

  12. Improving the Quality of Informed Consent in Clinical Research with Information Technology.

    PubMed

    Taber, Celia; Warren, Jim; Day, Karen

    2016-01-01

    The clinical research industry has yet to fully embrace information technology (IT) for informed consent purposes, even though it is used indispensably in our everyday lives and in other areas of clinical research and healthcare. This paper presents findings of a meta-narrative literature review to discuss the potential for IT to improve the quality of clinical research informed consent. The review reveals three main rationales for including IT in research consent. First, in the current context consent documents frequently fail to be effective decision aids for patients, and the lack of patient centricity in the process. Second, social media provides opportunities for patients to consult with a broader community during research consent to seek broader support, and potential to participate in creating a more patient centric process. Third, multimedia tools provide opportunities for improved patient education, engagement and decision making during research consent. IT offers opportunities to achieve more meaningful research consent, but more research is needed to create an evidence base, policies and economic analyses on the return on investment of using IT in the process.

  13. [Informed consent in aesthetic plastic surgery].

    PubMed

    Fenger, H

    2006-02-01

    The informed consent plays a very decisive part in aesthetic plastic surgery. As there is often no medical indication in plastic surgery, the patient has to be informed about all the facts of an operation, especially about the possible risks. The legal requests for therapeutic and economic clarification gain in importance. The jurisdiction in Germany demands a merciless clarification for the patient. The patient needs to be clarified about all facts early enough so that he has a sufficient amount of time to weigh-up the pros und cons of the operation and if necessary to take advice from someone else. The sufficient documentation is very important at the sight of the extensive burden of proof at the expense of the physician.

  14. Legal issues in blood banking. Elements of informed consent.

    PubMed

    Sherman, L A

    1996-12-01

    In the past, informed consent in pathology was confined chiefly to autopsies. Changes in both consent law and pathology practice led to consent being important in a broader sense in the laboratory. Areas discussed in this article include blood transfusion, tissue specimens, fine needle aspiration, and phlebotomy.

  15. Research without informed patient consent in incompetent patients.

    PubMed

    Dobb, G J

    2015-05-01

    Most patients needing intensive care cannot give informed consent to participation in research. This includes the most acutely and severely ill, with the highest mortality and morbidity where research has the greatest potential to improve patient outcomes. In these circumstances consent is usually sought from a substitute decision maker, but while survivors of intensive care believe substitute decision makers will look after their interests, evidence suggests substitute decision makers are poorly equipped for this task. Various models have been suggested for research without patient informed consent when intervention is urgent and cannot wait until first person consent is possible, including a waiver of consent if conditions are met. A nationally consistent model is proposed for Australia with a robust process for initial waiver of consent followed by first person consent to further research-related procedures or ongoing follow-up when this can be competently provided.

  16. Who is the patient? Disclosure of information and consent in anesthesia and intensive care (informed consent).

    PubMed

    Korusić, Andelko; Merc, Vlasta; Duzel, Viktor; Tudorić-Djeno, Ivana; Zidak, Davorka; Brundula, Ana; Sojcić, Natasa; Milanović, Rudolf; Barić, Ada; Beslić, Gabrijela

    2013-09-01

    Physicians have always strived to uphold all the ethical postulates of the medical profession in all aspects of the practice, however with the vast advances in science and technology, numerous ethical dilemmas regarding all aspects of life and ultimately death have emerged. Medical decisions however, are no longer in the sole jurisdiction of traditional Hippocratic medicine but are now deliberated and delivered by the patient and they are comprised of a number of additional determining aspects such as psychological, social, legal, religious, esthetic, administrative etc., which all together represent the complete best interest of the patient. This is the basic goal of the "Informed Consent". The widening of legal boundaries regarding professional liability may consequentially lead to a "defensive medicine" and a deterioration in the quality of healthcare. In the Republic of Croatia there a four types of liability and the hyperproduction of laws which regulate healthcare geometrically increase the hazards to which physicians are exposed to on a daily basis. When evaluating the Croatian informed consent for anesthesia, we can come to the conclusion that it is completely impractical and as such entirely unnecessary. Anesthesiologists should concentrate on an informed consent which would in brief explain all the necessary information a "reasonable" anesthesiologist would disclose to a "reasonable" patient so that a patient could undertake a diagnostic or therapeutic procedure unburdened and with complete confidence in the physicians who are involved in the treatment of the respective patient.

  17. 42 CFR 441.257 - Informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... procedure at any time before the sterilization without affecting the right to future care or treatment and...) An interpreter was provided if the individual to be sterilized did not understand the language used on the consent form or the language used by the person obtaining consent; (4) The individual to be...

  18. 49 CFR 11.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 1 2011-10-01 2011-10-01 false Documentation of informed consent. 11.117 Section 11.117 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed...

  19. 49 CFR 11.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 1 2012-10-01 2012-10-01 false Documentation of informed consent. 11.117 Section 11.117 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed...

  20. [Informed consent in the patients' rights law].

    PubMed

    Figueroa G, Rodolfo

    2012-10-01

    The new regulation of patients' rights creates the right to informed consent, which allows accepting or refusing any medical treatment. Also, the patient has the right to be appropriately informed about a variety of aspects determined by the law. Patient's autonomy has limits. Artificial acceleration of death, euthanasia or assisted suicide are not permitted. The problem is that the law does not define those situations. The law provides the intervention of Ethics Committees when the doctor considers that the patient exposes himself to severe harm or the risk of death which would be avoided. This intervention impinges on patient's autonomy. Patients have the right to request discharge and medical facilities could discharge patients against their will if they do not accept medical recommendations. These limitations on autonomy should be explained because the law apparently makes the distinction between killing, letting die and the Double Effect Doctrine. There is plenty of literature questioning the validity of both. The law fails to regulate part of the medical practice, regarding life and death decisions. A lack of consensus could explain this omission. Doctors have a right to conscientious objection to some patient's requests.

  1. Communicating disclosure risk in informed consent statements.

    PubMed

    Singer, Eleanor; Couper, Mick P

    2010-09-01

    For several years, we have experimented with various ways of communicating disclosure risk and harm to respondents in order to determine how these affect their willingness to participate in surveys. These experiments, which used vignettes administered to an online panel as well as a mail survey sent to a national probability sample, have demonstrated that (a) the probability of disclosure alone has no apparent effect on people's willingness to participate in the survey described, (b) the sensitivity of the survey topic has such an effect, and (c) making explicit the possible harms that might result from disclosure also reduces willingness to participate, in both the vignette and the mail experiments. As a last study in this series, we experimented with different ways of describing disclosure risk in informed consent statements that might more plausibly be used in real surveys, again using vignettes administered to an online panel. As suggested by our earlier work, we found that the precise wording of the confidentiality assurance had little effect on respondents' stated willingness to participate in the hypothetical survey described. However, the experimental manipulations did have some effect on perceptions of the risks and benefits of participation, suggesting that they are processed by respondents. And, as we have found in our previous studies, the topic of the survey has a consistent and statistically significant effect on stated willingness to participate. We explore some implications of these findings for researchers seeking to provide adequate information to potential survey respondents without alarming them unnecessarily.

  2. Autonomy, consent and responsibility. Part II. Informed consent in medical care and in the law.

    PubMed

    Mellado, J M

    Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility.

  3. Information for Industrial Development,

    DTIC Science & Technology

    Information processing, *Technology transfer, * Industries , Information transfer, Industrial engineering , Planning, Research management, Investments...Operation, Industrial production, Data bases, Information systems, User needs, Symposia

  4. [Readability of surgical informed consent in Spain].

    PubMed

    San Norberto, Enrique María; Gómez-Alonso, Daniel; Trigueros, José M; Quiroga, Jorge; Gualis, Javier; Vaquero, Carlos

    2014-03-01

    To assess the readability of informed consent documents (IC) of the different national surgical societies. During January 2012 we collected 504 IC protocols of different specialties. To calculate readability parameters the following criteria were assessed: number of words, syllables and phrases, syllables/word and word/phrase averages, Word correlation index, Flesch-Szigriszt index, Huerta Fernández index, Inflesz scale degree and the Gunning-Fog index. The mean Flesch-Szigriszt index was 50.65 ± 6,72, so readability is considered normal. There are significant differences between specialties such as Urology (43.00 ± 4.17) and Angiology and Vascular Surgery (63.00 ± 3.26, P<.001). No IC would be appropriate for adult readability according to the Fernández-Huerta index (total mean 55.77 ± 6.57); the IC of Angiology and Vascular Surgery were the closest ones (67.85 ± 3.20). Considering the Inflesz scale degree (total mean of 2.84 ± 3,23), IC can be described as «somewhat difficult». There are significant differences between the IC of Angiology and Vascular Surgery (3.23 ± 0.47) that could be qualified as normal, or Cardiovascular Surgery (2.79 ± 0.43) as «nearly normal readability»; and others such as Urology (1, 70 ± 0.46, P<.001) and Thoracic Surgery (1.90 ± 0.30, P<.001), with a readability between «very» and «somewhat» difficult. The Gunning-Fog indexes are far from the readability for a general audience (total mean of 26.29 ± 10,89). IC developed by scientific societies of different surgical specialties do not have an adequate readability for patients. We recommend the use of readability indexes during the writing of these consent forms. Copyright © 2012 AEC. Published by Elsevier Espana. All rights reserved.

  5. Anesthesiological ethics: can informed consent be implied?

    PubMed

    Spike, Jeffrey R

    2012-01-01

    Surgical ethics is a well-recognized field in clinical ethics, distinct from medical ethics. It includes at least a dozen important issues common to surgery that do not exist in internal medicine simply because of the differences in their practices. But until now there has been a tendency to include ethical issues of anesthesiology as a part of surgical ethics. This may mask the importance of ethical issues in anesthesiology, and even help perpetuate an unfortunate view that surgeons are "captain of the ship" in the operating theater (leaving anesthesiologists in a subservient role). We will have a better ethical understanding if we see surgery and anesthesia as two equal partners, ethically as well as in terms of patient care. Informed consent is one such issue, but it is not limited to that. Even on the topic of what type of anesthesia to use, anesthesiologists have often felt subsumed to the surgeon's preferences. This commentary takes the case study and uses it as a exemplar for this very claim: it is time to give due recognition for a new field in clinical ethics, ethics in anesthesia.

  6. Contemporary interpretation of informed consent: autonomy and paternalism.

    PubMed

    Robertson, Louise

    2016-06-01

    The Supreme Court's decision in the Montgomery case has questioned what is meant by 'informed consent'. Clinicians must establish who is a reasonable patient and exactly what they want to know. Obtaining informed consent requires a relationship to be built between patient and clinician and must respect patient autonomy.

  7. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Section 50.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed consent. Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a subject...

  8. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Section 50.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed consent. Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a subject...

  9. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Section 50.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed consent. Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a subject...

  10. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Section 50.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed consent. Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a subject...

  11. 21 CFR 50.20 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Section 50.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.20 General requirements for informed consent. Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a subject...

  12. Informed Consent in Research on Second Language Acquisition

    ERIC Educational Resources Information Center

    Thomas, Margaret; Pettitt, Nicole

    2017-01-01

    The practice of securing informed consent from research participants has a relatively low profile in second language (L2) acquisition research, despite its prominence in the biomedical and social sciences. This review article analyses the role that informed consent now typically plays in L2 research; discusses an example of an L2 study where…

  13. 22 CFR 225.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Documentation of informed consent. 225.117 Section 225.117 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN SUBJECTS § 225.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section...

  14. 14 CFR 1230.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Documentation of informed consent. 1230.117 Section 1230.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  15. 14 CFR 1230.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Documentation of informed consent. 1230.117 Section 1230.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  16. 14 CFR 1230.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true General requirements for informed consent. 1230.116 Section 1230.116 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.116 General requirements for informed consent. Except as...

  17. 14 CFR 1230.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Documentation of informed consent. 1230.117 Section 1230.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  18. 14 CFR 1230.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false General requirements for informed consent. 1230.116 Section 1230.116 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.116 General requirements for informed consent. Except as...

  19. 14 CFR 1230.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Documentation of informed consent. 1230.117 Section 1230.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION PROTECTION OF HUMAN SUBJECTS § 1230.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  20. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Documentation of informed consent. 97.117 Section 97.117 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal...) § 97.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this...

  1. 32 CFR 219.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 2 2010-07-01 2010-07-01 false Documentation of informed consent. 219.117 Section 219.117 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.117 Documentation of informed consent....

  2. 16 CFR 1028.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Documentation of informed consent. 1028.117 Section 1028.117 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  3. 28 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Documentation of informed consent. 46.117 Section 46.117 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this...

  4. 45 CFR 690.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false Documentation of informed consent. 690.117 Section 690.117 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.117 Documentation of informed consent. (a) Except as provided in...

  5. Consent, Informal Organization and Job Rewards: A Mixed Methods Analysis

    ERIC Educational Resources Information Center

    Laubach, Marty

    2005-01-01

    This study uses a mixed methods approach to workplace dynamics. Ethnographic observations show that the consent deal underlies an informal stratification that divides the workplace into an "informal periphery," a "conventional core" and an "administrative clan." The "consent deal" is defined as an exchange of autonomy, voice and schedule…

  6. 38 CFR 16.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 1 2013-07-01 2013-07-01 false Documentation of informed consent. 16.117 Section 16.117 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.117 Documentation of informed consent. (a) Except as provided in...

  7. 28 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Documentation of informed consent. 46.117 Section 46.117 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this...

  8. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Documentation of informed consent. 26.117 Section 26.117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF... EPA § 26.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of...

  9. 28 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Documentation of informed consent. 46.117 Section 46.117 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this...

  10. 28 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Documentation of informed consent. 46.117 Section 46.117 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN SUBJECTS § 46.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this...

  11. 32 CFR 219.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 2 2014-07-01 2014-07-01 false Documentation of informed consent. 219.117 Section 219.117 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.117 Documentation of informed consent....

  12. Consent, Informal Organization and Job Rewards: A Mixed Methods Analysis

    ERIC Educational Resources Information Center

    Laubach, Marty

    2005-01-01

    This study uses a mixed methods approach to workplace dynamics. Ethnographic observations show that the consent deal underlies an informal stratification that divides the workplace into an "informal periphery," a "conventional core" and an "administrative clan." The "consent deal" is defined as an exchange of autonomy, voice and schedule…

  13. Pregnant women's views on informed consent for research in labour.

    PubMed

    George, R T; Butcher, M; Yentis, S M

    2014-08-01

    Studies of the optimal treatment of accidental dural puncture occurring during epidural insertion in labour are difficult for practical reasons and because of the ethical issues around seeking consent. In a recent study of accidental dural puncture, participants were assigned to one of two treatment groups and only informed about the study and consent sought, after treatment. We sought the views of parturients on the timing of consent for such a study. After ethical approval and written consent, 100 nulliparous women in the third trimester of pregnancy completed a structured, facilitated questionnaire, rating the acceptability of the consent process occurring: (i) in antenatal clinic; (ii) after the epidural was requested in labour; (iii) after the accidental dural puncture had occurred but before treatment; (iv) after the allocated treatment; or (v) without consent (waived consent). Results were analysed with the Friedman and Wilcoxon signed-rank tests. Antenatal consent was considered the most acceptable option, whilst consent on request for epidural analgesia and after accidental dural puncture were least acceptable. Consent after treatment and waived consent were rated in-between these extremes. There was a statistically significant difference between these three groups (P<0.0001). There was a wide range of opinions on each option presented. Antenatal consent was the preferred option but if this is not possible and the need for the research is strong, consent for the use of women's data after intervention, or waived consent, is acceptable to many women. It is important to seek the views of the participants themselves before planning research with difficult ethical aspects. Copyright © 2014. Published by Elsevier Ltd.

  14. Informed Consent for AAA Repair: The Patient’s Perspective

    PubMed Central

    Berman, Loren; Curry, Leslie; Gusberg, Richard; Dardik, Alan; Fraenkel, Liana

    2009-01-01

    BACKGROUND Although information about risks, benefits and alternatives to intervention is central to ensuring adequate informed consent, patients are often not well-informed about potential adverse outcomes when they are considering whether to have surgery. Whether or not to undergo surgery for abdominal aortic aneurysm (AAA), and whether to have open or endovascular repair (EVAR), is a complex decision that relies heavily on patient preferences, and yet little is known about the patient perspective on informed consent in this context. Understanding patients’ views on their decision-making processes and the quality of surgeon-patient communication could inform improvements in informed consent for AAA repair. METHODS We conducted in-depth interviews with AAA patients (n=20) who underwent open AAA repair, endovascular repair, or declined surgery. Data were independently transcribed and analyzed by a team of individuals with diverse backgrounds, using the constant comparative method of analysis and systematic coding procedures. RESULTS We identified four central themes characterizing patients’ experiences with informed consent for AAA repair: 1) some patients perceived that there was no choice regarding whether or not to have surgery; 2) some patients did not feel adequately informed prior to making a decision; 3) patients differed in the scope and content of information they desired during informed consent; and 4) trust in the surgeon had an impact on the informed consent process. CONCLUSION Our research highlights the limitations of the informed consent encounter in the current clinical context, and points to several ways in which informed consent could be improved. Adapting the informed consent encounter to incorporate the patient’s perspective is critical in order to ensure that the decision regarding AAA repair is consistent with the patient’s informed preference. PMID:18572357

  15. Experiences with Obtaining Informed Consent for Genomic Sequencing

    PubMed Central

    Bernhardt, Barbara A.; Roche, Myra I.; Perry, Denise L.; Scollon, Sarah R.; Tomlinson, Ashley N.; Skinner, Debra

    2016-01-01

    Despite the increased utilization of genome and exome sequencing, little is known about the actual content and process of informed consent for sequencing. We addressed this by interviewing 29 genetic counselors and research coordinators experienced in obtaining informed consent for sequencing in research and clinical settings. Interviews focused on the process and content of informed consent; patients/participants’ common questions, concerns and misperceptions; and challenges to obtaining informed consent. Content analysis of transcribed interviews revealed that the main challenges to obtaining consent related to the broad scope and uncertainty of results, and patient/ participants’ unrealistic expectations about the likely number and utility of results. Interviewees modified their approach to sessions according to contextual issues surrounding the indication for testing, type of patient, and timing of testing. With experience, most interviewees structured sessions to place less emphasis on standard elements in the consent form and technological aspects of sequencing. They instead focused on addressing misperceptions and helping patients/participants develop realistic expectations about the types and implications of possible results, including secondary findings. These findings suggest that informed consent sessions should focus on key issues that may be misunderstood by patients/participants. Future research should address the extent to which various stakeholders agree on key elements of informed consent. PMID:26198374

  16. Informed consent for paediatric clinical trials in Europe

    PubMed Central

    Lepola, Pirkko; Needham, Allison; Mendum, Jo; Sallabank, Peter; Neubauer, David; de Wildt, Saskia

    2016-01-01

    Objective Paediatric clinical trials are often conducted as multinational trials. Informed consent or assent is part of the ethics committee approval for clinical trials. The consent requirements vary between countries due to national laws and regulations, which are not harmonised in Europe. These discrepancies can present challenges for paediatric clinical trials. The aim of this study was to assemble these consent and assent requirements across the European Economic Area. The collated national requirements have not been publicly available before, despite a real need for this data. Methods National consent and assent requirements for paediatric clinical trials were analysed and collated for 25 European Union Member States and 2 European Free Trade Association countries until the end of 2014. The data were retrieved from existing databases and through communication with the competent authorities and selected ethics committees. Results from a literature search for international or national guidelines, declarations and conventions and academic societies' publications served as comparison material. Results Consent and assent requirements are heterogeneous across these countries. We compiled our findings in ‘The Informed Consent and Assent Tool Kit’, a table including 27 national consent and assent requirements listed by individual country. Conclusions Wide variation in paediatric consents and assents presents challenges for multinational paediatric trials in Europe. The toolkit is available for all those involved in paediatric clinical trials and ethics committees, providing a new platform for proactive feedback on informed consent requirements, and may finally lead to a needed harmonisation process, including uniform standards accepted across Europe. PMID:27226526

  17. Epidural analgesia for labour: maternal knowledge, preferences and informed consent.

    PubMed

    Fröhlich, S; Tan, T; Walsh, A; Carey, M

    2011-01-01

    Epidural analgesia has become increasingly popular as a form of labour analgesia in Ireland. However obtaining true inform consent has always been difficult. Our study recruited 100 parturients who had undergone epidural analgesia for labour, aimed to determine the information they received prior to regional analgesia, and to ascertain their preferences regarding informed consent. Only 65 (65%) of patients planned to have an epidural. Knowledge of potential complications was variable and inaccurate, with less than 30 (30%) of women aware of the most common complications. Most women 79 (79%) believed that discomfort during labour affected their ability to provide informed consent, and believe consent should be taken prior to onset of labour (96, 96%). The results of this study helps define the standards of consent Irish patients expect for epidural analgesia during labour.

  18. Orthodontic informed consent considering information load and serial position effect.

    PubMed

    Pawlak, Caroline E; Fields, Henry W; Beck, F Michael; Firestone, Allen R

    2015-03-01

    Previous research has demonstrated that current methods of informed consent are relatively ineffective as shown by poor recall and comprehension by adolescent patients and their parents. The purpose of this study was to determine whether adding a short videotape presentation reiterating the issues related to informed consent to a modified informed consent document that emphasizes a limited number of core and patient-specific custom "chunks" at the beginning of an informed consent presentation improved the recall and comprehension of the risks, benefits, and alternatives of orthodontic treatment. A second objective was to evaluate the current related data for recommendable practices. Seventy patient-parent pairs were randomly divided into 2 groups. The intervention group (group A) patients and parents together reviewed a customized slide show and a short videotape presentation describing the key risks of orthodontic treatment. Group B followed the same protocol without viewing the videotape. All patients and parents were interviewed independently by research assistants using an established measurement tool with open-ended questions. Interviews were transcribed and scored for the appropriateness of responses using a previously established codebook. Lastly, the patients and parents were given 2 reading literacy tests, 1 related to health and 1 with general content followed by the self-administered demographic and psychological state questionnaires. There were no significant differences between the groups for sociodemographic variables. There were no significant differences between the groups for overall recall and comprehension; recall and comprehension for the domains of treatment, risk, and responsibility; and recall and comprehension for core, general, and custom items. The positional effects were limited in impact. When compared with previous studies, these data further demonstrate the benefit of improved readability and audiovisual supplementation with the

  19. 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

  20. The process of informed consent for urgent abdominal surgery

    PubMed Central

    Kay, R; Siriwardena, A

    2001-01-01

    Objectives—To assess perceptions of the informed consent process in patients undergoing urgent abdominal surgery. Design—A prospective observational study was carried out using structured questionnaire-based interviews. Patients who had undergone urgent abdominal surgery were interviewed in the postoperative period to ascertain their perceptions of the informed consent process. Replies were compared to responses obtained from a control group undergoing elective surgery, to identify factors common to the surgical process and those specific to urgent surgery. Patients' perceptions of received information were also compared to the information perceived to have been provided by the consent obtainers. Setting—Gastrointestinal surgical service of a university teaching hospital. Patients—Seventy-four consecutive patients undergoing urgent abdominal surgery and 80 control patients undergoing elective surgery. Main measurements—Principal outcome measures were patients' perceptions of factors interfering with the ability to give informed consent, assessment of the quality of informed consent and the degree of discussion of the expected outcomes. Results—Forty-nine of the seventy-four (66%) patients undergoing urgent surgery perceived that pain did not affect their ability to give informed consent. Twenty-seven reported an adverse effect of analgesia on the ability to give informed consent. Only 22% of patients undergoing urgent surgery perceived that there had been any discussion of potential side effects and complications of surgery. Conclusion–The majority of patients in this series with acute intra-abdominal surgical conditions perceive that they retain the ability to give informed consent for surgery. There is a need for improved discussion of therapeutic options and likely outcomes. Key Words: Informed consent • urgent abdominal surgery PMID:11417021

  1. Impact of verbal explanation and modified consent materials on orthodontic informed consent.

    PubMed

    Carr, Kelly M; Fields, Henry W; Beck, F Michael; Kang, Edith Y; Kiyak, H Asuman; Pawlak, Caroline E; Firestone, Allen R

    2012-02-01

    Comprehension of informed consent information has been problematic. The purposes of this study were to evaluate the effectiveness of a shortened explanation of an established consent method and whether customized slide shows improve the understanding of the risks and limitations of orthodontic treatment. Slide shows for each of the 80 subject-parent pairs included the most common core elements, up to 4 patient-specific custom elements, and other general elements. Group A heard a presentation of the treatment plan and the informed consent. Group B did not hear the presentation of the informed consent. All subjects read the consent form, viewed the customized slide show, and completed an interview with structured questions, 2 literacy tests, and a questionnaire. The interviews were scored for the percentages of correct recall and comprehension responses. Three informed consent domains were examined: treatment, risk, and responsibility. These groups were compared with a previous study group, group C, which received the modified consent and the standard slide show. No significant differences existed between groups A, B, and C for any sociodemographic variables. Children in group A scored significantly higher than did those in group B on risk recall and in group C on overall comprehension, risk recall and comprehension, and general risks and limitations questions. Children in group B scored significantly higher than did those in group C on overall comprehension, treatment recall, and risk recall. Elements presented first in the slide show scored better than those presented later. This study suggested little advantage of a verbal review of the consent (except for patients for risk) when other means of review such as the customized slide show were included. Regression analysis suggested that patients understood best the elements presented first in the informed consent slide show. Consequently, the most important information should be presented first to patients, and any

  2. Informed Consent in Decision-Making in Pediatric Practice.

    PubMed

    Katz, Aviva L; Webb, Sally A

    2016-08-01

    Informed consent should be seen as an essential part of health care practice; parental permission and childhood assent is an active process that engages patients, both adults and children, in their health care. Pediatric practice is unique in that developmental maturation allows, over time, for increasing inclusion of the child's and adolescent's opinion in medical decision-making in clinical practice and research. This technical report, which accompanies the policy statement "Informed Consent in Decision-Making in Pediatric Practice" was written to provide a broader background on the nature of informed consent, surrogate decision-making in pediatric practice, information on child and adolescent decision-making, and special issues in adolescent informed consent, assent, and refusal. It is anticipated that this information will help provide support for the recommendations included in the policy statement. Copyright © 2016 by the American Academy of Pediatrics.

  3. Sub-orbital commercial human spaceflight and informed consent.

    PubMed

    Carminati, Maria-Vittoria; Griffith, Doug; Campbell, Mark R

    2011-02-01

    Commercial spaceflight is expected to rapidly develop in the near future. This will begin with sub-orbital missions and then progress to orbital flights. Technical informed consent of spaceflight participants is required by the commercial spaceflight operator for regulatory purposes. Additionally, though not required by regulation, the aerospace medicine professional involved in the medical screening of both spaceflight participants and crewmembers will be asked to assist operators in obtaining medical informed consent for liability purposes. The various federal and state regulations regarding informed consent for sub-orbital commercial spaceflight are evolving and are unfamiliar to most aerospace medical professionals and are reviewed and discussed.

  4. Surgeons' silence: a history of informed consent in orthopaedics.

    PubMed

    Jones, Kevin B

    2007-01-01

    The moment of decision to proceed with surgical intervention is charged with some of the deepest uncertainties in medicine, but has long been cloaked under the confidence asserted by the traditionally custodial surgeon. This paper reviews the history and ethical basis for informed surgical consent. Beginning with theoretical foundations and the changing ethics of medical decision making since the ancient Greeks, it then reviews how the stage was set for informed consent by technological breakthroughs that made surgical interventions tolerable and acceptably safe. Finally, the legal generation of the doctrine of informed consent is reviewed and the current state of disclosure, shared decision-making, and uncertainty explored.

  5. Ethical Issues Regarding Informed Consent for Minors for Space Tourism

    NASA Astrophysics Data System (ADS)

    Marsh, Melvin S.

    2010-01-01

    This paper describes the difficulty with informed consent and debates whether or not whether adults should be able to ethically, morally, and legally consent for their children during the high-risk activity of space tourism. The experimental nature of space vehicles combined with the high likelihood of medical complications and the destination places space tourism legally in the category of "adventure activities," which include adventure travel to exotic locations as well as adventure sports, such as mountain climbing, rafting, etc. which carry a high risk of danger (http://rescommunis.wordpress.com/2008/02/14/interview-tracey-l-knutson-adventure-sports-defense-attorney-on-space-tourism-risk-and-informed-consente/). However, unlike other adventure sports, adults currently cannot consent for their minor children. Other topics also receive attention, such as a "mature minors" clause, radiation exposure of potential future children, and other difficulties preventing adults from legally consenting to space travel.

  6. A randomized controlled trial of an electronic informed consent process.

    PubMed

    Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

    2014-12-01

    A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

  7. Screening for prostate cancer. How can patients give informed consent?

    PubMed Central

    Marshall, K. G.

    1993-01-01

    Many urologists in North America are increasingly enthusiastic about prostatic cancer screening. Annual digital rectal examination is almost universally endorsed, and prostate-specific antigen testing is favored by most. But doctors really should not screen by either method without patients' informed consent. However, the information required for informed consent is complex and contradictory, difficult for physicians to give and for patients to absorb. PMID:7505673

  8. Pragmatic Randomized Trials Without Standard Informed Consent?: A National Survey

    PubMed Central

    Nayak, Rahul K; Wendler, David; Miller, Franklin G.; Kim, Scott Y.H.

    2017-01-01

    Background There is significant debate over whether written consent is necessary for low-risk, pragmatic randomized controlled trials (RCT). Objective To assess the U.S. public’s views regarding alternatives to written consent for low-risk pragmatic RCTs. Design National experimental survey (2-by-2 factorial design) examining support for written consent versus general notification or verbal consent in two research scenarios. Setting Web-based survey conducted in December 2014. Participants 2130 U.S. adults sampled from a nationally representative probability-based online panel (response rate, 64%). Measurements Respondent’s recommendation to an ethics review board and personal preference as a potential participant for how to obtain consent/notification in the two research scenarios. Results A majority in each of the four arms (ranging from 60.3% to 71.5%) recommended written informed consent. Personal preferences generally tracked that advice. Most (78.9%) believed the pragmatic RCTs did not pose additional risks but 62.5% of these respondents would still recommend written consent. In contrast, a substantial minority in all arms (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent. Limitations Framing effects could impact respondents’ attitudes and non-respondents may differ in levels of trust towards research or healthcare institutions. Conclusions A majority of the public endorsed written informed consent over the most widely considered alternatives for low-risk pragmatic RCTs; however, a substantial minority endorsed general notification or verbal consent. Primary Funding Source Time-sharing Experiments in the Social Sciences and Intramural Research Program of the National Institutes of Health, Clinical Center. PMID:26215125

  9. Informed consent for surgery: risk discussion and documentation

    PubMed Central

    Hanson, Melissa; Pitt, Dennis

    2017-01-01

    Summary Informed consent for surgery has become a critical component of surgical practice. There are specific legal requirements for what has to be disclosed to patients and for the accompanying documentation. The hospital consent for surgery form with the patient’s signature is a small part of the process. A quality assurance review of the documentation of informed consent by our surgical group indicated major deficiencies and prompted this article (and its Appendix containing further information). Our intent was to inform surgeons about modern standards and to discuss particular challenges. Informed consent for surgery entails what surgeons communicate to their patients about the proposed surgery and is a key element in the trust patients have in surgeons. It is of increasing importance, and we must keep up to date with patient and legal expectations. PMID:28234594

  10. Informed Consent Documentation for Lumbar Puncture in the Emergency Department

    PubMed Central

    Anderson, Hannah Elise; Keenly, Lisa D.; Vinson, David R.

    2014-01-01

    Introduction: Informed consent is a required process for procedures performed in the emergency department (ED), though it is not clear how often or adequately it is obtained by emergency physicians. Incomplete performance and documentation of informed consent can lead to patient complaints, medico-legal risk, and inadequate education for the patient/guardian about the procedure. We undertook this study to quantify the incidence of informed consent documentation in the ED setting for lumbar puncture (LP) and to compare rates between pediatric (<18 years) and adult patients. Methods: In this retrospective cohort study, we reviewed the ED electronic health records (EHR) for all patients who underwent successful LPs in 3 EDs between April 2010 and June 2012. Specific elements of informed consent documentation were reviewed. These elements included the presence of general ED and LP-specific consent forms, signatures of patient/guardian, witness, and physician, documentation of purpose, risks, benefits, alternatives, and explanation of the LP. We also reviewed the use of educational material about the LP and LP-specific discharge information. Results: Our cohort included 937 patients; 179 (19.1%) were pediatric. A signed general ED consent form was present in the EHR for 809 (86%) patients. A consent form for the LP was present for 524 (56%) patients, with signatures from 519 (99%) patients/guardians, 327 (62%) witnesses, and 349 (67%) physicians. Documentation rates in the EHR were as follows: purpose (698; 74%), risks (742; 79%), benefits (605; 65%), alternatives (635; 68%), and explanation for the LP (57; 6%). Educational material about the LP was not documented as having been given to any of the patients and LP-specific discharge information was documented as given to 21 (2%) patients. No significant differences were observed in the documentation of informed consent elements between pediatric and adult patients. Conclusion: General ED consent was obtained in the vast

  11. On the Ottoman consent documents for medical interventions and the modern concept of informed consent.

    PubMed

    Kara, Mahmut A; Aksoy, Sahin

    2006-09-01

    Information for patients prior to medical intervention is one of the principles of modern medical practice. In this study, we looked at an earlier practice of this principle. Ottoman judges had record books called sicil. One of the categories in sicils was the consent documents called riza senedi, which was a patient-physician contract approved by the courts. These contracts were especially for the protection of physicians from punishment if the patient dies. It is not clear whether patients were informed properly or not. Consent for minors was obtained from parents. However, a situation where an adult does not have the capacity to consent, was not clear in these documents. Any sign of free withdrawal of consent was not found in these records. Due to the legal system of Ottoman State, these contracts were related to Islamic law rather than modern civil law. We aim, in this paper, to present a legal practice, which is possible to consider as an early example of the informed consent practice.

