What Do Ethical Guidelines for Epidemiology Say About an Ethics Review? A Qualitative Systematic Review.

PubMed

Piasecki, Jan; Waligora, Marcin; Dranseika, Vilius

2017-06-01

Epidemiological research is subject to an ethics review. The aim of this qualitative review is to compare existing ethical guidelines in English for epidemiological research and public health practice in regard to the scope and matter of an ethics review. Authors systematically searched PubMed, Google Scholar and Google Search for ethical guidelines. Qualitative analysis (constant comparative method) was applied to categorize important aspects of the an ethics review process. Eight ethical guidelines in English for epidemiological research were retrieved. Five main categories that are relevant to the review of epidemiological research by Institutional Review Boards/Research Ethics Committees were distinguished. Within the scope of main categories, fifty-nine subcategories were analyzed. There are important differences between the guidelines in terms of the scope and matter of an ethics review. Not all guidelines encompass all identified ethically important issues, and some do not define precisely the scope and matter of an ethics review, leaving much to the ethics of the individual researchers and the discretion of IRBs/RECs.

The Medical Ethics Curriculum in Medical Schools: Present and Future.

PubMed

Giubilini, Alberto; Milnes, Sharyn; Savulescu, Julian

2016-01-01

In this review article we describe the current scope, methods, and contents of medical ethics education in medical schools in Western English speaking countries (mainly the United Kingdom, the United States, and Australia). We assess the strengths and weaknesses of current medical ethics curricula, and students' levels of satisfaction with different teaching approaches and their reported difficulties in learning medical ethics concepts and applying them in clinical practice. We identify three main challenges for medical ethics education: counteracting the bad effects of the "hidden curriculum," teaching students how to apply ethical knowledge and critical thinking to real cases in clinical practice, and shaping future doctors' right character through ethics education. We suggest ways in which these challenges could be addressed. On the basis of this analysis, we propose practical guidelines for designing, implementing, teaching, and assessing a medical ethics program within a four-year medical course. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

How young is too young: ethical concerns in genital surgery of the transgender MTF adolescent.

PubMed

Milrod, Christine

2014-02-01

During the last decade, the age of youths presenting for gender confirmation has steadily fallen. Transgender adolescents are being treated with gonadotropin-releasing hormone analogues and subsequently cross-sex hormones at early or midpuberty, with genital surgery as the presumed final step in treatment for female-affirmed (male-to-female) individuals. Despite the minimum age of 18 as eligibility to undergo irreversible procedures, anecdotal reports show that vaginoplasties of female-affirmed patients under 18 have been performed by surgeons, thereby contravening the World Professional Association for Transgender Health Standards of Care. The purpose of this article is (i) to provide a review of salient factors regarding genital surgery in transgender adolescents; (ii) to review various ethical protocols for determining maturity in gender dysphoric individuals under 18; and (iii) to present a new systematic set of ethical principles largely derived from the surgical management of youths with disorders of sex development and adapted to the needs of transitioning adolescents. A literature review of the topic was performed. Ethical guidelines derived from applied treatment protocols of children with disorders of sex development were written. Progressing from the current state of ethical standards and clinical assumptions, a new development of ethical guidelines for genital surgery in the female-affirmed transgender adolescent was created. There were no controlled studies of vaginoplasties performed on female-affirmed adolescents under 18 years of age. A new set of ethical guidelines was created in order to support treatment professionals in their decision making process. Professionals across disciplines treating female-affirmed adolescents can utilize the proposed ethical guidelines to facilitate decision making on a case-by-case basis in order to protect both patients and practitioners. These guidelines may also be used in support of more open discussions and disclosures of surgical results that could further the advancement of treatment in this emerging population. © 2013 International Society for Sexual Medicine.

Medical internet ethics: a field in evolution.

PubMed

Dyer, K A; Thompson, C D

2001-01-01

As in any new field, the merger of medicine, e-commerce and the Internet raises many questions pertaining to ethical conduct. Key issues include defining the essence of the patient-provider relationship, establishing guidelines and training for practicing online medicine and therapy, setting standards for ethical online research, determining guidelines for providing quality healthcare information and requiring ethical conduct for medical and health websites. Physicians who follow their professional code of ethics are obligated not to exploit the relationship they have with patients, nor allow anyone else working with them to do so. Physicians and therapists are obligated to serve those who place trust in them for treatment, whether in face-to-face or online Internet encounters with patients or clients. This ethical responsibility to patients and clients is often in direct conflict with the business model of generating profits. Healthcare professionals involved in Medical Internet Ethics need to define the scope of competent medical and healthcare on the Internet. The emerging ethical issues facing medicine on the Internet, the current state of medical ethics on the Internet and questions for future directions of study in this evolving field are reviewed in this paper.

Monitoring ethical, legal, and social issues in developing population genetic databases.

PubMed

Austin, Melissa A; Harding, Sarah E; McElroy, Courtney E

2003-01-01

To characterize ethical, legal, and social issues unique to population genetic database research and to determine the relevance of international recommendations and guidelines for addressing these issues in the development of "genebank" projects globally. Building on our previous description of eight international genebanks, we conducted a comprehensive electronic search and literature review of relevant publications and consulted national and international documents applicable to genebank research. We identified and characterized five categories of ethical, legal, and social issues unique to genebank development: sponsorship and benefit-sharing, neutrality and regulatory power of ethics committees, public engagement, consent, and data protection. We illustrate these issues with examples from specific genebanks. Not all of the issues are addressed in current international guidelines, many of which are nonspecific and unenforceable. The trend of genebank development promises to provide new discoveries to the field of medical science and to greatly improve public health. However, there is a growing need for more explicit, enforceable, and coordinated international guidelines relevant to the development and implementation of genebanks. By comparing ethical, legal and social issues as they arise in genebanks, researchers can better evaluate how to best use these projects to improve public health while protecting participating populations.

The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review.

PubMed

Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

2016-01-01

When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care. To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. A systematic review in Medline (publications in English or German between 2000 and 2014) and Google Books (with no restrictions) was conducted. Ethical issues were identified by qualitative text analysis and normative analysis. The literature review retrieved 106 references that together mentioned 27 ethical issues in clinical care of kidney failure. This set of ethical issues was structured into a matrix consisting of seven major categories and further first and second-order categories. The systematically-derived matrix helps raise awareness and understanding of the complexity of ethical issues in kidney failure. It can be used to identify ethical issues that should be addressed in specific training programs for clinicians, clinical practice guidelines, or other types of policies dealing with kidney failure.

The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review

PubMed Central

Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

2016-01-01

Background When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care. Aim To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. Method A systematic review in Medline (publications in English or German between 2000 and 2014) and Google Books (with no restrictions) was conducted. Ethical issues were identified by qualitative text analysis and normative analysis. Results The literature review retrieved 106 references that together mentioned 27 ethical issues in clinical care of kidney failure. This set of ethical issues was structured into a matrix consisting of seven major categories and further first and second-order categories. Conclusions The systematically-derived matrix helps raise awareness and understanding of the complexity of ethical issues in kidney failure. It can be used to identify ethical issues that should be addressed in specific training programs for clinicians, clinical practice guidelines, or other types of policies dealing with kidney failure. PMID:26938863

Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study.

PubMed

De Smit, Elisabeth; Kearns, Lisa S; Clarke, Linda; Dick, Jonathan; Hill, Catherine L; Hewitt, Alex W

2016-01-01

Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs) and Research Governance Offices (RGOs) across Australia. In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA), for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a "National Ethics Application Form" and three a "Low Negligible Risk" form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22) and panel review turnaround time (range nine to 136 days). We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently.

Institutional initiatives in professional scientific ethics: three case studies

NASA Astrophysics Data System (ADS)

Nickless, Edmund; Bilham, Nic

2015-04-01

Learned and professional scientific bodies can play a vital role in promoting ethical behaviours, giving practical substance to theoretical consideration of geoethical principles and complementing the efforts of individual scientists and practitioners to behave in a professional and ethical manner. Institutions may do this through mandatory professional codes of conduct, by developing guidelines and initiatives to codify and stimulate the uptake of best practice, and through wider initiatives to engender a culture conducive to such behaviours. This presentation will outline three current institutional initiatives which directly or indirectly address scientific ethics: i. The UK Science Council's Declaration on Diversity, Equality and Inclusion. ii. Development and promulgation of the American Geosciences Institute's (AGI) Guidelines for Ethical Professional Conduct. iii. The American Geophysical Union's (AGU) Scientific Code of Conduct and Professional Ethics. The focus of the Science Council and its member bodies (including the Geological Society of London) on diversity is of central importance when considering ethical behaviours in science. First, improving equality and diversity in the science workforce is at the heart of ethical practice, as well as being essential to meeting current and future skills needs. Second, in addition to demographic diversity (whether in terms of gender, race, economic status, sexuality or gender identity, etc), an important dimension of diversity in science is to allow space for a plurality of scientific views, and to nurture dissenting voices - essential both to the development of scientific knowledge and to its effective communication to non-technical audiences.

Writing about Clients: Developing Composite Case Material and Its Rationale

ERIC Educational Resources Information Center

Duffy, Maureen

2010-01-01

Ethical guidelines of the 4 major professional associations representing counselors and psychotherapists are reviewed. To help clarify thinking about writing up clinical cases, 3 kinds of cases are described. The author concludes that the current guidelines for clinician authors in writing about clients for publication or presentation are…

Ethical Considerations of Community-based Participatory Research: Contextual Underpinnings for Developing Countries

PubMed Central

Jamshidi, Ensiyeh; Morasae, Esmaeil Khedmati; Shahandeh, Khandan; Majdzadeh, Reza; Seydali, Elham; Aramesh, Kiarash; Abknar, Nina Loori

2014-01-01

Background: The nature of community-based participatory research (CBPR) poses distinctive ethical challenges. In the absence of organized guidelines, a remarkable amount of researchers’ time and energy will be spent tackling these ethical challenges. The study aimed to explore ethical issues and principles potentially arising when conducting CBPR. Methods: This qualitative study conducted in CBPR Center of Tehran University of Medical Sciences. Required data were gathered through systematic literature review and semi-structured interviews. Representatives of community, academia, and nongovernmental organizations (NGOs) participated in our study. Ten interviews with representatives of partner organizations, four group interviews with academic staff, and four with representatives of community were conducted. Repeated thematic analysis was used to elicit ethics-related overarching themes from transcribed interviews. As recommendations, these themes were then organized into a set of CBPR-related ethical issues and principles. Results: Four CBPR ethical guidelines (including 173 articles) were selected from a systematic review. Overarching themes relating to ethical principles which emerged from interviews were as follows: Trust, transparency and accountability, equity and inclusion, power imbalance, tolerance and conflict management, and attention to cultural sensitivity. Practical principles that emerged included: Consensus rather than informed consent, ownership of data and research achievements, and sustainability and maintenance of relationships. According to findings and in comparison to international guidelines, the present study put more emphasis on cultural sensitivity and sustainability as CBPR ethical tangles. Conclusions: Community-based participatory research ethical challenges are of the same kind in most parts of the world. However, some discrepancies exist that calls for local scrutiny. Future use and critic of current explored ethical issues and principles are highly encouraged. PMID:25400893

Payment of research participants: current practice and policies of Irish research ethics committees.

PubMed

Roche, Eric; King, Romaine; Mohan, Helen M; Gavin, Blanaid; McNicholas, Fiona

2013-09-01

Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Postal survey of all RECs in Ireland. Response rate was 62.5% (n=50). 80% of RECs reported not to have any established policy on the payment of research subjects while 20% had refused ethics approval to studies because the investigators proposed to pay research participants. The most commonly cited concerns were the potential for inducement and undermining of voluntary consent. There is considerable variability among RECs on the payment of research participants and a lack of clear consensus guidelines on the subject. The development of standardised guidelines on the payment of research subjects may enhance recruitment of research participants.

Doing No Harm and Getting It Right: Guidelines for Ethical Research with Immigrant Communities

ERIC Educational Resources Information Center

Hernández, María G.; Nguyen, Jacqueline; Casanova, Saskias; Suárez-Orozco, Carola; Saetermoe, Carrie L.

2013-01-01

This chapter provides a guide to research logistics and ethics in studying immigrant families. The authors outline major pragmatic issues in research design and data collection to which all scholars must attend, although current practices often do not respond to the idiosyncratic issues related to vulnerable immigrant populations (e.g.,…

Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report.

PubMed

Carrieri, D; Bewshea, C; Walker, G; Ahmad, T; Bowen, W; Hall, A; Kelly, S

2016-09-27

Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients in light of research findings affecting research and clinical practices. The group was deliberately multidisciplinary to ensure that a diversity of views was represented. This report outlines the main ethical issues, areas of best practice and principles underlying ethical clinically based genomic research discussed during the meeting. The main point emerging from the discussion is that ethical principles, rather than being formulaic, should guide researchers/clinicians to identify who the main stakeholders are to consult with for a specific project and to incorporate their voices/views strategically throughout the lifecycle of each project. We believe that the mix of principles and practical guidelines outlined in this report can contribute to current debates on how to conduct ethical clinically based genomic research. 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/

Nurses' attitudes towards euthanasia in conflict with professional ethical guidelines.

PubMed

Terkamo-Moisio, Anja; Kvist, Tarja; Kangasniemi, Mari; Laitila, Teuvo; Ryynänen, Olli-Pekka; Pietilä, Anna-Maija

2017-02-01

Despite the significant role of nurses in end-of-life care, their attitudes towards euthanasia are under-represented both in the current literature and the controversial debate that is ongoing in several countries. What are the attitudes towards euthanasia among Finnish nurses? Which characteristics are associated with those attitudes? Cross-sectional web-based survey. Participants and research context: A total of 1003 nurses recruited via the members' bulletin of the Finnish Nurses Association and social media. Ethical considerations: Ethical approval was obtained from the Committee on Research Ethics of the university to which the authors were affiliated. The majority (74.3%) of the participants would accept euthanasia as part of Finnish healthcare, and 61.8% considered that Finland would benefit from a law permitting euthanasia. Most of the nurses (89.9%) thought that a person must have the right to decide on his or her own death; 77.4% of them considered it likely that they would themselves make a request for euthanasia in certain situations. The value of self-determination and the ability to choose the moment and manner of one's death are emphasized in the nurses' attitudes towards euthanasia. A continuous dialogue about euthanasia and nurses' shared values is crucial due to the conflict between nurses' attitudes and current ethical guidelines on nursing.

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

Consensus Among International Ethical Guidelines for the Provision of Videoconferencing-Based Mental Health Treatments.

PubMed

Sansom-Daly, Ursula M; Wakefield, Claire E; McGill, Brittany C; Wilson, Helen L; Patterson, Pandora

2016-05-18

Online technologies may reduce barriers to evidence-based mental health care, yet they also create numerous ethical challenges. Recently, numerous professional organizations and expert groups have produced best-practice guidelines to assist mental health professionals in delivering online interventions in an ethically and clinically sound manner. However, there has been little critical examination of these international best-practice guidelines regarding appropriate electronic mental health (e-mental health) service delivery via technologies such as videoconferencing (including Skype), particularly for specific, vulnerable populations. Further, the extent to which concordance exists between these guidelines remains unclear. Synthesizing this literature to provide clear guidance to both mental health professionals and researchers is critical to ensure continued progress in the field of e-mental health. This study aims to review all currently available ethical and best-practice guidelines relating to videoconferencing-delivered mental health treatments in order to ascertain the recommendations for which international consensus could be found. Additionally, this review examines the extent to which each set of guidance addresses several key special populations, including children and young people, and populations living with illness. This systematic review examined guidelines using a two-armed search strategy, examining (1) professional organizations' published guidance; and (2) MEDLINE, PsycINFO, and EMBASE for the past ten years. In order to determine consensus for best-practice, a recommendation was considered "firm" if 50% or more of the reviewed guidelines endorsed it and "tentative" if recommended by fewer guidelines than these. The professional guidelines were also scored by two raters using the Appraisal of Guidelines for Research and Evaluation II (AGREE-II) criteria. In the study, 19 guidelines were included, yielding 11 specific "firm" and a further 123 "tentative-level" recommendations regarding the appropriateness of e-mental health, competence, legal and regulatory issues, confidentiality, consent, professional boundaries, and crisis management. International consensus yielded firm guidance across almost all areas except professional boundaries and some aspects of determining the appropriateness of e-mental health. Few guidelines specifically addressed special populations. Overall guideline quality varied; however, 42% (8/19) of the guidelines scored at least 5 out of 7. This synthesis of guidelines provides a foundation for clinicians and researchers utilizing e-mental health worldwide. The lack of specific guidance relating to special populations is an area warranting further attention in order to strengthen mental health professionals' and researchers' capacity to ethically and effectively tailor e-mental health interventions to these groups.

What do international ethics guidelines say in terms of the scope of medical research ethics?

PubMed

Bernabe, Rosemarie D L C; van Thiel, Ghislaine J M W; van Delden, Johannes J M

2016-04-26

In research ethics, the most basic question would always be, "which is an ethical issue, which is not?" Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus (or lack thereof). In this manuscript, we attempted to do just that. We extracted the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative. We found that there is no consensus on the majority of the imperatives and that in only 8.2% of the imperatives were there at least moderate consensus (i.e., consensus of at least 3 of the 5 ethics guidelines). Of the 12 clusters (Basic Principles; Research Collaboration; Social Value; Scientific Validity; Participant Selection; Favorable Benefit/Risk Ratio; Independent Review; Informed Consent; Respect for Participants; Publication and Registration; Regulatory Sanctions; and Justified Research on the Vulnerable Population), Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least. There was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences.

Review of national research ethics regulations and guidelines in Middle Eastern Arab countries

PubMed Central

2012-01-01

Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. PMID:23234422

In Defense of a Social Value Requirement for Clinical Research

PubMed Central

Wendler, David; Rid, Annette

2017-01-01

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present paper assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. PMID:28060427

In Defense of a Social Value Requirement for Clinical Research.

PubMed

Wendler, David; Rid, Annette

2017-02-01

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. © 2017 John Wiley & Sons Ltd.

Teaching about genetic testing issues in the undergraduate classroom: a case study.

PubMed

Rogers, Jill Cellars; Taylor, Ann T S

2011-06-01

Educating undergraduates about current genetic testing and genomics can involve novel and creative teaching practices. The higher education literature describes numerous pedagogical approaches in the laboratory designed to engage science and liberal arts students. Often these experiences involve students analyzing their own genes for various polymorphisms, some of which are associated with disease states such as an increased risk for developing cancer. While the literature acknowledges possible ethical ramifications of such laboratory exercises, authors do not present recommendations or rubrics for evaluating whether or not the testing is, in fact, ethical. In response, we developed a laboratory investigation and discussion which allowed undergraduate science students to explore current DNA manipulation techniques to isolate their p53 gene, followed by a dialogue probing the ethical implications of examining their sample for various polymorphisms. Students never conducted genotyping on their samples because of ethical concerns, so the discussion served to replace actual genetic testing in the class. A basic scientist led the laboratory portion of the assignment. A genetic counselor facilitated the discussion, which centered around existing ethical guidelines for clinical genetic testing and possible challenges of human genotyping outside the medical setting. In their final papers, students demonstrated an understanding of the practice guidelines established by the genetics community and acknowledged the ethical considerations inherent in p53 genotyping. Given the burgeoning market for personalized medicine, teaching undergraduates about the psychosocial and ethical dimensions of human gene testing seems important and timely, and introduces an additional role genetic counselors can play in educating consumers about genomics.

A Brief Report on the Ethical and Legal Guides For Technology Use in Marriage and Family Therapy.

PubMed

Pennington, Michael; Patton, Rikki; Ray, Amber; Katafiasz, Heather

2017-10-01

Marriage and family therapists (MFTs) use ethical codes and state licensure laws/rules as guidelines for best clinical practice. It is important that professional codes reflect the potential exponential use of technology in therapy. However, current standards regarding technology use lack clarity. To explore this gap, a summative content analysis was conducted on state licensure laws/rules and professional ethical codes to find themes and subthemes among the many aspects of therapy in which technology can be utilized. Findings from the content analysis indicated that while there have been efforts by both state and professional organizations to incorporate guidance for technology use in therapy, a clear and comprehensive "roadmap" is still missing. Future scholarship is needed that develops clearer guidelines for therapists. © 2017 American Association for Marriage and Family Therapy.

An eight-year follow-up national study of medical school and general hospital ethics committees in Japan

PubMed Central

Akabayashi, Akira; Slingsby, Brian T; Nagao, Noriko; Kai, Ichiro; Sato, Hajime

2007-01-01

Background Ethics committees and their system of research protocol peer-review are currently used worldwide. To ensure an international standard for research ethics and safety, however, data is needed on the quality and function of each nation's ethics committees. The purpose of this study was to describe the characteristics and developments of ethics committees established at medical schools and general hospitals in Japan. Methods This study consisted of four national surveys sent twice over a period of eight years to two separate samples. The first target was the ethics committees of all 80 medical schools and the second target was all general hospitals with over 300 beds in Japan (n = 1457 in 1996 and n = 1491 in 2002). Instruments contained four sections: (1) committee structure, (2) frequency of annual meetings, (3) committee function, and (4) existence of a set of guidelines for the refusal of blood transfusion by Jehovah's Witnesses. Results Committee structure was overall interdisciplinary. Frequency of annual meetings increased significantly for both medical school and hospital ethics committees over the eight years. The primary activities for medical school and hospital ethics committees were research protocol reviews and policy making. Results also showed a significant increase in the use of ethical guidelines, particularly those related to the refusal of blood transfusion by Jehovah's Witnesses, among both medical school and hospital ethics committees. Conclusion Overall findings indicated a greater recognized degree of responsibilities and an increase in workload for Japanese ethics committees. PMID:17598923

Ethics Reporting in Biospecimen and Genetic Research: Current Practice and Suggestions for Changes

PubMed Central

Chin, William Wei Lim; Wieschowski, Susanne; Prokein, Jana; Illig, Thomas

2016-01-01

Modern approaches for research with human biospecimens employ a variety of substantially different types of ethics approval and informed consent. In most cases, standard ethics reporting such as “consent and approval was obtained” is no longer meaningful. A structured analysis of 120 biospecimen studies recently published in top journals revealed that more than 85% reported on consent and approval, but in more than 90% of cases, this reporting was insufficient and thus potentially misleading. Editorial policies, reporting guidelines, and material transfer agreements should include recommendations for meaningful ethics reporting in biospecimen research. Meaningful ethics reporting is possible without higher word counts and could support public trust as well as networked research. PMID:27483445

Ethical standards for mental health and psychosocial support research in emergencies: review of literature and current debates.

PubMed

Chiumento, Anna; Rahman, Atif; Frith, Lucy; Snider, Leslie; Tol, Wietse A

2017-02-08

Research in emergencies is needed to understand the prevalence of mental health and psychosocial problems and strengthen the evidence base for interventions. All research - including operational needs assessments, programme monitoring and evaluation, and formal academic research - must be conducted ethically. While there is broad consensus on fundamental principles codified in research ethics guidelines, these do not address the ethical specificities of conducting mental health and psychosocial support (MHPSS) research with adults in emergencies. To address this gap, this paper presents a review of multidisciplinary literature to identify specific ethical principles applicable to MHPSS research in emergencies. Fifty-nine sources meeting the literature review inclusion criteria were analysed following a thematic synthesis approach. There was consensus on the relevance of universal ethical research principles to MHPSS research in emergencies, including norms of participant informed consent and protection; ensuring benefit arises from research participation; researcher neutrality, accountability, and safety; and the duty to ensure research is well designed and accounts for contextual factors in emergency settings. We go onto discuss unresolved issues by highlighting six current debates relating to the application of ethics in emergency settings: (1) what constitutes fair benefits?; (2) how should informed consent be operationalised?; (3) is there a role for decision making capacity assessments?; (4) how do risk management approaches impact upon the construction of ethical research?; (5) how can ethical reflection best be achieved?, and (6) are ethical review boards sufficiently representative and equipped to judge the ethical and scientific merit of emergency MHPSS research? Underlying these debates is a systemic tension between procedural ethics and ethics in practice. In summary, underpinning the literature is a desire to ensure the protection of participants exposed to emergencies and in need of evidence-based MHPSS. However, there is a lack of agreement on how to contextualise guidelines and procedures to effectively maximise the perspectives of researchers, participants and ethical review boards. This is a tension that the field must address to strengthen ethical MHPSS research in emergencies.

The Council for International Organizations and Medical Sciences (CIOMS) guidelines on ethics of clinical trials.

PubMed

Macrae, Duncan J

2007-05-01

Numerous bodies from many countries, including governments, government regulatory departments, research organizations, medical professional bodies, and health care providers, have issued guidance or legislation on the ethical conduct of clinical trials. It is possible to trace the development of current guidelines back to the post-World War II Nuremburg war crimes trials, more specifically the "Doctors' Trial." From that trial emerged the Nuremburg Code, which set out basic principles to be observed when conducting research involving human subjects and which subsequently formed the basis for comprehensive international guidelines on medical research, such as the Declaration of Helsinki. Most recently, the Council for International Organizations and Medical Sciences (CIOMS) produced detailed guidelines (originally published in 1993 and updated in 2002) on the implementation of the principles outlined in the Declaration of Helsinki. The CIOMS guidelines set in an appropriate context the challenges of present-day clinical research, by addressing complex issues including HIV/AIDS research, availability of study treatments after a study ends, women as research subjects, safeguarding confidentiality, compensation for adverse events, as well guidelines on consent.

What Next? Translating AGI's 2015 Guidelines for Ethical Professional Conduct into Practice

NASA Astrophysics Data System (ADS)

Boland, M. A.; Keane, C.

2016-12-01

In 2015, the American Geosciences Institute (AGI) published a revised version of the 1999 Guidelines for Ethical Professional Conduct, an aspirational document outlining ethical principles that should inform the professional behavior of all geoscientists. The revised Guidelines reflect a consensus of opinion among AGI's 51 member societies and show an evolution in thinking about geoscience ethics. The Guidelines also represent a foundational document to support the expansion of ethical guidelines by individual societies and organizations. Publishing the Guidelines was a significant milestone but aspirations need to be matched by action. We examine several developments that implement aspects of the Guidelines, including the development of a consensus statement regarding access and inclusion of individuals living with disabilities in the geosciences, a Joint AGI/Geological Society of America Societies meeting on professional conduct, geoethics training initiatives, and efforts to foster international cooperation in recognizing and implementing ethical practice in the geosciences. In addition, we examine the level of success in using these Guidelines as philosophical cornerstones for a number of international projects, such as Resourcing Future Generations and the International Raw Materials Observatory, that bring geoscience directly into contact with large societal issues.

Ethical Challenges of Medicine and Health on the Internet: A Review

PubMed Central

2001-01-01

Knowledge and capabilities, particularly of a new technology or in a new area of study, frequently develop faster than the guidelines and principles needed for practitioners to practice ethically in the new arena; this is particularly true in medicine. The blending of medicine and healthcare with e-commerce and the Internet raises many questions involving what sort of ethical conduct should be expected by practitioners and developers of the medical Internet. Some of the early pioneers in medical and healthcare Web sites pushed the ethical boundaries with questionable, even unethical, practices. Many involved with the medical Internet are now working to reestablish patient and consumer trust by establishing guidelines to determine how the fundamentals of the medical code of ethical conduct can best be adapted for the medical/healthcare Internet. Ultimately, all those involved in the creation, maintenance, and marketing of medical and healthcare Web sites should be required to adhere to a strict code of ethical conduct, one that has been fairly determined by an impartial international organization with reasonable power to regulate the code. This code could also serve as a desirable, recognizable label-of-distinction for ethical Web sites within the medical and healthcare Internet community. One challenge for those involved with the medical and healthcare Internet will be to determine what constitutes "Medical Internet Ethics" or "Healthcare Internet Ethics," since the definition of medical ethics can vary from country to country. Therefore, the emerging field of Medical/ Healthcare Internet Ethics will require careful thought and insights from an international collection of ethicists in many contributing areas. This paper is a review of the current status of the evolving field of Medical/Healthcare Internet Ethics, including proposed definitions and identification of many diverse areas that may ultimately contribute to this multidisciplinary field. The current role that medicine and health play in the growing area of Internet communication and commerce and many of the ethical challenges raised by the Internet for the medical community are explored and some possible ways to address these ethical challenges are postulated. PMID:11720965

Ethical challenges of medicine and health on the Internet: a review.

PubMed

Dyer, K A

2001-01-01

Knowledge and capabilities, particularly of a new technology or in a new area of study, frequently develop faster than the guidelines and principles needed for practitioners to practice ethically in the new arena; this is particularly true in medicine. The blending of medicine and healthcare with e-commerce and the Internet raises many questions involving what sort of ethical conduct should be expected by practitioners and developers of the medical Internet. Some of the early pioneers in medical and healthcare Web sites pushed the ethical boundaries with questionable, even unethical, practices. Many involved with the medical Internet are now working to reestablish patient and consumer trust by establishing guidelines to determine how the fundamentals of the medical code of ethical conduct can best be adapted for the medical/healthcare Internet. Ultimately, all those involved in the creation, maintenance, and marketing of medical and healthcare Web sites should be required to adhere to a strict code of ethical conduct, one that has been fairly determined by an impartial international organization with reasonable power to regulate the code. This code could also serve as a desirable, recognizable label-of-distinction for ethical Web sites within the medical and healthcare Internet community. One challenge for those involved with the medical and healthcare Internet will be to determine what constitutes "Medical Internet Ethics" or "Healthcare Internet Ethics," since the definition of medical ethics can vary from country to country. Therefore, the emerging field of Medical/ Healthcare Internet Ethics will require careful thought and insights from an international collection of ethicists in many contributing areas. This paper is a review of the current status of the evolving field of Medical/Healthcare Internet Ethics, including proposed definitions and identification of many diverse areas that may ultimately contribute to this multidisciplinary field. The current role that medicine and health play in the growing area of Internet communication and commerce and many of the ethical challenges raised by the Internet for the medical community are explored and some possible ways to address these ethical challenges are postulated.

Curriculum Guidelines on Ethics and Professionalism in Dentistry.

ERIC Educational Resources Information Center

Journal of Dental Education, 1989

1989-01-01

Guidelines developed by the American Association of Dental Schools for curriculum development aids are presented. The dental ethics curriculum should provide opportunities for refining skills of ethical analysis so students are able to apply ethical principles to problems in the profession. (MLW)

THE ETHICS OF SHAM SURGERY IN PARKINSON'S DISEASE: BACK TO THE FUTURE?

PubMed Central

Swift, Teresa; Huxtable, Richard

2013-01-01

Despite intense academic debate in the recent past over the use of ‘sham surgery’ control groups in research, there has been a recent resurgence in their use in the field of neurodegenerative disease. Yet the primacy of ethical arguments in favour of sham surgery controls is not yet established. Preliminary empirical research shows an asymmetry between the views of neurosurgical researchers and patients on the subject, while different ethical guidelines and regulations support conflicting interpretations. Research ethics committees faced with a proposal involving sham surgery should be aware of its ethical complexities. An overview of recent and current placebo-controlled surgical trials in the field of Parkinson's Disease is provided here, followed by an analysis of the key ethical issues which such trials raise. PMID:22150772

Code of ethics for the national pharmaceutical system: Codifying and compilation

PubMed Central

Salari, Pooneh; Namazi, Hamidreza; Abdollahi, Mohammad; Khansari, Fatemeh; Nikfar, Shekoufeh; Larijani, Bagher; Araminia, Behin

2013-01-01

Pharmacists as one of health-care providers face ethical issues in terms of pharmaceutical care, relationship with patients and cooperation with the health-care team. Other than pharmacy, there are pharmaceutical companies in various fields of manufacturing, importing or distributing that have their own ethical issues. Therefore, pharmacy practice is vulnerable to ethical challenges and needs special code of conducts. On feeling the need, based on a shared project between experts of the ethics from relevant research centers, all the needs were fully recognized and then specified code of conduct for each was written. The code of conduct was subject to comments of all experts involved in the pharmaceutical sector and thus criticized in several meetings. The prepared code of conduct is comprised of professional code of ethics for pharmacists, ethics guideline for pharmaceutical manufacturers, ethics guideline for pharmaceutical importers, ethics guideline for pharmaceutical distributors, and ethics guideline for policy makers. The document was compiled based on the principles of bioethics and professionalism. The compiling the code of ethics for the national pharmaceutical system is the first step in implementing ethics in pharmacy practice and further attempts into teaching the professionalism and the ethical code as the necessary and complementary effort are highly recommended. PMID:24174954

Re-evaluating ethical concerns in planned emergency research involving critically ill patients: an interpretation of the guidance document from the United States Food and Drug Administration.

PubMed

Smischney, Nathan J; Onigkeit, James A; Hinds, Richard F; Nicholson, Wayne T

2015-01-01

U.S. federal regulations require that certain ethical elements be followed to protect human research subjects. The location and clinical circumstances of a proposed research study can differ substantially and can have significant implications for these ethical considerations. Both the location and clinical circumstances are particularly relevant for research in intensive care units (ICUs), where patients are often unable to provide informed consent to participate in a proposed research intervention. Our goal is to elaborate on the updated 2013 U.S. Food and Drug Administration (FDA) guidance document regarding an exemption from the requirement of obtaining informed consent from patients or their surrogates and to address certain elements within that document, thereby assisting clinicians in developing a framework for emergency research in accordance with the regulatory bodies at their own institutions and in the United States. Review of the 2011 and updated FDA guidance document on exemption from informed consent. The current process of obtaining informed consent within ICUs needs to be revisited, especially for research in which timely informed consent is not likely. In particular, the process of obtaining informed consent may not be appropriate or even ethical for critically ill patients in extremis who require an intervention for which there is no current acceptable standard of care and clinical equipoise exists. We provide clinicians with a viewpoint that further elaborates on the FDA guidance document. The viewpoints provided herein are those of the authors and are therefore inherently limited by the personal views of a selected few. Other clinicians or researchers may not interpret the FDA guidelines in a similar manner. Moreover, the discussion of a guideline document is a limitation in and of itself. The guidelines set forth by the FDA are precisely that-guidelines. Therefore, they may not be followed as outlined in the guidance document within one's own institution. Our goal is that, by elaborating on the guidelines for planned research involving human subjects in the ICU, institutional regulatory bodies may gain a better understanding in drafting their own document when faced with a clinician or a researcher who wishes to conduct planned research in an ICU. We believe that the interpretations provided will allow clinicians to safely undertake planned research in ICUs without endangering the main tenets of ethical research involving human participants. This research is needed for the advancement of care in the critically ill. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

Researcher Perceptions of Ethical Guidelines and Codes of Conduct

PubMed Central

Giorgini, Vincent; Mecca, Jensen T.; Gibson, Carter; Medeiros, Kelsey; Mumford, Michael D.; Connelly, Shane; Devenport, Lynn D.

2014-01-01

Ethical codes of conduct exist in almost every profession. Field-specific codes of conduct have been around for decades, each articulating specific ethical and professional guidelines. However, there has been little empirical research on researchers’ perceptions of these codes of conduct. In the present study, we interviewed faculty members in six research disciplines and identified five themes bearing on the circumstances under which they use ethical guidelines and the underlying reasons for not adhering to such guidelines. We then identify problems with the manner in which codes of conduct in academia are constructed and offer solutions for overcoming these problems. PMID:25635845

Gathering Sensitive Stories

ERIC Educational Resources Information Center

Daley, Kathryn

2012-01-01

Discussions of research ethics are often focused on research ethics guidelines. These guidelines are useful in designing ethical research projects but are not designed to guide the interpersonal interactions that occur once researchers are out in the field. Drawing from Noddings' care theory, this article argues that making ethical decisions when…

Authorship Concerns and Who Truly Owns a Research Idea?

PubMed Central

Tran, Duc Q.; Kemper, Alex R.; Geme, Joseph W. St.; Lantos, John D.

2015-01-01

Researchers often face dilemmas about authorship. When the researchers are graduate students, fellows, or junior faculty, the dilemmas might involve discussions about fair criteria for more senior faculty to be acknowledged as key contributors or authors on manuscripts. This “Ethics Rounds” presents a case in which a fellow faced such a dilemma. We review current journal guidelines for authorship and some ethical considerations that should help make this process more streamlined. PMID:26459651

Research ethics for a globalised world: the revised CIOMS international guidelines.

PubMed

Ehni, Hans-Jöerg; Wiesing, Urban

2017-01-01

On December 6, 2016, the Council of International Organisations of Medical Sciences published a new version of its guidelines with the title "International Ethical Guidelines for Health-related Research Involving Humans." In this article we briefly describe the revision process and the structure and content of these guidelines. We outline some of its main guidelines such as the ones on social value, post-trial access, and risk-benefit ratio. In our overall evaluation we come to the conclusion that the CIOMS guidelines manage to strike a balance between the protection of human participants in health-related research and the promotion of such research activities in an exemplary way. The guidelines combine key principles with a guide to their application based on the state of the art in research ethics. Thus they represent a timely and indispensable orientation for researchers, ethics committees, and other stakeholders in health-related research.

Ethics in clinical research: the Indian perspective.

PubMed

Sanmukhani, J; Tripathi, C B

2011-03-01

Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.

How certain boundaries and ethics diminish therapeutic effectiveness.

PubMed

Lazarus, Arnold A

1994-01-01

When taken too far, certain well-intentioned ethical guidelines can become transformed into artificial boundaries that serve as destructive prohibitions and thereby undermine clinical effectiveness. Rigid roles and strict codified rules of conduct between therapist and client can obstruct a clinician's artistry. Those anxious conformists who go entirely by the book, and who live in constant fear of malpractice suits, are unlikely to prove significantly helpful to a broad array of clients. It is my contention that one of the worst professional/ethical violations is to permit current risk-management principles to take precedence over humane interventions.

Kamakahi vs ASRM and the future of compensation for human eggs.

PubMed

Klitzman, Robert L; Sauer, Mark V

2015-08-01

A recent lawsuit that alleges that the American Society for Reproductive Medicine (ASRM) engages in price-fixing by capping the amount of compensation paid for human oocytes has several critical ethical and policy implications that have received relatively little attention. ASRM has argued that ceilings on donor compensation prevent enticement, exploitation, and oocyte commodification. Critics counter that low donor compensation decreases supply, because fewer women are then interested in donating, which then increases prices for the service that physicians, not donors, accrue, and that ethical goals can be better achieved through enhanced informed consent, hiring egg donor advocates, and better counseling and screening. Yet, if compensation caps are removed, questions emerge concerning what the oocyte market would then look like. Informed consent is an imperfect process. Beyond the legal and economic questions of whether ASRM violates the Sherman Anti-trust Act also lie crucial questions of whether human eggs should be viewed as other products. We argue that human eggs differ from other factory-produced goods and should command moral respect. Although eggs (or embryos) are not equivalent to human beings, they deserve special consideration, because of their potential for human life, and thus have a different moral status. ASRM's current guidelines appear to address, even if imperfectly, ethical challenges that are related to egg procurement for infertility treatment. Given public concerns about oocyte commodification and ASRM's wariness of government regulations, existing guidelines may represent a compromise by aiding patients who seek eggs, while simultaneously trying to avoid undue influence, exploitation, and eugenics. Although the ultimate outcome of this lawsuit remains unclear, policy makers, providers, lawyers, judges, and others should attend seriously to these issues. Alternatives to current ASRM guidelines may be possible (eg, raising the current caps to, say, $12,000 or $15,000, potentially increasing donation, while still avoiding certain ethical difficulties) and warrant close consideration. These complex conflicting ethical issues deserve more attention than they have received because they affect key aspects of clinical practice and the lives of countless patients. Copyright © 2015. Published by Elsevier Inc.

Kamakahi vs ASRM and the future of compensation for human eggs

PubMed Central

Klitzman, Robert L.; Sauer, Mark V.

2015-01-01

A recent lawsuit that alleges that the American Society for Reproductive Medicine (ASRM) engages in price-fixing by capping the amount of compensation paid for human oocytes has several critical ethical and policy implications that have received relatively little attention. ASRM has argued that ceilings on donor compensation prevent enticement, exploitation, and oocyte commodification. Critics counter that low donor compensation decreases supply, because fewer women are then interested in donating, which then increases prices for the service that physicians, not donors, accrue, and that ethical goals can be better achieved through enhanced informed consent, hiring egg donor advocates, and better counseling and screening. Yet, if compensation caps are removed, questions emerge concerning what the oocyte market would then look like. Informed consent is an imperfect process. Beyond the legal and economic questions of whether ASRM violates the Sherman Anti-trust Act also lie crucial questions of whether human eggs should be viewed as other products. We argue that human eggs differ from other factory-produced goods and should command moral respect. Although eggs (or embryos) are not equivalent to human beings, they deserve special consideration, because of their potential for human life, and thus have a different moral status. ASRM’s current guidelines appear to address, even if imperfectly, ethical challenges that are related to egg procurement for infertility treatment. Given public concerns about oocyte commodification and ASRM’s wariness of government regulations, existing guidelines may represent a compromise by aiding patients who seek eggs, while simultaneously trying to avoid undue influence, exploitation, and eugenics. Although the ultimate outcome of this lawsuit remains unclear, policy makers, providers, lawyers, judges, and others should attend seriously to these issues. Alternatives to current ASRM guidelines may be possible (eg, raising the current caps to, say, $12,000 or $15,000, potentially increasing donation, while still avoiding certain ethical difficulties) and warrant close consideration. These complex conflicting ethical issues deserve more attention than they have received because they affect key aspects of clinical practice and the lives of countless patients. PMID:25816784

Research ethics committees in Japan: A perspective from thirty years of experience at Tokushima University.

PubMed

Yanagawa, Hiroaki; Katashima, Rumi; Takeda, Noriaki

2015-01-01

The first Japanese ethics committee for biomedical research involving human subjects was established at Tokushima University in 1982. Although this committee was not formed as a response to national directives, the government eventually developed ethical guidelines, such as the Ethical Guidelines for Clinical Studies that were established in 2003. The practical impact of such guidelines was a rapid increase in the number of protocols seeking ethics committee approval and, accordingly, an increase in the workload of ethics committees. This review describes the activity of the ethics committee at Tokushima University during the last thirty years and discusses the infrastructure that best supports the activities of this committee. In addition, we address the issues that ethics committees now face and discuss future directions. J. Med. Invest. 62: 114-118, August, 2015.

Research in disaster settings: a systematic qualitative review of ethical guidelines.

PubMed

Mezinska, Signe; Kakuk, Péter; Mijaljica, Goran; Waligóra, Marcin; O'Mathúna, Dónal P

2016-10-21

Conducting research during or in the aftermath of disasters poses many specific practical and ethical challenges. This is particularly the case with research involving human subjects. The extraordinary circumstances of research conducted in disaster settings require appropriate regulations to ensure the protection of human participants. The goal of this study is to systematically and qualitatively review the existing ethical guidelines for disaster research by using the constant comparative method (CCM). We performed a systematic qualitative review of disaster research ethics guidelines to collect and compare existing regulations. Guidelines were identified by a three-tiered search strategy: 1) searching databases (PubMed and Google Scholar), 2) an Internet search (Google), and 3) a search of the references in the included documents from the first two searches. We used the constant comparative method (CCM) for analysis of included guidelines. Fourteen full text guidelines were included for analysis. The included guidelines covered the period 2000-2014. Qualitative analysis of the included guidelines revealed two core themes: vulnerability and research ethics committee review. Within each of the two core themes, various categories and subcategories were identified. Some concepts and terms identified in analyzed guidelines are used in an inconsistent manner and applied in different contexts. Conceptual clarity is needed in this area as well as empirical evidence to support the statements and requirements included in analyzed guidelines.

Realizing good care within a context of cross-cultural diversity: an ethical guideline for healthcare organizations in Flanders, Belgium.

PubMed

Denier, Yvonne; Gastmans, Chris

2013-09-01

In our globalizing world, health care professionals and organizations increasingly experience cross-cultural challenges in care relationships, which give rise to ethical questions regarding "the right thing to do" in such situations. For the time being, the international literature lacks examples of elaborated ethical guidelines for cross-cultural healthcare on the organizational level. As such, the ethical responsibility of healthcare organizations in realizing cross-cultural care remains underexposed. This paper aims to fill this gap by offering a case-study that illustrates the bioethical practice on a large-scale organizational level by presenting the ethical guideline developed in the period 2007-2011 by the Ethics Committee of Zorgnet Vlaanderen, a Christian-inspired umbrella organization for over 500 social profit healthcare organizations in Flanders, Belgium. The guideline offers an ethical framework within which fundamental ethical values are being analyzed within the context of cross-cultural care. The case study concludes with implications for healthcare practice on four different levels: (1) the level of the healthcare organization, (2) staff, (3) care receivers, and (4) the level of care supply. The study combines content-based ethics with process-based benchmarks. Copyright © 2013. Published by Elsevier Ltd.

HIV vaccine research--South Africa's ethical-legal framework and its ability to promote the welfare of trial participants.

PubMed

Strode, Ann; Slack, Catherine; Mushariwa, Muriel

2005-08-01

An effective ethical-legal framework for the conduct of research is critical. We describe five essential components of such a system, review the extent to which these components have been realised in South Africa, present brief implications for the ethical conduct of clinical trials of HIV vaccines in South Africa and make recommendations. The components of an effective ethical-legal system that we propose are the existence of scientific ethical and policy-making structures that regulate research; research ethics committees (RECs) that ethically review research; national ethical guidelines and standards; laws protecting research participants; and mechanisms to enforce and monitor legal rights and ethical standards. We conclude that the ethical-legal framework has, for the most part, the necessary institutions, and certain necessary guidelines but does not have many of the laws needed to protect and promote the rights of persons participating in research, including HIV vaccine trials. Recommendations made include advocacy measures to finalise and implement legislation, development of regulations, analysis and comparison of ethical guidelines, and the development of measures to monitor ethical-legal rights at trial sites.

Establishment of medical education upon internalization of virtue ethics: bridging the gap between theory and practice.

PubMed

Madani, Mansoureh; Larijani, Bagher; Madani, Ensieh; Ghasemzadeh, Nazafarin

2017-01-01

During medical training, students obtain enough skills and knowledge. However, medical ethics accomplishes its goals when, together with training medical courses, it guides students behavior towards morality so that ethics-oriented medical practice is internalized. Medical ethics is a branch of applied ethics which tries to introduce ethics into physicians' practice and ethical decisions; thus, it necessitates the behavior to be ethical. Therefore, when students are being trained, they need to be supplied with those guidelines which turn ethical instructions into practice to the extent possible. The current text discusses the narrowing of the gap between ethical theory and practice, especially in the field of medical education. The current study was composed using analytical review procedures. Thus, classical ethics philosophy, psychology books, and related articles were used to select the relevant pieces of information about internalizing behavior and medical education. The aim of the present study was to propose a theory by analyzing the related articles and books. The attempt to fill the gap between medical theory and practice using external factors such as law has been faced with a great deal of limitations. Accordingly, the present article tries to investigate how and why medical training must take internalizing ethical instructions into consideration, and indicate the importance of influential internal factors. Virtue-centered education, education of moral emotions, changing and strengthening of attitudes through education, and the wise use of administrative regulations can be an effective way of teaching ethical practice in medicine.

Establishment of medical education upon internalization of virtue ethics: bridging the gap between theory and practice

PubMed Central

Madani, Mansoureh; Larijani, Bagher; Madani, Ensieh; Ghasemzadeh, Nazafarin

2017-01-01

During medical training, students obtain enough skills and knowledge. However, medical ethics accomplishes its goals when, together with training medical courses, it guides students behavior towards morality so that ethics-oriented medical practice is internalized. Medical ethics is a branch of applied ethics which tries to introduce ethics into physicians’ practice and ethical decisions; thus, it necessitates the behavior to be ethical. Therefore, when students are being trained, they need to be supplied with those guidelines which turn ethical instructions into practice to the extent possible. The current text discusses the narrowing of the gap between ethical theory and practice, especially in the field of medical education. The current study was composed using analytical review procedures. Thus, classical ethics philosophy, psychology books, and related articles were used to select the relevant pieces of information about internalizing behavior and medical education. The aim of the present study was to propose a theory by analyzing the related articles and books. The attempt to fill the gap between medical theory and practice using external factors such as law has been faced with a great deal of limitations. Accordingly, the present article tries to investigate how and why medical training must take internalizing ethical instructions into consideration, and indicate the importance of influential internal factors. Virtue-centered education, education of moral emotions, changing and strengthening of attitudes through education, and the wise use of administrative regulations can be an effective way of teaching ethical practice in medicine. PMID:29282423

Developing an Ethical Framework for All Geoscientists: AGI Guidelines for Ethical Professional Conduct

NASA Astrophysics Data System (ADS)

Boland, Maeve A.; Leahy, P. Patrick; Keane, Christopher M.

2016-04-01

In 1997, a group of geoscientists and others recognized the need for a broad-based set of ethical standards for the geosciences that would be an expression of the highest common denominator of values for the profession. The American Geosciences Institute (AGI) coordinated the development of the 1999 AGI Guidelines for Ethical Professional Conduct and their subsequent revision in 2015. AGI is a nonprofit federation of 51 geoscientific and professional organizations that span the geosciences and have approximately 250,000 members. AGI serves as a voice for shared interests in the geoscience community and one of its roles is to facilitate collaboration and discussion among its member societies on matters of common or overarching concern. In this capacity, AGI convened a working group to create the 1999 Guidelines for Ethical Professional Conduct and a further working group to revise the Guidelines in 2015 through a consensus process involving all member societies. The Guidelines are an aspirational document, setting out ideals and high levels of achievement for the profession. They have no provision for disciplinary of enforcement action and they do not supersede the ethics statements or codes of any member society. The 1999 Guidelines pay considerable attention to the professional behavior of geoscientists. The 2015 Guidelines place greater emphasis on the societal context of the geosciences and the responsibilities of geoscientists in areas such as communication, education, and the challenges of understanding complex natural systems. The 2015 Guidelines have been endorsed by 29 member societies to date. To translate the aspirations in the Guidelines into specific actions, AGI has facilitated discussions on the practical implications of aspects of the Guidelines. One outcome of these discussions has been a Consensus Statement Regarding Access and Inclusion of Individuals Living with Disabilities in the Geosciences.

Systematic and transparent inclusion of ethical issues and recommendations in clinical practice guidelines: a six-step approach.

PubMed

Mertz, Marcel; Strech, Daniel

2014-12-04

Clinical practice guidelines (CPGs), a core tool to foster medical professionalism, differ widely in whether and how they address disease-specific ethical issues (DSEIs), and current manuals for CPG development are silent on this issue. The implementation of an explicit method faces two core challenges: first, it adds further complexity to CPG development and requires human and financial resources. Second, in contrast to the in-depth treatment of ethical issues that is standard in bioethics, the inclusion of DSEIs in CPGs need to be more pragmatic, reductive, and simplistic, but without rendering the resulting recommendations useless or insufficiently justified. This paper outlines a six-step approach, EthicsGuide, for the systematic and transparent inclusion of ethical issues and recommendations in CPGs. The development of EthicsGuide is based on (a) methodological standards in evidence-based CPG development, (b) principles of bioethics, (c) research findings on how DSEIs are currently addressed in CPGs, and (d) findings from two proof-of-concept analyses of the EthicsGuide approach. The six steps are 1) determine the DSEI spectrum and the need for ethical recommendations; 2) develop statements on which to base ethical recommendations; 3) categorize, classify, condense, and paraphrase the statements; 4) write recommendations in a standard form; 5) validate and justify recommendations, making any necessary modifications; and 6) address consent. All six steps necessarily come into play when including DSEIs in CPGs. If DSEIs are not explicitly addressed, they are unavoidably dealt with implicitly. We believe that as ethicists gain greater involvement in decision-making about health, personal rights, or economic issues, they should make their methods transparent and replicable by other researchers; and as ethical issues become more widely reflected in CPGs, CPG developers have to learn how to address them in a methodologically adequate way. The approach proposed should serve as a basis for further discussion on how to reach these goals. It breaks open the black box of what ethicists implicitly do when they develop recommendations. Further, interdisciplinary discussion and pilot tests are needed to explore the minimal requirements that guarantee a simplified procedure which is still acceptable and does not become mere window dressing.

Pacific Health Research Guidelines: The Cartography of an Ethical Relationship

ERIC Educational Resources Information Center

Mila-Schaaf, Karlo

2009-01-01

In 2004 the Health Research Council of New Zealand (HRC) published a set of "Guidelines on Pacific health research". The Guidelines were an attempt to articulate the features of ethical research relationships with Pacific peoples living in Aotearoa New Zealand. This article describes the process of developing these guidelines, using…

Volunteers in plastic surgery guidelines for providing surgical care for children in the less developed world: part II. Ethical considerations.

PubMed

Schneider, William J; Migliori, Mark R; Gosain, Arun K; Gregory, George; Flick, Randall

2011-09-01

Many international volunteer groups provide free reconstructive plastic surgery for the poor and underserved in developing countries. An essential issue in providing this care is that it meets consistent guidelines for both quality and safety-a topic that has been addressed previously. An equally important consideration is how to provide that care in an ethical manner. No literature presently addresses the various issues involved in making those decisions. With these ethical considerations in mind, the Volunteers in Plastic Surgery Committee of the American Society of Plastic Surgeons/Plastic Surgery Foundation undertook a project to create a comprehensive set of guidelines for volunteer groups planning to provide this type of reconstructive plastic surgery in developing countries. The committee worked in conjunction with the Society for Pediatric Anesthesia on this project. The Board of the American Society of Plastic Surgeons/Plastic Surgery Foundation has approved the ethical guidelines created for the delivery of care in developing countries. The guidelines address the variety of ethical decisions that may be faced by a team working in an underdeveloped country. These guidelines make it possible for a humanitarian effort to anticipate the types of ethical decisions that are often encountered and be prepared to deal with them appropriately. Any group seeking to undertake an international mission trip in plastic surgery should be able to go to one source to find a detailed discussion of the perceived needs in providing ethical humanitarian care. This document was created to satisfy that need and is a companion to our original guidelines addressing safety and quality.

Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

PubMed

Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

2008-08-01

To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits. However, in our clinical practice it is vital that clinical audits are undertaken for evaluation purposes. The findings of this study raise awareness of inconsistent ethical processes and highlight the need for expedient ethical review for clinical audits.

Ethics of clinical trials in Nigeria.

PubMed

Okonta, Patrick I

2014-05-01

The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

Ethics of clinical trials in Nigeria

PubMed Central

Okonta, Patrick I.

2014-01-01

The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria. PMID:25013247

Ethical Guidelines for Counselors when Working with Clients with Terminal Illness Requesting Physician Aid in Dying

ERIC Educational Resources Information Center

Kurt, Layla J.; Piazza, Nick J.

2012-01-01

In 2005, the American Counseling Association (ACA) introduced a new ethical standard for counselors working with clients with terminal illness who are considering hastened death options. The authors' purpose is to inform counselors of the Death With Dignity Act and explore relevant ethical guidelines in the "ACA Code of Ethics" (ACA, 2005).

[Ethics guidelines for the creation and use of registries for biomedical research purposes].

PubMed

Abajo Iglesias, Francisco J de; Feito Grande, Lydia; Júdez Gutiérrez, Javier; Martín Arribas, M Concepción; Terracini, Benedetto; Pàmpols Ros, Teresa; Campos Castelló, Jaime; Martín Uranga, Amelia; Abascal Alonso, Moisés; Herrera Carranza, Joaquín; Sánchez Martínez, María José

2008-01-01

The clinical information stored in registries and records of different types is a fundamental tool for biomedical research. Up until just a few years ago, hardly any limitations existed on the creation and use of epidemiological registries or the use of information from pre-existing records for research purposes. This situation has changed substantially due mainly to the growing importance current laws place upon the safeguarding of the privacy and confidentiality of personal data. Although the legal framework is already quite explicit, a certain degree of leeway exists for ethical debate and prudence advice for the purpose of conducting valid, useful research with this information which will also respect the rights of the subjects and the laws in force. These guidelines deal with those aspects which have been considered relevant from an ethical standpoint in the handling of records and registries for research-related purposes, including not only the use but also the creation proper of the registries. A total of twenty-four recommendations are provided, grouped into ten sections: warranting of the creation of registry, organization and definition of responsibilities, scientific validity of the research project, ethical requirements of the collections of anonymous and anonymized data, ethical requirements of the registries including personal data, uses of medical records for research purposes, use of historical records of deceased individuals, contact with the research subjects, notification of results and review by a Research Ethics Committee.

Justice in international clinical research.

PubMed

Pratt, Bridget; Loff, Bebe

2011-08-01

Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global justice. This paper argues that the conflation of debates about justice at the micro and macro-levels has not only resulted in the placement of obligations upon the wrong actors but has also served to exclude relevant actors from the ethical picture. Suggestions for who should properly bear macro-level obligations of justice in international clinical research are offered. The paper further contends that, unlike researchers who violate informed consent requirements, no similar type of accountability exists for obligations of global justice, even for those obligation-bearers (incorrectly) identified by current ethics guidelines. © 2010 Blackwell Publishing Ltd.

Authorship Concerns and Who Truly Owns a Research Idea?

PubMed

Syed, Sana; Tran, Duc Q; Kemper, Alex R; Geme, Joseph W St; Lantos, John D

2015-11-01

Researchers often face dilemmas about authorship. When the researchers are graduate students, fellows, or junior faculty, the dilemmas might involve discussions about fair criteria for more senior faculty to be acknowledged as key contributors or authors on manuscripts. This "Ethics Rounds" presents a case in which a fellow faced such a dilemma. We review current journal guidelines for authorship and some ethical considerations that should help make this process more streamlined. Copyright © 2015 by the American Academy of Pediatrics.

Between universalism and relativism: a conceptual exploration of problems in formulating and applying international biomedical ethical guidelines.

PubMed

Tangwa, G B

2004-02-01

In this paper, the author attempts to explore some of the problems connected with the formulation and application of international biomedical ethical guidelines, with particular reference to Africa. Recent attempts at revising and updating some international medical ethical guidelines have been bedevilled by intractable controversies and wrangling regarding both the content and formulation. From the vantage position of relative familiarity with both African and Western contexts, and the privilege of having been involved in the revision and updating of one of the international ethical guidelines, the author reflects broadly on these issues and attempts prescribing an approach from both the theoretical and practical angles liable to mitigate, if not completely eliminate, some of the problems and difficulties.

Primary care of adults with developmental disabilities

PubMed Central

Sullivan, William F.; Berg, Joseph M.; Bradley, Elspeth; Cheetham, Tom; Denton, Richard; Heng, John; Hennen, Brian; Joyce, David; Kelly, Maureen; Korossy, Marika; Lunsky, Yona; McMillan, Shirley

2011-01-01

Abstract Objective To update the 2006 Canadian guidelines for primary care of adults with developmental disabilities (DD) and to make practical recommendations based on current knowledge to address the particular health issues of adults with DD. Quality of evidence Knowledgeable health care providers participating in a colloquium and a subsequent working group discussed and agreed on revisions to the 2006 guidelines based on a comprehensive review of publications, feedback gained from users of the guidelines, and personal clinical experiences. Most of the available evidence in this area of care is from expert opinion or published consensus statements (level III). Main message Adults with DD have complex health issues, many of them differing from those of the general population. Good primary care identifies the particular health issues faced by adults with DD to improve their quality of life, to improve their access to health care, and to prevent suffering, morbidity, and premature death. These guidelines synthesize general, physical, behavioural, and mental health issues of adults with DD that primary care providers should be aware of, and they present recommendations for screening and management based on current knowledge that practitioners can apply. Because of interacting biologic, psychoaffective, and social factors that contribute to the health and well-being of adults with DD, these guidelines emphasize involving caregivers, adapting procedures when appropriate, and seeking input from a range of health professionals when available. Ethical care is also emphasized. The guidelines are formulated within an ethical framework that pays attention to issues such as informed consent and the assessment of health benefits in relation to risks of harm. Conclusion Implementation of the guidelines proposed here would improve the health of adults with DD and would minimize disparities in health and health care between adults with DD and those in the general population. PMID:21571716

Ethics as an Undergraduate Psychology Outcome: When, Where, and How to Teach It

ERIC Educational Resources Information Center

Ruiz, Ana; Warchal, Judith

2014-01-01

The American Psychological Association (APA) recently approved a new set of "Guidelines for the undergraduate psychology major, version 2.0" (APA, 2013a) which addressed ethics specifically. Yet the teaching of ethics receives little attention in publications, national and international institutes, and conferences. Few guidelines for…

Genetic Testing for Minors: Comparison between Italian and British Guidelines

PubMed Central

Tozzo, Pamela; Caenazzo, Luciana; Rodriguez, Daniele

2012-01-01

Genetic testing in children raises many important ethical, legal, and social issues. One of the main concerns is the ethically inappropriate genetic testing of minors. Various European countries established professional guidelines which reflect the different countries perspectives regarding the main ethical issues involved. In this paper, we analyze the Italian and the British guidelines by highlighting differences and similarities. We discuss presymptomatic, predictive, and carrier testing because we consider them to be the more ethically problematic types of genetic testing in minors. In our opinion, national guidelines should take into account the different needs in clinical practice. At the same time, in the case of genetic testing the national and supranational protection of minors could be strengthened by approving guidelines based on a common framework of principles and values. We suggest that the Oviedo Convention could represent an example of such a common framework or, at least, it could lead to articulate it. PMID:22567400

Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi.

PubMed

Mungwira, Randy G; Nyangulu, Wongani; Misiri, James; Iphani, Steven; Ng'ong'ola, Ruby; Chirambo, Chawanangwa M; Masiye, Francis; Mfutso-Bengo, Joseph

2015-12-02

This paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi. The current research ethics regulations and guidelines in Malawi do not allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes. In conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi.

Council for International Organizations of Medical Sciences (CIOMS) Ethical Guidelines: advancements and unsolved topics in 2016 upgrade.

PubMed

Borgeat Meza, Marjorie; Luengo-Charath, Ximena; Arancibia, Marcelo; Madrid, Eva

2018-04-25

In 2016, the new edition of the Council for International Organizations of Medical Sciences (CIOMS) Ethical Guidelines was released, which are universally acknowledged as ethical standards in biomedical research. In this article, we critically analyze the improvements and shortcomings of the CIOMS Ethical Guidelines 2016. Among the improvements are the relevance assigned to the social value of research and its effects on decision-making and the creation of public policies; the research development in low-resources scenarios; the communities’ involvement in the research process; the determination of participants’ vulnerability and changes on informed consent related proceedings. Despite the improved harmonization with scientific, technologic and social changes, and that the guidelines provide a tool for researchers and members of research ethics committees alike, some topics remain unsolved, namely the management of participants’ minimal risk and conflicts of interest involved in research, and the development of research in low-incomes scenarios. Nonetheless, we recognize that these new guidelines constitute a progress regarding the context and needs of populations in which research will be conducted, with greater community involvement in the different phases of the investigation project, thus allowing them to access the potential benefits. The impact of the CIOMS Ethical Guidelines 2016, should be appraised over time, particularly in socio-sanitary inequities scenarios and in the context of commercial interests of industry on biomedical research.

Mental health and psychosocial support in crisis and conflict: report of the Mental Health Working Group.

PubMed

Allden, K; Jones, L; Weissbecker, I; Wessells, M; Bolton, P; Betancourt, T S; Hijazi, Z; Galappatti, A; Yamout, R; Patel, P; Sumathipala, A

2009-01-01

The Working Group on Mental Health and Psychosocial Support was convened as part of the 2009 Harvard Humanitarian Action Summit. The Working Group chose to focus on ethical issues in mental health and psychosocial research and programming in humanitarian settings. The Working Group built on previous work and recommendations, such as the Inter-Agency Standing Committee's Guidelines on Mental Health and Psychosocial Support in Emergency Settings. The objective of this working group was to address one of the factors contributing to the deficiency of research and the need to develop the evidence base on mental health and psychosocial support interventions during complex emergencies by proposing ethical research guidelines. Outcomes research is vital for effective program development in emergency settings, but to date, no comprehensive ethical guidelines exist for guiding such research efforts. Working Group members conducted literature reviews which included peer-reviewed publications, agency reports, and relevant guidelines on the following topics: general ethical principles in research, cross-cultural issues, research in resource-poor countries, and specific populations such as trauma and torture survivors, refugees, minorities, children and youth, and the mentally ill. Working Group members also shared key points regarding ethical issues encountered in their own research and fieldwork. The group adapted a broad definition of the term "research", which encompasses needs assessments and data gathering, as well as monitoring and evaluation. The guidelines are conceptualized as applying to formal and informal processes of assessment and evaluation in which researchers as well as most service providers engage. The group reached consensus that it would be unethical not to conduct research and evaluate outcomes of mental health and psychosocial interventions in emergency settings, given that there currently is very little good evidence base for such interventions. Overarching themes and issues generated by the group for further study and articulation included: purpose and benefits of research, issues of validity, neutrality, risk, subject selection and participation, confidentiality, consent, and dissemination of results. The group outlined several key topics and recommendations that address ethical issues in conducting mental health and psychosocial research in humanitarian settings. The group views this set of recommendations as a living document to be further developed and refined based on input from colleagues representing different regions of the globe with an emphasis on input from colleagues from low-resource countries.

Challenges in the research ethics review of cluster randomized trials: international survey of investigators.

PubMed

Chaudhry, Shazia H; Brehaut, Jamie C; Grimshaw, Jeremy M; Weijer, Charles; Boruch, Robert; Donner, Allan; Eccles, Martin P; McRae, Andrew D; Saginur, Raphael; Skea, Zoë C; Zwarenstein, Merrick; Taljaard, Monica

2013-04-01

Cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines for several reasons. For one, the units of allocation, intervention, and observation often may differ within a single trial. In the absence of tailored and internationally accepted ethics guidelines for CRTs, researchers and research ethics committees have no common standard by which to judge ethically appropriate practices in CRTs. Moreover, lack of familiarity with and consideration of the unique features of the CRT design by research ethics committees may cause difficulties in the research ethics review process, and amplify problems such as variability in the requirements and decisions reached by different research ethics committees. We aimed to characterize research ethics review of CRTs, examine investigator experiences with the ethics review process, and assess the need for ethics guidelines for CRTs. An electronic search strategy implemented in MEDLINE was used to identify and randomly sample 300 CRTs published in English language journals from 2000 to 2008. A web-based survey with closed- and open-ended questions was administered to corresponding authors in a series of six contacts. The survey response rate was 64%. Among 182 of 285 eligible respondents, 91% indicated that they had sought research ethics approval for the identified CRT, although only 70% respondents reported research ethics approval in the published article. Nearly one-third (31%) indicated that they have had to meet with ethics committees to explain aspects of their trials, nearly half (46%) experienced variability in the ethics review process in multijurisdictional trials, and 38% experienced negative impacts of the ethics review process on their trials, including delays in trial initiation (28%), increased costs (10%), compromised ability to recruit participants (16%), and compromised methodological quality (9%). Most respondents (74%; 95% confidence interval (CI): 67%-80%) agreed or strongly agreed that there is a need to develop ethics guidelines for CRTs, and (70%; 95% CI: 63%-77%) that ethics committees could be better informed about distinct ethical issues surrounding CRTs. Thirty-six percent of authors did not respond to the survey. Due to the absence of comparable results from a representative sample of authors of individually randomized trials, it is unclear to what extent the reported challenges result from the CRT design. CRT investigators are experiencing challenges in the research ethics review of their trials, including excessive delays, variability in process and outcome, and imposed requirements that can have negative consequences for study conduct. Investigators identified a clear need for ethics guidelines for CRTs and education of research ethics committees about distinct ethical issues in CRTs.

[Ethical guidelines on genetic testing and gene therapy].

PubMed

Fukushima, Yoshimitsu

2005-03-01

According to the recent and rapid advances in molecular genetics research, genetic testing and gene therapy have a potential of giving unexpected influence to the human beings. To prevent and to solve various ethical, legal and social implementations (ELSI) of genetic testing and gene therapy, several guidelines have been established. In Japan, all researchers and all clinicians have to know and keep the following three guidelines on genetic testing and a guideline on gene therapy: 1) "Guidelines for Researches on Human Genome and Gene (2001)" by the three Ministries (Education, Health and Economy), 2) "Guidelines for Genetic Testing (2001)" by the Genetic--medicine--related 10 societies, 3) "Ethical Principles on Entrusted Genetic Testing (2001)" by the Japan Registered Clinical Laboratories Association, and 4) "Guidelines for Clinical Research on Gene Therapy (2002)" by the two Ministries (Health and Education).

75 FR 27387 - Sentencing Guidelines for United States Courts

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-14

... Practice and Procedure 4.1. William K. Sessions III, Chair. 1. Amendment: Chapter Five, Part A, is amended... scholarly literature, current federal and state practices, and feedback in various forms from federal judges... to prevent further similar criminal conduct, including assessing the compliance and ethics program...

Surgical “Placebo” Controls

PubMed Central

Tenery, Robert; Rakatansky, Herbert; Riddick, Frank A.; Goldrich, Michael S.; Morse, Leonard J.; O’Bannon, John M.; Ray, Priscilla; Smalley, Sherie; Weiss, Matthew; Kao, Audiey; Morin, Karine; Maixner, Andrew; Seiden, Sam

2002-01-01

Objective To set ethical guidelines on the use of surgical placebo controls in the design of surgical trials. Background Data Ethical concerns recently arose from surgical trials where subjects in the control arm underwent surgical procedures that had the appearance of a therapeutic intervention, but during which the essential therapeutic maneuver was omitted. Although there are ethical guidelines on the use of a placebo in drug trials, little attention has been paid to the use of a surgical placebo control in surgical trials. Methods The Council on Ethical and Judicial Affairs developed ethical guidelines based on a wide literature search and consultation with experts. Results Surgical placebo controls should be limited to studies of new surgical procedures aimed at treating diseases that are not amenable to other surgical therapies, and are reasonably anticipated to be susceptible to substantial placebo effects. If the standard nonsurgical treatment is efficacious and acceptable to the patient, then it must be offered as part of the study design. Conclusions Surgical placebo controls should be used only when no other trial design will yield the requisite data and should always be accompanied by a rigorous informed consent process and a careful consideration of the related risks and benefits. The recommended ethical guidelines were adopted as AMA ethics policy and are now incorporated in the AMA’s Code of Medical Ethics. PMID:11807373

Ethics Guidelines in Environmental Epidemiology: Their Development and Challenges We Face.

PubMed

Kramer, Shira; Soskolne, Colin L

2017-06-01

This review integrates historical developments and key events in bringing ethics into epidemiology in general and into environmental epidemiology in particular. The goal is to provide context for and discern among the various approaches and motivations that drive the need for ethical conduct in support of the public interest. The need for ethics guidelines in epidemiology is different from developments in other biomedical-related fields by virtue of its focus on populations rather than on individuals. The need for ethics guidelines in environmental epidemiology as a subspecialty of epidemiology stems from the larger scale of its mission than that of epidemiology per se. Ethics guidelines in the field of environmental epidemiology have been established. They articulate not only the profession's core values and mission, but more specifically, they address the environmental epidemiologist's obligations to the participants in research, to colleagues, and to employers. They are the product of consensus, scholarship, and diligent stewardship over several decades. The next challenge is ensuring their value and impact. The forces that support professional and institutional success, and the power of special interests, are the major threats to achieving the goals of ethical conduct and research for the public good. In environmental epidemiology, these threats have global implications.

Between universalism and relativism: a conceptual exploration of problems in formulating and applying international biomedical ethical guidelines

PubMed Central

Tangwa, G

2004-01-01

In this paper, the author attempts to explore some of the problems connected with the formulation and application of international biomedical ethical guidelines, with particular reference to Africa. Recent attempts at revising and updating some international medical ethical guidelines have been bedevilled by intractable controversies and wrangling regarding both the content and formulation. From the vantage position of relative familiarity with both African and Western contexts, and the privilege of having been involved in the revision and updating of one of the international ethical guidelines, the author reflects broadly on these issues and attempts prescribing an approach from both the theoretical and practical angles liable to mitigate, if not completely eliminate, some of the problems and difficulties. PMID:14872078

End-of-life care policy: An integrated care plan for the dying

PubMed Central

Myatra, Sheila Nainan; Salins, Naveen; Iyer, Shivakumar; Macaden, Stanley C.; Divatia, Jigeeshu V.; Muckaden, Maryann; Kulkarni, Priyadarshini; Simha, Srinagesh; Mani, Raj Kumar

2014-01-01

Purpose: The purpose was to develop an end-of-life care (EOLC) policy for patients who are dying with an advanced life limiting illness and to develop practical procedural guidelines for limiting inappropriate therapeutic medical interventions and improve the quality of care of the dying within an ethical framework and through a professional and family/patient consensus process. Evidence: The Indian Society of Critical Care Medicine (ISCCM) published its first guidelines on EOLC in 2005 [1] which was later revised in 2012.[2] Since these publications, there has been an exponential increase in empirical information and discussion on the subject. The literature reviewed observational studies, surveys, randomized controlled studies, as well as guidelines and recommendations, for education and quality improvement published across the world. The search terms were: EOLC; do not resuscitate directives; withdrawal and withholding; intensive care; terminal care; medical futility; ethical issues; palliative care; EOLC in India; cultural variations. Indian Association of Palliative Care (IAPC) also recently published its consensus position statement on EOLC policy for the dying.[3] Method: An expert committee of members of the ISCCM and IAPC was formed to make a joint EOLC policy for the dying patients. Proposals from the chair were discussed, debated, and recommendations were formulated through a consensus process. The members extensively reviewed national and international established ethical principles and current procedural practices. This joint EOLC policy has incorporated the sociocultural, ethical, and legal perspectives, while taking into account the needs and situation unique to India. PMID:25249748

Guidelines for the Selection of Topical Content in ESL Programs

ERIC Educational Resources Information Center

Deckert, Glenn

2004-01-01

The author contends that the topical content of ESL lesson materials in schools and universities is of ethical significance. Based on an established model for ethical judgment in social services, five guidelines for ethical selection of lesson topics are proposed and illustrated. Lesson topics must help ESL students: (a) adjust to local…

A review of improved ethical practices in environmental and public health research: case examples from native communities.

PubMed

Quigley, Dianne

2006-04-01

This article presents a review of 14 case studies and articles of research ethics issues in the conduct of environmental and public health research with Native American and other indigenous populations. The purpose of this review is to highlight new practices in the ethical conduct of research with native community populations. The findings from this review can promote more dialogue and policy development on the issue of community protections in research. Formal guidelines exist in ethical codes for individual rights as human subjects, but there is a lack of development on community rights in the ethics of research. This review illustrates how community-based participatory research practices can provide working guidelines that can overcome past research harms. More important, the compilations of guidelines offer tested field methods for improving the ethical conduct of research with native community populations.

Legal and ethical issues in research.

PubMed

Yip, Camille; Han, Nian-Lin Reena; Sng, Ban Leong

2016-09-01

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees.

Career Counseling and the Information Highway: Heeding the Road Signs.

ERIC Educational Resources Information Center

O'Halloran, Theresa M.; Fahr, Alicia V.; Keller, Jenny R.

2002-01-01

Traveling the "information highway" in the process of career counseling or providing career counseling services via the Internet pose additional challenges for counselors. The authors use current ethical guidelines to guide discussion of, and possible resolutions to, challenges posed by incorporating the Internet into career counseling. (Contains…

The Vulnerability of Study Participants in the Context of Transnational Biomedical Research: From Conceptual Considerations to Practical Implications.

PubMed

Orth, Helen Grete; Schicktanz, Silke

2017-08-01

Outsourcing clinical trials sponsored by pharmaceutical companies from industrialized countries to low- (middle)-income countries - summarized as transnational biomedical research (TBR) - has lead to many concerns about ethical standards. Whether study participants are particularly vulnerable is one of those concerns. However, the concept of vulnerability is still vague and varies in its definition. Despite the fact that important international ethical guidelines such as the Declaration of Helsinki by the World Medical Association or the Ethical Guidelines for Biomedical Research Involving Human Subjects by the Council of International Organizations of Medical Sciences refer to vulnerability as ethical principle, each of their approaches are different. To overcome these shortcomings, we analyze and unite different approaches of vulnerability and develop practical criteria in order to operationalize the concept especially for the context of TBR. These criteria refer to the context of a study as well as the characteristics and the current living situation of study participants. Based on a case study of an HIV-vaccine-trial conducted in India we demonstrate how those criteria can be applied in a retrospective way to identify potential ethical conflicts. The criteria can also indicate a prospective function for ethical pre-assessment. For this, we provide an outlook for three major topics: 1. Vulnerability as a normative concept: Different ways of protection; 2. The relevance of transparency and 3. Vulnerability as an instrument to increase decision participation of human subjects. © 2016 John Wiley & Sons Ltd.

The ethical implications of genetic testing in the classroom.

PubMed

Taylor, Ann T S; Rogers, Jill Cellars

2011-07-01

The development of classroom experiments where students examine their own DNA is frequently described as an innovative teaching practice. Often these experiences involve students analyzing their genes for various polymorphisms associated with disease states, like an increased risk for developing cancer. Such experiments can muddy the distinction between classroom investigation and medical testing. Although the goals and issues surrounding classroom genotyping do not directly align with those of clinical testing, instructors can use the guidelines and standards established by the medical genetics community when evaluating the ethics of human genotyping. We developed a laboratory investigation and discussion which allowed undergraduate science students to explore current DNA manipulation techniques to isolate their p53 gene, followed by a dialogue probing the ethical implications of examining their sample for various polymorphisms. Students never conducted genotyping on their samples because of the ethical concerns presented in this paper, so the discussion replaced the actual genetic testing in the class. A science faculty member led the laboratory portion, while a genetic counselor facilitated the discussion of the ethical concepts underlying genetic counseling: autonomy, beneficence, confidentiality, and justice. In their final papers, students demonstrated an understanding of the practice guidelines established by the genetics community and acknowledged the ethical considerations inherent in p53 genotyping. Given the burgeoning market for personalized medicine, teaching undergraduates about the psychosocial and ethical dimensions of human genetic testing is important and timely. Moreover, incorporating a genetic counselor in the classroom discussion provided a rich and dynamic discussion of human genetic testing. Copyright © 2011 Wiley Periodicals, Inc.

Medical Education and the Pharmaceutical Industry: A Review of Ethical Guidelines and Their Implications for Psychiatric Training

ERIC Educational Resources Information Center

Geppert, Cynthia M. A.

2007-01-01

Objective: This article reviews and summarizes eight ethical guidelines of major professional organizations regarding the pharmaceutical industry's role in the psychiatric education of trainees. Method: The author conducted a literature review of research and guidelines pertaining to the pharmaceutical industry's relationship to trainees, with…

Current state of ethics literature synthesis: a systematic review of reviews.

PubMed

Mertz, Marcel; Kahrass, Hannes; Strech, Daniel

2016-10-03

Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical considerations. Manuals for clinical guideline development or health technology assessment (HTA) do not explain how to search, analyze, and synthesize relevant normative information in a systematic and transparent manner. In the scientific literature, however, systematic or semi-systematic reviews of ethics literature already exist, and scholarly debate on their opportunities and limitations has recently bloomed. A systematic review was performed of all existing systematic or semi-systematic reviews for normative ethics literature on medical topics. The study further assessed how these reviews report on their methods for search, selection, analysis, and synthesis of ethics literature. We identified 84 reviews published between 1997 and 2015 in 65 different journals and demonstrated an increasing publication rate for this type of review. While most reviews reported on different aspects of search and selection methods, reporting was much less explicit for aspects of analysis and synthesis methods: 31 % did not fulfill any criteria related to the reporting of analysis methods; for example, only 25 % of the reviews reported the ethical approach needed to analyze and synthesize normative information. While reviews of ethics literature are increasingly published, their reporting quality for analysis and synthesis of normative information should be improved. Guiding questions are: What was the applied ethical approach and technical procedure for identifying and extracting the relevant normative information units? What method and procedure was employed for synthesizing normative information? Experts and stakeholders from bioethics, HTA, guideline development, health care professionals, and patient organizations should work together to further develop this area of evidence-based health care.

Ethical publishing in intensive care medicine: A narrative review

PubMed Central

Wiedermann, Christian J

2016-01-01

Ethical standards in the context of scientific publications are increasingly gaining attention. A narrative review of the literature concerning publication ethics was conducted as found in PubMed, Google Scholar, relevant news articles, position papers, websites and other sources. The Committee on Publication Ethics has produced guidelines and schedules for the handling of problem situations that have been adopted by professional journals and publishers worldwide as guidelines to authors. The defined requirements go beyond the disclosure of conflicts of interest or the prior registration of clinical trials. Recommendations to authors, editors and publishers of journals and research institutions were formulated with regard to issues of authorship, double publications, plagiarism, and conflicts of interest, with special attention being paid to unethical research behavior and data falsification. This narrative review focusses on ethical publishing in intensive care medicine. As scientific misconduct with data falsification damage patients and society, especially if fraudulent studies are considered important or favor certain therapies and downplay their side effects, it is important to ensure that only studies are published that have been carried out with highest integrity according to predefined criteria. For that also the peer review process has to be conducted in accordance with the highest possible scientific standards and making use of available modern information technology. The review provides the current state of recommendations that are considered to be most relevant particularly in the field of intensive care medicine. PMID:27652208

The human rights context for ethical requirements for involving people with intellectual disability in medical research.

PubMed

Iacono, T; Carling-Jenkins, R

2012-11-01

The history of ethical guidelines addresses protection of human rights in the face of violations. Examples of such violations in research involving people with intellectual disabilities (ID) abound. We explore this history in an effort to understand the apparently stringent criteria for the inclusion of people with ID in research, and differences between medical and other research within a single jurisdiction. The history of the Helsinki Declaration and informed consent within medical research, and high-profile examples of ethical misconduct involving people with ID and other groups are reviewed. The UN Convention on the Rights of Persons with Disabilities is then examined for its research implications. This background is used to examine a current anomaly within an Australian context for the inclusion of people with ID without decisional capacity in medical versus other types of research. Ethical guidelines have often failed to protect the human rights of people with ID and other vulnerable groups. Contrasting requirements within an Australian jurisdiction for medical and other research would seem to have originated in early deference to medical authority for making decisions on behalf of patients. Stringent ethical requirements are likely to continue to challenge researchers in ID. A human rights perspective provides a framework for engaging both researchers and vulnerable participant groups. © 2012 The Authors. Journal of Intellectual Disability Research © 2012 Blackwell Publishing Ltd.

Forthcoming ethical issues in biological psychiatry.

PubMed

Helmchen, Hanfried

2005-01-01

Ethical issues in biological psychiatry are framed by (i) progress in the neurosciences, and (ii) a changing socio-cultural context. With regard to forthcoming neurotechniques to modify specifically defined brain functions by pharmacological substances with selective effects, by activating neuroplasticity including neurogenesis, or by implantation of neuronal tissues or computer-brain interfaces, etc., ethical problems will develop (i) at the border between therapy of diseases and enhancement of abilities in healthy people with regard to effects on society (e.g., social justice: equal access, loss of societal diversity) as well as on human value systems (e.g., personality, efforts, conditio humana), and (ii) at the border between the medical system and the wellness market with regard to financing what by whom? Ethical dilemmas in psychiatry develop (i) between the individual's best and the common good (demanded from outside medicine), (ii) among different ethical principles (inside medicine), iii) if solutions are influenced by personal reasons without observing ethical principles. Ethical guidelines are necessary for ethical orientation, but may protect against misconduct only (i) if psychiatrists are educated in ethics and (ii) if psychiatric acting is under continuous debate (by ethical review boards or the public). Thus, if we psychiatrists will become ethically sensitive by reflecting and perhaps solving our current ethical dilemmas we will be prepared to deal with forthcoming ethical issues in biological psychiatry.

Bioethics for human geneticists: models for reasoning and methods for teaching.

PubMed Central

Parker, L. S.

1994-01-01

The ethical issues raised by the Human Genome Project (HGP) and by human genetics in general are not entirely novel. In fact, the ethical issues surrounding genetic research and the provision of genetic services fit into the evolution of bioethics, a field of inquiry which has its roots in concerns of the 1970s, concerns about the dignity and self-determination of individuals and about the development of medical technologies. Although bioethics has been largely occupied with patient-centered concerns, attention is currently shifting toward socially oriented issues, such as the justice of the existing health-care system. Genetic counseling has already incorporated many of the lessons of early bioethics and, as a profession, adheres to a consultand-centered ethic which reflects the values incorporated into the doctrine of informed consent, which is a cornerstone of bioethics. The mandate of the Ethical, Legal, and Social Implications Program of the HGP--to anticipate ethical problems arising from advances in genetics and to educate the public about genetics--reflects not only the nonpaternalistic approach of early bioethics but also bioethics' increasing attention to the ethical import of systemic and institutional factors, as well as an anticipatory and preventive approach to dealing with ethical concerns. Because bioethics has so much to contribute to current consideration of ethical issues in human genetics, it is important to provide training in ethics to those working in the field. Guidelines for using a case-oriented approach are suggested. PMID:8279464

What Should I Do?

ERIC Educational Resources Information Center

Shelton, Charles

1993-01-01

Suggests that codes of ethics developed by educators and youth ministers can provide guidelines for dealing with social and personal dilemmas. Offers basic ethical guidelines for youth workers and suggests ways of implementing the principles in action. (MAB)

Proposed ethical guidelines and legislative framework for permitting gestational surrogacy in Singapore.

PubMed

Heng, Boon Chin

2007-09-01

Gestational surrogacy is currently banned in Singapore but is much debated. Some ethical guidelines and legislation for permitting gestational surrogacy in Singapore are proposed and discussed including: (i) review and approval of gestational surrogacy by the Ministry of Health on a case-by-case basis; (ii) stringent guidelines for gonadotrophin stimulation, IVF and ICSI procedures in 'traditional' surrogacy; (iii) restriction of gestational surrogates to parous married women with stable family relationships; (iv) exclusion of foreign women from acting as gestational surrogates, except for close relatives of the recipient couple; (v) reimbursement and/or compensation of gestational surrogates based on the direct expenses model; (vi) exclusion of medical professionals from surrogate recruitment and reimbursement; (vii) the surrogacy contract must make it legally binding for the prospective recipient couple to accept the child, even if it is born with congenital deformities; (viii) stringent guidelines for combining surrogacy with egg donation from a third woman, who is neither the social nor gestational mother. Policymakers in Singapore should conduct a public referendum on the legalization of gestational surrogacy and actively consult the views of healthcare professionals, religious and community leaders, as well as the general public, before reaching any decision.

Summary of the British Transplantation Society UK Guidelines for Living Donor Liver Transplantation.

PubMed

Manas, Derek; Burnapp, Lisa; Andrews, Peter Antony

2016-06-01

The British Transplantation Society Guidelines for Living Donor Liver Transplantation was published in July 2015 and is the first national guideline in the field of living donor liver transplantation. The guideline aims to review the evidence relating to the evaluation process of both recipient and donor candidates; address the moral and ethical issues surrounding the procedure; outline the technical aspects of the procedure, including the middle hepatic vein controversy and the "small for size syndrome"; review donor and recipient outcomes and complications including donor mortality; and examine evidence relating to the advantages and disadvantages of living donor liver transplantation. In line with previous guidelines published by the BTS, the guideline has used the Grading of Recommendations Assessment, Development and Evaluation system to rate the strength of evidence and recommendations. This article summarizes the Statements of Recommendation contained in the guideline, which provide a framework for the delivery of living liver donation in the United Kingdom and may be of wide international interest. It is recommended that the full guideline document is consulted for details of the relevant references and evidence base. This may be accessed at http://www.bts.org.uk/BTS/Guidelines_Standards/Current/BTS/Guidelines_Standards/Current_Guidelines.aspx?hkey=e285ca32-5920-4613-ac08-fa9fd90915b5.

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.

The full spectrum of ethical issues in dementia care: systematic qualitative review.

PubMed

Strech, Daniel; Mertz, Marcel; Knüppel, Hannes; Neitzke, Gerald; Schmidhuber, Martina

2013-06-01

Integrating ethical issues in dementia-specific training material, clinical guidelines and national strategy plans requires an unbiased awareness of all the relevant ethical issues. To determine systematically and transparently the full spectrum of ethical issues in clinical dementia care. We conducted a systematic review in Medline (restricted to English and German literature published between 2000 and 2011) and Google books (with no restrictions). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in clinical dementia care. The literature review retrieved 92 references that together mentioned a spectrum of 56 ethical issues in clinical dementia care. The spectrum was structured into seven major categories that consist of first- and second-order categories for ethical issues. The systematically derived spectrum of ethical issues in clinical dementia care presented in this paper can be used as training material for healthcare professionals, students and the public for raising awareness and understanding of the complexity of ethical issues in dementia care. It can also be used to identify ethical issues that should be addressed in dementia-specific training programmes, national strategy plans and clinical practice guidelines. Further research should evaluate whether this new genre of systematic reviews can be applied to the identification of ethical issues in other cognitive and somatic diseases. Also, the practical challenges in addressing ethical issues in training material, guidelines and policies need to be evaluated.

Ancillary Care in South African HIV Vaccine Trials: Addressing Needs, Drafting Protocols, and Engaging Community

PubMed Central

Slack, Catherine M.

2014-01-01

There has been debate about sponsor-investigator ethical responsibilities to address participants’ medical needs in trials in resource-constrained contexts. Certain ethical guidelines make detailed recommendations. This study explored whether ethical guideline recommendations for care in HIV vaccine trials were being met, and whether stakeholders were facing difficulties addressed by guidelines. It sampled key stakeholders involved in two trials across five sites in South Africa, and reviewed relevant documentation. It concluded that sites were largely meeting guideline recommendations for addressing needs, with some exceeding these. Recommendations for writing protocols were only partially achieved. Recommendations for engaging participating community were mostly met, except for “moral negotiation” recommendations. Suggestions are made to strengthen practices, and to improve guidelines so they address empirical concerns. PMID:24572086

Revised CIOMS research ethics guidance: on the importance of process for credibility.

PubMed

Schuklenk, Udo

2017-01-01

This paper reviews the 2016 CIOMS International Ethical Guidelines for Health-related Research Involving Humans. I argue that these new guidelines constitute a significant improvement over the guidelines they replace. However, the procedures put in place by CIOMS resulted in an authoring group consisting of a majority of authors and advisors hailing from the global North, while the guidelines squarely aim at influencing policies in the global South. I question CIOMS' strategy to produce a consensus based document, and raise concerns about frequent appeals to authority designed to establish the credibility of these guidelines and the processes that led to them. It is unclear why it should be the role of a small organisation such as CIOMS to try to guide the research ethics policies in countries of the global South.

Ancillary care in South African HIV vaccine trials: addressing needs, drafting protocols, and engaging community.

PubMed

Slack, Catherine M

2014-02-01

There has been debate about sponsor-investigator ethical responsibilities to address participants' medical needs in trials in resource-constrained contexts. Certain ethical guidelines make detailed recommendations. This study explored whether ethical guideline recommendations for care in HIV vaccine trials were being met, and whether stakeholders were facing difficulties addressed by guidelines. It sampled key stakeholders involved in two trials across five sites in South Africa, and reviewed relevant documentation. It concluded that sites were largely meeting guideline recommendations for addressing needs, with some exceeding these. Recommendations for writing protocols were only partially achieved. Recommendations for engaging participating community were mostly met, except for "moral negotiation" recommendations. Suggestions are made to strengthen practices, and to improve guidelines so they address empirical concerns.

Best Practice Guidelines on Publication Ethics: a Publisher's Perspective

PubMed Central

Graf, Chris; Wager, Elizabeth; Bowman, Alyson; Fiack, Suzan; Scott-Lichter, Diane; Robinson, Andrew

2007-01-01

These Best Practice Guidelines on Publication Ethics describe Blackwell Publishing's position on the major ethical principles of academic publishing and review factors that may foster ethical behavior or create problems. The aims are to encourage discussion, to initiate changes where they are needed, and to provide practical guidance, in the form of Best Practice statements, to inform these changes. Blackwell Publishing recommends that editors adapt and adopt the suggestions outlined to best fit the needs of their own particular publishing environment. PMID:17206953

Best Practice Guidelines on Publication Ethics: a publisher's perspective.

PubMed

Graf, Chris; Wager, Elizabeth; Bowman, Alyson; Fiack, Suzan; Scott-Lichter, Diane; Robinson, Andrew

2007-01-01

These Best Practice Guidelines on Publication Ethics describe Blackwell Publishing's position on the major ethical principles of academic publishing and review factors that may foster ethical behavior or create problems. The aims are to encourage discussion, to initiate changes where they are needed, and to provide practical guidance, in the form of Best Practice statements, to inform these changes. Blackwell Publishing recommends that editors adapt and adopt the suggestions outlined to best fit the needs of their own particular publishing environment.

Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

PubMed

Dawson, Liza; Zwerski, Sheryl

2015-06-01

This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

Professional Ethics in Astronomy: The AAS Ethics Statement

NASA Astrophysics Data System (ADS)

Marvel, Kevin B.

2013-01-01

It is fundamental to the advancement of science that practicing scientists adhere to a consistent set of professional ethical principles. Recent violations of these principles have led a decreased trust in the process of science and scientific results. Although astronomy is less in the spotlight on these issues than medical science or climate change research, it is still incumbent on the field to follow sound scientific process guided by basic ethical guidelines. The American Astronomical Society, developed a set of such guidelines in 2010. This contribution summarizes the motivation and process by which the AAS Ethics Statement was produced.

Drug regulators and ethics: which GCP issues are also ethical issues?

PubMed

Bernabe, Rosemarie D L C; van Thiel, Ghislaine J M W; Breekveldt, Nancy S; van Delden, Johannes J M

2016-02-01

Within the European Union (EU), good clinical practice (GCP) provides an ethical mandate to regulators; however, it is unclear what the content of that mandate is. By looking at the correspondence between GCP and ethical imperatives, we identify that the mandate is within the following: principles; benefit-risk ratio; scientific validity; results publication; informed consent; respect for participants; and special populations. There are also cases when regulations were ethical but were not pairable to an imperative, and when the former were stricter than the latter. Hence, we suggest closer cooperation between ethics committees and regulators to ensure that future versions of ethics guidelines cover the ethically relevant regulations that were not directly pairable to any imperative, and cooperation between GCP legislative bodies and ethics guideline-making bodies to resolve the discordant areas. Copyright © 2015 Elsevier Ltd. All rights reserved.

Research Ethics Review and Aboriginal Community Values: Can the Two be Reconciled?

PubMed

Glass, Kathleen Cranley; Kaufert, Joseph

2007-06-01

CONTEMPORARY RESEARCH ETHICS REVIEW COMMITTEES (RECs) are heavily influenced by the established academic or health care institutional frameworks in which they operate, sharing a cultural, methodological and ethical perspective on the conduct of research involving humans. The principle of autonomous choice carries great weight in what is a highly individualistic decision-making process in medical practice and research. This assumes that the best protection lies in the ability of patients or research participants to make competent, voluntary, informed choices, evaluating the risks and benefits from a personal perspective. Over the past two decades, North American and international indigenous researchers, policy makers and communities have identified key issues of relevance to them, but ignored by most institutional or university-based RECs. They critique the current research review structure, and propose changes on a variety of levels in an attempt to develop more community sensitive research ethics review processes. In doing so, they have emphasized recognition of collective rights including community consent. Critics see alternative policy guidelines and community-based review bodies as challenging the current system of ethics review. Some view them as reflecting a fundamental difference in values. In this paper, we explore these developments in the context of the political, legal and ethical frameworks that have informed REC review. We examine the process and content of these frameworks and ask how this contrasts with emerging Aboriginal proposals for community-based research ethics review. We follow this with recommendations on how current REC review models might accommodate the requirements of both communities and RECs.

Legal and ethical issues in research

PubMed Central

Yip, Camille; Han, Nian-Lin Reena; Sng, Ban Leong

2016-01-01

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees. PMID:27729698

Psychiatry and online social media: potential, pitfalls and ethical guidelines for psychiatrists and trainees.

PubMed

Frankish, Katherine; Ryan, Christopher; Harris, Anthony

2012-06-01

This paper proposes ethical guidelines for psychiatrists and psychiatry trainees when interacting with social media. A three-stage process was followed in the development of these guidelines. A literature review provided situations and possible broad rules as to how social media could be ethically engaged. A roundtable discussion by a panel of invited psychiatrists, psychiatry trainees, psychologists, e-health practitioners, lawyers and consumers was held to discuss the situations and to better formulate the ethical principles upon which psychiatrists could act. These vignettes and principles were then broadly discussed at a seminar held at the 2011 RANZCP Congress. Finally, this paper was circulated to the original invitees for final comment. A set of recommendations for working with social media were developed. The new social media provides important avenues for communication, education and treatment. These avenues pose ethical and practical dilemmas that can be resolved by the application of established ethical principles. Practical recommendations for navigating social media are proposed.

The Virtue of Principle Ethics.

ERIC Educational Resources Information Center

Bersoff, Donald N.

1996-01-01

Presents arguments against adopting virtue ethics as a guiding concept in developing counseling guidelines: (1) virtue ethics is irrelevant in the resolution of most ethics cases; (2) virtue and principle ethics overlap; (3) principle ethics are more suited to acting and deciding; (4) the emphasis on virtue ethics increases the possibility of…

An unexplored ethical issue in clinical research: disclosure of individual findings in the Creando Posibilidades [Creating Possibilities] study.

PubMed

Stein, Karen Farchaus; Keller, Colleen; Fishstrom, Astrid

2013-06-01

Individual disclosure refers to the presumptive ethical responsibility of an investigator to communicate to a study participant information that was collected as a part of a research study protocol and is specific to the individual. Currently, there are no federal regulatory guidelines specifying the conditions and management of disclosure of health-related individual-specific information. In this report, the authors discuss the challenges associated with individual disclosure in the context of a longitudinal descriptive study. Arguments favoring disclosure and those challenging disclosure as a general ethical duty are presented. Finally, strategies for addressing individual disclosure are discussed using a research exemplar in which risk behaviors related to health outcomes were measured. Copyright © 2013 Wiley Periodicals, Inc.

Ethical Guidelines for Teaching Psychology at the Secondary School Level. High School Psychology Teacher: Volume 9, Number 3, January 1979.

ERIC Educational Resources Information Center

American Psychological Association, Washington, DC. Clearinghouse on Precollege Psychology.

Approved by the American Psychological Association (APA), these guidelines are designed to help high school psychology teachers make decisions relating to ethical problems in their classrooms. The guidelines cover three areas: the use of animals in school science behavior projects, the use of human participants in research or demonstrations…

Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries

PubMed Central

2014-01-01

Background Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs’ perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently. Methods A web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required (full, expedited, or no review) and the identification of research subjects at cluster and individual levels. Results A total of 189 (35%) of 542 chairs responded. Overall, 144 (84%, 95% CI 79 to 90%) agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 (92%, 95% CI 88 to 96%) agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement. Conclusions Research ethics committees identified a clear need for ethics guidelines for CRTs and education about distinct ethical issues in CRTs. There is disagreement among committees, even within the same countries, with respect to key questions in the ethics review of CRTs. This disagreement reflects variability of opinion and practices pointing toward possible gaps in knowledge, and supports the need for explicit guidelines for the ethical conduct and review of CRTs. PMID:24495542

Reporting transparency: making the ethical mandate explicit.

PubMed

Nicholls, Stuart G; Langan, Sinéad M; Benchimol, Eric I; Moher, David

2016-03-16

Improving the transparency and quality of reporting in biomedical research is considered ethically important; yet, this is often based on practical reasons such as the facilitation of peer review. Surprisingly, there has been little explicit discussion regarding the ethical obligations that underpin reporting guidelines. In this commentary, we suggest a number of ethical drivers for the improved reporting of research. These ethical drivers relate to researcher integrity as well as to the benefits derived from improved reporting such as the fair use of resources, minimizing risk of harms, and maximizing benefits. Despite their undoubted benefit to reporting completeness, questions remain regarding the extent to which reporting guidelines can influence processes beyond publication, including researcher integrity or the uptake of scientific research findings into policy or practice. Thus, we consider investigation on the effects of reporting guidelines an important step in providing evidence of their benefits.

Anticipating issues related to increasing preimplantation genetic diagnosis use: a research agenda.

PubMed

Klitzman, Robert; Appelbaum, Paul S; Chung, Wendy; Sauer, Mark

2008-01-01

Increasing use of preimplantation genetic diagnosis (PGD) poses numerous clinical, social, psychological, ethical, legal and policy dilemmas, many of which have received little attention. Patients and providers are now considering and using PGD for a widening array of genetic disorders, and patients may increasingly seek 'designer babies.' In the USA, although governmental oversight policies have been discussed, few specific guidelines exist. Hence, increasingly, patients and providers will face challenging ethical and policy questions of when and for whom to use PGD, and how it should be financed. These issues should be better clarified and addressed through collection of data concerning the current use of PGD in the USA, including factors involved in decision making about PGD use, as well as the education of the various communities that are, and should be, involved in its implementation. Improved understanding of these issues will ultimately enhance the development and implementation of future clinical guidelines and policies.

Expanding the Use of Continuous Sedation Until Death: Moving Beyond the Last Resort for the Terminally Ill.

PubMed

LiPuma, Samuel H; DeMarco, Joseph P

2015-01-01

As currently practiced, the use of continuous sedation until death (CSD) is controlled by clinicians in a way that may deny patients a key choice in controlling their dying process. Ethical guidelines from the American Medical Association and the American Academy of Pain Medicine describe CSD as a "last resort," and a position statement from the American Academy of Hospice and Palliative Medicine describe it as "an intervention reserved for extreme situations." Accordingly, patients must progress to unremitting pain and suffering and reach a last-resort stage before the option to pursue CSD is considered. Alternatively, we present and defend a new guideline in which decisionally capable, terminally ill patients who have a life expectancy of less than six months may request CSD before being subjected to the refractory suffering of a treatment of "last resort." Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

A living wage for research subjects.

PubMed

Phillips, Trisha B

2011-01-01

Offering cash payments to research subjects is a common recruiting method, but this practice continues to be controversial because of its potential to compromise the protection of human subjects. Federal regulations and guidelines currently allow researchers to pay subjects for participation, but they say very little about how much researchers can pay their subjects. This paper argues that the federal regulations and guidelines should implement a standard payment formula. It argues for a wage payment model, and critically examines three candidates for a base wage: the nonfarm production wage, the FLSA minimum wage, and a living wage. After showing that the nonfarm production wage is too high to satisfy ethical criteria, and the minimum wage is too low, this paper concludes that the wage payment model with a base wage equivalent to a living wage is the best candidate for a standard payment formula in human subjects research. © 2011 American Society of Law, Medicine & Ethics, Inc.

The concept of 'vulnerability' in research ethics: an in-depth analysis of policies and guidelines.

PubMed

Bracken-Roche, Dearbhail; Bell, Emily; Macdonald, Mary Ellen; Racine, Eric

2017-02-07

The concept of vulnerability has held a central place in research ethics guidance since its introduction in the United States Belmont Report in 1979. It signals mindfulness for researchers and research ethics boards to the possibility that some participants may be at higher risk of harm or wrong. Despite its important intended purpose and widespread use, there is considerable disagreement in the scholarly literature about the meaning and delineation of vulnerability, stemming from a perceived lack of guidance within research ethics standards. The aim of this study was to assess the concept of vulnerability as it is employed in major national and international research ethics policies and guidelines. We conducted an in-depth analysis of 11 (five national and six international) research ethics policies and guidelines, exploring their discussions of the definition, application, normative justification and implications of vulnerability. Few policies and guidelines explicitly defined vulnerability, instead relying on implicit assumptions and the delineation of vulnerable groups and sources of vulnerability. On the whole, we found considerable richness in the content on vulnerability across policies, but note that this relies heavily on the structure imposed on the data through our analysis. Our results underscore a need for policymakers to revisit the guidance on vulnerability in research ethics, and we propose that a process of stakeholder engagement would well-support this effort.

Incentives for Organ Donation: Proposed Standards for an Internationally Acceptable System

PubMed Central

2012-01-01

Incentives for organ donation, currently prohibited in most countries, may increase donation and save lives. Discussion of incentives has focused on two areas: (1) whether or not there are ethical principles that justify the current prohibition and (2) whether incentives would do more good than harm. We herein address the second concern and propose for discussion standards and guidelines for an acceptable system of incentives for donation. We believe that if systems based on these guidelines were developed, harms would be no greater than those to today’s conventional donors. Ultimately, until there are trials of incentives, the question of benefits and harms cannot be satisfactorily answered. PMID:22176925

Against the principle that the individual shall have priority over science.

PubMed

Helgesson, G; Eriksson, S

2008-01-01

This paper highlights a feature common to many ethical guidelines--namely, the idea that the interests of the individual shall always prevail over the interests of science and society. The paper presents how some major ethical guidelines treat the balancing of research interests against those of research subjects and spells out the difficulties in interpreting the principle of the primacy of the individual in a way that can be action-guiding. It suggests various alternative interpretations of the primacy of the individual and argues that they do not hold. Finally, the implications of this analysis for ethical guidelines are discussed.

The evolution of health policy guidelines for assisted reproduction in the Republic of Ireland, 2004-2009.

PubMed

Walsh, David J; Ma, Mary L; Sills, Eric Scott

2011-06-24

This analysis reports on Irish regulatory policies for in vitro fertilisation (IVF) from 2004-2009, in the context of membership changes within the Medical Council of Ireland. To achieve this, the current (2009) edition of the Guide to Professional Conduct & Ethics was compared with the immediately preceding version (2004). The statutory composition of the Medical Council from 2004-2009 was also studied. Content analysis of the two editions identified the following differences: 1) The 2004 guide states that IVF "should only be used after thorough investigation has failed to reveal a treatable cause of the infertility", while the 2009 guide indicates IVF "should only be used after thorough investigation has shown that no other treatment is likely to be effective"; 2) The 2004 stipulation stating that fertilized ovum (embryo) "must be used for normal implantation and must not be deliberately destroyed" is absent from the 2009 guidelines; 3) The option to donate "unused fertilised ova" (embryos) is omitted from the 2009 guidelines; 4) The 2009 guidelines state that ART should be offered only by "suitably qualified professionals, in appropriate facilities, and according to the international best practice"; 5) The 2009 guidelines introduce criteria that donations as part of a donor programme should be "altruistic and non-commercial". These last two points represent original regulatory efforts not appearing in the 2004 edition. The Medical Practitioners Act 2007 reduced the number of physicians on the Medical Council to 6 (of 25) members. The ethical guidelines from 2004 preceded this change, while the reconstituted Medical Council published the 2009 version. Between 2004 and 2009, substantial modifications in reproductive health policy were incorporated into the Medical Council's ethical guidelines. The absence of controlling Irish legislation means that patients and IVF providers in Ireland must rely upon these guidelines by default. Our critique traces the evolution of public policy on IVF during a time when the membership of the Medical Council changed radically; reduced physician contribution to decision-making was associated with diminished protection for IVF-derived embryos in Ireland. Considerable uncertainty on IVF practice in Ireland remains.