  12. Assessing the content, presentation, and readability of dental informed consents.

    PubMed

    Glick, Aaron; Taylor, David; Valenza, John A; Walji, Muhammad F

    2010-08-01

    Informed consents are important aids in helping patients make optimal decisions. Little knowledge exists about the quality of dental informed consents. Fifty-two informed consents used throughout the University of Texas Health Science Center at Houston Dental Branch were evaluated based on the quality of their content, readability, and presentation. Content quality was judged on four basic elements: description of procedure, risk, benefits, and alternatives. Of the clinical consents, 26 percent of forms contained all four of the basic content elements, 48 percent contained three of four elements, 16 percent contained two of four elements, and 10 percent contained one of four elements. Presentation quality was judged on twelve criteria items. The average clinical consent included seven out of twelve presentation items, and the average nonclinical consent included eight out of twelve items. Readability was judged using three standard instruments for rating readability: Flesch Reading Ease, Flesch-Kincaid Grade-Level, and Simple Measure of Gobbledygook (SMOG) grading. Average Flesch-Kincaid Grade-Level was 12.7 (range, 7.4 to 19.1), significantly higher than the recommended ninth grade level (p<.001). The results suggest that many existing dental informed consents may be improved by 1) increasing the comprehensiveness of the content, 2) improving the design and layout, and 3) reducing the readability levels for patient comprehension.

  13. "Informed" Consent: An Audit of Informed Consent of Cesarean Section Evaluating Patient Education and Awareness.

    PubMed

    Kirane, Akhilesh G; Gaikwad, Nandkishor B; Bhingare, Prashant E; Mule, Vidya D

    2015-12-01

    Better diagnosis and early referral due to increased health care coverage have increased the cesarean deliveries at tertiary-care hospitals of India. Improvements in the health care system raise many concerns and need of cross-checking system in place to counter the problems pertaining to patient education and participation of patient. While most of the cesarean sections are done in good faith for the patient, it does not escape the purview of consumer awareness and protection. This cross-sectional study was undertaken at a tertiary level government institution to understand the level of awareness of 220 patients regarding the various aspects of cesarean delivery which are essential for women to know before giving an informed consent. 71 % of the women had knowledge about the indication and need to do cesarean delivery. Of these, only one-third (25 % of total women) were properly explained about procedure and complications. Other demographic and social characteristics were also evaluated. While the health care schemes have had their improved results, the onus lies upon the caregivers to improve and maintain the quality of health care in these tertiary-care government hospitals in proportion to the increase in patient load. The results of this study highlight the need for proper counseling of patients regarding complications of cesarean section. The fact that only 25 % of total cases were explained proper procedure and complication as opposed to 71 % of patients having proper knowledge about the indication of cesarean section points out the lack of information in seemingly "informed" consent. To bring about awareness about the risks and complications of cesarean section, there is a need that patients be counseled during the antenatal visits, specifically when patients visit near term for antenatal check up.

  14. 32 CFR 219.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a...

  15. 32 CFR 219.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a...

  16. 15 CFR 27.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy...

  17. 38 CFR 16.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... AFFAIRS PROTECTION OF HUMAN SUBJECTS § 16.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research...

  18. 15 CFR 27.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy...

  19. 16 CFR 1028.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... HUMAN SUBJECTS § 1028.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy...

  20. 32 CFR 219.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a...

  1. 16 CFR 1028.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... HUMAN SUBJECTS § 1028.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy...

  2. 45 CFR 690.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research...

  3. 16 CFR 1028.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... HUMAN SUBJECTS § 1028.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy...

  4. 15 CFR 27.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy...

  5. 15 CFR 27.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... OF HUMAN SUBJECTS § 27.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy...

  6. 45 CFR 690.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... FOUNDATION PROTECTION OF HUMAN SUBJECTS § 690.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research...

  7. 32 CFR 219.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a...

  8. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1117 Documentation of informed consent. (a...

  9. Informed consent for research participation in frail older persons.

    PubMed

    Barron, Jeremy S; Duffey, Patricia L; Byrd, Linda Jo; Campbell, Robin; Ferrucci, Luigi

    2004-02-01

    Informed consent has been the most scrutinized and controversial aspect of clinical research ethics. Institutional review boards (IRBs), government regulatory agencies, and the threat of litigation have all contributed to increasingly detailed consent documents that hope to ensure that subjects are not misled or coerced. Unfortunately, the growing regulatory burden on researchers has not succeeded in protecting subjects, but has rather made the consent process less effective and has discouraged research on vulnerable populations. As a matter of fact, investigators and ethicists continue to identify failures of the consenting process, particularly concerning participation in research of older individuals. The challenges involved in ensuring appropriate consent from the elderly include physical frailty, reduced autonomy and privacy, and impaired decision-making capacity due to dementia, delirium, or other neuropsychiatric illnesses. Ageism among investigators also contributes to failure of informed consent. The evaluation and continuing re-evaluation of an individual's decision-making capacity is critical but difficult. In the most extreme cases, the older adult's ability to participate in the consent process is clearly impaired. However, in many instances, the decision-making capacity is only partially impaired but declines during the course of a research project. Implementing methods of effective communication may enable many frail elderly individuals to make informed decisions. Special challenges are posed by research on end-of-life care, which typically involves frail, older subjects who are uniquely vulnerable, and research is conducted in institutional settings where subtle violations of autonomy are routine. Clearly, the frail elderly represent a vulnerable population that deserves special attention when developing and evaluating an informed consent process. Two important ethical conflicts should be kept in mind. First, although vulnerable older patients must

  10. Informed consent in neurosurgery—translating ethical theory into action

    PubMed Central

    Schmitz, Dagmar; Reinacher, Peter C

    2006-01-01

    Objective Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans. Methods By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed. Results The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician–patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence. Conclusion To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent. PMID:16943326

  11. Informed consent in neurosurgery--translating ethical theory into action.

    PubMed

    Schmitz, Dagmar; Reinacher, Peter C

    2006-09-01

    Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans. By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed. The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician-patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence. To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent.

  12. [Informed consent and neuromodulation techniques for psychiatric purposes: an introduction].

    PubMed

    Mandarelli, Gabriele; Moscati, Filippo Maria; Venturini, Paola; Ferracuti, Stefano

    2013-01-01

    The aim of this review was to investigate informed consent-related issues concerning vagus nerve stimulation and deep brain stimulation in the treatment of psychiatric disorders. We searched the principal medical databases for studies concerning informed consent, as well as ethical and deontological issues in psychosurgery. Data were critically analysed. We also provided guidelines for the evaluation of accuracy of the informed consent in such treatments. Despite major deontological and ethical implications, there is substantial lack of information pertaining informed consent decision-making in psychiatric patients with an indication for psychosurgery. In clinical research studies, deep brain stimulation and vagus nerve stimulation have been mainly used in drug-resistant major depressive disorder, Tourette syndrome and obsessive-compulsive disorder. Existing data on efficacy and tolerability, as well as those studies indicating the risk for incapacity in drug-resistant severe mental disorders, suggest the need to achieve a better understanding of the capacity to consent to psychosurgery in patients affected by mental disorders. Informed consent decision-making in clinical trials of deep brain stimulation and vagus nerve stimulation in psychiatric patients is largely unknown and deserves further investigation.

  13. [Ethical and regulatory requirements for conducting clinical trials: patient information and patient informed consent].

    PubMed

    Schwarz, J A

    2005-04-01

    Written informed consent must be obtained from legally competent subjects, after having been duly informed verbally and in writing, before participation in a clinical trial with pharmaceutical products or medical devices. For persons or minors incapable of giving their informed legal consent, the written consent of the subject's legal representative is mandatory. The subject's presumed or expressed wish must be considered.

  14. Informed consent and the law--an English legal perspective.

    PubMed

    Hassan, Majid

    2008-01-01

    'Informed consent' is a widely used term, but its application in a legal perspective can be varied. American and Commonwealth jurisdictions have developed a 'patient-based' true informed consent approach, whereas in the English legal system a 'doctor-based' approach has traditionally been applied in relation to disclosure of risk. This article will seek to compare these approaches and give a brief overview of some of the key legal rulings which have shaped the requirement of consent. The decision in the English case of Chester vs. Afshar is considered as showing the significance the court attached to the principle of autonomy and using ethical and policy considerations to depart from established principles of English law relating to consent to treatment and disclosure of risk. This review is intended as general information and not as legal advice which should be sought from defence organisation and specialist health care lawyers.

  15. Information, consent and perceived coercion: patients' perspectives on electroconvulsive therapy.

    PubMed

    Rose, Diana S; Wykes, Til H; Bindman, Jonathan P; Fleischmann, Pete S

    2005-01-01

    Electroconvulsive therapy (ECT) is a procedure that attracts special safeguards under common law for voluntary patients and under both current and proposed mental health legislation, for those receiving compulsory treatment. To review patients' views on issues of information, consent and perceived coercion. Seventeen papers and reports were identified that dealt with patients' views on information and consent in relation to ECT; 134 'testimonies' or first-hand accounts were identified. The papers and reports were subjected to a descriptive systematic review. The testimony data were analysed qualitatively. Approximately half the patients reported that they had received sufficient information about ECT and side-effects. Approximately a third did not feel they had freely consented to ECT even when they had signed a consent form. Clinician-led research evaluates these findings to mean that patients trust their doctors, whereas user-led work evaluates similar findings as showing inadequacies in informed consent. Neither current nor proposed safeguards for patients are sufficient to ensure informed consent with respect to ECT, at least in England and Wales.

  16. Informed consent and ethical issues in military medical research.

    PubMed

    McManus, John; Mehta, Sumeru G; McClinton, Annette R; De Lorenzo, Robert A; Baskin, Toney W

    2005-11-01

    Informed consent in military research shares many of the same fundamental principles and regulations that govern civilian biomedical research. In fact, much of modern research ethics is grounded in events that occurred in the context of war or government-sponsored research. Despite these similarities and common origins, research in the military has additional requirements designed to preserve service members' informed consent rights. The special nature of the superior-subordinate relationship in the military necessitates careful protections to avoid perceptions of coercion or undue influence on a military subject. Additionally, current legal and regulatory requirements for advanced informed consent significantly restrict the flexibility of the military to conduct research using waiver of consent. This has implications on the ability of the nation to develop effective medical treatments for the global war on terrorism. Nevertheless, work is under way to realign defense research policy with the norms of civilian biomedical practice. Future directions include the adoption of waivers for military emergency research, and the cautious introduction of human subject studies on the battlefield. This paper discusses historical background, regulatory differences, and concerns and challenges of some of these regulatory differences for research personnel that apply to informed consent and waiver of said informed consent for emergency research conducted by the U.S. military.

  17. Surgical informed consent in children: a systematic review.

    PubMed

    Chotai, Pranit N; Nollan, Richard; Huang, Eunice Y; Gosain, Ankush

    2017-06-01

    The purpose of the article was to analyze current literature on surgeon and parents' understanding and role in the informed consent process for children undergoing surgery. A systematic database search (MEDLINE, EMBASE, PsycINFO, and EBM Reviews) was performed to identify articles concerning any aspect of the surgical informed consent for children undergoing an invasive procedure. Articles analyzing informed consent in research studies, non-English-language articles, review articles, case reports and/or series, letters-commentaries, and dentistry and/or nursing-related articles were excluded. Articles meeting inclusion criteria were analyzed to identify common themes related to the process of informed consent. One hundred seventy-eight articles were identified on primary search, after removing duplicates and screening titles for relevance, 83 abstracts were reviewed. Thirty-two additional abstracts were identified by secondary search. Twelve of 115 articles met inclusion criteria. Analysis identified five different study themes. Information delivered during consent (Content) was studied in five articles (42%), three (25%) studied the mechanics or delivery of the information (Delivery), three (25%) studied parent participation and discussion (Interchange), six articles (50%) discussed surgeons' perceptions or the parents' ability to understand or recall the information (Comprehension), and five articles (42%) evaluated surgeon or parent satisfaction or anxiety (Satisfaction). None of the articles studied all five categories. Studies of the surgical informed consent process in children are scarce. Prospective studies evaluating surgeon and parent perception regarding the Content, Delivery, and Interchange of information as well as Comprehension and Satisfaction are needed to understand barriers to the surgeon-patient relationship and to optimize the informed consent process in children undergoing surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. From informed consent to informed request: strengthening shared decisionmaking.

    PubMed

    Malik, Aisha Y; Foster, Charles

    2014-01-01

    Obtaining valid consent is regarded as essential before there can be an ethically or legally appropriate medical intervention. The justification is, simply, that patient autonomy should be respected. The patient's body is hers, and she has a right to do with it what she chooses. In order for that choice to be real, it has to be a choice made by a patient who is competent to make it. That competence has two elements. First, the patient must have the cognitive hardware and software necessary to receive, retain and process the information, weighing the benefits and the burdens of the proposed treatment against each other. Second, the inputs must be the relevant ones: the information to be processed must be (i) accurate and (ii) sufficient.

  19. Are Good Intentions Good Enough?: Informed Consent Without Trained Interpreters

    PubMed Central

    de Voogd, Katherine B.

    2007-01-01

    Objective To examine the informed consent process when trained language interpreters are unavailable. Background Ensuring sufficient patient understanding for informed consent is especially challenging for patients with Limited English Proficiency (LEP). While US law requires provision of competent translation for LEP patients, such services are commonly unavailable. Design and Participants Qualitative data was collected in 8 prenatal genetics clinics in Texas, including interviews and observations with 16 clinicians, and 30 Latina patients. Using content analysis techniques, we examined whether the basic criteria for informed consent (voluntariness, discussion of alternatives, adequate information, and competence) were evident for each of these patients, contrasting LEP patients with patients not needing an interpreter. We present case examples of difficulties related to each of these criteria, and compare informed consent scores for consultations requiring interpretation and those which did not. Results We describe multiple communication problems related to the use of untrained interpreters, or reliance on clinicians’ own limited Spanish. These LEP patients appear to be consistently disadvantaged in each of the criteria we examined, and informed consent scores were notably lower for consultations which occurred across a language barrier. Conclusions In the absence of adequate Spanish interpretation, it was uncertain whether these LEP patients were provided the quality and content of information needed to assure that they are genuinely informed. We offer some low-cost practice suggestions that might mitigate these problems, and improve the quality of language interpretation, which is essential to assuring informed choice in health care for LEP patients. PMID:17443367

  20. Different Aspects of Informed Consent in Aesthetic Surgeries

    PubMed Central

    Nejadsarvari, Nasrin; Ebrahimi, Ali

    2014-01-01

    Providing an informed consent has an important role in promotion of medical treatments and reduction of judiciary litigations in this process. Today with cultural changes and wide propagation that is usually charming, the request for aesthetic surgery has an increasing trend. These problems with complexity of cosmetic surgeries lead to deeper differences of information between plastic surgeons and patients, so the discussion on giving information to a patient is of great importance. Regarding the elective choice of aesthetic surgeries, there is a need on providing a standard informed consent form. There are some problems on advertisements of aesthetic surgeries by non-plastic surgeons, taking insufficient or incorrect information to the patients affecting the patients’ autonomy. In fact, correct operative information should be share with the patients. Probable complications and alternative procedures should be presented to the patient to choose an operative option freely and without any charming. Obtaining a written informed consent can protect researchers and their sponsor institutions from any litigation. Patients with psychiatric problems can not benefit from aesthetic surgery and also they have no competency for giving any informed consent. So psychiatric problems can even worsen the surgical interventions. In this article, fundamentals of plastic surgery to provide an informed consent were reviewed and the legal and ethical considerations were evaluated. PMID:25489529

  1. Informed consent and decision making by cataract patients.

    PubMed

    Kiss, Christopher G; Richter-Mueksch, Sibylla; Stifter, Eva; Diendorfer-Radner, Gabriela; Velikay-Parel, Michaela; Radner, Wolfgang

    2004-01-01

    To investigate decision making by patients on the day before cataract surgery and to evaluate to what extent the informed consent process influences the patients' decision regarding consent. On the day before surgery, 70 patients (mean +/- SD age, 70.3 +/- 10.3 years) underwent a standardized informed consent procedure. They were also invited to answer 15 questions established in interdisciplinary cooperation among clinical psychologists, lawyers, and ophthalmologists. We assessed presurgical information and personal estimation of risks in cataract surgery; the patient-physician relationship regarding surgery-related decisions; and evaluations of the informed consent procedure and the patients' decision. Questionnaire answers indicated that 28 (40%) of the 70 participating patients arrived for surgery without any information; 16 (23%) believed that there were surgical procedures without risks; and 53 (76%) estimated that there were no risks for their cataract surgery. A physician-dominated decision for surgery was preferred by 31 patients (44%); 16 (26%) wanted to decide together with their ophthalmologist. Possible risks of a sight-threatening complication did not influence 54 patients' (77%) decisions, and 55 patients (78%) said the informed consent process did not influence their decision. The remaining 15 (22%) stated that the informed consent process positively confirmed their decision. Informed consent 1 day preoperatively does not seem to influence the decision for cataract surgery. Cognitive dissonance as part of a decision-making process makes changes in an already chosen option unlikely. The resulting limited decisive potential is very important for credibility in a trial and has to be considered in ophthalmologic surgery.

  2. Informed consent and nurses' roles: a survey of Indonesian practitioners.

    PubMed

    Susilo, Astrid P; van Dalen, Jan; Chenault, Michelene N; Scherpbier, Albert

    2014-09-01

    In Southeast Asia, the process of obtaining informed consent is influenced by both culture and policy at the hospital and national level. Both physicians and nurses play vital roles in this process, but physicians influence the roles of nurses. Since the physicians and nurses often have different perspectives, it is important to investigate their views about the informed consent process and nurses' roles therein and whether there is a difference between ideal and experienced practice (reality), and whether this differs across hospitals. A questionnaire was developed and a survey was conducted among physicians and nurses. Using exploratory factor analysis a three factor structure was determined: 'nurses' roles', 'barriers in informed consent', and 'adequacy of information'. Non-parametric tests were applied to compare nurses and physicians, and hospital setting. Responses were obtained from 129 physicians and 616 nurses from two Indonesian hospitals. Those hospitals differ in ownership, location, and size. The study was reviewed by the hospital ethical committee. Participation was voluntary and confidentiality was ensured by keeping the responses anonymous. Physicians and nurses differ significantly on all three factors. The scores reflecting disparity between ideal and reality regarding nurses' roles varied across professions, while barriers in informed consent differed between hospitals. The differences between ideal and reality indicated that improvement in the informed consent process and nurses' roles therein is called for. Varying views between physicians and nurses on nurses' roles may hinder collaboration. The differences between hospital settings showed interventions may have to be customized for different settings. Views on nurses' roles vary across professions. Views on barriers in informed consent vary across hospitals. Therefore interprofessional education is needed to promote interprofessional collaboration and intervention to improve informed consent

  3. [Informed consent in clinical practice and medical research].

    PubMed

    Santillan-Doherty, Patricio; Cabral-Castañeda, Antonio; Soto-Ramírez, Luis

    2003-01-01

    The present paper deals with the basic aspects, influences and elements that constitute Informed Consent seeing it as a process and not only as an administrative format. Both the patient-physician relationship, as well as the research subject-investigator relationship, should be seen in the same manner, in spite of recognizing specific objectives for each one. For this reason, Informed Consent should not be different regarding both clinical as well as research activities. The patient-physician relationship presents a disbalance of power within the relationship in favor of the physician; this adds to the moral considerations that take place within both participants. Informed Consent should be defined in a broad sense as all those actions that promote a process of communication and dialogue which facilitates a person in order to make decisions with respect of an action, practice or product that have an impact on his/her body, intimacy or other vital spaces. Informed Consent has influences that originate in basic bioethical principles (autonomy, beneficience, non-maleficence, justice), professional and international declarations (Hippocratic Oath, Declaration of Helsinki), as well as legal considerations pertinent to each country. In our country legality emmanates from the General Health Law which, unfortunately, only contemplates Informed Consent as part of the relation established in clinical research. However, the Official Medican Norm on the Clinical Record establishes the conditions where Informed Consent must be obtained during clinical as well as research activities. Primary components of Informed Consent (revelation, capacity to understand and voluntariness), can be better understood when divided into several elements: information, voluntariness, risks and benefits, confidentiality, return of information, utility of the process and management of fragility. Informed Consent should be legally instrumented in an explicit written manner (administrative formats

  4. Observing communication skills for informed consent: an examiner's experience.

    PubMed

    Srinivasan, J

    1999-12-01

    To examine medical students' communication skills and competence regarding informed consent during an objective structured clinical examination (OSCE). At the University of Toronto, 22 candidates wrote MCCQE part II as a prerequisite for medical licensure. The candidates' performance at one station involving informed consent was assessed using binary checklists and global ratings. Candidates were assessed for their clinical skills in approaching the problem, knowledge of subject matter, attitude towards the situation, and communication ability with the patient. Of the candidates, 90 per cent performed well and demonstrated their ability to effectively deal with the patient's physical concerns. Only 50 per cent performed relevant mental-status examinations; and 50 per cent of the candidates seemed to be biased and physician-centered. They were unable to acknowledge the associated psychological issues that might influence the patient's decision in the process of informed consent. Only a few expressed their concern and empathy, and were able to guide the patient in making an autonomous decision about surgical procedures. The OSCE seems to be an appropriate and effective means to evaluate clinical competence in psychiatry. The variation in candidates' performance, however, suggests a greater need to improve clinical skills, particularly those that are relevant to psychological considerations in obtaining informed consent and providing required information to patients. Thus, emphasis should be given in undergraduate teaching programs to addressing effective means of assessing patients' competency and their ability to give informed consent.

  5. Improving the informed consent process in international collaborative rare disease research: effective consent for effective research

    PubMed Central

    Gainotti, Sabina; Turner, Cathy; Woods, Simon; Kole, Anna; McCormack, Pauline; Lochmüller, Hanns; Riess, Olaf; Straub, Volker; Posada, Manuel; Taruscio, Domenica; Mascalzoni, Deborah

    2016-01-01

    The increased international sharing of data in research consortia and the introduction of new technologies for sequencing challenge the informed consent (IC) process, adding complexities that require coordination between research centres worldwide. Rare disease consortia present special challenges since available data and samples may be very limited. Thus, it is especially relevant to ensure the best use of available resources but at the same time protect patients' right to integrity. To achieve this aim, there is an ethical duty to plan in advance the best possible consent procedure in order to address possible ethical and legal hurdles that could hamper research in the future. Therefore, it is especially important to identify key core elements (CEs) to be addressed in the IC documents for international collaborative research in two different situations: (1) new research collections (biobanks and registries) for which information documents can be created according to current guidelines and (2) established collections obtained without IC or with a previous consent that does not cover all CEs. We propose here a strategy to deal with consent in these situations. The principles have been applied and are in current practice within the RD-Connect consortia – a global research infrastructure funded by the European Commission Seventh Framework program but forward looking in terms of issues addressed. However, the principles established, the lessons learned and the implications for future research are of direct relevance to all internationally collaborative rare-disease projects. PMID:26860059

  6. Routinisation of informed consent in online health care systems.

    PubMed

    Ploug, Thomas; Holm, Søren

    2015-04-01

    To investigate (1) the extent to which informed consent is routinised, i.e., given habitually and without reflection, in relation to the use of web-portals containing personal health information, and (2) the reasons given by users for routinised and non-routinised consent behaviour. Anonymous web-questionnaire among users of the official Danish health information web-portal, Sundhed.dk. Sundhed.dk allows Danish residents access to their electronic patient records and other personal health information and allows them to update some of this information. Use of the portal requires explicit consent to the terms and conditions of use and the data protection policies of the site. Degree to which information materials are read before use of the portal. Reasons given for reading or not reading materials. Seventy-nine percent of respondents read half or less of the information materials before using the portal. The main reasons given for not reading (all) of the materials relate to the length of the materials, the frequency of having to read such things, and the perception that use of the portal is 'low risk'. The reasons given for reading and not reading indicate that the consent process is routinised. Most users of Sundhed.dk do not provide informed consent before using the portal, since most do not read the information fully. The reasons given for not reading strongly supports the idea that consent has become a routinised behaviour in this context. This finding is important because web-portals offering access to personal health information held by the health care system are becoming ever more frequent. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  7. Rethinking Informed Consent in Research on Heroin-Assisted Treatment.

    PubMed

    Uusitalo, Susanne; Broers, Barbara

    2015-09-01

    Can heroin addicts give consent to research on trials in which heroin is prescribed to them? Analyses of addicts and informed consent have been objects of debate in several articles. Informed consent requires the agent not only to be competent but also to give consent voluntarily. This has been questioned because of alleged features of heroin addiction. Until recently the discussion has focused on heroin addicts' desires for heroin, whether these are irresistible and thus pose a problem for giving consent. Still, in light of empirical evidence, there seems to be a consensus more or less that the problem is not whether the addicts can resist their desire for heroin. A recent article concentrates specifically on heroin addicts' false assumptions of options and voluntariness. We argue that the prevailing framing of the options in this discussion in terms of heroin and access to it is problematic. The way in which the options are typically laid out suggests an assumption that participation in the research is allegedly based on the addicts' views on using the drug. We argue that this way of presenting the options is, first, a mismatch to the studies carried out and, second, symptomatic of potential misconceptions about heroin addiction and addicts. Furthermore, we also suggest that the account of voluntariness needs to be realistic in order for subjects to be able to give consent voluntarily in actual situations, and for medical research to carry out studies on improving outcomes in addiction treatment in an ethical way.

  8. Informed Consent Conversations and Documents: A Quantitative Comparison

    PubMed Central

    Koyfman, Shlomo A.; Reddy, Chandana A.; Hizlan, Sabahat; Leek, Angela C.; Kodish, Eric

    2015-01-01

    Background Informed consent for clinical research includes two components: informed consent documents (ICD) and informed consent conversations (ICC). Readability software has been used to help simplify the language of the ICD, but rarely employed to assess the language during the ICC, which may influence the quality of informed consent. This analysis was completed to determine if length and reading levels of transcribed ICCs are lower than their corresponding ICDs for selected clinical trials, and to assess whether investigator experience affected use of simpler language and comprehensiveness. Methods Prospective study where ICCs were audio-recorded at 6 institutions when families were offered participation in pediatric phase I oncology trials. Word count, Flesch-Kincaid Grade Level (FKGL) and Flesch Reading Ease Score (FRES) of ICCs were compared to corresponding ICDs, including the frequency that investigators addressed 8 pre-specified critical consent elements during the ICC. Results Sixty-nine unique physician/protocol pairs were identified. Overall, ICCs contained fewer words (4,677 vs. 6,364; p=0.0016), had lower FKGL (6 vs. 9.7; p=<0.0001) and higher FRES (77.8 vs. 56.7; p<0.0001) than their respective ICDs, but were more likely to omit critical consent elements, such as voluntariness (55%) and dose limiting toxicities (26%). Years of investigator experience was not correlated with reliably covering critical elements or decreased linguistic complexity. Conclusions Clinicians use more understandable language during ICCs than the corresponding ICD, but less reliably cover elements critical to fully informed consent. Focused efforts at providing communication training for clinician-investigators should be done to optimize the synergy between the ICD and conversation. PMID:26505269

  9. Elements of informed consent and decision quality were poorly correlated in informed consent documents.

    PubMed

    Brehaut, Jamie C; Carroll, Kelly; Elwyn, Glyn; Saginur, Raphael; Kimmelman, Jonathan; Shojania, Kaveh; Syrowatka, Ania; Nguyen, Trang; Fergusson, Dean

    2015-12-01

    Although informed consent (IC) documents must contain specific elements, inclusion of these elements may be insufficient to encourage high-quality decision making. We assessed the extent to which documents conform to IC standards and how well conformity to decision quality (DQ) standards can be predicted by IC standards, IC document characteristics, and study characteristics. We obtained 139 IC documents for trials registered with ClinicalTrials.gov from study investigators. Using a four-point scale, two raters independently assessed each IC document on 36 IC standard items and 9 DQ items. Overall agreement between raters across all 45 items was 93%. Across the 36 IC standards items, conformity was generally quite high but variable, with 20 items showing conformity of 80% or more and seven items showing conformity of 50% or lower. IC standards concordance, overall length of the IC document, and country of study were all significant predictors of DQ standards but together accounted for less than 20% of the variance in DQ standards. Conformity to recommendations for improving IC documents was relatively high but variable. The extent to which an IC document conformed to these recommendations was only moderately related to whether it conformed to recommendations for improving DQ. Existing IC regulations may not describe the optimal approach to helping people make good study participation decisions. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. Elements for adequate informed consent in the surgical context.

    PubMed

    Abaunza, Hernando; Romero, Klaus

    2014-07-01

    Given a history of atrocities and violations of ethical principles, several documents and regulations have been issued by a wide variety of organizations. They aim at ensuring that health care and clinical research adhere to defined ethical principles. A fundamental component was devised to ensure that the individual has been provided the necessary information to make an informed decision regarding health care or participation in clinical research. This article summarizes the history and regulations for informed consent and discusses suggested components for adequate consent forms for daily clinical practice in surgery as well as clinical research.

  11. Informed or Misinformed Consent? Abortion Policy in the United States.

    PubMed

    Daniels, Cynthia R; Ferguson, Janna; Howard, Grace; Roberti, Amanda

    2016-04-01

    Since 2010, the United States has witnessed a dramatic expansion of state-based restrictions on abortion. The most common of these are informed consent statutes, which require that a woman seeking an abortion receive a state-authored informational packet before the abortion procedure can be performed. These laws, in addition to requiring the provision of information about alternatives to and risks of abortion, all also require details of embryological and fetal development. This article presents the findings of a comprehensive study of state-authored informed consent materials regarding embryological and fetal development. To conduct this study, we recruited a panel of experts in human anatomy to assess the accuracy of these materials in the context of the constitutional standard established inPlanned Parenthood of Southeastern Pennsylvania et al. v. Robert P. Casey et al.(505 U.S. 833 (1992)): that such information must be "truthful" and "nonmisleading." We find that nearly one-third of the informed consent information is medically inaccurate, that inaccurate information is concentrated primarily in the earlier weeks of pregnancy and is clustered around particular body systems. We discuss the implications of our findings for the question of the constitutionality of informed consent laws as they have been implemented in practice. Copyright © 2016 by Duke University Press.

  12. INFORMED CONSENT: THE MEDICAL AND LEGAL CHALLENGE OF OUR TIME

    PubMed Central

    Séllos Simões, Luiz Carlos

    2015-01-01

    Objective: To assess the real importance of obtaining informed consent, through an appropriate form, and its role in the outcome from civil liability claims. Methods: The wordings of the current Brazilian law and jurisprudence were compared with rulings from the State Court of the State of Rio de Janeiro, in 269 civil liability claims against healthcare professionals and hospitals. Results: Favorable and unfavorable outcomes (i.e. acquittals and convictions) were compared, and possible variations in the verdicts were discussed in relation to whether informed consent forms had been filled out or not. Conclusions: Obtaining informed consent, by means of appropriate forms, is still not a widespread practice in the Brazilian healthcare or judicial systems. It is recommended that this practice be adopted in the manner described in this paper, since this is prescribed in Brazilian law. PMID:27022541

  13. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the subject may discontinue participation at any time without penalty or loss of benefits to which the... the study. (c) When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed...

  14. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the subject may discontinue participation at any time without penalty or loss of benefits to which the... the study. (c) When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed...

  15. Relational autonomy in informed consent (RAIC) as an ethics of care approach to the concept of informed consent.

    PubMed

    Osuji, Peter I

    2017-07-28

    The perspectives of the dominant Western ethical theories, have dominated the concepts of autonomy and informed consent for many years. Recently this dominant understanding has been challenged by ethics of care which, although, also emanates from the West presents a more nuanced concept: relational autonomy, which is more faithful to our human experience. By paying particular attention to relational autonomy, particularity and Process approach to ethical deliberations in ethics of care, this paper seeks to construct a concept of informed consent from the perspective of ethics of care which is here called relational autonomy-in-informed consent (RAIC). Thus, providing a broader theoretical basis for informed consent beyond the usual theoretical perspectives that are particularly Western. Care ethics provides such a broader basis because it appeals to a global perspective that encompasses lessons from other cultures, and this will help to enrich the current ideas of bioethics principles of autonomy and informed consent. This objective will be achieved by exploring the ethics of care emphasis on relationships based on a universal experience of caring; and by contrasting its concept of autonomy as relational with the understanding of autonomy in the approaches of the dominant moral theories that reflect rational, individualistic, and rights-oriented autonomy of the American liberalism.

  16. [Informed consent of the surgical patient].

    PubMed

    Kovács, József

    2014-02-01

    The article analyses the consequences of the paradigm shift in the surgical practice in the last fifty years. The earlier, paternalistic physician-patient relationship has been replaced by an equal one, which is based on informing the patient and involving him or her in the treatment decisions. This shift did not happen uniformly in various medical subspecialties. In this respect, surgery is more conservative than general medicine. The article analyses the most frequent problems of informing patients, and examines the major elements of information, together with their technical conditions in surgery. It reflects on specifics of surgical information disclosure and conditions of refusing medical interventions.

  17. The informed consent process in randomised controlled trials: a nurse-led process.

    PubMed

    Cresswell, Pip; Gilmour, Jean

    2014-03-01

    Clinical trials are carried out with human participants to answer questions about the best way to diagnose, treat and prevent illness. Participants must give informed consent to take part in clinical trials that requires understanding of how clinical trials work and their purpose. Randomised controlled trials provide strong evidence but their complex design is difficult for both clinicians and participants to understand. Increasingly, ensuring informed consent in randomised controlled trials has become part of the clinical research nurse role. The aim of this study was to explore in depth the clinical research nurse role in the informed consent process using a qualitative descriptive approach. Three clinical research nurses were interviewed and data analysed using a thematic analysis approach. Three themes were identified to describe the process of ensuring informed consent. The first theme, Preparatory partnerships, canvassed the relationships required prior to initiation of the informed consent process. The second theme, Partnering the participant, emphasises the need for ensuring voluntariness and understanding, along with patient advocacy. The third theme, Partnership with the project, highlights the clinical research nurse contribution to the capacity of the trial to answer the research question through appropriate recruiting and follow up of participants. Gaining informed consent in randomised controlled trials was complex and required multiple partnerships. A wide variety of skills was used to protect the safety of trial participants and promote quality research. The information from this study contributes to a greater understanding of the clinical research nurse role, and suggests the informed consent process in trials can be a nurse-led one. In order to gain collegial, employer and industry recognition it is important this aspect of the nursing role is acknowledged.

  18. Should informed consent be based on rational beliefs?

    PubMed Central

    Savulescu, J; Momeyer, R W

    1997-01-01

    Our aim is to expand the regulative ideal governing consent. We argue that consent should not only be informed but also based on rational beliefs. We argue that holding true beliefs promotes autonomy. Information is important insofar as it helps a person to hold the relevant true beliefs. But in order to hold the relevant true beliefs, competent people must also think rationally. Insofar as information is important, rational deliberation is important. Just as physicians should aim to provide relevant information regarding the medical procedures prior to patients consenting to have those procedures, they should also assist patients to think more rationally. We distinguish between rational choice/action and rational belief. While autonomous choice need not necessarily be rational, it should be based on rational belief. The implication for the doctrine of informed consent and the practice of medicine is that, if physicians are to respect patient autonomy and help patients to choose and act more rationally, not only must they provide information, but they should care more about the theoretical rationality of their patients. They should not abandon their patients to irrationality. They should help their patients to deliberate more effectively and to care more about thinking rationally. We illustrate these arguments in the context of Jehovah's Witnesses refusing life-saving blood transfusions. Insofar as Jehovah's Witnesses should be informed of the consequences of their actions, they should also deliberate rationally about these consequences. PMID:9358347

  19. Toward a construct definition of informed consent comprehension.

    PubMed

    Buccini, Laura D; Caputi, Peter; Iverson, Don; Jones, Caroline

    2009-03-01

    VARIATION IN HOW INFORMED CONSENT comprehension tests have been developed may be largely due to the absence of a standardized construct definition. Developing a construct definition would provide a standardized framework for determining how an instrument should be constructed, implemented, interpreted, and applied. Therefore, we utilized the Delphi consensus approach with an international expert panel (N = 19) to gather knowledge, opinions and eventually consensus for a construct definition. Expert consensus was achieved after three revision cycles. While acknowledging that there are limitations to this study, it nonetheless should be considered as a step toward standardization of a construct definition of informed consent comprehension.

  20. An ethical analysis of exception from informed consent regulations.

    PubMed

    Morris, Marilyn C

    2005-11-01

    Federal regulations enacted in 1996 allow clinical research with an exception from informed consent in select emergency circumstances. Such research is only permitted when the therapy may directly benefit the research participant and it is not possible to conduct the research with informed consent. Among others, protective mechanisms include a process of community consultation and public disclosure and the establishment of a mandatory data safety monitoring board. Although the regulations do not preserve the right of self-determination of the research participant, the author argues that they do provide an ethical means to advance the science of resuscitation.

  1. Beyond informed consent: the therapeutic misconception and trust.

    PubMed

    de Melo-Martín, I; Ho, A

    2008-03-01

    The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those receiving ordinary treatment may seriously undermine the informed consent of research subjects. Hence, most theoretical and empirical work on the problems of the therapeutic misconception has been directed to evaluate whether, and to what degree, this confusion invalidates the consent of subjects. We argue here that this focus on the understanding component of informed consent, while important, might be too narrow to capture the ethical complexity of the therapeutic misconception. We show that concerns about misplaced trust and exploitation of such trust are also relevant, and ought to be taken into account, when considering why the therapeutic misconception matters ethically.

  2. 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.

  3. The Use of Multimedia in the Informed Consent Process

    PubMed Central

    Jimison, Holly B.; Sher, Paul P.; Appleyard, Richard; LeVernois, Yvonne

    1998-01-01

    Abstract Objective: The goal of the project was to create recommendations and design specifications for a multimedia tool to enhance the informed consent process for clinical trials. The authors focused on the needs of patients with potential cognitive impairment. Design: The authors first performed a needs assessment using focus groups and interviews with health care researchers, institutional review board members, and three groups of patients (who had depression, breast cancer, or schizophrenia). Their feedback was incorporated into the design of a prototype multimedia tool. The design included general modules with information about clinical trials and informed consent as well as trial-specific modules. The authors then used the resulting prototype multimedia tool for informed consent in follow-up focus groups and interviews to obtain feedback on the feasibility and potential effectiveness of using such a tool routinely for clinical trials. Results: The authors showed that it was feasible to adapt a structured multimedia informed consent system to a specific clinical trial and to incorporate techniques to improve the understandability of informed consent content. Patients generally felt the prototype system was useful and could replace the paper document. They felt using the system would be less stressful, because they would have a greater sense of control and could proceed at their own pace. They liked the hierarchic and modular approach to providing information and felt that the use of video made information more understandable. Researchers and institutional review board members also found the system to be valuable in these ways but had concerns about how to review the system for potential biases in presentation and about the legal issues associated with replacing the paper document. PMID:9609494

  4. Immunization information system opt-in consent: at what cost?

    PubMed

    Boom, Julie A; Sahni, Leila C; Nelson, Cynthia S; Dragsbaek, Anna C; Franzini, Luisa

    2010-01-01

    Immunization information systems (IISs) are confidential, population-based systems that contain immunization data for children, and, in some cases, adults, within a geographic area. There are generally two models for participation in an IIS, termed voluntary exclusion or "opt-out" and voluntary inclusion or "opt-in." Using the Texas opt-in consent system and statewide IIS (ImmTrac), we describe the costs associated with obtaining opt-in consent in hospitals as part of the birth registration process and in provider offices for children without prior consent. We also estimate the costs associated with a hypothetical opt-out system. Between October 2006 and August 2007, project staff conducted on-site time studies for patients in 8 birthing hospitals (n = 281), 16 provider offices (n = 131), and ImmTrac state offices in Austin, Texas (n = 100). Total costs per child and costs per year were estimated using a time-and-motion study in which the time associated with discussing ImmTrac and obtaining ImmTrac consent was measured. The annual costs associated with obtaining consent for Texas' opt-in IIS are estimated at $1 389 804.61. The average per child cost associated with ImmTrac consent completed at birth is $2.00, whereas the per child cost for consent completed in provider offices is $2.64. The annual costs of operating an alternative, opt-out system are estimated at $110 714.03, or $0.29 per child. This cost analysis demonstrated that the proposed opt-out costs were substantially less than the actual opt-in model currently utilized. Changing to an opt-out system could redirect limited healthcare funding to more critical areas such as vaccine purchasing and administration.

  5. Effects of presentation method on the understanding of informed consent.

    PubMed

    Moseley, T H; Wiggins, M N; O'Sullivan, P

    2006-08-01

    Knowledge of which presentation methods impart the most information to patients can improve the informed consent discussion. The purpose of this study was to determine if the comprehension and recall of the informed consent discussion varied with presentation method. Randomised, prospective study at the University of Arkansas for Medical Sciences. 90 freshmen medical students were randomly assigned to one of three groups and separately went through an informed consent on cataract surgery. Group A heard an informed consent presentation. Group B was shown diagrams while hearing the same presentation. Group C heard the consent and then watched an informational video on cataract surgery. A 10 point multiple choice quiz was administered after the presentation and repeated again 1 week later. Scores from each group were averaged as number correct out of 10 questions. For same day scores, group C scores (7.70 (SD 1.24)) were significantly higher than group A (6.39 (1.63)). One week testing revealed that group C (6.96 (1.62)) recalled more between the two time periods and scored significantly higher than groups A (5.15 (2.11)) and B (5.54 (1.64)). This study found differences in the participants' ability to recall facts based on the manner in which the material was presented. It clearly demonstrated that the use of visual aids improved the ability to remember facts and risks associated with cataract surgery beyond a verbal presentation alone. It also showed a benefit of the repetition of information as provided by audiovisual presentations that can be used in conjunction with the physician-patient discussion.

  6. 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

  7. 45 CFR 690.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 3 2014-10-01 2014-10-01 false Documentation of informed consent. 690.117 Section 690.117 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION... legally authorized representative, but in any event, the investigator shall give either the subject or the...

  8. 45 CFR 690.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 3 2011-10-01 2011-10-01 false General requirements for informed consent. 690.116 Section 690.116 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE... subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A...

  9. 45 CFR 690.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 3 2011-10-01 2011-10-01 false Documentation of informed consent. 690.117 Section 690.117 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION... legally authorized representative, but in any event, the investigator shall give either the subject or the...

  10. 45 CFR 690.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 3 2012-10-01 2012-10-01 false Documentation of informed consent. 690.117 Section 690.117 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION... legally authorized representative, but in any event, the investigator shall give either the subject or the...

  11. 45 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Section 46.116 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human...

  12. 45 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Section 46.116 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human...

  13. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... may involve a human being as a subject in research covered by this policy unless the investigator has... 7 Agriculture 1 2012-01-01 2012-01-01 false General requirements for informed consent. 1c.116 Section 1c.116 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.116...

  14. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... may involve a human being as a subject in research covered by this policy unless the investigator has... 7 Agriculture 1 2013-01-01 2013-01-01 false General requirements for informed consent. 1c.116 Section 1c.116 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.116...

  15. 45 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Section 46.116 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROTECTION OF HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human...

  16. 22 CFR 225.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 22 Foreign Relations 1 2014-04-01 2014-04-01 false General requirements for informed consent. 225.116 Section 225.116 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN...

  17. 28 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 28 Judicial Administration 2 2011-07-01 2011-07-01 false General requirements for informed consent. 46.116 Section 46.116 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN...

  18. 49 CFR 11.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... investigator may involve a human being as a subject in research covered by this policy unless the investigator... 49 Transportation 1 2011-10-01 2011-10-01 false General requirements for informed consent. 11.116 Section 11.116 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11...

  19. 22 CFR 225.116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 22 Foreign Relations 1 2013-04-01 2013-04-01 false General requirements for informed consent. 225.116 Section 225.116 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN...

  20. 28 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 28 Judicial Administration 2 2014-07-01 2014-07-01 false General requirements for informed consent. 46.116 Section 46.116 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN...

  1. 22 CFR 225.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 22 Foreign Relations 1 2012-04-01 2012-04-01 false General requirements for informed consent. 225.116 Section 225.116 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN...

  2. 28 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., no investigator may involve a human being as a subject in research covered by this policy unless the... 28 Judicial Administration 2 2012-07-01 2012-07-01 false General requirements for informed consent. 46.116 Section 46.116 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) PROTECTION OF HUMAN...

  3. 49 CFR 11.116 - General requirements for informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... investigator may involve a human being as a subject in research covered by this policy unless the investigator... 49 Transportation 1 2012-10-01 2012-10-01 false General requirements for informed consent. 11.116 Section 11.116 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11...

  4. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... may involve a human being as a subject in research covered by this policy unless the investigator has... 7 Agriculture 1 2011-01-01 2011-01-01 false General requirements for informed consent. 1c.116 Section 1c.116 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.116...

  5. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... may involve a human being as a subject in research covered by this policy unless the investigator has... 7 Agriculture 1 2014-01-01 2014-01-01 false General requirements for informed consent. 1c.116 Section 1c.116 Agriculture Office of the Secretary of Agriculture PROTECTION OF HUMAN SUBJECTS § 1c.116...

  6. 49 CFR 11.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... investigator may involve a human being as a subject in research covered by this policy unless the investigator... 49 Transportation 1 2014-10-01 2014-10-01 false General requirements for informed consent. 11.116 Section 11.116 Transportation Office of the Secretary of Transportation PROTECTION OF HUMAN SUBJECTS § 11...

  7. 32 CFR 219.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive... time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional...

  8. Informed consent in medical treatment: conflict or consensus.

    PubMed

    Matta, A M

    2006-06-01

    The author reviews the legal theory and practice of the requirements for informed consent. He uses a discussion of relevant cases and judgements from courts in the UK, USA, Australia and Malaysia to illustrate apparently conflicting attitudes exemplified by these cases. From this he aims to form some consensus in their application to everyday practice.

  9. 15 CFR 27.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... or its agents from liability for negligence. (a) Basic elements of informed consent. Except as...) The research or demonstration project is to be conducted by or subject to the approval of state or...) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or...

  10. 7 CFR 1c.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... for negligence. (a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of... project is to be conducted by or subject to the approval of state or local government officials and is... for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to...

  11. 40 CFR 26.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... PROTECTION OF HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or... from liability for negligence. (a) Basic elements of informed consent. Except as provided in paragraph... project is to be conducted by or subject to the approval of State or local government officials and is...

  12. 45 CFR 46.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.116 General requirements...) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in... subject to the approval of state or local government officials and is designed to study, evaluate, or...

  13. 38 CFR 16.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... institution or its agents from liability for negligence. (a) Basic elements of informed consent. Except as...) The research or demonstration project is to be conducted by or subject to the approval of state or...) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or...

  14. Informed consent in Croatia. A work in progress.

    PubMed

    Vučemilo, Luka; Borovečki, Ana

    2014-07-01

    As Croatia makes the transition from one political system and type of economy to another, there are inevitable social and political changes that have a profound affect on the healthcare system. This article charts some of the progress of change with respect to patients' rights and informed consent.

  15. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Elements of informed consent. 50.25 Section 50.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION... and that notes the possibility that the Food and Drug Administration may inspect the records. (6)...

  16. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Elements of informed consent. 50.25 Section 50.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION... and that notes the possibility that the Food and Drug Administration may inspect the records. (6)...

  17. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 1 2013-07-01 2013-07-01 false Documentation of informed consent. 97.117 Section 97.117 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research...

  18. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 1 2014-07-01 2014-07-01 false Documentation of informed consent. 97.117 Section 97.117 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research...

  19. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 1 2011-07-01 2011-07-01 false Documentation of informed consent. 97.117 Section 97.117 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research...

  20. Teaching the Process of Obtaining Informed Consent to Medical Students.

    ERIC Educational Resources Information Center

    Johnson, Shirley M.; And Others

    1992-01-01

    A unit on informed consent for first-year osteopathy students consists of pre- and posttests, a lecture, readings, small-group discussion, a model videotaped interview, and students' videotaped interviews with a simulated patient. Students were most successful in establishing patient rapport and discussion, least successful in conflict resolution…

  1. Informed Consent in Opioid Therapy: A Potential Obligation and Opportunity

    PubMed Central

    Cheatle, Martin D.; Savage, Seddon R.

    2012-01-01

    The majority of patients receiving opioids for the spectrum of pain disorders experiences negligible or short-term adverse effects (AEs), and rarely develops addiction. However, a subset of this population encounters significant difficulties with opioid therapy. These problems include protracted AEs, as well as misuse, abuse and addiction, which can result in significant morbidity and mortality and makes informed consent an important consideration. Opioid treatment agreements (OTAs), which may include documentation of informed consent, have been employed to promote the safe use of opioids for pain. There is debate regarding the effectiveness of OTAs in reducing the risk of opioid misuse; however, most practitioners recognize that OTAs provide an opportunity to discuss the potential risks and benefits of opioid therapy and to establish mutually agreed upon treatment goals, a clear plan of treatment, and circumstances for continuation and discontinuation of opioids. Informed consent is an important component of an OTA but is not often the focus of consideration in discussions of OTAs. This article examines the principles, process, and content of informed consent for opioid therapy of pain in the context of OTAs. PMID:22445273

  2. Informed Consent, Disclosure, and Performance of Human Research Subjects.

    ERIC Educational Resources Information Center

    Mason, Emanuel J.; Remer, Rory

    The effects of conditions of informed consent and disclosure on the performance of 84 students doing a statistics laboratory assignment for an introductory graduate course in statistics at a state university in the southeast were studied. Four separate classes taught by three instructors were included. Subjects ranged in age from 22 to 47 years,…

  3. Confidentiality and Informed Consent: School Counsellors' Perceptions of Ethical Practices

    ERIC Educational Resources Information Center

    Lehr, Ron; Lehr, Andria; Sumarah, John

    2007-01-01

    This article presents the findings of in-depth interviews with school counsellors in Nova Scotia on issues related to confidentiality and informed consent. Of the 224 school counsellors in the province, 43 counsellors, representing all school boards, agreed to a 45-minute semi-structured telephone interview focusing on their current practices…

  4. Demoralisation: its impact on informed consent and medical care.

    PubMed

    Kissane, D W

    2001-11-19

    Demoralisation, a mental state characterised by hopelessness and meaninglessness, can be differentiated from depression in that demoralised patients can enjoy the present, their lack of hope being confined to the future. However, like severe depression, demoralisation can interfere with a person's capacity to give informed consent. Doctors and other health professionals are also subject to demoralisation, which influences medical care.

  5. 22 CFR 225.116 - General requirements for informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false General requirements for informed consent. 225.116 Section 225.116 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT PROTECTION OF HUMAN..., no investigator may involve a human being as a subject in research covered by this policy unless the...

  6. Assessing elements of informed consent among living donors

    PubMed Central

    Valapour, M; Kahn, JP; Bailey, R; Matas, AJ

    2011-01-01

    Living organ donors – 50% of solid organ donors in the United States – represent a unique population who accept medical risk for the benefit of another. One of the main justifications for this practice has been respect for donor autonomy, as realized through informed consent. In this retrospective study of living donors, we investigate 2 key criteria of informed consent: (1) depth of understanding and (2) degree of voluntariness. In our survey of 262 living kidney donors 2 to 40 months post donation, we found that more than 90% understood the effects of living donation on recipient outcomes, the screening process, and the short-term medical risks of donation. In contrast, only 69% understood the psychological risks of donation; 52% the long-term medical risks of donation; and 32%, the financial risks of donation. Understanding the effects of living donation on recipient outcomes was the only factor that would affect donors' decision to donate again. 40% of donors reported feeling some pressure to donate. Donors who are related to the recipient were more likely to report feeling pressure to donate. We conclude that more studies of informed consent are needed to identify factors that may compromise the validity of informed consent. PMID:21158924

  7. Informed Consent for Return of Incidental Findings in Genomic Research

    PubMed Central

    Appelbaum, Paul S.; Waldman, Cameron R.; Fyer, Abby; Klitzman, Robert; Parens, Erik; Martinez, Josue; Price, W. Nicholson; Chung, Wendy K.

    2013-01-01

    Purpose Researchers face the dilemma of how to obtain consent for return of incidental findings (IFs) from genomic research. We surveyed and interviewed investigators and study participants, with the goal of providing suggestions for how to shape the consent process. Methods We performed an online survey of 254 US genetic researchers identified through the NIH RePORTER database and abstracts from the 2011 American Society of Human Genetics meeting; and qualitative semi-structured interviews with 28 genomic researchers and 20 research participants. Results Most researchers and participants endorsed disclosure of a wide range of information about return of IFs, including: risks, benefits, impact on family members, data security, and procedures for return of results in the event of death or incapacity and for recontact. However, most researchers were willing to devote 30 minutes or less to this process, and expressed concerns that disclosed information would overwhelm participants, a concern shared by many participants themselves. Conclusion There is a disjunction between the views of investigators and participants about the amount of information that should be disclosed and the practical realities of the research setting, including time available for consent discussions. This strongly suggests the need for innovative approaches to the informed consent process. PMID:24158054

  8. 40 CFR 209.19 - Informal settlement and consent agreement.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... agreement. 209.19 Section 209.19 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE... Informal settlement and consent agreement. (a) Settlement policy. The Agency encourages settlement of the... Environmental Appeals Board whenever settlement or compromise is proposed. A copy shall be served on all other...

  9. Informed Consent in Educational Settings and the Novice Researcher

    ERIC Educational Resources Information Center

    Sanderson, Lara

    2010-01-01

    Research ethics are of fundamental importance to any research. They define and shape the research process from the very beginning as they are the code on which academics rely on as guiding practice in the field (Hopf, 2004). Informed consent is an interesting concept as it is interwoven with other ethical issues that include power, privacy and…

  10. Informed consent in opioid therapy: a potential obligation and opportunity.

    PubMed

    Cheatle, Martin D; Savage, Seddon R

    2012-07-01

    Most patients receiving opioids for the spectrum of pain disorders tolerate opioids well without major complications. However, a subset of this population encounters significant difficulties with opioid therapy (OT). These problems include protracted adverse effects, as well as misuse, abuse, and addiction, which can result in significant morbidity and mortality and make informed consent an important consideration. Opioid treatment agreements (OTAs), which may include documentation of informed consent, have been used to promote the safe use of opioids for pain. There is a debate regarding the effectiveness of OTAs in reducing the risk of opioid misuse; however, most practitioners recognize that OTAs provide an opportunity to discuss the potential risks and benefits of OT and establish mutually agreed-on treatment goals, a clear plan of treatment, and circumstances for continuation and discontinuation of opioids. Informed consent is an important component of an OTA but not often the focus of consideration in discussions of OTAs. This article examines the principles, process, and content of informed consent for OT of pain in the context of OTAs.

  11. Informed Consent Policies Governing Medical Students' Interactions with Patients.

    ERIC Educational Resources Information Center

    Cohen, Daniel L.; And Others

    1987-01-01

    To determine compliance with the guidelines of the U.S. government and the Joint Committee on Accreditation of Hospitals pertaining to informed consent, hospital administrators, medical school department chairpersons, and medical school deans were surveyed about policies on student involvement in patient care. (Author/MLW)

  12. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides...

  13. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides...

  14. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides...

  15. 40 CFR 26.1117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides...

  16. 40 CFR 26.1116 - General requirements for informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this... study involves research, an explanation of the purposes of the research and the expected duration of...

  17. 40 CFR 26.1116 - General requirements for informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this... provided to each subject: (1) A statement that the study involves research, an explanation of the...

  18. Heroin addiction and voluntary choice: the case of informed consent.

    PubMed

    Henden, Edmund

    2013-09-01

    Does addiction to heroin undermine the voluntariness of heroin addicts' consent to take part in research which involves giving them free and legal heroin? This question has been raised in connection with research into the effectiveness of heroin prescription as a way of treating dependent heroin users. Participants in such research are required to give their informed consent to take part. Louis C. Charland has argued that we should not presume that heroin addicts are competent to do this since heroin addiction by nature involves a loss of ability to resist the desire for heroin. In this article, I argue that Charland is right that we should not presume that heroin addicts are competent to consent, but not for the reason he thinks. In fact, as Charland's critics correctly point out, there is plenty of evidence showing that heroin addicts can resist their desire for heroin. These critics are wrong, however, to conclude from this that we should presume that heroin addicts are competent to give their voluntary consent. There are, I shall argue, other conditions associated with heroin addiction that might constrain heroin addicts' choice in ways likely to undermine the voluntariness of their consent. In order to see this, we need to move beyond the focus on the addicts' desires for heroin and instead consider the wider social and psychological circumstances of heroin addiction, as well as the effects these circumstances may have on the addicts' beliefs about the nature of their options.

  19. Use of altered informed consent in pragmatic clinical research

    PubMed Central

    McKinney, Ross E.; Beskow, Laura M.; Ford, Daniel E.; Lantos, John D.; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J.; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

    2015-01-01

    There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to IRBs as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients’ rights and interests. PMID:26374677

  20. Use of altered informed consent in pragmatic clinical research.

    PubMed

    McKinney, Ross E; Beskow, Laura M; Ford, Daniel E; Lantos, John D; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

    2015-10-01

    There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients' rights and interests.

  1. Improving participant comprehension in the informed consent process.

    PubMed

    Cohn, Elizabeth; Larson, Elaine

    2007-01-01

    To critically analyze studies published within the past decade about participants' comprehension of informed consent in clinical research and to identify promising intervention strategies. Integrative review of literature. The Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, and the Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched. Inclusion criteria included studies (a) published between January 1, 1996 and January 1, 2007, (b) designed as descriptive or interventional studies of comprehension of informed consent for clinical research, (c) conducted in nonpsychiatric adult populations who were either patients or volunteer participants, (d) written in English, and (e) published in peer-reviewed journals. Of the 980 studies identified, 319 abstracts were screened, 154 studies were reviewed, and 23 met the inclusion criteria. Thirteen studies (57%) were descriptive, and 10 (43%) were interventional. Interventions tested included simplified written consent documents, multimedia approaches, and the use of a trained professional (consent educator) to assist in the consent process. Collectively, no single intervention strategy was consistently associated with improved comprehension. Studies also varied in regard to the definition of comprehension and the tools used to measure it. Despite increasing regulatory scrutiny, deficiencies still exist in participant comprehension of the research in which they participate, as well as differences in how comprehension is measured and assessed. No single intervention was identified as consistently successful for improving participant comprehension, and results indicated that any successful consent process should at a minimum include various communication modes and is likely to require one-to-one interaction with someone knowledgeable about the study.

  2. Informed consent in trauma: does written information improve patient recall of risks? A prospective randomised study.

    PubMed

    Smith, Hannah K; Manjaly, Joseph G; Yousri, Taher; Upadhyay, Neil; Taylor, Hazel; Nicol, Stephen G; Livingstone, James A

    2012-09-01

    Informed consent is vital to good surgical practice. Pain, sedative medication and psychological distress resulting from trauma are likely to adversely affect a patient's ability to understand and retain information thus impairing the quality of the consent process. This study aims to assess whether provision of written information improves trauma patient's recall of the risks associated with their surgery. 121 consecutive trauma patients were randomised to receive structured verbal information or structured verbal information with the addition of supplementary written information at the time of obtaining consent for their surgery. Patients were followed up post-operatively (mean 3.2 days) with a questionnaire to assess recall of risks discussed during the consent interview and satisfaction with the consent process. Recall of risks discussed in the consent interview was found to be significantly improved in the group receiving written and verbal information compared to verbal information alone (mean questionnaire score 41% vs. 64%), p=0.0014 using the Mann-Whitney U test. Patient satisfaction with the consent process was improved in the group receiving written and verbal information and 90% of patients in both groups expressed a preference for both written and verbal information compared to verbal information alone. Patients awaiting surgery following trauma can pose a challenge to adequately inform about benefits conferred, the likely post operative course and potential risks. Written information is a simple and cost-effective means to improve the consent process and was popular with patients. Copyright © 2011 Elsevier Ltd. All rights reserved.

  3. Informed Consent in the Changing Landscape of Research.

    PubMed

    Hammer, Marilyn J

    2016-09-01

    The history of informed consent dates back as early as the 16th century (Selek, 2010). The current tenets of informed consent pertaining to the ethical conduct of research on human participants predominately stems from the 1947 Nuremberg Code (National Institutes of Health, 2016), which was created following the Nuremberg trials at the end of World War II. The unethical conduct of research on human participants during the Holocaust, coupled with experiments (e.g., the Tuskegee syphilis study), prompted a more formalized structure for ensuring the well-being and autonomy of human participants in research studies. The World Medical Association (2013) created the Declaration of Geneva in 1948 (Fischer, 2006), followed by the Declaration of Helsinki in 1964, to apply ethical principles to medical research involving human participants (Fischer, 2006; Rickham, 1964). A decade later, on July 12, 1974, the National Research Act was signed into law (U.S. Department of Health and Human Services [HHS], 1979). Through this act, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed and charged with developing guidelines for the conduct of biomedical and behavioral research. The guidelines were established in the Belmont Report (HHS, 1979; U.S. Department of Health, Education, and Welfare, 1979), which continues to be periodically updated. The Belmont Report describes the general principles of respect for persons, beneficence, and justice, and it outlines the process of obtaining informed consent to ensure that these principles are followed (HHS, 1979). In 1998, an informed consent checklist was instituted (HHS, 1998). Although clearly outlined, defined, and described in consent forms, it is beneficial to revisit how informed participants are when they enter research studies, particularly for patients undergoing treatment for cancer. This article will provide an overview of several areas for consideration. 
.

  4. Aspects of vulnerable patients and informed consent in clinical trials

    PubMed Central

    Kuthning, Maria; Hundt, Ferdinand

    2013-01-01

    Scope: To discuss the rationale behind informed consent in clinical trials focusing on vulnerable patients from a European and German viewpoint. Methods: Scientific literature search via PubMed, Medline, Google. Results: Voluntary informed consent is the cornerstone of policies regulating clinical trials. To enroll a patient into a clinical trial without having obtained written and signed consent is to be considered as a serious issue in the conduct of a clinical trial. Development of ethical guidance for physicians started before Christ Era with the Hippocratic Oath. Main function of consent, as articulated in all guidelines developed for clinical research, is to facilitate an individual’s freedom of choice, respect autonomy, and thus to ensure welfare of the participants in clinical trials. Minors are unable to provide legally binding informed consent, this issue is addressed through a combination of parental permission and minor’s assent. Illiteracy is a critical problem that affects all corners of our earth; it has no boundaries and exists among every race and ethnicity, age group, and economic class. New strategies to improve communication with patients including the use of videotapes or animated cartoon illustrations could be taught. Finally the time with the potential participant seems to be the best way to improve understanding. Conclusion: Discovery of life saving and life enhancing new treatments requires partnership that is based on good communication and trust between patients and researchers, sponsors, ethics committees, authorities, lawyers and politicians so that vulnerable patients can benefit from the results of well controlled clinical trials. PMID:23346043

  5. Clinical writing about clients: is informed consent sufficient?

    PubMed

    Barnett, Jeffrey E

    2012-03-01

    The use of client information in clinical writings or presentations may be very helpful in advancing the knowledge base of the profession. Yet, the very act of asking a client for permission to use their treatment information in this way may be detrimental to the therapeutic alliance and treatment process. As such, great care must be taken in how such issues are considered and acted upon. Sieck's article (2011, Obtaining clinical writing informed consent versus using client disguise and recommendations for practice. Psychotherapy, 49, pp. 3-11.) on the use of informed consent for obtaining permission to use a client's treatment information for professional writing and presentations is examined and discussed. The nature and role of the informed consent process is accentuated; psychotherapist needs and goals and client vulnerabilities are each addressed in the context of the relevant sections of the APA Ethics Code and each psychotherapist's obligation to act only in ways consistent with each client's best interests. Recommendations for a thoughtful consideration of these issues are presented, consistent with Sieck's proposed decision-making process for use in these situations.

  6. [Formal quality assessment of informed consent documents in 9 hospitals].

    PubMed

    Calle-Urra, J E; Parra-Hidalgo, P; Saturno-Hernández, P J; Martínez-Martínez, M J; Navarro-Moya, F J

    2013-01-01

    Informed consent forms are very important in the process of medical information. The aim of this study is to design reliable formal quality criteria of these documents and their application in the evaluation of those used in the hospitals of a regional health service. Criteria have been designed from the analysis of existing regulations, previous studies and consultation with key experts. The interobserver concordance was assessed using the kappa index. Criteria evaluation was performed on 1425 documents of 9 hospitals. A total of 19 criteria used in the evaluation of the quality of informed consent forms have been obtained. Kappa values were higher than 0,60 in 17 of them and higher than 0,52 in the other 2. The average number of defects per document was 7.6, with a high-low ratio among hospitals of 1.84. More than 90% of the documents had defects in the information on consequences and contraindications, and in about 90% it did not mention the copy to the patient. More than 60% did not comply with stating the purpose of the procedure, a statement of having understood and clarified doubts, and the treatment options. A tool has been obtained to reliably assess the formal quality of the informed consent forms. The documents assessed have a wide margin for improvement related to giving a copy to the patient, and some aspects of the specific information that patients should receive. Copyright © 2012 SECA. Published by Elsevier Espana. All rights reserved.

  7. [The Use of Informed Consent in Clinical Nursing Practice].

    PubMed

    Cheng, Chun-Ting; Lin, Chiu-Chu

    2017-02-01

    Obtaining informed consent and ensuring patient autonomy are critical to implementing a patient-centered model of healthcare. Informed consent is a complex process of communication that includes three elements: disclosure, competence in making decisions, and voluntariness. However, individual patient factors, doctor-patient interaction, and cultural issues are known to influence the process of obtaining informed consent. Individual patient factors include the ability of patients to understand and determine their intent; doctor-patient interaction includes communication skills; and cultural issues include the expectations of patients with regard to family involvement in medical decision-making and in decision-making motives. After assessing the relevant influencing factors, healthcare providers typically provide patients with comprehensive information on the benefits and risks of treatment as well as related alternatives. Moreover, healthcare providers typically provide patients with audio/video, Internet, and written information with illustrations based on individual patient needs. In addition to the above, we suggest that healthcare providers proactively adopt the perspective of patients in order to better encourage patients to address questions, to engage with patients in more productive discussions, and to take the initiative to explain and clarify patients' questions in order to minimize anxiety. This approach will help ensure that patients are adequately informed and free from coercion so that they make appropriate healthcare-related decisions. However, even under this optimal situation, healthcare providers must emphasize the needs of their patients and respect their decisions.

  8. Epidural analgesia during labour - maternal understanding and experience - informed consent.

    PubMed

    Mahomed, K; Chin, D; Drew, A

    2015-01-01

    Women obtain information on epidural analgesia from various sources. For epidural for pain relief in labour this is provided by the anaesthetist as part of the consenting process. There is much discussion about the inadequacy of this consenting process; we report on women's knowledge, experience and recall of this process at a regional hospital with a 24-h epidural service. Fifty-four women were interviewed within 72 h of a vaginal birth. 91% of the women had acquired information from friends, relatives and antenatal classes. Lack of recall of benefits of epidural analgesia accounted for 26 (38%) and 25 (26%) of the responses, respectively. Similarly in terms of amount of pain relief they could expect, 13 (21%) could not remember and 13 (21%) thought that it may not work. We suggest use of varying methods of disseminating information and wider utilisation of anaesthetists in the antenatal educational programmes.