ESPEN guideline on ethical aspects of artificial nutrition and hydration.

PubMed

Druml, Christiane; Ballmer, Peter E; Druml, Wilfred; Oehmichen, Frank; Shenkin, Alan; Singer, Pierre; Soeters, Peter; Weimann, Arved; Bischoff, Stephan C

2016-06-01

The worldwide debate over the use of artificial nutrition and hydration remains controversial although the scientific and medical facts are unequivocal. Artificial nutrition and hydration are a medical intervention, requiring an indication, a therapeutic goal and the will (consent) of the competent patient. The guideline was developed by an international multidisciplinary working group based on the main aspects of the Guideline on "Ethical and Legal Aspects of Artificial Nutrition" published 2013 by the German Society for Nutritional Medicine (DGEM) after conducting a review of specific current literature. The text was extended and introduced a broader view in particular on the impact of culture and religion. The results were discussed at the ESPEN Congress in Lisbon 2015 and accepted in an online survey among ESPEN members. The ESPEN Guideline on Ethical Aspects of Artificial Nutrition and Hydration is focused on the adult patient and provides a critical summary for physicians and caregivers. Special consideration is given to end of life issues and palliative medicine; to dementia and to specific situations like nursing care or the intensive care unit. The respect for autonomy is an important focus of the guideline as well as the careful wording to be used in the communication with patients and families. The other principles of Bioethics like beneficence, non-maleficence and justice are presented in the context of artificial nutrition and hydration. In this respect the withholding and withdrawing of artificial nutrition and/or hydration is discussed. Due to increasingly multicultural societies and the need for awareness of different values and beliefs an elaborated chapter is dedicated to cultural and religious issues and nutrition. Last but not least topics like voluntary refusal of nutrition and fluids, and forced feeding of competent persons (persons on hunger strike) is included in the guideline. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Ethics of animal research in human disease remediation, its institutional teaching; and alternatives to animal experimentation.

PubMed

Cheluvappa, Rajkumar; Scowen, Paul; Eri, Rajaraman

2017-08-01

Animals have been used in research and teaching for a long time. However, clear ethical guidelines and pertinent legislation were instated only in the past few decades, even in developed countries with Judeo-Christian ethical roots. We compactly cover the basics of animal research ethics, ethical reviewing and compliance guidelines for animal experimentation across the developed world, "our" fundamentals of institutional animal research ethics teaching, and emerging alternatives to animal research. This treatise was meticulously constructed for scientists interested/involved in animal research. Herein, we discuss key animal ethics principles - Replacement/Reduction/Refinement. Despite similar undergirding principles across developed countries, ethical reviewing and compliance guidelines for animal experimentation vary. The chronology and evolution of mandatory institutional ethical reviewing of animal experimentation (in its pioneering nations) are summarised. This is followed by a concise rendition of the fundamentals of teaching animal research ethics in institutions. With the advent of newer methodologies in human cell-culturing, novel/emerging methods aim to minimise, if not avoid the usage of animals in experimentation. Relevant to this, we discuss key extant/emerging alternatives to animal use in research; including organs on chips, human-derived three-dimensional tissue models, human blood derivates, microdosing, and computer modelling of various hues. © 2017 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics.

The Ethics of Sharing Plastic Surgery Videos on Social Media: Systematic Literature Review, Ethical Analysis, and Proposed Guidelines.

PubMed

Dorfman, Robert G; Vaca, Elbert E; Fine, Neil A; Schierle, Clark F

2017-10-01

Recent videos shared by plastic surgeons on social media applications such as Snapchat, Instagram, and YouTube, among others, have blurred the line between entertainment and patient care. This has left many in the plastic surgery community calling for the development of more structured oversight and guidance regarding video sharing on social media. To date, no official guidelines exist for plastic surgeons to follow. Little is known about the ethical implications of social media use by plastic surgeons, especially with regard to video sharing. A systematic review of the literature on social media use in plastic surgery was performed on October 31, 2016, with an emphasis on ethics and professionalism. An ethical analysis was conducted using the four principles of medical ethics. The initial search yielded 87 articles. Thirty-four articles were included for analyses that were found to be relevant to the use of social media in plastic surgery. No peer-reviewed articles were found that mentioned Snapchat or addressed the ethical implications of sharing live videos of plastic surgery on social media. Using the four principles of medical ethics, it was determined that significant ethical concerns exist with broadcasting these videos. This analysis fills an important gap in the plastic surgery literature by addressing the ethical issues concerning live surgery broadcasts on social media. Plastic surgeons may use the guidelines proposed here to avoid potential pitfalls.

ENHANCING RESEARCH ETHICS REVIEW SYSTEMS IN EGYPT: THE FOCUS OF AN INTERNATIONAL TRAINING PROGRAM INFORMED BY AN ECOLOGICAL DEVELOPMENTAL APPROACH TO ENHANCING RESEARCH ETHICS CAPACITY

PubMed Central

Edwards, Hillary Anne; Hifnawy, Tamer; Silverman, Henry

2014-01-01

Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed “too great an emphasis on guidelines and research ethics review”, which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment to ethical practices that are reinforced by upstream enabling conditions (strong civil society, public accountability, and trust in basic transactional processes), which are in turn influenced by developmental conditions (basic freedoms of political freedoms, economic facilities, social opportunities, transparency guarantees, and protective security). Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities. PMID:24894063

Enhancing Research Ethics Review Systems in Egypt: The Focus of an International Training Program Informed by an Ecological Developmental Approach to Enhancing Research Ethics Capacity.

PubMed

Edwards, Hillary Anne; Hifnawy, Tamer; Silverman, Henry

2015-12-01

Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed 'too great an emphasis on guidelines and research ethics review', which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment to ethical practices that are reinforced by upstream enabling conditions (strong civil society, public accountability, and trust in basic transactional processes), which are in turn influenced by developmental conditions (basic freedoms of political freedoms, economic facilities, social opportunities, transparency guarantees, and protective security). Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities. © 2014 John Wiley & Sons Ltd.

Ethics of fetal tissue transplantation.

PubMed Central

Sanders, L M; Giudice, L; Raffin, T A

1993-01-01

Now that the Clinton Administration has overturned the ban on federal funding for fetal tissue transplantation, old ethical issues renew their relevance and new ethical issues arise. Is fetal tissue transplantation necessary and beneficial? Are fetal rights violated by the use of fetal tissue in research? Is there a moral danger that the potential of fetal tissue donation will encourage elective abortions? Should pregnant women be allowed to designate specific fetal transplant recipients? What criteria should be used to select fetal tissue transplants? Whose consent should be required for the use of fetal tissue for transplantation? We review the current state of clinical research with fetal tissue transplantation, the legal history of fetal tissue research, the major arguments against the use of fetal tissue for transplantation, and the new postmoratorium ethical dilemmas. We include recommendations for guidelines to govern the medical treatment of fetal tissue in transplantation. Images PMID:8236984

[Surgery and the zeitgeist: what happened to ethics and moral?].

PubMed

Schneider, L; Tuffs, A; Büchler, M W

2014-03-01

Ethical and moral topics have always been an integral part of surgery. The rapid progress of highly advanced medicine has induced public discussions about medico-ethical problems as well as respective legislation. Interdisciplinary ethical committees, appointed by political as well as professional associations, have published guidelines concerning current ethical topics. However, what about the doctor's attitude and the influence of the ever changing "Zeitgeist"? With the surplus of unproven health information on the web, modern information technologies have changed the doctor-patient relationship. Active leadership of the doctor is still required. For the benefit of the patient the physician should confront increasing economic pressures and the requirements of higher performance levels with competence. Indications have to be based on the results of valid quality controls. Special moral standards should be applied for working within the surgical community and for the pursuit of a career in academic surgery. By strengthening mutual respect and the community spirit surgery will remain attractive for aspiring young doctors.

Health research ethics review and needs of institutional ethics committees in Tanzania.

PubMed

Ikingura, J K B; Kruger, M; Zeleke, W

2007-09-01

This study was undertaken to describe the performance of health research ethics review procedures of six research centres in Tanzania. Data collection was done through a self-administered questionnaire and personal interviews. The results showed that there were on average 11 members (range = 8-14) in each Research Ethic Committee. However, female representation in the committees was low (15.2%). The largest proportion of the committee members was biomedical scientists (51.5%). Others included medical doctors (19.7%), social scientists (7.6%), laboratory technologists (10.6%), religious leaders (4.5%), statisticians (3.0%), teachers (1.5%) and lawyers (1.5). Committee members had different capacities to carry out review of research proposals (no capacity = 2%; limited capacity = 15%; moderate capacity = 20%; good capacity = 48%, excellent capacity = 13%). Only half of the respondents had prior ethics review training. Although the majority deemed that ethical guidelines were very important (66%), there were challenges in the use of ethical guidelines which included lack of awareness on the national accreditation mechanisms for ethics committee (59%). Adherence to ethical principles and regulations was influenced by being a scientist (OR = 42.47), being an employee of a professional organization (OR = 15.25), and having an interests in the use of ethical guidelines (OR = 10.85) These findings indicate the need for capacity strengthening (through training and resource support), inclusion of more female representation and other mandatory professions to the research ethics committees.

Qualitative research ethics on the spot: Not only on the desktop.

PubMed

Øye, Christine; Sørensen, Nelli Øvre; Glasdam, Stinne

2016-06-01

The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position. Based on three different cases from three different research studies, the article explores and discusses research ethical dilemmas. First, and especially, the article addresses the challenges for gatekeepers who influence the informant's decisions to participate in research. Second, the article addresses the challenges in following research ethical guidelines related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research. Research ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop. © The Author(s) 2015.

Touching ethics: assessing the applicability of ethical rules for safe touch in CAM--outcomes of a CAM (complementary and alternative medicine) practitioner survey in Israel.

PubMed

Schiff, Elad; Ben-Arye, Eran; Shilo, Margalit; Levy, Moti; Schachter, Leora; Weitchner, Na'ama; Golan, Ofra; Stone, Julie

2011-02-01

Recently, ethical guidelines regarding safe touch in CAM were developed in Israel. Publishing ethical codes does not imply that they will actually help practitioners to meet ethical care standards. The effectiveness of ethical rules depends on familiarity with the code and its content. In addition, critical self-examination of the code by individual members of the profession is required to reflect on the moral commitments encompassed in the code. For the purpose of dynamic self-appraisal, we devised a survey to assess how CAM practitioners view the suggested ethical guidelines for safe touch. We surveyed 781 CAM practitioners regarding their perspectives on the safe-touch code. There was a high level of agreement with general statements regarding ethics pertaining to safe touch with a mean rate of agreement of 4.61 out of a maximum of 5. Practitioners concurred substantially with practice guidelines for appropriate touch with a mean rate of agreement of 4.16 out of a maximum of 5. Attitudes toward the necessity to touch intimate areas for treatment purposes varied with 78.6% of respondents strongly disagreeing with any notion of need to touch intimate areas during treatment. 7.9% neither disagreed nor agreed, 7.9% slightly agreed, and 7.6% strongly agreed with the need for touching intimate areas during treatment. There was a direct correlation between disagreement with touching intimate areas for therapeutic purposes and agreement with general statements regarding ethics of safe touch (Spearman r=0.177, p<0.0001), and practice guidelines for appropriate touch (r=0.092, p=0.012). A substantial number of practitioners agreed with the code, although some findings regarding the need to touch intimate area during treatments were disturbing. Our findings can serve as a basis for ethical code development and implementation, as well as for educating CAM practitioners on the ethics of touch. Copyright © 2010 Elsevier Ltd. All rights reserved.

A different perspective: anesthesia for extreme premature infants: is there an age limitation or how low should we go?

PubMed

Lönnqvist, Per-Arne

2018-06-01

To put in perspective, the various challenges that faces pediatric anesthesiologists because of the recently lowered limits with regards to the viability of a fetus. Both medical and ethical considerations will be highlighted. Issues related to: who should anesthetize these tiny babies; can we provide adequate and legal monitoring during the anesthetic; does these immature babies need hypnosis and amnesia and the moral/ethical implications associated with being involved with care of doubtful long-term outcome are reviewed. There does currently not exist sufficient research data to provide any evidence-based guidelines for the anesthetic handling of extreme premature infants. Current practice relies on extrapolations from other patient groups and from attempting to preserve normal physiology. Thus, focused research initiatives within this specific field of anesthesia should be a priority. Furthermore, in-depth multiprofessional ethical discussions regarding long-term outcome of aggressive care of extremely premature babies are urgently needed, including the new concepts of disability-free survival and number-need-to-suffer.

Completing the Circle: A Model for Effective Community Review of Environmental Health Research

PubMed Central

Shepard, Peggy Morrow; Corbin-Mark, Cecil D.

2009-01-01

While it is well understood that multiple and cumulative environmental stressors negatively impact health at the community level, existing ethical research review procedures are designed to protect individual research participants but not communities. Increasing concerns regarding the ethical conduct of research in general and environmental and genetic research in particular underscore the need to expand the scope of current human participant research regulations and ethical guidelines to include protections for communities. In an effort to address this issue, West Harlem Environmental Action (WE ACT), a nonprofit, community-based environmental justice organization in New York City that has been involved in community–academic partnerships for the past decade, used qualitative interview data to develop a pilot model for community review of environmental health science research. PMID:19890159

Ethical considerations when employing fake identities in online social networks for research.

PubMed

Elovici, Yuval; Fire, Michael; Herzberg, Amir; Shulman, Haya

2014-12-01

Online social networks (OSNs) have rapidly become a prominent and widely used service, offering a wealth of personal and sensitive information with significant security and privacy implications. Hence, OSNs are also an important--and popular--subject for research. To perform research based on real-life evidence, however, researchers may need to access OSN data, such as texts and files uploaded by users and connections among users. This raises significant ethical problems. Currently, there are no clear ethical guidelines, and researchers may end up (unintentionally) performing ethically questionable research, sometimes even when more ethical research alternatives exist. For example, several studies have employed "fake identities" to collect data from OSNs, but fake identities may be used for attacks and are considered a security issue. Is it legitimate to use fake identities for studying OSNs or for collecting OSN data for research? We present a taxonomy of the ethical challenges facing researchers of OSNs and compare different approaches. We demonstrate how ethical considerations have been taken into account in previous studies that used fake identities. In addition, several possible approaches are offered to reduce or avoid ethical misconducts. We hope this work will stimulate the development and use of ethical practices and methods in the research of online social networks.

Ethics of xenotransplantation: animal issues, consent, and likely transformation of transplant ethics.

PubMed

Daar, A S

1997-01-01

The shortage of organs, breakthroughs in research, involvement of biotechnology companies, absence of ethically more acceptable alternatives, and a vaguely perceived "time to put man on the moon" feeling have contributed to the current reawakening of interest in xenotransplantation. The focus of ethical attention has changed from the moral correctness of using animals for research/therapy to an increasingly appreciated danger of the establishment and spread of xenozoonoses in recipients, their contacts, and the general public. The United Kingdom has established an embargo on clinical trials and has set up a national regulatory authority to oversee and coordinate the development of research, establish guidelines, and decide on when trials can proceed. In the United States, on the other hand, the overall attitude is to "proceed with caution," and the Food and Drug Administration has approved a number of xenotransplant studies. The Public Health Service guidelines on reducing infection risk are still evolving and are likely to end up being more cautions than they are currently. There are a number of reasons for not using subhuman primates for xenotransplantation, including their closeness to humans, the likelihood of passing on infections, their depletability (gorillas, chimpanzees), their slow breeding, and the expense of breeding them under specified-pathogen free conditions. The pig, although domesticated and familiar, is too distant to evoke the same feelings we have for primates, has the correct-size organs, is probably less likely to pass on infections, breeds rapidly, and is not endangered; moreover, millions of them are eaten every year. Although drawing ethical conclusions is difficult, at this stage of knowledge and debate it seems acceptable to manipulate pigs genetically and to proceed to using their organs for xenotransplantation trials when infection control measures and the scientific base justify it. The question of informed consent is likely to be a vexing one. It might end up more of a binding legal contract than consent as we understand it now. Xenotransplantation is also unlikely to cost less than, or significantly alleviate the shortage of, cadaveric organs in the short term. The international dimension of the risk of infection is becoming obvious, but there has so far been no effort to convene an international forum to agree on universally acceptable guidelines.

Female Reproductive Health After Childhood, Adolescent, and Young Adult Cancers: Guidelines for the Assessment and Management of Female Reproductive Complications

PubMed Central

Metzger, Monika L.; Meacham, Lillian R.; Patterson, Briana; Casillas, Jacqueline S.; Constine, Louis S.; Hijiya, Nobuko; Kenney, Lisa B.; Leonard, Marcia; Lockart, Barbara A.; Likes, Wendy; Green, Daniel M.

2013-01-01

Purpose As more young female patients with cancer survive their primary disease, concerns about reproductive health related to primary therapy gain relevance. Cancer therapy can often affect reproductive organs, leading to impaired pubertal development, hormonal regulation, fertility, and sexual function, affecting quality of life. Methods The Children's Oncology Group Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancer (COG-LTFU Guidelines) are evidence-based recommendations for screening and management of late effects of therapeutic exposures. The guidelines are updated every 2 years by a multidisciplinary panel based on current literature review and expert consensus. Results This review summarizes the current task force recommendations for the assessment and management of female reproductive complications after treatment for childhood, adolescent, and young adult cancers. Experimental pretreatment as well as post-treatment fertility preservation strategies, including barriers and ethical considerations, which are not included in the COG-LTFU Guidelines, are also discussed. Conclusion Ongoing research will continue to inform COG-LTFU Guideline recommendations for follow-up care of female survivors of childhood cancer to improve their health and quality of life. PMID:23382474

Rights and Wrongs of Ethics Training.

ERIC Educational Resources Information Center

Rice, Dan; Dreilinger, Craig

1990-01-01

Ethics initiatives should provide employees with the tools they need to identify, clarify, and resolve ethical issues. Training efforts should focus on defining desired outcomes and considering the company's values and guidelines in working toward solutions to ethical problems. (SK)

The impact of medical tourism and the code of medical ethics on advertisement in Nigeria

PubMed Central

Makinde, Olusesan Ayodeji; Brown, Brandon; Olaleye, Olalekan

2014-01-01

Advances in management of clinical conditions are being made in several resource poor countries including Nigeria. Yet, the code of medical ethics which bars physician and health practices from advertising the kind of services they render deters these practices. This is worsened by the incursion of medical tourism facilitators (MTF) who continue to market healthcare services across countries over the internet and social media thereby raising ethical questions. A significant review of the advertisement ban in the code of ethics is long overdue. Limited knowledge about advances in medical practice among physicians and the populace, the growing medical tourism industry and its attendant effects, and the possibility of driving brain gain provide evidence to repeal the code. Ethical issues, resistance to change and elitist ideas are mitigating factors working in the opposite direction. The repeal of the code of medical ethics against advertising will undoubtedly favor health facilities in the country that currently cannot advertise the kind of services they render. A repeal or review of this code of medical ethics is necessary with properly laid down guidelines on how advertisements can be and cannot be done. PMID:25722776

The impact of medical tourism and the code of medical ethics on advertisement in Nigeria.

PubMed

Makinde, Olusesan Ayodeji; Brown, Brandon; Olaleye, Olalekan

2014-01-01

Advances in management of clinical conditions are being made in several resource poor countries including Nigeria. Yet, the code of medical ethics which bars physician and health practices from advertising the kind of services they render deters these practices. This is worsened by the incursion of medical tourism facilitators (MTF) who continue to market healthcare services across countries over the internet and social media thereby raising ethical questions. A significant review of the advertisement ban in the code of ethics is long overdue. Limited knowledge about advances in medical practice among physicians and the populace, the growing medical tourism industry and its attendant effects, and the possibility of driving brain gain provide evidence to repeal the code. Ethical issues, resistance to change and elitist ideas are mitigating factors working in the opposite direction. The repeal of the code of medical ethics against advertising will undoubtedly favor health facilities in the country that currently cannot advertise the kind of services they render. A repeal or review of this code of medical ethics is necessary with properly laid down guidelines on how advertisements can be and cannot be done.

Ethics in a Postmodern Age: Lapsing into Legalism.

ERIC Educational Resources Information Center

Haswell, Janis E.

2003-01-01

Discusses the publication of "Guidelines for the Ethical Treatment of Students and Student Writing in Composition Studies" in the journal "College Composition and Communication." Notes that the Guidelines were developed as a reaction to the present situation wherein (1) student writing increasingly is the subject of English teachers' publications…

Mega-sized concerns from the nano-sized world: the intersection of nano- and environmental ethics.

PubMed

Attia, Peter

2013-09-01

As rapid advances in nanotechnology are made, we must set guidelines to balance the interests of both human beneficiaries and the environment by combining nanoethics and environmental ethics. In this paper, I reject Leopoldian holism as a practical environmental ethic with which to gauge nanotechnologies because, as a nonanthropocentric ethic, it does not value the humans who will actually use the ethic. Weak anthropocentrism is suggested as a reasonable alternative to ethics without a substantial human interest, as it treats nonhuman interests as human interests. I also establish the precautionary principle as a useful situational guideline for decision makers. Finally, I examine existing and potential applications of nanotechnology, including water purification, agriculture, mining, energy, and pollutant removal, from the perspective of weak anthropocentrism using the precautionary principle.

Unconventional combinations of prospective parents: ethical challenges faced by IVF providers.

PubMed

Klitzman, Robert

2017-02-28

Professional guidelines have addressed ethical dilemmas posed by a few types of nontraditional procreative arrangements (e.g., gamete donations between family members), but many questions arise regarding how providers view and make decisions about these and other such arrangements. Thirty-seven ART providers and 10 patients were interviewed in-depth for approximately 1 h each. Interviews were systematically analyzed. Providers faced a range of challenges and ethical dilemmas concerning both the content and the process of decisions about requests for unconventional interfamilial and other reproductive combinations. Providers vary in how they respond - what they decide, who exactly decides (e.g., an ethics committee or not), and how - often undergoing complex decision-making processes. These combinations can involve creating or raising the child, and can shift over time - from initial ART treatment through to the child's birth. Patients' requests can vary from fully established to mere possibilities. Arrangements may also be unstable, fluid, or unexpected, posing challenges. Difficulties emerge concerning not only familial but social, combinations (e.g., between friends). These arrangements can involve blurry and confusing roles, questions about the welfare of the unborn child, and unanticipated and unfamiliar questions about how to weigh competing moral and scientific concerns - e.g., the autonomy of the individuals involved, and the potential risks and benefits. Clinicians may feel that these requests do not "smell right"; and at first respond with feelings of "yuck," and only later, carefully and explicitly consider the ethical principles involved. Proposed arrangements may, for instance, initially be felt to involve consanguineous individuals, but not in fact do so. Obtaining and verifying full and appropriate informed consent can be difficult, given implicit familial and/or cultural expectations and senses of duty. Social attitudes are changing, yet patients' views of these issues may also vary, based on their cultural backgrounds. These data, the first to examine how clinicians make decisions about unconventional reproductive arrangements, highlight several critical ethical questions and ambiguities, and variations in clinicians' responses. While several professional guidelines exist, the current data highlight additional challenges, and have vital implications for improving future guidelines, practice, education and research. Not applicable.

The design and content of orthodontic practise websites in the UK is suboptimal and does not correlate with search ranking.

PubMed

Patel, Annika; Cobourne, Martyn T

2015-08-01

This study investigated standards of ethical advertising; design and content; and information quality associated with UK dental practice websites offering orthodontic treatment. The World Wide Web was searched from a UK-based computer using the Google search engine combined with the term 'orthodontic braces'. The first 100 UK-based dental practice websites were pooled and saved following duplicate removal. Websites were evaluated for compliance with current General Dental Council ethical advertising guidelines; accessibility, usability, and reliability using the LIDA instrument (a validated outcome tool for healthcare website design and content evaluation); and quality of information using the DISCERN toolkit (a validated method of quality assessment for online written patient information). Nine per cent of websites demonstrated full compliance with current guidelines on ethical advertising. Mean total LIDA score was 110/144 (76%) [range: 51-135; 35-94%]. Eleven websites reached a gold standard of 90% or more for total LIDA score. Mean total DISCERN score was 48/75 (64%) [range: 19-73; 25-97%]. Five websites achieved a total DISCERN score above 90%. Spearman's rank correlation coefficients demonstrated no significant correlations between LIDA (0.1669; P = 0.4252, confidence interval [CI]: -0.2560 to 0.5362) or DISCERN (0.3572; P = 0.0796, CI: -0.0565 to 0.663) score and ranking amongst the 25 highest ranked websites. Most UK websites offering orthodontic services are not fully compliant with national guidelines relating to ethical advertising. Validated measures of website design (LIDA) and information quality (DISCERN) showed wide variation amongst sites. No correlation existed between ranking amongst the highest 25 sites and either of these measures. This investigation was limited to a subsample of UK-only websites; and whilst not representative of European-wide sites, it does suggest that in the UK at least website quality can be improved. © The Author 2014. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Ethical issues in perinatal mental health research.

PubMed

Brandon, Anna R; Shivakumar, Geetha; Lee, Simon Craddock; Inrig, Stephen J; Sadler, John Z

2009-11-01

To review the background of current ethical standards for the conduct of perinatal mental health research and describe the ethical challenges in this research domain. Current literature reflects a growing sentiment in the scientific community that having no information regarding the impact of psychiatric treatment on the mother and developing fetus/infant poses dangers that may exceed the risks involved in research. However, without sufficient consensus across the scientific community, both regulatory bodies and perinatal researchers find themselves without a framework for decision making that satisfactorily limits the risks and facilitates the benefits of participation of pregnant and lactating women in clinical research. Psychiatric research in perinatal mental health is critically important as it enables clinicians and patients to participate in informed decision-making concerning treatment for psychiatric disorders. Specific areas of concern include fetal safety, maternal risk, the therapeutic misconception, commercial interests, forensic/legal issues, the informed consent process, and study design. Developing guidelines that address ethical challenges and include the views and concerns of multiple stakeholders could improve the access of perinatal women to the benefits of participation in mental health research in addition to providing evidence-based mental healthcare for this subpopulation.

Barriers and facilitators influencing ethical evaluation in health technology assessment.

PubMed

Assasi, Nazila; Schwartz, Lisa; Tarride, Jean-Eric; O'Reilly, Daria; Goeree, Ron

2015-01-01

The objective of this study was to explore barriers and facilitators influencing the integration of ethical considerations in health technology assessment (HTA). The study consisted of two complementary approaches: (a) a systematic review of the literature; and (b) an eighteen-item online survey that was distributed to fifty-six HTA agencies affiliated with the International Network of Agencies for Health Technology Assessment. The review identified twenty-six relevant articles. The most often cited barriers in the literature were: scarcity, heterogeneity and complexity of ethical analysis methods; challenges in translating ethical analysis results into knowledge that is useful for decision makers; and lack of organizational support in terms of required expertise, time and financial resources. The most frequently cited facilitators included: usage of value-based appraisal methods, stakeholder and public engagement, enhancement of practice guidelines, ethical expertise, and educational interventions. Representatives of twenty-six (46.5 percent) agencies from nineteen countries completed the survey. A median of 10 percent (interquartile range, 5 percent to 50 percent) of the HTA products produced by the agencies was reported to include an assessment of ethical aspects. The most commonly perceived barriers were: limited ethical knowledge and expertise, insufficient time and resources, and difficulties in finding ethical evidence or using ethical guidelines. Educational interventions, demand by policy makers, and involvement of ethicists in HTA were the most commonly perceived facilitators. Our results emphasize the importance of simplification of ethics methodology and development of good practice guidelines in HTA, as well as capacity building for engaging HTA practitioners in ethical analyses.

Simulation as an ethical imperative and epistemic responsibility for the implementation of medical guidelines in health care.

PubMed

Garbayo, Luciana; Stahl, James

2017-03-01

Guidelines orient best practices in medicine, yet, in health care, many real world constraints limit their optimal realization. Since guideline implementation problems are not systematically anticipated, they will be discovered only post facto, in a learning curve period, while the already implemented guideline is tweaked, debugged and adapted. This learning process comes with costs to human health and quality of life. Despite such predictable hazard, the study and modeling of medical guideline implementation is still seldom pursued. In this article we argue that to systematically identify, predict and prevent medical guideline implementation errors is both an epistemic responsibility and an ethical imperative in health care, in order to properly provide beneficence, minimize or avoid harm, show respect for persons, and administer justice. Furthermore, we suggest that implementation knowledge is best achieved technically by providing simulation modeling studies to anticipate the realization of medical guidelines, in multiple contexts, with system and scenario analysis, in its alignment with the emerging field of implementation science and in recognition of learning health systems. It follows from both claims that it is an ethical imperative and an epistemic responsibility to simulate medical guidelines in context to minimize (avoidable) harm in health care, before guideline implementation.

Social work, technology, and ethical practices: a review and evaluation of the national association of social workers' technology standards.

PubMed

Lopez, Amy

2014-10-01

Information and communication technologies (ICTs) are becoming essential to social work practice by providing increased treatment possibilities and reducing barriers to service. While recognizing the importance of ICTs in practice, social work practitioners have had concerns about ethical use. In response, NASW compiled the Standards for Technology and Social Work Practice. While the guidelines set the groundwork, they were not embedded in a process that would allow them to adapt to the swift pace of ICT changes. This article reviews the current Standards, evaluates how these have been implemented by practitioners, and offers suggestions for updates.

The Italian Code of Medical Deontology. Historical, ethical and legal issues.

PubMed

Patuzzo, Sara; De Stefano, Francesco; Ciliberti, Rosagemma

2018-06-15

Medical deontology is increasingly important, owing to the interests and rights which the medical profession involves. This paper focuses on the relationships of the Italian Code of Medical Deontology (CMD) with both the ethical and legal dimensions, in order to clarify the role of medical ethics within the medical profession, society and the overall system of the sources of law. The authors analyze the CMD from an ethical perspective and through the new doctrinal guidelines and current trends in the Italian law courts. From an ethical point of view,  moral philosophical analysis scarcely seems to  address professional medical ethics. Nonetheless, the CMD needs to undergo careful ethical analysis. From a legal perspective, the Italian CMD contains provisions which do not have  an official legal nature. However, they are directly binding for medical practitioners, and therefore could be understood as a supplement to the general rules of the legal system. At an ethical level, rigorous debate on the CMD is indispensable, in order to update its specific principles and to make it a real moral normative document. At a legislative level, there is a possible contradiction between a legal system that does not take into account the CMD, but which then attributes significant importance to the violation of its rules.

A Developmental Approach to the Teaching of Ethical Decision Making.

ERIC Educational Resources Information Center

Neukrug, Edward S.

1996-01-01

Examines the newly adopted code of ethics, reviews some ethical decision-making models, and hypothesizes how the maturity of a student might mediate the effective use of codes and of decision-making models. Provides a model for human service educators that integrates ethical guidelines and ethical decision-making models. (RJM)

Developing Ethical Adult Educators: A Re-Examination of the Need for a Code of Ethics

ERIC Educational Resources Information Center

Hatcher, Tim; Storberg-Walker, Julia

2003-01-01

The moral philosophies and normative ethical guidelines of a profession influence its practice and research. More than simply assigning merit or worth to outcomes or processes, ethics is the milieu in which professionals establish integrity and develop solidarity through normative ethical worldviews. Thus, in increasingly complex contexts, adult…

Ethics Education and Its Influences on Rehabilitation Counseling Master's Students

ERIC Educational Resources Information Center

Tsai, Yi-Hua

2013-01-01

The importance of ethics in helping professions and ethics education in counselor preparation programs have been stressed and discussed greatly. In order to foster helping professionals' ethical behaviors to ensure clients' rights and welfare, professional organizations have developed codes of ethics to serve as guidelines for helping…

Rubber dam application in endodontic practice: an update on critical educational and ethical dilemmas.

PubMed

Ahmed, H M A; Cohen, S; Lévy, G; Steier, L; Bukiet, F

2014-12-01

Proper isolation is an essential prerequisite for successful endodontic treatment. This article aims to provide an update on the prevalence of rubber dam (RD) use, and the role of education along with attitudes of general dental practitioners (GDPs) and patients towards the application of RD in endodontics. Critical ethical issues are also highlighted. Using certain keywords, an electronic search was conducted spanning the period from January 1983 to April 2013 to identify the available related investigations, and the pooled data were then analysed. The results show that although RD is the Standard of Care in endodontic practice, there is a clear discrepancy in what GDPs are taught in dental school and what they practice after graduation. There is little scientific evidence to support the application of RD; however, patient safety and clinical practice guidelines indicate that it is unnecessary and unethical to consider a cohort study to prove what is already universally agreed upon. A few clinical situations may require special management which should be highlighted in the current guidelines. This would pave the way for clear and straightforward universal guidelines. © 2014 Australian Dental Association.

A critical analysis of Australian policies and guidelines for water immersion during labour and birth.

PubMed

Cooper, Megan; McCutcheon, Helen; Warland, Jane

2017-10-01

Accessibility of water immersion for labour and/or birth is often dependent on the care provider and also the policies/guidelines that underpin practice. With little high quality research about the safety and practicality of water immersion, particularly for birth, policies/guidelines informing the practice may lack the evidence necessary to ensure practitioner confidence surrounding the option thereby limiting accessibility and women's autonomy. The aims of the study were to determine how water immersion policies and/or guidelines are informed, who interprets the evidence to inform policies/guidelines and to what extent the policy/guideline facilitates the option for labour and birth. Phase one of a three-phase mixed-methods study critically analysed 25 Australian water immersion policies/guidelines using critical discourse analysis. Policies/guidelines pertaining to the practice of water immersion reflect subjective opinions and views of the current literature base in favour of the risk-focused obstetric and biomedical discursive practices. Written with hegemonic influence, policies and guidelines impact on the autonomy of both women and practitioners. Policies and guidelines pertaining to water immersion, particularly for birth reflect opinion and varied interpretations of the current literature base. A degree of hegemonic influence was noted prompting recommendations for future maternity care policy and guidelines'. The Human Research Ethics Committee of the University of South Australia approved the research. Copyright © 2017 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

The Nuremberg Code–A critique

PubMed Central

Ghooi, Ravindra B.

2011-01-01

The Nuremberg Code drafted at the end of the Doctor’s trial in Nuremberg 1947 has been hailed as a landmark document in medical and research ethics. Close examination of this code reveals that it was based on the Guidelines for Human Experimentation of 1931. The resemblance between these documents is uncanny. It is unfortunate that the authors of the Nuremberg Code passed it off as their original work. There is evidence that the defendants at the trial did request that their actions be judged on the basis of the 1931 Guidelines, in force in Germany. The prosecutors, however, ignored the request and tried the defendants for crimes against humanity, and the judges included the Nuremberg Code as a part of the judgment. Six of ten principles in Nuremberg Code are derived from the 1931 Guidelines, and two of four newly inserted principles are open to misinterpretation. There is little doubt that the Code was prepared after studying the Guidelines, but no reference was made to the Guidelines, for reasons that are not known. Using the Guidelines as a base document without giving due credit is plagiarism; as per our understanding of ethics today, this would be considered unethical. The Nuremberg Code has fallen by the wayside; since unlike the Declaration of Helsinki, it is not regularly reviewed and updated. The regular updating of some ethics codes is evidence of the evolving nature of human ethics. PMID:21731859

The Nuremberg Code-A critique.

PubMed

Ghooi, Ravindra B

2011-04-01

The Nuremberg Code drafted at the end of the Doctor's trial in Nuremberg 1947 has been hailed as a landmark document in medical and research ethics. Close examination of this code reveals that it was based on the Guidelines for Human Experimentation of 1931. The resemblance between these documents is uncanny. It is unfortunate that the authors of the Nuremberg Code passed it off as their original work. There is evidence that the defendants at the trial did request that their actions be judged on the basis of the 1931 Guidelines, in force in Germany. The prosecutors, however, ignored the request and tried the defendants for crimes against humanity, and the judges included the Nuremberg Code as a part of the judgment. Six of ten principles in Nuremberg Code are derived from the 1931 Guidelines, and two of four newly inserted principles are open to misinterpretation. There is little doubt that the Code was prepared after studying the Guidelines, but no reference was made to the Guidelines, for reasons that are not known. Using the Guidelines as a base document without giving due credit is plagiarism; as per our understanding of ethics today, this would be considered unethical. The Nuremberg Code has fallen by the wayside; since unlike the Declaration of Helsinki, it is not regularly reviewed and updated. The regular updating of some ethics codes is evidence of the evolving nature of human ethics.

Ethics and Rationing Access to Dialysis in Resource-Limited Settings: The Consequences of Refusing a Renal Transplant in the South African State Sector.

PubMed

Etheredge, Harriet; Paget, Graham

2015-12-01

Resource constraints in developing countries compel policy makers to ration the provision of healthcare services. This article examines one such set of Guidelines: A patient dialysing in the state sector in South Africa may not refuse renal transplantation when a kidney becomes available. Refusal of transplantation can lead to exclusion from the state-funded dialysis programme. This Guideline is legally acceptable as related to Constitutional stipulations which allow for rationing healthcare resources in South Africa. Evaluating the ethical merit of the Guideline, and exploring the ethical dilemma it poses, proves a more complex task. We examine the actions of healthcare professionals as constrained by the Guideline. From a best interests framework, we argue that in these circumstances directing patient decision making (pressurising a patient to undergo renal transplantation) is not necessarily unethical or unacceptably paternalistic. We then scrutinise the guideline itself through several different ethical 'lenses'. Here, we argue that bioethics does not provide a definitive answer as to the moral merit of rationing dialysis under these circumstances, however it can be considered just in this context. We conclude by examining a potential pitfall of the Guideline: Unwilling transplant recipients may not comply with immunosuppressive medication, which raises questions for policies based on resource management and rationing. © 2014 John Wiley & Sons Ltd.

The challenge of developing ethical guidelines for a research infrastructure

NASA Astrophysics Data System (ADS)

Kutsch, Werner Leo

2016-04-01

The mission of the Integrated Carbon Observation System (ICOS RI) is to enable research to understand the greenhouse gas (GHG) budgets and perturbations. The ICOS RI provides the long-term observations required to understand the present state and predict future behaviour of the global carbon cycle and GHG emissions. Technological developments and implementations, related to GHGs, will be promoted by the linking of research, education and innovation. In order to provide this data ICOS RI is a distributed research infrastructure. The backbones of ICOS RI are the national measurement stations such as ICOS atmosphere, ecosystem and ocean stations. ICOS Central Facilities are the European level ICOS RI Centres, which have the specific tasks in collecting and processing the data and samples received from the national measurement networks. During the establishment of ICOS RI ethical guidelines were developed. These guidelines describe principles of ethics in the research activities that should be applied within ICOS RI. They should be acknowledged and followed by all researchers affiliated to ICOS RI and should be supported by all participating institutions. The presentation describes (1) the general challenge to develop ethical guidelines in a complex international infrastructure and (2) gives an overview about the content that includes different kinds of conflicts of interests, data ethics and social responsibility.

Overview on health research ethics in Egypt and North Africa.

PubMed

Marzouk, Diaa; Abd El Aal, Wafaa; Saleh, Azza; Sleem, Hany; Khyatti, Meriem; Mazini, Loubna; Hemminki, Kari; Anwar, Wagida A

2014-08-01

Developing countries, including Egypt and North African countries, need to improve their quality of research by enhancing international cooperation and exchanges of scientific information, as well as competing for obtaining international funds to support research activities. Research must comply with laws and other requirements for research that involves human subjects. The purpose of this article is to overview the status of health research ethics in Egypt and North African countries, with reference to other Middle Eastern countries. The EU and North African Migrants: Health and Health Systems project (EUNAM) has supported the revision of the status of health research ethics in Egypt and North African countries, by holding meetings and discussions to collect information about research ethics committees in Egypt, and revising the structure and guidelines of the committees, as well as reviewing the literature concerning ethics activities in the concerned countries. This overview has revealed that noticeable efforts have been made to regulate research ethics in certain countries in the Middle East. This can be seen in the new regulations, which contain the majority of protections mentioned in the international guidelines related to research ethics. For most of the internationally registered research ethics committees in North African countries, the composition and functionality reflect the international guidelines. There is growing awareness of research ethics in these countries, which extends to teaching efforts to undergraduate and postgraduate medical students. © The Author 2014. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Do ethical Guidelines make a difference to decision-making?

PubMed

Osborn, M; Day, R; Komesaroff, P; Mant, A

2009-12-01

The different levels of knowledge and understanding of attitudes to and use by physicians of the Royal Australasian College of Physicians (RACP) Guidelines for ethical relationships between physicians and the pharmaceutical industry are unknown. The aim of this study was to explore how physician Fellows of the RACP relate to and use the ethical Guidelines of the RACP regarding relationships with the pharmaceutical industry. Focus group discussions and in-depth face-to-face interviews were used to gather information from physicians who responded to invitations placed in electronic newsletters or through word of mouth. Five focus groups and eight in-depth interviews were conducted with 56 practising physicians in Australia and New Zealand. Most physicians were aware of the RACP ethical Guidelines (3rd edition, 2006), but only a few used them to resolve ethical dilemmas or to influence their decision-making in relation to interacting with the pharmaceutical industry. Ethical standards used or approaches to decision-making practices related to interactions with the pharmaceutical industry were most likely to have been developed through past experiences, peer pressure or decisions that were considered to be 'in the best interests of their patients'. There were strong opinions expressed about relationships with the pharmaceutical industry and how these relationships often lead to feelings of humiliation. Some felt they were prostituting themselves for the sake of acquiring funding for staff positions, medical devices, research or attendance at conferences. Very few physicians recollected having any assistance on how to deal with the pharmaceutical industry during their training, and those few who did recollect such input through their curricula and education felt they did not benefit. RACP Guidelines on ethical guidance for relating to the pharmaceutical industry have not been used by most physicians, and very few had read or referred to the Guidelines. Reliance on 'previous' experience, opinions of peers and 'value to patients' had most influence on attitudes and behaviours in interactions with industry. Many physicians felt uncomfortable and embarrassed about interactions with industry, especially varying levels of dependence on industry for resources.

Challenges in biobank governance in Sub-Saharan Africa

PubMed Central

2013-01-01

Background Biological sample and data transfer within and out of Africa is steeped in controversy With the H3Africa project now aiming to establish biobanks in Africa, it is essential that there are ethical and legal governance structures in place to oversee the operation of these biobanks. Such governance is essential to ensuring that donors are protected, that cultural perspectives are respected and that researchers have a ready availability of ethically sourced biological samples. Methods A literature review of all legislation, regulations, guidelines and standard operating procedures on informed consent, confidentiality and the transfer of biological samples amongst countries in Sub-Saharan Africa was conducted. In addition, an examination of the websites of departments of health and national ethics committees was performed. Researchers and research ethics scholars in the field in various African countries were contacted for assistance. A literature review of all studies examining participants views on issues related to biobanking in Africa was carried out and five separate studies were found. Results It was found that biobanking guidelines differ substantially across Sub-Saharan Africa regarding biobanking and often conflicted across borders. This has the potential to negatively impact collaboration. Furthermore, the guidelines in place often do not recognise the ethical difficulties arising from the transfer of biological samples and are unsuitable to regulate biobanks. Additionally, there is insufficient research into the views of research participants and stakeholders on the use of biological /samples. Conclusion Collaboration is necessary to ensure the success of biobanking projects in Africa. To achieve this, there should be some harmonization of guidelines across Africa which would aid in transferring biological samples across borders. These guidelines should reflect the unique ethical issues arising out of the storage and secondary uses of biological samples. Finally, further research into the views of research participants is necessary. Such studies should aid in the drafting of any new harmonization guidelines. PMID:24025667

Challenges in biobank governance in Sub-Saharan Africa.

PubMed

Staunton, Ciara; Moodley, Keymanthri

2013-09-11

Biological sample and data transfer within and out of Africa is steeped in controversy With the H3Africa project now aiming to establish biobanks in Africa, it is essential that there are ethical and legal governance structures in place to oversee the operation of these biobanks. Such governance is essential to ensuring that donors are protected, that cultural perspectives are respected and that researchers have a ready availability of ethically sourced biological samples. A literature review of all legislation, regulations, guidelines and standard operating procedures on informed consent, confidentiality and the transfer of biological samples amongst countries in Sub-Saharan Africa was conducted. In addition, an examination of the websites of departments of health and national ethics committees was performed. Researchers and research ethics scholars in the field in various African countries were contacted for assistance. A literature review of all studies examining participants views on issues related to biobanking in Africa was carried out and five separate studies were found. It was found that biobanking guidelines differ substantially across Sub-Saharan Africa regarding biobanking and often conflicted across borders. This has the potential to negatively impact collaboration. Furthermore, the guidelines in place often do not recognise the ethical difficulties arising from the transfer of biological samples and are unsuitable to regulate biobanks. Additionally, there is insufficient research into the views of research participants and stakeholders on the use of biological /samples. Collaboration is necessary to ensure the success of biobanking projects in Africa. To achieve this, there should be some harmonization of guidelines across Africa which would aid in transferring biological samples across borders. These guidelines should reflect the unique ethical issues arising out of the storage and secondary uses of biological samples. Finally, further research into the views of research participants is necessary. Such studies should aid in the drafting of any new harmonization guidelines.

Unconsented HIV Testing in Cases of Occupational Exposure: Ethics, Law, and Policy

PubMed Central

Cowan, Ethan; Macklin, Ruth

2012-01-01

Post-exposure prophylaxis (PEP) has substantially reduced the risk of acquiring human immunodeficiency virus (HIV) after an occupational exposure; nevertheless, exposure to HIV remains a concern for emergency department providers. According to published guidelines, PEP should be taken only when source patients are HIV positive or have risk factors for HIV. Initiating PEP when source patients are uninfected puts exposed persons at risk from taking toxic drugs with no compensating benefit. Forgoing PEP if the source is infected results in increased risk of acquiring HIV. What should be done if source patients refuse HIV testing? Is it justifiable to test the blood of these patients over their autonomous objection? The authors review current law and policy and perform an ethical analysis to determine if laws permitting unconsented testing in cases of occupational exposure can be ethically justified. PMID:22994417

Controlling pain and reducing misuse of opioids

PubMed Central

Kotalik, Jaro

2012-01-01

Abstract Objective To help family physicians achieve an ethical balance in their opioid prescribing practices. Quality of evidence MEDLINE was searched for English-language articles published between 1985 and 2011. Most available evidence was level III. Main message It is essential to follow practice guidelines when prescribing opioids, except when another course of action is demonstrably justified. In addition, when considering the appropriateness of an opioid prescription, with its many ethical implications, the decision can be usefully guided by the application of the ethical principles of beneficence, nonmaleficence, respect for autonomy, and justice. As well, it is essential to keep current about legal and regulatory changes and provincial electronic registries of opioid prescriptions. Conclusion Physicians need to ensure that their patients’ pain is properly assessed and managed. Reaching optimal pain control might necessitate prescribing opioids. But the obligation to provide pain relief needs to be balanced with an equally important responsibility not to expose patients to risk of addiction and not to create opportunities for drug diversion, trafficking, and the addiction of others. Basic ethical principles can provide a framework to help physicians make ethically appropriate decisions about opioid prescribing. PMID:22611604

Ethical concerns and career satisfaction in obstetrics and gynecology: a review of recent findings from the Collaborative Ambulatory Research Network.

PubMed

Farrow, Victoria A; Leddy, Meaghan A; Lawrence, Hal; Schulkin, Jay

2011-09-01

Obstetricians-gynecologists (ob-gyns) are frequently confronted with situations that have ethical implications (e.g., whether to accept gifts or samples from drug companies or disclosing medical errors to patients). Additionally, various factors, including specific job-related tasks, costs, and benefits, may impact ob-gyns' career satisfaction. Ethical concerns and career satisfaction can play a role in the quality of women's health care. This article summarizes the studies published between 2005 and 2009 by the Research Department of the American College of Obstetricians and Gynecologists, which encompass ethical concerns regarding interactions with pharmaceutical representatives and patient safety/medical error reporting, as well as ob-gyn career satisfaction. Additionally, a brief discussion regarding ethical concerns in the ob-gyn field, in general, highlights key topics for the last 30 years. Ethical dilemmas continue to be of concern for ob-gyns. Familiarity with guidelines on appropriate interactions with industry is associated with lower percentages of potentially problematic relationships with pharmaceutical industries. Physicians report that the expense of patient safety initiatives is one of the top barriers for improving patient safety, followed by fear of liability. Overall, respondents reported being satisfied with their careers. However, half of the respondents reported that they were extremely concerned about the impact of professional liability costs on the duration of their careers. Increased familiarity with guidelines may lead to a decreased ob-gyn reliance on pharmaceutical representatives and free samples, whereas specific and practical tools may help them implement patient safety techniques. The easing of malpractice insurance and threat of litigation may enhance career satisfaction among ob-gyns. This article will discuss related findings in recent years. Obstetricians & Gynecologists and Family Physicians. After the completing the CME activity, physicians should be better able to analyze how interactions with pharmaceutical industry may pose ethical dilemmas, examine current barriers to implementing patient safety initiatives, and evaluate the factors that influence career satisfaction among obstetrician-gynecologists.

Ethics-sensitivity of the Ghana national integrated strategic response plan for pandemic influenza.

PubMed

Laar, Amos; DeBruin, Debra

2015-05-07

Many commentators call for a more ethical approach to planning for influenza pandemics. In the developed world, some pandemic preparedness plans have already been examined from an ethical viewpoint. This paper assesses the attention given to ethics issues by the Ghana National Integrated Strategic Plan for Pandemic Influenza (NISPPI). We critically analyzed the Ghana NISPPI's sensitivity to ethics issues to determine how well it reflects ethical commitments and principles identified in our review of global pandemic preparedness literature, existing pandemic plans, and relevant ethics frameworks. This paper reveals that important ethical issues have not been addressed in the Ghana NISPPI. Several important ethical issues are unanticipated, unacknowledged, and unplanned for. These include guidelines on allocation of scarce resources, the duties of healthcare workers, ethics-sensitive operational guidelines/protocols, and compensation programs. The NISPPI also pays scant attention to use of vaccines and antivirals, border issues and cooperation with neighboring countries, justification for delineated actions, and outbreak simulations. Feedback and communication plans are nebulous, while leadership, coordination, and budgeting are quite detailed. With respect to presentation, the NISPPI's text is organized around five thematic areas. While each area implicates ethical issues, NISPPI treatment of these areas consistently fails to address them. Our analysis reveals a lack of consideration of ethics by the NISPPI. We contend that, while the plan's content and fundamental assumptions provide support for implementation of the delineated public health actions, its consideration of ethical issues is poor. Deficiencies include a failure to incorporate guidelines that ensure fair distribution of scarce resources and a lack of justification for delineated procedures. Until these deficiencies are recognized and addressed, Ghana runs the risk of rolling out unjust and ethically indefensible actions with real negative effects in the event of a pandemic. Soliciting inputs from the public and consultation with ethicists during the next revision of the NISPPI will be useful in addressing these issues.

Social media and organ donation: Ethically navigating the next frontier.

PubMed

Henderson, M L; Clayville, K A; Fisher, J S; Kuntz, K K; Mysel, H; Purnell, T S; Schaffer, R L; Sherman, L A; Willock, E P; Gordon, E J

2017-11-01

As the organ shortage continues to grow, the creation of social media communities by transplant hospitals and the public is rapidly expanding to increase the number of living donors. Social media communities are arranged in myriad ways and without standardization, raising concerns about transplant candidates' and potential donors' autonomy and quality of care. Social media communities magnify and modify extant ethical issues in deceased and living donation related to privacy, confidentiality, professionalism, and informed consent, and increase the potential for undue influence and coercion for potential donors and transplant candidates. Currently, no national ethical guidelines have been developed in the United States regarding the use of social media to foster organ transplantation. We provide an ethical framework to guide transplant stakeholders in using social media for public and patient communication about transplantation and living donation, and offer recommendations for transplant clinical practice and future research. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.

On the Necessity of Ethical Guidelines for Novel Neurotechnologies.

PubMed

Goering, Sara; Yuste, Rafael

2016-11-03

Because novel neurotechnologies may alter human identity and society in profound ways, we advocate for the early integration of ethics into neurotechnology. We recommend developing and adopting a set of guidelines, like the Belmont Report on human subject research, as a framework for development and use of brain-related technologies. Copyright © 2016 Elsevier Inc. All rights reserved.

Brief Report: Stony Brook Guidelines on the Ethics of the Care of People with Autism and Their Families

ERIC Educational Resources Information Center

Post, Stephen G.; Pomeroy, John; Keirns, Carla C.; Cover, Virginia Isaacs; Dorn, Michael Leverett; Boroson, Louis; Boroson, Florence; Coulehan, Anne; Coulehan, Jack; Covell, Kim; Kubasek, Kim; Luchsinger, Elizabeth; Nichols, Shana; Parles, James; Schreiber, Linda; Tetenbaum, Samara P.; Walsh, Rose Ann

2013-01-01

The increased prevalence of autism spectrum disorders (ASD), with associated societal and clinical impacts, calls for a broad community-based dialogue on treatment related ethical and social issues. The Stony Brook Guidelines, based on a community dialogue process with affected individuals, families and professionals, identify and discuss the…

Ethics in Pharmacy Curriculum for Undergraduate Pharmacy Students: A Needs Assessment Study.