  9. Consenting to donation: an examination of current practices in informed consent for tissue donation in the US

    PubMed Central

    Siminoff, Laura A.

    2012-01-01

    Informed consent is the primary moral principle guiding the donation of human tissue for transplant purposes. When patients’ donation wishes are not known, family members making the decision about tissue donation should be provided with requisite information needed to make informed donation decisions. Using a unique dataset of 1,016 audiotaped requests for tissue obtained from 15 US tissue banking organizations, we examined whether the information provided to families considering tissue donation met current standards for informed consent. The results indicated that many elements of informed consent were missing from the donation discussions, including the timeframe for procurement, autopsy issues, the involvement of both for-profit and nonprofit organizations, and the processing, storage and distribution of donated tissue. A multiple linear regression analysis also revealed that nonwhites and family members of increased age received less information regarding tissue donation than did younger, white decision makers. Recommendations for improving the practice of obtaining consent to tissue donation are provided. PMID:22395736

  10. Fiberoptic endoscopic evaluation of swallowing (FEES): proposal for informed consent

    PubMed Central

    Nacci, A; Ursino, F; La Vela, R; Matteucci, F; Mallardi, V; Fattori, B

    2008-01-01

    Summary Fiberoptic endoscopic evaluation of swallowing (FEES) is now a first choice method for studying swallowing disorders on account of the various advantages it offers: easy to use, very well tolerated, allows bedside examination and is economic. Nevertheless, this diagnostic procedure is not without risks, the most probable consequences of which include discomfort, gagging and/or vomiting, vasovagal syncope, epistaxis, mucosal perforation, adverse reactions to topical anaesthetics and laryngospasm. The risks involved with FEES stress the importance of informing the patient of these; this is an important aspect in medicine that necessarily and immediately implies receiving the patient’s so-called “informed consent”. Informed consent should be obtained not only by means of specific printed forms but also after the patient has had an interview with the physician who will be performing the procedure and who will offer information according to the personal clinical, psychological, cultural and linguistic situation of the patient and in keeping with the type of procedure proposed. In the case of FEES, as with other invasive or non-invasive diagnostic procedures, therefore, routine written and signed consent, together with a patient/physician interview should fulfil what is known as “complete information”. In this report, a specific form for informed consent to FEES procedures, is proposed. PMID:18939710

  11. Legal issues affecting confidentiality and informed consent in reproductive health.

    PubMed

    Rockett, L R

    2000-01-01

    The law governing confidentiality and informed consent has acquired unique characteristics in the area of reproductive health, as a consequence of both the establishment of a constitutional right to privacy in reproductive health matters and the reaction of those politically and morally opposed to the exercise of that right. The primary issues have involved: 1) the right of minors to receive reproductive health services without parental consent, which remains a political battleground; 2) laws requiring physicians to provide information to pregnant patients that is intended, not to inform them of the risks and benefits of the procedure, but to discourage them from obtaining abortions; 3) coerced and prohibited sterilizations; 4) court-ordered contraception and procedures to protect the fetus; and 5) restrictions on counseling about abortion, contraception, sterilization, and other reproductive health services authorized by state conscience or noncompliance clauses that shield such restrictions from the usual ethical, medical, and legal rules governing informed consent. The last area is of profound significance to the ability of women to make informed decisions about their reproductive health options. In the current economic environment, which fuels mergers and acquisitions involving sectarian and nonsectarian institutions, women are increasingly being put at risk as a result of such restrictions.

  12. Informed consent in colonoscopy: A comparative analysis of 2 methods.

    PubMed

    Sanguinetti, J M; Lotero Polesel, J C; Iriarte, S M; Ledesma, C; Canseco Fuentes, S E; Caro, L E

    2015-01-01

    The manner in which informed consent is obtained varies. The aim of this study is to evaluate the level of knowledge about colonoscopy and comparing 2 methods of obtaining informed consent. A comparative, cross-sectional, observational study was conducted on patients that underwent colonoscopy in a public hospital (Group A) and in a private hospital (Group B). Group A received information verbally from a physician, as well as in the form of printed material, and Group B only received printed material. A telephone survey was carried out one or 2 weeks later. The study included a total of 176 subjects (group A [n=55] and group B [n=121]). As regards education level, 69.88% (n=123) of the patients had completed university education, 23.29% (n= 41) secondary level, 5.68% (n=10) primary level, and the remaining subjects (n=2) had not completed any level of education. All (100%) of the subjects knew the characteristics of the procedure, and 99.43% were aware of its benefits. A total of 97.7% received information about complications, 93.7% named some of them, and 25% (n=44) remembered major complications. All the subjects received, read, and signed the informed consent statement before the study. There were no differences between the groups with respect to knowledge of the characteristics and benefits of the procedure, or the receipt and reading of the consent form. Group B responded better in relation to complications (P=.0027) and group A had a better recollection of the major complications (P<.0001). Group A had a higher number of affirmative answers (P<.0001). The combination of verbal and written information provides the patient with a more comprehensive level of knowledge about the procedure. Copyright © 2014 Asociación Mexicana de Gastroenterología. Published by Masson Doyma México S.A. All rights reserved.

  13. Informed consent in experimentation involving mentally impaired persons: ethical issues.

    PubMed

    Petrini, Carlo

    2010-01-01

    The problem of experimentation involving subjects whose mental condition prevents them from understanding information and providing proper informed consent has been addressed in various codes, declarations, conventions, treaties and regulations adopted by national, international and supranational institutions and authorities. This article summarizes the basic ethical criteria these documents provide and stresses the historical development from the nearly total exclusion of incapacitated subjects, established in the mid-twentieth century, to their contemporary inclusion in clinical trials on certain ethical conditions. The problem of proxy consent by legal representatives for participation in clinical trials is addressed particularly in reference to current Italian regulations. Exceptions to human experimentation requirements in emergency situations are also briefly discussed.

  14. Language use in the informed consent discussion for emergency procedures.

    PubMed

    McCarthy, Danielle M; Leone, Katrina A; Salzman, David H; Vozenilek, John A; Cameron, Kenzie A

    2012-01-01

    The field of health literacy has closely examined the readability of written health materials to optimize patient comprehension. Few studies have examined spoken communication in a way that is comparable to analyses of written communication. The study objective was to characterize the structural elements of residents' spoken words while obtaining informed consent. Twenty-six resident physicians participated in a simulated informed consent discussion with a standardized patient. Audio recordings of the discussions were transcribed and analyzed to assess grammar statistics for evaluating language complexity (e.g., reading grade level). Transcripts and time values were used to assess structural characteristics of the dialogue (e.g., interactivity). Discussions were characterized by physician verbal dominance. The discussions were interactive but showed significant differences between the physician and patient speech patterns for all language complexity metrics. In this study, physicians spoke significantly more and used more complex language than the patients.

  15. Historical trends in the timing of informed consent for research into intrapartum complications.

    PubMed

    Patel, D; Nasir, S; Elati, A; Vernon, G; Weeks, A D

    2012-02-01

    Obtaining informed consent for clinical trials involving the management of intrapartum complications is complex. This article describes the strategies used to obtain consent over the last 60 years using data from the Cochrane Library. Of 138 intrapartum randomised studies, 37% had no record of the consent procedures. Of the remainder, 74% sought consent only when the complication developed, 11% sought consent from all women in early labour, and 13% gave all women antenatal information and then sought written consent when the complication arose. Despite the existence of ethics guidelines for intrapartum consent, many studies fail to follow their advice.

  16. Informed Consent in Decision-Making in Pediatric Practice.

    PubMed

    2016-08-01

    Informed consent should be seen as an essential part of health care practice; parental permission and childhood assent is an active process that engages patients, both adults and children, in health care. Pediatric practice is unique in that developmental maturation allows, over time, for increasing inclusion of the child's and adolescent's opinion in medical decision-making in clinical practice and research. Copyright © 2016 by the American Academy of Pediatrics.

  17. Informed Consent, Body Property, and Self-Sovereignty.

    PubMed

    Rao, Radhika

    2016-09-01

    Recent cases involving biosamples taken from indigenous tribes and newborn babies reveal the emptiness of informed consent. This venerable doctrine often functions as a charade, a collective fiction which thinly masks the uncomfortable fact that the subjects of human research are not actually afforded full information regarding the types of research that may be contemplated, nor do they provide meaningful consent. But if informed consent fails to provide adequate protection to the donors of biological materials, why not turn to principles of property law? Property is power, yet current law permits everyone except for those who donate biological materials to possess property rights. The reluctance to invoke property probably stems from fears of resurrecting slavery and the commodification of human beings. But ironically, avoidance of property transforms the subjects of human research into objects that can be owned only by others, resulting in new forms of oppression and exploitation. Human research subjects are autonomous individuals who should not only possess the power to contribute their biological materials, but also the right to help control the course of research, and to share in the resulting benefits or profits. Conferring body property might enable research subjects to regain power and a measure of self-sovereignty. © 2016 American Society of Law, Medicine & Ethics.

  18. Patient Privacy, Consent, and Identity Management in Health Information Exchange

    PubMed Central

    Hosek, Susan D.; Straus, Susan G.

    2013-01-01

    Abstract The Military Health System (MHS) and the Veterans Health Administration (VHA) have been among the nation's leaders in health information technology (IT), including the development of health IT systems and electronic health records that summarize patients' care from multiple providers. Health IT interoperability within MHS and across MHS partners, including VHA, is one of ten goals in the current MHS Strategic Plan. As a step toward achieving improved interoperability, the MHS is seeking to develop a research roadmap to better coordinate health IT research efforts, address IT capability gaps, and reduce programmatic risk for its enterprise projects. This article contributes to that effort by identifying gaps in research, policy, and practice involving patient privacy, consent, and identity management that need to be addressed to bring about improved quality and efficiency of care through health information exchange. Major challenges include (1) designing a meaningful patient consent procedure, (2) recording patients' consent preferences and designing procedures to implement restrictions on disclosures of protected health information, and (3) advancing knowledge regarding the best technical approaches to performing patient identity matches and how best to monitor results over time. Using a sociotechnical framework, this article suggests steps for overcoming these challenges and topics for future research. PMID:28083296

  19. Informed consent in human experimentation before the Nuremberg code.

    PubMed

    Vollmann, J; Winau, R

    1996-12-07

    The issue of ethics with respect to medical experimentation in Germany during the 1930s and 1940s was crucial at the Nuremberg trials and related trials of doctors and public health officials. Those involved in horrible crimes attempted to excuse themselves by arguing that there were no explicit rules governing medical research on human beings in Germany during the period and that research practices in Germany were not different from those in allied countries. In this context the Nuremberg code of 1947 is generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent. New research, however, indicates that ethical issues of informed consent in guidelines for human experimentation were recognised as early as the nineteenth century. These guidelines shed light on the still contentious issue of when the concepts of autonomy, informed consent, and therapeutic and non-therapeutic research first emerged. This issue assumes renewed importance in the context of current attempts to assess liability and responsibility for the abuse of people in various experiments conducted since the second world war in the United States, Canada, Russia, and other nations.

  20. Informed consent in human experimentation before the Nuremberg code.

    PubMed Central

    Vollmann, J.; Winau, R.

    1996-01-01

    The issue of ethics with respect to medical experimentation in Germany during the 1930s and 1940s was crucial at the Nuremberg trials and related trials of doctors and public health officials. Those involved in horrible crimes attempted to excuse themselves by arguing that there were no explicit rules governing medical research on human beings in Germany during the period and that research practices in Germany were not different from those in allied countries. In this context the Nuremberg code of 1947 is generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent. New research, however, indicates that ethical issues of informed consent in guidelines for human experimentation were recognised as early as the nineteenth century. These guidelines shed light on the still contentious issue of when the concepts of autonomy, informed consent, and therapeutic and non-therapeutic research first emerged. This issue assumes renewed importance in the context of current attempts to assess liability and responsibility for the abuse of people in various experiments conducted since the second world war in the United States, Canada, Russia, and other nations. Images p1445-a p1446-a PMID:8973233

  1. Audit of the informed consent process as a part of a clinical research quality assurance program.

    PubMed

    Lad, Pramod M; Dahl, Rebecca

    2014-06-01

    Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.

  2. Description of a Mobile-based Electronic Informed Consent System Development.

    PubMed

    Hwang, Min-A; Kwak, In Ja

    2015-01-01

    Seoul National University Hospital constructed and implemented a computer-based informed consent system in December 2011. As of 2013, 30% of the informed consents were still filled out manually on paper. Patients and medical staff continuously suggested the implementation of a system for electronic informed consent using portable devices. Therefore, a mobile-based system for electronic informed consent was developed in 2013 to prevent the issues that arise with computer-based systems and paper informed consent. The rate of filling out electronic informed consent increased from 69% to 95% following the implementation of the mobile-based electronic informed consent. This construction of a mobile-based electronic informed consent system would be a good reference point for the development of a mobile-based Electronic Medical Record and for various mobile system environments in medical institutions.

  3. Legal and Ethical Aspects of Informed Consent: A Nursing Research Perspective.

    ERIC Educational Resources Information Center

    Cassidy, Virginia R.; Oddi, Lorys F.

    1986-01-01

    Issues related to the doctrine of informed consent for research on human subjects are discussed as they concern the conduct of nursing research. They include the subject's capacity to consent, disclosure of information, and freedom to decide. (MSE)

  4. Informed consent to donate embryos for research purposes.

    PubMed

    Nelson, Erin; Mykitiuk, Roxanne; Nisker, Jeff

    2008-09-01

    To develop guidance for clinicians participating in the informed choice process with respect to the donation of human embryos for research purposes. 1. As indicated in the Canadian Institutes of Health Research Guidelines and the Assisted Human Reproduction Act, specific consent from both the gamete and embryo providers is required before embryos can be used for research purposes. The gamete donors may be different individuals than the embryo providers when donated gametes are used to create embryos. 2. The consent process should inform potential donors of the possible types of (and for final consent, the specific) research project(s) for which the embryos will be used; the risks involved in donating embryos to research, such as not having these embryos available for their reproductive purposes; the fact that the woman/couple will not benefit personally from donating embryos to research; the potential for commercial gain by others; the possibility that they will be contacted in future about the disposition of the embryos; the fact that confidentiality cannot be absolutely guaranteed. 3. Designation of cryopreserved embryos no longer be required for reproductive purposes to be donated to research, donated to another couple, or discarded should be discussed prior to gamete retrieval and made at the time of cryopreservation, with the understanding that in the future, final consent will be requested. The final decision as to the donation of cryopreserved embryos research should not be made until after the woman/ couple decide they no longer require the embryos for their reproductive purposes. The decision to end cryopreservation should be made separately from the decision regarding disposition of the embryos. The woman/couple will have to be re-contacted regarding the final disposition of their embryos. 4. As a result of lack of scientific data regarding the predictability of microscopic characterization of embryos and potential for pregnancy, it is recommended that

  5. 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.

  6. New abortion laws introduce informed and parental consent.

    PubMed

    1991-01-01

    As recently a 1986, in another Pennsylvania abortion law, the US Supreme Court had struck down informed consent laws concerning abortion that required doctors to describe fetal development and discuss abortion alternatives. However, in Planned Parenthood of Southeastern Pennsylvania v. Casey, the court upheld a law with these exact provisions. The decision was made using Justice O'Connor's undue burden formula. In the court's opinion, this law will not cause abortion providers to stop providing any abortions, nor restrict access to abortion services for women. The law also has a parental consent clause. New York State family planning clinics attempted to gain an injunction against the Title X gag rule but were denied by 2nd Circuit Court of Appeals. A Florida court ruling found a woman not guilty of child abuse for taking cocaine while pregnant. Between 80-100 women have been arrested nationwide on similar charges.

  7. Towards better-informed consent: Research with livestock-keepers and informal traders in East Africa.

    PubMed

    Cooper, Tarni Louisa; Kirino, Yumi; Alonso, Silvia; Lindahl, Johanna; Grace, Delia

    2016-06-01

    With the rise of the One Health paradigm, ethicists have called for new research approaches, considering the interdependent relationships of humans, animals, and their environment. These relationships can be particularly complex within resource-poor, smallholder livestock systems, necessitating a rigorous informed-consent process. Little has been published on informed consent beyond human-subject research. This paper outlines two studies on informed consent, for research identifying diseases of animal and human importance, within smallholder livestock value chains. Firstly, a randomized independent-group study compared three communication tools (written, cartoons, and photographs) for informing 22 Tanzanian livestock-keepers before seeking their consent. A significant difference in comprehension and engagement in the informed-consent process was found between tools, and cartoons had the highest (i.e. best combined comprehension and engagement) scores. Most (21 out of 22) farmers answered half or more the questions correctly, but none were able to answer all questions. Comprehension testing allowed identification of common misunderstandings, such as immediate benefits the farmers would receive and the process to be used for relaying research results. Dialogue stimulated by cartoons and photographs allowed researchers to determine and respond to participants' varied relationships with their livestock. The second study assessed preferred methods for indicating consent among informal-sector milk vendors in Nairobi, Kenya. Of consenting participants, 61% (140/230) indicated consent verbally, 39% (90/230) signed consent and none chose thumbprint. There was a significant enumerator-effect on both overall consent and the methods chosen. Several of these findings echo those published in human-medical research. Additionally, highlighted here is the importance of facilitating dialogue during the informed-consent process in One Health research, for a more nuanced understanding

  8. 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.

  9. Informed consent for special procedures: electroconvulsive therapy and psychosurgery.

    PubMed

    Beloucif, Sadek

    2013-04-01

    Informed consent has become the cornerstone of the expression of patient's autonomy for ethical and sound patient-physician relationships. However, some severe psychiatric diseases markedly hinder the ability of selected patients to ensure a proper consent. Confronted with mentally disabled individuals whose condition may lead to violence or inflicting it on others, society must carry out its duty of protecting those who are particularly vulnerable, while respecting and protecting these disabled individuals. The recent update in the indications and more detailed understanding of electroconvulsive therapy, and the technical ability of obtaining less invasive or reversible techniques of psychosurgery, has renewed interest in these impressive and efficient techniques. Specifically, the emergence of new and promising cerebral neurostimulation techniques for treating Parkinson's disease have led to considering their extension to severe psychiatric disorders. This method can mimic the effects of 'conventional' psychosurgery, but in a potentially reversible and adaptable way, thus avoiding many undesirable side-effects of lesional surgery. Ensuring an ethical decision-making process and the appropriateness of consent becomes of paramount importance. Consent can be relatively easy to secure in selected patients who are often fully aware of their torments (such as those suffering from severe refractory depression of obsessive-compulsive disorders) whose suffering may be such that they are ready to accept, or for that matter demand, such actions. However, the duty of physicians is to realize that pains should always be taken to do as much good (and as little harm) as possible, while respecting the freedom of decision of those who seek to help.

  10. Informed consent in robotic surgery: quality of information and patient perception

    PubMed Central

    Pozzi, Giada; Borghi, Felice; Pellegrino, Luca; Di Lorenzo, Pierpaolo; Amato, Bruno; Santangelo, Michele; Niola, Massimo; Martino, Valter; Capasso, Emanuele

    2016-01-01

    Abstract Introduction Obtaining a valid informed consent in the medical and surgical field is a long debated issue in the literature. In robotic surgery we believe in the necessity to follow three arrangements to make the informed consent more complete. Material and methods This study presents correlations and descriptions based on forensic medicine concepts research, literature review, and the proposal of an integration in the classic concept of informed consent. Conclusion In robotic surgery we believe in the necessity to follow three arrangements to make the IC more complete. Integrate the information already present in the informed consent with data on the surgeon’s experience in RS, the number of procedures of the department and the regional map of expertises by procedure. PMID:28352808

  11. Informed consent procedures: responsibilities of researchers in developing countries.

    PubMed

    Sanchez, S; Salazar, G; Tijero, M; Diaz, S

    2001-10-01

    We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision-making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to discuss it with partners or relatives; and perceived benefits such as quality of care, non-cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk-benefit balance was strongly influenced by women's needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision-making process enhances women's ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process.

  12. Informed consent: what health care professionals need to know, Part 2.

    PubMed

    Fiesta, J

    1999-07-01

    In Part 1, the author explained that although the responsibility to obtain informed consent typically rests with physicians, nurse managers need to understand their role as caregivers and members of the health care team. This month, read about informed consent issues such as the verbal contract, emergency procedures, and the patient's competence to consent.

  13. The informed consent: a study of the efficacy of informed consents and the associated role of language barriers.

    PubMed

    Clark, Steven; Mangram, Alicia; Ernest, Dunn; Lebron, Ricardo; Peralta, Lauren

    2011-01-01

    Obtaining informed consent before performing invasive procedures and operations has become a standard practice at all medical institutions in the United States. All agree that patients should be both conscious of and in agreement with their medical care. Though patients routinely sign consent forms with numerous risks and complications detailed, there are only a limited amount of reports that study if these patients have a thorough understanding of those risks and complications. Confounding the issue of the efficacy of informed consents is the growing population of patients who do not speak English. To obtain objective data on the efficacy of informed consents and the role of language barriers we looked at how well patients who consented to have a laparoscopic cholecystectomy understood the complications associated with this procedure. We conducted a randomized prospective study of all patients seen in the General Surgery Resident Outpatient Clinic who presented for an elective cholecystectomy. Fifty patients agreed to participate in our study. Participants were split into two groups. In the first group (the control group) surgical benefits, risks and complications were explained in the usual fashion. In the second group, after hearing the standard explanation of surgical risks, complications and benefits, patients watched a PowerPoint presentation with illustrations on laparoscopic cholecystectomy. Patients from both groups then took a ten question assessment based on the presentations that they encountered. Spanish speaking patients were addressed with an interpreter and given a Spanish PowerPoint presentation with a Spanish assessment. The patients' age, education level, income, and birth country were also studied. Fifty-two percent of the patients in the study were born outside of the United States. All of the non-US born patients were Hispanic and their primary language was Spanish. The average age of the studied patients was 38. Sixty-eight percent of the

  14. Live liver donors' information needs: A qualitative study of practical implications for informed consent.

    PubMed

    Gordon, Elisa J; Mullee, Jack; Skaro, Anton; Baker, Talia

    2016-09-01

    As live donor liver transplantation is increasingly used to expand the donor pool, concerns remain regarding how best to obtain live liver donors' informed consent. This study assessed donors' information preferences and their perceptions of informed consent. Cognitive interviews were conducted with donors by telephone about how knowledge items in a new survey instrument were material to informed consent, between November 2011 and April 2012. Thematic analysis was used to analyze qualitative data until reaching saturation. Twenty-nine liver donors participated (85% participation). Donors commonly reported being unable to understand or retain much information disclosed during education. Donors preferred information about major donation risks, eg, death and minor risks that would likely affect their daily lives, eg, wound infection. Donors expressed less interest in information about their rights, confidentiality, or the medical procedure itself. Donors' preferences varied regarding statistical information. Many perceived the disclosure of risk information to be excessive, and rationalized risks they believed to be uncommon or not serious. Donors were disappointed by the brevity of the postdonation hospital stay. Our findings suggest that the complexity and volume of disclosed information during evaluation were difficult for donors to adequately comprehend. Donors' lack of appreciation for the seriousness of complications may undermine their ability to provide informed consent. Future research should develop effective methods of information delivery to enhance informed consent. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Why does informed consent fail? A discourse analytic approach.

    PubMed

    Ness, David E; Kiesling, Scott F; Lidz, Charles W

    2009-01-01

    Informed consent often fails to meet the intended goals that a prospective subject should understand fully and choose autonomously to participate in research. The current study is an attempt to understand such failures by applying linguistic methods of discourse analysis to the transcripts of informed consent interviews. Elements of conversation and of the frame of discourse were analyzed to understand how the participants shaped their spoken interaction during the interview. We looked at the degree to which the subject appeared to be fully informed, at the problem of therapeutic misconception, and at the degree to which the subject was helped to explore concerns relevant to the choice at hand. We found that lapses or miscommunications could be understood specifically in terms of conversational elements and framing. This kind of detailed, language-based analysis is an alternative to approaches that are more abstract and inferential, such as those that are based upon the attitudes or the cognitive performance of speakers. We discuss possible educational and research implications of this approach.

  16. Cross-cultural perspectives on research participation and informed consent.

    PubMed

    Barata, Paula C; Gucciardi, Enza; Ahmad, Farah; Stewart, Donna E

    2006-01-01

    This study examined Portuguese Canadian and Caribbean Canadian immigrants' perceptions of health research and informed consent procedures. Six focus groups (three in each cultural group) involving 42 participants and two individual interviews were conducted. The focus groups began with a general question about health research. This was followed by three short role-plays between the moderator and the assistant. The role-plays involved a fictional health research study in which a patient is approached for recruitment, is read a consent form, and is asked to sign. The role-plays stopped at key moments at which time focus group participants were asked questions about their understanding and their perceptions. Focus group transcripts were coded in QSR NUDIST software using open coding and then compared across cultural groups. Six overriding themes emerged: two were common in both the Portuguese and Caribbean transcripts, one emphasized the importance of trust and mistrust, and the other highlighted the need and desire for more information about health research. However, these themes were expressed somewhat differently in the two groups. In addition, there were four overriding themes that were specific to only one cultural group. In the Portuguese groups, there was an overwhelming positive regard for the research process and an emphasis on verbal as opposed to written information. The Caribbean participants qualified their participation in research studies and repeatedly raised images of invasive research.

  17. 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

  18. GCP compliance and readability of informed consent forms from an emerging hub for clinical trials

    PubMed Central

    Nair, Satish Chandrasekhar; Ibrahim, Halah

    2015-01-01

    Background: The rapid expansion of trials in emerging regions has raised valid concerns about research subject protection, particularly related to informed consent. The purpose of this study is to assess informed consent form (ICF) compliance with Good Clinical Practice (GCP) guidelines and the readability easeof the ICFs in Abu Dhabi, a potential destination for clinical trials in the UAE. Materials and Methods: A multicenter retrospective cross-sectional analysis of 140 ICFs from industry sponsored and non-sponsored studies was conducted by comparing against a local standard ICF. Flesch-Kincaid Reading Scale was used to assess the readability ease of the forms. Results: Non-sponsored studies had significantly lower overall GCP compliance of 55.8% when compared to 79.5% for industry sponsored studies. Only 33% of sponsored and 16% of non-sponsored studies included basic information on the participants' rights and responsibilities. Flesch-Kincaid Reading ease score for the informed consent forms from industry sponsored studies was significantly higher 48.9 ± 4.8 as compared to 38.5 ± 8.0 for non-sponsored studies, though both were more complex than recommended. Reading Grade Level score was also higher than expected, but scores for the ICFs from the industry sponsored studies were 9.7 ± 0.7, significantly lower as compared to 12.2 ± 1.3 for non-sponsored studies. Conclusion: In spite of the undisputed benefits of conducting research in emerging markets readability, comprehension issues and the lack of basic essential information call for improvements in the ICFs to protect the rights of future research subjects enrolled in clinical trials in the UAE. PMID:25878956

  19. Marriage of professional and technical tasks: a strategy to improve obtaining informed consent.

    PubMed

    Steinemann, Susan; Furoy, Daniel; Yost, Fredrick; Furumoto, Nancy; Lam, Geoffrey; Murayama, Kenric

    2006-05-01

    Education in obtaining informed consent, combined with technical training using a stepwise approach, may improve resident knowledge of, confidence in, and frequency of obtaining consent for bedside procedures. Surgical trainees were randomized to receive a lecture on obtaining informed consent. Knowledge of, confidence in, and frequency of obtaining consent were assessed. Subsequent first-year residents received combined technical and consent training using a stepwise approach. Residents listed key steps for procedures before and after training, were observed for consent and technical competency on patients, and were assessed on frequency of obtaining consent by follow-up chart review. Knowledge and confidence improved after lecture instruction, but consent rate (21%) did not. Stepwise training increased resident awareness of obtaining informed consent as a key step (19% to 77%) and increased frequency of obtaining consent (89% for proctored procedures and 79% in follow-up). Education alone improves knowledge but not practice of obtaining consent. Teaching the consent process concomitantly with technical training may increase awareness and performance of obtaining informed consent for bedside procedures.

  20. Managing the "known unknowns": theranostic cancer nanomedicine and informed consent.

    PubMed

    Jotterand, Fabrice; Alexander, Archie A

    2011-01-01

    The potential clinical applications and the economic benefits of theranostics represent a tremendous incentive to push research and development forward. However, we should also carefully examine the possible downsides. In this chapter, we address the issue of how theranostics might challenge our current concept of informed consent, especially the disclosure of information concerning diagnosis and treatment options to human subjects. We argue that our lack of data concerning long-term effects and risks of nanoparticles on human health and the environment could undermine the process when it comes to weighing the risks against the benefits. Our lack of an agreed upon framework for risk management in nanomedicine may require us to adopt an "upstream" approach that emphasizes communication and transparency among all relevant stakeholders to help them make informed choices that enable safety or progress.

  1. [Patient autonomy and informed consent - ethical and legal issues].

    PubMed

    Wolf-Braun, Barbara; Wilke, Hans-Joachim

    2015-03-01

    Informing patients about the benefits and risks of and alternatives to proposed medical or surgical procedures is crucial to the patient-physician relationship. It is a legal and ethical precondition to a patient's informed consent to a course of action. Particularly in cases of serious illness and when there are far reaching implications for a patient's lifestyle, this process entails much more than just imparting information. Indeed, it is a dialogue through which the physician empowers the patient to reach a decision which reflects the patient's life situation and system of values. This process promotes patient autonomy. Studies have shown that this approach builds trust, increases patient satisfaction with health care and results in a higher degree of professional fulfilment for the physician.

  2. Informed consent in the Pakistani milieu: the physician's perspective

    PubMed Central

    Jafarey, A; Farooqui, A

    2005-01-01

    Informed consent enjoys an unassailable position in both clinical and research situations as a safeguard of patients' rights. Keeping the patient involved in the decision making process is easier when there is direct communication with the individual. The Pakistani milieu offers challenges to this process because crucial decision making is often done by family members or is left entirely up to the attending physician. There seems to be a general acceptance of this shifting of focus from the individual to other players. This also raises certain ethical dilemmas for physicians who may feel uncomfortable with communication which excludes the patient or in accepting a paternalistic primary decision making role. The objective of this informal qualitative study was to ascertain physicians' perceptions regarding the process of information delivery to the patient in the Pakistani context and the various influences acting upon it. PMID:15681673

  3. [About medical accidents and their medicolegal implications. Information and consent].

    PubMed

    El Banna, S; Beauthier, F; Beauthier, J P

    2013-01-01

    Medical practice today is not simple because of various factors impinging on the doctor-patient relationship. The concept of consent arises from the ethical principle of patient autonomy and basic human rights. It is also the rule of law (Civil Code article 16-3) that guarantees the patient's right and freedom to decide what should or should not happen to his/her body and to gather information before undergoing a test/procedure/surgery. No one else has the right to coerce the patient to act in a particular way. The authors after a reflexion about medical accidents and their medicolegal implications, discuss the means to display in order to provide to the patients the adequate information about their disease and proposed treatment, therefore protecting the medical practitioner from the consequences of insufficient or ill information.

  4. Hope and Persuasion by Physicians During Informed Consent

    PubMed Central

    Miller, Victoria A.; Cousino, Melissa; Leek, Angela C.; Kodish, Eric D.

    2014-01-01

    Purpose To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. Patients and Methods Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. Results The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower. Conclusion Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain. PMID:25199753

  5. Hope and persuasion by physicians during informed consent.

    PubMed

    Miller, Victoria A; Cousino, Melissa; Leek, Angela C; Kodish, Eric D

    2014-10-10

    To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower. Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain. © 2014 by American Society of Clinical Oncology.

  6. [Introduction of an accreditation system for hospital informed consent forms].

    PubMed

    López-Picazo, J J; Tomás-Garcia, N; Calle-Urra, J E; Parra-Hidalgo, P; Valverde-Iniesta, J J

    2015-01-01

    To describe an accreditation system for informed consent forms (ICF) in a tertiary hospital, as an intervention to improve their quality, and to check the improvements achieved. Following an external evaluation of the ICF quality in a public hospital in Murcia (Spain), an accreditation committee set the ICF requirements and associated procedures. Effectiveness is assessed by comparing two external evaluations carried out by the EMCA Program (2011 and 2013) and based on 19 criteria and a sample of 60 ICF for every public hospital in Murcia Region. To be accredited, every ICF must meet the 19 external criteria plus 5 based on legibility, readability and scientific and technical validity. A form to fill in the contents of every ICF was agreed, which would be reviewed, approved and validated for five years. Before the implementation, 8.2 defects/ICF were detected. The accreditation system obtained an 89% improvement (0.9 defects/ICF) and achieved significant improvements in 18 criteria, 16 of which are benchmarked. The accreditation system achieved a substantial improvement in the ICF (obtaining a better result in external evaluations) and guarantees their contents, legibility and readability. This system needs to be extended to other hospitals, since it is not clear whether common ICFs would be suitable. However, this improvement is structural and does not guarantee that the overall information/consent procedure is done properly, thus complementary strategies for measurement and improvement are required. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

  7. Informed consent under the European Convention on Biomedicine and the UNESCO Declaration on Bioethics.

    PubMed

    Salako, Solomon E

    2011-03-01

    The desirability of obtaining freely given consent is universally accepted. The point, however, is that there is no unanimity on the definition of informed consent or its application in bioethics. Whether informed consent is based on principalism or casuistry or the virtue theory, the problem is how to handle the ethically complex situation created in the interface between informed consent and social justice under international biomedical instruments. This article will proceed by offering detailed historical and critical analyses of informed consent under the European Convention on Human Rights and Biomedicine 1997 and The UNESCO Universal Declaration on Bioethics and Human Rights 2005. Three conceptions of justice will be utilised to show that the doctrine of informed consent has driven the ethos of research on human beings and shaped the physician-patient relationship; and that casuistry and virtue theory are consistent with and not rivals of a principle-based account of informed consent.

  8. Pharmaceutical information systems and possible implementations of informed consent - developing an heuristic

    PubMed Central

    2012-01-01

    Background Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. Analysis The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context. Results and Conclusion Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system. The danger of routinisation of consent is identified. The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent. PMID:23157854

  9. Informed consent with suicidal patients: Rethinking risks in (and out of) treatment.

    PubMed

    Rudd, M David; Joiner, Thomas; Brown, Gregory K; Cukrowicz, Kelly; Jobes, David A; Silverman, Morton; Cordero, Liliana

    2009-12-01

    Informed consent is uniformly accepted as essential to the treatment process. However, the relevant literature has not discussed issues of risk specific to suicidal patients, nor has such information routinely been included in the informed consent process. The implications of including suicide-specific risk information in the informed consent process is discussed and examples provided. (PsycINFO Database Record (c) 2010 APA, all rights reserved).

  10. [Informed consent analysis and its role in modern medicine].

    PubMed

    Payne, Jan

    2015-01-01

    "Informed consent" is a term adopted by the contemporary medicine in all its fields. There may seem that it is a plain rendering of information to the patient followed by her/his decision about further procedures but the facts are different. Actually this relationship between patient and doctor has an intricate nature. It guarantees an ethical frame and structure of any treatment afforded to the patient and it covers all the possible dilemmas as conflicts of any two principles taken from any contemporary medical code while it allows no simple resolution. Individual steps require a compromise based on continuous discussion between both sides. In this process means controlled by the doctor and patients goals must be conscientiously distinguished since a goal or meaning of live is not an expertise of the doctor and the doctor is obliged solely to revere them whereas to develop means or tools (organon) in all its manners is on the other side her/his main task.

  11. 34 CFR 303.401 - Definitions of consent, native language, and personally identifiable information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 2 2011-07-01 2010-07-01 true Definitions of consent, native language, and personally... Definitions of consent, native language, and personally identifiable information. As used in this subpart— (a... which consent is sought, in the parent's native language or other mode of communication; (2) The...

  12. Intentional Learning: The Need for Explicit Informed Consent in Higher Education.

    ERIC Educational Resources Information Center

    Connelly, R. J.

    2000-01-01

    Argues that student consent should be practiced in higher education, and that general education, which emphasizes critical thinking, should bear the greatest responsibility for promoting this movement. Discusses the history of informed consent in medicine and paternalism in health care and higher education, stressing that consent in postsecondary…

  13. 34 CFR 303.401 - Definitions of consent, native language, and personally identifiable information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 2 2010-07-01 2010-07-01 false Definitions of consent, native language, and personally... Definitions of consent, native language, and personally identifiable information. As used in this subpart— (a... which consent is sought, in the parent's native language or other mode of communication; (2) The parent...

  14. Research and the IRB: When Consent Information Refers to Risk and to Deception.

    ERIC Educational Resources Information Center

    Finney, Phillip D.

    An experiment which varied indications about the possibility of psychological risk and deception in consent information provided to subjects prior to participation in Asch's (1952) line-judgment task is presented. The number of erroneous line-judgments (conformity) made by subjects across five consent treatments and a no-consent control group were…

  15. Autonomy, consent and responsability. Part 1: limitations of the principle of autonomy as a foundation of informed consent.

    PubMed

    Mellado, J M

    2016-01-01

    Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

  16. De facto gatekeeping and informed consent in intensive care.

    PubMed

    Burrows, R C; Hodgson, R E

    1997-01-01

    Medical decision-making is based on the doctrine of informed consent which is, in turn, based on autonomy, which represents one of four pillars of medical ethics, the others being beneficence, non-malfeasance and social justice. Decision-making in intensive care with respect to the withdrawal of treatment, in particular ventilator therapy, is often extremely difficult for patients or their relatives and they would rather not make any decision other than to insist on the maintenance of therapy in spite of sound, reasonable medical advice that such therapy is of no value to the patient. Aside from issues of a dignified death, this is likely to be to the detriment of other patients who might be refused admission to intensive care and thus is counter to the dictates of social justice. Under these circumstances, there would appear to be a need to give authority to the reasonable medical decision to discontinue resuscitation.

  17. Money for research participation: does in jeopardize informed consent?

    PubMed

    Grady, C

    2001-01-01

    Some are concerned about the possibility that offering money for research participation can constitute coercion or undue influence capable of distorting the judgment of potential research subjects and compromising the voluntariness of their informed consent. The author recognizes that more often than not there are multiple influences leading to decisions, including decisions about research participation. The concept of undue influence is explored, as well as the question of whether or not there is something uniquely distorting about money as opposed to a chance for treatment or medical care. An amount of money that is not excessive and is calculated on the basis of time or contribution may, rather than constitute an undue inducement, be an indication of respect for the time and contribution that research subjects make.

  18. VICO: Ontology-based representation and integrative analysis of Vaccination Informed Consent forms.

    PubMed

    Lin, Yu; Zheng, Jie; He, Yongqun

    2016-01-01

    Although signing a vaccination (or immunization) informed consent form is not a federal requirement in the US and Canada, such a practice is required by many states and pharmacies. The content and structures of these informed consent forms vary, which makes it hard to compare and analyze without standardization. To facilitate vaccination informed consent data standardization and integration, it is important to examine various vaccination informed consent forms, patient answers, and consent results. In this study, we report a Vaccination Informed Consent Ontology (VICO) that extends the Informed Consent Ontology and integrates related OBO foundry ontologies, such as the Vaccine Ontology, with a focus on vaccination screening questionnaire in the vaccination informed consent domain. Current VICO contains 993 terms, including 248 VICO specific terms and 709 terms imported from 17 OBO Foundry ontologies. VICO ontologically represents and integrates 12 vaccination informed consent forms from the Walgreens, Costco pharmacies, Rite AID, University of Maryland College Park, and the government of Manitoba, Canada. VICO extends Informed Consent Ontology (ICO) with vaccination screening questionnaires and questions. Our use cases and examples demonstrate five usages of VICO. First, VICO provides standard, robust and consistent representation and organization of the knowledge in different vaccination informed consent forms, questionnaires, and questions. Second, VICO integrates prior knowledge, e.g., the knowledge of vaccine contraindications imported from the Vaccine Ontology (VO). Third, VICO helps manage the complexity of the domain knowledge using logically defined ontological hierarchies and axioms. VICO glues multiple schemas that represent complex vaccination informed consent contents defined in different organizations. Fourth, VICO supports efficient query and comparison, e.g., through the Description Language (DL)-Query and SPARQL. Fifth, VICO helps discover new

  19. Obtaining written informed consent for the administration of local anesthetic in dentistry.

    PubMed

    Orr, Daniel L; Curtis, William J

    2005-11-01

    The purpose of this study was to examine the frequency with which dentists obtain written informed consent for the administration of local anesthetic in dentistry. The authors administered an informal survey to 252 dentists. Most respondents who practiced a dental specialty or limited their practice to anesthesiology for dentistry obtained written informed consent for the administration of local anesthetic. Most general practitioners did not. Written informed consent appears to be obtained more often by dental specialists and dentists limiting their practices to anesthesiology for dentistry than by general practitioners. All dentists may want to consider obtaining written informed consent for the administration of local anesthetic.

  20. The politics of information: informed consent in abortion and end-of-life decision making.

    PubMed

    Suter, Sonia M

    2013-01-01

    The politics of reproduction dominate the political landscape now more than ever. One area of controversy has been informed consent statutes for abortion, which have been praised by the pro-life movement but derided by the pro-choice movement. More recently, legislatures have begun to enact informed consent statutes with respect to end-of-life decision making, an area almost as politically controversial as abortion. Like many abortion disclosure laws, some of these have been entitled "Right to Know" statutes. Yet, the supporters and opponents of each set of statutes tend not to be the same, aligning to a large extent based on their place in the culture wars over life and death. In this Article, I strive not only to show the remarkably similar critiques each side marshals but also to use these concerns to think in more nuanced ways about the goals of informed consent and whether the disclosure mandates achieve those goals. I first argue in favor of the aspirational goals of informed consent as a process that allows patients to participate in their medical decision making. While conceding the inherently political nature of abortion and end-of-life care, I also contend that the significance of decisions regarding those matters warrants, at least in theory, legislative efforts to ensure that patients have the opportunity to engage in deliberative and informed decision making. In describing and responding to the similar critiques of both sets of laws--the political bias of the statutes; the efforts to persuade, especially with non-medical information; the potential vulnerability of the targeted audience; and the interference with physician discretion--I uncover and challenge some of the presumptions about informed consent inherent in those critiques. Although information that persuades or influences is not per se problematic, I argue that disclosure of information that is inaccurate, untrue, or emotionally inflammatory harms informed consent. Even well-crafted informed

  1. Informed Consent in cross-cultural perspective: clinical research in the Tibetan Autonomous Region, PRC.

    PubMed

    Adams, Vincanne; Miller, Suellen; Craig, Sienna; Sonam; Nyima; Droyoung; Le, Phuoc V; Varner, Micheal

    2007-12-01

    Procedures of Informed Consent are considered a high priority for international biomedical research. However, informed consent protocols are not necessarily transferable across cultural, national or ethnic groups. Recent debates identify the need for balancing ethical universals with practical and local conditions and paying attention to questions of cultural competence when it comes to the Informed Consent process for clinical biomedical research. This article reports on the results of a two-year effort to establish a culturally appropriate Informed Consent process for biomedical research in the Tibet Autonomous Region in the People's Republic of China. A team of Tibetan and American researchers, physicians, health professionals and medical anthropologists conducted the research. The Informed Consent was specifically for undertaking a triple-blind, double placebo-controlled randomized clinical trial of a Tibetan medicine compared with Misoprostol for reducing postpartum blood loss. The findings suggest greater need for flexibility and cooperation in establishing Informed Consent protocols across cultures and nations.

  2. What emergency physicians should know about informed consent: legal scenarios, cases, and caveats.

    PubMed

    Moore, Gregory P; Moffett, Peter M; Fider, Cyril; Moore, Malia J

    2014-08-01

    The basic concept of obtaining informed consent is familiar to emergency physicians, and many consider themselves well versed on the topic; however, lack of obtaining proper informed consent is a frequent source of lawsuits. The legal definitions and nuances of informed consent might surprise even the most experienced physician. This article will detail the historical legal evolution of the concept of informed consent. It will also report defining and recent court cases that illustrate the current medical-legal status of informed consent. Special scenarios, caveats, and documentation recommendations are discussed. After reading this article the emergency physician will know how to practice and document the appropriate aspects of informed consent in emergency medicine, as well as understand available legal defenses if a lawsuit should arise.

  3. Dignity and informed consent in the treatment of mature minors.

    PubMed

    Bello, Bidemi Ademola

    2010-12-01

    In today's world, as evinced in various human rights provisions, emphasis is placed on the assertion and protection of the entrenched rights of every human and particularly the dignity of humans and respect of human autonomy. Medical/health workers are concerned about protecting every patient's right to the dignity of his or her person. This led to the formulation of the concept of self determination and informed consent in medical diagnosis and treatments. However, serious concern is placed on these principles especially as it affects mature minors, a group of individuals who by conduct demand a level of respect but may at the same time be viewed as not capable of making the "best" informed decisions, especially about health. The following issues may arise as a result of the aforementioned concerns: --are mature young ones entitled to right of self determination and informed consent despite the alleged fear that they may lack capacity to make informed decisions? --if no, who should decide on their behalf--their parents, their medical/health provider or the society/government (especially since the 3 (three) interested groups may have different and conflicting stands on what is best for the child); --if the answer to the initial question is yes, to what extent should mature minors be informed of their medical choices and be allowed to exercise their right of self determination? --should they be guided? --and who should so guide them? In resolving the above issue, due consideration has been given not only to legal and bio-ethical provisions of some countries but also to international conventions which several countries are party to. Thereafter, it became clear that most authorities are of the view that mature minors should be fully informed and be allowed to have a say in health decisions, coaching them with few exceptions. Ultimately, because of the importance of respect for human dignity, autonomy and self determination along with medical disclosure in today

  4. Informed consent and the history of inclusion of women in clinical research.

    PubMed

    Stevens, Patricia E; Pletsch, Pamela K

    2002-12-01

    The purposes of this paper are to (a) discuss the troubled history of informed consent for research on women and its ramifications for women's participation in clinical trials; (b) interrogate current informed consent practices as to their accountability and justice in the treatment of women; and (c) recommend to nurse researchers and clinical nurses ways of improving the practice of informed consent in research with women.

  5. Paper trails, trailing behind: improving informed consent to IVF through multimedia applications

    PubMed Central

    Madeira, Jody Lyneé; Andraka-Christou, Barbara

    2016-01-01

    Though intended to educate patients on the risks, benefits, side effects and alternatives within medical treatment, informed consent documents may have unanticipated consequences for patients. Patients may regard these forms as little more than a ritual to access treatment. Or patients may perceive that these forms exist to protect doctors rather than to contribute to a meaningful, patient-protective educational interaction. To rehabilitate the informed consent project, this essay considers the baggage that informed consent documents have acquired through practical use, explores patients' and providers' lived experience of informed consent, and considers whether a multimedia consent application would be a viable solution to the various difficulties that currently erode perceptions of and confidence in the informed consent process. PMID:27774231

  6. Status of informed consent in the original articles published in a medical journal of Bangladesh.

    PubMed

    Mollah, As

    2008-01-01

    Informed consent and other ethical issues are included in every guideline of research ethics. Taking informed consent from the participants is essential in human health research. The health researchers are not addressing adequately the issues of informed consent and other relevant issues. In many of the published articles in our country, there is no mention of informed consent and other relevant ethical issues. In this study, a 5-years retrospective review was performed on the original articles that described research involving human subjects, and published in the "Journal of Bangladesh College of Physicians and Surgeons" in the period of 1999 to 2003. The objectives of this review were: i) to document whether the author has mentioned about informed consent in the published original article; and ii) to document whether the author has addressed the informed consent procedure in appropriate details. Fifty three original articles were reviewed, only in 7(13.2%) articles the author has mentioned that informed consent was taken from the participants. In 19 (63%) articles, where the subjects were minors or incompetent, there was no mention from whom informed consent was taken. Only in 2(3.7%) articles, the authors have mentioned about the approval of Ethical Review Committee, and in 4(7.5%) articles about the funding agency. Other ethical issues were also ignored. The study documents deficiencies in informed consent and relevant ethical issues in the published articles. This finding demands greater attention to ethical standards on the part of investigators and the editors.

  7. 2002 Industry Studies: Information Technology

    DTIC Science & Technology

    2002-01-01

    Information Technology ABSTRACT: The information technology (IT) industry represents a vital interest of the United States. The IT industry fuels...2. REPORT TYPE N/A 3. DATES COVERED - 4. TITLE AND SUBTITLE 2002 Industry Studies: Information Technology 5a. CONTRACT NUMBER 5b. GRANT...Executive Office of the President, Washington, DC Software & Information Industry Association, Washington, DC Information Technology Association of America

  8. [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.

  9. Comparison of participant information and informed consent forms of five European studies in genetic isolated populations

    PubMed Central

    Mascalzoni, Deborah; Janssens, A Cecile JW; Stewart, Alison; Pramstaller, Peter; Gyllensten, Ulf; Rudan, Igor; van Duijn, Cornelia M; Wilson, James F; Campbell, Harry; Quillan, Ruth Mc

    2010-01-01

    Family-based research in genetically isolated populations is an effective approach for identifying loci influencing variation in disease traits. In common with all studies in humans, those in genetically isolated populations need ethical approval; however, existing ethical frameworks may be inadequate to protect participant privacy and confidentiality and to address participants' information needs in such populations. Using the ethical–legal guidelines of the Council for International Organizations of Medical Sciences (CIOMS) as a template, we compared the participant information leaflets and consent forms of studies in five European genetically isolated populations to identify additional information that should be incorporated into information leaflets and consent forms to guarantee satisfactorily informed consent. We highlight the additional information that participants require on the research purpose and the reasons why their population was chosen; on the potential risks and benefits of participation; on the opportunities for benefit sharing; on privacy; on the withdrawal of consent and on the disclosure of genetic data. This research raises some important issues that should be addressed properly and identifies relevant types of information that should be incorporated into information leaflets for this type of study. PMID:19826451

  10. Information sheets and informed consent forms for clinical study participants: towards standardised recommendations?

    PubMed

    Chassany, Olivier; Bernard-Harlaut, Micheline; Guy, Gilles; Billon, Nathalie

    2009-01-01

    Subjects taking part in biomedical research must be provided with legible and intelligible information enabling them to freely give their informed consent. At present, sponsors tend to provide many different types of information, not all of which is directly connected with or indeed really informative about studies for those taking part.As a result of this observation, a round table was convened during the Clinical Pharmacology meetings to deliberate on the creation of a charter concerning the drafting of information documents for biomedical research participants as well as a code of good practice for the preparation of such documents.Recommendations were made based on the efforts of the various working groups concerned, such as the French National Conference of Ethics Committees (CNCP), users' representatives, patients associations and the French industrial and institutional sponsors association (CPI), together with proposals contained in the literature.The deliberations of the round table may be subsumed under the following 3 categories and 14 points: 1) Format: design, drafting rules, layout, table of contents, glossary. 2) CONTENT: introductory page, description of the study, risks, benefits. 3) Regulatory aspects: legal aspects, CNIL message (data protection), financial aspects, conflict of interests, model and varied signatures. This document should help make research in France more attractive and it was decided after the Clinical Pharmacology meeting to submit the charter and related documents for approval by the various actors involved: DGS (Direction Générale de la Santé), Afssaps (Agence Française de Sécurité Sanitaire des Produits de Santé), CNCP, CPI and LEEM (Les entreprises du médicament). Once the charter has been validated, it will be made available to Sponsors and Ethics Committees in order to ensure greater uniformity and legibility regarding information given to study subjects.

  11. Informed consent: what is it? Who can give it? How do we improve it?

    PubMed

    Neff, Margaret J

    2008-10-01

    The freedom to choose is integral to our daily lives, directs our interactions with patients, and is a key component of our conduct of human-subjects research. Most of the historical errors and atrocities in human experimentation had at their core a failure of consent. In response to those events, national and international law developed to direct researchers to a process of informed consent to participate in research. The application of this process, though, can be challenging. What does this process look like? Does it require written documentation, and if so what type? Who can give informed consent? Though researchers worldwide would agree on the concept of informed consent, the nuts and bolts of applying this ideal can create obstacles to researchers, confusion to subjects, and increasing regulations that may or may not help achieve the goal. I will review the current regulatory guidelines, summarize the types of consent, and consider options for improving the informed-consent process.

  12. 76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... HUMAN SERVICES Guidance on Exculpatory Language in Informed Consent, Draft AGENCY: Office for Human... the availability of a draft guidance entitled, ``Guidance on Exculpatory Language in Informed Consent... will supersede OHRP's November 15, 1996 guidance document entitled ```Exculpatory Language' in Informed...

  13. [Intracerebral aneurysm--treatment options, informed consent, and legal aspects].

    PubMed

    Burkhardt, Jan-Karl; Burkhardt, Werner Friedrich; Zinn, Pascal Olivier; Bozinov, Oliver; Bertalanffy, Helmut

    2011-01-01

    All medical subspecialties and, in particular, high-tech field neurosurgery are subject to continuous change in therapeutic concepts due to novel treatment options emerging through research and evolution in the field. Hence, the question arises if the patient's informed consent needs to be adjusted in the face of multiple therapeutic options with different configurations of risk/benefit relationships. In this paper we discuss different therapeutic scenarios with regard to ruptured intracerebral aneurysms (RIA) and unruptured intracerebral aneurysms (UIA), and we advise the medical doctor involved in the process. Indeed, experienced neurosurgeons and endovascular interventionalists are very familiar with the management of these scenarios; likewise, interns, residents, and otherwise affiliated physicians may be faced with these situations. In general, asymptomatic and mentally capacitated patients as well as legal guardians of minor patients and of mentally incapacitated patients with incidental aneurysms and more than one therapeutic option need to be accurately informed about the advantages and disadvantages of the treatment options available to them. In case of emergency or when treating a mentally disabled patient who is incapable of making a sound judgment and has no legal guardian, the attending doctor will have to choose the best possible treatment option. Copyright © 2010. Published by Elsevier GmbH.

  14. Electroconvulsive therapy, the placebo effect and informed consent.

    PubMed

    Blease, Charlotte Rosalind

    2013-03-01

    Major depressive disorder is not only the most widespread mental disorder in the world, it is a disorder on the rise. In cases of particularly severe forms of depression, when all other treatment options have failed, the use of electroconvulsive therapy (ECT) is a recommended treatment option for patients. ECT has been in use in psychiatric practice for over 70 years and is now undergoing something of a restricted renaissance following a sharp decline in its use in the 1970s. Despite its success in treating severe depression there is continued debate as to the effectiveness of ECT: in some studies, it is argued that ECT is marginally more effective than sham ECT. In addition, there is still no clear explanation of how ECT works; among the range of hypotheses proposed it is claimed that ECT may work by harnessing placebo effects. In light of the uncertainties over the mechanism of action of ECT and given the risk of serious side effects that ECT may produce, I contend that the process of informed consent must include comprehensive accounts of these uncertainties. I examine the possible consequences of providing adequate information to potential ECT patients, including the consideration that ECT may still prove to be effective even if physicians are open about the possibility of it working as a placebo. I conclude that if we value patient autonomy as well as the professional reputation of medical practitioners, a fuller description of ECT must be provided to patients and their carers.

  15. 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.

  16. 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

  17. Monetary incentives improve recall of research consent information: it pays to remember.

    PubMed

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

    2009-04-01

    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, the authors randomly assigned 31 drug court clients participating in a clinical research trial to a control group that received a standard informed consent procedure or to a group that received 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 control group (65% vs. 42%, p<.01). Findings from this study have important implications for the ethical conduct of human subject research. The incentivized consent procedure may be useful for improving consent recall in research studies, particularly those involving potentially serious side effects. The results also provide an important "proof of concept" regarding the utility of motivational procedures for improving recall of consent information.

  18. Patient-reported conformity of informed consent procedures and participation in clinical research.

    PubMed

    Agoritsas, T; Perneger, T V

    2011-02-01

    There is growing evidence that the quality of informed consent in clinical research is often sub-optimal. To explore the conformity of patient recruitment with recommended informed consent procedures among patients who were invited to participate in a clinical study at a general teaching hospital, and to examine the association between consent procedures and the patients' decision to participate. All inpatients discharged during a 1-month period were invited to complete a mailed survey in which they reported whether they were invited to participate in a study and whether 13 recommended elements of informed consent actually occurred. Among 1303 respondents, 265 (20.3%) reported that they had been invited to participate in a study, and 191 (72.1%) accepted. While the majority of potential participants were fully informed about practical issues related to the study (e.g. what their participation would consist in), <50% were informed of possible risks or benefits, and only 20% about the origin of the study funds. Only 60% reported satisfactory answers to items assessing the overall information process (e.g. explanations were easy to understand). Older and sicker patients reported lower levels of conformity with informed consent procedures, as did patients who refused to participate in a study. Our results confirm that informed consent procedures fail to meet standards for many patients. In particular, consent information should be adapted to the needs of older and sicker patients. Improving the quality of informed consent may increase patients' participation in clinical research.

  19. The informed consent in Southern Italy does not adequately inform parents about infant vaccination.

    PubMed

    Attena, Francesco; Valdes Abuadili, Amanda; Marino, Sara

    2014-02-28

    Vaccination centres in the Campania Region, southern Italy, vaccinate children with a hexavalent vaccine that contains the mandatory vaccines diphtheria, tetanus, poliomyelitis, and viral Hepatitis B. This vaccine also includes two non-mandatory vaccines, pertussis and Haemophilus influenzae type B. Information about these optional vaccines should be communicated to the parents, and informed consent should be obtained from parents before vaccination. We explored whether informed consent was delivered to the parents, whether they signed the consent form, and whether they read and acquired the information about the vaccination that their child would receive. Childhood immunisations are provided at specific public health vaccination centres, "Unità Operative Materno-infantili's" (UOMIs). We selected four UOMI from the Campania Region where we interviewed 1039 parents bringing their children for the 1st, 2nd, or 3rd doses of hexavalent vaccine. The consent forms were collected from the four vaccination centres and were analysed with respect to clarity and completeness. Most of the respondents (89.5%) were mothers between 20 and 39 years of age (80.4% vs 59.6% of the fathers), they were married (87.2% vs 93.5% of the fathers), and only one-half of them were employed (50.2% vs 92.6% of the fathers). The informed consent form was received from 58.1% of the parents and signed by 52.8%, but read by 35.0% of them. Only 1.5% of parents knew which vaccines were mandatory, and 25.0% of them believed that the entire hexavalent vaccine was mandatory. When we asked the parents which non-mandatory vaccinations were administered to their children, only 0.5% indicated the Haemophilus influenzae type B and none indicated the pertussis vaccine. Thirty-six per cent of the parents replied that their child had not received any non-mandatory vaccines. No parents were informed by the operators that their children would receive non-mandatory vaccines. In our study, consent procedures did

  20. The informed consent in Southern Italy does not adequately inform parents about infant vaccination

    PubMed Central

    2014-01-01

    Background Vaccination centres in the Campania Region, southern Italy, vaccinate children with a hexavalent vaccine that contains the mandatory vaccines diphtheria, tetanus, poliomyelitis, and viral Hepatitis B. This vaccine also includes two non-mandatory vaccines, pertussis and Haemophilus influenzae type B. Information about these optional vaccines should be communicated to the parents, and informed consent should be obtained from parents before vaccination. We explored whether informed consent was delivered to the parents, whether they signed the consent form, and whether they read and acquired the information about the vaccination that their child would receive. Methods Childhood immunisations are provided at specific public health vaccination centres, "Unità Operative Materno-infantili’s" (UOMIs). We selected four UOMI from the Campania Region where we interviewed 1039 parents bringing their children for the 1st, 2nd, or 3rd doses of hexavalent vaccine. The consent forms were collected from the four vaccination centres and were analysed with respect to clarity and completeness. Results Most of the respondents (89.5%) were mothers between 20 and 39 years of age (80.4% vs 59.6% of the fathers), they were married (87.2% vs 93.5% of the fathers), and only one-half of them were employed (50.2% vs 92.6% of the fathers). The informed consent form was received from 58.1% of the parents and signed by 52.8%, but read by 35.0% of them. Only 1.5% of parents knew which vaccines were mandatory, and 25.0% of them believed that the entire hexavalent vaccine was mandatory. When we asked the parents which non-mandatory vaccinations were administered to their children, only 0.5% indicated the Haemophilus influenzae type B and none indicated the pertussis vaccine. Thirty-six per cent of the parents replied that their child had not received any non-mandatory vaccines. No parents were informed by the operators that their children would receive non-mandatory vaccines

  1. [Is my patient able to provide informed consent? A practical guideline].

    PubMed

    Vinkers, Christiaan H; van de Kraats, Gerrit B; Biesaart, Monique C; Tijdink, Joeri K

    2014-01-01

    Patient autonomy is a fundamental issue. Sometimes it is unclear whether a patient is capable to consent to a treatment decision. The treating physician judges whether a patient is able to provide informed consent. This judgement is a medical and not a legal decision. Considerations as to whether a patient can provide informed consent should always be systematically and in detail included in the medical records and should be periodically re-evaluated. Even if a patient incapable to consent to a particular medical decision, efforts should be put into finding the optimal treatment (proportional, effective and least substantial). It can be useful to involve a psychiatrist as a second and independent judge of a patient's ability to provide informed consent. A psychiatrist can also judge whether a psychiatric or cognitive disorder influences the ability to consent.

  2. The Readability of Information and Consent Forms in Clinical Research in France

    PubMed Central

    Ménoni, Véronique; Lucas, Noël; Leforestier, Jean François; Dimet, Jérôme; Doz, François; Chatellier, Gilles; Tréluyer, Jean-Marc; Chappuy, Hélène

    2010-01-01

    Background Quantitative tools have been developed to evaluate the readability of written documents and have been used in several studies to evaluate information and consent forms. These studies all showed that such documents had a low level of readability. Our objective is to evaluate the readability of Information and Consent Forms (ICFs) used in clinical research. Methods and Findings Clinical research protocols were collected from four public clinical research centers in France. Readability was evaluated based on three criteria: the presence of an illustration, the length of the text and its Flesch score. Potential effects of protocol characteristics on the length and readability of the ICFs were determined. Medical and statutory parts of the ICF form were analyzed separately. The readability of these documents was compared with that of everyday contracts, press articles, literary extracts and political speeches. We included 209 protocols and the corresponding 275 ICFs. The median length was 1304 words. Their Flesch readability scores were low (median: 24), and only about half that of selected press articles. ICF s for industrially sponsored and randomized protocols were the longest and had the highest readability scores. More than half (52%) of the text in ICFs concerned medical information, and this information was statistically (p<0.05) more readable (Flesch: 28) than statutory information (Flesch: 21). Conclusion Regardless of the field of research, the ICFs for protocols included had poor readability scores. However, a prospective analysis of this test in French should be carried out before it is put into general use. PMID:20485505

  3. 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

  4. [Informed consent or choice? An ethical dilemma in oncology practice].

    PubMed

    Vennin, Philippe

    2007-05-01

    How articulate information, mutidisciplinary practice, choice and decision of the treatment in a good patient-doctor relationship, an ethical relationship ? Doctor is an expert who gets the information (patients have more and more others sources of information). Choice of the treatment depends of the facts (the evidence) and personal values (the preferences). The selection between the different options (most often they are several options) may be done by the physician or by physicians in a multidisciplinary clinics, in the presence of the patient or not. The final decision to do or not the treatment belongs to the patient (who is not always aware of that). Initial sharing of the information between patient and doctor may permit the patient to choose himself the best option. More complete is sharing of the information, more the patient is able to do a free choice (without the influence of the doctor). It is often possible (genetics, prevention, screening, adjuvant treatments) to share in full the available information (knowing its relativity and limits). In oncology, the full sharing of the information is not always realistic, neither asked by the patient. Nevertheless, it is possible to go progressively with the patient to a preferred choice through a deliberative process, a co-construction of the decision. But often, the doctor refer to a pre-established protocol, build by physicians, representing the choice of the majority (doctors and/or patients) in the "same" situation. Only one option is offered to the patient from whom consent is asked, the information been then delivered to explain the choice already done. This paternalistic attitude is very effective, comfortable and don't alter the satisfaction of the majority of the patients, however, it limits the patient's autonomy. The patient is not allowed to choose between all the possibilities but accept or refuse the doctor's choice. With the extreme variability of the situations, it would be illusive to defend a

  5. Information Technology Industry 2004

    DTIC Science & Technology

    2004-01-01

    process, or transmit information goods and services” i It includes goods-producing industries related to the Internet and electronic commerce...the rest of the world. Finally, worldwide use of the Internet will continue to grow driving demand for both goods and services. Sector Analysis...nearly $1.0 trillion in 2001 to $1.5 trillion in 2006.xx Much of this growth is due to the Internet , both in the building of its infrastructure and for

  6. The right of minors to confidentiality and informed consent.

    PubMed

    Weisleder, Pedro

    2004-02-01

    Doctor-patient confidentiality is a precept of adolescent medicine. In general, physicians honor the privacy of adolescents unless there is evidence that the youngster is engaging in dangerous activities. An otherwise healthy 16 year old was referred for headache evaluation. During the portion of the interview conducted outside the presence of his mother, the patient revealed using marijuana and cocaine regularly and LSD (lysergic acid diethylamide), hallucinogenic mushrooms, and "Ecstasy" (3,4-methylenedioxymethamphetamine) occasionally. Given this information, and as allowed by North Carolina's General Statutes, the patient was offered confidential treatment for illegal substance abuse; he declined the offer. He also turned down the request to forgo his right to privacy so that his parents could be made aware of his addiction. As a result of the patient's drug use and disregard of its consequences, it was determined that notification of a parent was essential to his life or health; thus, confidentiality was breached. Although substance abuse is a behavior that threatens the abuser's health and life, state and federal laws vary regarding the rights of minors to confidential evaluation and treatment. For this article, laws that govern minors' rights to consent to confidential treatment for illegal substance abuse were reviewed. The aforementioned case is used as a catalyst for discussion.

  7. When is informed consent required in cluster randomized trials in health research?

    PubMed Central

    2011-01-01

    This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice? We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it

  8. Using principles of health literacy to enhance the informed consent process.

    PubMed

    Lorenzen, Bonne; Melby, Constance E; Earles, Barb

    2008-07-01

    THE LANGUAGE COMMONLY used in procedural/surgical consent forms often exceeds the average reading level of US patients, and many do not read the document before signing it. INCORPORATING READER-FRIENDLY language and formatting makes it more likely that patients will read the document, understand it, and therefore give informed consent. Adding "teach back" into the document provides a means of evaluating patient understanding. USING READER-FRIENDLY procedural/surgical consent documents merges the objectives of both health literacy and informed consent.

  9. Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial.