PubMed

Salari, Pooneh; Abdollahi, Mohammad

2017-01-01

Recent advances in pharmacy practice have created serious ethical challenges for the pharmacists. Pursuing a new philosophy of practice is required to overcome these challenges and optimize the standard of care. In this regard, the current ethics guideline in the Pharmacy curriculum used in Tehran University of Medical Sciences, does not provide a fully comprehensive understanding of the issue. Therefore, the aim of the present study was to revise the current curriculum based on a needs assessment study. In this study, a two-part questionnaire was presented to pharmacists to obtain their views on the importance of topics in their daily routine practice. Part one of the questionnaire consisted of demographic data and part two of 23 topics in pharmacy ethics. Out of a total of 200 questionnaires, 158 questionnaires were returned. We reached consensus on 24 topics, of which 8 topics gained a score of higher than 4 (the highest score was considered to be 5) and the rest obtained a score of 3 and higher. The highest score pertained to the pharmacists' relationship with patients, awareness of the rules and regulations, and medication error. Based on the results, a revised curriculum was designed for ethics in pharmacy. It seems that the designed curriculum is context-based and will develop appropriate educational material regarding pharmacists' requirements in daily practice. Consideration of interactive methods for teaching the curriculum is highly recommended.

[Coercive procedures in forensic psychiatry : Current treatment practice in forensic psychiatric hospitals from a medical ethics perspective].

PubMed

Jakovljević, A-K; Wiesemann, C

2016-07-01

In 2011 the legal foundations of coercive treatment in German forensic psychiatric clinics were declared to be unconstitutional. In the present study we analyzed the frequency of coercive procedures in forensic psychiatric hospitals before and after 2011, the consequences for medical care as well as the ethical assessments by attending chief physicians. By a questionnaire-based survey of views of attending chief physicians in forensic psychiatric clinics in 2013, data on the current state of patient care were collected and analyzed from an ethical perspective. These were compared with treatment data from a large forensic psychiatric clinic collected over the period 2007-2013. Even after 2011 coercive forms of treatment were applied in forensic psychiatric hospitals. In practice, there is a high degree of legal uncertainty regarding the limits of coercive treatment. Of all patients treated in forensic psychiatric clinics in 2012, on average 13 % had been in isolation at least once, approximately 3 % had been treated under fixation at least once and 2.2 % had been subjected to coercive medical treatment at least once. From an ethical perspective an open debate about the practice of coercive treatment is urgently required. Legal regulations, ethical guidelines and treatment standards have to be developed for the special situation of patient care in forensic psychiatric hospitals.

Marriage and Family Counseling: Ethics in Context

ERIC Educational Resources Information Center

Southern, Stephen; Smith, Robert L.; Oliver, Marvarene

2005-01-01

Codes of ethics typically provide rules and guidelines for best practices in marriage and family counseling. An emerging model for ethical decision making emphasizes the ethics of virtues and aspirations. Exploring fundamental models of helping, as well as contemporary issues in community systems, affords context for examining the professional…

Ethics in Practice

ERIC Educational Resources Information Center

Medlin, E. Lander

2010-01-01

Ethics is defined as a set of guidelines and/or rules for the conduct of individual behavior in an organization or civil society. This ethical code of conduct is intended to guide policies, practices, and decision-making for employees on behalf of the organization. This article explores the importance of ethics, the basis for making ethical…

The ethical use of paradoxical interventions in psychotherapy.

PubMed Central

Foreman, D M

1990-01-01

The purpose of this paper is to establish ethical guidelines for the use of paradoxical interventions in psychotherapy. These are defined as interventions which are counterintuitive, coercive, and which require non-observance by the client. Arguments are developed to show that such interventions are associated with a psychology that understands individuals solely in terms of their relationship: a 'strong interactionist' position. Ethical principles consistent with such a position are considered, and from these it is derived that: paradox is an ethical technique with resistive patients; it requires consent; its content should be consistent with general ethical principles, especially those of beneficence and non-maleficence; non-paradoxical techniques should be preferred when possible; and it should not be used as an assessment procedure. It is concluded that research is needed to explore the effect of such ethical guidelines of effectiveness, though preliminary impressions are encouraging. PMID:2287016

Human and animal research guidelines: aligning ethical constructs with new scientific developments.

PubMed

Ferdowsian, Hope

2011-10-01

Both human research and animal research operate within established standards and procedures. Although the human research environment has been criticized for its sometimes inefficient and imperfect process, reported abuses of human subjects in research served as the impetus for the establishment of the Nuremberg Code, Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the resulting Belmont Report. No similar, comprehensive and principled effort has addressed the use of animals in research. Although published policies regarding animal research provide relevant regulatory guidance, these policies have not emerged from the process of specifying consistent and reasoned ethical principles. The lack of a fundamental effort to explore the ethical issues and principles regarding the use of animals in research has led to unclear and disparate policies. Recent studies have increased our understanding of animal cognition and emotion, suggesting that animals' potential for experiencing a wide variety of harms, such as pain and fear, is greater than has been previously appreciated. Furthermore, relationships between methods of captivity and certain laboratory procedures and the resulting adverse physical, social and psychological effects have been established. In light of this information, current protections may need to be reconsidered and modified. This paper explores the historical convergence and divergence in the creation of human and animal research guidelines, as well as opportunities to align ethical frameworks with new scientific discoveries. © 2011 Blackwell Publishing Ltd.

Making a difference: incorporating theories of autonomy into models of informed consent.

PubMed

Delany, C

2008-09-01

Obtaining patients' informed consent is an ethical and legal obligation in healthcare practice. Whilst the law provides prescriptive rules and guidelines, ethical theories of autonomy provide moral foundations. Models of practice of consent, have been developed in the bioethical literature to assist in understanding and integrating the ethical theory of autonomy and legal obligations into the clinical process of obtaining a patient's informed consent to treatment. To review four models of consent and analyse the way each model incorporates the ethical meaning of autonomy and how, as a consequence, they might change the actual communicative process of obtaining informed consent within clinical contexts. An iceberg framework of consent is used to conceptualise how ethical theories of autonomy are positioned and underpin the above surface, and visible clinical communication, including associated legal guidelines and ethical rules. Each model of consent is critically reviewed from the perspective of how it might shape the process of informed consent. All four models would alter the process of obtaining consent. Two models provide structure and guidelines for the content and timing of obtaining patients' consent. The two other models rely on an attitudinal shift in clinicians. They provide ideas for consent by focusing on underlying values, attitudes and meaning associated with the ethical meaning of autonomy. The paper concludes that models of practice that explicitly incorporate the underlying ethical meaning of autonomy as their basis, provide less prescriptive, but more theoretically rich guidance for healthcare communicative practices.

Ethical, social, and legal issues surrounding studies of susceptible populations and individuals.

PubMed Central

Soskolne, C L

1997-01-01

Calls for professional accountability have resulted in the development of ethics guidelines by numerous specialty and subspecialty groups of scientists. Indeed, guidelines among some health professions now address vulnerable and dependent groups: but these are silent on issues related to biomarkers. In parallel, attention has been drawn to human rights concerns associated with attempts to detect hypersusceptible workers, especially in democratic countries. Despite this, concern for vulnerable populations grows as advances in biomarker technology make the identification of genetic predisposition and susceptibility markers of both exposure and outcome more attainable. In this article, the principles derived from the ethical theory of utilitarianism provide the basis for principle-based ethical analysis. In addition, the four principles of biomedical ethics--respect for autonomy, beneficence, nonmaleficence, and social justice--are considered for biomarker studies. The need for a context in which ethical analysis is conducted and from which prevailing social values are shown to drive decisions of an ethical nature is emphasized; these include statutory regulation and law. Because biomarker studies can result in more harm than good, special precautions to inform research participants prior to any involvement in the use of biomarkers are needed. In addition, safeguards to maintain the privacy of data derived from biomarker studies must be developed and implemented prior to the application of these new technologies. Guidelines must be expanded to incorporate ethical, social, and legal considerations surrounding the introduction of new technologies for studying susceptible populations and individuals who may be vulnerable to environmental exposures. PMID:9255569

[How to Understand "Clinical Ethics" and "Research Ethics" in Clinical Settings--Incorporation of IRB, REC, and CEC in Hospital Organizations].

PubMed

Ita, Koichiro

2016-02-01

As the traditional definition of "medical ethics" has recently changed markedly with advances in medical knowledge and technology, medical doctors and researchers in Japan are required to understand and apply both research and clinical ethics. Quite frequently, ethical problems in clinical settings cannot be addressed by the simple application of good will, hard work, and perseverance by medical personnel. The Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Education, Culture, Sports, Science and Technology (MEXT) have jointly published "Ethical Guidelines for Clinical Studies;" however, clear guidelines (legal, ministerial, or governmental) outlining the expectations regarding clinical ethics do not exist. All medical personnel face deep ethical dilemmas. In these instances, if the fulfillment of 'ethics' relies solely on the capacity of personnel to apply their own individual moral efforts, the result will be burn-out among these workers who have a strong sense of responsibility. In order to avoid this, a system which comprises multiple physicians, nurses, and other personnel must be established, allowing collaboration when an appropriate response is required. A major factor supporting this approach is the offering of Clinical Ethics Consultations.

Improving opioid safety practices in primary care: protocol for the development and evaluation of a multifaceted, theory-informed pilot intervention for healthcare providers

PubMed Central

Leece, Pamela; Buchman, Daniel Z; Hamilton, Michael; Timmings, Caitlyn; Shantharam, Yalnee; Moore, Julia; Furlan, Andrea D

2017-01-01

Introduction In North America, drug overdose deaths are reaching unprecedented levels, largely driven by increasing prescription opioid-related deaths. Despite the development of several opioid guidelines, prescribing behaviours still contribute to poor patient outcomes and societal harm. Factors at the provider and system level may hinder or facilitate the application of evidence-based guidelines; interventions designed to address such factors are needed. Methods and analysis Using implementation science and behaviour change theory, we have planned the development and evaluation of a comprehensive Opioid Self-Assessment Package, designed to increase adherence to the Canadian Opioid Guideline among family physicians. The intervention uses practical educational and self-assessment tools to provide prescribers with feedback on their current knowledge and practices, and resources to improve their practice. The evaluation approach uses a pretest and post-test design and includes both quantitative and qualitative methods at baseline and 6 months. We will recruit a purposive sample of approximately 10 family physicians in Ontario from diverse practice settings, who currently treat patients with long-term opioid therapy for chronic pain. Quantitative data will be analysed using basic descriptive statistics, and qualitative data will be analysed using the Framework Method. Ethics and dissemination The University Health Network Research Ethics Board approved this study. Dissemination plan includes publications, conference presentations and brief stakeholder reports. This evidence-informed, theory-driven intervention has implications for national application of opioid quality improvement tools in primary care settings. We are engaging experts and end users in advisory and stakeholder roles throughout our project to increase its national relevance, application and sustainability. The performance measures could be used as the basis for health system quality improvement indicators to monitor opioid prescribing. Additionally, the methods and approach used in this study could be adapted for other opioid guidelines, or applied to other areas of preventive healthcare and clinical guideline implementation processes. PMID:28446522

Board Certified Behavior Analysts and Related Ethical and Professional Practice Considerations for Rural Schools

ERIC Educational Resources Information Center

Menendez, Anthony L.; Mayton, Michael R.; Yurick, Amanda L.

2017-01-01

When rural school districts employ Board Certified Behavior Analysts (BCBAs) to assist in meeting the needs of students with disabilities, it is important that they be aware of the ethical and professional guidelines to which BCBAs are required to adhere. This article describes the role of these guidelines within the practice of BCBAs and presents…

A Grassroots Community Dialogue on the Ethics of the Care of People with Autism and Their Families: The Stony Brook Guidelines.

PubMed

Post, Stephen G; Pomeroy, John; Keirns, Carla; Cover, Virginia Isaacs; Dorn, Michael Leverett

2017-06-01

The increased recognition and reported prevalence of autism spectrum disorders (ASD) combined with the associated societal and clinical impact call for a broad grassroots community-based dialogue on treatment related ethical and social issues. In these Stony Brook Guidelines, which were developed during a full year of community dialogue (2010-2011) with affected individuals, families, and professionals in the field, we identify and discuss topics of paramount concern to the ASD constituency: treatment goals and happiness, distributive justice, managing the desperate hopes for a cure, sibling responsibilities, intimacy and sex, diagnostic ethics, and research ethics. The members of the dialogue core committee included doctors, ethicists, administrators, social workers, ministers, disability experts, and many family members of individuals with autism who were especially engaged in community activities on behalf of their constituency, including siblings, parents, and grandparents. Our guidelines are not based on "top-down" imposition of professional expertise, but rather on a "bottom-up" grass roots attention to the voices of affected individuals and families speaking from experience. These guidelines can inform clinical practice, but they also are meaningful for the wider social conversation emerging over the treatment of individuals with ASD.

[Ethical issues in the practice of advance directives, living wills, and self-determination in end of life care].

PubMed

Fang, Hui-Feng; Jhing, Huei-Yu; Lin, Chia-Chin

2009-02-01

The Hospice-Palliative Care Act, enacted in Taiwan in 2000, was designed to respect the end of life medical wishes of patients with incurable illnesses, safeguard the rights of these patients, and provide clinical guidelines for healthcare workers responsible to provide end of life care. Self-determination is a core element of human dignity. Advance directive documents include a living will, and durable power of attorney for healthcare. This article reviews current issues and ethical dilemmas with regard to advance directives. Patients, family members, and clinicians may require better education on the Hospice-Palliative Care Act in order to respect more appropriately patient end of life medical care wishes.

Ethics guidelines, health research and Indigenous Australians.

PubMed

Anderson, Ian; Griew, Robert; McAullay, Daniel

2003-02-01

In this paper we overview the findings of a literature review that was undertaken to guide the revision of the Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Health Research (NH&MRC, 1991). The literature reviewed, in general, supported the development of specific research guidelines for Aboriginal and Torres Strait Islander contexts. The findings of this review were analysed thematically, and a number of key issues were identified for consideration in the review process. We present a summary of these key issues. In the final section of the paper we consider in more detail two of the key issues raised in the review process (the assessment of relevance or benefit of proposed research; and the process of consultation and negotiation of collective consent) in order to critically consider how these issue should be engaged in revised guidelines. On the basis of this analysis, it is our contention that specific guidelines on key issues are limited to the extent to which they can anticipate all possible research contexts. In order to address this problem, and guide researchers, guidelines should also explicitly outline the values, from an Aboriginal and Torres Islander perspective that are foundational to an ethical research process.

Ethical regulations for innovative surgery: the last frontier?

PubMed

Reitsma, Angelique M; Moreno, Jonathan D

2002-06-01

There are no clear federal regulations governing innovative surgery, even though general guidelines regulating research with human subjects do exist. We hypothesized that US surgeons are unaware of Department of Health and Human Services regulations, rarely seek IRB review, generally oppose outside regulation of innovative surgery, and are uncertain what constitutes innovation and research. These circumstances, if true, would pose a significant ethical problem and present potential harm to patients as unwitting subjects of research. In a pilot study we reviewed 527 issues of US surgical and medical journals, selecting 59 articles published between 1992 and 2000, that described innovative surgery. Corresponding authors from university hospitals (71%) and other facilities (29%) were sent an anonymous questionnaire. The survey was conducted between November 2000 and May 2001. Twenty-one questionnaires were returned, completed with responses, constituting a 35% overall response rate. Fourteen authors confirmed their work was research, yet only six had sought prior IRB review. The majority of authors (15 of 21) did not submit their protocol to IRB. Only seven authors had mentioned the innovative nature of the procedure in the informed consent form. Seven authors claimed familiarity with Office for Human Research Protections definitions of research and human subject. Two-thirds of the respondents stated that government regulations for the protection of human subjects of innovative surgery would not be appropriate. The current system of definitions, ethical theories, and voluntary professional guidelines may be inadequate to meet the challenge of surgical innovation. Further research is proposed to examine the adequacy of the existing guidelines.

Frameworks for Teaching and Learning Business Ethics within the Global Context: Background of Ethical Theories

ERIC Educational Resources Information Center

White, Judith; Taft, Susan

2004-01-01

In this article, we provide a summary of several major traditional and contemporary philosophical and psychological perspectives on ethical conduct for businesses, along with five different sets of internationally accepted ethical guidelines for corporations operating anywhere in the world. We include examples of corporate codes of conduct from…

End-of-Life Decision Making in Palliative Care and Recommendations of the Council of Europe: Qualitative Secondary Analysis of Interviews and Observation Field Notes.

PubMed

Martins Pereira, Sandra; Fradique, Emília; Hernández-Marrero, Pablo

2018-05-01

End-of-life decisions (ELDs) are embedded in clinical, sociocultural, political, economic, and ethical concerns. In 2014, the Council of Europe (CoE) through its Committee on Bioethics launched the "Guide on the decision-making process regarding medical treatment in end-of-life situations," aiming at improving decision-making processes and empowering professionals in making ELDs. To analyze if end-of-life decision making in palliative care (PC) is consistent with this Guide and to identify if disputed/controversial issues are part of current ELDs. Qualitative secondary analysis. Four qualitative datasets, including 44 interviews and 9 team observation field notes from previous studies with PC teams/professionals in Portugal. An analysis grid based on the abovementioned guide was created considering three dimensions: ethical and legal frameworks, decision-making process, and disputed/controversial issues. The majority of the professionals considered the ethical principle of autonomy paramount in end-of-life decision making. Justice and beneficence/nonmaleficence were also valued. Although not mentioned in the Guide, the professionals also considered other ethical principles when making ELDs, namely, responsibility, integrity, and dignity. Most of the interviewees and field notes referred to the collective interprofessional dimension of the decision-making process. Palliative sedation and the wish to hasten death were the most mentioned disputed/controversial issues. The nature, limitations, and benefits of qualitative secondary analysis are discussed. End-of-life decision-making processes made by Portuguese PC teams seem to be consistent with the guidelines of the CoE. Further research is needed about disputed/controversial issues and the actual use, effectiveness, and impact of ethical guidelines for end-of-life decision making on professionals' empowerment and for all parties involved.

Consumerism in prenatal diagnosis: a challenge for ethical guidelines

PubMed Central

Henn, W.

2000-01-01

The ethical guidelines for prenatal diagnosis proposed by the World Health Organisation (WHO), as well as by national regulations, only refer to paternity and gender of the fetus as unacceptable, disease-unrelated criteria for prenatal selection, as no other such parameters are at hand so far. This perspective is too narrow because research on complex genetic systems such as cognition and ageing is about to provide clinically applicable tests for genetic constituents of potentially desirable properties such as intelligence or longevity which could be misused as parameters for prenatal diagnosis. Moreover, there is an increasing number of prenatally testable genetic traits, such as heritable deafness, which are generally regarded as pathological but desired by some prospective parents and taken into account as parameters for pro-disability selection. To protect prenatal diagnosis from ethically unacceptable genetic consumerism, guidelines must be clarified as soon as possible and updated towards a worldwide restriction of prenatal genetic testing to immediately disease-determining traits. Key Words: Genetics • prenatal diagnosis • ethics • consumerism PMID:11129845

Feminist Family Therapy: Ethical Considerations for the Clinician.

ERIC Educational Resources Information Center

Costa, Luann; Sorenson, Jody

1993-01-01

Notes the traditional minimization of gender and power issues in the cultural context by systemic family therapists. Presents five questions that can serve as guidelines in examining ethical and personal issues and provides ethical considerations for the clinician. (Author/NB)

Genetics and education: the ethics of shaping human identity.

PubMed

Ravitsky, Vardit

2002-10-01

This paper suggests an analogy between education and genetic interventions as means of shaping the identity of children and future adults. It proposes to look at issues discussed in the philosophy of education as a possible source of insight for ethical guidelines regarding future genetic interventions. The paper focuses on situations of conflict between parents and state regarding the authority to determine the child s best interests. It describes the current formulation of the conflict in the literature as lacking the crucial element of the child s right to a cultural identity. It argues that this element is a necessary component in an ethical analysis of the child s best interests in a multicultural, liberal society which respects diversity. The paper therefore proposes a better model for the moral evaluation of identity-shaping decisions and offers some implications of this model for genetics.

The Chennai floods of 2015: urgent need for ethical disaster management guidelines.

PubMed

Mariaselvam, Suresh; Gopichandran, Vijayaprasad

2016-01-01

India has suffered several natural disasters in recent years. The super cyclone of Orissa in 1999 and the tsunami on the southeastern coast in 2004, both led to major developments in disaster management abilities in the country. Almost a decade after the last major disaster that hit south India, the recent floods in Chennai in 2015 brought to the fore a whole set of ethical considerations. There were issues of inequity in the relief and response activities, conflicts and lack of coordination between the government and non-government relief and response, more emphasis on short-term relief activities rather than rehabilitation and reconstruction, and lack of crisis standards of care in medical services. This paper highlights these ethical issues and the need for ethical guidelines and an ethical oversight mechanism for disaster management and response.

Ethical management guidelines for the shanghai disease-based biobank network.

PubMed

Zhu, Shu; Shen, Mingxian; Qiu, Xiangxing; Gan, Rongxing; Hu, Qingli

2015-02-01

The Ethical Management Guidelines for the Shanghai Disease-Based Biobank Network are intended to safeguard the interests of all the participants, to standardize the construction, management, and resource sharing of the Shanghai Disease-based Biobank Network, to promote the development of medical research, and to improve public health and well-being. The guidelines contain seven chapters: General Principles; Informed Consent; Use of Bio-samples from Persons without the Capacity to Consent; Privacy and Confidentiality; Applications of Use of Biological Samples and Data; Intellectual Property and Resource Sharing; and Conflict of Interest.

Against risk-benefit review of prisoner research.

PubMed

Chwang, Eric

2010-01-01

The 2006 Institute of Medicine (IOM) report, 'Ethical Considerations for Research Involving Prisoners', recommended five main changes to current US Common Rule regulations on prisoner research. Their third recommendation was to shift from a category-based to a risk-benefit approach to research review, similar to current guidelines on pediatric research. However, prisoners are not children, so risk-benefit constraints on prisoner research must be justified in a different way from those on pediatric research. In this paper I argue that additional risk-benefit constraints on prisoner research are unnecessary: the current Common Rule regulations, omitting category-based restrictions but conjoined with the IOM report's other four main recommendations, ensure that prisoner research is as ethical as non-prisoner research is. I explain why four problems which which may be more prevalent in prisons and which risk-benefit constraints may seem to address - coercion, undue inducements, exploitation, and protection from harm - are in fact not solved by adding further risk-benefit constraints on prisoner research.

Ongoing ethical issues concerning authorship in biomedical journals: an integrative review

PubMed Central

Kornhaber, Rachel Anne; McLean, Loyola M; Baber, Rodney J

2015-01-01

Health professionals publishing within the field of health sciences continue to experience issues concerning appropriate authorship, which have clinical, ethical, and academic implications. This integrative review sought to explore the key issues concerning authorship from a bioethical standpoint, aiming to explore the key features of the authorship debate. Studies were identified through an electronic search, using the PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Scopus databases of peer-reviewed research, published between 2009 and 2014, limited to English language research, with search terms developed to reflect the current issues of authorship. From among the 279 papers identified, 20 research papers met the inclusion criteria. Findings were compiled and then arranged to identify themes and relationships. The review incorporated a wide range of authorship issues encompassing equal-credited authors, honorary (guest/gift) and ghost authorship, perception/experiences of authorship, and guidelines/policies. This review suggests that the International Committee of Medical Journal Editors’ (ICMJE) recommended guidelines for authorship are not reflected in current authorship practices within the domain of health sciences in both low-and high-impact-factor journals. This devaluing of the true importance of authorship has the potential to affect the validity of authorship, diminish the real contributions of the true authors, and negatively affect patient care. PMID:26257520

Ongoing ethical issues concerning authorship in biomedical journals: an integrative review.

PubMed

Kornhaber, Rachel Anne; McLean, Loyola M; Baber, Rodney J

2015-01-01

Health professionals publishing within the field of health sciences continue to experience issues concerning appropriate authorship, which have clinical, ethical, and academic implications. This integrative review sought to explore the key issues concerning authorship from a bioethical standpoint, aiming to explore the key features of the authorship debate. Studies were identified through an electronic search, using the PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Scopus databases of peer-reviewed research, published between 2009 and 2014, limited to English language research, with search terms developed to reflect the current issues of authorship. From among the 279 papers identified, 20 research papers met the inclusion criteria. Findings were compiled and then arranged to identify themes and relationships. The review incorporated a wide range of authorship issues encompassing equal-credited authors, honorary (guest/gift) and ghost authorship, perception/experiences of authorship, and guidelines/policies. This review suggests that the International Committee of Medical Journal Editors' (ICMJE) recommended guidelines for authorship are not reflected in current authorship practices within the domain of health sciences in both low-and high-impact-factor journals. This devaluing of the true importance of authorship has the potential to affect the validity of authorship, diminish the real contributions of the true authors, and negatively affect patient care.

Integrated empirical ethics: loss of normativity?

PubMed

van der Scheer, Lieke; Widdershoven, Guy

2004-01-01

An important discussion in contemporary ethics concerns the relevance of empirical research for ethics. Specifically, two crucial questions pertain, respectively, to the possibility of inferring normative statements from descriptive statements, and to the danger of a loss of normativity if normative statements should be based on empirical research. Here we take part in the debate and defend integrated empirical ethical research: research in which normative guidelines are established on the basis of empirical research and in which the guidelines are empirically evaluated by focusing on observable consequences. We argue that in our concrete example normative statements are not derived from descriptive statements, but are developed within a process of reflection and dialogue that goes on within a specific praxis. Moreover, we show that the distinction in experience between the desirable and the undesirable precludes relativism. The normative guidelines so developed are both critical and normative: they help in choosing the right action and in evaluating that action. Finally, following Aristotle, we plead for a return to the view that morality and ethics are inherently related to one another, and for an acknowledgment of the fact that moral judgments have their origin in experience which is always related to historical and cultural circumstances.

AIDS: Balancing Confidentiality and the Duty to Protect.

ERIC Educational Resources Information Center

Lynch, Sherry K.

1993-01-01

Explores legal and ethical responsibilities of counselors working with human immunodeficiency virus-infected students and reviews guidelines for making critical decisions involving these students. Court decisions, Kitchner's (1985) five ethical principles, and ethical standards of several professional associations are considered. (Author/NB)

Keeping Kids Safe from a Design Perspective: Ethical and Legal Guidelines for Designing a Video-Based App for Children

ERIC Educational Resources Information Center

Zydney, Janet Mannheimer; Hooper, Simon

2015-01-01

Educators can use video to gain invaluable information about their students. A concern is that collecting videos online can create an increased security risk for children. The purpose of this article is to provide ethical and legal guidelines for designing video-based apps for mobile devices and the web. By reviewing the literature, law, and code…

Clinical report--guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations.

PubMed

Shaddy, Robert E; Denne, Scott C

2010-04-01

The proper ethical conduct of studies to evaluate drugs in children is of paramount importance to all those involved in these types of studies. This report is an updated revision to the previously published guidelines from the American Academy of Pediatrics in 1995. Since the previous publication, there have been great strides made in the science and ethics of studying drugs in children. There have also been numerous legislative and regulatory advancements that have promoted the study of drugs in children while simultaneously allowing for the protection of this particularly vulnerable group. This report summarizes these changes and advances and provides a framework from which to guide and monitor the ethical conduct of studies to evaluate drugs in children.

Leave No Trace! Land Ethics [and] Tread Lightly! On Public and Private Land. A National Land Use Ethics Program.

ERIC Educational Resources Information Center

Forest Service (USDA), Washington, DC.

This document consists of two brochures that provide land ethics guidelines for outdoor recreationists. The brochures provide techniques that visitors can use to help reduce evidence of their presence in the back country, designated "Wilderness" areas. The first brochure, titled "Leave no Trace! Land Ethics," provides…

Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey

PubMed Central

Wager, Elizabeth; Woolley, Karen; Adshead, Viv; Cairns, Angela; Fullam, Josh; Gonzalez, John; Grant, Tom; Tortell, Stephanie

2014-01-01

Objective To gather information about current practices and implementation of publication guidelines among publication professionals working in or for the pharmaceutical industry. Design/setting Web-based survey publicised via email and social media to members of the International Society for Medical Publication Professionals (ISMPP) and other organisations from November 2012 to February 2013. Participants 469 individuals involved in publishing industry-sponsored research in peer-reviewed journals, mainly working in pharmaceutical or device companies (‘industry’, n=144), communication agencies (‘agency’, n=238), contract research organisations (CRO, n=15) or as freelancers (n=34). Most respondents (78%) had worked on medical publications for ≥5 years and 62% had a PhD/MD. Results Over 90% of industry, agency and CRO respondents routinely refer to Good Publication Practice (GPP2) and the International Committee of Medical Journal Editors’ Uniform Requirements. Most respondents (78% industry, 79% agency) received mandatory training on ethical publication practices. Over 90% of respondents’ companies had publication guidelines or policies and required medical writing support to be acknowledged in publications (96% industry, 99% agency). Many industry respondents used publication management tools to monitor compliance with company guidelines and about half (46%) stated that their company had formal publication audits. Fewer agencies audited adherence to guidelines but 20% of agency respondents reported audits of employees and 6% audits of freelancers. Of concern, 37% of agency respondents reported requests from authors or sponsors that they believed were unethical, although 93% of these requests were withdrawn after respondents explained the need for compliance with guidelines. Most respondents’ departments (63% industry, 58% agency, 60% CRO) had been involved in publishing studies with negative or inconclusive results. Conclusions Within this sample, most publication professionals working in or for industry were aware of, and applying, major publication guidelines. However, the survey also identified specific areas where education and promotion of guidelines are needed to ensure ethical publication practices. PMID:24747794

Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey.

PubMed

Wager, Elizabeth; Woolley, Karen; Adshead, Viv; Cairns, Angela; Fullam, Josh; Gonzalez, John; Grant, Tom; Tortell, Stephanie

2014-04-19

To gather information about current practices and implementation of publication guidelines among publication professionals working in or for the pharmaceutical industry. Web-based survey publicised via email and social media to members of the International Society for Medical Publication Professionals (ISMPP) and other organisations from November 2012 to February 2013. 469 individuals involved in publishing industry-sponsored research in peer-reviewed journals, mainly working in pharmaceutical or device companies ('industry', n=144), communication agencies ('agency', n=238), contract research organisations (CRO, n=15) or as freelancers (n=34). Most respondents (78%) had worked on medical publications for ≥5 years and 62% had a PhD/MD. Over 90% of industry, agency and CRO respondents routinely refer to Good Publication Practice (GPP2) and the International Committee of Medical Journal Editors' Uniform Requirements. Most respondents (78% industry, 79% agency) received mandatory training on ethical publication practices. Over 90% of respondents' companies had publication guidelines or policies and required medical writing support to be acknowledged in publications (96% industry, 99% agency). Many industry respondents used publication management tools to monitor compliance with company guidelines and about half (46%) stated that their company had formal publication audits. Fewer agencies audited adherence to guidelines but 20% of agency respondents reported audits of employees and 6% audits of freelancers. Of concern, 37% of agency respondents reported requests from authors or sponsors that they believed were unethical, although 93% of these requests were withdrawn after respondents explained the need for compliance with guidelines. Most respondents' departments (63% industry, 58% agency, 60% CRO) had been involved in publishing studies with negative or inconclusive results. Within this sample, most publication professionals working in or for industry were aware of, and applying, major publication guidelines. However, the survey also identified specific areas where education and promotion of guidelines are needed to ensure ethical publication practices.

Ethics, equality and evidence in health promotion Danish guidelines for municipalities.

PubMed

Vallgårda, Signild

2014-06-01

The Danish National Board of Health has expressed its commitment to social equality in health, evidence-informed health promotion and public health ethics, and has issued guidelines for municipalities on health promotion, in Danish named prevention packages. The aim of this article is to analyse whether the Board of Health adheres to ideals of equality, evidence and ethics in these guidelines. An analysis to detect statements about equity, evidence and ethics in 10 health promotion packages directed at municipalities with the aim of guiding the municipalities towards evidence-informed disease prevention and health promotion. Despite declared intentions of prioritizing social equality in health, these intentions are largely absent from most of the packages. When health inequalities are mentioned, focus is on the disadvantaged or the marginalized. Several interventions are recommended, where there is no evidence to support them, notwithstanding the ambition of interventions being evidence-informed. Ethical considerations are scanty, scattered and unsystematically integrated. Further, although some packages mention the importance of avoiding stigmatization, there is little indicating how this could be done. Including reduction of health inequalities and evidence-informed and ethically defendable interventions in health promotion is a challenge, which is not yet fully met by the National Board of Health. When judged from liberal ethical principles, only few of the suggested interventions are acceptable, i.e., those concerning information, but from a paternalistic view, all interventions that may actually benefit the citizens are justified. © 2014 the Nordic Societies of Public Health.

How to introduce medical ethics at the bedside - Factors influencing the implementation of an ethical decision-making model.

PubMed

Meyer-Zehnder, Barbara; Albisser Schleger, Heidi; Tanner, Sabine; Schnurrer, Valentin; Vogt, Deborah R; Reiter-Theil, Stella; Pargger, Hans

2017-02-23

As the implementation of new approaches and procedures of medical ethics is as complex and resource-consuming as in other fields, strategies and activities must be carefully planned to use the available means and funds responsibly. Which facilitators and barriers influence the implementation of a medical ethics decision-making model in daily routine? Up to now, there has been little examination of these factors in this field. A medical ethics decision-making model called METAP was introduced on three intensive care units and two geriatric wards. An evaluation study was performed from 7 months after deployment of the project until two and a half years. Quantitative and qualitative methods including a questionnaire, semi-structured face-to-face and group-interviews were used. Sixty-three participants from different professional groups took part in 33 face-to-face and 9 group interviews, and 122 questionnaires could be analysed. The facilitating factors most frequently mentioned were: acceptance and presence of the model, support given by the medical and nursing management, an existing or developing (explicit) ethics culture, perception of a need for a medical ethics decision-making model, and engaged staff members. Lack of presence and acceptance, insufficient time resources and staff, poor inter-professional collaboration, absence of ethical competence, and not recognizing ethical problems were identified as inhibiting the implementation of the METAP model. However, the results of the questionnaire as well as of explicit inquiry showed that the respondents stated to have had enough time and staff available to use METAP if necessary. Facilitators and barriers of the implementation of a medical ethics decision-making model are quite similar to that of medical guidelines. The planning for implementing an ethics model or guideline can, therefore, benefit from the extensive literature and experience concerning the implementation of medical guidelines. Lack of time and staff can be overcome when people are convinced that the benefits justify the effort.

Commentary: The forensic report--an inevitable nexus for resolving ethics dilemmas.

PubMed

Weinstock, Robert

2013-01-01

Ethics-related dilemmas arise in forensic psychiatry as in all psychiatric practice. Although most can be resolved by following the AAPL Ethics Guidelines and the AAPL Ethics Questions and Answers, the more complex ones inevitably have no easy solutions. Ethics-based duties can conflict without clear guidance on prioritization. Weighing competing factors necessitates more than merely following a rule, since there are potentially conflicting rules, and ethical practitioners may prioritize them differently. Concerns pertaining to the death penalty and defendants who are victims of discrimination are especially difficult. Such considerations usually are in the realm of aspirational ethics, with conclusions open to debate. They need consideration by most practitioners concerned with determining the most ethical course of action. Much as it is insufficient for an ethical citizen merely to avoid breaking the law, it is not enough to avoid violating any one guideline while remaining blind to context. Most such dilemmas need resolution long before testimony and arise first in the way the forensic assessment is conducted and in decisions on the data to be included in a report and how they are presented. Although there can be legitimate differences of opinion about how to weigh and resolve conflicting considerations, ethics-related dilemmas should not be sidestepped.

Ethical clinical translation of stem cell interventions for neurologic disease.

PubMed

Cote, David J; Bredenoord, Annelien L; Smith, Timothy R; Ammirati, Mario; Brennum, Jannick; Mendez, Ivar; Ammar, Ahmed S; Balak, Naci; Bolles, Gene; Esene, Ignatius Ngene; Mathiesen, Tiit; Broekman, Marike L

2017-01-17

The application of stem cell transplants in clinical practice has increased in frequency in recent years. Many of the stem cell transplants in neurologic diseases, including stroke, Parkinson disease, spinal cord injury, and demyelinating diseases, are unproven-they have not been tested in prospective, controlled clinical trials and have not become accepted therapies. Stem cell transplant procedures currently being carried out have therapeutic aims, but are frequently experimental and unregulated, and could potentially put patients at risk. In some cases, patients undergoing such operations are not included in a clinical trial, and do not provide genuinely informed consent. For these reasons and others, some current stem cell interventions for neurologic diseases are ethically dubious and could jeopardize progress in the field. We provide discussion points for the evaluation of new stem cell interventions for neurologic disease, based primarily on the new Guidelines for Stem Cell Research and Clinical Translation released by the International Society for Stem Cell Research in May 2016. Important considerations in the ethical translation of stem cells to clinical practice include regulatory oversight, conflicts of interest, data sharing, the nature of investigation (e.g., within vs outside of a clinical trial), informed consent, risk-benefit ratios, the therapeutic misconception, and patient vulnerability. To help guide the translation of stem cells from the laboratory into the neurosurgical clinic in an ethically sound manner, we present an ethical discussion of these major issues at stake in the field of stem cell clinical research for neurologic disease. © 2016 American Academy of Neurology.

Guidelines for Teaching Cross-Cultural Clinical Ethics: Critiquing Ideology and Confronting Power in the Service of a Principles-Based Pedagogy.

PubMed

Brunger, Fern

2016-03-01

This paper presents a pedagogical framework for teaching cross-cultural clinical ethics. The approach, offered at the intersection of anthropology and bioethics, is innovative in that it takes on the "social sciences versus bioethics" debate that has been ongoing in North America for three decades. The argument is made that this debate is flawed on both sides and, moreover, that the application of cross-cultural thinking to clinical ethics requires using the tools of the social sciences (such as the critique of the universality of the Euro-American construct of "autonomy") within (rather than in opposition to) a principles-based framework for clinical ethics. This paper introduces the curriculum and provides guidelines for how to teach cross-cultural clinical ethics. The learning points that are introduced emphasize culture in its relation to power and underscore the importance of viewing both biomedicine and bioethics as culturally constructed.

Providing ethical guidance for collaborative research in developing countries

PubMed Central

Morris, Nina

2015-01-01

Experience has shown that the application of ethical guidelines developed for research in developed countries to research in developing countries can be, and often is, impractical and raises a number of contentious issues. Various attempts have been made to provide guidelines more appropriate to the developing world context; however, to date these efforts have been dominated by the fields of bioscience, medical research and nutrition. There is very little advice available for those seeking to undertake collaborative social science or natural science research in developing countries and what is there tends to be held within disparate sources. Charting the development of a set of ethics documentation for future use by the Ecosystem Services for Poverty Alleviation (ESPA) programme research community, this paper outlines past and present attitudes towards ethics procedures amongst this community and suggests ways in which ethics procedures might be made more relevant and user-friendly to researchers working in this area. PMID:26640509

[Cost-conscious medical decisions. Normative guidance within the conflicting demands of ethics and economics].

PubMed

Marckmann, G; In der Schmitten, J

2014-05-01

Under the current conditions in the health care system, physicians inevitably have to take responsibility for the cost dimension of their decisions on the level of single cases. This article, therefore, discusses the question how physicians can integrate cost considerations into their clinical decisions at the microlevel in a medically rational and ethically justified way. We propose a four-step model for "ethical cost-consciousness": (1) forego ineffective interventions as required by good evidence-based medicine, (2) respect individual patient preferences, (3) minimize the diagnostic and therapeutic effort to achieve a certain treatment goal, and (4) forego expensive interventions that have only a small or unlikely (net) benefit for the patient. Steps 1-3 are ethically justified by the principles of beneficence, nonmaleficence, and respect for autonomy, step 4 by the principles of justice. For decisions on step 4, explicit cost-conscious guidelines should be developed locally or regionally. Following the four-step model can contribute to ethically defensible, cost-conscious decision-making at the microlevel. In addition, physicians' rationing decisions should meet basic standards of procedural fairness. Regular cost-case discussions and clinical ethics consultation should be available as decision support. Implementing step 4, however, requires first of all a clear political legitimation with the corresponding legal framework.

Ethical and Sociocultural Aspects of Sexual Function and Dysfunction in Both Sexes.

PubMed

Atallah, Sandrine; Johnson-Agbakwu, Crista; Rosenbaum, Talli; Abdo, Carmita; Byers, E Sandra; Graham, Cynthia; Nobre, Pedro; Wylie, Kevan; Brotto, Lori

2016-04-01

This study aimed to highlight the salient sociocultural factors contributing to sexual health and dysfunction and to offer recommendations for culturally sensitive clinical management and research as well for an ethically sound sexual health care, counseling and medical decision-making. There are limited data on the impact of sociocultural factors on male and female sexual function as well as on ethical principles to follow when clinical care falls outside of traditional realms of medically indicated interventions. This study reviewed the current literature on sociocultural and ethical considerations with regard to male and female sexual dysfunction as well as cultural and cosmetic female and male genital modification procedures. It is recommended that clinicians evaluate their patients and their partners in the context of culture and assess distressing sexual symptoms regardless of whether they are a recognized dysfunction. Both clinicians and researchers should develop culturally sensitive assessment skills and instruments. There are a number of practices with complex ethical issues (eg, female genital cutting, female and male cosmetic genital surgery). Future International Committee of Sexual Medicine meetings should seek to develop guidelines and associated recommendations for a separate, broader chapter on ethics. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Perception of studying dental law and ethics among postgraduate dental students in the UK.

PubMed

Wassif, H S

2015-08-14

Law and ethics is an integral part of medical and dental professional practice. The subject is touched upon in the undergraduate curriculum. Historically, dentists interested in postgraduate study in this subject have accessed courses on medical law and ethics. While there are areas of shared interest (for example, consent, confidentiality) there are differences in emphasis and content (for example, end of life care, organ transplants, etc) which are not relevant to dentistry. A new postgraduate certificate (PgCert) course was approved by the University of Bedfordshire designed specifically for dental practitioners, making it the only university accredited course in the UK that is specific to dental staff. Students' perception of the subject of dental law and ethics at a postgraduate level was not known. The first PgCert student cohort was assessed at the start and the end of the course using two questionnaires. Sixteen students, all qualified dental practitioners working in the UK, took part. The perception toward the subject of dental law and ethics was in-line with the current guideline and regulations governing the dental profession. Perception of dental law was clearer at the end of the course compared to the beginning while dental ethics remained a challenging subject.

[Ethics and biomedical research].

PubMed

Goussard, Christophe

2007-01-01

Ethics in biomedical research took off from the 1947 Nuremberg Code to its own right in the wake of the Declaration of Helsinki in 1964. Since then, (inter)national regulations and guidelines providing a framework for clinical studies and protection for study participants have been drafted and implemented, while ethics committees and drug evaluation agencies have sprung up throughout the world. These two developments were crucial in bringing about the protection of rights and safety of the participants and harmonization of the conduct of biomedical research. Ethics committees and drug evaluation agencies deliver ethical and scientific assessments on the quality and safety of the projects submitted to them and issue respectively approvals and authorizations to carry out clinical trials, while ensuring that they comply with regulatory requirements, ethical principles, and scientific guidelines. The advent of biomedical ethics, together with the responsible commitment of clinical investigators and of the pharmaceutical industry, has guaranteed respect for the patient, for whom and with whom research is conducted. Just as importantly, it has also ensured that patients reap the benefit of what is the primary objective of biomedical research: greater life expectancy, well-being, and quality of life.

Ethics in research.

PubMed

Bevan, Joan C

2007-04-01

This review will examine research ethics in the context of globalization of clinical trials and recent rapid developments in bioscience. It will focus on international ethical guidelines and the functions of research ethics review boards in research governance. Consent issues in genetic research, which must comply with privacy laws by protecting confidentiality and privacy of personal health data, will be discussed. There has been a rapid expansion of genomic and proteonomic research and biotechnology in the last decade. International ethical guidelines have been updated and the bioscience industry has developed ethics policies. At the same time, problems in academic anesthesia in the US and UK have been identified, leading to recommendations to train physician-scientists in anesthesia to stimulate research activity in the future. Anesthesiologists are joining interdisciplinary research teams and the concept of evidence-based translational research is emerging. Anesthesiologists are moving towards participation in interdisciplinary research teams. They are well placed to speed the translation of research discovery into clinical practice and provide evidence-based perioperative care. This review provides the ethical framework that anesthesiologists will need to meet the challenges of this changing pattern of practice.

Mental health research, ethics and multiculturalism.

PubMed

Bailes, Marion J; Minas, I Harry; Klimidis, Steven

2006-01-01

In this paper we examine ethical issues relevant to conducting mental health research with refugees and immigrant communities that have cultural orientations and social organisation that are substantially different to those of the broader Australian community, and we relate these issues to NH&MRC Guidelines. We describe the development and conduct of a mental health research project carried out recently in Melbourne with the Somali community, focusing on ethical principles involved, and relating these to the NH&MRC National Statement on Ethical Conduct in Research Involving Humans, and the NH&MRC document Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research. The experience of conducting mental health research with the Somali community highlights the fact that the principles of inclusion and benefit enunciated in the NH&MRC document Values and Ethics are particularly pertinent when conducting research with refugees and immigrant communities that are culturally distant to those of the broader Australian community. These principles inform issues of research design and consent, as well as guiding respectful engagement with the participating community and communication of the research findings.

A case report of embryo donation: ethical and clinical implications for psychologists.

PubMed

Rizk, Marianne; Pawlak, Stacey

2016-10-01

Third-party reproduction is a growing field, and an increasing body of literature considers the ethics of embryo donation. Due to the psychosocial complexities that generally accompany the donation and/or use of donor embryos, psychologists can play a pivotal role in these specialised fertility cases. While laws in the USA are in place to regulate the medical procedures involved in embryo donation, only unenforceable guidelines exist for psychologists specialising in fertility cases. The presentation of this case study aims to: (1) clarify the ethical concerns that fertility psychologists should consider in similar situations by assessing whether American Society of Reproductive Medicine (ASRM) and the American Psychological Association (APA) guidelines compete or complement one another within this case of embryo donation and (2) consider the interests, obligations and rights of all parties involved. Several principles, standards and guidelines that must be considered are described. Overall, the APA Ethics Code and the ASRM Guidelines appear to complement one another for most aspects of this case. Fertility psychologists should consider the clinical implications of the interests, rights and duties of all involved parties, including themselves. 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/

Breaking bad news revisited: the push for negotiated disclosure and changing practice implications.

PubMed

Arber, Anne; Gallagher, Ann

2003-04-01

This article revisits the ethical, legal, professional and emotional issues involved with disclosing bad news. The authors examine the push for disclosure that has come from a number of quarters in the UK, including ethical and legal challenges, in particular the Bristol Royal Inquiry Report, professional codes of conduct, health policy and the expectations of the public. The contribution of nurses to breaking bad news is not widely discussed in the literature. With the development of new nursing roles and evidence-based practice it is timely to consider the role of nurses in this process. The article highlights some limitations with current guidelines for breaking bad news, in particular, that these guidelines tend to be constructed from a professional standpoint and lack patient-centred evidence. The issue of emotional labour and how it relates to giving bad news is discussed with respect to professional staff and patients. The article concludes by raising some practice implications, including: the importance of context and continuity; the significance of information and support; the desirable qualities of the professional; and issues to consider in determining patient preferences.

Palliative sedation: not just normal medical practice. Ethical reflections on the Royal Dutch Medical Association's guideline on palliative sedation.

PubMed

Janssens, Rien; van Delden, Johannes J M; Widdershoven, Guy A M

2012-11-01

The main premise of the Royal Dutch Medical Association's (RDMA) guideline on palliative sedation is that palliative sedation, contrary to euthanasia, is normal medical practice. Although we do not deny the ethical distinctions between euthanasia and palliative sedation, we will critically analyse the guideline's argumentation strategy with which euthanasia is demarcated from palliative sedation. First, we will analyse the guideline's main premise, which entails that palliative sedation is normal medical treatment. After this, we will critically discuss three crucial propositions of the guideline that are used to support this premise: (1) the patient's life expectancy should not exceed 2 weeks; (2) the aim of the physician should be to relieve suffering and (3) expert consultation is optional. We will conclude that, if inherent problematic aspects of palliative sedation are taken seriously, palliative sedation is less normal than it is now depicted in the guideline.

Ethical Considerations When Making Exceptions to “Rules” in Psychiatry

PubMed Central

2014-01-01

This article explores several contexts in which psychiatrists may face having to decide whether to make exceptions to rules or guidelines when treating their patients. Contexts discussed include paternalistically going against a patient’s autonomy, violating professional psychiatric standards of care, and clashing with some kind of institutional policy. The author contends that standard guidelines cannot possibly apply optimally to all patients, and thus there will be times when exceptions to these guidelines must be made by the psychiatrist. In addition to discussing the ethical considerations, the author offers some suggestions when faced with certain conflicting situations. PMID:24653941

Guidelines for the use of cell lines in biomedical research

PubMed Central

Geraghty, R J; Capes-Davis, A; Davis, J M; Downward, J; Freshney, R I; Knezevic, I; Lovell-Badge, R; Masters, J R W; Meredith, J; Stacey, G N; Thraves, P; Vias, M

2014-01-01

Cell-line misidentification and contamination with microorganisms, such as mycoplasma, together with instability, both genetic and phenotypic, are among the problems that continue to affect cell culture. Many of these problems are avoidable with the necessary foresight, and these Guidelines have been prepared to provide those new to the field and others engaged in teaching and instruction with the information necessary to increase their awareness of the problems and to enable them to deal with them effectively. The Guidelines cover areas such as development, acquisition, authentication, cryopreservation, transfer of cell lines between laboratories, microbial contamination, characterisation, instability and misidentification. Advice is also given on complying with current legal and ethical requirements when deriving cell lines from human and animal tissues, the selection and maintenance of equipment and how to deal with problems that may arise. PMID:25117809

Guidelines for the use of cell lines in biomedical research.

PubMed

Geraghty, R J; Capes-Davis, A; Davis, J M; Downward, J; Freshney, R I; Knezevic, I; Lovell-Badge, R; Masters, J R W; Meredith, J; Stacey, G N; Thraves, P; Vias, M

2014-09-09

Cell-line misidentification and contamination with microorganisms, such as mycoplasma, together with instability, both genetic and phenotypic, are among the problems that continue to affect cell culture. Many of these problems are avoidable with the necessary foresight, and these Guidelines have been prepared to provide those new to the field and others engaged in teaching and instruction with the information necessary to increase their awareness of the problems and to enable them to deal with them effectively. The Guidelines cover areas such as development, acquisition, authentication, cryopreservation, transfer of cell lines between laboratories, microbial contamination, characterisation, instability and misidentification. Advice is also given on complying with current legal and ethical requirements when deriving cell lines from human and animal tissues, the selection and maintenance of equipment and how to deal with problems that may arise.

The full spectrum of ethical issues in the care of patients with ALS: a systematic qualitative review.

PubMed

Seitzer, F; Kahrass, H; Neitzke, G; Strech, D

2016-02-01

Dealing systematically with ethical issues in amyotrophic lateral sclerosis (ALS) care requires an unbiased awareness of all the relevant ethical issues. The aim of the study was to determine systematically and transparently the full spectrum of ethical issues in ALS care. We conducted a systematic review in Medline and Google Books (restricted to English and German literature published between 1993 and 2014). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in ALS care. The literature review retrieved 56 references that together mentioned a spectrum of 103 ethical issues in ALS care. The spectrum was structured into six major categories that consist of first and second-order categories of ethical issues. The systematically derived spectrum of ethical issues in ALS care presented in this paper raises awareness and understanding of the complexity of ethical issues in ALS care. It also offers a basis for the systematic development of informational and training materials for health professionals, patients and their relatives, and society as a whole. Finally, it supports a rational and fair selection of all those ethical issues that should be addressed in health policies, position papers and clinical practice guidelines. Further research is needed to identify ways to systematically select the most relevant ethical issues not only in the clinical environment, but also for the development of clinical practice guidelines.

Shaking Up the Debate: Ensuring the Ethical Use of DBS Intervention Criteria for Mid-Stage Parkinson's Patients.

PubMed

Eijkholt, Marleen; Cabrera, Laura Y; Ramirez-Zamora, Adolfo; Pilitsis, Julie G

2017-07-01

Deep brain stimulation (DBS) is a well-established treatment for the management of severe motor fluctuations in advanced Parkinson's disease (PD). Until recently, device regulation, medical, and insurance practices limited DBS to patients with advanced stages of PD. In February 2016 this changed, however, when the US Food and Drug Administration (FDA) granted formal approval for the use of brain stimulator in mid-stage PD patients. In this article, we examine whether DBS in mid-stage PD can be ethically justified beyond the FDA approval. We scrutinize the current risk-benefit profile, the costs-benefit profile, and the capacity for informed consent requirement, to ask if use of subthalamic nucleus (STN) in mid-stage DBS is ethically appropriate. We propose that mid-stage DBS decisions could be appropriate under a shared decision-making model, which embraces a broad quality of life perspective. Although it might be too premature to know how the FDA decision will affect medical and insurance practices, we conclude by arguing that revisions to persisting guidelines seems justified both on scientific and ethical grounds. © 2017 International Neuromodulation Society.