    PubMed

    Bobb, Morgan R; Van Heukelom, Paul G; Faine, Brett A; Ahmed, Azeemuddin; Messerly, Jeffrey T; Bell, Gregory; Harland, Karisa K; Simon, Christian; Mohr, Nicholas M

    2016-07-01

    Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study was to determine whether patient comprehension of telemedicine-enabled research informed consent is noninferior to standard face-to-face (F2F) research informed consent. A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic emergency department (ED) to test whether telemedicine-enabled research informed consent provided noninferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of 0.12% oral chlorhexidine gluconate in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard F2F consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc.) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified quality of informed consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. A total of 131 patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to F2F consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p = 0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Telemedicine is noninferior to F2F consent for delivering research informed consent, with no detected

  10. Meaningful Informed Consent with Young Children: Looking Forward through an Interactive Narrative Approach

    ERIC Educational Resources Information Center

    Mayne, Fiona; Howitt, Christine; Rennie, Léonie

    2016-01-01

    Ideas about ethical research with young children are evolving at a rapid rate. Not only can young children participate in the informed consent process, but researchers now also recognize that the process must be meaningful for them. As part of a larger study, this article reviews children's rights and informed consent literature as the foundation…

  11. 46 CFR Exhibit No. 2 to Subpart S... - Respondent's Consent Form for Informal Adjudication

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 9 2013-10-01 2013-10-01 false Respondent's Consent Form for Informal Adjudication No. Exhibit No. 2 to Subpart S of Part 502 Shipping FEDERAL MARITIME COMMISSION GENERAL AND ADMINISTRATIVE.... S, Exh. 2 Exhibit No. 2 to Subpart S of Part 502—Respondent's Consent Form for Informal Adjudication...

  12. 46 CFR Exhibit No. 2 to Subpart S... - Respondent's Consent Form for Informal Adjudication

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 9 2012-10-01 2012-10-01 false Respondent's Consent Form for Informal Adjudication No. Exhibit No. 2 to Subpart S of Part 502 Shipping FEDERAL MARITIME COMMISSION GENERAL AND ADMINISTRATIVE.... S, Exh. 2 Exhibit No. 2 to Subpart S of Part 502—Respondent's Consent Form for Informal Adjudication...

  13. 46 CFR Exhibit No. 2 to Subpart S... - Respondent's Consent Form for Informal Adjudication

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 9 2010-10-01 2010-10-01 false Respondent's Consent Form for Informal Adjudication No. Exhibit No. 2 to Subpart S of Part 502 Shipping FEDERAL MARITIME COMMISSION GENERAL AND ADMINISTRATIVE.... S, Exh. 2 Exhibit No. 2 to Subpart S of Part 502—Respondent's Consent Form for Informal Adjudication...

  14. 46 CFR Exhibit No. 2 to Subpart S... - Respondent's Consent Form for Informal Adjudication

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 9 2011-10-01 2011-10-01 false Respondent's Consent Form for Informal Adjudication No. Exhibit No. 2 to Subpart S of Part 502 Shipping FEDERAL MARITIME COMMISSION GENERAL AND ADMINISTRATIVE.... S, Exh. 2 Exhibit No. 2 to Subpart S of Part 502—Respondent's Consent Form for Informal Adjudication...

  15. 46 CFR Exhibit No. 2 to Subpart S... - Respondent's Consent Form for Informal Adjudication

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 9 2014-10-01 2014-10-01 false Respondent's Consent Form for Informal Adjudication No. Exhibit No. 2 to Subpart S of Part 502 Shipping FEDERAL MARITIME COMMISSION GENERAL AND ADMINISTRATIVE.... S, Exh. 2 Exhibit No. 2 to Subpart S of Part 502—Respondent's Consent Form for Informal Adjudication...

  16. Meaningful Informed Consent with Young Children: Looking Forward through an Interactive Narrative Approach

    ERIC Educational Resources Information Center

    Mayne, Fiona; Howitt, Christine; Rennie, Léonie

    2016-01-01

    Ideas about ethical research with young children are evolving at a rapid rate. Not only can young children participate in the informed consent process, but researchers now also recognize that the process must be meaningful for them. As part of a larger study, this article reviews children's rights and informed consent literature as the foundation…

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

    PubMed

    Vučemilo, Luka; Borovečki, Ana

    2015-01-01

    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. 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. 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%. 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.

  18. Random Assignment and Informed Consent: A Case Study of Multiple Perspectives

    ERIC Educational Resources Information Center

    Walker, Robert; Hoggart, Lesley; Hamilton, Gayle

    2008-01-01

    Although random assignment is generally the preferred methodology in impact evaluations, it raises numerous ethical concerns, some of which are addressed by securing participants' informed consent. However, there has been little investigation of how consent is obtained in social experiments and the amount of information that can be conveyed--and…

  19. A National Survey Concerning the Ethical Aspects of Informed Consent and Role of Medical Students.

    ERIC Educational Resources Information Center

    Cohen, Daniel L.; And Others

    1988-01-01

    A national sample of medical students was surveyed to identify the ways the students obtained informed consent from their patients and to learn the students' views of certain issues concerning informed consent. All the students were less forthright about their status when given the opportunity to perform invasive procedures. (Author/MLW)

  20. 34 CFR 99.30 - Under what conditions is prior consent required to disclose information?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 1 2010-07-01 2010-07-01 false Under what conditions is prior consent required to disclose information? 99.30 Section 99.30 Education Office of the Secretary, Department of Education FAMILY... Information From Education Records? § 99.30 Under what conditions is prior consent required to...

  1. Health literacy predicts participant understanding of orally-presented informed consent information.

    PubMed

    Ownby, Raymond L; Acevedo, Amarilis; Goodman, Kenneth; Caballero, Joshua; Waldrop-Valverde, Drenna

    Informed consent for participation in studies with human subjects is a critically important aspect of clinical research, but research has shown that many potential subjects do not understand information relevant to their participation. A better understanding of factors related to participant understanding of study-related information is thus important. As part of a study to develop a new measure of health literacy, participants viewed a 50 second video in their preferred language (Spanish or English) of a clinician presenting informed consent information. They then responded to six questions about it. In progressively more complicated regression models, we evaluated the relation of demographic variables, general cognitive ability, and health literacy to participants' recall of the information. In a model that only included demographic variables, Spanish language, black race and older age were associated with poorer performance. In a model that included the effects of general cognitive ability and health literacy as well as demographics, education and health literacy were related to performance. Informed consent interventions that take potential research subjects' levels of health literacy into account may result in better understanding of research-related information that can inform their decision to participate.

  2. Informed consent: a survey of general dental practitioners in Belgaum city.

    PubMed

    Kotrashetti, Vijayalakshmi S; Kale, Alka D; Hebbal, Mamata; Hallikeremath, Seema R

    2010-01-01

    The informed consent process allows the patient or legal guardian to participate in and retain autonomy over the medical service received. Obtaining informed consent may also decrease the practitioner's liability from claims associated with miscommunication. The aim of this study was to assess knowledge and practices of general dental practitioners (GDPs) regarding informed consent. 118 GDPs in Belgaum city, Karnataka, India, were given questionnaires asking for information on their knowledge and practices related to informed consent. The questions covered general information, treatment-specific issues and the consent process. 80 responses were received out of which 44 were complete. 63.6% of GDPs reported that they obtained written consent. All of them reported that they obtained only general consent. 4 of them obtained written consent in the local language. 37 said they gave a detailed explanation of the procedure. 3 said they did not inform their patients on radiation exposure. Dentists should upgrade their knowledge regarding legal jurisprudence and legal medicine to avoid any litigation.

  3. Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials.

    PubMed

    Sengupta, Sohini; Lo, Bernard; Strauss, Ronald P; Eron, Joseph; Gifford, Allen L

    2011-11-01

    Assessing and improving informed consent understanding is equally important as obtaining consent from participants in clinical trial research, but developing interventions to target gaps in participants' informed consent understanding remains a challenge. We used a randomized controlled study design to pilot test an educational intervention to improve actual informed consent understanding of new enrollees in the Adult AIDS Clinical Trial Group (AACTG). Questionnaires were administered to 24 enrollees to assess their baseline understanding on eight elements of informed consent associated with AIDS clinical trials. Enrollees who scored 18/21(85%) or less were randomly assigned to in-person, targeted education (intervention), or delayed education (control). Two follow-up assessments were administered. Repeated measures ANOVA was performed to determine intervention effectiveness in improving actual informed consent understanding over time. Actual understanding improved at the immediate post-intervention time point with a significant score difference of 2.5 when comparing the intervention and delayed groups. In addition, there was a significant score difference of 3.2 when comparing baseline to three-month follow-up for the two groups, suggesting a statistically significant intervention effect to improve actual understanding of the basic elements of informed consent. The findings demonstrated that one-time targeted education can improve actual informed consent understanding one week after the intervention, but retention of these concepts may require periodic monitoring to ensure comprehension throughout the course of a clinical trial.

  4. Impediments to obtaining informed consent for clinical research in trauma patients.

    PubMed

    Dutton, Richard P; Stansbury, Lynn G; Hemlock, Bethany; Hess, John R; Scalea, Thomas M

    2008-04-01

    Informed consent is required for, but a substantial barrier to, clinic research in trauma care. Exceptions have been established but remain controversial, and little objective data are available to illuminate this debate. We prospectively assessed 2,011 consecutive patients admitted to the R Adams Cowley Shock Trauma Center of the University of Maryland Medical System for the potential to give consent for a hypothetical research trial within 1 hour of admission or whether consent could be obtained from a legally authorized representative (LAR) within 3 hours. These data were then linked with demographic, transport, physiologic, and injury data. Complete data were available for 1,734 patients: 982 (57%) appeared able to consent and 752 (43%) appeared unable to consent. Of the latter, LAR consent was potentially available for 404, leaving 348 (46%, 20% of all admissions) unconsentable. Those apparently able to consent were significantly less injured than those unable, but a third were subsequently found to have objective barriers to giving consent, and a further third had findings strongly suggestive of impairment. For those unable to consent, subsequent LAR consent was strongly associated with being a minor or being a woman. Lack of LAR consent was strongly associated with being the victim of intentional injury, with being an African-American male and-for European-American men only-with being transported greater distances. Severely injured trauma patients can seldom provide consent for research studies, and LARs are often unavailable. Further efforts to develop workable mechanisms for exception from informed consent are justified.

  5. Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond.

    PubMed

    Yoshizawa, Go; Sasongko, Teguh H; Ho, Chih-Hsing; Kato, Kazuto

    2017-01-01

    The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia - the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More

  6. The informed consent process in older patients who developed delirium: a clinical epidemiologic study.

    PubMed

    Auerswald, K B; Charpentier, P A; Inouye, S K

    1997-11-01

    Delirium, defined as an acute, fluctuating disorder of attention and cognition, is a serious and increasingly common problem for hospitalized older persons. Delirium poses unique ethical challenges for the informed consent process, notably the preservation of patient autonomy in the face of potentially fluctuating decision-making capacity. To clarify these issues, we examined the informed consent process in a group of hospitalized older patients who developed delirium. Eighty-four hospitalized patients aged >70 years who developed delirium during hospitalization at a large urban teaching hospital. We conducted a clinical epidemiologic investigation of informed consent in 173 medical and surgical procedures performed in 84 patients. Clinical researchers carried out detailed cognitive evaluation of patients on or near the consent date. A separate blinded researcher extracted medical record information on the procedures and informed consent process variables. Of 173 procedures, 33 (19%) had no documentation of any consent, and 34 (20%) used surrogate consent. There were no documented assessments of competency/ decisional capacity; cognitive assessments were done in 7 (4%) cases, and legal consults in 2 (1%) cases. Discussion of potential risks of the procedure with patient or surrogate were documented in 61 (35%) cases. In multivariable analysis, independent predictors for failure to obtain consent were presence of delirium (adjusted odds ratio [OR] = 2.7, 95% confidence interval [CI] 1.3, 5.3) and less invasive procedure (OR = 5.0, CI 2.0, 12.8). Although cognitive impairment predicted surrogate use, we found that 47% of cases with substantial impairment did not involve use of a surrogate, whereas surrogates signed for 4% of cases with normal mental status near the time of consent. Our results highlight the ethical challenges that delirium poses for the informed consent process, including the high rate of no consent, lack of cognitive and decisional capacity

  7. Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond

    PubMed Central

    Yoshizawa, Go; Sasongko, Teguh H.; Ho, Chih-Hsing; Kato, Kazuto

    2017-01-01

    The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia – the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More

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

    SciTech Connect

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

    2003-09-15

    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 and 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

  9. How is informed consent related to emotions and empathy? An exploratory neuroethical investigation.

    PubMed

    Supady, Alexander; Voelkel, Antonie; Witzel, Joachim; Gubka, Udo; Northoff, Georg

    2011-05-01

    Informed consent is crucial in daily clinical practice and research in medicine and psychiatry. A recent neuroethical investigation explored the psychological factors that are crucial in determining whether or not subjects give consent. While cognitive functions have been shown to play a central role, the impact of empathy and emotions on subjects' decisions in informed consent remains unclear. To evaluate the impact of empathy and emotions on subjects' decision in informed consent in an exploratory study. Decisional capacity and informed consent to a subsequent imaging study were evaluated with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). Empathy and emotion recognition were measured with the Multifaceted Empathy Test (MET) and the Florida Affect Battery (FAB). Psychiatric subjects were recruited from a general psychiatric hospital and a forensic state hospital. A mixed group of 98 healthy men and forensic and non-forensic psychiatric subjects were investigated. Both empathy (MET) and emotion recognition (FAB) correlated with MacCAT-CR scores. Higher cognitive empathy and good emotion recognition (compared with low empathy and emotion recognition) were associated with increased decisional capacity and higher rates of refusal to give informed consent. This study shows an empirical relationship between decision-making and informed consent, on the one hand, and emotions and empathy on the other. While this study is exploratory and preliminary, the findings of a relationship between informed consent, emotions and empathy raise important neuroethical questions with regard to an emotional-social concept of informed consent and potential clinical implications for testing informed consent.

  10. [Analysis of informed consent readibility in intensive care].

    PubMed

    Ramírez-Puerta, M R; Fernández-Fernández, R; Frías-Pareja, J C; Yuste-Ossorio, M E; Narbona-Galdó, S; Peñas-Maldonado, L

    2013-11-01

    To analyze the readability of informed consent documents (IC) used in an intensive care department and in the Andalusian Healthcare System (AHS). A descriptive study was carried out. The Intensive Care Unit of a tertiary Hospital, and the AHS. A review and analysis was made of the existing 14 IC models in the Intensive Care Unit and of another 14 IC models offered by the AHS, using the following readability scores: Flesch, Sentence complexity, LEGIN, Fernández-Huerta, Szigriszt and INFLESZ. Twenty-four IC (85.7%) failed to satisfy some of the indexes, while three (10.7%) did not satisfy any of them. Four documents (14.3%) satisfied all the indexes analyzed, and therefore are easy to understand. Flesch score: satisfied by one of the ICU IC (7.1%) and by three of the AHS documents (21.4%). Sentence complexity score: satisfied by 11 of the ICU IC (78.6%) and by 13 of the AHS documents (92.8%). Fernández-Huerta score: satisfied by four of the ICU IC (28.6%) and by 13 of the AHS documents (92.8%). Szigriszt score: satisfied by two of the ICU IC (14.3%) and by 11 of the AHS documents (64.3%). INFLESZ score: satisfied by two of the ICU IC (14.3%) and by 10 of the AHS documents (71.4%). The documents analyzed are generally difficult to read and understand by most people, and do not satisfy the basic purpose for which they were drafted. Copyright © 2012 Elsevier España, S.L. and SEMICYUC. All rights reserved.

  11. Predictors of ethical approval and informed consent in orthodontic RCTs.

    PubMed

    Fitzgerald, Rhian C; Burnside, Girvan; Harrison, Jayne E

    2013-09-01

    Determine the number of orthodontic randomized controlled trials (RCTs) published in four key orthodontic journals from 1 January 2001 to 31 December 2010, whether details about ethical approval (EA) and/or informed consent (IC) were reported and identify predictors for reporting EA and IC in orthodontic RCTs. Retrospective observational study. American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), Angle Orthodontist (AO), European Journal of Orthodontics (EJO) and Journal of Orthodontics (JO) from 2001 to 2010. AJODO, AO, EJO and JO were handsearched to identify all RCTs published from 1 January 2001 to 31 December 2010. The RCTs were assessed to identify: inclusion of details about EA and IC, publication journal, number of authors, number and location of centres involved, perceived statistician involvement, publication year and inclusion of random* in either the title, abstract or body of the text. 218 RCTs were published. 109 (48·6%) had reported both EA and IC, 59 (27·1%) neither and 53 (12·9%) either EA or IC. Factors associated with an RCT reporting obtaining EA and IC: number of authors (P<0·001), random* in title (P<0·001), random* in abstract but not title (P<0·001), location of origin (P = 0·001), publication year (P = 0·003), journal of publication (P = 0·004) and number of centres (P = 0·008). Logistic regression suggested the most significant indicators of reporting EA and IC were: publication in the JO (P = 0·018), >6 authors (P<0·001), random* in the abstract but not title (P = 0·004) and publication after 2004 (P = 0·001). RCTs were most likely to have reported EA and IC when published in the JO, after 2004 while having more than six authors and random* in the abstract but not title.

  12. Qualitative study of patient consent for health information exchange in an HIV clinic.

    PubMed

    Ramos, S Raquel; Bakken, Suzanne

    2014-01-01

    Health information exchange (HIE) is the secure, electronic transfer and/or accessibility of clinical data among healthcare providers. In the United States (US), the consent process for participation varies state to state. New York State (NYS) mandates written patient consent. The purpose of this study was to examine workflow and perceptions related to obtaining HIE consent in an HIV clinic. We used contextual inquiry to observe the HIE consent-related workflow of four registration clerks for a total of 4 hours on two weekdays and subsequently created a flow chart and sequence model diagram. Clerks were also interviewed and the resulting narrative data were coded into themes. Observational and interview data suggested that patient privacy/confidentiality/trust, high volume workflow, and multiple competing demands affect the patient HIE consent process. Additional qualitative data needs to be gathered from the perspectives of patients and clinicians about the HIE consent process.

  13. Why we should not seek individual informed consent for participation in health services research.

    PubMed

    Cassell, J; Young, A

    2002-10-01

    Ethics committees now require that individuals give informed consent to much health services research, in the same way as for clinical research. This is misguided. Existing ethical guidelines do not help us decide how to seek consent in these cases, and have allowed managerial experimentation to remain largely unchecked. Inappropriate requirements for individual consent can institutionalise health inequalities and reduce access to services for vulnerable groups. This undermines the fundamental purpose of the National Health Service (NHS), and ignores our rights and duties as its members, explored here. Alternative forms of community consent should be actively pursued.

  14. Changing constructions of informed consent: qualitative research and complex social worlds.

    PubMed

    Miller, Tina; Boulton, Mary

    2007-12-01

    Informed consent is a concept which attempts to capture and convey what is regarded as the appropriate relationship between researcher and research participant. Definitions have traditionally emphasised respect for autonomy and the right to self-determination of the individual. However, the meaning of informed consent and the values on which it is based are grounded in society and the practicalities of social relationships. As society changes, so too do the meaning and practice of informed consent. In this paper, we trace the ways in which the meaning and practice of informed consent has changed over the last 35 years with reference to four qualitative studies of parenting and children in the UK which we have undertaken at different points in our research careers. We focus in particular on the shifting boundaries between the professional and personal, and changing expressions of agency and power in a context of heightened perceptions of risk in everyday life. We also discuss developments in information and communication technologies as a factor in changing both the formal requirements for and the situated practicalities of obtaining informed consent. We conclude by considering the implications for informed consent of both increasing bureaucratic regulation and increasingly sophisticated information and communication technologies and suggest strategies for rethinking and managing 'consent' in qualitative research practice.

  15. 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

  16. Improving the Process of Informed Consent for PCI: Patient Outcomes from the ePRISM Study

    PubMed Central

    Spertus, John A.; Bach, Richard; Bethea, Charles; Chhatriwalla, Adnan; Curtis, Jeptha P.; Gialde, Elizabeth; Guerrero, Mayra; Gosch, Kensey; Jones, Philip; Kugelmass, Aaron; Leonard, Bradley M.; McNulty, Edward J.; Shelton, Marc; Ting, Henry H.; Decker, Carole

    2014-01-01

    Background While the process of informed consent is designed to transfer knowledge of the risks and benefits of treatment and to engage patients in shared medical decision-making, this is poorly done in routine clinical care. We assessed the impact of a novel informed consent form for percutaneous coronary intervention (PCI) that is more simply written, includes images of the procedure and embeds individualized estimates of outcomes on multiple domains of successful informed consent and shared decision-making. Methods We interviewed 590 PCI patients receiving traditional consent documents and 527 patients receiving novel ePRISM consents at 9 US centers and compared patients' perceptions, knowledge transfer and engagement in medical decision-making. Heterogeneity across sites was assessed and adjusted for using hierarchical models. Results Site-adjusted analyses revealed more frequent review (72% for ePRISM vs. 45% for original consents) and better understanding of the ePRISM consents (odds ratios (ORs)=1.8–3.0, depending upon the outcome) with marked heterogeneity across sites (median relative difference (MRD) in the ORs of ePRISM's effect = 2–3.2). Patients receiving ePRISM consents better understood the purposes and risks of the procedure (ORs=1.9–3.9, MRDs=1.1–6.2), engaged more in shared decision-making (proportional OR=2.1 [95%CI=1.02–4.4], MRD=2.2) and discussed stent options with their physicians (58% vs. 31%; site-adjusted odds ratio=2.7 [95% CI=1.2, 6.3], MRD=2.6) more often. Conclusions A personalized consent document improved the process of informed consent and shared decision-making. Marked heterogeneity across hospitals highlights that consent documents are but one aspect of engaging patients in understanding and participating in treatment. PMID:25641532

  17. Variability in the Perception of Informed Consent for IV-tPA during Telestroke Consultation

    PubMed Central

    Thomas, Lisa; Viswanathan, Anand; Cochrane, Thomas I.; Johnson, John; O’Brien, Janice; McMahon, Marilyn; Santimauro, Janine Marie; Schwamm, Lee H.

    2012-01-01

    Objective: To study the perception of informed consent among various raters for thrombolysis in acute ischemic stroke patients receiving intravenous tissue plasminogen activator (IV-tPA). Methods: Twenty randomly selected videotaped telestroke consultations of acute stroke patients administered IV-tPA were retrospectively reviewed. Adequacy of informed consent was reviewed by five raters: a neurologist and emergency physician who routinely treat stroke, a medical risk management paralegal, a bioethicist, and a lay person. Raters assessed the quality of the informed consent presentation by the treating physician and the degree of understanding demonstrated by the patient/family authorizing consent. Factors associated with adequacy of consent were analyzed. Results: Consent was rated as adequately understood by the patient-family in 78.6% cases. Agreement between all five raters with regard to the patient-family understanding of consent was poor and also between the subgroups of non-physician and physician (all k < 0.20). Similarly, the quality of the physician consent process was poor for agreement between all five raters (k = 0.07) or between the subgroup of the three non-physician raters (k = −0.06) and fair between the two physician raters (k = 0.24). The legal reviewer and the bioethicist rated the physician consent process as being of lower quality than did the two physicians and the layperson. Conclusion: Despite high variability in the perception of informed consent among raters in this time-sensitive clinical situation, almost 80% of patients were rated by all reviewers as having adequate understanding of risks and benefits of tPA. This suggests the need for a standardized but brief tPA consent process that includes patient/family demonstration of understanding. PMID:23015805

  18. Variability in the Perception of Informed Consent for IV-tPA during Telestroke Consultation.

    PubMed

    Thomas, Lisa; Viswanathan, Anand; Cochrane, Thomas I; Johnson, John; O'Brien, Janice; McMahon, Marilyn; Santimauro, Janine Marie; Schwamm, Lee H

    2012-01-01

    To study the perception of informed consent among various raters for thrombolysis in acute ischemic stroke patients receiving intravenous tissue plasminogen activator (IV-tPA). Twenty randomly selected videotaped telestroke consultations of acute stroke patients administered IV-tPA were retrospectively reviewed. Adequacy of informed consent was reviewed by five raters: a neurologist and emergency physician who routinely treat stroke, a medical risk management paralegal, a bioethicist, and a lay person. Raters assessed the quality of the informed consent presentation by the treating physician and the degree of understanding demonstrated by the patient/family authorizing consent. Factors associated with adequacy of consent were analyzed. Consent was rated as adequately understood by the patient-family in 78.6% cases. Agreement between all five raters with regard to the patient-family understanding of consent was poor and also between the subgroups of non-physician and physician (all k < 0.20). Similarly, the quality of the physician consent process was poor for agreement between all five raters (k = 0.07) or between the subgroup of the three non-physician raters (k = -0.06) and fair between the two physician raters (k = 0.24). The legal reviewer and the bioethicist rated the physician consent process as being of lower quality than did the two physicians and the layperson. Despite high variability in the perception of informed consent among raters in this time-sensitive clinical situation, almost 80% of patients were rated by all reviewers as having adequate understanding of risks and benefits of tPA. This suggests the need for a standardized but brief tPA consent process that includes patient/family demonstration of understanding.

  19. The role of effective communication in achieving informed consent for clinical trials.

    PubMed

    Pick, Andrew; Gilbert, Kayleigh; McCaul, James

    2014-11-11

    Informed consent is fundamental to the protection of the rights, safety and wellbeing of patients in clinical research. For consent to be valid, patients must first be given all the information they need about the proposed research to be able to decide whether they would like to take part. This material should be presented in a way that is easy for them to understand. This article explores the importance of communication in clinical research, and how more effective communication with patients during the informed consent process can ensure they are fully informed.

  20. Informed decision making and abortion: crisis pregnancy centers, informed consent, and the first amendment.

    PubMed

    Ahmed, Aziza

    2015-01-01

    Shifting laws and regulations increasingly displace the centrality of women's health concerns in the provision of abortion services. This is exemplified by the growing presence of deceptive Crisis Pregnancy Centers alongside new informed consent laws designed to dissuade women from seeking abortions. Litigation on informed consent is further complicated in the clinical context due to the increased mobilization of facts - such as the gestational age or sonogram of the fetus - delivered with the intent to dissuade women from accessing abortion. In other words, factual information utilized for ideological purpose. To preserve a woman's autonomy and decision-making capacity, there must be a concerted effort on the part of legislators and courts to place a woman's health at the center of abortion law and policy.

  1. CTEPP STANDARD OPERATING PROCEDURE FOR OBTAINING INFORMED CONSENT (SOP-1.13)

    EPA Science Inventory

    The CTEPP informed consent procedures are described in the SOP. After an eligible subject provides verbal consent, staff schedule a visit to meet with the subject in person to explain study activities and answer questions about the study. During the visit, staff demonstrate how...

  2. CTEPP STANDARD OPERATING PROCEDURE FOR OBTAINING INFORMED CONSENT (SOP-1.13)

    EPA Science Inventory

    The CTEPP informed consent procedures are described in the SOP. After an eligible subject provides verbal consent, staff schedule a visit to meet with the subject in person to explain study activities and answer questions about the study. During the visit, staff demonstrate how...

  3. Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial

    PubMed Central

    Ruan, Xiangcai; Tang, Haoying; Yang, Weizhong; Xian, Zhuanhua; Lu, Min

    2017-01-01

    Purpose. To investigate whether adding video assistance to traditional verbal informed consent advisement improved satisfaction among cataract surgery patients. Methods. This trial enrolled 80 Chinese patients with age-related cataracts scheduled to undergo unilateral phacoemulsification surgery. Patients were randomized into two groups: the video group watched video explaining cataract-related consent information and rewatched specific segments of the video at their own discretion, before receiving traditional verbal consent advisement; the control group did not watch the video. Outcomes included patient satisfaction, refusal to consent, time to complete the consent process, and comprehension measured by a ten-item questionnaire. Results. All 80 enrolled patients signed informed consent forms. Compared with the control group, members of the video group exhibited greater satisfaction (65% versus 86%, p = 0.035) and required less time to complete the consent process (12.3 ± 6.7 min versus 5.6 ± 5.4 min, p < 0.001), while also evincing levels of comprehension commensurate with those reported for patients who did not watch the video (accuracy rate, 77.5% versus 80.2%, p = 0.386). Conclusion. The video-assisted informed consent process had a positive impact on patients' cataract surgery experiences. Additional research is needed to optimize patients' comprehension of the video. PMID:28191349

  4. 15 CFR 27.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...'s legally authorized representative. When this method is used, there shall be a witness to the oral... record linking the subject and the research would be the consent document and the principal risk would be... wants documentation linking the subject with the research, and the subject's wishes will govern; or (2...

  5. 7 CFR 1c.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...'s legally authorized representative. When this method is used, there shall be a witness to the oral... record linking the subject and the research would be the consent document and the principal risk would be... wants documentation linking the subject with the research, and the subject's wishes will govern; or (2...

  6. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by...'s legally authorized representative. When this method is used, there shall be a witness to the oral... record linking the subject and the research would be the consent document and the principal risk would be...

  7. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.117 Documentation of... representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall... the research would be the consent document and the principal risk would be potential harm resulting...

  8. 22 CFR 225.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... record linking the subject and the research would be the consent document and the principal risk would be...) That the research presents no more than minimal risk of harm to subjects and involves no procedures for... statement regarding the research. (Approved by the Office of Management and Budget under control number...

  9. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by... record linking the subject and the research would be the consent document and the principal risk would be... wants documentation linking the subject with the research, and the subject's wishes will govern; or (2...

  10. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.117 Documentation of... the research would be the consent document and the principal risk would be potential harm resulting... linking the subject with the research, and the subject's wishes will govern; or (2) That the research...

  11. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.117 Documentation of... the research would be the consent document and the principal risk would be potential harm resulting... linking the subject with the research, and the subject's wishes will govern; or (2) That the research...

  12. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.117 Documentation of... the research would be the consent document and the principal risk would be potential harm resulting... linking the subject with the research, and the subject's wishes will govern; or (2) That the research...

  13. 34 CFR 97.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects... record linking the subject and the research would be the consent document and the principal risk would be... wants documentation linking the subject with the research, and the subject's wishes will govern; or (2...

  14. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by... record linking the subject and the research would be the consent document and the principal risk would be... wants documentation linking the subject with the research, and the subject's wishes will govern; or (2...

  15. 45 CFR 46.117 - Documentation of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... HUMAN SUBJECTS Basic HHS Policy for Protection of Human Research Subjects § 46.117 Documentation of... the research would be the consent document and the principal risk would be potential harm resulting... linking the subject with the research, and the subject's wishes will govern; or (2) That the research...

  16. 40 CFR 26.117 - Documentation of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... HUMAN SUBJECTS Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by... record linking the subject and the research would be the consent document and the principal risk would be... wants documentation linking the subject with the research, and the subject's wishes will govern; or (2...

  17. 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

  18. A tiered-layered-staged model for informed consent in personal genome testing

    PubMed Central

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

    2013-01-01

    In recent years, developments in genomics technologies have led to the rise of commercial personal genome testing (PGT): broad genome-wide testing for multiple diseases simultaneously. While some commercial providers require physicians to order a personal genome test, others can be accessed directly. All providers advertise directly to consumers and offer genetic risk information about dozens of diseases in one single purchase. The quantity and the complexity of risk information pose challenges to adequate pre-test and post-test information provision and informed consent. There are currently no guidelines for what should constitute informed consent in PGT or how adequate informed consent can be achieved. In this paper, we propose a tiered-layered-staged model for informed consent. First, the proposed model is tiered as it offers choices between categories of diseases that are associated with distinct ethical, personal or societal issues. Second, the model distinguishes layers of information with a first layer offering minimal, indispensable information that is material to all consumers, and additional layers offering more detailed information made available upon request. Finally, the model stages informed consent as a process by feeding information to consumers in each subsequent stage of the process of undergoing a test, and by accommodating renewed consent for test result updates, resulting from the ongoing development of the science underlying PGT. A tiered-layered-staged model for informed consent with a focus on the consumer perspective can help overcome the ethical problems of information provision and informed consent in direct-to-consumer PGT. PMID:23169494

  19. 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

  20. 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

  1. Architecture of a consent management suite and integration into IHE-based regional health information networks

    PubMed Central

    2011-01-01

    Background The University Hospital Heidelberg is implementing a Regional Health Information Network (RHIN) in the Rhine-Neckar-Region in order to establish a shared-care environment, which is based on established Health IT standards and in particular Integrating the Healthcare Enterprise (IHE). Similar to all other Electronic Health Record (EHR) and Personal Health Record (PHR) approaches the chosen Personal Electronic Health Record (PEHR) architecture relies on the patient's consent in order to share documents and medical data with other care delivery organizations, with the additional requirement that the German legislation explicitly demands a patients' opt-in and does not allow opt-out solutions. This creates two issues: firstly the current IHE consent profile does not address this approach properly and secondly none of the employed intra- and inter-institutional information systems, like almost all systems on the market, offers consent management solutions at all. Hence, the objective of our work is to develop and introduce an extensible architecture for creating, managing and querying patient consents in an IHE-based environment. Methods Based on the features offered by the IHE profile Basic Patient Privacy Consent (BPPC) and literature, the functionalities and components to meet the requirements of a centralized opt-in consent management solution compliant with German legislation have been analyzed. Two services have been developed and integrated into the Heidelberg PEHR. Results The standard-based Consent Management Suite consists of two services. The Consent Management Service is able to receive and store consent documents. It can receive queries concerning a dedicated patient consent, process it and return an answer. It represents a centralized policy enforcement point. The Consent Creator Service allows patients to create their consents electronically. Interfaces to a Master Patient Index (MPI) and a provider index allow to dynamically generate XACML

  2. Architecture of a consent management suite and integration into IHE-based Regional Health Information Networks.

    PubMed

    Heinze, Oliver; Birkle, Markus; Köster, Lennart; Bergh, Björn

    2011-10-04

    The University Hospital Heidelberg is implementing a Regional Health Information Network (RHIN) in the Rhine-Neckar-Region in order to establish a shared-care environment, which is based on established Health IT standards and in particular Integrating the Healthcare Enterprise (IHE). Similar to all other Electronic Health Record (EHR) and Personal Health Record (PHR) approaches the chosen Personal Electronic Health Record (PEHR) architecture relies on the patient's consent in order to share documents and medical data with other care delivery organizations, with the additional requirement that the German legislation explicitly demands a patients' opt-in and does not allow opt-out solutions. This creates two issues: firstly the current IHE consent profile does not address this approach properly and secondly none of the employed intra- and inter-institutional information systems, like almost all systems on the market, offers consent management solutions at all. Hence, the objective of our work is to develop and introduce an extensible architecture for creating, managing and querying patient consents in an IHE-based environment. Based on the features offered by the IHE profile Basic Patient Privacy Consent (BPPC) and literature, the functionalities and components to meet the requirements of a centralized opt-in consent management solution compliant with German legislation have been analyzed. Two services have been developed and integrated into the Heidelberg PEHR. The standard-based Consent Management Suite consists of two services. The Consent Management Service is able to receive and store consent documents. It can receive queries concerning a dedicated patient consent, process it and return an answer. It represents a centralized policy enforcement point. The Consent Creator Service allows patients to create their consents electronically. Interfaces to a Master Patient Index (MPI) and a provider index allow to dynamically generate XACML-based policies which are

  3. Informed consent procedures with cognitively impaired patients: A review of ethics and best practices.

    PubMed

    Fields, Lindy Marie; Calvert, James Douglas

    2015-08-01

    The objectives of this article are to discuss ethical issues of informed consent in cognitively impaired patients and review considerations for capacity determination. We will also discuss how to evaluate capacity, determine competence, and obtain informed consent when a patient is deemed incompetent. This review emphasizes how to carry out informed consent procedures when capacity is questionable and discusses measures supported for use when determining cognitively impaired patients' ability to consent. Information was gathered from medical and psychological codes of ethics, peer-reviewed journals, published guidelines from health-care organizations (e.g., American Medical Association), and scholarly books. Google Scholar and PsycINFO were searched for articles related to 'informed consent' and 'cognitive impairment' published in English between 1975 and 2014. Relevant sources referenced in retrieved publications were subsequently searched and reviewed. We selected 49 sources generated by our search. Sources were included in our review if they presented information related to at least one of our focus areas. These areas included: review of informed consent ethics and procedures, review of cognitive impairment evaluations, recommendations for measuring cognitive capacity, and alternative forms of informed consent. Patients' cognitive impairments can hinder the ability of patients to understand treatment options. Evaluating the capacity of patients with cognitive impairment to understand treatment options is vital for valid informed consent and should be guided by best practices. Thus, proper identification of patients with questionable capacity, capacity evaluation, and determination of competence, as well as reliance upon appropriate alternative consent procedures, are paramount. © 2015 The Authors. Psychiatry and Clinical Neurosciences © 2015 Japanese Society of Psychiatry and Neurology.