A model for ethical practices in clinical phonetics and linguistics.

PubMed

Powell, Thomas W

2007-01-01

The emergence of clinical phonetics and linguistics as an area of scientific inquiry gives rise to the need for guidelines that define ethical and responsible conduct. The diverse membership of the International Clinical Phonetics and Linguistics Association (ICPLA) and the readership of this journal are uniquely suited to consider ethical issues from diverse perspectives. Accordingly, this paper introduces a multi-tiered six-factor model for ethical practices to stimulate discussion of ethical issues.

Perceptions and attitudes of community pharmacists toward professional ethics and ethical dilemmas in the workplace.

PubMed

Vuković Rodríguez, Jadranka; Juričić, Živka

2018-05-01

Formal training in pharmacy ethics is relatively new in Croatia, and the professional code of ethics is more than 20 years old. Very little is known about how practicing pharmacists implement ethical considerations and relevant professional guidelines in their work. This study aimed to provide the first description of the perceptions and attitudes of Croatian community pharmacists toward ethics in pharmacy practice, how often they face certain ethical dilemmas and how they resolve them. A cross-sectional survey of 252 community pharmacists, including community pharmacists and pre-licensing trainees, was conducted in Zagreb, Croatia. This group accounts for 18% of licensed pharmacists in Croatia. The survey questions included four sections: general sociodemographic information, multiple-choice questions, pre-defined ethical scenarios, and ethical scenarios filled in by respondents. More than half of pharmacists (62.7%) face ethical dilemmas in everyday work. Nearly all (94.4%) are familiar with the current professional code of ethics in Croatia, but only 47.6% think that the code reflects the changes that the pharmacy profession faces today. Most pharmacists (83.3%) solve ethical dilemmas on their own, while nearly the same proportion (75.4%) think that they are not adequately trained to deal with ethical dilemmas. The pre-defined ethical scenarios experienced by the largest proportion of pharmacists are being asked to dispense a drug to someone other than the patient (93.3%), an unnecessary over-the-counter medicine (84.3%), a generic medicine clinically equivalent to the prescribed one (79.4%), or hormonal contraception over the counter (70.4%). The results demonstrate a need to improve formal pharmacy ethics education and training in how to assess ethical issues and make appropriate decisions, which implies the need for stronger collaboration between pharmacists and their professional association. Our results also highlight an urgent need to revise and update the Croatian code of ethics for pharmacists. Copyright © 2017 Elsevier Inc. All rights reserved.

Management of medical confidentiality in English professional football clubs: some ethical problems and issues

PubMed Central

Waddington, I; Roderick, M; Bundred, P

2002-01-01

Objective: To examine the ways in which confidential matters are dealt with in the context of the relationship between the club doctor (or physiotherapist) and the player as patient in English professional football clubs. Methods: Semistructured tape recorded interviews with 12 club doctors, 10 club physiotherapists, and 27 current and former players. A questionnaire was also sent to 90 club doctors; 58 were returned. Results: There is among club doctors and physiotherapists no commonly held code of ethics governing how much and what kind of information about players may properly be passed on to managers; associated with this, there is considerable variation from one club to another in terms of the amount and kind of information passed on to managers. In some clubs, medical staff attempt to operate more or less on the basis of the rules governing confidentiality that apply in general practice, but in other clubs, medical staff are more ready to pass on personal information about players. In some situations, this raises serious ethical questions. Conclusions: Guidelines dealing with confidentiality in practitioner-patient relationships in medical practice have long been available and have recently been restated, specifically in relation to the practice of sports medicine, by the British Olympic Association, the British Medical Association, and the Football Association. This is a welcome first step. However, if the guidelines are to have an impact on practice, detailed consideration needs to be given to ensuring their effective implementation; if this is to be achieved, consideration also needs to be given to identifying those aspects of the culture and organisation of professional football clubs that may hinder the full and effective implementation of those guidelines. PMID:11916894

Management of medical confidentiality in English professional football clubs: some ethical problems and issues.

PubMed

Waddington, I; Roderick, M

2002-04-01

To examine the ways in which confidential matters are dealt with in the context of the relationship between the club doctor (or physiotherapist) and the player as patient in English professional football clubs. Semistructured tape recorded interviews with 12 club doctors, 10 club physiotherapists, and 27 current and former players. A questionnaire was also sent to 90 club doctors; 58 were returned. There is among club doctors and physiotherapists no commonly held code of ethics governing how much and what kind of information about players may properly be passed on to managers; associated with this, there is considerable variation from one club to another in terms of the amount and kind of information passed on to managers. In some clubs, medical staff attempt to operate more or less on the basis of the rules governing confidentiality that apply in general practice, but in other clubs, medical staff are more ready to pass on personal information about players. In some situations, this raises serious ethical questions. Guidelines dealing with confidentiality in practitioner-patient relationships in medical practice have long been available and have recently been restated, specifically in relation to the practice of sports medicine, by the British Olympic Association, the British Medical Association, and the Football Association. This is a welcome first step. However, if the guidelines are to have an impact on practice, detailed consideration needs to be given to ensuring their effective implementation; if this is to be achieved, consideration also needs to be given to identifying those aspects of the culture and organisation of professional football clubs that may hinder the full and effective implementation of those guidelines.

Waiver Culture: The Unintended Consequence of Ethics Compliance

ERIC Educational Resources Information Center

Genova, Gina L.

2008-01-01

The passage of the U.S. Sarbanes-Oxley Act (2002) spawned a series of compliance and ethics programs --the revised Principles of Federal Prosecution of Business Organizations known as the Thompson Memo (Thompson, 2003), the revised Federal Sentencing Guidelines that included the Effective Compliance and Ethics Program and the corporate…

Ethical and Legal Issues Regarding Selective Abortion of Fetuses with Down Syndrome.

ERIC Educational Resources Information Center

Glover, Noreen M.; Glover, Samuel J.

1996-01-01

Selective abortion of fetuses with Down syndrome is discussed in terms of abortion perspectives, genetic testing, legislation, and ethical principles. The ethical principles of autonomy, beneficence, nonmaleficence, fidelity, and justice are offered as guidelines for the examination of legal standards imposed by legislation. (Author/PB)

Ethics, Governance, Research and Enterprise

ERIC Educational Resources Information Center

Lategan, Laetus; Hooper, Peter

2009-01-01

The focus of this paper is to reflect on research ethics practices at universities and particularly on the additional considerations needed as "enterprise" becomes a key driver across the sector internationally. The outcome of the paper is to identify suitable guidelines for dealing with the management of research ethics in this changing…

Health sciences librarians' awareness and assessment of the Medical Library Association Code of Ethics for Health Sciences Librarianship: the results of a membership survey.

PubMed

Byrd, Gary D; Devine, Patricia J; Corcoran, Kate E

2014-10-01

The Medical Library Association (MLA) Board of Directors and president charged an Ethical Awareness Task Force and recommended a survey to determine MLA members' awareness of and opinions about the current Code of Ethics for Health Sciences Librarianship. THE TASK FORCE AND MLA STAFF CRAFTED A SURVEY TO DETERMINE: (1) awareness of the MLA code and its provisions, (2) use of the MLA code to resolve professional ethical issues, (3) consultation of other ethical codes or guides, (4) views regarding the relative importance of the eleven MLA code statements, (5) challenges experienced in following any MLA code provisions, and (6) ethical problems not clearly addressed by the code. Over 500 members responded (similar to previous MLA surveys), and while most were aware of the code, over 30% could not remember when they had last read or thought about it, and nearly half had also referred to other codes or guidelines. The large majority thought that: (1) all code statements were equally important, (2) none were particularly difficult or challenging to follow, and (3) the code covered every ethical challenge encountered in their professional work. Comments provided by respondents who disagreed with the majority views suggest that the MLA code could usefully include a supplementary guide with practical advice on how to reason through a number of ethically challenging situations that are typically encountered by health sciences librarians.

Health sciences librarians' awareness and assessment of the Medical Library Association Code of Ethics for Health Sciences Librarianship: the results of a membership survey

PubMed Central

Byrd, Gary D.; Devine, Patricia J.; Corcoran, Kate E.

2014-01-01

Objective: The Medical Library Association (MLA) Board of Directors and president charged an Ethical Awareness Task Force and recommended a survey to determine MLA members' awareness of and opinions about the current Code of Ethics for Health Sciences Librarianship. Methods: The task force and MLA staff crafted a survey to determine: (1) awareness of the MLA code and its provisions, (2) use of the MLA code to resolve professional ethical issues, (3) consultation of other ethical codes or guides, (4) views regarding the relative importance of the eleven MLA code statements, (5) challenges experienced in following any MLA code provisions, and (6) ethical problems not clearly addressed by the code. Results: Over 500 members responded (similar to previous MLA surveys), and while most were aware of the code, over 30% could not remember when they had last read or thought about it, and nearly half had also referred to other codes or guidelines. The large majority thought that: (1) all code statements were equally important, (2) none were particularly difficult or challenging to follow, and (3) the code covered every ethical challenge encountered in their professional work. Implications: Comments provided by respondents who disagreed with the majority views suggest that the MLA code could usefully include a supplementary guide with practical advice on how to reason through a number of ethically challenging situations that are typically encountered by health sciences librarians. PMID:25349544

An overview on ethical issues about sperm donation.

PubMed

Gong, Dan; Liu, Yu-Lin; Zheng, Zhong; Tian, Yi-Fei; Li, Zheng

2009-11-01

Beyond the scientific progress in assisted reproductive technologies (ART), it is necessary to discuss the ethical considerations behind these advances. Ethical issues concerning sperm donation have been considered and discussed by government and non-governmental agencies, the public, media and academic institutions in many countries. Recommendations and guidelines concerning sperm donation issues vary from country to country and between professional groups within countries. This paper attempts to present an overview of findings and reports from various agencies concerning the ethics of sperm donation. The following topics are considered: limiting the number of donor offspring; minimizing risk of infection and genetics from sperm donors; age requirements for sperm donors; and anonymity versus non-anonymity of sperm donors. The diversity of policies shows that each country has its unique set of guidelines tailored toward its own specific needs. Similarly, countries designing their own procedures and guidelines concerning reproductive medicine must tailor them toward their own needs and practical considerations. In Mainland China, the anonymous policy for sperm donation should still be carried out, and the number of donor offspring should be revaluated. ART procedures must be conducted in a way that is respectful of those involved. Ethical principles must respect the interests and welfare of persons who will be born as well as the health and psychosocial welfare of all participants, including sperm donors.

EASE Guidelines for Authors and Translators of Scientific Articles to be Published in English

PubMed Central

2014-01-01

This concise and readable set of editorial guidelines was first published by the European Association of Science Editors (EASE) in 2010 and is updated annually. It is freely available in more than 20 languages at http://ease.org.uk/publications/author-guidelines. The document is aimed to help scientists worldwide in successful presentation of their research results and in correct translation of manuscripts into English. Moreover, it draws attention to ethical issues, like authorship criteria, plagiarism, conflict of interests, etc. Eight appendices provide examples or more detailed information on selected topics (Abstracts, Ambiguity, Cohesion, Ethics, Plurals, Simplicity, Spelling, and Text-tables). Widespread use of EASE Guidelines should increase the efficiency of international scientific communication. PMID:25132718

EASE Guidelines for Authors and Translators of Scientific Articles to be Published in English.

PubMed

2014-06-01

This concise and readable set of editorial guidelines was first published by the European Association of Science Editors (EASE) in 2010 and is updated annually. It is freely available in more than 20 languages at http://ease.org.uk/publications/author-guidelines. The document is aimed to help scientists worldwide in successful presentation of their research results and in correct translation of manuscripts into English. Moreover, it draws attention to ethical issues, like authorship criteria, plagiarism, conflict of interests, etc. Eight appendices provide examples or more detailed information on selected topics (Abstracts, Ambiguity, Cohesion, Ethics, Plurals, Simplicity, Spelling, and Text-tables). Widespread use of EASE Guidelines should increase the efficiency of international scientific communication.

Ethical guidelines for the evaluation of living organ donors

PubMed Central

Wright, Linda; Faith, Karen; Richardson, Robert; Grant, David

2004-01-01

Transplantation is an effective, life-prolonging treatment for organ failure. Demand has steadily increased over the past decade, creating a shortage in the supply of organs. In addition, the number of deceased organ donors has reached a plateau. Living-donor transplantation is increasingly an option, influenced by favourable clinical outcomes and increased waiting times at most transplant centres across North America. Living-donor kidney transplants have exceeded deceased-donor transplant rates at some centres. Organ donations from living donors have challenged transplant programs to develop a framework for determining donor acceptability. After a multidisciplinary consensus-building process of discussion and debate, the Multi-Organ Transplant Program of the University Health Network in Toronto has developed ethical guidelines for these procedures. These proposed guidelines address ethical concerns related to selection criteria and procedures, voluntariness, informed consent and disclosure of risks and benefits to both donor and recipient. PMID:15646438

Ethical aspects in tissue research: thematic analysis of ethical statements to the research ethics committee

PubMed Central

2012-01-01

Background Many studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies. Methods The data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n = 688). These included a total of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning. Results The researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research. Conclusion The written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies. PMID:22873761

Ethical aspects of genome diversity research: genome research into cultural diversity or cultural diversity in genome research?

PubMed

Ilkilic, Ilhan; Paul, Norbert W

2009-03-01

The goal of the Human Genome Diversity Project (HGDP) was to reconstruct the history of human evolution and the historical and geographical distribution of populations with the help of scientific research. Through this kind of research, the entire spectrum of genetic diversity to be found in the human species was to be explored with the hope of generating a better understanding of the history of humankind. An important part of this genome diversity research consists in taking blood and tissue samples from indigenous populations. For various reasons, it has not been possible to execute this project in the planned scope and form to date. Nevertheless, genomic diversity research addresses complex issues which prove to be highly relevant from the perspective of research ethics, transcultural medical ethics, and cultural philosophy. In the article at hand, we discuss these ethical issues as illustrated by the HGDP. This investigation focuses on the confrontation of culturally diverse images of humans and their cosmologies within the framework of genome diversity research and the ethical questions it raises. We argue that in addition to complex questions pertaining to research ethics such as informed consent and autonomy of probands, genome diversity research also has a cultural-philosophical, meta-ethical, and phenomenological dimension which must be taken into account in ethical discourses. Acknowledging this fact, we attempt to show the limits of current guidelines used in international genome diversity studies, following this up by a formulation of theses designed to facilitate an appropriate inquiry and ethical evaluation of intercultural dimensions of genome research.

Enhancing the African bioethics initiative.

PubMed

Ogundiran, Temidayo O

2004-10-15

Medical ethics has existed since the time of Hippocrates. However, formal training in bioethics did not become established until a few decades ago. Bioethics has gained a strong foothold in health sciences in the developed world, especially in Europe and North America. The situation is quite different in many developing countries. In most African countries, bioethics - as established and practiced today in the west- is either non-existent or is rudimentary. Though bioethics has come of age in the developed and some developing countries, it is still largely "foreign" to most African countries. In some parts of Africa, some bioethics conferences have been held in the past decade to create research ethics awareness and ensure conformity to international guidelines for research with human participants. This idea has arisen in recognition of the genuine need to develop capacity for reviewing the ethics of research in Africa. It is also a condition required by external sponsors of collaborative research in Africa. The awareness and interest that these conferences have aroused need to be further strengthened and extended beyond research ethics to clinical practice. By and large, bioethics education in schools that train doctors and other health care providers is the hook that anchors both research ethics and clinical ethics. This communication reviews the current situation of bioethics in Africa as it applies to research ethics workshops and proposes that in spite of the present efforts to integrate ethics into biomedical research in Africa, much still needs to be done to accomplish this. A more comprehensive approach to bioethics with an all-inclusive benefit is to incorporate formal ethics education into health training institutions in Africa.

Compliance of disease awareness campaigns in printed Dutch media with national and international regulatory guidelines.

PubMed

Leonardo Alves, Teresa; Martins de Freitas, Auramarina F; van Eijk, Martine E C; Mantel-Teeuwisse, Aukje K

2014-01-01

The European legislation prohibits prescription-only medicines' advertising but allows pharmaceutical companies to provide information to the public on health and diseases, provided there is no direct or indirect reference to a pharmaceutical product. Various forms of promotion have become increasingly common in Europe including "disease-oriented" campaigns. To explore examples of disease awareness campaigns by pharmaceutical companies in the Netherlands, by assessing their compliance with the World Health Organization (WHO) Ethical Criteria for medicinal drug promotion and the Dutch guidelines for provision of information by pharmaceutical companies. Materials referring to health/disease and treatments published in the most widely circulated newspapers and magazines were collected from March to May 2012. An evaluation tool was developed based on relevant underlying principles from the WHO ethical criteria and Dutch self-regulation guidelines. Collected disease awareness advertisements were used to pilot the evaluation tool and to explore the consistency of information provided with the WHO and Dutch criteria. Eighty materials met our inclusion criteria; 71 were published in newspapers and 9 in magazines. The large majority were news items but 21 were disease awareness advertisements, of which 5 were duplicates. Fifteen out of the 16 disease awareness campaigns were non-compliant with current guidelines mainly due to lack of balance (n = 12), absence of listed author and/or sponsor (n = 8), use of misleading or incomplete information (n = 5) and use of promotional information (n = 5). None mentioned a pharmaceutical product directly. Disease Awareness Campaigns are present in Dutch printed media. Although no brand names were mentioned, the lack of compliance of disease awareness campaigns with the current regulations is alarming. There were information deficiencies and evidence of information bias. A key concern is that the context in which the information is provided, mostly through indirect referral, is likely to support treatment with the sponsor's product.

Compliance of Disease Awareness Campaigns in Printed Dutch Media with National and International Regulatory Guidelines

PubMed Central

Leonardo Alves, Teresa; Martins de Freitas, Auramarina F.; van Eijk, Martine E. C.; Mantel-Teeuwisse, Aukje K.

2014-01-01

Background The European legislation prohibits prescription-only medicines' advertising but allows pharmaceutical companies to provide information to the public on health and diseases, provided there is no direct or indirect reference to a pharmaceutical product. Various forms of promotion have become increasingly common in Europe including “disease-oriented” campaigns. Objectives To explore examples of disease awareness campaigns by pharmaceutical companies in the Netherlands, by assessing their compliance with the World Health Organization (WHO) Ethical Criteria for medicinal drug promotion and the Dutch guidelines for provision of information by pharmaceutical companies. Methods Materials referring to health/disease and treatments published in the most widely circulated newspapers and magazines were collected from March to May 2012. An evaluation tool was developed based on relevant underlying principles from the WHO ethical criteria and Dutch self-regulation guidelines. Collected disease awareness advertisements were used to pilot the evaluation tool and to explore the consistency of information provided with the WHO and Dutch criteria. Findings Eighty materials met our inclusion criteria; 71 were published in newspapers and 9 in magazines. The large majority were news items but 21 were disease awareness advertisements, of which 5 were duplicates. Fifteen out of the 16 disease awareness campaigns were non-compliant with current guidelines mainly due to lack of balance (n = 12), absence of listed author and/or sponsor (n = 8), use of misleading or incomplete information (n = 5) and use of promotional information (n = 5). None mentioned a pharmaceutical product directly. Conclusion Disease Awareness Campaigns are present in Dutch printed media. Although no brand names were mentioned, the lack of compliance of disease awareness campaigns with the current regulations is alarming. There were information deficiencies and evidence of information bias. A key concern is that the context in which the information is provided, mostly through indirect referral, is likely to support treatment with the sponsor's product. PMID:25198776

Electroshock Experiment at Albany Violates Ethics Guidelines

ERIC Educational Resources Information Center

Smith, R. Jeffrey

1977-01-01

Reports the University of New York at Albany has been charged with violations of federal and state regulations for not obtaining approval of an ethics committee to conduct research on human subjects. (SL)

Mandated Reporting of Suspected Child Abuse: Ethics, Law and Policy. First Edition.

ERIC Educational Resources Information Center

Kalichman, Seth C.

Intended for those working in the human services professions as well as students, clinicians, and researchers, this book provides specific suggestions and guidelines for dealing with the ethical issue of required reporting of known or suspected child abuse. The book provides a comprehensive review of research findings, ethical issues, and current…

Ethical Challenges and Complexities of Including People with Intellectual Disability as Participants in Research

ERIC Educational Resources Information Center

Iacono, Teresa

2006-01-01

The aim of this article is to consider the implications for research involving people with intellectual disability--a vulnerable group--of ethics committees' attempts to apply these guidelines. The issue explored is whether committees such as Human Research Ethics Committees (HRECS) and Institutional Review Boards (IRBs) are becoming increasingly…

In-home monitoring of persons with dementia: ethical guidelines for technology research and development.

PubMed

Mahoney, Diane F; Purtilo, Ruth B; Webbe, Frank M; Alwan, Majd; Bharucha, Ashok J; Adlam, Tim D; Jimison, Holly B; Turner, Beverly; Becker, S Ann

2007-07-01

Innovative technologies are rapidly emerging that offer caregivers the support and means to assist older adults with cognitive impairment to continue living "at home." Technology research and development efforts applied to older adults with dementia invoke special grant review and institutional review board concerns, to ensure not only safe but also ethically appropriate interventions. Evidence is emerging, however, that tensions are growing between innovators and reviewers. Reviewers with antitechnology biases are in a position to stifle needed innovation. Technology developers who fail to understand the clinical and caregiving aspects of dementia may design applications that are not in alignment with users' capabilities. To bridge this divide, we offer an analysis of the ethical issues surrounding home monitoring, a model framework, and ethical guidelines for technology research and development for persons with Alzheimer's disease and their caregivers.

Commentary: Mapping a changing landscape in the ethics of forensic psychiatry.

PubMed

Grubin, Don

2008-01-01

In 1984, Alan Stone, writing in the Bulletin of the American Academy of Psychiatry and the Law, stated that "forensic psychiatrists are without any clear guidelines as to what is proper and ethical," adding that because of the nature of psychiatry and the realities of the law, no such guidelines can be drawn. Put starkly, his conclusion was that the practice of forensic psychiatry is fundamentally unethical. In the same issue, several contemporary commentators criticized his position, arguing that he misunderstood the social context of forensic psychiatry and that, in any case, he was wrong to say that ethics standards did not exist. In this article, these questions are reviewed again, starting from the principle articulated by the philosopher, A. J. Ayer, that that there is no such thing as an ethical fact.

Progress towards a world-wide code of conduct

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

Lee, J.A.N.; Berleur, J.

1994-12-31

In this paper the work of the International Federation for Information Processing (IFIP) Task Group on Ethics is described and the recommendations presented to the General Assembly are reviewed. While a common code of ethics or conduct has been not recommended for consideration by the member societies of IMP, a set of guidelines for the establishment and evaluation of codes has been produced and procedures for the assistance of code development have been established within IMP. This paper proposes that the data collected by the Task Group and the proposed guidelines can be used as a tool for the studymore » of codes of practice providing a teachable, learnable educational module in courses related to the ethics of computing and computation, and looks at the next steps in bringing ethical awareness to the IT community.« less

Proposed Guidelines for Operating Counselor Education and Supervision Training Clinics

ERIC Educational Resources Information Center

Lauka, Justin D.; McCarthy, Amanda K.

2013-01-01

The purpose of this article is to justify and present a set of guidelines for the effective and ethical administration of counselor education and supervision training clinics. Responding directly to a call for creating guidelines, the authors address core issues surrounding their development. Benefits for clear and accessible guidelines and risks…

Specialty Guidelines for Forensic Psychology

ERIC Educational Resources Information Center

American Psychologist, 2013

2013-01-01

In the past 50 years forensic psychological practice has expanded dramatically. Because the practice of forensic psychology differs in important ways from more traditional practice areas (Monahan, 1980) the "Specialty Guidelines for Forensic Psychologists" were developed and published in 1991 (Committee on Ethical Guidelines for Forensic…

The Care Dialog: the "ethics of care" approach and its importance for clinical ethics consultation.

PubMed

Schuchter, Patrick; Heller, Andreas

2018-03-01

Ethics consultation in institutions of the healthcare system has been given a standard form based on three pillars: education, the development of guidelines and concrete ethics consultation in case conferences. The spread of ethics committees, which perform these tasks on an organizational level, is a remarkable historic achievement. At the same time it cannot be denied that modern ethics consultation neglects relevant aspects of care ethics approaches. In our essay we present an "ethics of care" approach as well as an empirical pilot project-"Ethics from the bottom up"-which organizes ethics consultation based on this focus. Findings and philosophy of the project will be discussed as far as relevant for ethics consultation in the healthcare system.

The conduct of Australian Indigenous primary health care research focusing on social and emotional wellbeing: a systematic review.

PubMed

Farnbach, Sara; Eades, Anne-Maree; Gwynn, Josephine D; Glozier, Nick; Hackett, Maree L

2018-06-14

Objectives and importance of study: Values and ethics: guidelines for ethical conduct in Aboriginal and Torres Strait Islander health research (Values and ethics) describes key values that should underpin Aboriginal and Torres Strait Islander (Indigenous)-focused health research. It is unclear how research teams address this document in primary health care research. We systematically review the primary health care literature focusing on Indigenous social and emotional wellbeing (SEWB) to identify how Values and ethics and community preferences for standards of behaviour (local protocols) are addressed during research. Systematic review in accordance with PRISMA Guidelines and MOOSE Guidelines for Meta-Analyses and Systematic Reviews of Observational Studies. We searched four databases and one Indigenous-specific website for qualitative, quantitative and mixed-method studies published since Values and ethics was implemented (2003). Included studies were conducted in primary health care services, focused on Indigenous SEWB and were conducted by research teams. Using standard data extraction forms, we identified actions taken (reported by authors or identified by us) relating to Values and ethics and local protocols. A total of 25 studies were included. Authors of two studies explicitly mentioned the Values and ethics document, but neither reported how their actions related to the document's values. In more than half the studies, we identified at least three actions relating to the values. Some actions related to multiple values, including use of culturally sensitive research processes and involving Indigenous representatives in the research team. Local protocols were rarely reported. Addressing Values and ethics appears to improve research projects. The academic community should focus on culturally sensitive research processes, relationship building and developing the Indigenous research workforce, to facilitate acceptable research that affects health outcomes. For Values and ethics to achieve its full impact and to improve learning between research teams, authors should be encouraged to report how the principles are addressed during research, including barriers and enablers that are encountered.

Ethical issues related to screening for preeclampsia.

PubMed

Jørgensen, Jennifer M; Hedley, Paula L; Gjerris, Mickey; Christiansen, Michael

2014-09-01

The implementation of new methods of treating and preventing disease raises many question of both technical and moral character. Currently, many studies focus on developing a screening test for preeclampsia (PE), a disease complicating 2-8% of pregnancies, potentially causing severe consequences for pregnant women and their fetuses. The purpose is to develop a test that can identify pregnancies at high risk for developing PE sufficiently early in pregnancy to allow for prophylaxis. However, the question of implementing a screening test for PE does not only involve an evaluation of technical feasibility and clinical efficacy, it also requires an analysis of how the test influences the conditions and choices for those tested. This study evaluates state-of-the-art techniques for preeclampsia screening in an ethical framework, pointing out the central areas of moral relevance within the context of such screening activity. Furthermore, we propose ethical guidelines that a screening programme for PE should meet in order to become an uncontroversial addition to prenatal health care. © 2012 John Wiley & Sons Ltd.

Reducing the ecological impact of field research.

PubMed

Bezanson, Michelle; Stowe, Rochelle; Watts, Sean M

2013-01-01

Researchers and students at biological field stations, especially in remote areas, are subject to leaving "footprints," as we conduct research, work, and live in sensitive ecosystems. These footprints include travel, personal trash and waste, and field equipment (e.g. flagging, tree markers, plot markers, trail markers, monitoring devices, etc.). In this commentary, we argue that the field of primatology's commitment to minimum impact research should be more explicitly and visibly integrated into our ethical protocols with regard to field research and instruction in sensitive environments. We review current ethical codes and potential solutions to reducing our "researcher footprints" while conducting fieldwork. Using Costa Rica as an example, we address how sustainable fieldwork differs among varying cultural contexts and argue that researchers should be made responsible and accountable for how our presence, research, and teaching might impact the environment. We conclude by recommending a set of guidelines to be added to ethical protocols regarding research design, station policies, and the conduct of research and teaching in the field. © 2012 Wiley Periodicals, Inc.

Placebos in clinical practice and research.

PubMed Central

De Deyn, P P; D'Hooge, R

1996-01-01

The main current application of placebo is in clinical research. The term placebo effect refers to diverse non-specific, desired or non-desired effects of substances or procedures and interactions between patient and therapist. Unpredictability of the placebo effect necessitates placebo-controlled designs for most trials. Therapeutic and diagnostic use of placebo is ethically acceptable only in few well-defined cases. While "therapeutic" application of placebo almost invariably implies deception, this is not the case for its use in research. Conflicts may exist between the therapist's Hippocratic and scientific obligations. The authors provide examples in neuropsychiatry, illustrating that objective scientific data and well-considered guidelines may solve the ethical dilemma. Placebo control might even be considered an ethical obligation but some provisos should be kept in mind: (a) no adequate therapy for the disease should exist and/or (presumed) active therapy should have serious side-effects; (b) placebo treatment should not last too long; (c) placebo treatment should not inflict unacceptable risks, and (d) the experimental subject should be adequately informed and informed consent given. PMID:8798935

Nephrology nurses' perspectives on difficult ethical issues and practice guideline for shared decision making.

PubMed

Rabetoy, Christy Price; Bair, Bradley C

2007-01-01

Nephrologists and nephrology nurses have struggled with the technological, financial, and ethical concerns surrounding the life sustaining treatment of hemodialysis for as long as this treatment as been available. One of the overriding issues for the nephrology community has been appropriate utilization of this technology and the appropriate restraint for prescribing dialysis. Since the inception of dialysis, there has been discussion of guidelines for deciding who should receive and who should not receive this therapy. In 2000, a clinical guideline was developed to assist in directing the care of patients. The knowledge and acceptance of this guideline by nephrologists has been researched in the past. However, there is no data of knowledge and acceptance of the guideline by nephrology clinical nurses or nephrology nurse practitioners. A survey was conducted to begin to ascertain this information in order to better understand the perspectives of nephrology nurses.

Clinical ethics protocols in the clinical ethics committees of Madrid.

PubMed

Herreros, Benjamin; Ramnath, Venktesh R; Bishop, Laura; Pintor, Emilio; Martín, María Dolores; Sánchez-González, Miguel A

2014-03-01

Currently, The nature and scope of Clinical Ethics Protocols (CEPs) in Madrid (Spain) are not well understood. The main objective is to describe the features of 'guideline/recommendation' type CEPs that have been or are being developed by existing Clinical Ethics Committees (CECs) in Madrid. Secondary objectives include characterisation of those CECs that have been the most prolific in reference to CEP creation and implementation and identification of any trends in future CEP development. We collected CEPs produced and in process by CECs accredited in the public hospitals in Madrid, Spain, from 1996 to 2008. CECs developed 30 CEPs, with 10 more in process. The most common topic is refusal of treatment (seven CEPs developed; two in process). If CEPs addressing terminal illness, Do-Not-Resuscitate orders and advance directives are placed into a separate 'ethical problems at the end of life' category, this CEP subject emerges as the most common (eight developed; four in process). There is a relationship between the age of the CEC and the development of CEPs (the oldest CECs have developed more CEPs). CECs now seem to be more likely to engage in CEP development. The CECs in Madrid, Spain, have developed a significant number of CEPs (30 in total and 10 in process) and there is a trend towards continued development. The most frequent topics are ethical problems at the end of life and refusal of treatment by the patient.

What Medical Writing Means To Me

PubMed Central

Wager, Elizabeth

2007-01-01

This is a personal account based on many years experience as a medical writer. It considers aspects of medical writing with particular focus on the intellectual and ethical dilemmas it can raise. What makes medical writing both so interesting and so challenging is the fact that it often takes place at the border between different disciplines. For example, it straddles both science and art. Ethical issues also arise at the boundaries between academia and commerce. Until recently there have been few guidelines to help navigate such potentially dangerous territory. I have been privileged to be involved in developing two such guidelines and I describe how I hope the Good Publication Practice guidelines for pharmaceutical companies and the European Medical Writers Association guidelines may improve the practice of this fascinating profession, Medical Writing. PMID:22058630

What medical writing means to me.

PubMed

Wager, Elizabeth

2007-01-01

This is a personal account based on many years experience as a medical writer. It considers aspects of medical writing with particular focus on the intellectual and ethical dilemmas it can raise. What makes medical writing both so interesting and so challenging is the fact that it often takes place at the border between different disciplines. For example, it straddles both science and art. Ethical issues also arise at the boundaries between academia and commerce. Until recently there have been few guidelines to help navigate such potentially dangerous territory. I have been privileged to be involved in developing two such guidelines and I describe how I hope the Good Publication Practice guidelines for pharmaceutical companies and the European Medical Writers Association guidelines may improve the practice of this fascinating profession, Medical Writing.

Guidelines for psychological evaluations in child protection matters.

PubMed

2013-01-01

The problems of abused and neglected children are epidemic in our society (U.S. Department of Health and Human Services, Administration on Children, Youth, and Families, 2008) and create issues that psychologists may be called upon to address. Psychologists are positioned to contribute significantly to decision making in child protection matters. Psychological data and expertise may provide sources of information and a perspective not otherwise available to courts regarding the functioning of parties, and thus may increase the fairness of decisions by the court, state agency, or other party. such matters. These guidelines are a revision of the 1999 "Guidelines for Psychological Evaluations in Child Protection Matters" (American Psychological Association [APA], 1999). These guidelines are informed by APA's "Ethical Principles of Psychologists and Code of Conduct" ("APA Ethics Code"; APA, 2002a, 2010).

Good collaborative practice: reforming capacity building governance of international health research partnerships.

PubMed

Ward, Claire Leonie; Shaw, David; Sprumont, Dominique; Sankoh, Osman; Tanner, Marcel; Elger, Bernice

2018-01-08

In line with the policy objectives of the United Nations Sustainable Development Goals, this commentary seeks to examine the extent to which provisions of international health research guidance promote capacity building and equitable partnerships in global health research. Our evaluation finds that governance of collaborative research partnerships, and in particular capacity building, in resource-constrained settings is limited but has improved with the implementation guidance of the International Ethical Guidelines for Health-related Research Involving Humans by The Council for International Organizations of Medical Sciences (CIOMS) (2016). However, more clarity is needed in national legislation, industry and ethics guidelines, and regulatory provisions to address the structural inequities and power imbalances inherent in international health research partnerships. Most notably, ethical partnership governance is not supported by the principal industry ethics guidelines - the International Conference on Harmonization Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) Good Clinical Practice (ICH-GCP). Given the strategic value of ICH-GCP guidelines in defining the role and responsibility of global health research partners, we conclude that such governance should stipulate the minimal requirements for creating an equitable environment of inclusion, mutual learning, transparency and accountability. Procedurally, this can be supported by i) shared research agenda setting with local leadership, ii) capacity assessments, and iii) construction of a memorandum of understanding (MoU). Moreover, the requirement of capacity building needs to be coordinated amongst partners to support good collaborative practice and deliver on the public health goals of the research enterprise; improving local conditions of health and reducing global health inequality. In this respect, and in order to develop consistency between sources of research governance, ICH-GCP should reference CIOMS ethical guidelines as the established standard for collaborative partnership. Moreover, greater commitment and support should be given to co-ordinate, strengthen and enforce local laws requiring equitable research partnerships and health system strengthening.

The ethics of data collection: unintended consequences?

PubMed

Wainwright, Delia; Sambrook, Sally

2010-01-01

The aims is to consider the political and ethical challenges involved in conducting ethnographic managerial/organisational behaviour research within the highly regulated health and social care context, in light of the emergence of more stringent "ethical approval" policies and requirements set by Local Research Ethics Committees in the United Kingdom. In the attempt and requirement to protect "vulnerable" employees, this paper aims to present an unintended paradox of consequences when participants voluntarily revealed themselves. The authors briefly review literature on research ethics and present an understanding of the ethical regulations currently existing within the British National Health Service. Within an ethnographic case study exploring the psychological contract, the authors consider the issues that arose during one stage of data collection: a qualitative questionnaire survey with 13 participants, including members of the lead author's team. Incorporating excerpts from the researcher's reflexive journal, the paper exposes the struggles of being an "insider" researcher and the tensions this raises for data analysis when participants voluntarily revealed themselves. Ethnography is at "risk" within health and social care and ethnographic "managerial" research is likely to be unduly restricted and potentially threatened. The evidence suggests that some employees either did not wish to be protected or, conversely, felt compelled to reveal their identities, raising questions of their motivation and creating a paradox of unintended consequences. This paper offers an insight into the challenges of conducting nurse-managerial ethnography in compliance with ethical guidelines, yet disrupted by participants. The findings will be useful to other nurse-researchers attempting to conduct insider research.

Marketing Approval of Ethical Kampo Medicines.

PubMed

Hakamatsuka, Takashi

2017-01-01

Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

ISPOR Code of Ethics 2017 (4th Edition).

PubMed

Santos, Jessica; Palumbo, Francis; Molsen-David, Elizabeth; Willke, Richard J; Binder, Louise; Drummond, Michael; Ho, Anita; Marder, William D; Parmenter, Louise; Sandhu, Gurmit; Shafie, Asrul A; Thompson, David

2017-12-01

As the leading health economics and outcomes research (HEOR) professional society, ISPOR has a responsibility to establish a uniform, harmonized international code for ethical conduct. ISPOR has updated its 2008 Code of Ethics to reflect the current research environment. This code addresses what is acceptable and unacceptable in research, from inception to the dissemination of its results. There are nine chapters: 1 - Introduction; 2 - Ethical Principles respect, beneficence and justice with reference to a non-exhaustive compilation of international, regional, and country-specific guidelines and standards; 3 - Scope HEOR definitions and how HEOR and the Code relate to other research fields; 4 - Research Design Considerations primary and secondary data related issues, e.g., participant recruitment, population and research setting, sample size/site selection, incentive/honorarium, administration databases, registration of retrospective observational studies and modeling studies; 5 - Data Considerations privacy and data protection, combining, verification and transparency of research data, scientific misconduct, etc.; 6 - Sponsorship and Relationships with Others (roles of researchers, sponsors, key opinion leaders and advisory board members, research participants and institutional review boards (IRBs) / independent ethics committees (IECs) approval and responsibilities); 7 - Patient Centricity and Patient Engagement new addition, with explanation and guidance; 8 - Publication and Dissemination; and 9 - Conclusion and Limitations. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Health, human rights, and the conduct of clinical research within oppressed populations

PubMed Central

Mills, Edward J; Singh, Sonal

2007-01-01

Background Clinical trials evaluating interventions for infectious diseases require enrolling participants that are vulnerable to infection. As clinical trials are conducted in increasingly vulnerable populations, issues of protection of these populations become challenging. In settings where populations are forseeably oppressed, the conduct of research requires considerations that go beyond common ethical concerns and into issues of international human rights law. Discussion Using examples of HIV prevention trials in Thailand, hepatitis-E prevention trials in Nepal and malaria therapeutic trials in Burma (Myanmar), we address the inadequacies of current ethical guidelines when conducting research within oppressed populations. We review existing legislature in the United States and United Kingdom that may be used against foreign investigators if trial hardships exist. We conclude by making considerations for research conducted within oppressed populations. PMID:17996056

Dual loyalties and the ethical and human rights obligations of occupational health professionals.

PubMed

London, Leslie

2005-04-01

Underlying most ethical dilemmas in occupational health practice is the problem of Dual Loyalties where health professionals have simultaneous obligations, explicit or implicit, to a third party, usually a private employer. A literature review was undertaken of case studies of workplace occupational health conflicts, international human rights and ethical codes and strategies for managing dual loyalties, complemented by iterative discussions in an international working group convened to address the problem of Dual Loyalties. Violations of the worker-patient's human rights may arise from: (1) the incompatibility of simultaneous obligations; (2) pressure on the professional from the third party; and (3) separation of the health professional's clinical role from that of a social agent. The practitioner's contractual relationship with the third party is often the underlying problem, being far more explicit than their moral obligation to patients, and encouraging a social identification at the expense of a practitioner's professional identity. Because existing ethical guidelines lack specificity on managing Dual Loyalties in occupational health, guidelines that draw on human rights standards have been developed by the working group. These guidelines propose standards for individual professional conduct and complementary institutional mechanisms to address the problem. Copyright (c) 2005 Wiley-Liss, Inc.

NAEYC Code of Ethical Conduct. Revised = Codigo de Conducta Etica. Revisada

ERIC Educational Resources Information Center

National Association of Elementary School Principals (NAESP), 2005

2005-01-01

This document presents a code of ethics for early childhood educators that offers guidelines for responsible behavior and sets forth a common basis for resolving ethical dilemmas encountered in early education. It represents the English and Spanish versions of the revised code. Its contents were approved by the NAEYC Governing Board in April 2005…

Commentary: justice and medical research: a global perspective.

PubMed

Benatar, S R

2001-08-01

Economic globalization has profound implications for health. The scale of injustice at a global level, reflected in inexorably widening disparities in wealth and health, also has critical implications for health related research--in particular when the opportunities for exploiting research subjects are carefully considered. The challenge of developing universal guidelines for international clinical research is addressed against the background of a polarizing, yet interdependent, world in which all are ultimately threatened by lack of social justice. It is proposed that in such a world there is a need for new ways of thinking about research and its relevance to health at a global level. Responsibility to use knowledge and power wisely requires more radical changes to guidelines for research ethics than are currently under consideration.

Ethical analysis of non-medical fetal ultrasound.

PubMed

Leung, John Lai Yin; Pang, Samantha Mei Che

2009-09-01

Obstetric ultrasound is the well-recognized prenatal test used to visualize and determine the condition of a pregnant woman and her fetus. Apart from the clinical application, some businesses have started promoting the use of fetal ultrasound machines for nonmedical reasons. Non-medical fetal ultrasound (also known as 'keepsake' ultrasound) is defined as using ultrasound to view, take a picture, or determine the sex of a fetus without a medical indication. Notwithstanding the guidelines and warnings regarding ultrasound safety issued by governments and professional bodies, the absence of scientifically proven physical harm to fetuses from this procedure seems to provide these businesses with grounds for rapid expansion. However, this argument is too simplistic because current epidemiological evidence is not synchronous with advancing ultrasound technology. As non-medical fetal ultrasound has aroused very significant public attention, a thorough ethical analysis of this topic is essential. Using a multifaceted approach, we analyse the ethical perspective of non-medical fetal ultrasound in terms of the expectant mother, the fetus and health professionals. After applying four major theories of ethics and principles (the precautionary principle; theories of consequentialism and impartiality; duty-based theory; and rights-based theories), we conclude that obstetric ultrasound practice is ethically justifiable only if the indication for its use is based on medical evidence. Non-medical fetal ultrasound can be considered ethically unjustifiable. Nevertheless, the ethical analysis of this issue is time dependent owing to rapid advancements in ultrasound technology and the safety issue. The role of health professionals in ensuring that obstetric ultrasound is an ethically justifiable practice is also discussed.

Innovative Telemonitoring Enhanced Care Programme for Chronic Heart Failure (ITEC-CHF) to improve guideline compliance and collaborative care: protocol of a multicentre randomised controlled trial

PubMed Central

Jayasena, Rajiv; Maiorana, Andrew; Dowling, Alison; Chen, Sheau Huey; Karunanithi, Mohan; Layland, Jamie; Edwards, Iain

2017-01-01

Introduction Chronic heart failure (CHF) is a life-threatening chronic disease characterised by periodic exacerbations and recurrent hospitalisations. In the management of CHF, patient compliance with evidence-based clinical guidelines is essential, but remains difficult practically. The objective of this study is to examine whether an Innovative Telemonitoring Enhanced Care Programme for CHF (ITEC-CHF) improves patients’ compliance, and associated health and economic outcomes. Methods and analysis An open multicentre randomised controlled trial has been designed. Patients will be recruited and randomised to receive either ITEC-CHF (n=150) or usual care CHF (n=150) for at least 6 months. ITEC-CHF combines usual care and an additional telemonitoring service including remote weight monitoring, structured telephone support and nurse-led collaborative care. The primary outcomes are the compliance rates with the best-practice guidelines for daily weight monitoring. The secondary outcomes include the compliance with other guideline recommendations (health maintenance, medication, diet and exercise), health (health-related quality of life, risk factors, functional capacity and psychological states) and economic outcomes related to the use of healthcare resources such as hospital readmissions and general practitioner/emergency department visits. Ethics and dissemination The clinical trial has been approved by Peninsula Health Human Research Ethics Committee (HREC Reference: HREC/14/PH/27), Royal Perth Hospital Human Research Ethics Committee (Reference: 15-081) and the Curtin University Human Research Ethics Committee (Reference: HR 181/2014). We will disseminate the final results to the public via conferences and journal publications. A final study report will also be provided to the ethics committees. Trial registration number Registered with Australian New Zealand Clinical Trial Registry (ACTRN12614000916640). PMID:28993389

Truth-telling, decision-making, and ethics among cancer patients in nursing practice in China.

PubMed

Ling, Dong-Lan; Yu, Hong-Jing; Guo, Hui-Ling

2017-01-01

Truth-telling toward terminally ill patients is a challenging ethical issue in healthcare practice. However, there are no existing ethical guidelines or frameworks provided for Chinese nurses in relation to decision-making on truth-telling of terminal illness and the role of nurses thus is not explicit when encountering this issue. The intention of this paper is to provide ethical guidelines or strategies with regards to decision-making on truth-telling of terminal illness for Chinese nurses. This paper initially present a case scenario and then critically discuss the ethical issue in association with ethical principles and philosophical theories. Instead of focusing on attitudes toward truth disclosure, it aims to provide strategies regarding this issue for nurses. It highlights and discusses some of the relevant ethical assumptions around the perceived role of nurses in healthcare settings by focusing on nursing ethical virtues, nursing codes of ethics, and philosophical perspectives. And Confucian culture is discussed to explicate that deontology does not consider family-oriented care in China. Treating each family individually to explore the family's beliefs and values on this issue is essential in healthcare practice and nurses should tailor their own approach to individual needs regarding truth-telling in different situations. Moreover, the Chinese Code of Ethics should be modified to be more specific and applicable. Finally, a narrative ethics approach should be applied and teamwork between nurses, physicians and families should be established to support cancer patients and to ensure their autonomy and hope. Ethical considerations: This paper was approved by the Ethics Committee of The Second Affiliated Hospital of Guangzhou Medical University. The authors have obtained consent to use the case study and it has been anonymised to preserve the patient's confidentiality.

Photo-editing in Orthodontics: How Much is Too Much?.

PubMed

Kapoor, Priyanka

2015-01-01

Digital photography and radiology are the mainstay of orthodontic records but current image editing software programs nave led to increase in instances of digital forgery and scientific misconduct. In the present study, digital image data of orthodontic study casts and photographs were altered using software such as [Microsoft Paint6 1, Picasa3.1, Adobe Photoshop3.6]. Based on ethical guidelines on digital image manipulations, cropping or intensity adjustments in moderation to entire image were considered permissible while cloning or color adjustments were deemed unethical.

[How do first codes of medical ethics inspire contemporary physicians?].

PubMed

Paprocka-Lipińska, Anna; Basińska, Krystyna

2014-02-01

First codes of medical ethics appeared between 18th and 19th century. Their formation was inspired by changes that happened in medicine, positive in general but with some negative setbacks. Those negative consequences revealed the need to codify all those ethical duties, which were formerly passed from generation to generation by the word of mouth and individual example by master physicians. 210 years has passed since the publication of "Medical Ethics" by Thomas Percival, yet essential ethical guidelines remain the same. Similarly, ethical codes published in Poland in 19 century can still be an inspiration to modem physicians.

The impact of institutional ethics on academic health sciences library leadership: a survey of academic health sciences library directors.

PubMed

Tooey, Mary Joan M J; Arnold, Gretchen N

2014-10-01

Ethical behavior in libraries goes beyond service to users. Academic health sciences library directors may need to adhere to the ethical guidelines and rules of their institutions. Does the unique environment of an academic health center imply different ethical considerations? Do the ethical policies of institutions affect these library leaders? Do their personal ethical considerations have an impact as well? In December 2013, a survey regarding the impact of institutional ethics was sent to the director members of the Association of Academic Health Sciences Libraries. The objective was to determine the impact of institutional ethics on these leaders, whether through personal conviction or institutional imperative.

The impact of institutional ethics on academic health sciences library leadership: a survey of academic health sciences library directors

PubMed Central

Tooey, Mary Joan (M.J.); Arnold, Gretchen N.

2014-01-01

Ethical behavior in libraries goes beyond service to users. Academic health sciences library directors may need to adhere to the ethical guidelines and rules of their institutions. Does the unique environment of an academic health center imply different ethical considerations? Do the ethical policies of institutions affect these library leaders? Do their personal ethical considerations have an impact as well? In December 2013, a survey regarding the impact of institutional ethics was sent to the director members of the Association of Academic Health Sciences Libraries. The objective was to determine the impact of institutional ethics on these leaders, whether through personal conviction or institutional imperative. PMID:25349542

Practical guidelines for setting up neurosurgery skills training cadaver laboratory in India.

PubMed

Suri, Ashish; Roy, Tara Sankar; Lalwani, Sanjeev; Deo, Rama Chandra; Tripathi, Manjul; Dhingra, Renu; Bhardwaj, Daya Nand; Sharma, Bhawani Shankar

2014-01-01

Though the necessity of cadaver dissection is felt by the medical fraternity, and described as early as 600 BC, in India, there are no practical guidelines available in the world literature for setting up a basic cadaver dissection laboratory for neurosurgery skills training. Hands-on dissection practice on microscopic and endoscopic procedures is essential in technologically demanding modern neurosurgery training where ethical issues, cost constraints, medico-legal pitfalls, and resident duty time restrictions have resulted in lesser opportunities to learn. Collaboration of anatomy, forensic medicine, and neurosurgery is essential for development of a workflow of cadaver procurement, preservation, storage, dissection, and disposal along with setting up the guidelines for ethical and legal concerns.

The ethical tightrope: politics of intimacy and consensual method in sexuality research.

PubMed

Zago, Luiz F; Holmes, Dave

2015-06-01

This paper seeks to analyze the construction of ethics in sexuality research in which qualitative methods are employed in the field of social sciences. Analyses are based on a bibliographic review of current discussions on research methods of queer theory and on the authors' own experiences of past research on sexuality. The article offers a theoretical perspective on the ways ethnography and in-depth interviews become methods that can rely on a consensual method and create a politics of intimacy between the researchers and research participants. The politics of intimacy may contribute to the production of a politically engaged knowledge while escaping from the moral matrix that usually governs the relationship between researchers and research participants. It is argued here that the researcher's sexed and gendered body matters for fieldwork; that the consensual method among participants may be employed in sexuality research as a fruitful tool; and that the relationships created among researchers and participants can pose a challenge to predetermined ethical guidelines in research. As a result, discussions problematize the existence of a politics of intimacy in sexuality research that is characterized by ethical relations among research participants. © 2014 John Wiley & Sons Ltd.

Diabetes and end of life: ethical and methodological issues in gathering evidence to guide care.

PubMed

Dunning, Trisha; Duggan, Nicole; Savage, Sally; Martin, Peter

2013-03-01

Providing palliative care for people with diabetes at the end of life is part of the chronic disease care trajectory, but end of life care is complex and the presence of diabetes further complicates management. The aim of the paper is to discuss the ethical and methodological issues encountered when undertaking research to develop guidelines for managing diabetes at the end of life and the strategies used to address the issues. The issues emerged as we developed guidelines for managing diabetes at the end of life, which included conducting individual interviews with 14 people with diabetes requiring palliative care and 10 family members. A reflexive researcher journal was maintained throughout the guideline development process. The interview transcripts and researcher's journal were analysed to determine key methodological, ethical and researcher-related issues. Key themes were vulnerability of the sampling population, methodological issues included recruiting participants and ensuring rigor, ethical issues concerned benefit and risk, justice, autonomy, privacy, professional boundaries and informed consent. Researcher-related issues were identified such as managing participant distress and their own emotional distress. People were willing to discuss end of life diabetes management preferences. Undertaking research with people at the end of life is complex because of their vulnerability and the ethical issues involved. However, the ethical principles of autonomy and justice apply and people should be given the relevant information and opportunity to decide whether to participate or not. © 2012 The Authors. Scandinavian Journal of Caring Sciences © 2012 Nordic College of Caring Science.

Critical analysis of the Council for International Organizations of Medical Sciences 2016 International Guidelines for health-related research involving humans.

PubMed

Kottow Lang, Miguel Hugo

2017-05-15

This paper presents a preliminary discussion of the Council for International Organizations of Medical Sciences (CIOMS), recently issued “International Ethical Guidelines for Health-related Research Involving Humans” (2016) that acknowledges the document’s declared concern of the protection of human subjects and awareness of their needs and interests in “low-resource settings”. Nevertheless, guideline recommendations present exceptional situations –vulnerability, mental incompetence- wherein voluntary and consented participation may be reduced or omitted under three concurrent conditions: compelling scientific value, the need to include persons that will not benefit directly from participation, exposure to minimal or slight risks. CIOMS 2016 extends the range of issues than need deliberation and regulation, but it does not clarify controversial issues in research ethics. The indetermination of special situations that would allow incomplete or absent informed disclosure weakens rigorous ethical norms and opens up to slippery slopes of permissiveness that may be harmful to host-nations and participants of biomedical studies.

A systematic literature review on the ethics of palliative sedation: an update (2016).

PubMed

Henry, Blair

2016-09-01

Palliative sedation has been the subject of intensive debate since its first appearance in 1990. In a 2010 review of palliative sedation, the following areas were identified as lacking in consensus: inconsistent terminology, its use in nonphysical suffering, the ongoing experience of distress, and concern that the practice of palliative sedation may hasten death. This review looks at the literature over the past 6 years and provides an update on these outstanding concerns. Good clinical guidelines and policies are still required to address issues of emotional distress and waylay concerns that palliative sedation hastens death. The empirical evidence suggests some movement toward consensus on the practice of palliative sedation. However, a continued need exists for evidence-informed practice guidelines, education, and research to support the ethical practice of palliative sedation at the end of life. Until that time, clinicians are advised to adopt a framework or guideline that has been expert driven to ensure consistent and ethical use of palliative sedation at the end of life.

Stakeholder views of ethical guidance regarding prevention and care in HIV vaccine trials.

PubMed

Moorhouse, Rika; Slack, Catherine; Quayle, Michael; Essack, Zaynab; Lindegger, Graham

2014-06-30

South Africa is a major hub of HIV prevention trials, with plans for a licensure trial to start in 2015. The appropriate standards of care and of prevention in HIV vaccine trials are complex and debated issues and ethical guidelines offer some direction. However, there has been limited empirical exploration of South African stakeholders' perspectives on ethical guidance related to prevention and care in HIV vaccine trials. Site staff, Community Advisory Board members and Research Ethics Committee members involved with current HIV vaccine trials in South Africa were invited to participate in an exploration of their views. A questionnaire listed 10 care and 10 prevention recommendations drawn from two widely available sets of ethical guidelines for biomedical HIV prevention trials. Respondents (n = 98) rated each recommendation on five dimensions: "Familiarity with", "Ease of Understanding", "Ease of Implementing", "Perceived Protection", and "Agreement with" each ethical recommendation. The ratings were used to describe stakeholder perspectives on dimensions for each recommendation. Dimension ratings were averaged across the five dimensions and used as an indication of overall merit for each recommendation. Differences were explored across dimensions, between care-oriented and prevention-oriented recommendations, and between stakeholder groups. Both care and prevention recommendations were rated highly overall, with median ratings well above the scale midpoint. In general, informed consent recommendations were most positively rated. Care-related recommendations were rated significantly more positively than prevention-related recommendations, with the five lowest-rated recommendations being prevention-related. The most problematic dimension across all recommendations was "Ease of Implementing," and the least problematic was "Agreement with," suggesting the most pressing stakeholder concerns are practical rather than theoretical; that is, respondents agree with but see barriers to the attainment of these recommendations. We propose that prevention recommendations be prioritized for refinement, especially those assigned bottom-ranking scores for "Ease of Implementing", and/ or "Ease of Understanding" in order to assist vaccine stakeholders to better comprehend and implement these recommendations. Further qualitative research could also assist to better understand nuances in stakeholder reservations about implementing such recommendations.

Stakeholder views of ethical guidance regarding prevention and care in HIV vaccine trials

PubMed Central

2014-01-01

Background South Africa is a major hub of HIV prevention trials, with plans for a licensure trial to start in 2015. The appropriate standards of care and of prevention in HIV vaccine trials are complex and debated issues and ethical guidelines offer some direction. However, there has been limited empirical exploration of South African stakeholders’ perspectives on ethical guidance related to prevention and care in HIV vaccine trials. Methods Site staff, Community Advisory Board members and Research Ethics Committee members involved with current HIV vaccine trials in South Africa were invited to participate in an exploration of their views. A questionnaire listed 10 care and 10 prevention recommendations drawn from two widely available sets of ethical guidelines for biomedical HIV prevention trials. Respondents (n = 98) rated each recommendation on five dimensions: “Familiarity with”, “Ease of Understanding”, “Ease of Implementing”, “Perceived Protection”, and “Agreement with” each ethical recommendation. The ratings were used to describe stakeholder perspectives on dimensions for each recommendation. Dimension ratings were averaged across the five dimensions and used as an indication of overall merit for each recommendation. Differences were explored across dimensions, between care-oriented and prevention-oriented recommendations, and between stakeholder groups. Results Both care and prevention recommendations were rated highly overall, with median ratings well above the scale midpoint. In general, informed consent recommendations were most positively rated. Care-related recommendations were rated significantly more positively than prevention-related recommendations, with the five lowest-rated recommendations being prevention-related. The most problematic dimension across all recommendations was “Ease of Implementing,” and the least problematic was “Agreement with,” suggesting the most pressing stakeholder concerns are practical rather than theoretical; that is, respondents agree with but see barriers to the attainment of these recommendations. Conclusions We propose that prevention recommendations be prioritized for refinement, especially those assigned bottom-ranking scores for “Ease of Implementing”, and/ or “Ease of Understanding” in order to assist vaccine stakeholders to better comprehend and implement these recommendations. Further qualitative research could also assist to better understand nuances in stakeholder reservations about implementing such recommendations. PMID:24981027

Enhancing the African bioethics initiative

PubMed Central

Ogundiran, Temidayo O

2004-01-01

Background Medical ethics has existed since the time of Hippocrates. However, formal training in bioethics did not become established until a few decades ago. Bioethics has gained a strong foothold in health sciences in the developed world, especially in Europe and North America. The situation is quite different in many developing countries. In most African countries, bioethics – as established and practiced today in the west- is either non-existent or is rudimentary. Discussion Though bioethics has come of age in the developed and some developing countries, it is still largely "foreign" to most African countries. In some parts of Africa, some bioethics conferences have been held in the past decade to create research ethics awareness and ensure conformity to international guidelines for research with human participants. This idea has arisen in recognition of the genuine need to develop capacity for reviewing the ethics of research in Africa. It is also a condition required by external sponsors of collaborative research in Africa. The awareness and interest that these conferences have aroused need to be further strengthened and extended beyond research ethics to clinical practice. By and large, bioethics education in schools that train doctors and other health care providers is the hook that anchors both research ethics and clinical ethics. Summary This communication reviews the current situation of bioethics in Africa as it applies to research ethics workshops and proposes that in spite of the present efforts to integrate ethics into biomedical research in Africa, much still needs to be done to accomplish this. A more comprehensive approach to bioethics with an all-inclusive benefit is to incorporate formal ethics education into health training institutions in Africa. PMID:15488145

Knowing and avoiding plagiarism during scientific writing.

PubMed

Kumar, P Mohan; Priya, N Swapna; Musalaiah, Svvs; Nagasree, M

2014-09-01

Plagiarism has become more common in both dental and medical communities. Most of the writers do not know that plagiarism is a serious problem. Plagiarism can range from simple dishonesty (minor copy paste/any discrepancy) to a more serious problem (major discrepancy/duplication of manuscript) when the authors do cut-copy-paste from the original source without giving adequate credit to the main source. When we search databases like PubMed/MedLine there is a lot of information regarding plagiarism. However, it is still a current topic of interest to all the researchers to know how to avoid plagiarism. It's time to every young researcher to know ethical guidelines while writing any scientific publications. By using one's own ideas, we can write the paper completely without looking at the original source. Specific words from the source can be added by using quotations and citing them which can help in not only supporting your work and amplifying ideas but also avoids plagiarism. It is compulsory to all the authors, reviewers and editors of all the scientific journals to know about the plagiarism and how to avoid it by following ethical guidelines and use of plagiarism detection software while scientific writing.

Knowing and Avoiding Plagiarism During Scientific Writing

PubMed Central

Kumar, P Mohan; Priya, N Swapna; Musalaiah, SVVS; Nagasree, M

2014-01-01

Plagiarism has become more common in both dental and medical communities. Most of the writers do not know that plagiarism is a serious problem. Plagiarism can range from simple dishonesty (minor copy paste/any discrepancy) to a more serious problem (major discrepancy/duplication of manuscript) when the authors do cut-copy-paste from the original source without giving adequate credit to the main source. When we search databases like PubMed/MedLine there is a lot of information regarding plagiarism. However, it is still a current topic of interest to all the researchers to know how to avoid plagiarism. It's time to every young researcher to know ethical guidelines while writing any scientific publications. By using one's own ideas, we can write the paper completely without looking at the original source. Specific words from the source can be added by using quotations and citing them which can help in not only supporting your work and amplifying ideas but also avoids plagiarism. It is compulsory to all the authors, reviewers and editors of all the scientific journals to know about the plagiarism and how to avoid it by following ethical guidelines and use of plagiarism detection software while scientific writing. PMID:25364588

Ethics in international health research: a perspective from the developing world.

PubMed Central

Bhutta, Zulfiqar Ahmed

2002-01-01

Health research plays a pivotal role in addressing inequities in health and human development, but to achieve these objectives the research must be based on sound scientific and ethical principles. Although it is accepted that ethics play a central role in health research in developing countries, much of the recent debate has focused on controversies surrounding internationally sponsored research and has taken place largely without adequate participation of the developing countries. The relationship between ethical guidelines and regulations, and indigenously sponsored and public health research has not been adequately explored. For example, while the fundamental principles of ethical health research, such as community participation, informed consent, and shared benefits and burdens, remain sacrosanct other issues, such as standards of care and prior agreements, merit greater public debate within developing countries. In particular, the relationship of existing ethical guidelines to epidemiological and public health research merits further exploration. In order to support health research in developing countries that is both relevant and meaningful, the focus must be on developing health research that promotes equity and on developing local capacity in bioethics. Only through such proactive measures can we address the emerging ethical dilemmas and challenges that globalization and the genomics revolution will bring in their wake. PMID:11953789

Ethics guidelines for research with the recently dead.

PubMed

Pentz, Rebecca D; Cohen, Cynthia B; Wicclair, Mark; DeVita, Michael A; Flamm, Anne Lederman; Youngner, Stuart J; Hamric, Ann B; McCabe, Mary S; Glover, Jacqueline J; Kittiko, Winona J; Kinlaw, Kathy; Keller, James; Asch, Adrienne; Kavanagh, John J; Arap, Wadih

2005-11-01

The objective of the multidisciplinary expert Consensus Panel on Research with the Recently Dead (CPRRD) was to craft ethics guidelines for research with the recently dead. The CPRRD recommends that research with the recently dead: (i) receive scientific and ethical review and oversight; (ii) involve the community of potential research subjects; (iii) be coordinated with organ procurement organizations; (iv) not conflict with organ donation or required autopsy; (v) use procedures respectful of the dead; (vi) be restricted to one procedure per day; (vii) preferably be authorized by first-person consent, though both general advance research directives and surrogate consent are acceptable; (viii) protect confidentiality; (ix) not impose costs on subjects' estates or next of kin and not involve payment; (x) clearly explain ultimate disposition of the body.

Progress in animal experimentation ethics: a case study from a Brazilian medical school and from the international medical literature.

PubMed

Ramalli, Edvaldo Luiz; Ho, Wanli; Alves, Mônica; Rocha, Eduardo Melani

2012-09-01

This study describes in Brazil and in the global biomedical community the time course of the development of animal research welfare guidelines. The database of the Ethics Committee of the Faculty of Medicine of Ribeirao Preto (EC/FMRP-USP), Brazil, was surveyed since its inception in 2002 as the regulations became more stringent to provide better protection of animal research welfare at this institution. Medline database was evaluated to identify the number of publications in the period between 1968 and 2008 that used research animals and were in compliance with established ethics guidelines. The EC/FMRP-USP evaluated 979 projects up until 2009. Most of the applications came from Department of Physiology and the most frequently requested species was the rat. In 2004, national research funding agencies started to request prior approval from institutional review ethics committees prior to application review and this requirement became federal law in Brazil in 2008. The analysis of international publications revealed a relative reduction in studies involving research animals (18% in 1968 to 7.5% in 2008). The present work showed that in the last four decades major changes occurred in the guidelines dictating use of research animals occurred and they are being adopted by developing countries. Moreover, animal welfare concern in the scientific community preceded the introduction of journal guidelines for this purpose. Furthermore, in Brazil it was anticipated that laws were needed to protect animal research welfare from being not upheld.

Throwing Out the Relativity Bath Water without Losing the Diversity Baby: Teaching Diversity versus Relativity in a Communication Ethics Course.

ERIC Educational Resources Information Center

Martinson, Jay; Haughey, Paul

This paper holds that despite, or perhaps because of, the development of recent ideas about diversity and cultural relativity, universities are obligated to teach communication ethics. Further, it holds that the implications of giving bachelor's degrees to students who do not have a solid grasp of universal ethical guidelines are potentially…

Regulations and Ethical Considerations for Astronomy Education Research II: Resources and Worked Examples

NASA Astrophysics Data System (ADS)

Brogt, Erik; Dokter, Erin; Antonellis, Jessie; Buxner, Sanlyn

This article discusses the legal and ethical requirements of human subjects research proposals in astronomy education research. We present an overview of the relevant laws, regulations, and guidelines that inform an Institutional Review Board evaluation of proposed research. We also present examples of potential research projects in astronomy education research and discuss their ethical issues.

Trade in human tissue products.

PubMed

Tonti-Filippini, Nicholas; Zeps, Nikolajs

2011-03-07

Trade in human tissue in Australia is prohibited by state law, and in ethical guidelines by the National Health and Medical Research Council: National statement on ethical conduct in human research; Organ and tissue donation by living donors: guidelines for ethical practice for health professionals. However, trade in human tissue products is a common practice especially for: reconstructive orthopaedic or plastic surgery; novel human tissue products such as a replacement trachea created by using human mesenchymal stem cells; biomedical research using cell lines, DNA and protein provided through biobanks. Cost pressures on these have forced consideration of commercial models to sustain their operations. Both the existing and novel activities require a robust framework to enable commercial uses of human tissue products while maintaining community acceptability of such practices, but to date no such framework exists. In this article, we propose a model ethical framework for ethical governance which identifies specific ethical issues such as: privacy; unique value of a person's tissue; commodification of the body; equity and benefit to the community; perverse incentives; and "attenuation" as a potentially useful concept to help deal with the broad range of subjective views relevant to whether it is acceptable to commercialise certain human tissue products.

The emergence of an ethical duty to disclose genetic research results: international perspectives.

PubMed

Knoppers, Bartha Maria; Joly, Yann; Simard, Jacques; Durocher, Francine

2006-11-01

The last decade has witnessed the emergence of international ethics guidelines discussing the importance of disclosing global and also, in certain circumstances, individual genetic research results to participants. This discussion is all the more important considering the advent of pharmacogenomics and the increasing incidence of 'translational' genetic research in the post-genomic era. We surveyed both the literature and the ethical guidelines using selective keywords. We then analyzed our data using a qualitative method approach and singled out countries or policies that were representative of certain positions. From our findings, we conclude that at the international level, there now exists an ethical duty to return individual genetic research results subject to the existence of proof of validity, significance and benefit. Even where these criteria are met, the right of the research participant not to know also has to be taken into consideration. The existence of an ethical duty to return individual genetic research results begs several other questions: Who should have the responsibility of disclosing such results and when? To whom should the results be disclosed? How? Finally, will this ethical 'imperative' become a legally recognized duty as well?

Exploring perceptions and experiences of Bolivian health researchers with research ethics.

PubMed

Sullivan, Sarah; Aalborg, Annette; Basagoitia, Armando; Cortes, Jacqueline; Lanza, Oscar; Schwind, Jessica S

2015-04-01

In Bolivia, there is increasing interest in incorporating research ethics into study procedures, but there have been inconsistent application of research ethics practices. Minimal data exist regarding the experiences of researchers concerning the ethical conduct of research. A cross-sectional study was administered to Bolivian health leaders with research experience (n = 82) to document their knowledge, perceptions, and experiences of research ethics committees and infrastructure support for research ethics. Results showed that 16% of respondents reported not using ethical guidelines to conduct their research and 66% indicated their institutions did not consistently require ethics approval for research. Barriers and facilitators to incorporate research ethics into practice were outlined. These findings will help inform a comprehensive rights-based research ethics education program in Bolivia. © The Author(s) 2015.

Do editorial policies support ethical research? A thematic text analysis of author instructions in psychiatry journals.

PubMed

Strech, Daniel; Metz, Courtney; Knüppel, Hannes

2014-01-01

According to the Declaration of Helsinki and other guidelines, clinical studies should be approved by a research ethics committee and seek valid informed consent from the participants. Editors of medical journals are encouraged by the ICMJE and COPE to include requirements for these principles in the journal's instructions for authors. This study assessed the editorial policies of psychiatry journals regarding ethics review and informed consent. The information given on ethics review and informed consent and the mentioning of the ICMJE and COPE recommendations were assessed within author's instructions and online submission procedures of all 123 eligible psychiatry journals. While 54% and 58% of editorial policies required ethics review and informed consent, only 14% and 19% demanded the reporting of these issues in the manuscript. The TOP-10 psychiatry journals (ranked by impact factor) performed similarly in this regard. Only every second psychiatry journal adheres to the ICMJE's recommendation to inform authors about requirements for informed consent and ethics review. Furthermore, we argue that even the ICMJE's recommendations in this regard are insufficient, at least for ethically challenging clinical trials. At the same time, ideal scientific design sometimes even needs to be compromised for ethical reasons. We suggest that features of clinical studies that make them morally controversial, but not necessarily unethical, are analogous to methodological limitations and should thus be reported explicitly. Editorial policies as well as reporting guidelines such as CONSORT should be extended to support a meaningful reporting of ethical research.

5 CFR 2601.202 - Procedure.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure. 2601.202 Section 2601.202 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.202 - Procedure.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Procedure. 2601.202 Section 2601.202 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.201 - Delegation.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Delegation. 2601.201 Section 2601.201 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.204 - Conditions for acceptance.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Conditions for acceptance. 2601.204 Section 2601.204 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.202 - Procedure.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Procedure. 2601.202 Section 2601.202 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.204 - Conditions for acceptance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Conditions for acceptance. 2601.204 Section 2601.204 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.201 - Delegation.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Delegation. 2601.201 Section 2601.201 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.202 - Procedure.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Procedure. 2601.202 Section 2601.202 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.201 - Delegation.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Delegation. 2601.201 Section 2601.201 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.204 - Conditions for acceptance.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Conditions for acceptance. 2601.204 Section 2601.204 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.204 - Conditions for acceptance.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Conditions for acceptance. 2601.204 Section 2601.204 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

The fiduciary obligation of the physician-researcher in phase IV trials

PubMed Central

2014-01-01

Background In this manuscript, we argue that within the context of phase IV, physician-researchers retain their fiduciary obligation to treat the patient-participants. Discussion We first clarify why the perspective that research ethics ought to be differentiated from clinical ethics is not applicable in phase IV, and therefore, why therapeutic orientation is most convivial in this phase. Next, assuming that ethics guidelines may be representative of common morality, we show that ethics guidelines see physician-researchers primarily as physicians and only secondarily as researchers. We then elaborate on what a fiduciary obligation is and how some of the obligations are default duties. Lastly, we look at the fiduciary obligation of the physician-researcher in phase IV interventional trials. Conclusion The fiduciary obligation to treat is not as easily waived as in earlier trials. Assuming the entwinement of research and practice in phase IV, physician-researchers, in collaboration with other researchers, investigators, and research ethics committees, should ensure that in terms of study design, methodology, and research practice, the therapeutic value of the research to the patient-participants is not diminished. PMID:24507449

RELIGIOUS, SPIRITUAL, AND TRADITIONAL BELIEFS AND PRACTICES AND THE ETHICS OF MENTAL HEALTH RESEARCH IN LESS WEALTHY COUNTRIES*

PubMed Central

NOLAN, JENNIFER A.; WHETTEN, KATHRYN; KOENIG, HAROLD G.

2013-01-01

This discussion article contributes to ethics reform by introducing the contribution of religious, spiritual, and traditional beliefs and practices to both subject vulnerability and patient improvement. A growing body of evidence suggests that religious, spiritual, and traditional beliefs and practices may provide positive benefits, although in some cases mixed or negative consequences to mental and physical health. These beliefs and practices add a new level of complexity to ethical deliberations, in terms of what ignoring them may mean for both distributive justice and respect for persons. International ethical guidelines need to be created that are expansive enough to cover an array of social groups and circumstances. It is proposed that these guidelines incorporate the religious, spiritual, and/or traditional principles that characterize a local population. Providing effective mental healthcare requires respecting and understanding how differences, including ones that express a population's religious, spiritual, or traditional belief systems, play into the complex deliberations and negotiations that must be undertaken if researchers are to adhere to ethical imperatives in research and treatment. PMID:22439296

Development of ethical rules for boundaries of touch in complementary medicine--outcomes of a Delphi process.

PubMed

Schiff, Elad; Ben-Arye, Eran; Shilo, Margalit; Levy, Moti; Schachter, Leora; Weitchner, Na'ama; Golan, Ofra; Stone, Julie

2010-11-01

The practice of complementary medicine (CAM) often involves touch. The unique philosophy of many CAM therapies, and the setting in which treatments are provided create a therapeutic space which may be less clearly defined than in conventional settings - a space in which the boundaries between professional touch and personal/intimate touch may become easily obscured. Thus, complementary therapists need clear definitions and firm boundaries in order to maintain therapeutic efficacy and commitment. The aim of the process described in this article, was to develop ethical guidelines for boundaries of touch that will promote the safety and protection of the public which use CAM. Through a modified Delphi process, a diverse group of CAM practitioners, physicians, ethicists, legal consultants, health policy specialists, and representatives from the public, developed Ethical Rules for Boundaries of Touch in CAM. These guidelines may be implemented in ethical codes of professional CAM organizations, and also serve as a foundation for curriculums in ethics in CAM schools. Copyright © 2010 Elsevier Ltd. All rights reserved.

Health research involving First Nations, Inuit and Métis children and their communities

PubMed Central

Starkes, Jill M; Baydala, Lola T

2014-01-01

Canadian and international guidelines address the ethical conduct of health research in general and the issues affecting Indigenous populations in particular. This statement summarizes, for clinicians and researchers, relevant ethical and practical considerations for health research involving Aboriginal children and youth. While not intended to duplicate findings arising from lengthy collaborative processes, it does highlight ‘wise practices’ that have successfully generated knowledge relevant to, respectful of and useful for Aboriginal children, youth and their communities. Further research on current health issues and inequities should lead to practical, effective and culturally relevant applications. Expanding our knowledge of ways to address the health disparities facing Canada’s Aboriginal children and youth can inform health policy and the provision of services. Community-based participatory research is proposed as a means to achieve this goal. PMID:24596485

Sex, lies and training programs: the ethics of consensual sexual relationships between psychiatrists and trainee psychiatrists.

PubMed

Ryan, C J

1998-06-01

The aim of this paper is to chart the ethical territory surrounding the issue of consensual sexual relationships between psychiatrists and doctors training in psychiatry. The arguments for and against the prohibition of such relationships are critically examined both in general and in a number of specific circumstances. There should not be a general prohibition against such relationships, but a prohibition should apply in certain special circumstances. Such circumstances include occasions when the psychiatrist is currently supervising the trainee, when a particular psychiatrist has repeated sexual relationships with trainees and when a group of psychiatrists voluntarily pledge to abstain from such relationships. Institutions involved in psychiatric training should develop guidelines for dealing with such relationships, adopting a generally permissive attitude toward them with clear exceptions in special cases.

The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trials.

PubMed

Djulbegovic, Benjamin; Cantor, Alan; Clarke, Mike

2003-01-01

Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."

Advancing Ethical Neuroscience Research.

PubMed

Borah, B Rashmi; Strand, Nicolle K; Chillag, Kata L

2016-12-01

As neuroscience research advances, researchers, clinicians, and other stakeholders will face a host of ethical challenges. The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has published two reports that provide recommendations on how to advance research endeavors ethically. The commission addressed, among other issues, how to prioritize different types of neuroscience research and how to include research participants who have impaired consent capacity. The Bioethics Commission's recommendations provide a foundation for ethical guidelines as neuroscience research advances and progresses. © 2016 American Medical Association. All Rights Reserved.

Best practice & research in anaesthesiology issue on new approaches in clinical research ethics in clinical research.

PubMed

Schwenzer, Karen J

2011-12-01

The history of ethics in clinical research parallels the history of abuse of human beings. The Nuremberg Code, Declaration of Helsinki, and the Belmont Report laid the foundations for modern research ethics. In the United States, the OHRP and the FDA provide guidelines for the ethical conduct of research. Investigators should be familiar with regulations concerning informed consent, doing research in vulnerable populations, and protection of privacy. Copyright © 2011 Elsevier Ltd. All rights reserved.

Ethical practice under fire: deployed physicians in the global war on terrorism.

PubMed

Sessums, Laura L; Collen, Jacob F; O'Malley, Patrick G; Jackson, Jeffery L; Roy, Michael J

2009-05-01

The Global War on Terrorism brings significant ethical challenges for military physicians. From Abu Ghraib to Guantanamo Bay, the actions of health care providers have come under considerable scrutiny. Military providers have dual roles as military officers and medical professionals, which have the potential to come into conflict. Often they are inadequately prepared to manage this conflict. We review pertinent historical precedents, applicable laws, ethical guidelines, and military regulations. We also present examples of ethical challenges deployed clinicians have faced and their ethical solution. Finally, we propose a practical strategy to educate physicians on how to manage complex ethical dilemmas in war time settings.

Ethical and Legal Considerations in Dental Caries Research Using Human Subjects: Conference Summary.

ERIC Educational Resources Information Center

Jenny, Joanna

1980-01-01

Guidelines of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research are discussed. It is concluded that dentistry must not uncritically accept guidelines meant for a broader class of research, that guidelines can be misapplied, and that researchers must educate themselves on the Commission…

The Terri Schiavo case: legal, ethical, and medical perspectives.

PubMed

Perry, Joshua E; Churchill, Larry R; Kirshner, Howard S

2005-11-15

Although tragic, the plight of Terri Schiavo provides a valuable case study. The conflicts and misunderstandings surrounding her situation offer important lessons in medicine, law, and ethics. Despite media saturation and intense public interest, widespread confusion lingers regarding the diagnosis of persistent vegetative state, the judicial processes involved, and the appropriateness of the ethical framework used by those entrusted with Terri Schiavo's care. First, the authors review the current medical understanding of persistent vegetative state, including the requirements for patient examination, the differential diagnosis, and the practice guidelines of the American Academy of Neurology regarding artificial nutrition and hydration for patients with this diagnosis. Second, they examine the legal history, including the 2000 trial, the 2002 evidentiary hearing, and the subsequent appeals. The authors argue that the law did not fail Terri Schiavo, but produced the highest-quality evidence and provided the most judicial review of any end-of-life guardianship case in U.S. history. Third, they review alternative ethical frameworks for understanding the Terri Schiavo case and contend that the principle of respect for autonomy is paramount in this case and in similar cases. Far from being unusual, the manner in which Terri Schiavo's case was reviewed and the basis for the decision reflect a broad medical, legal, and ethical consensus. Greater clarity regarding the persistent vegetative state, less apprehension of the presumed mysteries of legal proceedings, and greater appreciation of the ethical principles at work are the chief benefits obtained from studying this provocative case.

Eli Lilly and Company's bioethics framework for human biomedical research.

PubMed

Van Campen, Luann E; Therasse, Donald G; Klopfenstein, Mitchell; Levine, Robert J

2015-11-01

Current ethics and good clinical practice guidelines address various aspects of pharmaceutical research and development, but do not comprehensively address the bioethical responsibilities of sponsors. To fill this void, in 2010 Eli Lilly and Company developed and implemented a Bioethics Framework for Human Biomedical Research to guide ethical decisions. (See our companion article that describes how the framework was developed and implemented and provides a critique of its usefulness and limitations.) This paper presents the actual framework that serves as a company resource for employee education and bioethics deliberations. The framework consists of four basic ethical principles and 13 essential elements for ethical human biomedical research and resides within the context of our company's mission, vision and values. For each component of the framework, we provide a high-level overview followed by a detailed description with cross-references to relevant well regarded guidance documents. The principles and guidance described should be familiar to those acquainted with research ethics. Therefore the novelty of the framework lies not in the foundational concepts presented as much as the attempt to specify and compile a sponsor's bioethical responsibilities to multiple stakeholders into one resource. When such a framework is employed, it can serve as a bioethical foundation to inform decisions and actions throughout clinical planning, trial design, study implementation and closeout, as well as to inform company positions on bioethical issues. The framework is, therefore, a useful tool for translating ethical aspirations into action - to help ensure pharmaceutical human biomedical research is conducted in a manner that aligns with consensus ethics principles, as well as a sponsor's core values.

Standards and guidelines for HIV prevention research: considerations for local context in the interpretation of global ethical standards.

PubMed

Haire, Bridget G; Folayan, Morenike Oluwatoyin; Brown, Brandon

2014-09-01

While international standards are important for conducting clinical research, they may require interpretation in particular contexts. Standard of care in HIV prevention research is now complicated, given that there are now two new biomedical prevention interventions - 'treatment-as-prevention', and pre-exposure prophylaxis--in addition to barrier protection, counselling, male circumcision and treatment of sexually transmissible infections. Proper standards of care must be considered with regard to both normative guidance and the circumstances of the particular stakeholders--the community, trial population, researchers and sponsors. In addition, the special circumstances of the lives of participants need to be acknowledged in designing trial protocols and study procedures. When researchers are faced with the dilemma of interpretation of international ethics guidelines and the realities of the daily lives of persons and their practices, the decisions of the local ethics committee become crucial. The challenge then becomes how familiar ethics committee members in these local settings are with these guidelines, and how their interpretation and use in the local context ensures the respect for persons and communities. It also includes justice and the fair selection of study participants without compromising data quality, and ensuring that the risks for study participants and their community do not outweigh the potential benefits.

5 CFR 2601.203 - Conflict of interest analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Conflict of interest analysis. 2601.203 Section 2601.203 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.203 - Conflict of interest analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Conflict of interest analysis. 2601.203 Section 2601.203 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.203 - Conflict of interest analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Conflict of interest analysis. 2601.203 Section 2601.203 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.203 - Conflict of interest analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Conflict of interest analysis. 2601.203 Section 2601.203 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

[Learning objectives achievement in ethics education for medical school students].

PubMed

Chae, Sujin; Lim, Kiyoung

2015-06-01

This study aimed to examine the necessity for research ethics and learning objectives in ethics education at the undergraduate level. A total of 393 fourth-year students, selected from nine medical schools, participated in a survey about learning achievement and the necessity for it. It was found that the students had very few chances to receive systematic education in research ethics and that they assumed that research ethics education was provided during graduate school or residency programs. Moreover, the students showed a relatively high learning performance in life ethics, while learning achievement was low in research ethics. Medical school students revealed low interest in and expectations of research ethics in general; therefore, it is necessary to develop guidelines for research ethics in the present situation, in which medical education mainly focuses on life ethics.

(ETHNO-)MEDICAL ETHICS IN GLOBALIZING CHINA: TRACING LOCAL KNOWLEDGE AND ADAPTATION OF BIOMEDICINE.

PubMed

Micollier, Evelyne

2015-12-01

Encounters between several bodies of therapeutic knowledge have led to a restructuring of the entire health system, including a transformation in medical ethics. Defining "new ethics" with both Chinese and international characteristics, is part of the ongoing knowledge production process: plural health ideas, practices and medical sciences develop within the broader framework of social and economic transition. Such transition simultaneously reveals and encourages China's influence and position in an era of globalization including in the technical and knowledge production domains. Re-alignments in medical ethics in Reform China (post-1979) highlight a rather under-explored aspect of medical plurality enabling these ethics to be used as an analytical lens to provide information about social and political issues. In this article, two sets of ethical principles, one from Late Imperial China (Late Ming Era), the other from post-Mao China (1980s), are detailed and analysed. They were selected as case-studies mainly because they reflected at the time of their emergence an on-going radical change in society in the realm of health and medicine. Therefore both sets unveil the process of legitimizing a "Chinese medicine" in a context of epistemological shift: such a process takes various conceptual and practicalforms framed along the lines of the current dominant ideological system and constrained by socio-economic and political factors. Finally, issues relative to research ethics, bioethics and the New Health Reform guidelines raised in the 2000s, which represents also a significant historical turn for China, are discussed. Drawn from the overall discussion throughout the text, several concluding remarks contribute to advocate for "win-win" encounters--from the East to the West and from the South to the South, and for more implementable transnational/global ethics designing.

The quality of Internet advertising in aesthetic surgery: an in-depth analysis.

PubMed

Wong, Wendy W; Camp, Matthew C; Camp, Jennifer S; Gupta, Subhas C

2010-09-01

The aesthetic market is a growing business, as evidenced by the American Society for Aesthetic Plastic Surgery (ASAPS) reporting an increase of 147% in the number of cosmetic procedures performed by members since 1997. This market is consumer-oriented, relying heavily on advertising for survival amid the increasing provider competition. The authors evaluate trends, ethics, and efficacy of Internet advertising in aesthetic surgery. Medical cosmetic providers in Southern California and their Web sites were catalogued through sales lists from manufacturers (Medicis and Allergan) and combined with advertised providers of surgical treatments. Using the ASAPS/American Society of Aesthetic Plastic Surgeons (ASPS) and American Medical Association Codes of Ethics as guidelines, scores were assigned to each Web site and evaluated with the provider's board certification. A geographical analysis determined whether the presence of high numbers of competitors had an impact on the adherence to ethical guidelines for advertising. To examine patient preferences in physician advertising, a survey was conducted online. Board-certified plastic surgeons showed the highest total ethical scores, followed by otolaryngologists, oromaxillofacial surgeons, and ophthalmologists. No decrement in the quality of the advertising was found in densely competitive environments. A consistent correlation was found between superior compliance with ethical guidelines and board certification in plastic surgery. The patient preference survey of 208 individuals demonstrated their desire for a well-trained, board-certified plastic surgeon to perform their cosmetic procedures. Although plastic surgeons demonstrate greater overall compliance with the ASAPS/ASPS Advertising Code of Ethics, they can continue to improve. With the large variety of cosmetic physicians offering the same procedures, maintaining open, honest, and forthright communication with the public is essential.

Ethics Certification of Health Information Professionals.

PubMed

Kluge, Eike-Henner; Lacroix, Paulette; Ruotsalainen, Pekka

2018-04-22

 To provide a model for ensuring the ethical acceptability of the provisions that characterize the interjurisdictional use of eHealth, telemedicine, and associated modalities of health care deliveiy that are currently in place.  Following the approach initiated in their Global Protection of Health Data project within the Security in Health Information Systems (SiHIS) working group of the International Medical Informatics Association (IMIA), the authors analyze and evaluate relevant privacy and security approaches that are intended to stem the erosion of patients' trustworthiness in the handling of their sensitive information by health care and informatics professionals in the international context.  The authors found that while the majority of guidelines and ethical codes essentially focus on the role and functioning of the institutions that use EHRs and information technologies, little if any attention has been paid to the qualifications of the health informatics professionals (HIPs) who actualize and operate information systems to deal with or address relevant ethical issues.  The apparent failure to address this matter indicates that the ethical qualification of HIPs remains an important security issue and that the Global Protection of Health Data project initiated by the SiHIS working group in 2015 should be expanded to develop into an internationally viable method of certification. An initial model to this effect is sketched and discussed. Georg Thieme Verlag KG Stuttgart.

Live kidney donations and the ethic of care.

PubMed

Kane, Francis; Clement, Grace; Kane, Mary

2008-09-01

In this paper, we seek to re-conceptualize the ethical framework through which ethicists and medical professionals view the practice of live kidney donations. The ethics of organ donation has been understood primarily within the framework of individual rights and impartiality, but we show that the ethic of care captures the moral situation of live kidney donations in a more coherent and comprehensive way, and offers guidance for practitioners that is more attentive to the actual moral transactions among donors and recipients. A final section offers guidelines for the practice of live kidney transplants that emerge from an ethic of care.

Implementing ethics in the professions: examples from environmental epidemiology.

PubMed

Soskolne, Colin L; Sieswerda, Lee E

2003-04-01

The need to integrate ethics into professional life, from the grassroots up, has been recognized, and a comprehensive ethics program has been proposed as a model. The model includes the four dimensions of: consensus building, ethics guidelines development and review, education, and implementation. The activities of the International Society for Environmental Epidemiology (ISEE) are presented as examples and compared with the proposed model. Several innovative activities are described and incentives for ethical professional conduct are highlighted. The examples are provided for emulation by other professional organizations in the hope that, thereby, greater protection of the public interest will be achieved.

Disparate compensation policies for research related injury in an era of multinational trials: a case study of Brazil, Russia, India, China and South Africa.

PubMed

Chingarande, George Rugare; Moodley, Keymanthri

2018-02-17

Compensation for research related injuries is a subject that is increasingly gaining traction in developing countries which are burgeoning destinations of multi center research. However, the existence of disparate compensation rules violates the ethical principle of fairness. The current paper presents a comparison of the policies of Brazil, Russia, India, China and South Africa (BRICS). A systematic search of good clinical practice guidelines was conducted employing search strategies modeled in line with the recommendations of ADPTE Collaboration (2007). The search focused on three main areas namely bibliographic data bases, clinical practice guidelines data bases and a restricted internet search. A manual search of references cited in relevant guideline documents was also conducted. The search terms, Medical Subject Headings (MeSH) and key words were developed for a PubMed platform and then adapted for all other data bases. The search terms were kept constant for each country with the only difference being the country name. The documents so obtained were subjected to systematic content analysis. The study revealed that there is vast panoply of regulations which exist on a continuum. On one extreme is India with comprehensive regulations that are codified into law, and on the other end there is China which does not have specific laws regulating research related injuries. There are a number of differences and similarities such as mandatory insurance requirements, existence of no fault compensation, compensable injuries and the role of research ethics committees. It is imperative to enact legislations that protect participants without stifling the research enterprise. There is need for consistency and ideally harmonization of such regulations at a global level. A model policy on compensation for research related injuries should borrow from the best aspects of the different country policies and should be informed by the cardinal ethics principles of autonomy, justice and beneficence.

Creating Ethical University-Industry Partnerships.

ERIC Educational Resources Information Center

Streharsky, Charmaine Judy

1993-01-01

Basic ethical guidelines for intellectual property disputes between universities and industry include (1) negotiate in best faith; (2) vest patent ownership in the university partner; (3) grant the industrial partner exclusive license in most desired field of use; (4) allow industrial partner to negotiate over serendipitous discoveries outside…

Picturing neuroscience research through a human rights lens: Imaging first-episode schizophrenic treatment-naive individuals

PubMed Central

Eijkholt, Marleen; Anderson, James A.; Illes, Judy

2012-01-01

In this paper we examine imaging research involving first-episode schizophrenic treatment-naive individuals (FESTNIs) through a legal human rights lens; in particular, the lens of the Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research. We identify a number of ethical and legal hot spots highlighted by the Protocol, and offer a series of recommendations designed to ensure the human rights compatibility of this research. Subsequently, we argue that the lack of reporting on design elements related to ethical concerns frustrates commitments at the heart of the human rights approach, namely, transparency and openness to international scrutiny. To redress this problem, we introduce two norms for the first time: ethical transparency, and ethical reproducibility. When concluding, we offer a set of reporting guidelines designed to operationalize these norms in the context of imaging research involving FESTNIs. Though we will not make this case here, we believe that parallel reporting guidelines should be incorporated into other areas of research involving human subjects. PMID:22304987

Curricular priorities for business ethics in medical practice and research: recommendations from Delphi consensus panels.

PubMed

DuBois, James M; Kraus, Elena M; Gursahani, Kamal; Mikulec, Anthony; Bakanas, Erin

2014-11-15

No published curricula in the area of medical business ethics exist. This is surprising given that physicians wrestle daily with business decisions and that professional associations, the Institute of Medicine, Health and Human Services, Congress, and industry have issued related guidelines over the past 5 years. To fill this gap, the authors aimed (1) to identify the full range of medical business ethics topics that experts consider important to teach, and (2) to establish curricular priorities through expert consensus. In spring 2012, the authors conducted an online Delphi survey with two heterogeneous panels of experts recruited in the United States. One panel focused on business ethics in medical practice (n = 14), and 1 focused on business ethics in medical research (n = 12). Panel 1 generated an initial list of 14 major topics related to business ethics in medical practice, and subsequently rated 6 topics as very important or essential to teach. Panel 2 generated an initial list of 10 major topics related to business ethics in medical research, and subsequently rated 5 as very important or essential. In both domains, the panel strongly recommended addressing problems that conflicts of interest can cause, legal guidelines, and the goals or ideals of the profession. The Bander Center for Medical Business Ethics at Saint Louis University will use the results of the Delphi panel to develop online curricular resources for each of the highest rated topics.

Do Editorial Policies Support Ethical Research? A Thematic Text Analysis of Author Instructions in Psychiatry Journals

PubMed Central

Strech, Daniel; Metz, Courtney; Knüppel, Hannes

2014-01-01

Introduction According to the Declaration of Helsinki and other guidelines, clinical studies should be approved by a research ethics committee and seek valid informed consent from the participants. Editors of medical journals are encouraged by the ICMJE and COPE to include requirements for these principles in the journal’s instructions for authors. This study assessed the editorial policies of psychiatry journals regarding ethics review and informed consent. Methods and Findings The information given on ethics review and informed consent and the mentioning of the ICMJE and COPE recommendations were assessed within author’s instructions and online submission procedures of all 123 eligible psychiatry journals. While 54% and 58% of editorial policies required ethics review and informed consent, only 14% and 19% demanded the reporting of these issues in the manuscript. The TOP-10 psychiatry journals (ranked by impact factor) performed similarly in this regard. Conclusions Only every second psychiatry journal adheres to the ICMJE’s recommendation to inform authors about requirements for informed consent and ethics review. Furthermore, we argue that even the ICMJE’s recommendations in this regard are insufficient, at least for ethically challenging clinical trials. At the same time, ideal scientific design sometimes even needs to be compromised for ethical reasons. We suggest that features of clinical studies that make them morally controversial, but not necessarily unethical, are analogous to methodological limitations and should thus be reported explicitly. Editorial policies as well as reporting guidelines such as CONSORT should be extended to support a meaningful reporting of ethical research. PMID:24901366

Ethical Challenges in Promoting the Implementation of Preventive Interventions: Report of the SPR Task Force.

PubMed

Leadbeater, Bonnie J; Dishion, Tom; Sandler, Irwin; Bradshaw, Catherine P; Dodge, Kenneth; Gottfredson, Denise; Graham, Phillip W; Lindstrom Johnson, Sarah; Maldonado-Molina, Mildred M; Mauricio, Anne M; Smith, Emilie Phillips

2018-06-23

Prevention science researchers and practitioners are increasingly engaged in a wide range of activities and roles to promote evidence-based prevention practices in the community. Ethical concerns invariably arise in these activities and roles that may not be explicitly addressed by university or professional guidelines for ethical conduct. In 2015, the Society for Prevention Research (SPR) Board of Directors commissioned Irwin Sandler and Tom Dishion to organize a series of roundtables and establish a task force to identify salient ethical issues encountered by prevention scientists and community-based practitioners as they collaborate to implement evidence-based prevention practices. This article documents the process and findings of the SPR Ethics Task Force and aims to inform continued efforts to articulate ethical practice. Specifically, the SPR membership and task force identified prevention activities that commonly stemmed from implementation and scale-up efforts. This article presents examples that illustrate typical ethical dilemmas. We present principles and concepts that can be used to frame the discussion of ethical concerns that may be encountered in implementation and scale-up efforts. We summarize value statements that stemmed from our discussion. We also conclude that the field of prevention science in general would benefit from standards and guidelines to promote ethical behavior and social justice in the process of implementing evidence-based prevention practices in community settings. It is our hope that this article serves as an educational resource for students, investigators, and Human Subjects Review Board members regarding some of the complexity of issues of fairness, equality, diversity, and personal rights for implementation of preventive interventions.

Ethics review of health research on human participants in South Africa.

PubMed

van Wyk, Christa

2010-06-01

In terms of South African legislation, all health research on human participants must be submitted to an accredited research ethics committee for independent ethics review. Health research covers a broad spectrum of research, including clinical trials. This article sets out the ethical-legal framework for the functioning and composition of such committees. It also deals with the newly created National Health Research Ethics Council, which registers and audits health research ethics committees. Special attention is given to the conduct of clinical trials. In conclusion, it is submitted that the National Health Act, the Draft Regulations Relating to Research on Human Subjects, and two sets of ethical guidelines adopted by the Department of Health provide a much needed and coherent ethical-legal framework for research in South Africa.

Report of the Committee on Ethics

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

Not Available

1992-01-01

This report provides an update on ethics issues and decisions under the recently revised District of Columbia Rules of Professional Responsibility, the proposed rules of conduct issued by the Office of Government Ethics is applicable to employees of the Department of Energy (DOE) and the Federal Energy Regulatory Commission (FERC), federal statutory guidelines governing post-employment restrictions on former government employees, and important developments in the FERC's rules governing ex parte communication.

Research ethics and approval process: A guide for new GP researchers.

PubMed

Liaw, Siaw-Teng; Tam, Chun Wah Michael

2015-06-01

The underlying moral principles and values, and the virtues held as desirable for a researcher, should be reflected upon and embedded in the research. The foundation step is to download the National Health and Medical Research Council's (NHMRC's) National Statement on Ethical Conduct in Human Research and the NHMRC's Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research to use as references. This paper draws on the experience of The Royal Australian College of General Practitioners' (RACGP's) National Research and Evaluation Ethics Committee to provide an eight-step approach to the research ethics process. The researcher should use the research ethics process as an opportunity to foster and guide the development and conduct of ethical research.

Evaluating the ethical acceptability of animal research.

PubMed

Bout, Henriëtte J; Fentener van Vlissingen, J Martje; Karssing, Edgar D

2014-11-01

The ethical acceptability of animal research is typically evaluated on a case-by-case basis. Legislation such as Directive 2010/63/EU on the protection of animals used for scientific purposes provides guidance for ethical evaluation of animal use proposals but does not dictate the outcome, leaving this determination to the ethical review committees of individual institutions. The authors assess different ethics models and how these are reflected in the guidelines of Directive 2010/63/EU. They also describe a matrix for carrying out harm-benefit analyses of animal use proposals, which they identified by examining the practices of three ethical review committees in the Netherlands. Finally, they discuss how this matrix can be applied by ethical review committees at other institutions.

Ethical Guidelines for the Teaching of Psychology in the Secondary School.

ERIC Educational Resources Information Center

American Psychological Association, Washington, DC.

These guidelines are intended to assist high school psychology teachers in safeguarding the rights and welfare of students and experimental subjects while promoting high-quality instruction. There are three sets of guidelines. The first set deals with the use of animals in school science behavior projects. The major goal of such projects should be…

Outcome of a research ethics training workshop among clinicians and scientists in a Nigerian university.

PubMed

Ajuwon, Ademola J; Kass, Nancy

2008-01-24

In Nigeria, as in other developing countries, access to training in research ethics is limited, due to weak social, economic, and health infrastructure. The project described in this article was designed to develop the capacity of academic staff of the College of Medicine, University of Ibadan, Nigeria to conduct ethically acceptable research involving human participants. Three in-depth interviews and one focus group discussion were conducted to assess the training needs of participants. A research ethics training workshop was then conducted with College of Medicine faculty. A 23-item questionnaire that assessed knowledge of research ethics, application of principles of ethics, operations of the Institutional Review Board (IRB) and ethics reasoning was developed to be a pre-post test evaluation of the training workshop. Ninety-seven workshop participants completed the questionnaire before and after the workshop; 59 of them completed a second post-test questionnaire one month after the workshop. The trainees came from a multi-disciplinary background including medicine, nursing, pharmacy, social science and laboratory science. The mean scores for knowledge of the principles of research ethics rose from 0.67 out of 3 points at pre-test to 2.25 at post-test (p < 0.05). Also, 42% correctly mentioned one international guideline or regulation at pretest, with most of those knowing of the Declaration of Helsinki. Trainees' knowledge of the operations of an IRB increased from 6.05 at pre-test to 6.29 at post test out of 7 points. Overall, participants retained much of the knowledge acquired from the workshop one month after its completion. The training improved participants' knowledge of principles of research ethics, international guidelines and regulations and operations of IRBs. It thus provided an opportunity for research ethics capacity development among academic staff in a developing country institution.

Professional Ethics for Climate Scientists

NASA Astrophysics Data System (ADS)

Peacock, K.; Mann, M. E.

2014-12-01

Several authors have warned that climate scientists sometimes exhibit a tendency to "err on the side of least drama" in reporting the risks associated with fossil fuel emissions. Scientists are often reluctant to comment on the implications of their work for public policy, despite the fact that because of their expertise they may be among those best placed to make recommendations about such matters as mitigation and preparedness. Scientists often have little or no training in ethics or philosophy, and consequently they may feel that they lack clear guidelines for balancing the imperative to avoid error against the need to speak out when it may be ethically required to do so. This dilemma becomes acute in cases such as abrupt ice sheet collapse where it is easier to identify a risk than to assess its probability. We will argue that long-established codes of ethics in the learned professions such as medicine and engineering offer a model that can guide research scientists in cases like this, and we suggest that ethical training could be regularly incorporated into graduate curricula in fields such as climate science and geology. We recognize that there are disanalogies between professional and scientific ethics, the most important of which is that codes of ethics are typically written into the laws that govern licensed professions such as engineering. Presently, no one can legally compel a research scientist to be ethical, although legal precedent may evolve such that scientists are increasingly expected to communicate their knowledge of risks. We will show that the principles of professional ethics can be readily adapted to define an ethical code that could be voluntarily adopted by scientists who seek clearer guidelines in an era of rapid climate change.

Evolution of Ethics in Clinical Research and Ethics Committee

PubMed Central

Das, Nilay Kanti; Sil, Amrita

2017-01-01

Ethics are the moral values of human behavior and the principles which govern these values. The situation becomes challenging for a doctor when he assumes the role of researcher. The doctor-researcher has to serve both the roles and at times the zeal of an investigator has the potential to cloud the morality of the physician inside. It is very important to realize that exploiting the faith of patients is an offence that tantamount to a crime. Medical science is one discipline where the advancement of knowledge is hugely guided by research and mankind has benefitted from many experiments. However benefit and risk are the two faces of the same coin. Various unethical human experiments made us realize that the whims of researchers need to be reined and led to the evolution of the first guidelines for researcher, the Nuremberg code. Thereafter the Good Clinical Practice guidelines serve as the guiding doctrine of clinical research. The principles of ethics rest on the four pillars of autonomy, beneficence, justice, non-maleficence and recently two more pillars are added which includes, confidentiality and honesty. Ethics committees serve as a guardian of these principles. The multidisciplinary Ethics Committee ensures a competent review of the ethical aspects of the project proposal submitted and does it free from any bias or external influence. Ethical review of clinical trial applications follows a decentralized process in India, and requires Ethics Committee approval for each trial site. All Ethics committees have to be registered with Drug Controller General of India (DCGI) without which they cannot approve any clinical trial protocol and has come into effect from 25th February 2013. PMID:28794547

Evolution of Ethics in Clinical Research and Ethics Committee.

PubMed

Das, Nilay Kanti; Sil, Amrita

2017-01-01

Ethics are the moral values of human behavior and the principles which govern these values. The situation becomes challenging for a doctor when he assumes the role of researcher. The doctor-researcher has to serve both the roles and at times the zeal of an investigator has the potential to cloud the morality of the physician inside. It is very important to realize that exploiting the faith of patients is an offence that tantamount to a crime. Medical science is one discipline where the advancement of knowledge is hugely guided by research and mankind has benefitted from many experiments. However benefit and risk are the two faces of the same coin. Various unethical human experiments made us realize that the whims of researchers need to be reined and led to the evolution of the first guidelines for researcher, the Nuremberg code. Thereafter the Good Clinical Practice guidelines serve as the guiding doctrine of clinical research. The principles of ethics rest on the four pillars of autonomy, beneficence, justice, non-maleficence and recently two more pillars are added which includes, confidentiality and honesty. Ethics committees serve as a guardian of these principles. The multidisciplinary Ethics Committee ensures a competent review of the ethical aspects of the project proposal submitted and does it free from any bias or external influence. Ethical review of clinical trial applications follows a decentralized process in India, and requires Ethics Committee approval for each trial site. All Ethics committees have to be registered with Drug Controller General of India (DCGI) without which they cannot approve any clinical trial protocol and has come into effect from 25th February 2013.

Viewpoint discrimination and contestation of ideas on its merits, leadership and organizational ethics: expanding the African bioethics agenda.