  4. Informed consent in human oocyte, embryo, and embryonic stem cell research.

    PubMed

    Lo, Bernard; Chou, Vicki; Cedars, Marcelle I; Gates, Elena; Taylor, Robert N; Wagner, Richard M; Wolf, Leslie; Yamamoto, Keith R

    2004-09-01

    Research with human oocytes, embryos, and additional embryonic stem cell lines is needed to address important scientific questions and to fulfill the promise of stem cell transplantation for degenerative diseases. Proponents need to develop guidelines for the appropriate conduct of embryonic stem cell research. Such guidelines will help build public trust and acceptance for this research. In this article, we offer recommendations for informed consent, discussing who should give consent, what the consent process should cover, when consent should be obtained, and who should obtain consent. Consent to use embryos for research should be obtained from oocyte and sperm donors as well as from the woman or couple undergoing infertility treatment. The consent discussion must cover information that donors need to know to make an informed decision about various types of research. Donations for research should be discussed at the initiation of advanced infertility treatment and reconfirmed if possible at the time of actual donation for research. Treating assisted reproduction technology physicians can help with the consent process, provided that they are not involved in the research.

  5. Informed consent in the context of research involving acute injuries and emergencies.

    PubMed

    Costa, M L; Tutton, E; Achten, J; Grant, R; Slowther, A M

    2017-02-01

    Traditionally, informed consent for clinical research involves the patient reading an approved Participant Information Sheet, considering the information presented and having as much time as they need to discuss the study information with their friends and relatives, their clinical care and the research teams. This system works well in the 'planned' or 'elective' setting. But what happens if the patient requires urgent treatment for an injury or emergency? This article reviews the legal framework which governs informed consent in the emergency setting, discusses how the approach taken may vary according to the details of the emergency and the treatment required, and reports on the patients' view of providing consent following a serious injury. We then provide some practical tips for managing the process of informed consent in the context of injuries and emergencies. Cite this article: Bone Joint J 2017;99-B:147-150. ©2017 The British Editorial Society of Bone & Joint Surgery.

  6. Personalized disclosure by information-on-demand: attending to patients' needs in the informed consent process.

    PubMed

    Siegal, Gil; Bonnie, Richard J; Appelbaum, Paul S

    2012-01-01

    Obtaining informed consent has typically become a stylized ritual of presenting and signing a form, in which physicians are acting defensively and patients lack control over the content and flow of information. This leaves patients at risk both for being under-informed relative to their decisional needs and of receiving more information than they need or desire. By personalizing the process of seeking and receiving information and allowing patients to specify their desire for information in a prospective manner, we aim to shift genuine control over the informational process to patients. A new paradigm of Information on Demand, such as we suggest, would also enhance legal certainty, achieve greater congruence between the information patients want and the information they receive, and promote more meaningful patient-physician interactions, a desirable outcome that has been difficult to achieve by other means. © 2012 American Society of Law, Medicine & Ethics, Inc.

  7. 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

  8. The perceived information in obtained from the informed consent in Iranian patients with cancer in clinical studies.

    PubMed

    Ghiyasvandian, Sharzad; Bolourchifard, Fariba; Parsa Yekta, Zohreh

    2014-10-29

    One of the basic issues in clinical studies is to receive the informed consent; that is to say, all the activities applied in patient's involvement in the information, decision-making, ability and volunteering in diagnosis, cure and care. In as much as most cancer patients require information about their individual needs, the present study is conducted to determine the perceived information from the informed consent of clinical studies in cancer patients. This is a descriptive study. Fifty cancer patients hospitalized for participating in the clinical study was chosen according to the convenience sampling. Tools used in this research included the questionnaire (individual and social features) and the check list about patient's right and cancer patient's information before and after receiving informed consent in clinical studies (10 items on a Likert rating scale). To validate the study, content and formal validation was used. Data in this research were analyzed using descriptive statistics (frequency, mean and standard deviation) and the software of SPSS 16. In general, the mean of the scores obtained from cancer patients' perceived information before completing the informed consent of the clinical studies was 14 ± 3.5 and after consent of the clinical studies was 16 ± 2.4. The cancer patients' perceived information before and after consent of the clinical studies was weak. Based on the findings of the present study, the rate of the information the cancer patients received, before completing the informed consent form, was low, but after completing the informed consent form this rate was again low. Therefore, conducting similar and wider studies is recommended to unveil the factors affecting perceiving information and how to promote the quality of the informed consent in other hospitals in Iran.

  9. The challenges of informed consent for rapid HIV testing in labor.

    PubMed

    Jamieson, Denise J; O'Sullivan, Mary Jo; Maupin, Robert; Cohen, Mardge; Webber, Mayris P; Nesheim, Steven; Lampe, Margaret; Garcia, Patricia; Lindsay, Michael; Bulterys, Marc

    2003-11-01

    Although increasing attention has been focused on the adequacy of the informed consent process for participation in research studies, there has been little systematic evaluation of the process, particularly when consent is obtained in the labor and delivery setting. The Mother Infant Rapid Intervention at Delivery (MIRIAD) study is an ongoing multisite study initiated by the Centers for Disease Control and Prevention (CDC) designed to evaluate the feasibility of offering 24-hour counseling and voluntary rapid HIV testing and antriretroviral therapy when indicated to women with unknown HIV status who are in labor. To address concerns about obtaining informed consent from women in labor, we have completed focus groups, conducted a pilot of the informed consent process among women in labor, developed flip-charts to enhance comprehension, and plan an ongoing evaluation of the informed consent process throughout the course of the MIRIAD study. In the pilot study, approximately 70% of women were able to state in their own words the purpose and benefits of the research study. Substantially fewer women (25%) were able to state one or more risks of the study. We hope that the MIRIAD study will make a valuable contribution by defining best approaches for informed consent and will provide guidance when it is necessary to obtain consent from laboring women for crucial interventions.

  10. Informed consent for chiropractic care: Comparing patients' perceptions to the legal perspective.

    PubMed

    Winterbottom, Melissa; Boon, Heather; Mior, Silvano; Facey, Marcia

    2015-06-01

    This study explored chiropractic patients' perceptions of exchanging risk information during informed consent and compared them with the legal perspective of the informed consent process. Interviews were conducted with 26 participants, recruited from chiropractic clinics. Transcripts were analysed using a constant comparative method of analysis. Participants experienced informed consent as an on-going process where risk information informed their decisions to receive treatment throughout four distinct stages. In the first stage, information acquired prior to arriving at the clinic for treatment shaped perceptions of risk. In stage two, participants assessed the perceived competence of their practitioners. Participants then signed the consent form and discussed the risks with their practitioners. Finally, they communicated with their practitioners during treatment to ensure their pain threshold was not crossed. These findings suggest that chiropractic patients perceive informed consent as a process involving communication with their practitioners, and that it is possible to educate patients about the risks associated with treatment while satisfying the legal requirements of informed consent. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. 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.

  12. Patients' beliefs regarding informed consent for low-risk pragmatic trials.

    PubMed

    Dal-Ré, Rafael; Carcas, Antonio J; Carné, Xavier; Wendler, David

    2017-09-18

    The requirement to obtain written informed consent may undermine the potential of pragmatic randomized clinical trials (pRCTs) to improve evidence-based care. This requirement could compromise trials statistical power or even force it to close them down prematurely. However, recent data from the U.S. and Spain suggest that a majority of the public endorses written consent for low-risk pRCTs. The present manuscript assesses whether this view is shared by patients. This was a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent versus verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing 2 drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. This web-based survey was conducted in May 2016. Two-thousand and eight adults who were representative of the Spanish population participated in the survey (response rate: 61%). Of these 2008 respondents, 338 indicated that they had been diagnosed with hypertension and were being treated with prescription medicines for this condition at the time of responding to the survey. The primary outcome measures were respondents' personal preference and recommendation to a research ethics committee regarding the use of written informed consent versus verbal consent or general notification. Overall, 74% of the 338 patient respondents endorsed written consent. In both scenarios, general notification received significantly more support (30.6%-44.7%) than verbal consent (13.3%-17.6%). 43% of respondents preferred and/or recommended general notification rather than written consent. As in the survey of the general public, more patients endorsed written consent than the alternative option. However, two factors suggest that a different approach to written consent should be investigated for low-risk pRCTs: a) a substantial minority of respondents supported general

  13. The role of nonverbal and verbal communication in a multimedia informed consent process.

    PubMed

    Plasek, Joseph M; Pieczkiewicz, David S; Mahnke, Andrea N; McCarty, Catherine A; Starren, Justin B; Westra, Bonnie L

    2011-01-01

    Nonverbal and verbal communication elements enhance and reinforce the consent form in the informed consent process and need to be transferred appropriately to multimedia formats using interaction design when re-designing the process. Observational, question asking behavior, and content analyses were used to analyze nonverbal and verbal elements of an informed consent process. A variety of gestures, interruptions, and communication styles were observed. In converting a verbal conversation about a textual document to multimedia formats, all aspects of the original process including verbal and nonverbal variation should be one part of an interaction community-centered design approach.

  14. Patients' consent preferences for research uses of information in electronic medical records: interview and survey data

    PubMed Central

    Willison, Donald J; Keshavjee, Karim; Nair, Kalpana; Goldsmith, Charlie; Holbrook, Anne M

    2003-01-01

    Objectives To assess patients' preferred method of consent for the use of information from electronic medical records for research. Design Interviews and a structured survey of patients in practices with electronic medical records. Setting Family practices in southern Ontario, Canada. Participants 123 patients: 17 were interviewed and 106 completed a survey. Main outcome measures Patients' opinions and concerns on use of information from their medical records for research and their preferences for method of consent. Results Most interviewees were willing to allow the use of their information for research purposes, although the majority preferred that consent was sought first. The seeking of consent was considered an important element of respect for the individual. Most interviewees made little distinction between identifiable and anonymised data. Research sponsored by private insurance firms generated the greatest concern, and research sponsored by foundation the least. Sponsorship by drug companies evoked negative responses during interview and positive responses in the survey. Conclusions Patients are willing to allow information from their medical records to be used for research, but most prefer to be asked for consent either verbally or in writing. What is already known on this topicLegislation is being introduced worldwide to restrict the circumstances under which personal information may be used for secondary purposes without consentLittle empirical information exists about patients' concerns over privacy and preferences for consent for use of such information for researchWhat this study addsPatients are willing to allow personal information to be used for research purposes but want to be actively consulted firstPatients make little distinction between identifiable and non-identifiable informationMost patients prefer a time limit for their consent PMID:12586673

  15. Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.

    PubMed

    Lawrence, Dana J

    2011-11-01

    To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby

  16. 14 CFR § 1230.116 - General requirements for informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... PROTECTION OF HUMAN SUBJECTS (Eff. until 2-14-14) § 1230.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in...

  17. Negotiating the informed-consent process in developing countries: a comparison of Swaziland and Pakistan.

    PubMed

    Upvall, M; Hashwani, S

    2001-09-01

    Protecting the rights of research participants when conducting studies within an international context presents many challenges. The purpose of this article was to compare and contrast the process of obtaining informed consent in two very different countries - Swaziland and Pakistan. Major aspects of the informed-consent process presented included identification of gatekeepers, seeking permission from officials, negotiating with these officials and Institutional Review Board (IRB) committees in regard to the type of data to be collected, and explaining informed consent to participants in the field. Data for this article is based upon qualitative research of collaboration between nurses and healers in Swaziland and from a variety of studies completed in Pakistan. These studies demonstrate the inadequacy and complexity of applying western-based concepts of informed consent to developing countries.

  18. The Practice of Research Ethics in Lebanon and Qatar: Perspectives of Researchers on Informed Consent.

    PubMed

    Nakkash, Rima; Qutteina, Yara; Nasrallah, Catherine; Wright, Katharine; El-Alti, Leila; Makhoul, Jihad; Al-Ali, Khalid

    2017-09-01

    Informed consent requirements for conducting research with human participants are set by institutional review boards (IRBs) following established guidelines. Despite this, researchers continue to face challenges in seeking and obtaining informed consent. This study discusses researchers' views of such problems in Lebanon and Qatar, which vary in research regulation. We conducted in-depth interviews with 52 academic researchers from various fields of research in both countries and analyzed them using thematic analysis. Important disjunctions emerged between IRB requirements and actual practice. Variations in obtaining informed consent were affected by the research context, type of research, and the prevalent cultural norms and values. Regulatory systems and guidelines for informed consent do not necessarily ensure ethical research conduct. Implications for improvement are presented.

  19. Improving Informed Consent with Minority Participants: Results from Researcher and Community Surveys

    PubMed Central

    Quinn, Sandra Crouse; Garza, Mary A.; Butler, James; Fryer, Craig S.; Casper, Erica T.; Thomas, Stephen B.; Barnard, David; Kim, Kevin H.

    2013-01-01

    Strengthening the informed consent process is one avenue for improving recruitment of minorities into research. This study examines that process from two different perspectives, that of researchers and that of African American and Latino community members. Through the use of two separate surveys, we compared strategies used by researchers with the preferences and attitudes of community members during the informed consent process. Our data suggest that researchers can improve the informed consent process by incorporating methods preferred by the community members along with methods shown in the literature for increasing comprehension. With this approach, the informed consent process may increase both participants’ comprehension of the material and overall satisfaction, fostering greater trust in research and openness to future research opportunities. PMID:23324203

  20. A videotape intervention to enhance the informed consent process for medical and psychiatric treatment research.

    PubMed

    Wirshing, Donna A; Sergi, Mark J; Mintz, Jim

    2005-01-01

    This study evaluated a brief educational video designed to enhance the informed consent process for people with serious mental and medical illnesses who are considering participating in treatment research. Individuals with schizophrenia who were being recruited for ongoing clinical trials, medical patients without self-reported psychiatric comorbidity, and university undergraduates were randomly assigned to view either a highly structured instructional videotape about the consent process in treatment research or a control videotape that presented only general information about bioethical issues in human research. Knowledge about informed consent was measured before and after viewing. Viewing the experimental videotape resulted in larger gains in knowledge about informed consent. Standardized effect sizes were large in all groups. The videotape was thus an effective teaching tool across diverse populations, ranging from individuals with severe chronic mental illness to university undergraduates.

  1. A Development of Automatic Audit System for Written Informed Consent using Machine Learning.

    PubMed

    Yamada, Hitomi; Takemura, Tadamasa; Asai, Takahiro; Okamoto, Kazuya; Kuroda, Tomohiro; Kuwata, Shigeki

    2015-01-01

    In Japan, most of all the university and advanced hospitals have implemented both electronic order entry systems and electronic charting. In addition, all medical records are subjected to inspector audit for quality assurance. The record of informed consent (IC) is very important as this provides evidence of consent from the patient or patient's family and health care provider. Therefore, we developed an automatic audit system for a hospital information system (HIS) that is able to evaluate IC automatically using machine learning.

  2. 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

  3. Rates and determinants of informed consent: a case study of an international thromboprophylaxis trial.

    PubMed

    Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Meade, Laurie; O'Callaghan, Nicole; Vallance, Shirley; Galt, Pauline; Rajbhandari, Dorrilyn; Rocha, Marcelo; Mehta, Sangeeta; Ferguson, Niall D; Hall, Richard; Fowler, Robert; Burns, Karen; Qushmaq, Ismael; Ostermann, Marlies; Heels-Ansdell, Diane; Cook, Deborah

    2013-02-01

    Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials. The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143). Throughout the 4-year trial, research personnel approached eligible critically ill patients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily. The trial was conducted in 67 centers in 6 countries. A total of 3764 patients were randomized. The overall consent rate was 82.2% (range, 50%-100%) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1% and 9.9% of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95% confidence interval, 2.42-4.86; P < .001 for those with >10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, <0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95% confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95% confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001). Characteristics of study centers, research

  4. Evaluation of the Informed Consent Process of a Multicenter Tuberculosis Treatment Trial

    PubMed Central

    Chapman, Kimberley N.; Pevzner, Eric; Mangan, Joan M.; Breese, Peter; Lamunu, Dorcas; Shrestha-Kuwahara, Robin; Nakibali, Joseph G.; Goldberg, Stefan V.

    2016-01-01

    Background Ethical principles obligate researchers to maximize study participants’ comprehension during the informed consent process for clinical trials. A pilot evaluation of the consent process was conducted during an international clinical trial of treatment for pulmonary tuberculosis to assess the feasibility of conducting an evaluation in a larger population and to guide these future efforts. Methods Study staff administered an informed consent assessment tool (ICAT) to a convenience sample of trial participants, measuring comprehension of consent components as derived from the Common Rule and FDA Title 21 Part 50, and satisfaction with the process. Participating site staff completed a consent process questionnaire about consent practices at their respective sites and provided improvement recommendations. ICAT scores and corresponding practices were compared where both were completed. Results ICATs (n = 54) were submitted from one site in Spain (n = 10), one in Uganda (n = 30), and five in the United States (n = 14). Participants were primarily male (76%), born in Africa (n = 31, 57%), and had a median age of 27 years (interquartile range [IQR]: 24–42). Median ICAT scores were 80% (IQR: 67–93) for comprehension and 89% (IQR: 78–100) for satisfaction. Ugandan participants scored higher than participants from other sites on comprehension (87% vs. 64%) and satisfaction (100% vs. 78%). Staff from 14 sites completed consent process questionnaires. Median ICAT scores for comprehension and satisfaction were higher at sites that utilized visual aids. Practice recommendations included shorter forms, simpler documents, and supplementary materials. Conclusions Participants achieved high levels (≥80%) of comprehension and satisfaction with their current consent processes. Higher ICAT scores at one site suggest an additional evaluation may identify approaches to improve comprehension and satisfaction in future trials. Through this pilot evaluation, complexities

  5. Obtaining clinical writing informed consent versus using client disguise and recommendations for practice.

    PubMed

    Sieck, Barbara C

    2012-03-01

    Clinical writing about psychotherapy clients has long been a part of didactic texts and research articles because it allows new treatments and interventions to be presented in an effective and memorable way. The main ways that clinicians write about their clients include obtaining informed consent, using client disguise, or creating case composites. Although many clinicians use a combination of all three approaches, this article specifically addresses the implications of using clinical writing informed consent. The present article begins with a brief history of clinical writing and an examination of the relevant standards in the current APA Ethics Code and the Health Insurance Portability and Accountability Act; this is followed by a discussion of the benefits of engaging in the clinical writing informed consent process. Subsequently, the limitations of using clinical writing informed consent are explored, including the potentially negative impact on the therapeutic alliance and the client's progress. The article concludes that clinicians should be cautious when deciding to engage in clinical writing informed consent. Recommendations in the form of a checklist are provided to help clinicians identify when it is most appropriate to use client disguise or case composites, and how to do so, as well as when it is appropriate to engage in clinical writing informed consent. Future directions are considered.

  6. Impact of informed consent on patient decisions regarding third molar removal.

    PubMed

    Göcmen, G; Atalı, O; Gonul, O; Goker, K

    2017-02-01

    We investigated whether the order in which patients learned about complication risks affected their anxiety about and willingness to undergo the removal of their third molar. In total, 171 patients (65 males, 106 females) were included in the study. The distributions of gender and the position of mandibular third molars were recorded. The Amsterdam Preoperative Anxiety and Information Scale and Spielberger's State-Trait Anxiety Inventory were used to evaluate anxiety. Associations of anxiety with timing (pre/post), gender, and the order in which the information was presented in the consent form were analyzed. The most common angulations were horizontal (26.3%) and mesioangular (60.2%), and these were more common in women. All patients obtained significantly higher anxiety scores after reading the consent form. There was no significant difference in anxiety scores, according to the order of information. In total, 88 patients underwent surgery, whereas 83 postponed the extraction after reading the consent form. Women were significantly more anxious than men before the procedure. Patients showed lower anxiety levels after the procedure (P < 0.05). Increased anxiety was not associated with the order in which information was presented in the informed consent form. However, the informed consent form itself was a major contributor to increased patient anxiety. Further studies regarding the contents of consent forms and their effects on patient anxiety and decisions regarding third molar removal are needed.

  7. Living Organ Donation and Informed Consent in the United States: Strategies to Improve the Process.

    PubMed

    Henderson, Macey L; Gross, Jed Adam

    2017-03-01

    About 6,000 individuals participate in the U.S. transplant system as a living organ donor each year. Organ donation (most commonly a kidney or part of liver) by living individuals is a unique procedure, where healthy patients undergo a major surgical operation without any direct functional benefit to themselves. In this article, the authors explore how the ideal of informed consent guides education and evaluation for living organ donation. The authors posit that informed consent for living organ donation is a process. Though the steps in this process are partially standardized through national health policy, they can be improved through institutional structures at the local, transplant center-level. Effective structures and practices aimed at supporting and promoting comprehensive informed consent provide more opportunities for candidates to ask questions about the risks and benefits of living donation and to opt out voluntarily Additionally, these practices could enable new ways of measuring knowledge and improving the consent process.

  8. Long term clinical trials: how much information do participants retain from the informed consent process?

    PubMed

    Griffin, Joan M; Struve, James K; Collins, Dorothea; Liu, An; Nelson, David B; Bloomfield, Hanna E

    2006-10-01

    Previous studies report mixed results about how much information study participants actually can read, understand and retain after completing the informed consent process; fewer studies have examined disparities in the retention and recall of information by patient factors, such as age, education, and race. Not retaining or being able to recall information from the informed consent process has potentially important ethical and legal implications and consequences for research quality and integrity, especially when found in populations that commonly are underserved or underrepresented in clinical trials. To determine how much basic knowledge participants finishing a five-year, multi-center, double-blinded randomized, placebo-controlled clinical trial had about the study, participants (n=1,789) were asked at their final follow-up visit three multiple-choice questions: (1) the study's purpose; (2) the name of the medication under investigation; (3) the main side effect of the medication. The associations between knowledge of these fundamental details and participant social and demographic factors were investigated. A majority of participants correctly recalled the study's purpose (64.7%) and medication (79.6%), but few correctly reported the main side effect (31.1%). In spite of relatively high recall for study purpose and medication, disparities by age, education and race exist. Increasing age was significantly associated with higher odds of incorrectly recalling both the study purpose and the name of the study medication. Likewise those with less than a high school education were more likely to incorrectly identify the study's purpose and the name of the study medication. Black and other non-white race or ethnic groups were more than two and a half times as likely to incorrectly identify the study's purpose. These findings suggest that even the most basic information may not be understood or retained by important subgroups of patients enrolled in clinical trials

  9. 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.

  10. 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

  11. 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.

  12. Chart documentation of informed consent for operative vaginal delivery: is it adequate?

    PubMed

    Nichols, Catherine Matthews; Pendlebury, Laura C; Jennell, Jamie

    2006-12-01

    To determine the documentation frequency of informed consent for women undergoing a trial of nonemergent instrumental delivery. A retrospective chart review of instrumented vaginal deliveries from 1992 to 2005 was performed. Cases were identified from a Labor and Delivery database and hospital records were reviewed for documentation of associated risks, general consent for the procedure, indication, and option of cesarean delivery (CD). Three hundred forty six charts were reviewed: 246 were excluded for an emergency delivery (19%), misclassification (25%), or lost notes (27%). In the remaining 100 cases, 61% had a general consent for instrumented vaginal delivery. Documentation of any maternal or neonatal risks was found in 3% and 0%, respectively. The option of a cesarean delivery was documented in 22% of the cases. When comparing 5-year time intervals before and after 2000, there was no increased frequency in documentation of maternal or neonatal risks. Documentation of informed consent for instrumented vaginal delivery is inconsistent and should be improved.

  13. Placebo treatments, informed consent and 'the grip of a false picture'.

    PubMed

    Glackin, Shane Nicholas

    2015-08-01

    It is widely supposed that the prescription of placebo treatments to patients for therapeutic purposes is ethically problematic on the grounds that the patient cannot give informed consent to the treatment, and is therefore deceived by the physician. This claim, I argue, rests on two confusions: one concerning the meaning of 'informed consent' and its relation to the information available to the patient, and another concerning the relation of body and mind. Taken together, these errors lead naturally to the conclusion that the prescription of placebos to unwitting patients is unethical. Once they are dispelled, I argue, we can see that providing 'full' information against a background of metaphysical confusion may make a patient less informed and that the 'therapeutic' goal of relieving the patient of such confusions is properly the duty of the philosopher rather than the physician. Therapeutic placebos therefore do not violate the patient's informed consent or the ethical duties of the doctor.

  14. Internet based patient education improves informed consent for elective orthopaedic surgery: a randomized controlled trial.

    PubMed

    Fraval, Andrew; Chandrananth, Janan; Chong, Yew M; Coventry, Lillian S; Tran, Phong

    2015-02-07

    Obtaining informed consent is an essential step in the surgical pathway. Providing adequate patient education to enable informed decision making is a continued challenge of contemporary surgical practice. This study investigates whether the use of a patient information website, to augment patient education and informed consent for elective orthopaedic procedures is an effective measure. A randomised controlled trial was conducted comparing the quality of informed consent provided by a standard discussion with the treating surgeon compared to augmentation of this discussion with an online education resource (www.orthoanswer.org). Participants were recruited from orthopaedic outpatient clinics. Patients undergoing five common orthopaedic procedures were eligible to participate in the trial. The primary outcome measure was knowledge about their operation. Satisfaction with their informed consent and anxiety relating to their operation were the secondary outcome measures. There was a statistically significant increase in patient knowledge for the intervention arm as compared to the control arm (p < 0.01). Patients in the intervention arm, had an average score of 69.25% (SD 14.91) correct answers as compared to 47.38% (SD 17.77) in the control arm. Satisfaction was also improved in the intervention arm (p = 0.043). There was no statistically significant difference between the control and intervention arm relating to their anxiety scores (p = 0.195). The use of a patient education website as an augment to informed consent improves patient knowledge about their planned operation as well as satisfaction with the consent process whilst not increasing their anxiety levels. We recommend that all patients be directed to web based education tools to augment their consent. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614001058662 .

  15. Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

    PubMed Central

    Sumathipala, Athula; Siribaddana, Sisira; Hewege, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

    2008-01-01

    Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal. PMID:18267015

  16. Relevant Information and Informed Consent in Research: In Defense of the Subjective Standard of Disclosure.

    PubMed

    Dranseika, Vilius; Piasecki, Jan; Waligora, Marcin

    2017-02-01

    In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the cultural context, talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups.

  17. Public preferences on written informed consent for low-risk pragmatic clinical trials in Spain.

    PubMed

    Dal-Ré, Rafael; Carcas, Antonio J; Carné, Xavier; Wendler, David

    2017-09-01

    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. 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. 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. 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. © 2017 The

  18. Electronic processing of informed consents in a global pharmaceutical company environment.

    PubMed

    Vishnyakova, Dina; Gobeill, Julien; Oezdemir-Zaech, Fatma; Kreim, Olivier; Vachon, Therese; Clade, Thierry; Haenning, Xavier; Mikhailov, Dmitri; Ruch, Patrick

    2014-01-01

    We present an electronic capture tool to process informed consents, which are mandatory recorded when running a clinical trial. This tool aims at the extraction of information expressing the duration of the consent given by the patient to authorize the exploitation of biomarker-related information collected during clinical trials. The system integrates a language detection module (LDM) to route a document into the appropriate information extraction module (IEM). The IEM is based on language-specific sets of linguistic rules for the identification of relevant textual facts. The achieved accuracy of both the LDM and IEM is 99%. The architecture of the system is described in detail.

  19. Informed consent in physical medicine and rehabilitation. The physician/patient relationship--the doctor as a fiduciary.

    PubMed

    Carlisle, John R

    2002-05-01

    This article reviews the principle of informed consent and the ethical and legal bases upon which it rests. The process of obtaining an appropriate informed consent is explored, and the elements that make a consent valid are delineated. The principles of substitute decision-making and the special rules applied to circumstances such as emergency, therapeutic privilege, refusal of consent, and medical necessity are discussed. The concept of the relationship between physician and patient as a fiduciary relationship is explored as the fundamental basis for the modern doctrine of informed consent.

  20. A Qualitative Study into Dependent Relationships and Voluntary Informed Consent for Research in Pediatric Oncology.

    PubMed

    Dekking, Sara A S; van der Graaf, Rieke; Schouten-van Meeteren, Antoinette Y N; Kars, Marijke C; van Delden, Johannes J M

    2016-04-01

    In pediatric oncology, many oncologists invite their own patients to participate in research. Inclusion within a dependent relationship is considered to potentially compromise voluntariness of consent. Currently, it is unknown to what extent those involved in pediatric oncology experience the dependent relationship as a threat to voluntary informed consent, and what they see as safeguards to protect voluntary informed consent within a dependent relationship. We performed a qualitative study among key actors in pediatric oncology to explore their experiences with the dependent relationship and voluntary informed consent. We conducted three focus groups and 25 semi-structured, in-depth interviews with pediatric oncologists, research coordinators, Research Ethics Committee members, parents of children with cancer, and adolescents with cancer. Professionals regarded the dependent relationship both as a potential threat to and as a positive influence on voluntary decision making. Parents and adolescents did not feel as though dependency upon the oncologist influenced their decisions. They valued the involvement of their own physician in the informed consent process. The professionals suggested three strategies to protect voluntariness: emphasizing voluntariness; empowering families; involvement of an independent person. Although the dependent relationship between pediatric oncologists, patients and parents may be problematic for voluntary informed consent, this is not necessarily the case. Moreover, the involvement of treating physicians may even have a positive impact on the informed consent process. Although we studied pediatric oncology, our results may also apply to many other fields of pediatric medicine where research and care are combined, for example, pediatric rheumatology, neurology and nephrology. Clinical trials in these fields are inevitably often designed, initiated and conducted by medical specialists closely involved in patient care.

  1. Theoretical Model of Critical issues in Informed Consent in HIV Vaccine Trials

    PubMed Central

    Lewis, Cindi A.; Dewhurst, Stephen; McMahon, James M.; Bunce, Catherine A.; Keefer, Michael C.; Alio, Amina P.

    2014-01-01

    The informed consent (IC) process for HIV vaccine trials poses unique challenges and would benefit from improvements to its historically-based structure and format. Here, we propose a theoretical framework that provides a basis for systematically evaluating and addressing these challenges. The proposed framework follows a linear pathway, starting with the precondition of voluntariness, three main variables of valid decision-making (competency, provision of information and understanding) and then the consequential outcome of either refusal or consent to participate. The existing literature reveals that culturally appropriate provision of information and resultant understanding by the vaccine trial participant are among the most significant factors influencing the authenticity of valid decision-making, though they may be overridden by other considerations, such as individual altruism, mistrust and HIV-related stigma. Community collaborations to foster bidirectional transmission of information and more culturally tailored consenting materials therefore represent a key opportunity to enhance the informed consent process. By providing a visual synopsis of the issues most critical to IC effectiveness in a categorical and relational manner, the framework provided here presents HIV vaccine researchers a tool by which the informed consent process can be more systematically evaluated and consequently improved. PMID:24865892

  2. Applying a sociolinguistic model to the analysis of informed consent documents.

    PubMed

    Granero-Molina, José; Fernández-Sola, Cayetano; Aguilera-Manrique, Gabriel

    2009-11-01

    Information on the risks and benefits related to surgical procedures is essential for patients in order to obtain their informed consent. Some disciplines, such as sociolinguistics, offer insights that are helpful for patient-professional communication in both written and oral consent. Communication difficulties become more acute when patients make decisions through an informed consent document because they may sign this with a lack of understanding and information, and consequently feel deprived of their freedom to make their choice about different treatments or surgery. This article discusses findings from documentary analysis using the sociolinguistic SPEAKING model, which was applied to the general and specific informed consent documents required for laparoscopic surgery of the bile duct at Torrecárdenas Hospital, Almería, Spain. The objective of this procedure was to identify flaws when information was provided, together with its readability, its voluntary basis, and patients' consent. The results suggest potential linguistic communication difficulties, different languages being used, cultural clashes, asymmetry of communication between professionals and patients, assignment of rights on the part of patients, and overprotection of professionals and institutions.