PubMed

Chima, Sylvester C; Mduluza, Takafira; Kipkemboi, Julius

2013-01-01

The 3rd Pan-African Ethics Human Rights and Medical Law (3rd EHRML) conference was held in Johannesburg on July 7, 2013, as part of the Africa Health Congress. The conference brought together bioethicists, researchers and scholars from South Africa, Zimbabwe, Kenya and Nigeria working in the field of bioethics as well as students and healthcare workers interested in learning about ethical issues confronting the African continent. The conference which ran with a theme of "Bioethical and legal perspectives in biomedical research and medical practice in Africa with a focus on: Informed consent, HIV-AIDS & Tuberculosis, leadership & organizational ethics, patients and healthcare workers rights," was designed to expand the dialogue on African bioethics beyond the traditional focus on research ethics and the ethical dilemmas surrounding the conduct of biomedical research in developing countries. This introductory article highlights some of areas of focus at the conference including issues of leadership, organizational ethics and patients and healthcare workers rights in Africa. We analyze the importance of free speech, public debate of issues, argumentation and the need to introduce the teaching and learning of ethics to students in Africa in accordance with UNESCO guidelines. This article also focuses on other challenges confronting Africa today from an ethical standpoint, including the issues of poor leadership and organizational ethics which are main contributors to the problems prevalent in African countries, such as poverty, poor education and healthcare delivery systems, terrorism, social inequities, infrastructural deficits and other forms of 'structural violence' confronting vulnerable African communities. We believe that each of the eight articles included in this supplement, which have been rigorously peer-reviewed are a good example of current research on bioethics in Africa, and explore some new directions towards broadening the African bioethics agenda as we move forward to a new dawn for Africa in the 21st century.

Viewpoint discrimination and contestation of ideas on its merits, leadership and organizational ethics: expanding the African bioethics agenda

PubMed Central

2013-01-01

The 3rd Pan-African Ethics Human Rights and Medical Law (3rd EHRML) conference was held in Johannesburg on July 7, 2013, as part of the Africa Health Congress. The conference brought together bioethicists, researchers and scholars from South Africa, Zimbabwe, Kenya and Nigeria working in the field of bioethics as well as students and healthcare workers interested in learning about ethical issues confronting the African continent. The conference which ran with a theme of "Bioethical and legal perspectives in biomedical research and medical practice in Africa with a focus on: Informed consent, HIV-AIDS & Tuberculosis, leadership & organizational ethics, patients and healthcare workers rights," was designed to expand the dialogue on African bioethics beyond the traditional focus on research ethics and the ethical dilemmas surrounding the conduct of biomedical research in developing countries. This introductory article highlights some of areas of focus at the conference including issues of leadership, organizational ethics and patients and healthcare workers rights in Africa. We analyze the importance of free speech, public debate of issues, argumentation and the need to introduce the teaching and learning of ethics to students in Africa in accordance with UNESCO guidelines. This article also focuses on other challenges confronting Africa today from an ethical standpoint, including the issues of poor leadership and organizational ethics which are main contributors to the problems prevalent in African countries, such as poverty, poor education and healthcare delivery systems, terrorism, social inequities, infrastructural deficits and other forms of 'structural violence' confronting vulnerable African communities. We believe that each of the eight articles included in this supplement, which have been rigorously peer-reviewed are a good example of current research on bioethics in Africa, and explore some new directions towards broadening the African bioethics agenda as we move forward to a new dawn for Africa in the 21st century. PMID:24564890

Palliative Sedation: An Analysis of International Guidelines and Position Statements.

PubMed

Gurschick, Lauren; Mayer, Deborah K; Hanson, Laura C

2015-09-01

To describe the suggested clinical practice of palliative sedation as it is presented in the literature and discuss available guidelines for its use. CINAHL, PubMed, and Web of Science were searched for publications since 1997 for recommended guidelines and position statements on palliative sedation as well as data on its provision. Keywords included palliative sedation, terminal sedation, guidelines, United States, and end of life. Inclusion criteria were palliative sedation policies, frameworks, guidelines, or discussion of its practice, general or oncology patient population, performance of the intervention in an inpatient unit, for humans, and in English. Exclusion criteria were palliative sedation in children, acute illness, procedural, or burns, and predominantly ethical discussions. Guidelines were published by American College of Physicians-American Society of Internal Medicine (2000), Hospice and Palliative Nurses Association (2003), American Academy of Hospice and Palliative Medicine (2006), American Medical Association (2008), Royal Dutch Medical Association (2009), European Association for Palliative Care (2009), National Hospice and Palliative Care Organization (2010), and National Comprehensive Cancer Network (2012). Variances throughout guidelines include definitions of the practice, indications for its use, continuation of life-prolonging therapies, medications used, and timing/prognosis. The development and implementation of institutional-based guidelines with clear stance on the discussed variances is necessary for consistency in practice. Data on provision of palliative sedation after implementation of guidelines needs to be collected and disseminated for a better understanding of the current practice in the United States. © The Author(s) 2014.

International service learning programs: ethical issues and recommendations.

PubMed

Reisch, Rebecca A

2011-08-01

Inequities in global health are increasingly of interest to health care providers in developed countries. In response, many academic healthcare programs have begun to offer international service learning programs. Participants in these programs are motivated by ethical principles, but this type of work presents significant ethical challenges, and no formalized ethical guidelines for these activities exist. In this paper the ethical issues presented by international service learning programs are described and recommendations are made for how academic healthcare programs can carry out international service learning programs in a way that minimizes ethical conflicts and maximizes benefits for all stakeholders. Issues related to project sustainability and community involvement are emphasized. © 2011 Blackwell Publishing Ltd.

Ethical Dilemmas in Disaster Medicine

PubMed Central

Ozge Karadag, C; Kerim Hakan, A

2012-01-01

Background Disasters may lead to ethical challenges that are different from usual medical practices. In addition, disaster situations are related with public health ethics more than medical ethics, and accordingly may require stronger effort to achieve a balance between individual and collective rights. This paper aims to review some ethical dilemmas that arise in disasters and mainly focuses on health services. Disasters vary considerably with respect to their time, place and extent; therefore, ethical questions may not always have `one-size-fits-all` answers. On the other hand, embedding ethical values and principles in every aspect of health-care is of vital importance. Reviewing legal and organizational regulations, developing health-care related guidelines, and disaster recovery plans, establishing on-call ethics committees as well as adequate in-service training of health-care workers for ethical competence are among the most critical steps. It is only by making efforts before disasters, that ethical challenges can be minimized in disaster responses. PMID:23285411

Accountability through Documentation: What Are Best Practices for School Counselors?

ERIC Educational Resources Information Center

Wehrman, Joseph D.; Williams, Rhonda; Field, Julaine; Schroeder, Shanna Dahl

2010-01-01

This article provides an analysis of important considerations for documentation for school counselors. Although the American School Counseling Association (ASCA) does not provide a national protocol for documentation of school counseling services, the ASCA Ethical guidelines provide insight into ethical record keeping which protects student…

End-of-life decisions for extremely low-gestational-age infants: why simple rules for complicated decisions should be avoided.

PubMed

Dupont-Thibodeau, Amélie; Barrington, Keith J; Farlow, Barbara; Janvier, Annie

2014-02-01

Interventions for extremely preterm infants bring up many ethical questions. Guidelines for intervention in the "periviable" period generally divide infants using predefined categories, such as "futile," "beneficial," and "gray zone" based on completed 7-day periods of gestation; however, such definitions often differ among countries. The ethical justification for using gestational age as the determination of the category boundaries is rarely discussed. Rational criteria used to make decisions regarding life-sustaining interventions must incorporate other important prognostic information. Precise guidelines based on imprecise data are not rational. Gestational age-based guidelines include an implicit judgment of what is deemed to be an unacceptably poor chance of "intact" survival but fail to explore the determination of acceptability. Furthermore, unclear definitions of severe disability, the difficulty, or impossibility, of accurately predicting outcome in the prenatal or immediate postnatal period make such simplistic formulae inappropriate. Similarly, if guidelines for intervention for the newborn are based on the "qualitative futility" of survival, it should be explicitly stated and justified according to established ethical guidelines. They should discuss whether newborn infants are morally different to older individuals or explain why thresholds recommended for intervention are different to recommendations for those in older persons. The aim should be to establish individualized goals of care with families while recognizing uncertainty, rather than acting on labels derived from gestational age categories alone. Copyright © 2014 Elsevier Inc. All rights reserved.

Navigating the legal and ethical foundations of informed consent and confidentiality in integrated primary care.

PubMed

Hudgins, Cathy; Rose, Sandra; Fifield, Peter Y; Arnault, Steve

2013-03-01

This article describes findings from ongoing research and analysis of current literature in addition to discussions with leaders in the field, communications with lawyers and administrators of advocacy and government agencies pertaining to integrated primary care (IPC). Standards of care are established based on a myriad of factors, including professional codes of ethics, case law, state and federal laws, professional standards, existing best practices, current professional guidelines, administrative rules and regulations, and licensing board regulations. Regulations may differ for behavioral health and medical providers, posing challenges in IPC settings. This article provides a review of these regulations, particularly 42CFR Part 2, a federal law governing confidentiality for substance abuse programs, Health Insurance Portability and Accountability Act (HIPAA), and state laws relevant to patient care in IPC settings. On the basis of findings from the study, the authors make recommendations related to patient care practices concerning informed consent and release of information procedures, treatment and warm hand-off protocols, documentation and electronic record keeping, agreements with other providers, and billing. (PsycINFO Database Record (c) 2013 APA, all rights reserved).

Opportunity to discuss ethical issues during clinical learning experience.

PubMed

Palese, Alvisa; Gonella, Silvia; Destrebecq, Anne; Mansutti, Irene; Terzoni, Stefano; Morsanutto, Michela; Altini, Pietro; Bevilacqua, Anita; Brugnolli, Anna; Canzan, Federica; Ponte, Adriana Dal; De Biasio, Laura; Fascì, Adriana; Grosso, Silvia; Mantovan, Franco; Marognolli, Oliva; Nicotera, Raffaela; Randon, Giulia; Tollini, Morena; Saiani, Luisa; Grassetti, Luca; Dimonte, Valerio

2018-01-01

Undergraduate nursing students have been documented to experience ethical distress during their clinical training and felt poorly supported in discussing the ethical issues they encountered. Research aims: This study was aimed at exploring nursing students' perceived opportunity to discuss ethical issues that emerged during their clinical learning experience and associated factors. An Italian national cross-sectional study design was performed in 2015-2016. Participants were invited to answer a questionnaire composed of four sections regarding: (1) socio-demographic data, (2) previous clinical learning experiences, (3) current clinical learning experience quality and outcomes, and (4) the opportunity to discuss ethical issues with nurses in the last clinical learning experience (from 0 - 'never' to 3 - 'very much'). Participants and research context: Participants were 9607 undergraduate nursing students who were attending 95 different three-year Italian baccalaureate nursing programmes, located at 27 universities in 15 Italian regions. Ethical considerations: This study was conducted in accordance with the Human Subject Research Ethics Committee guidelines after the research protocol was approved by an ethics committee. Overall, 4707 (49%) perceived to have discussed ethical issues 'much' or 'very much'; among the remaining, 3683 (38.3%) and 1217 (12.7%) students reported the perception of having discussed, respectively, 'enough' or 'never' ethical issues emerged in the clinical practice. At the multivariate logistic regression analysis explaining 38.1% of the overall variance, the factors promoting ethical discussion were mainly set at the clinical learning environment levels (i.e. increased learning opportunities, self-directed learning, safety and nursing care quality, quality of the tutorial strategies, competences learned and supervision by a clinical nurse). In contrast, being male was associated with a perception of less opportunity to discuss ethical issues. Nursing faculties should assess the clinical environment prerequisites of the settings as a context of student experience before deciding on their accreditation. Moreover, the nursing faculty and nurse managers should also enhance competence with regard to discussing ethical issues with students among clinical nurses by identifying factors that hinder this learning opportunity in daily practice.

A Summary of Important Documents in the Field of Research Ethics

PubMed Central

Fischer, Bernard A

2006-01-01

Today's researchers are obligated to conduct their studies ethically. However, it often seems a daunting task to become familiar with the important ethical codes required to do so. The purpose of this article is to examine the content of those ethical documents most relevant to the biomedical researcher. Documents examined include the Nuremberg Code, the Declaration of Helsinki, Henry Beecher's landmark paper, the Belmont Report, the U.S. Common Rule, the Guideline for Good Clinical Practice, and the National Bioethics Advisory Commission's report on research protections for the mentally ill. PMID:16192409

Some guidelines for the ethical development of ubiquitous computing.

PubMed

Greenfield, Adam

2008-10-28

At a time when both the landscape of everyday life and the choices available to us there are increasingly conditioned by ubiquitous information processing systems, it seems wise to articulate some general principles guiding their ethical design and deployment. I here enunciate five broad guidelines for the designers of such systems, including recommendations that they be devised in such a way as to default to harmlessness, be conservative of time, be conservative of face, be self-disclosing and be deniable. I conclude with some observations about the likelihood of any such principles winning usefully widespread voluntary adherence.

APPLYING RESEARCH ETHICS GUIDELINES: THE VIEW FROM A SUB-SAHARAN RESEARCH ETHICS COMMITTEE

PubMed Central

Henderson, Gail E.; Corneli, Amy L.; Mahoney, David B.; Nelson, Daniel K.; Mwansambo, Charles

2009-01-01

Considerable variation has been demonstrated in applying regulations across research ethics committees (RECs) in the U.S., U.K., and European nations. With the rise of international research collaborations, RECs in developing countries apply a variety of international regulations. We conducted a qualitative descriptive pilot study with members of the national REC in Malawi to determine criteria they use to review research, and their views on international collaborations. Qualitative content analysis demonstrated that international guidelines are interpreted in light of local African conditions such that emphasis is placed on examining benefit to the community and ensuring the informed consent process translates concepts in locally-meaningful ways. Members suggest that RECs often must comply with regulations that do not fit local conditions. Recommendations are provided for improving such international collaborations. PMID:19385794

Deciding about patients' requests for extraction: ethical and legal guidelines.

PubMed

Broers, Dyonne L M; Brands, Wolter G; Welie, Jos V M; de Jongh, Ad

2010-02-01

and Overview. Dentists frequently are faced with patients' requests for an extraction, sometimes of the entire dentition. In this article, the authors offer guidelines to help dentists and oral surgeons make decisions regarding such requests for extraction. In most cases of patients' requesting extractions, the ethical principle of nonmaleficence will play a decisive role in the dentist's decision making. In cases in which the request appears influenced by a specific mental condition such as a phobia of dental treatment, extraction rarely is justifiable. Practice Implications. Dental professionals should keep in mind that they cannot be forced to carry out treatment that is at odds with the ethical principle of nonmaleficence or that is outside of the bounds of accepted treatment. To aid dentists in making treatment decisions in such cases, the authors present a flowchart that integrates possible considerations.

A modified Delphi study towards developing a guideline to inform policy on fetal alcohol spectrum disorders in South Africa: a study protocol

PubMed Central

Mukumbang, Ferdinand C; Okop, Kufre J; Beytell, Anna-Marie

2018-01-01

Introduction Maternal alcohol consumption during pregnancy can result in mental and physical birth defects in individuals. These birth defects are usually described as fetal alcohol spectrum disorders (FASDs). With an estimated 183–259 per 1000 children born with FASDs, South Africa is identified to have the highest prevalence of FASDs in the world. Nevertheless, there is a lack of appropriate policies, guidelines and interventions addressing the issues around FASDs. This protocol outlines a proposed process for developing a guideline to inform policies on FASDs. Methods and analysis This process will have three phases. Phase I will be carried out in three steps; we plan to conduct a document review of available policies on the prevention and management of FASDs and update the existing systematic review on FASDs interventions. The aim of the two reviews is to explore the availability and content of existing policies and global interventions on FASDs. In addition, we will conduct two exploratory qualitative studies to obtain the perspectives of various stakeholders on the existing or possible guidelines and policies for the management of FASDs and available interventions and services. In phase II, we will aggregate the findings of the previous phase to develop a prototype guideline. In phase III, using the developed prototype, we will apply the Delphi approach with experts on FASDs, soliciting their opinions on the nature and content of the proposed guidelines for policies. The information gathered will be used to modify the prototype to formulate a policy guideline on FASDs. The data will be analysed using thematic analysis and narrative synthesis. Ethics and dissemination Ethical clearance has been obtained from the ethics committee of the university and governmental departments. The findings will be disseminated through publications and the guideline will be submitted to relevant departments. PMID:29703853

Ethics in Psychotherapy and Counseling: A Practical Guide. Second Edition.

ERIC Educational Resources Information Center

Pope, Kenneth S.; Vasquez, Melba J. T.

Although they may be reflected in professional guidelines, formal standards, or law, ethics are not static codes. They are an active process by which the individual therapist or counselor struggles with the sometimes bewildering, always unique constellation of questions, responsibilities, contexts, and competing demands of helping another person.…

An Ethical Frame for Research with Immigrant Families

ERIC Educational Resources Information Center

Nguyen, Jacqueline; Hernández, María G.; Saetermoe, Carrie L.; Suárez-Orozco, Carola

2013-01-01

In this introduction, the editors give an overview of the ways the volume addresses the growing individual and institutional calls for increased clarity and rigor in methodological, ethical, and practical research policies and guidelines for conducting research with immigrant individuals, families, and communities. In addition to summarizing the…

A Normative Code of Conduct for Admissions Officers

ERIC Educational Resources Information Center

Hodum, Robert L.

2012-01-01

The increasing competition for the desired quantity and quality of college students, along with the rise of for-profit institutions, has amplified the scrutiny of behavior and ethics among college admissions professionals and has increased the need for meaningful ethical guidelines and codes of conduct. Many other areas of responsibility within…

Ethical Issues in Rural Programs for Behavior Analysis for Students with Disabilities

ERIC Educational Resources Information Center

Young-Pelton, Cheryl A.; Dotson, Tyler D.

2017-01-01

Procedures derived from the field of applied behavior analysis (ABA) have extensive research support for use with students with disabilities, such as autism spectrum disorder, intellectual disability, and emotional and behavioral disorders. These procedures should be implemented within the parameters of professional and ethical guidelines to…

How an Exchange of Perspectives Led to Tentative Ethical Guidelines for Visual Ethnography

ERIC Educational Resources Information Center

Pope, Clive C.; De Luca, Rosemary; Tolich, Martin

2010-01-01

Qualitative research, especially visual ethnography, is an iterative not a linear process, replete with good intentions, false starts, mistaken assumptions, miscommunication and a continually revised statement of the problem. That the camera freezes everything and everyone in the frame only complicates ethical considerations. This work, jointly…

Teaching Business Ethics in the Global South: Control, Resistance, and Phronesis

ERIC Educational Resources Information Center

Karam, Charlotte M.; Sidani, Yusuf M.; Showail, Sammy

2015-01-01

We explore academic literature on business ethics education and critically compare the themes emerging from different contexts. Outlining guidelines for analysis based on Southern Theory, we conduct a content analysis on a selection of English, peer-reviewed articles and then critically compare emergent themes from across the…

The Practical Aspects of Online Counseling: Ethics, Training, Technology, and Competency

ERIC Educational Resources Information Center

Mallen, Michael J.; Vogel, David L.; Rochlen, Aaron B.

2005-01-01

This article addresses the practical aspects of online counseling, including ethics, training, supervision, technology, and competency issues. The authors discuss online counseling's strengths and limitations and present guidelines for what types of clients and counseling psychologists may be appropriate for online counseling. To illustrate the…

Reporting Child Sexual Abuse: Ethical Dilemmas, and Guidelines for Decision Making.

ERIC Educational Resources Information Center

Zambelli, Grace C.; Lee, Sandra S.

All states have laws mandating that certain individuals report suspected occurrences of child abuse. Mandatory reporting statutes, their administration, and their judicial interpretation have created many ethical, legal, and clinical dilemmas. The abrogation of the confidentiality in the therapeutic relationship is probably the foremost ethical…

Improving Research Participant Ethics: The Utility of an Online Educational Module

ERIC Educational Resources Information Center

Barber, Larissa K.; Bailey, Sarah F.; Bagsby, Patricia G.

2015-01-01

The undergraduate psychology curriculum often does not address guidelines for acceptable participant behavior. This two-part study tested the efficacy of a recently developed online learning module on ethical perceptions, knowledge, and behavior. In the preliminary quasi-experiment, students who viewed the module did not have higher…

A framework to link international clinical research to the promotion of justice in global health.

PubMed

Pratt, Bridget; Loff, Bebe

2014-10-01

How international research might contribute to justice in global health has not been substantively addressed by bioethics. Theories of justice from political philosophy establish obligations for parties from high-income countries owed to parties from low and middle-income countries. We have developed a new framework that is based on Jennifer Ruger's health capability paradigm to strengthen the link between international clinical research and justice in global health. The 'research for health justice' framework provides direction on three aspects of international clinical research: the research target, research capacity strengthening, and post-trial benefits. It identifies the obligations of justice owed by national governments, research funders, research sponsors, and investigators to trial participants and host communities. These obligations vary from those currently articulated in international research ethics guidelines. Ethical requirements of a different kind are needed if international clinical research is to advance global health equity. © 2012 John Wiley & Sons Ltd.

Benefit sharing: it's time for a definition.

PubMed

Schroeder, D

2007-04-01

Benefit sharing has been a recurrent theme in international debates for the past two decades. However, despite its prominence in law, medical ethics and political philosophy, the concept has never been satisfactorily defined. In this conceptual paper, a definition that combines current legal guidelines with input from ethics debates is developed. Philosophers like boxes; protective casings into which they can put concisely-defined concepts. Autonomy is the human capacity for self-determination; beneficence denotes the virtue of good deeds, coercion is the intentional threat of harm and so on. What about benefit sharing? Does the concept have a box and are the contents clearly defined? The answer to this question has to be no. The concept of benefit sharing is almost unique in that various disciplines use it regularly without precise definitions. In this article, a definition for benefit sharing is provided, to eliminate unnecessary ambiguity.

Benefit sharing: it's time for a definition

PubMed Central

Schroeder, D

2007-01-01

Benefit sharing has been a recurrent theme in international debates for the past two decades. However, despite its prominence in law, medical ethics and political philosophy, the concept has never been satisfactorily defined. In this conceptual paper, a definition that combines current legal guidelines with input from ethics debates is developed. Philosophers like boxes; protective casings into which they can put concisely‐defined concepts. Autonomy is the human capacity for self‐determination; beneficence denotes the virtue of good deeds, coercion is the intentional threat of harm and so on. What about benefit sharing? Does the concept have a box and are the contents clearly defined? The answer to this question has to be no. The concept of benefit sharing is almost unique in that various disciplines use it regularly without precise definitions. In this article, a definition for benefit sharing is provided, to eliminate unnecessary ambiguity. PMID:17400617

Concerns for the worse off: fair innings versus severity.

PubMed

Nord, Erik

2005-01-01

The original fair innings argument is about claims on length of life. Alan Williams has suggested that the argument also should apply to quality of life. His 'generalised fair innings approach' on the one hand, and the severity approach on the other, are two ways of incorporating concerns for fairness in economic evaluation of health care. They are based on different ethical arguments and therefore partly lead to different results. Both approaches incorporate concerns for current and future severity. There is strong support for this in formal theories of justice and government guidelines, and a number of public surveys even indicate the strength of these concerns. The generalised fair innings approach additionally incorporates concerns for past suffering. Intuitively, this is not unreasonable, but there is at this point little ethical theory or empirical evidence to suggest the strength of such concerns. The fair innings argument can be decomposed in an 'equal innings argument' and a 'sufficient innings argument'. When the fair innings argument is applied to quality of life, its sufficient innings component implies that young people should have priority over old people when it comes to functional improvements and symptom relief for non-fatal conditions. This runs counter to both moral intuitions and official goverment guidelines in Norway and Sweden.

An uncommon skin condition illustrates the need for caution when prescribing for friends.

PubMed

Ares, Ella

2008-08-01

A dual-focused case study written to discuss the legal and medical hazards of informally writing prescriptions for friends or family members and to provide knowledge of early-stage mycosis fungoides (MF), its course, and treatment. A review of the prescribing practices of clinicians, the cognitive processes needed in diagnosis and treatment, the current ethical guidelines, and a review of MF, its course, and treatments. Treating acquaintances and family informally places clinicians at risk for liability and patients at risk for inaccurate diagnosis and treatment. This case illustrates the potential hazard of casually treating a friend for what looks like a benign condition. Resembling atopic dermatitis in its early stages, MF is the most common of a rare group of skin lymphomas. Early diagnosis and treatment are crucial for a better prognosis. Had this clinician complied with the request of her friend, his diagnosis would have been missed and timely treatment delayed. No matter what the prior relationship may have been, once a clinician treats a patient, a legally binding relationship begins, requiring the due standard of care. Nurse practitioners (NPs) need to be aware of the potential for error when treating acquaintances. Available NP standards of practice and ethical guidelines should address informal treatment situations.

Counterpoint: physician-industry relationships can be ethically established, and conflicts of interest can be ethically managed.

PubMed

White, Andrew P; Vaccaro, Alexander R; Zdeblick, Thomas

2007-05-15

Review of the nature of conflicts of interest in physician-industry relationships, with a focus on the efforts to ethically manage physician-industry relationships. To illustrate the perspective that physician-industry relationships can be ethically established, and conflicts of interest can be ethically managed. The interest in considering the appropriateness of physician-industry relationships has recently become focused on spine surgery. Many of the conflicts of interest inherent to these relationships have been interpreted as problematic, and have been scrutinized by the media, industry, medical and legal professions, and Federal government. The basis for conflicts of interest, manner in which bias may be introduced, and methods to reduce bias are presented. The potential risks and benefits to patients that are inherent to physician-industry relationships are considered. A framework, developed by medical ethicists, is provided to guide analysis of conflicts of interest in physician-industry relationships. Collaboration between spine surgeons and industry is necessary to improve patient care. The conflicts of interest that often arise in physician-industry relationships must be recognized, and keenly managed in order to eliminate the risk and maximize the benefit to the patient. Ethical management of conflicts must include disclosure. To preserve patient autonomy, management should also include a discussion of the quality of the medical evidence on which treatment recommendations are made. Guidelines from industry and medical professional organizations, including the "Standards of Professionalism" currently under development by the American Academy of Orthopedic Surgery, are also expected to aid in the ethical establishment and management of conflicts of interest. Careful consideration of conflicts of interest in physician-industry relationships has provided an opportunity to review our goals as physicians in society, and to continue collaborative advancement of our field for the benefit of our patients.

Ethical principles and concepts in medicine.

PubMed

Taylor, Robert M

2013-01-01

Clinical ethics is the application of ethical theories, principles, rules, and guidelines to clinical situations in medicine. Therefore, clinical ethics is analogous to clinical medicine in that general principles and concepts must be applied intelligently and thoughtfully to unique clinical circumstances. The three major ethical theories are consequentialism, whereby the consequences of an action determine whether it is ethical; deontology, whereby to be ethical is to do one's duty, and virtue ethics, whereby ethics is a matter of cultivating appropriate virtues. In the real world of medicine, most people find that all three perspectives offer useful insights and are complementary rather than contradictory. The most common approach to clinical ethical analysis is principlism. According to principlism, the medical practitioner must attempt to uphold four important principles: respect for patient autonomy, beneficence, nonmaleficence, and justice. When these principles conflict, resolving them depends on the details of the case. Alternative approaches to medical ethics, including the primacy of beneficence, care-based ethics, feminist ethics, and narrative ethics, help to define the limitations of principlism and provide a broader perspective on medical ethics. © 2013 Elsevier B.V. All rights reserved.

"Would you test your children without their consent?" and other sticky dilemmas in the field of cancer genetic testing.

PubMed

Brierley, Karina L; Bonadies, Danielle C; Moyer, Anne; Matloff, Ellen T

2014-09-01

Cancer genetic testing is surrounded by myriad ethical, legal, and psychosocial implications which are being revisited as testing expands into an everyday practice and into more complicated areas like whole exome and direct-to-consumer testing. We chose to survey cancer genetic counselors and physicians from a wide range of non-genetics specialties to determine what they would do if faced with the complex decisions associated with cancer genetic testing, how their views compare, and how they align with current guidelines and data. Genetic counselors were significantly more likely than non-genetics physicians to bill their insurance for testing (94.9 vs. 86.8 %; p = 0.001) and purchase life insurance before testing (86.6 vs. 68.6 %; p = 0.000) and were less likely to use an alias (3.2 vs. 13.2 %; p = 0.000) or order testing on their own DNA (15.3 vs. 24.2 %; p = 0.004). They were also less likely to test their minor children (0.9 vs. 33.1 %; p = 0.000) or test their children without their knowledge and consent/assent (1.4 vs.11.5 %; p = 0.000). The results of our study indicate that there is wide variation regarding what clinicians predict they would do in the areas of ethical, legal and psychosocial issues in cancer genetic testing. Cancer genetic counselors' choices are more aligned with professional guidelines, likely due to their experience in the field and awareness of current guidelines. These data are a starting point for a broader discussion of who should offer cancer genetic counseling and testing to patients, particularly as the complexity of the available testing options and associated issues increase with whole exome sequencing.

Ethical Issues Surrounding Personalized Medicine: A Literature Review.

PubMed

Salari, Pooneh; Larijani, Bagher

2017-03-01

More than a decade ago, personalized medicine was presented in modern medicine. Personalized medicine means that the right drug should be prescribed for the right patient based on genetic data. No doubt is developing medical sciences, and its shift into personalized medicine complicates ethical challenges more than before. In this review, we categorized all probable ethical considerations of personalized medicine in research and development and service provision. Based on our review, extensive changes in healthcare system including ethical changes are needed to overcome the ethical obstacles including knowledge gap and informed consent, privacy and confidentiality and availability of healthcare services. Furthermore social benefit versus science development and individual benefit should be balanced. Therefore guidelines and regulations should be compiled to represent the ethical framework; also ethical decision making should be day-to-day and individualized.

Transplant ethics under scrutiny – responsibilities of all medical professionals

PubMed Central

Trey, Torsten; Caplan, Arthur L.; Lavee, Jacob

2013-01-01

In this text, we present and elaborate ethical challenges in transplant medicine related to organ procurement and organ distribution, together with measures to solve such challenges. Based on internationally acknowledged ethical standards, we looked at cases of organ procurement and distribution practices that deviated from such ethical standards. One form of organ procurement is known as commercial organ trafficking, while in China the organ procurement is mostly based on executing prisoners, including killing of detained Falun Gong practitioners for their organs. Efforts from within the medical community as well as from governments have contributed to provide solutions to uphold ethical standards in medicine. The medical profession has the responsibility to actively promote ethical guidelines in medicine to prevent a decay of ethical standards and to ensure best medical practices. PMID:23444249

Transplant ethics under scrutiny - responsibilities of all medical professionals.

PubMed

Trey, Torsten; Caplan, Arthur L; Lavee, Jacob

2013-02-01

In this text, we present and elaborate ethical challenges in transplant medicine related to organ procurement and organ distribution, together with measures to solve such challenges. Based on internationally acknowledged ethical standards, we looked at cases of organ procurement and distribution practices that deviated from such ethical standards. One form of organ procurement is known as commercial organ trafficking, while in China the organ procurement is mostly based on executing prisoners, including killing of detained Falun Gong practitioners for their organs. Efforts from within the medical community as well as from governments have contributed to provide solutions to uphold ethical standards in medicine. The medical profession has the responsibility to actively promote ethical guidelines in medicine to prevent a decay of ethical standards and to ensure best medical practices.

It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North-South collaborative trials.

PubMed

Ravinetto, Raffaella; Tinto, Halidou; Diro, Ermias; Okebe, Joseph; Mahendradhata, Yodi; Rijal, Suman; Gotuzzo, Eduardo; Lutumba, Pascal; Nahum, Alain; De Nys, Katelijne; Casteels, Minne; Boelaert, Marleen

2016-01-01

The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs). Based on our field experience in LMICs, we developed a non-exhaustive set of recommendations for the improvement of GCP. These cover 3 domains: ethical, legal and operational, and 8 specific issues: the double ethical review of 'externally sponsored' trials; the informed consent procedure in minors and in illiterate people; post-trial access to newly-developed products for the trial communities; the role of communities as key research actors; the definition of sponsor; and the guidance for contractual agreements, laboratory quality management systems, and quality assurance of investigational medicinal products. Issues not covered in our analysis include among others biobanking, standard of care, and study designs. The international GCP codes de facto guide national legislators and funding agencies, so the current shortcomings may weaken the regulatory oversight of international research. In addition, activities neglected by GCP are less likely to be implemented or funded. If GCP are meant to serve the interests of global society, a comprehensive revision is needed. The revised guidelines should be strongly rooted in ethics, sensitive to different sociocultural perspectives, and allow consideration for trial-specific and context-specific challenges. This can be only achieved if all stakeholders, including researchers, sponsors, regulators, ethical reviewers and patients' representatives from LMICs, as well as non-commercial researchers and sponsors from affluent countries, are transparently involved in the revision process. We hope that our limited analysis would foster advocacy for a broad and inclusive revision of the international GCP codes, to make them at the same time 'global', 'context centred' and 'patient centred'.

The Application of Standards and Recommendations to Clinical Ethics Consultation in Practice: An Evaluation at German Hospitals.

PubMed

Schochow, Maximilian; Rubeis, Giovanni; Steger, Florian

2017-06-01

The executive board of the Academy for Ethics in Medicine (AEM) and two AEM working groups formulated standards and recommendations for clinical ethics consultation in 2010, 2011, and 2013. These guidelines comply with the international standards like those set by the American Society for Bioethics and Humanities. There is no empirical data available yet that could indicate whether these standards and recommendations have been implemented in German hospitals. This desideratum is addressed in the present study. We contacted 1.858 German hospitals between September 2013 and January 2014. A follow-up survey was conducted between October 2014 and January 2015. The data of the initial survey and the follow-up survey were merged and evaluated. The statements of the participants were compared with the standards and recommendations. The standards of the AEM concerning the tasks of clinical ethics consultation (including ethics consultation, ethics training and the establishment of policy guidelines) are employed by a majority of participants of the study. Almost all of these participants document their consultation activities by means of protocols or entries in the patient file. There are deviations from the recommendations of the AEM working groups regarding the drafting of statutes, activity reports, and financial support. The activities of clinical ethics consultation predominantly comply with the standards of the AEM and recommendations for the documentation. The recommendations for evaluation should be improved in practice. This applies particularly for activity reports in order to evaluate the activities. Internal evaluation could take place accordingly.

The development of ethical guidelines for nurses' collegiality using the Delphi method.

PubMed

Kangasniemi, Mari; Arala, Katariina; Becker, Eve; Suutarla, Anna; Haapa, Toni; Korhonen, Anne

2017-08-01

Nurses' collegiality is topical because patient care is complicated, requiring shared knowledge and working methods. Nurses' collaboration has been supported by a number of different working models, but there has been less focus on ethics. This study aimed to develop nurses' collegiality guidelines using the Delphi method. Two online panels of Finnish experts, with 35 and 40 members, used the four-step Delphi method in December 2013 and January 2014. They reformulated the items of nurses' collegiality identified by the literature and rated based on validity and importance. Content analysis and descriptive statistical methods were used to analyze the data, and the nurses' collegiality guidelines were formulated. Ethical considerations: Organizational approval was received, and an informed consent was obtained from all participants. Information about the voluntary nature of participation was provided. During the first Delphi panel round, a number of items were reformulated and added, resulting in 32 reformulated items. As a result of the second round, 8 of the 32 items scored an agreement rate of more than 75%, with the most rated item being collegiality means that professionals respect each other. The item with second highest rating was collegiality has a common objective: what is best for patients, followed by the third highest which was professional ethics is the basis of collegiality. Nurses' collegiality and its content are well recognized in clinical practice but seldom studied. Collegiality can be supported by guidelines, and nurses working in clinical practice, together with teachers and managers, have shared responsibilities to support and develop it. More research in different nursing environments is needed to improve understanding of the content and practice of nursing collegiality.

And lead us (not) into persuasion…? Persuasive technology and the ethics of communication.

PubMed

Spahn, Andreas

2012-12-01

The paper develops ethical guidelines for the development and usage of persuasive technologies (PT) that can be derived from applying discourse ethics to this type of technologies. The application of discourse ethics is of particular interest for PT, since 'persuasion' refers to an act of communication that might be interpreted as holding the middle between 'manipulation' and 'convincing'. One can distinguish two elements of discourse ethics that prove fruitful when applied to PT: the analysis of the inherent normativity of acts of communication ('speech acts') and the Habermasian distinction between 'communicative' and 'strategic rationality' and their broader societal interpretation. This essay investigates what consequences can be drawn if one applies these two elements of discourse ethics to PT.

Informed Dissent: Beyond IRB Ethics in Research.

ERIC Educational Resources Information Center

Wallace, David

2003-01-01

Proposes that educators and researchers need guidelines that not only address the potential power abuses in researcher/teacher to participant/student relationships, they also need guidelines that deal substantively with the impossibility of researchers taking completely objective, detached stances. Suggests several principles that should be…

Ethical issues in research with homeless youths.

PubMed

Ensign, Josephine; Ammerman, Seth

2008-05-01

This paper is a report of a study to document researcher, healthcare provider and programme administrators' experiences with ethical issues in research with homeless youths in North America. While there are legal and ethical guidelines for research with adolescents and with vulnerable populations in general, there are no specific guidelines for the ethical conduct of research with homeless youths. Using a web-based questionnaire, healthcare and social service providers, programme administrators and researchers working with homeless young people throughout the United States of America and Canada were surveyed in 2005. The survey group consisted of 120 individuals; a total of 72 individuals completed the survey. Survey questions included experiences with using incentives in research with homeless youths, consent and experiences with ethics review boards. Numerical data were analysed using frequencies and cross-tabulations. Text data were analysed qualitatively. Researchers doing mental health and/or substance use research tended to use money as a research incentive, whereas healthcare providers and programme administrators tended to use non-monetary incentives. The majority of respondents reported using written consent for research from homeless youths, including minors. Respondents reporting difficulties with ethics review boards were mainly involved with intervention research. Consensus is needed from a variety of stakeholders, including homeless youths and service providers, on use of various types of research incentives for different types of research, as well as use of consent for homeless youths who are minors.

Ethical aspects in placental perfusion studies: views of the researchers.

PubMed

Halkoaho, A; Pietilä, A-M; Vähäkangas, K

2011-07-01

Within the EU-project NewGeneris human placental perfusion has been used for predicting fetal exposure to food carcinogens. Within the work package of ethical aspects of the research, we studied opinions of the researchers (n = 23) who carried out perfusions of human placenta. Data were collected by focus group interviews (n = 12) and an open-ended questionnaire (n =19 of which 8 were also attending the group session) from scientists representing 9 different nationalities. Both types of data were analysed together thematically and with data triangulation. Studied researchers considered communication between all stakeholders extremely important. Good communication was considered a prerequisite for the recruitment of mothers to donate the placenta, as well as for the process of getting the informed consent. Voluntariness, confidentiality and societal meaning were mentioned as important by all studied researchers. Educating the hospital personnel was regarded as essential in order to provide the best possible information to the mothers. The researchers also pointed out that cultural aspects should be respected, and that in Western thinking placenta is mostly considered as waste. Some researchers suggested that current guidelines and processes for obtaining informed consent should be reviewed also from a cultural perspective. With the development of biobanks, the use of human tissues, including placenta will most probably increase in the future, and the awareness of ethical considerations both in legislation and in practice need support. Thus, continuous effort for better research ethics is essential and requires research on research ethics. Copyright © 2011 Elsevier Ltd. All rights reserved.

The status of ethics teaching and learning in U.S. dental schools.

PubMed

Lantz, Marilyn S; Bebeau, Muriel J; Zarkowski, Pamela

2011-10-01

The purpose of this study was to gather and analyze information about the status of ethics teaching and learning in U.S. dental schools and to recommend a curriculum development and research agenda for professional ethics in dental education. A survey to collect this information was developed by the authors and administered by the American Society for Dental Ethics. The results suggest that dental schools have adopted many of the recommendations for curricular content and learning strategies proposed in the 1989 American Association of Dental Schools (now American Dental Education Association) Curriculum Guidelines on Ethics and Professionalism in Dentistry. The survey was sent to the individual who directs the ethics curriculum at the fifty-six U.S. dental schools that had a full complement of enrolled predoctoral classes as of January 2008. All fifty-six schools responded to the survey. The data suggest that, in general, little time is devoted to ethics instruction in the formal curriculum. The mean number of contact hours of ethics instruction is 26.5 hours, which represents about 0.5 percent of the mean clock hours of instruction for dental education programs reported in the most recent American Dental Association survey of dental education. While the amount of time devoted to ethics instruction appears not to have changed much over the past thirty years, what has changed are what qualifies as ethics instruction, the pedagogies used, and the development and availability of norm-referenced learning outcomes assessments, which are currently used by a number of schools. We found that dental schools address a substantial list of topics in their ethics instruction and that there is general agreement as to the appropriateness of the topics and the ethics competencies that need to be developed and assessed. This study also identified the respondents' perceptions of unmet needs in ethics education. Four general themes emerged: the need for ethics to be more fully integrated across the curriculum, including carryover into the clinical years; the need to assess and ensure competence; the need for faculty development; and the need for more attention to method of instruction. Recommendations based on the study findings are offered for a curriculum development and research agenda for professional ethics in dental education.

Decisions You Can Live with

ERIC Educational Resources Information Center

Glanz, Jeffrey

2009-01-01

Resolving ethical dilemmas is no easy task, and there are no ready-made recipes or guidelines to follow. A principal, as a critically thinking individual with a well-thought-out belief system, will be challenged to think on his or her feet when confronting situations that require ethical decision making. This article presents three ethical…

Ethical Issues Affecting Human Participants in Community College Research

ERIC Educational Resources Information Center

Wurtz, Keith

2011-01-01

The increasing demand of constituents to conduct analyses in order to help inform the decision-making process has led to the need for Institutional Research (IR) guidelines for community college educators. One method of maintaining the quality of research conducted by IR staff is to include professional development about ethics. This article…

Reducing theft and embezzlement by encouraging ethical behavior.

PubMed

Weinstock, Donna

2010-01-01

Medical practices are often faced with employee embezzlement and theft. To protect themselves and their practices, physicians should have in place policies and procedures for identifying and handling unethical behaviors by employees. This article will deal with the need to set guidelines for what is considered ethical and professional conduct in the office.

Treating the Purple Menace: Ethical Considerations of Conversion Therapy and Affirmative Alternatives.

ERIC Educational Resources Information Center

Tozer, Erinn E.; McClanahan, Mary K.

1999-01-01

Outlines the ethical considerations for sexual orientation conversion therapy for lesbian, gay, and bisexual individuals. There are numerous reasons not to acquiesce to a client's desire to change his or her sexual orientation. Presents guidelines for responding to a client seeking reorientation and evaluating one's biases regarding lesbian, gay,…

Regulations and Ethical Considerations for Astronomy Education Research II: Resources and Worked Examples

ERIC Educational Resources Information Center

Brogt, Erik; Dokter, Erin; Antonellis, Jessie; Buxner, Sanlyn

2008-01-01

This article discusses the legal and ethical requirements of human subjects research proposals in astronomy education research. We present an overview of the relevant laws, regulations, and guidelines that inform an Institutional Review Board evaluation of proposed research. We also present examples of potential research projects in astronomy…

LEA in Private: A Privacy and Data Protection Framework for a Learning Analytics Toolbox

ERIC Educational Resources Information Center

Steiner, Christina M.; Kickmeier-Rust, Michael D.; Albert, Dietrich

2016-01-01

To find a balance between learning analytics research and individual privacy, learning analytics initiatives need to appropriately address ethical, privacy, and data protection issues. A range of general guidelines, model codes, and principles for handling ethical issues and for appropriate data and privacy protection are available, which may…

School Psychology: How Universal Are Ethical Principles Approved by International Associations?

ERIC Educational Resources Information Center

Pettifor, Jean L.

2004-01-01

Globalization is a dominant issue in all aspects of business and professional activities in the 21st Century. The International School Psychology Association and the International Test Commission have adopted ethics and competency guidelines to raise the standards of practice for their members. Other international organizations are doing likewise.…

Navigating the Legal and Ethical World of Overseas Contracts.

ERIC Educational Resources Information Center

Skinner, Karla Jo

1998-01-01

Referring to Iowa contract law, reviews ethical and legal aspects of overseas employment contracts signed by educators at recruitment fairs. Iowa Department of Education guidelines state the following aspects of a good contract: it is in writing; it states the salary, pay periods, benefits, and dates of employment; it lists special conditions and…

Hiring a professional medical writer: is it equivalent to ghostwriting?

PubMed Central

Das, Natasha; Das, Saurendra

2014-01-01

Authors of articles published in medical journals are often busy researchers who cannot afford time devoted to writing. Though they are experts in their own therapeutic area, more often than not, researchers find it difficult to actually write and publish their research. Professional medical writers with their expertise in writing clear, concise, comprehensible, and coherent content are often a great support to researchers. Their contribution to the manuscript is usually focused on getting a manuscript ready for publication. They are not authors unless they make substantial contribution to the study according to the guidelines of the International Committee of Medical Journal Editors (ICMJE). However, medical writing is not the same as ghostwriting. Ghostwriting is unethical. Medical writers can be legitimate contributors to the medical manuscript. Several international guidelines including the ICMJE guidelines require authors to acknowledge the contribution of medical writers in the published article. Medical writers whose name is publicly associated with the article in turn make an extra effort to ensure that all applicable publication ethics and style guidelines are adhered to. This article discusses the current international guidelines about the acknowledgement of writing assistance. It also emphasizes on how acknowledging medical writing support can go a long way in curbing the menace of scientific misconduct including ghostwriting. PMID:24627711

Hiring a professional medical writer: is it equivalent to ghostwriting?

PubMed

Das, Natasha; Das, Saurendra

2014-01-01

Authors of articles published in medical journals are often busy researchers who cannot afford time devoted to writing. Though they are experts in their own therapeutic area, more often than not, researchers find it difficult to actually write and publish their research. Professional medical writers with their expertise in writing clear, concise, comprehensible, and coherent content are often a great support to researchers. Their contribution to the manuscript is usually focused on getting a manuscript ready for publication. They are not authors unless they make substantial contribution to the study according to the guidelines of the International Committee of Medical Journal Editors (ICMJE). However, medical writing is not the same as ghostwriting. Ghostwriting is unethical. Medical writers can be legitimate contributors to the medical manuscript. Several international guidelines including the ICMJE guidelines require authors to acknowledge the contribution of medical writers in the published article. Medical writers whose name is publicly associated with the article in turn make an extra effort to ensure that all applicable publication ethics and style guidelines are adhered to. This article discusses the current international guidelines about the acknowledgement of writing assistance. It also emphasizes on how acknowledging medical writing support can go a long way in curbing the menace of scientific misconduct including ghostwriting.

The implications of starvation induced psychological changes for the ethical treatment of hunger strikers.

PubMed

Fessler, D M T

2003-08-01

To evaluate existing ethical guidelines for the treatment of hunger strikers in light of findings on psychological changes that accompany the cessation of food intake. Electronic databases were searched for (a) editorials and ethical proclamations on hunger strikers and their treatment; (b) studies of voluntary and involuntary starvation, and (c) legal cases pertaining to hunger striking. Additional studies were gathered in a snowball fashion from the published material cited in these databases. Material was included if it (a) provided ethical or legal guidelines; (b) shed light on psychological changes accompanying starvation, or (c) illustrated the practice of hunger striking. Authors' observations, opinions, and conclusions were noted. Although the heterogeneous nature of the sources precluded statistical analysis, starvation appears to be accompanied by marked psychological changes. Some changes clearly impair competence, in which case physicians are advised to follow advance directives obtained early in the hunger strike. More problematic are increases in impulsivity and aggressivity, changes which, while not impairing competence, enhance the likelihood that patients will starve themselves to death.

Ethical dimensions of genetics in pediatric neurology: a look into the future.

PubMed

Avard, Denise M; Knoppers, Bartha M

2002-03-01

Health care providers and families with children who participate in genetic research or who need specialized genetic services, including genetic testing, will encounter not only medical but difficult social, ethical, and legal questions surrounding pediatric genetic neurology. Children are often at the center of much of the genetic revolution and their unique needs raise special concerns about the risks and benefits associated with genetic research, particularly the issues of consent, the use of genetic databases, and gene therapy. Moreover, genetic research and testing raise important psychosocial risks. In this article we discuss some of the benefits and consequences of genetic technologies for children in relation to national and international guidelines. In particular, physicians, policy-makers, and families should be knowledgeable about the guidelines and have a good understanding of the psychosocial and ethical issues associated with genetics in pediatric neurology.

Addressing Authorship Issues Prospectively: A Heuristic Approach.

PubMed

Roberts, Laura Weiss

2017-02-01

Collaborative writing in academic medicine gives rise to more richly informed scholarship, and yet challenging ethical issues surrounding authorship are commonly encountered. International guidelines on authorship help clarify whether individuals who have contributed to a completed scholarly work have been correctly included as authors, but these guidelines do not facilitate intentional and proactive authorship planning or decisions regarding authorship order.In this Commentary, the author presents a heuristic approach to help collaborators clarify, anticipate, and resolve practical and ethically important authorship issues as they engage in the process of developing manuscripts. As this approach illustrates, assignment of authorship should balance work effort and professional responsibility, reflecting the effort and intellectual contribution and the public accountability of the individuals who participate in the work. Using a heuristic approach for managing authorship issues prospectively can foster an ethical, collaborative writing process in which individuals are properly recognized for their contributions.

AGU Launches Web Site for New Scientific Integrity and Professional Ethics Policy

NASA Astrophysics Data System (ADS)

Townsend, Randy

2013-03-01

AGU's Scientific Integrity and Professional Ethics policy, approved by the AGU Board of Directors and Council in December 2012, is now available online on a new Web site, http://ethics.agu.org. As the Web site states, the policy embodies a "set of guidelines for scientific integrity and professional ethics for the actions of the members and the governance of the Union in its internal activities; in its public persona; and most importantly, in the research and peer review processes of its scientific publications, its communications and outreach, and its scientific meetings."

Scientific Integrity and Professional Ethics at AGU - The Establishment and Evolution of an Ethics Program at a Large Scientific Society

NASA Astrophysics Data System (ADS)

McPhaden, Michael; Leinen, Margaret; McEntee, Christine; Townsend, Randy; Williams, Billy

2016-04-01

The American Geophysical Union, a scientific society of 62,000 members worldwide, has established a set of scientific integrity and professional ethics guidelines for the actions of its members, for the governance of the union in its internal activities, and for the operations and participation in its publications and scientific meetings. This presentation will provide an overview of the Ethics program at AGU, highlighting the reasons for its establishment, the process of dealing ethical breaches, the number and types of cases considered, how AGU helps educate its members on Ethics issues, and the rapidly evolving efforts at AGU to address issues related to the emerging field of GeoEthics. The presentation will also cover the most recent AGU Ethics program focus on the role for AGU and other scientific societies in addressing sexual harassment, and AGU's work to provide additional program strength in this area.

Ethical and Social Issues in Health Research Involving Incarcerated People.

PubMed

Coughlin, Steven S; Lewis, Sharon R; Smith, Selina A

2016-01-01

The use of inmates in research in the U.S. was restricted by the recommendations of the National Commission and by federal regulations and guidelines that followed. By the 1980s, many health care officials became concerned about the exclusion of inmates from experimental treatments for human immunodeficiency virus infection (HIV). These developments in ethics occurred in the context of racial/ethnic disparities in health. In this article, ethical considerations in clinical and public health research on HIV in prison and jail settings are considered. Ethical considerations in mental health research are summarized as well as issues pertaining to research involving female inmates. Issues related to oversight of research involving incarcerated people are considered along with the ethics of public health research. The ethics of research involving incarcerated people extends beyond traditional issues in human subjects ethics to include issues within the domains of bioethics and public health ethics.

Ethical and Social Issues in Health Research Involving Incarcerated People

PubMed Central

Coughlin, Steven S.; Lewis, Sharon R.; Smith, Selina A.

2016-01-01

The use of inmates in research in the U.S. was restricted by the recommendations of the National Commission and by federal regulations and guidelines that followed. By the 1980s, many health care officials became concerned about the exclusion of inmates from experimental treatments for human immunodeficiency virus infection (HIV). These developments in ethics occurred in the context of racial/ethnic disparities in health. In this article, ethical considerations in clinical and public health research on HIV in prison and jail settings are considered. Ethical considerations in mental health research are summarized as well as issues pertaining to research involving female inmates. Issues related to oversight of research involving incarcerated people are considered along with the ethics of public health research. The ethics of research involving incarcerated people extends beyond traditional issues in human subjects ethics to include issues within the domains of bioethics and public health ethics. PMID:27133509

Stem Cell Research and Clinical Translation: A Roadmap about Good Clinical Practice and Patient Care

PubMed Central

Scopetti, Matteo; Gatto, Vittorio

2017-01-01

The latest research achievements in the field of stem cells led in 2016 to the publication of “Guidelines for Stem Cell Research and Clinical Translation” by the International Society for Stem Cell Research (ISSCR). Updating the topics covered in previous publications, the new recommendations offer interesting ethical and scientific insights. Under the common principles of research integrity, protection of patient's welfare, respect for the research subjects, transparency and social justice, the centrality of good clinical practice, and informed consent in research and translational medicine is supported. The guidelines implement the abovementioned publications, requiring rigor in all areas of research, promoting the validity of the scientific activity results and emphasizing the need for an accurate and efficient public communication. This paper aims to analyze the aforementioned guidelines in order to provide a valid interpretive tool for experts. In particular, a research activity focused on the bioethical, scientific, and social implications of the new recommendations is carried out in order to provide food for thought. Finally, as an emerging issue of potential impact of current guidelines, an overview on implications of compensation for egg donation is offered. PMID:29090010

Stem Cell Research and Clinical Translation: A Roadmap about Good Clinical Practice and Patient Care.