  3. The informed consent aftermath of the genetic revolution. An Italian example of implementation.

    PubMed

    Artizzu, Federica

    2008-06-01

    A great part of human genetics research is carried out collecting data and building large databases of biological samples that are in a non-anonymous format. These constitute a valuable resource for future research. The construction of such databases and tissue banks facilitates important scientific progress. However, biobanks have been recognized as ethically problematic because they contain thousands of data that could expose individuals and populations to discrimination, stigmatization and psychological stress if misused. Informed consent is regarded as a cornerstone in the protection of personal autonomy in research involving human subjects. Yet in recent years this fundamental concept has been overwhelmed by the genomic revolution. From a general overview of international literature, it seems evident that informed consent issues have come into sharp focus, in particular in relation to the twin issues of time extension (blanket versus specific/repeated consent) and personal extension (group consent). After an introduction on obtaining informed consent in the context of genetic research, this paper addresses the apparent lack of a single, universal model of obtaining informed consent among populations involved in genetic research and it argues for the need to develop an ethical framework tailored to the specific features of each project. In order to support this theory of contextualizing, the case of a private biotechnology company, SharDNA is presented. The present paper explores the management of its biobank, developed from a genetic research project carried out on isolated populations living on the Italian island of Sardinia. In particular, the paper highlights how the company is tackling the problem of informed consent and other ethical requirements for genetic research, such as the respect of individual privacy, the population approach and the existing Italian legal regulatory framework.

  4. Informed consent for human genetic and genomic studies: a systematic review.

    PubMed

    Khan, A; Capps, B J; Sum, M Y; Kuswanto, C N; Sim, K

    2014-09-01

    As genetic and genomic studies grow in scale, there are ethical concerns related to the collection and use of genetic information. The emergence of large public databases potentially redefine the terms of participation in genetic and genomic research, and suggests the changing application of traditional ethical principles such as privacy or consent. For this study, we wanted to see whether such developments are reflected in the informed consent processes in human genetic and genomic studies. Therefore, we performed a systematic review of the empirical studies that examined informed consent involving large genetic databases in human genetic and genomic studies, grouped the identified issues related to the different stakeholders (including subjects, researchers, and institutional review boards) and discussed the limitations and implications of these findings. Major themes related to the place of bioethical considerations, procured tissues, people involved, process of informed consent and study procedures. Frequently raised issues included confidentiality of participants, documentation of informed consent, public attitudes, future use of participant samples or data, and disclosure of results. Awareness and attention to these bioethical issues as well as assiduousness in managing these concerns in genetic/genomic research would further strengthen and safeguard the rights, safety and well-being of genetic research participants. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  5. Spontaneous decision of organ donation in patients signing informed consent for liver transplantation.

    PubMed

    Heits, N; Guenther, R; Kuechler, T; Becker, T; Braun, F

    2013-05-01

    The shortage of postmortem donor organs is a well-known problem in Germany. Willingness in the general population is 80%, but less than 14% have an organ donor card. We evaluated the free decision of liver transplant candidates who filled out a donor card before signing the informed consent for the transplant procedure. We analyzed 122 patients of mean age 55.9 years (range, 15.4-74.1) who signed an informed consent for liver transplantation between January 10, 2007, and January 24, 2012. The patients received the original text of the German organ donor card with tick boxes on the informed consent form for liver transplantation. All patients were informed that their decision had no impact on further management. Patients were able to choose between (1) becoming a donor, (2) refusal, (3) transfer of the decision to another person, or (4) no decision. All patients signed the informed consent to be listed for liver transplantation: 73.8% (n = 90) chose to become a donor; 5.7% (n = 7) refused; 5.7% (n = 7) transferred the decision to another person; and 14.8% (n = 18) did not come to a decision. Interestingly, not all candidates for liver transplantation were willing to become an organ donor in the time of expressed consent. However, willingness to sign the donor card was much higher among liver transplant candidates compared with the general population.

  6. Surgical Consent of Children and Guardians for the Treatment of Adolescent Idiopathic Scoliosis is Incompletely Informed.

    PubMed

    Theologis, Alexander A; Anaya, Andres; Sabatini, Coleen; Sucato, Daniel J; Parent, Stefan; Erickson, Mark; Diab, Mohammad

    2016-01-01

    Prospective, multicenter cohort analysis. Assess children and guardian's comprehension of surgical consent for adolescent idiopathic scoliosis (AIS) surgery and factors associated with their comprehension. Informed consent is essential to the ethical practice of surgery. Little is known about how informed are children and guardians when consenting to operation for AIS. Guardians and their children (10-18 yr) undergoing spinal fusion for AIS were prospectively evaluated at 4 institutions. Each child and guardian was asked to complete a questionnaire of the risks, benefits and expected results of operative treatment and a self-assessment of overall comprehension. A site-survey questionnaire regarding teaching methods, timing between teaching and consent, and healthcare provider involved in the consent process was also used. Significance was assessed using logistic regression examining factors associated with good (≥6 scores correct) and poor (<6 scores correct) comprehension. One hundred seventy six pairs of patient/guardian were enrolled. Fifty-seven patient/guardian questionnaires were discarded due to incompleteness. A greater percentage of guardians had good overall comprehension of the surgical consent (patients: 59.7%; guardian: 71.4%). Post-operative mobility (patient 31%; guardian 42%) was poorly understood. Surgical risks (i.e., neurologic injury, infection, hardware failure, future sequelae) were modestly understood (40-70% correct). Factors associated with better understanding were older patient age (>12 yr), guardian with a college degree, obtaining consent by the attending surgeon and at a separate preoperative visit than the time of teaching, the use of visual aids, and participation in a "peer-support group" preoperatively. There was a trend toward guardians' and patients' self-assessment of understanding mirroring their respective objective performances. Patients who undergo surgical intervention for AIS and their guardians understand approximately

  7. Informed consent for biobanking research: cancer patient recruitment from rural communities in Maine.

    PubMed

    Morrison, Deborah G; Farah, Christopher; Hock, Janet M

    2013-04-01

    Biobanking research seeks to improve the diversity, availability, and quality of human specimens critical for translational research, including biospecimen collections from disadvantaged minorities. American rural whites are seldom represented in such initiatives as geographic isolation makes obtaining informed consent challenging. We report a case series of 83 newly diagnosed cancer patients, attending a rural community medical center, who consented to participate in cancer research. To enable pooling with population studies, we created a BioGeoBank using 2007 NCI and ISBER Best Practices, after a protocol approval by Eastern Maine Medical Center (EMMC) IRB and OHP HRPO. Informed consent forms were at Flesch-Kincaid 8th Grade reading level, supplemented by NCI educational brochures. Of 108 patients identified, 85 were eligible. Of these, 83 patients (49 lung cancer, 21 breast cancer, and 13 other cancers) consented to donate data, blood, and tissue specimens for future research, and maintained eligibility. Two years later, we executed a legacy protocol to transfer specimens to NCI's biorepository. Of the 69 surviving patients, 9 patients could not be contacted. All those contacted (60) agreed to provide additional data on environmental risks, and consented to specimen transfer. Self-organizing map analyses showed no evidence that age, education, income, familial susceptibility, or lifestyle factors were associated with consent to donate data or biospecimens. Cancer cases reported 1-3 co-morbid chronic diseases (mostly cardiovascular), near lifetime smoking and/or alcohol consumption; familial cancer risks, and many had a prior cancer history. Anecdotally, willingness to consent was based on altruistic hopes that research would generate knowledge to reduce cancer incidence. Our study shows that cancer patients from disadvantaged white rural communities with health disparities associated with geographic isolation are motivated to consent to participate and support

  8. [Informed consent in cardiology. The Committee on Informed Consent of the Commission on Professional Matters of the Sociedad Española de Cardiología].

    PubMed

    de los Reyes López, M; Iñíguez Romo, A; Goicolea de Oro, A; Funes López, B; Castro Beiras, A

    1998-10-01

    In the last thirty years, the clinical relationship between physicians and patients has been rather modified. There are several factors that have contributed to this change: a) New ways to execute medical practises, specially referred to the development of new techniques; b) Cultural changes in our western society, mainly in the mediterranean area, where there has been progress in the recognition of patients' autonomy to decide about their own lives, health and their own bodies; c) The increasing number of lawsuits, complaints and judgements about the problems that clinical information involves, particularly the informed consent in clinical practise. We consider it necessary to make an extensive and deep discussion from all of the areas in Medicine and Law, to analyze the different ethical and legal parts of the informed consent. For that reason the Spanish Society of Cardiology offers their members a basic document in order to reflect about these facts, developing arguments, justifications and supports. This document has also considered models, conditions to their applicability according to Spanish law, and the experience we have had. Finally, there is a list of diagnostic procedures and interventional practises in cardiology that might be preceded by a written informed consent document. We considered them by the name of Spanish Society of Cardiology recommendations.

  9. [Informed consent in the intragastric balloon supported by SENPE, SEEDO, SEN and SECO: legal aspects].

    PubMed

    Abilés, V; Martínez Olmos, M A; Escartí, M A; Bretón, I; Cáncer, E; Pelaez, N; Álvarez, V; Culebras, J M; Mazure, R A

    2012-01-01

    Intra-gastric balloon (IGB) is an invasive, temporary, non-surgical technique for the treatment of obesity. Its outcomes mainly depend on the patient's collaboration. The aim was to adapt the informed consent used for bariatric surgery to a method that has especial characteristics. We used the informed consent proposed by ASAC for bariatric surgery and 8 statements related to IGB included in the WESTLAW ES database. The review of the statements defines the IGB treatment as a curative-intended and non-satisfactive therapy with an obligation of the means used, but not the outcomes, by the treating physician. Moreover, the obligations of providing a correct and complete information -which includes the dietary regime- should be observed, as well as the possible therapeutic alternatives and finally, the proceeding used should be in written. The informed consent is a medico-legal document which content should consider the latest jurisprudence on the minimally invasive techniques for the treatment of obesity.

  10. 'No-suicide contracts' and informed consent: an analysis of ethical issues.

    PubMed

    Farrow, Tony L; O'Brien, Anthony J

    2003-03-01

    The 'no-suicide contract' is a frequently utilized tool in both the assessment and dispersal of suicidal patients. However, little attention has been given to questioning whether suicidal persons are able to give informed consent to enter such a contract. This article utilizes both the existing literature on no-suicide contracts and the results of recent research into the effects of this tool, to examine whether its use is consistent with the legal and ethical doctrine of informed consent. Particular attention is given to issues of competence, fullness of information, voluntariness and paternalistic intervention when no-suicide contracts are used. This analysis finds the tool to be problematic and suggests that individual patients' ability to give informed consent about a no-suicide contract needs to be carefully considered by clinicians.

  11. Collecting informed consent with juvenile justice populations: issues and implications for research.

    PubMed

    Wolbransky, Melinda; Goldstein, Naomi E S; Giallella, Christy; Heilbrun, Kirk

    2013-01-01

    Researchers must provide participants with opportunities to make informed decisions about whether to participate in research studies. Investigators conducting research with youth in the juvenile justice system face unique ethical, legal, and practical challenges to obtaining informed consent. Juvenile justice researchers must navigate multiple legal and ethical standards for collecting informed consent, take into account youths' dual vulnerabilities as children and prisoners, and overcome practical limitations to obtaining parental/guardian permission. Given the challenges and complexity of obtaining standard informed consent of youth in juvenile justice facilities, this paper provides suggestions for overcoming obstacles to recruiting these youth for research participation. It offers guidance for fostering the enrollment of juvenile justice youth in research studies using procedures that comply with ethical and legal standards for research with this dually vulnerable population. Copyright © 2013 John Wiley & Sons, Ltd.

  12. Informed consent for epidural analgesia in labour: a survey of UK practice.

    PubMed

    Middle, J V; Wee, M Y K

    2009-02-01

    Anaesthetists are legally obliged to obtain informed consent before performing regional analgesia in labour. A postal survey of consultant-led UK anaesthetic units was performed in September 2007 to assess practice regarding obtaining informed consent before inserting an epidural, and documentation of the risks discussed. The response rate was 72% (161/223). There was great variation between units regarding which risks women were informed about and the likely incidence of that risk. One hundred and twenty-three respondents out of 157 providing an epidural service (78%) supported a national standardised information card endorsed by the Obstetric Anaesthetists' Association, with all the benefits and risks stated, to be shown to all women before consenting to an epidural in labour.

  13. Nurses' roles in informed consent in a hierarchical and communal context.

    PubMed

    Susilo, Astrid P; Van Dalen, Jan; Scherpbier, Albert; Tanto, Sugiharto; Yuhanti, Patricia; Ekawati, Nora

    2013-06-01

    Although the main responsibility for informed consent of medical procedures rests with doctors, nurses' roles are also important, especially as patient advocates. Nurses' preparation for this role in settings with a hierarchical and communal culture has received little attention. We explored the views of hospital managers and nurses regarding the roles of nurses in informed consent and factors influencing these roles. We conducted a qualitative study in a private, multispecialty hospital in Indonesia. Semi-structured interviews were conducted with seven managers. Two rounds of focus group discussions with nurses (n = 27) were conducted. Constant comparative approach was used in the analysis. Nurses can act as manager, witness, information giver, and advocate in the informed consent process. These roles are influenced by nurses' preparedness, hospital culture and policy, patients' understanding, family involvement, and cost-related issues. In preparation for these tasks, nurses should acquire communication skills, clinical knowledge, and legal and ethical knowledge.

  14. Recruitment of subjects for clinical trials after informed consent: does gender and educational status make a difference?

    PubMed

    Gitanjali, B; Raveendran, R; Pandian, D G; Sujindra, S

    2003-01-01

    Researchers and investigators have argued that getting fully informed written consent may not be possible in the developing countries where illiteracy is widespread. To determine the percentage of patients who agree to participate in a trial after receiving either complete or partial information regarding a trial and to find out whether there were gender or educational status-related differences. To assess reasons for consenting or refusing and their depth of understanding of informed consent. A simulated clinical trial in two tertiary health care facilities on in-patients. An informed consent form for a mock clinical trial of a drug was prepared. The detailed / partial procedure was explained to a purposive sample of selected in-patients and their consent was asked for. Patients were asked to free list the reasons for giving or withholding consent. Their depth of understanding was assessed using a questionnaire. Chi-square test was used for statistical analyses. The percentages of those consenting after full disclosure 29/102 (30%) and after partial disclosure 15/50 (30%) were the same. There was a significant (p=0.043) gender difference with a lesser percentage of females (30%) consenting to participation in a trial. Educational status did not alter this percentage. Most patients withheld consent because they did not want to give blood or take a new drug. Understanding of informed consent was poor in those who consented. The fact that only one-third of subjects are likely to give consent to participate in a trial needs to be considered while planning clinical trials with a large sample size. Gender but not educational status influences the number of subjects consenting for a study. Poor understanding of the elements of informed consent in patients necessitates evolving better methods of implementing consent procedures in India.

  15. Informed consent and the security of the electronic health record (EHR): some policy considerations.

    PubMed

    Kluge, Eike-Henner W

    2004-03-31

    Various codes of ethics, and in particular the IMIA Code of Ethics for Health Information Professionals (HIPs), stipulate that the subject of an electronic health record (EHR) has a series of security rights with respect to her/his EHR, and that to some degree these rights center in the notion of informed consent. This paper examines the ethical basis of this position, outlines its implications for professionals, institutions and society in general, and identifies its limits. Further issues that will be discussed include who carries the responsibility for informed consent, what nature it should take, whether web-based EHRs present ethically unique problems, and related security implications.

  16. [Informed consent process in clinical trials: Insights of researchers, patients and general practitioners].

    PubMed

    Giménez, Nuria; Pedrazas, David; Redondo, Susana; Quintana, Salvador

    2016-10-01

    Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. GPs, researchers and patients involved in clinical trials. Included, 504 GPs, 108 researchers, and 71 patients. Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  17. Core information sets for informed consent to surgical interventions: baseline information of importance to patients and clinicians.

    PubMed

    Main, Barry G; McNair, Angus G K; Huxtable, Richard; Donovan, Jenny L; Thomas, Steven J; Kinnersley, Paul; Blazeby, Jane M

    2017-04-26

    Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient's values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be difficult for doctors to gauge the information needs of the individual patient. The aim of this paper is to describe 'core information sets' which are defined as a minimum set of consensus-derived information about a given procedure to be discussed with all patients. Importantly, they are intended to catalyse discussion of subjective importance to individuals. The model described in this paper applies health services research and Delphi consensus-building methods to an idea orginally proposed 30 years ago. The hypothesis is that, first, large amounts of potentially-important information are distilled down to discrete information domains. These are then, secondly, rated by key stakeholders in multiple iterations, so that core information of agreed importance can be defined. We argue that this scientific approach is key to identifying information important to all stakeholders, which may otherwise be communicated poorly or omitted from discussions entirely. Our methods apply systematic review, qualitative, survey and consensus-building techniques to define this 'core information'. We propose that such information addresses the 'reasonable patient' standard for information disclosure but, more importantly, can serve as a spring board for high-value discussion of importance to the individual patient. The application of established research methods can define information of core importance to informed consent. Further work will establish how best to incorporate

  18. Are informed consent forms for organ transplantation and donation too difficult to read?

    PubMed

    Gordon, Elisa J; Bergeron, Ashley; McNatt, Gwen; Friedewald, John; Abecassis, Michael M; Wolf, Michael S

    2012-01-01

    Informed consent for organ transplantation and donation is an ethical obligation, legally required, and considered as part of the Patient's Rights Condition of Medicare Participation for hospitals. National policy-makers recommend that informed consent forms and patient education materials be written at a low reading level (5th-8th grade level) to facilitate patient comprehension. We assessed reading levels of informed consent forms (CFs) for adult organ transplant recipients and living organ donors across US transplant centers. CFs were analyzed using three measures of reading level: Lexile Measure, Flesch-Kincaid Grade Level, and the Gunning Fog Index. Of active transplant centers contacted (N=209), 75 (36%) sent a total of 332 CFs. CFs were written, on average, at the college level, which is a considerably higher reading level than the standards set by policy-makers. CF reading levels were negatively correlated with transplant center volume (r=-0.119; p<0.03). CFs for intestine transplantation and for evaluation/listing were the easiest to read, while consent forms for liver transplantation/donation and pre-transplant agreements were the most difficult to read. Reducing CFs' reading level may help to increase patient comprehension for adequate informed consent. © 2011 John Wiley & Sons A/S.

  19. Patient Involvement in Informed Consent for Pediatric Phase I Cancer Research

    PubMed Central

    Miller, Victoria A.; Baker, Justin N.; Leek, Angela C.; Drotar, Dennis; Kodish, Eric

    2014-01-01

    Objective To examine children’s and adolescents’ involvement in the informed consent conference for phase I cancer trials and test associations with patient age, ease of understanding, and pressure to participate. Procedure Participants included 61 patients ages 7 through 21 years who were offered participation in a phase I trial. Consent conferences were audiotaped, transcribed, and coded for communication between patients and physicians and between patients and parents. Results Based on word counts, the mean proportion of the consent conference in which the physician was talking to the patient was 36%; the vast majority (73%) of this communication consisted of giving information. Physician-patient communication increased with age, but overall levels of patient-to-physician communication were low (3%). After controlling for patient age, greater physician-to-patient communication was associated with greater ease of understanding. Conclusions The focus on providing information in the context of informed consent may come at the expense of other communication exchanges that are important to patients, especially in the context of end of life decisions. Children and adolescents may benefit from the assent process when physicians direct more of their communication to them. Future research should identify the reasons for low patient communication during the consent conference and strategies to enhance their participation in decision making about phase I trial enrollment. PMID:24487916

  20. Assault in medical law: revisiting the boundaries of informed consent to medical treatment in South Africa.

    PubMed

    Wilson, Maria C I

    2009-05-01

    This article focuses on assault as a cause of action in medical law, with particular emphasis on the requirements for informed consent, both under common law and under the National Health Act 2003 (Sth Africa). In particular, the test for consent, adopted in Castell v De Greef 1994 (4) SA 408 (C), is analysed in detail. It is noted that the wording of this test for informed consent mirrors the wording of the test for negligence laid down in the Australian case of Rogers v Whitaker (1992) 175 CLR 479. Further, the relationship between the delictual elements of wrongfulness and fault in assault is discussed. It is argued that in South African law a valid consent to medical treatment requires knowledge not only of the general nature of medical treatment but also of the consequences of the treatment and, in determining which consequences should be disclosed to a patient, the constitutional rights to equality and self-determination support the application of a subjective patient-centred test for informed consent. However, it is also proposed that the broad right of a patient to information is reined in at the fault element of assault, so that a limited requirement of consciousness of wrongfulness on the part of the defendant negates liability for delictual assault.

  1. Informed consent: the rate-limiting step in acute stroke trials.

    PubMed

    Rose, David Z; Kasner, Scott E

    2011-01-01

    Successful implementation of a randomized clinical trial (RCT) for neuro-vascular emergencies such as cerebral infarction, intracerebral hemorrhage, or subarachnoid hemorrhage is extraordinarily challenging. Besides establishing an accurate, hyper-expedited diagnosis among many mimics in a person with acute neurological deficits, informed consent must be obtained from this vulnerable group of patients who may be unable to convey their own wishes, grasp the gravity of their situation, or give a complete history or examination. We review the influences, barriers, and factors investigators encounter when providing established and putative stroke therapies, and focus on informed consent, the most important research protector of human subjects, as the rate-limiting step for enrollment into acute stroke RCTs. The informed consent process has received relatively little attention in the stroke literature, but is especially important for stroke victims with acute cognitive, aural, lingual, motor, or visual impairments. Consent by a surrogate may not accurately reflect the patient's wishes. Further, confusion about trial methodology, negative opinions of placebo-controlled studies, and therapeutic misconception by patients or surrogates may impede trial enrollment and requires further study. Exception from informed consent offers an opportunity that is rarely if ever utilized for stroke RCTs. Ultimately, advancing the knowledge base and treatment paradigms for acute stroke is essential but autonomy, beneficence (non-malfeasance), and justice must also be carefully interwoven into any well-designed RCT.

  2. Challenges Associated with Informed Consent in Low- and Low-Middle-Income Countries

    PubMed Central

    Upjohn, Melissa; Wells, Kimberly

    2016-01-01

    Obtaining informed consent from research participants is a generally recognized step of undertaking research. While the concept of informed consent is well understood in western research environments, it requires further consideration when reviewing studies involving humans and owned animals in low- and low-middle-income countries (LMICs), in order to take account of different social, educational, and research norms. Here, we identify some of the challenges that need to be considered, and how they might affect the process of obtaining informed consent. We explain the approach taken by an animal welfare non-governmental organization working in LMICs to addressing these challenges. There are also questions that reviewers might consider when commenting on work originating in this context. PMID:27812525

  3. Closing the evidence gap in infectious disease: point-of-care randomization and informed consent.

    PubMed

    Huttner, A; Leibovici, L; Theuretzbacher, U; Huttner, B; Paul, M

    2017-02-01

    The informed consent document is intended to provide basic rights to patients but often fails to do so. Patients' autonomy may be diminished by virtue of their illness; evidence shows that even patients who appear to be ideal candidates for understanding and granting informed consent rarely are, particularly those with acute infections. We argue that for low-risk trials whose purpose is to evaluate nonexperimental therapies or other measures towards which the medical community is in a state of equipoise, ethics committees should play a more active role in a more standardized fashion. Patients in the clinic are continually subject to spontaneous 'pseudo-randomizations' based on local dogma and the anecdotal experience of their physicians. Stronger ethics oversight would allow point-of-care trials to structure these spontaneous randomizations, using widely available informatics tools, in combination with opt-out informed consent where deemed appropriate. Copyright © 2016. Published by Elsevier Ltd.

  4. Motivating donors to genetic research? Anthropological reasons to rethink the role of informed consent.

    PubMed

    Hoeyer, Klaus; Lynöe, Niels

    2006-01-01

    In this article we explore the contribution from social anthropology to the medical ethical debates about the use of informed consent in research, based on blood samples and other forms of tissue. The article springs from a project exploring donors' motivation for providing blood and healthcare data for genetic research to be executed by a Swedish start-up genomics company. This article is not confined to empirical findings, however, as we suggest that anthropology provides reason to reassess the theoretical understanding of autonomy as generally defined by Beauchamp and Childress. Careful consideration of the trust expressed by donors through the act of donation, furthermore, suggests that there is reason to redirect the ethical scrutiny from informed consent to issues concerning institutional arrangements and social responsibility. In particular, we suggest that an anthropological approach could facilitate a reconsideration of the political implications of using informed consent as a regulatory practice in tissue-based research.

  5. 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

  6. Using formative research to develop a context-specific approach to informed consent for clinical trials.

    PubMed

    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

    2006-12-01

    PARTICIPANT UNDERSTANDING is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturallyappropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-tochild 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.

  7. Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members.

    PubMed

    Koonrungsesomboon, Nut; Laothavorn, Junjira; Karbwang, Juntra

    2015-06-01

    The process of informed consent remains a constant challenge in clinical research. The aim of the present study was to evaluate the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) as required by internationally recognized regulations. Using eight case studies to illustrate basic ethical elements, the study involved 107 participants, mainly from the Asia Pacific and African regions. The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF. However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively. This suggests that participants' understanding of the underlying concepts of the required ICF elements is limited. Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed.

  8. Informed Consent in the Medical Care of Transgender and Gender-Nonconforming Patients.

    PubMed

    Cavanaugh, Timothy; Hopwood, Ruben; Lambert, Cei

    2016-11-01

    Informed consent as a model of care has evolved as an alternative to the standard model of care recommended by the World Professional Association for Transgender Health's Standards of Care, version 7, which emphasizes the importance of mental health professionals' role in diagnosing gender dysphoria and in assessing the appropriateness and readiness for gender-affirming medical treatments. By contrast, the informed consent model for gender-affirming treatment seeks to acknowledge and better support the patient's right to, and capability for, personal autonomy in choosing care options without the required involvement of a mental health professional. Clinicians' use of the informed consent model would enable them both to attain a richer understanding of transgender and gender-nonconforming patients and to deliver better patient care in general.

  9. Informed consent: knowledge, attitude and practice of the researchers in a postgraduate institute of Bangladesh.

    PubMed

    Shakoor, M A; Jaigirdar, Q H; Ullah, M A; Yunus, A B; Rashid, H A

    2009-07-01

    A prospective experimental study was conducted in a postgraduate institute in Dhaka, Bangladesh, from April '05 to September '05. A total of 214 doctors of a postgraduate medical institute were included in the study who was involved in research works. A written questionnaire was given to the respondents to assess their knowledge, attitude and practice about informed consent (IC). The data was analyzed statistically. Chi-Square test was done to see the level of significance. Regarding knowledge of IC, we found maximum participants were more or less knowledgeable about it. The attitude of the respondents was also in favour of taking IC. In practice, most of them had taken informed consent that was verbal (39.3%) and written (47.6%). But some of the researcher (13.1%) had not taken any informed consent. By the present study, it may be concluded that the researchers of the concerned institute were aware of IC.

  10. Medical devices; exception from general requirements for informed consent. Final rule.

    PubMed

    2011-06-24

    The Food and Drug Administration (FDA) is issuing a final regulation to confirm, with one change, the interim final rule (IFR) entitled "Medical Devices; Exception From General Requirements for Informed Consent." This final rule confirms the IFR's establishment of a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. FDA has created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. This final rule adds a requirement that the investigator submit the required documentation to FDA, in addition to submitting it to the reviewing Institutional Review Board (IRB).

  11. Implementing emergency research requiring exception from informed consent, community consultation, and public disclosure.

    PubMed

    Salzman, Joshua G; Frascone, Ralph J; Godding, Bobette K; Provo, Terry A; Gertner, Elie

    2007-10-01

    Conducting emergency research in the out-of-hospital and emergency department setting is a challenge because of the inability of patients to provide informed consent in many situations. Federal guidelines allowing research under an exception from informed consent for emergency research have been established (21 CRF 50.24). Community consultation and public disclosure, 2 required components of obtaining this exception, are seen by many as a barrier to resuscitation research. This article will provide a brief overview of the history of the exception from informed consent for emergency research and summarize our methods recently used to successfully complete community consultation and public disclosure for a trial evaluating 2 devices used during cardiopulmonary resuscitation in a large metropolitan area.

  12. Discretion, Judgment, and Informed Consent: Ethical and Practice Issues in Social Action.

    ERIC Educational Resources Information Center

    Torczyner, Jim

    1991-01-01

    Examines ethical considerations regarding advocacy and social action in atmosphere of uncertainty. Considers use of discretion and protection and defense of fundamental human rights in absence of organized, informed constituency. Examines informed consent and client's best interest when neither individual not collective group has autonomy through…

  13. Elective inguinal hernia repair: a unified informed consent, or who wants to know what?

    PubMed

    Losanoff, Julian E; Litwinczuk, Kathleen M; Ranella, Michael J; Basson, Marc D

    2009-04-01

    Informed consent is increasingly being standardized. We sought to evaluate variability in the amount and quality of information desired by patients in choosing whether to undergo elective surgical hernia repair, a prototypical low- to moderate-risk common procedure. Consecutive stable outpatients were asked to assume that they were considering hernia repair and interviewed with a standard questionnaire that asked them to rate their interest in learning about the natural history, pathology, and management of inguinal hernia as well as herniorrhaphy complications and postoperative recovery. Ninety-eight consecutive patients exhibited substantial interpersonal variability in their level of interest in receiving information. Although interest in some types of information tended to correlate with interest in other types of information, patients' degree of interest in receiving information about anesthesia during the procedure was independent of other variables. Education and previous exposure to individuals with hernias also affected interest in receiving potentially important information before deciding whether to consent to hernia surgery. Patients may vary with regard to the information they want to receive when deciding whether to consent to an invasive procedure. It may be preferable to individualize the consent process to patients' preferences rather than adhering to standardized content.

  14. The Necessity of Professional Disclosure and Informed Consent for Rehabilitation Counselors

    ERIC Educational Resources Information Center

    Carlisle, Jeffrey; Neulicht, Ann T.

    2010-01-01

    Within the rehabilitation counseling arena, professional disclosure and informed consent are critical concepts for the rehabilitation counselor to understand. Once understood, they become key components of a rehabilitation counselor's daily practice. Counselors need to provide sufficient prior information about their evaluation and services to…

  15. 32 CFR 806b.47 - Rules for releasing Privacy Act information without consent of the subject.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... release of personal information without the individual's consent only in the following instances: (a... a system of records about an individual and the Freedom of Information Act requires release of the...) Exception 4. The Bureau of the Census to plan or carry out a census or survey under Title 13, U.S.C. Section...

  16. Predictors of consent in tissue donation: interpersonal aspects and information provision during requests by phone.

    PubMed

    Dorflinger, Lindsey; Auerbach, Stephen M; Siminoff, Laura A

    2013-05-01

    To examine whether interpersonal behavior and provision of key information by tissue requesters (TRs) during phone requests for tissue donation with initially undecided next-of-kin (NOK) predict consent/refusal to donate. The sample consisted of 102 TR-NOK dyads in which NOK reported that they were initially undecided about their intentions to donate their loved ones' tissue. Audiorecordings of requests, gathered from a national sample of tissue banks, were coded to assess for interpersonal behavior of each interactant. The effects of TR and NOK interpersonal behavior as well as information provision by the TR on consent/refusal were examined. Expressions of disapproval by the TR strongly predicted NOK donation decision. Predictors of consent included fewer questions asked and more supportive statements made by the TR, as well as reassurance from the TR that donation would not lead to disfigurement or affect the appearance of the body. Aspects of the communication process between TR and NOK during requests for tissue donation significantly predict consent to donate among initially undecided NOK. TR trainings aimed at improving interpersonal skills and provision of key information could potentially increase tissue donation consent rates. Published by Elsevier Ireland Ltd.

  17. Innovation, informed consent, health research and the Supreme Court: Montgomery v Lanarkshire - a brave new world?

    PubMed

    Mchale, Jean V

    2017-10-01

    The Supreme Court decision in Montgomery v Lanarkshire ([2015] UKSC11) has been hailed as a landmark not least because the Court enshrines the doctrine of informed consent formally into English law for the first time in relation to medical treatment. This paper explores the decision in Montgomery. It examines what its implications may be in the future for the consent process in relation to health research and innovative treatment and whether it may prove a watershed moment leading to changing dialogues and expectations in relation to consent. First, the paper explores the concept of 'informed consent' in clinical research as seen through international, Council of Europe and EU instruments. Second, it considers how English law currently governs the provision of information to research participants in the context of clinical research. It questions whether such an approach will be sustainable in the future. Third, it discusses the decision of the UK Supreme Court in Montgomery v Lanarkshire and asks what might be the impact of this Supreme Court decision in the health research context. It asks whether Montgomery may result in new approaches to consent in health research and innovative treatment.

  18. 10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a DOE...

  19. 10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a DOE...

  20. 10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a DOE...