PubMed

Frati, Paola; Scopetti, Matteo; Santurro, Alessandro; Gatto, Vittorio; Fineschi, Vittorio

2017-01-01

The latest research achievements in the field of stem cells led in 2016 to the publication of "Guidelines for Stem Cell Research and Clinical Translation" by the International Society for Stem Cell Research (ISSCR). Updating the topics covered in previous publications, the new recommendations offer interesting ethical and scientific insights. Under the common principles of research integrity, protection of patient's welfare, respect for the research subjects, transparency and social justice, the centrality of good clinical practice, and informed consent in research and translational medicine is supported. The guidelines implement the abovementioned publications, requiring rigor in all areas of research, promoting the validity of the scientific activity results and emphasizing the need for an accurate and efficient public communication. This paper aims to analyze the aforementioned guidelines in order to provide a valid interpretive tool for experts. In particular, a research activity focused on the bioethical, scientific, and social implications of the new recommendations is carried out in order to provide food for thought. Finally, as an emerging issue of potential impact of current guidelines, an overview on implications of compensation for egg donation is offered.

[Ethical principles of management and planning during influenza pandemic].

PubMed

Kubar', O I; Asatrian, A Zh

2012-01-01

The article is dedicated to an actual problem of ethical component inclusion into the system of management and planning of epidemic control measures during threat emergence and in the course of influenza pandemic (epidemic) progress. Data regarding development of international ethical guidelines during influenza including WHO recommendations are presented and analysis of normative documents in Russian Federation is given. A necessity of comprehension and accounting of ethical values in pandemic preparedness is shown, main directions of action and responsibility are revealed. Key ethical positions of planning and implementation of measures during influenza pandemic are outlined, compliance with those determines the level of public support and thus provides the effectiveness of the implemented measures.

Ethical guidelines in pandemic influenza: recommendations of the Ethics Subcommittee of the Advisory Committee of the Director, Centers for Disease Control and Prevention.

PubMed

Kinlaw, Kathy; Barrett, Drue H; Levine, Robert J

2009-12-01

Because of the importance of including ethical considerations in planning efforts for pandemic influenza, in February 2005 the Centers for Disease Control and Prevention requested that the Ethics Subcommittee of the Advisory Committee to the Director develop guidance that would serve as a foundation for decision making in preparing for and responding to pandemic influenza. Specifically, the ethics subcommittee was asked to make recommendations regarding ethical considerations relevant to decision making about vaccine and antiviral drug distribution prioritization and development of interventions that would limit individual freedom and create social distancing. The ethics subcommittee identified a number of general ethical considerations including identification of clear goals for pandemic planning, responsibility to maximize preparedness, transparency and public engagement, sound science, commitment to the global community, balancing individual liberty and community interests, diversity in ethical decision making, and commitment to justice. These general ethical considerations are applied to the issues of vaccine and antiviral drug distribution and use of community mitigation interventions.

Dismembering the ethical physician

PubMed Central

Genuis, S J

2006-01-01

Physicians may experience ethical distress when they are caught in difficult clinical situations that demand ethical decision making, particularly when their preferred action may contravene the expectations of patients and established authorities. When principled and competent doctors succumb to patient wishes or establishment guidelines and participate in actions they perceive to be ethically inappropriate, or agree to refrain from interventions they believe to be in the best interests of patients, individual professional integrity may be diminished, and ethical reliability is potentially compromised. In a climate of ever‐proliferating ethical quandaries, it is essential for the medical community, health institutions, and governing bodies to pursue a judicious tension between the indispensable regulation of physicians necessary to maintain professional standards and preserve public safety, and the support for “freedom of conscience” that principled physicians require to practise medicine in keeping with their personal ethical orientation. PMID:16597808

Guidelines for responsible short-term global health activities: developing common principles.

PubMed

Lasker, Judith N; Aldrink, Myron; Balasubramaniam, Ramaswami; Caldron, Paul; Compton, Bruce; Evert, Jessica; Loh, Lawrence C; Prasad, Shailendra; Siegel, Shira

2018-02-07

Growing concerns about the value and effectiveness of short-term volunteer trips intending to improve health in underserved Global South communities has driven the development of guidelines by multiple organizations and individuals. These are intended to mitigate potential harms and maximize benefits associated with such efforts. This paper analyzes 27 guidelines derived from a scoping review of the literature available in early 2017, describing their authorship, intended audiences, the aspects of short term medical missions (STMMs) they address, and their attention to guideline implementation. It further considers how these guidelines relate to the desires of host communities, as seen in studies of host country staff who work with volunteers. Existing guidelines are almost entirely written by and addressed to educators and practitioners in the Global North. There is broad consensus on key principles for responsible, effective, and ethical programs--need for host partners, proper preparation and supervision of visitors, needs assessment and evaluation, sustainability, and adherence to pertinent legal and ethical standards. Host country staff studies suggest agreement with the main elements of this guideline consensus, but they add the importance of mutual learning and respect for hosts. Guidelines must be informed by research and policy directives from host countries that is now mostly absent. Also, a comprehensive strategy to support adherence to best practice guidelines is needed, given limited regulation and enforcement capacity in host country contexts and strong incentives for involved stakeholders to undertake or host STMMs that do not respect key principles.

High-level waste disposal, ethics and thermodynamics

NASA Astrophysics Data System (ADS)

Schwartz, Michael O.

2008-06-01

Moral philosophy applied to nuclear waste disposal can be linked to paradigmatic science. Simple thermodynamic principles tell us something about rightness or wrongness of our action. Ethical judgement can be orientated towards the chemical compatibility between waste container and geological repository. A container-repository system as close as possible to thermodynamic equilibrium is ethically acceptable. It aims at unlimited stability, similar to the stability of natural metal deposits within the Earth’s crust. The practicability of the guideline can be demonstrated.

Choosing Healthcare Options by Involving Canada's Elderly: a protocol for the CHOICE realist synthesis project on engaging older persons in healthcare decision-making

PubMed Central

Stolee, Paul; Elliott, Jacobi; McNeil, Heather; Boscart, Veronique; Heckman, George A; Hutchinson, Rebecca; Hedley, Margaret; Glouberman, Sholom; Judd, Maria

2015-01-01

Introduction While patient and citizen engagement has been recognised as a crucial element in healthcare reform, limited attention has been paid to how best to engage seniors—the fastest growing segment of the population and the largest users of the healthcare system. To improve the healthcare services for this population, seniors and their families need to be engaged as active partners in healthcare decision-making, research and planning. This synthesis aims to understand the underlying context and mechanisms needed to achieve meaningful engagement of older adults in healthcare decision-making, research and planning. Methods and analysis The CHOICE Knowledge Synthesis Project: Choosing Healthcare Options by Involving Canada's Elderly aims to address this issue by synthesising current knowledge on patient, family, and caregiver engagement. A realist synthesis will support us to learn from other patient and citizen engagement initiatives, from previous research, and from seniors, families and caregivers themselves. The synthesis will guide development or adaptation of a framework, leading to the development of best practice guidelines and recommendations for engagement of older people and their families and caregivers in clinical decision-making, healthcare delivery, planning and research. Ethics and dissemination The components of this protocol involving consultation with patients or caregivers have received ethics clearance from the University of Waterloo, Office of Research Ethics (ORE#19094). After completion of the project, we will amalgamate the information collected into a knowledge synthesis report which will include best practice guidelines and recommendations for patient, family and caregiver engagement in clinical and health system planning and research contexts. Results Will be further disseminated to citizens, clinicians, researchers and policymakers with the help of our partners. Trial registration number CRD42015024749. PMID:26534730

Ethics and data protection in human biomarker studies in environmental health.

PubMed

Casteleyn, Ludwine; Dumez, Birgit; Van Damme, Karel; Anwar, Wagida A

2013-08-01

Human biomarker studies in environmental health are essential tools to study the relationship between health and environment. They should ultimately contribute to a better understanding of environmentally induced adverse health effects and to appropriate preventive actions. To ensure the protection of the rights and dignity of study participants a complex legal and ethical framework is applied, consisting of several international directives, conventions, and guidelines, whether or not translated in domestic laws. Main characteristics of ethics and data protection in studies using biomarkers in the field of environmental health are summarized and current discussions on related questions and bottlenecks highlighted. In the current regulatory context, dominated by the protection of the individual study participant, difficulties are reported due to the different interpretation and implementation of the regulations of concern within and across borders. Advancement of consistency and compatibility is recommended and efforts are ongoing. An increasing demand for secondary use of data and samples poses additional challenges in finding a right balance between the individual rights of the study participants on the one hand and the common interest of, and potential benefit for the public or community at large on the other. Ethics committees could play a key role in assessing problems originating from the sometimes competing needs at individual and societal level. Building trust in science amongst (potential) study participants and within the community allows the inclusion of arguments from the societal perspective. This requires increased attention for respectful communication efforts. Striving for public participation in decision making processes may promote policy relevant research and the related translation of study results into action. Copyright © 2013 Elsevier GmbH. All rights reserved.

Duty-to-Warn Guidelines for Mental Health Counselors.

ERIC Educational Resources Information Center

Costa, Luann; Altekruse, Michael

1994-01-01

Summarizes legal cases in which duty-to-warn was an issue. Suggests that guidelines for counselors are few and lack definition. Offers a model to guide counselors in making clinical judgments in cases and case examples to exemplify possible ethical dilemmas in the practice of counseling. Includes 36 citations. (Author/CRR)

First Steps to Talking with Families and Staff: Guidelines for Listening Effectively.

ERIC Educational Resources Information Center

Eisenberg, Eileen

2002-01-01

Presents guidelines for child care administrators to become more effective in communicating with families and staff. Suggestions for beginning a dialogue include being visible and accessible, familiar, personable, professional, ethical, and timely. Details procedures for facilitating parent and staff meeting in a confident manner. Reiterates that…

Society for Academic Emergency Medicine Statement on Plagiarism.

PubMed

Asher, Shellie L; Iserson, Kenneth V; Merck, Lisa H

2017-10-01

The integrity of the research enterprise is of the utmost importance for the advancement of safe and effective medical practice for patients and for maintaining the public trust in health care. Academic societies and editors of journals are key participants in guarding scientific integrity. Avoiding and preventing plagiarism helps to preserve the scientific integrity of professional presentations and publications. The Society for Academic Emergency Medicine (SAEM) Ethics Committee discusses current issues in scientific publishing integrity and provides a guideline to avoid plagiarism in SAEM presentations and publications. © 2017 by the Society for Academic Emergency Medicine.

Online social network data as sociometric markers.

PubMed

Binder, Jens F; Buglass, Sarah L; Betts, Lucy R; Underwood, Jean D M

2017-10-01

Data from online social networks carry enormous potential for psychological research, yet their use and the ethical implications thereof are currently hotly debated. The present work aims to outline in detail the unique information richness of this data type and, in doing so, to support researchers when deciding on ethically appropriate ways of collecting, storing, publishing, and sharing data from online sources. Focusing on the very nature of social networks, their structural characteristics, and depth of information, we provide a detailed and accessible account of the challenges associated with data management and data storage. In particular, the general nonanonymity of network data sets is discussed, and an approach is developed to quantify the level of uniqueness that a particular online network bestows upon the individual maintaining it. Using graph enumeration techniques, we show that comparatively sparse information on a network is suitable as a sociometric marker that allows for the identification of an individual from the global population of online users. The impossibility of anonymizing specific types of network data carries implications for ethical guidelines and research practice. At the same time, network uniqueness opens up opportunities for novel research in psychology. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Whistle-Blowing as a Form of Advocacy: Guidelines for the Practitioner and Organization

ERIC Educational Resources Information Center

Greene, Annette D.; Latting, Jean Kantambu

2004-01-01

Advocacy has been an inherent component of social work since the mid-1800s. The NASW Code of Ethics explicitly promotes advocacy as an ethical stance against inhumane conditions. Whistle-blowing, on the other hand, occurs mostly in the business and public administration disciplines and is relatively unknown in the social work profession. Using…

The Danger-to-Self-or-Others Exception to Confidentiality. ACA Legal Series, Volume 8.

ERIC Educational Resources Information Center

Ahia, C. Emmanuel; Martin, Dan

A counselor's obligation to safeguard information shared in counseling has clinical, ethical, and legal implications. This volume focuses on the duty-to-warn exception in client confidentiality. It provides general ethical and legal guidelines and, where possible, specific information to help the practitioner make good choices. It is intended for…

Team-Based Simulation: Toward Developing Ethical Guidelines among American and Israeli Teachers in Jewish Schools

ERIC Educational Resources Information Center

Shapira-Lishchinsky, Orly; Glanz, Jeffrey; Shaer, Anat

2016-01-01

This study attempts to explore Israeli and American teachers' perceptions based on their ethical dilemmas in Jewish schools. A cross-national study was undertaken in Jewish schools, examining fifty teachers from Israel and fifty-one teachers from the United States. Designed with team-based simulations, this study revealed strong similarities…

Palliative sedation: ethical perspectives from Latin America in comparison with European recommendations.

PubMed

Manzini, Jorge L

2011-09-01

Palliative sedation is a standard procedure used in palliative care especially for patients at the very end of their lives, who are enduring otherwise intractable suffering. It consists of the administration of sedatives and, when necessary, other drugs, usually by infusion, either subcutaneously or intravenously, at the necessary rate to achieve the patient's relief, by means of reducing the consciousness of the patient. If this administration is not discontinued, the usual outcome is the patient's death. So, the most frequent criticisms regarding the procedure are those that consider it as a form of euthanasia. The intention of the review is analyzing the status questionis in Europe and Latin America. Current thinking and research about this issue refers especially to the terminology, the boundaries between palliative sedation and slow euthanasia, especially in pediatric settings, the lacking of precise definition for concepts such as refractory symptoms and unbearable suffering, and the place for existential suffering in this context; the ethical positioning of Latin-American normative and authors is similar to that of Europe. It does not seem that solution to the conflicting points will come from better guidelines or more experts' meetings. Instead, efforts should be directed to reinforce moral, professional integrity, within the framework of an ethics of virtue, as inherent to palliative care. Such ethics can effectively be taught and infused, and then required to all healthcare professionals.

Report of the Northern California Conference for Guidelines on Aid-in-Dying: definitions, differences, convergences, conclusions.

PubMed Central

Young, E W; Marcus, F S; Drought, T; Mendiola, M; Ciesielski-Carlucci, C; Alpers, A; Eaton, M; Koenig, B A; Loewy, E; Raffin, T A; Ross, C

1997-01-01

In September 1996, the Stanford University Center for Biomedical Ethics convened a conference entitled "Comprehensive Care of the Terminally Ill: The Northern California Consensus Development Conference for Guidelines on Aid-in-Dying." The regionally based, multidisciplinary conference gathered people from a variety of disciplines and diverse perspectives on physician aid-in-dying. This report documents important points of convergence, disagreement, and uncertainty that emerged from the conference and provides commentary on crucial issues: the definition of terminal illness, ensuring adequate palliative care, psychiatric challenges, coping with family pressures, the doctor-patient relationship, the managed care context, the role of ethics committees, and institutional challenges. Should physician aid-in-dying become a legal practice in California, the report will provide guidance to health care organizations, health professionals, and public policy officials engaged in local or state guideline or policy development. PMID:9217449

Excessive and disproportionate advertising in peer-reviewed journals.

PubMed

Friedman, Lee S; Richter, Elihu D

2006-01-01

The International Committee of Medical Journal Editors (ICMJE) has outlined ethical guidelines concerning the advertising practices of peer-reviewed journals that briefly discuss issues of excessive and disproportionate advertising. The authors evaluated these guidelines using quantitative data, assessing the types and frequencies of advertising in 2001 print issues of NEJM and JAMA, two principal members of ICMJE. Advertising ratios (ratio of advertisements to editorial content) were near unity in NEJM and 0.30 in JAMA, compared with reported ratios of 0.15 among low-circulation specialty science journals and 0.80 among high-circulation consumer magazines. In both journals, five corporations placed more than 50% of all display advertisements. The findings suggest a dissonance between the ethical guidelines and the de facto advertising practices of arguably the two most important member journals of the ICMJE. There is a need to define and apply standards for excessive and disproportionate advertising.

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.

PubMed

Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

2015-09-29

International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee.

Ethical limitations in patenting biotechnological inventions.

PubMed

Lugagnani, V

1999-01-01

In order to connect ethical considerations with practical limits to patentability, the moral judgement should possibly move from the exploitation of the invention to the nature and/or objectives of Research and Development (R&D) projects which have produced it: in other words, it appears quite reasonable and logical that Society is not rewarding unethical R&D activities by granting intellectual property rights. As far as biotechnology R&D is concerned, ethical guidance can be derived from the 1996 Council of EuropeOs OConvention for the protection of human rights and dignity of the human being with regard to the application of biology and medicineO, whose Chapter V - Scientific research - provides guidelines on: i. protection of persons undergoing research (e.g. informed consent); ii. protection of persons not able to consent to research; iii. research on embryos in vitro. As far as the specific point of patenting biotechnology inventions is concerned, the four exclusions prescribed by Directive 98/44/EC (i.e. human cloning, human germ-line gene therapy, use of human embryos for commercial purposes, unjustified animal suffering for medical purposes) are all we have in Europe in terms of ethical guidance to patentability. In Italy, in particular, we certainly need far more comprehensive legislation, expressing SocietyOs demand to provide ethical control of modern biotechnology. However it is quite difficult to claim that ethical concerns are being raised by currently awarded biotechnology patents related to living organisms and material thereof; they largely deal with the results of genomic R&D, purposely and usefully oriented toward improving health-care and agri-food processes, products and services. ONo patents on lifeOO can be an appealing slogan of militants against modern biotechnology, but it is far too much of an over-simplified abstraction to become the Eleventh Commandment our Society.

Patient participation: causing moral stress in psychiatric nursing?

PubMed

Jansen, Trine-Lise; Hanssen, Ingrid

2017-06-01

The aim of this study was to explore psychiatric nurses' experiences and perspectives regarding patient participation. Patient participation is an ambiguous, complex and poorly defined concept with practical/clinical, organisational, legal and ethical aspects, some of which in psychiatric units may cause ethical predicaments and moral stress in nurses, for instance when moral caring acts are thwarted by constraints. An explorative quantitative pilot study was conducted at a psychiatric subacute unit through three focus group interviews with a total of nine participants. A thematic analytic approach was chosen. Preliminary empirical findings were discussed with participants before the final data analysis. Ethical research guidelines were followed. Patient participation is a difficult ideal to realise because of vagueness of aim and content. What was regarded as patient participation differed. Some interviewees held that patients may have a say within the framework of restraints while others saw patient participation as superficial. The interviewees describe themselves as patient's spokespersons and contributing to patients participating in their treatment as a great responsibility. They felt squeezed between their ethical values and the 'system'. They found themselves in a negotiator role trying to collaborate with both the doctors and the patients. Privatisation of a political ideal makes nurses vulnerable to burn out and moral distress. Nurses have a particular ethical responsibility towards vulnerable patients, and may themselves be vulnerable when caught in situations where their professional and moral values are threatened. Unclear concepts make for unclear division of responsibility. Patient participation is often a neglected value in current psychiatric treatment philosophy. When healthcare workers' ethical sensibilities are compromised, this may result in moral stress. © 2016 Nordic College of Caring Science.

Ethics and the ethnography of medical research in Africa

PubMed Central

Molyneux, Sassy; Geissler, P. Wenzel

2008-01-01

The ethics of medical research have grown as an area of expertise and debate in recent years, with two broad approaches emerging in relation to transnational research: (1) the refinement of guidelines and strengthening of review, processes primarily to protect the right of individual research participants and strengthen interpersonal relations at the micro-level; and (2) considering more centrally, as crucial ethical concerns, the wider interests of whole populations, the functioning of research institutions, the processes of collaboration, and the ethics of inequitable international relations. We see the two areas of debate and action as complementary, and believe that social science conducted in and around transnational medical research environments can bring these two perspectives together in a more ‘situated ethics’ of research. To explore this idea for medical research in Africa, we organized a conference in December 2005 in Kilifi, Kenya. In this introduction we outline the two emerging approaches to medical ethics, summarise each of seven papers selected from the conference for inclusion in this special issue on ethics and ethnography, and finally highlight two areas of lively debate at the conference itself: the appropriateness and value of ethics guidelines and review boards for medical research; and the ethical review of social science research. Together, the papers and debates point to the importance of focusing on the ethics of relationships and on justice in both biomedicine and social science research, and on giving greater voice and visibility to the field staff who often play a crucial and under-supported role in ‘doing ethics’ in the field. They also point to the potential value of social science research on the range of relationships operating at different levels and time scales in medical research, including those surrounding community engagement activities, and the role and functioning of ethics review boards. We conclude by highlighting the ethical priority of capacity strengthening in medical research, social science and research ethics in Africa to ensure that local and national priorities and concerns are considered at both the micro and macro levels. PMID:18455856

Participatory action research: considerations for ethical review.

PubMed

Khanlou, N; Peter, E

2005-05-01

This paper addresses the distinctive nature of participatory action research (PAR) in relation to ethical review requirements. As a framework for conducting research and reducing health disparities, PAR is gaining increased attention in community and public health research. As a result, PAR researchers and members of Research Ethics Boards could benefit from an increased understanding of the array of ethical concerns that can arise. We discuss these concerns in light of commonly held ethical requirements for clinical research (social or scientific value, scientific validity, fair subject/participant selection, favourable risk-benefit ratio, independent review, informed consent, and respect for potential and enrolled participants) and refer to guidelines specifically developed for participatory research in health promotion. We draw from our community-based experiences in mental health promotion research with immigrant and culturally diverse youth to illustrate the ethical advantages and challenges of applying a PAR approach. We conclude with process suggestions for Research Ethics Boards.

Computer ethics and teritary level education in Hong Kong

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

Wong, E.Y.W.; Davison, R.M.; Wade, P.W.

1994-12-31

This paper seeks to highlight some ethical issues relating to the increasing proliferation of Information Technology into our everyday lives. The authors explain their understanding of computer ethics, and give some reasons why the study of computer ethics is becoming increasingly pertinent. The paper looks at some of the problems that arise in attempting to develop appropriate ethical concepts in a constantly changing environment, and explores some of the ethical dilemmas arising from the increasing use of computers. Some initial research undertaken to explore the ideas and understanding of tertiary level students in Hong Kong on a number of ethicalmore » issues of interest is described, and our findings discussed. We hope that presenting this paper and eliciting subsequent discussion will enable us to draw up more comprehensive guidelines for the teaching of computer related ethics to tertiary level students, as well as reveal some directions for future research.« less

Virtues and humanitarian ethics.

PubMed

Löfquist, Lars

2017-01-01

This paper analyses the contribution of virtue ethics, the study of good character traits, to the humanitarian context. It argues that a virtue ethics perspective paints a realistic picture of the use of ethical standards in morally complex circumstances. Virtuous relief workers can employ standards in their thinking, but they are also committed to professional excellence that goes beyond any formal code. The concept of virtue ethics places a stress on moral development, which can be facilitated by role models that impart modest and feasible ideals. However, virtue ethics cannot provide simple guidelines on how to resolve difficult situations. It is possible that two virtuous persons can disagree on what should be done in a particular instance. In addition, a virtue ethics perspective emphasises the need for both individuals and organisations to discuss the actual purpose of relief work in order to pinpoint the virtues of a good relief professional. © 2017 The Author(s). Disasters © Overseas Development Institute, 2017.

The ethical attitude of emergency physicians toward resuscitation in Korea.

PubMed

Bae, Hyuna; Lee, Sangjin; Jang, Hye Young

2008-05-01

This study was conducted to assess the various ethical attitudes of emergency specialists in Korea toward resuscitation. A questionnaire investigating the following key topics concerning the ethics of resuscitation was sent to emergency specialists in Korea: when not to attempt resuscitation, when to stop resuscitation, withdrawal of life-sustaining treatment, diagnosis of death by non-physicians, permission for family members to stay with the patient during resuscitation, and teaching with the body of the recently deceased patient. We found broad variation in medical practice at patient death and in the ethical considerations held and followed by emergency physicians (EPs) during resuscitation in Korea. Initiating and concluding resuscitation attempts were practiced according to ethical and cultural norms, as well as medical conditions. Guidelines for resuscitation ethics that are based on the Korean medico-legal background need to be developed. Education of EPs to solve the ethical dilemma in resuscitation is needed.

Ethics of infant relinquishment, cultural considerations, and obstetric conveniences.

PubMed

Callister, Lynn Clark

2011-01-01

Ethical issues relating to infant relinquishment, caring for culturally diverse women, the importance of shared power between women and their caregivers, and the provision of evidence-based practice versus reliance on obstetric conveniences are addressed in this article. Respectful care of women relinquishing their infants including use of appropriate language demonstrates moral and ethical nursing practice; providing cultural competent care of multilinguistic, multicultural, and multiethnic childbearing women and their families is an ethical imperative. Nurses practicing ethically will foster adoption of best practices on perinatal and neonatal units, and generate a clearly articulated vision of woman and family centered organizational culture. In ethical terms, this demonstrates respect for others as well as beneficence. Promoting the use of ethical nursing practice and evidence-based practice requires that nurses identify change agents, those who are champions and facilitators of evidence-based practice, and then reward such innovators and make sure that clinical guidelines be developed based on best practices.

Professional medical associations and their relationships with industry: a proposal for controlling conflict of interest.

PubMed

Rothman, David J; McDonald, Walter J; Berkowitz, Carol D; Chimonas, Susan C; DeAngelis, Catherine D; Hale, Ralph W; Nissen, Steven E; Osborn, June E; Scully, James H; Thomson, Gerald E; Wofsy, David

2009-04-01

Professional medical associations (PMAs) play an essential role in defining and advancing health care standards. Their conferences, continuing medical education courses, practice guidelines, definitions of ethical norms, and public advocacy positions carry great weight with physicians and the public. Because many PMAs receive extensive funding from pharmaceutical and device companies, it is crucial that their guidelines manage both real and perceived conflict of interests. Any threat to the integrity of PMAs must be thoroughly and effectively resolved. Current PMA policies, however, are not uniform and often lack stringency. To address this situation, the authors first identified and analyzed conflicts of interest that may affect the activities, leadership, and members of PMAs. The authors then went on to formulate guidelines, both short-term and long-term, to prevent the appearance or reality of undue industry influence. The recommendations are rigorous and would require many PMAs to transform their mode of operation and perhaps, to forgo valuable activities. To maintain integrity, sacrifice may be required. Nevertheless, these changes are in the best interest of the PMAs, the profession, their members, and the larger society.

Ethical concerns in early 21st century organ transplantation

PubMed Central

Waness, Abdelkarim

2011-01-01

Medical ethics is an indispensible and challenging aspect of clinical practice. This is particularly prominent in the field of organ transplantation. In this paper, initially, a clinical case with brain death that ended up as an organ donor will be presented. Following the presentation, important moral challenges which initially formed medical ethics and some highlights of it in organ transplantation will be discussed in detail. The impact of complex modern influential factors that might interfere with the practice of medical ethics in this field such as patients’ vulnerability, financial temptations, and legal regulations will be also dealt with. Finally, we shall propose practical guidelines aiming at improving the practice of medical ethics in the emerging issue of organ transplantation. PMID:23908752

South African Research Ethics Committee Review of Standards of Prevention in HIV Vaccine Trial Protocols.

PubMed

Essack, Zaynab; Wassenaar, Douglas R

2018-04-01

HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.

May Stakeholders be Involved in Design Without Informed Consent? The Case of Hidden Design.

PubMed

Pols, A J K

2017-06-01

Stakeholder involvement in design is desirable from both a practical and an ethical point of view. It is difficult to do well, however, and some problems recur again and again, both of a practical nature, e.g. stakeholders acting strategically rather than openly, and of an ethical nature, e.g. power imbalances unduly affecting the outcome of the process. Hidden Design has been proposed as a method to deal with the practical problems of stakeholder involvement. It aims to do so by taking the observation of stakeholder actions, rather than the outcomes of a deliberative process, as its input. Furthermore, it hides from stakeholders the fact that a design process is taking place so that they will not behave differently than they otherwise would. Both aspects of Hidden Design have raised ethical worries. In this paper I make an ethical analysis of what it means for a design process to leave participants uninformed or deceived rather than acquiring their informed consent beforehand, and to use observation of actions rather than deliberation as input for design, using Hidden Design as a case study. This analysis is based on two sets of normative guidelines: the ethical guidelines for psychological research involving deception or uninformed participants from two professional psychological organisations, and Habermasian norms for a fair and just (deliberative) process. It supports the conclusion that stakeholder involvement in design organised in this way can be ethically acceptable, though under a number of conditions and constraints.

Physician-industry relations. Part 1: individual physicians.

PubMed

Coyle, Susan L

2002-03-05

This is part 1 of a 2-part paper on ethics and physician-industry relationships. Part 1 offers advice to individual physicians; part 2 gives recommendations to medical education providers and medical professional societies. Physicians and industry have a shared interest in advancing medical knowledge. Nonetheless, the primary ethic of the physician is to promote the patient's best interests, while the primary ethic of industry is to promote profitability. Although partnerships between physicians and industry can result in impressive medical advances, they also create opportunities for bias and can result in unfavorable public perceptions. Many physicians and physicians-in-training think they are impervious to commercial influence. However, recent studies show that accepting industry hospitality and gifts, even drug samples, can compromise judgment about medical information and subsequent decisions about patient care. It is up to the physician to judge whether a gift is acceptable. A very general guideline is that it is ethical to accept modest gifts that advance medical practice. It is clearly unethical to accept gifts or services that obligate the physician to reciprocate. Conflicts of interest can arise from other financial ties between physicians and industry, whether to outside companies or self-owned businesses. Such ties include honorariums for speaking or writing about a company's product, payment for participating in clinic-based research, and referrals to medical resources. All of these relationships have the potential to influence a physician's attitudes and practices. This paper explores the ethical quandaries involved and offers guidelines for ethical business relationships.

Spinning the wheels: a CAPS survey of ethical issues in pediatric surgery.

PubMed

Bagwell, C E; Goodwin, S R

1992-11-01

To evaluate decision-making factors of pediatric surgeons when faced with ethical dilemmas in a clinical setting, questionnaires were mailed to members of the Canadian Association of Paediatric Surgeons. The surgeons were asked to respond to scenarios regarding ethical dilemmas in the treatment of children. Fifty-one responses (57%) were computer analyzed based on chosen responses to the clinical dilemma and demographic factors such as age, sex, marital status, country of citizenship, religion, and "religiousness," a determination of religious conviction as viewed by the respondent. In addition, ethical convictions were sought regarding abortion, fetal research, AIDS, HIV testing, denial of medical care due to religious beliefs (Jehovah's Witness), and limitations in health care access for indigents. In general, respondents found it difficult to separate ethical guidelines for determining aggressive treatment--absolute value of life; best interests of the child; parental authority; and ability of the child to engage in social, intellectual, or emotional attachments (quality of life)--in the face of actual patient care issues. In fact, results of this survey indicate that the operating surgeon applies his/her medical knowledge and surgical "experience" to each individual case, incorporating his or her own ethical beliefs (in a respondent's words: "In the operating room, the surgeon must satisfy his own conscience in making decisions") while cognizant of legal guidelines for "standard care" ("Decisions would be based on personal experience, and what the local society believes to be right").(ABSTRACT TRUNCATED AT 250 WORDS)

Research ethics and lessons from Hwanggate: what can we learn from the Korean cloning fraud?

PubMed

Saunders, R; Savulescu, J

2008-03-01

In this review of the Korean cloning scandal involving Woo-Suk Hwang, the nature of the disaster is documented and reasons why it occurred are suggested. The general problems it raises for scientific research are highlighted and six possible ways of improving practice are offered in the light of this case: (1) better education of science students; (2) independent monitoring and validation; (3) guidelines for tissue donation for research; (4) fostering of debate about ethically contentious research in science journals; (5) development of an international code of ethical research practice; (6) fostering of public involvement in ethical review and debate through the web.

Ethical issues in ageing.

PubMed

Fenech, Frederick F

2003-01-01

Population ageing, in both the developed and developing world, has put increasing demands on health resources; this has brought to the fore various ethical issues related to ageing. This paper examines moral issues that confront people as they grow old as well as those who are involved with them. The concepts of autonomy, dignity, justice and intergenerational solidarity are explored. Living wills and the role of a proxy could help to deal with the common ethical dilemmas related to death and dying. Positive action by governments to overcome ageism is recommended. The need to establish ethical guidelines, which take into consideration differences in religion, culture, ethnicity and race, is highlighted.

Ethics of emergency department triage: SAEM position statement. SAEM Ethics Committee (Society for Academic Emergency Medicine).

PubMed

1995-11-01

Emergency department overcrowding, the growth of managed care, and the high cost of emergency care are creating pressures to triage patients away from U.S. EDs. Paradoxically, this pressure to limit patient access to EDs has increased in spite of federal laws that restrict patient triage and transfer. The latter regulations view EDs as the safety net for the U.S. health care system. The SAEM Ethics Committee evaluated the ethical implications of policies that triage patients out of the ED prior to complete evaluation and treatment. The committee used these implications to develop practical guidelines, which are reported.

[Review of the methodological, ethical, legal and social issues of research projects in healthcare with big data].

PubMed

de Lecuona, Itziar

2018-05-31

The current model for reviewing research with human beings basically depends on decision-making processes within research ethics committees. These committees must be aware of the importance of the new digital paradigm based on the large-scale exploitation of datasets, including personal data on health. This article offers guidelines, with the application of the EU's General Data Protection Regulation, for the appropriate evaluation of projects that are based on the use of big data analytics in healthcare. The processes for gathering and using this data constitute a niche where current research is developed. In this context, the existing protocols for obtaining informed consent from participants are outdated, as they are based not only on the assumption that personal data are anonymized, but that they will continue to be so in the future. As a result, it is essential that research ethics committees take on new capabilities and revisit values such as privacy and freedom, updating protocols, methodologies and working procedures. This change in the work culture will provide legal security to the personnel involved in research, will make it possible to guarantee the protection of the privacy of the subjects of the data, and will permit orienting the exploitation of data to avoid the commodification of personal data in this era of deidentification, so that research meets actual social needs and not spurious or opportunistic interests disguised as research. Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

[Euthanasia and/or medically assisted suicide: Reflection on the new responsibility of the hospital pharmacist].

PubMed

Boissinot, L; Benamou, M; Léglise, P; Mancret, R-C; Huchon-Bécel, D

2014-03-01

Concern about euthanasia and medically assisted suicide is currently growing around the world and particularly in France. Though not authorized at present in France, the role of hospital pharmacist in this issue needs to be discussed. This article aims to gather medical and legal literature of European Union member states on these issues and particularly in France. To propose a practical thinking on the possible role of hospital pharmacist. Among European Union, euthanasia and/or assisted suicide have already been introduced in some member states' laws. In France, Leonetti law currently sets the legal framework for the management of end of life. To address the society's demand on these issues, French President F. Hollande made two ethics committees responsible for working on it. Both were mainly against euthanasia and assisted suicide. Though a bit forgotten in this debate, hospital pharmacist needs to be associated in the thinking, as the main "drug-keeper". Indeed, guidelines are necessary to outline and ensure a safe drug use, complying with professional ethics, if lethal doses are voluntarily prescribed. Pharmaceutical work is in constant evolution and is addressing new issues still unanswered, including assisted suicide and euthanasia. French pharmaceutical authorities should seize upon them, in order to guarantee pharmaceutical ethics. These practices, if authorized by law, should remain exceptional, and law strictly enforced. The pharmacist could be one of these "lawkeepers". Copyright © 2014 Elsevier Masson SAS. All rights reserved.

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

PubMed

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

2016-10-22

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

Internationalizing professional codes in engineering.

PubMed

Harris, Charles E

2004-07-01

Professional engineering societies which are based in the United States, such as the American Society of Mechanical Engineers (ASME, now ASME International) are recognizing that their codes of ethics must apply to engineers working throughout the world. An examination of the ethical code of the ASME International shows that its provisions pose many problems of application, especially in societies outside the United States. In applying the codes effectively in the international environment, two principal issues must be addressed. First, some Culture Transcending Guidelines must be identified and justified. Nine such guidelines are identified Second, some methods for applying the codes to particular situations must be identified Three such methods are specification, balancing, and finding a creative middle way.

Ethical challenges in the use of social service robots for elderly people.

PubMed

Körtner, T

2016-06-01

Socially assistive robots are increasingly discussed as solutions in care and domestic use for the support of senior adults; however, this raises ethical questions which hitherto have not been considered or were not predictable. The most important questions are those of privacy and data protection, safety and responsibility as well as involvement of vulnerable persons and deception. Consequently, the ethical principles of nonmaleficence, beneficence, autonomy and fairness should be transposed to robotics. Clear answers and solutions are not yet available for every ethical challenge in robotics; however, the development of ethical guidelines for deployment of robots and research in the field of social service robots (SSR) are essential steps in order to embed ethics into dealing with socially assistive robots. This article provides some practical suggestions on this issue from a robotics project.

Guidelines for infertility counselling in different countries: is there an emerging trend?

PubMed

Blyth, Eric

2012-07-01

It is widely accepted that infertility and involuntary childlessness, and the decision to engage with assisted reproduction technology (ART) services as a patient, donor or surrogate can entail wide-ranging psychosocial issues. Psychosocial counselling has, therefore, become valued as an integral element of ART services. The objective of this study was to begin to map out what exists globally by the way of guidelines for infertility counselling. Data were analysed from formal guidelines produced by seven national infertility counselling bodies, onetransnational infertility counselling organization, reports of the American Society for Reproductive Medicine Ethics Committee and Practice Committee and the ESHRE Task Force on Ethics and Law. Additional sources of data were the International Infertility Counseling Organization and counselling colleagues internationally. Four broad areas concerning contemporary practice in infertility counselling are identified: (i) the legal mandate for counselling; (ii) eligibility credentials for individuals carrying out professional counselling activities; (iii) different forms of counselling and (iv) counselling practice in relation to specific elements of assisted reproduction treatment. Internationally, the development of infertility guidelines is best described as a 'work in progress', although key trends are evident.

Outcomes associated with prescribed medications in older adults with multimorbidity: protocol for a scoping review

PubMed Central

Tricco, Andrea C; Vyas, Manav; Kohli, Kapil; Soin, Sarthak; Abaeian, Mitra; Watt, Stephanie; Straus, Sharon E

2017-01-01

Introduction Multimorbidity becomes increasingly prevalent with ageing. Polypharmacy is often associated with multimorbidity because patients accrue medications to treat each individual disease; however, there is uncertainty around the generalisability of disease-specific guidelines. Namely, the extrapolation of results from studies conducted in younger patients to older adults with multimorbidity. The main objective of this scoping review is to explore our current knowledge of the outcomes that older adults with multimorbidity experience from taking prescribed medications. Methods and analysis A scoping review will be conducted to explore what is known about the outcomes experienced by older adults with multimorbidity who are taking guideline-recommended medications and to identify areas for future research. In addition to searching the grey literature, the following databases will be searched from 1990 onward: MEDLINE, EMBASE, PsycINFO and the Cochrane Library. Experimental, quasi-experimental and non-experimental studies consisting of patients ≥65 years old who have two or more comorbid conditions (explicitly grouped together for the purpose of analysis) and who are being prescribed a guideline-recommended prescription medication for a chronic condition will be considered for inclusion in our scoping review. We will describe patient (eg, mortality, morbidity, quality of life) and health system (eg, number of emergency department visits or hospitalisations, cost to third-party payer) outcomes associated with the prescription of medications for older adults who have two or more chronic comorbid conditions. Two reviewers will complete all screening and data abstraction independently. Data will be synthesised with descriptive statistics. Ethics and dissemination Ethics approval is not required because this is a scoping review of published literature. Results will be disseminated through conference presentations and publication in a peer-reviewed journal. PMID:28235972

The Human Rights Context for Ethical Requirements for Involving People with Intellectual Disability in Medical Research

ERIC Educational Resources Information Center

Iacono, T.; Carling-Jenkins, R.

2012-01-01

Background: The history of ethical guidelines addresses protection of human rights in the face of violations. Examples of such violations in research involving people with intellectual disabilities (ID) abound. We explore this history in an effort to understand the apparently stringent criteria for the inclusion of people with ID in research, and…

Ethical Concerns About Human Genetic Enhancement in the Malay Science Fiction Novels.

PubMed

Isa, Noor Munirah; Hj Safian Shuri, Muhammad Fakhruddin

2018-02-01

Advancements in science and technology have not only brought hope to humankind to produce disease-free offspring, but also offer possibilities to genetically enhance the next generation's traits and capacities. Human genetic enhancement, however, raises complex ethical questions, such as to what extent should it be allowed? It has been a great challenge for humankind to develop robust ethical guidelines for human genetic enhancement that address both public concerns and needs. We believe that research about public concerns is necessary prior to developing such guidelines, yet the issues have not been thoroughly investigated in many countries, including Malaysia. Since the novel often functions as a medium for the public to express their concerns, this paper explores ethical concerns about human genetic enhancement expressed in four Malay science fiction novels namely Klon, Leksikon Ledang, Transgenesis Bisikan Rimba and Transgenik Sifar. Religion has a strong influence on the worldview of the Malays therefore some concerns such as playing God are obviously religious. Association of the negative image of scientists as well as the private research companies with the research on human genetic enhancement reflects the authors' concerns about the main motivations for conducting such research and the extent to which such research will benefit society.

A randomised controlled trial of an online menu planning intervention to improve childcare service adherence to dietary guidelines: a study protocol

PubMed Central

Yoong, Sze Lin; Grady, Alice; Wiggers, John; Flood, Victoria; Rissel, Chris; Finch, Meghan; Searles, Andrew; Salajan, David; O’Rourke, Ruby; Daly, Jaqueline; Gilham, Karen; Stacey, Fiona; Fielding, Alison; Pond, Nicole; Wyse, Rebecca; Seward, Kirsty; Wolfenden, Luke

2017-01-01

Introduction The implementation of dietary guidelines in childcare settings is recommended to improve child public health nutrition. However, foods provided in childcare services are not consistent with guidelines. The primary aim of the trial is to assess the effectiveness of a web-based menu planning intervention in increasing the mean number of food groups on childcare service menus that comply with dietary guidelines regarding food provision to children in care. Methods and analysis A parallel group randomised controlled trial will be undertaken with 54 childcare services that provide food to children within New South Wales, Australia. Services will be randomised to a 12-month intervention or usual care. The experimental group will receive access to a web-based menu planning and decision support tool and online resources. To support uptake of the web program, services will be provided with training and follow-up support. The primary outcome will be the number of food groups, out of 6 (vegetables, fruit, breads and cereals, meat, dairy and ‘discretionary’), on the menu that meet dietary guidelines (Caring for Children) across a 1-week menu at 12-month follow-up, assessed via menu review by dietitians or nutritionists blinded to group allocation. A nested evaluation of child dietary intake in care and child body mass index will be undertaken in up to 35 randomly selected childcare services and up to 420 children aged approximately 3–6 years. Ethics and dissemination Ethical approval has been provided by Hunter New England and University of Newcastle Human Research Ethics Committees. This research will provide high-quality evidence regarding the impact of a web-based menu planning intervention in facilitating the translation of dietary guidelines into childcare services. Trial findings will be disseminated widely through national and international peer-reviewed publications and conference presentations. Trial registration Prospectively registered with Australian New Zealand Clinical Trial Registry (ANZCTR) ACTRN12616000974404. PMID:28893755

Compensation for subjects of medical research: the moral rights of patients and the power of research ethics committees.

PubMed Central

Guest, S

1997-01-01

Awareness of the morally significant distinction between research and innovative therapy reveals serious gaps in the legal provision for compensation in the UK for injured subjects of medical research. Major problems are limitations inherent in negligence actions and a culture that emphasises indemnifying researchers before compensating victims. Medical research morally requires compensation on a no-fault basis even where there is proper consent on the part of the research subject. In particular, for drug research, there is insufficient provision in the current patient guidelines of the Association of the British Pharmaceutical Industry, since they make "no legal commitment" to paying compensation for injury to patient subjects. There is a need for the provision of both adequate insurance and contractual arrangements for making payments. The solution is for Local Research Ethics Committees (LRECs) to make use of their power to withhold approval of medical research where compensation is not legally enforceable. PMID:9220333

Considerations for the use of human participants in vector biology research: a tool for investigators and regulators.

PubMed

Achee, Nicole L; Youngblood, Laura; Bangs, Michael J; Lavery, James V; James, Stephanie

2015-02-01

A thorough search of the existing literature has revealed that there are currently no published recommendations or guidelines for the interpretation of US regulations on the use of human participants in vector biology research (VBR). An informal survey of vector biologists has indicated that issues related to human participation in vector research have been largely debated by academic, national, and local Institutional Review Boards (IRBs) in the countries where the research is being conducted, and that interpretations and subsequent requirements made by these IRBs have varied widely. This document is intended to provide investigators and corresponding scientific and ethical review committee members an introduction to VBR methods involving human participation and the legal and ethical framework in which such studies are conducted with a focus on US Federal Regulations. It is also intended to provide a common perspective for guiding researchers, IRB members, and other interested parties (i.e., public health officials conducting routine entomological surveillance) in the interpretation of human subjects regulations pertaining to VBR.

Blurred Lines: Ethical Implications of Social Media for Behavior Analysts.

PubMed

O'Leary, Patrick N; Miller, Megan M; Olive, Melissa L; Kelly, Amanda N

2017-03-01

Social networking has a long list of advantages: it enables access to a large group of people that would otherwise not be geographically convenient or possible to connect with; it reaches several different generations, particularly younger ones, which are not typically involved in discussion of current events; and these sites allow a cost effective, immediate, and interactive way to engage with others. With the vast number of individuals who use social media sites as a way to connect with others, it may not be possible to completely abstain from discussions and interactions on social media that pertain to our professional practice. This is all the more reason that behavior analysts attend to the contingencies specific to these tools. This paper discusses potential ethical situations that may arise and offers a review of the Behavior Analysis Certification Board (BACB) guidelines pertaining to social networking, as well as provides suggestions for avoiding or resolving potential violations relating to online social behavior.

Ethical issues in neurogenetics.

PubMed

Uhlmann, Wendy R; Roberts, J Scott

2018-01-01

Many neurogenetic conditions are inherited and therefore diagnosis of a patient will have implications for the patient's relatives and can raise ethical issues. Predictive genetic testing offers asymptomatic relatives the opportunity to determine their risk status for a neurogenetic condition, and professional guidelines emphasize patients' autonomy and informed, voluntary decision making. Beneficence and nonmaleficence both need to be considered when making decisions about disclosure and nondisclosure of genetic information and test results. There can be disclosure concerns and challenges in determining whose autonomy to prioritize when a patient makes a genetic testing decision that can reveal the genetic status of a relative (e.g., testing an adult child when the at-risk parent has not been tested). Ethical issues are prominent when genetic testing for neurogenetic conditions is requested prenatally, on minors, adoptees, adult children at 25% risk, and for individuals with psychiatric issues or cognitive impairment. Neurogenetic conditions can result in cognitive decline which can affect decisional capacity and lead to ethical challenges with decision making, informed consent, and determining the patient's ability to comprehend test results. The ethical implications of genetic testing and emerging issues, including direct-to-consumer genetic testing, disclosure of secondary findings from genomic sequencing, and use of apolipoprotein E testing in clinical and research settings, are also discussed. Resources for information about genetic testing practice guidelines, insurance laws, and directories of genetics clinics are included. Copyright © 2018 Elsevier B.V. All rights reserved.

Ethical Issues in Neurogenetics

PubMed Central

Uhlmann, Wendy R.; Roberts, J. Scott

2018-01-01

Many neurogenetic conditions are inherited and therefore diagnosis of a patient will have implications for their relatives and can raise ethical issues. Predictive genetic testing offers asymptomatic relatives the opportunity to determine their risk status for a neurogenetic condition, and professional guidelines emphasize patients’ autonomy and informed, voluntary decision-making. Beneficence and non-maleficence both need to be considered when making decisions about disclosure and nondisclosure of genetic information and test results. There can be disclosure concerns and issues of determining whose autonomy to prioritize when a patient makes a genetic testing decision that can reveal the genetic status of a relative (e.g. testing an adult child when the at-risk parent has not been tested). Ethical issues are prominent when genetic testing for neurogenetic conditions is requested prenatally, on minors, adoptees, adult children at 25% risk, and for individuals with psychiatric issues or cognitive impairment. Neurogenetic conditions can result in cognitive decline which can affect decisional capacity and lead to ethical challenges with decision-making, informed consent and determining the patient’s ability to comprehend test results. The ethical implications of genetic testing and emerging issues, including direct-to-consumer genetic testing, disclosure of secondary findings from genomic sequencing, and use of APOE testing in clinical and research settings, are also discussed. Resources for information about genetic testing practice guidelines, insurance laws and directories of genetics clinics are included. PMID:29325614

A Qualitative Study of Paramedic Duty to Treat During Disaster Response.

PubMed

Smith, Erin; Burkle, Frederick; Gebbie, Kristine; Ford, David; Bensimon, Cécile

2018-04-10

Disasters place unprecedented demands on emergency medical services and can test paramedics personal commitment as health care professionals. Despite this challenge, guidelines and codes of ethics are largely silent on the issue, providing little to no guidance on what is expected of paramedics or how they ought to approach their duty to treat in the face of risk. The objective of this research is to explore how paramedics view their duty to treat during disasters. The authors employed qualitative methods to gather Australian paramedic perspectives. Our findings suggest that paramedic decisions around duty to treat will largely depend on individual perception of risk and competing obligations. A code of ethics for paramedics would be useful, but ultimately each paramedic will interpret these suggested guidelines based on individual values and the situational context. Coming to an understanding of the legal issues involved and the ethical-social expectations in advance of a disaster may assist paramedics to respond willingly and appropriately. (Disaster Med Public Health Preparedness. 2018;page 1 of 6).

HIV/AIDS research conducted in the developing world and sponsored by the developed world: reporting of research ethics committee review in two countries.

PubMed

Chin, Lisa Judy; Rifai-Bashjawish, Hoda; Kleinert, Kelly; Saltman, Alexandra; Leu, Cheng-Shiun; Klitzman, Robert

2011-09-01

We explored how often journal articles reporting HIV research sponsored by a developed country, but conducted in a developing country, mention research ethics committee (REC) approval from both countries, and what factors are involved. Of all such 2007 articles on Medline conducted in one of four developing countries (N = 154), only 52% mentioned such dual approval. Mention of dual vs. single approval was more likely among articles with ≥ 50% sponsor country authors, and the United States as the sponsor country. Also, dual approval was more likely among articles that mentioned informed consent and funding, had ≥ 50% sponsor country authors, were biomedical (vs. psychosocial), and appeared in journals adopting International Committee Medical Journal Editors (ICMJE) guidelines. Dual approval was thus obtained in only half of the articles and was associated with ethical and logistic issues, indicating the need for clearer and more universally accepted guidelines.

Ethical guidelines for use of electronic mail between patients and physicians.

PubMed

Bovi, Amy M

2003-01-01

This report examines the ethical implications of electronic communication, focusing on the use of electronic mail (e-mail), considers its impact on a previously established patient-physician relationship, and the limitations in using e-mail to create a new patient-physician relationship. In its recommendations, this report offers guidance to physicians who use electronic mail to communicate with patients and online users. These guidelines maintain that e-mail should not be used to establish a patient-physician relationship, but rather to supplement personal encounters. When using e-mail, physicians hold the same ethical responsibilities to their patients as they do during other encounters and that information must be presented in a manner that meets professional standards. The report requires that physicians notify patients of e-mail's inherent limitations and that patients be given the opportunity to accept these limitations prior to the communication of privileged information. Finally, physicians should be aware of privacy and confidentiality concerns when using e-mail to communicate with patients.

Wishing away Plagiarism in Scientific Publications! Will it work? A situational analysis of Plagiarism policy of journals in PubMed.

PubMed

Debnath, Jyotindu; Cariappa, M P

2018-04-01

Plagiarism remains a scourge for the modern academia. There are inconsistencies in the plagiarism policy scientific journals. The aims of this study was to analyze types of published articles on 'Plagiarism' available on PubMed over last two decades against a backdrop of the plagiarism policy of the journals publishing such articles. A literature search on PubMed (https://www.ncbi.nlm.nih.gov/pubmed) was made using the search term "plagiarism" from 01 January 1997 till 29 March 17. All publications having 'plagiarism' in the title formed the study group. The following were noted: types of articles published, ethical and plagiarism policy of the journal as available in the Instructions to authors and or in the journal home page. A total of 582 publications from 320 journals were studied. Editorials (165, 28.3%) and Letters to the Editor (159, 27.3%) formed the bulk. Research articles (56, 9.6%), Review articles (51, 8.7%) and Commentaries (47, 8%) formed the remainder. Detailed ethical guidelines were present in 221 (69%). Outline ethical guidelines only were present in 15 (4.7%) journals. 49 (15.3%) journals did not have any ethical guidelines. Detailed description of the policy on plagiarism was found in 80 (25%) journals. Only an outline description was found in 29 (9%) journals while a plagiarism policy/statement was totally absent in 176 (55%) journals. There is a need to have a well defined plagiarism policy/statement for all scholarly journals easily visible on their home pages on the internet and also in their Instructions to Authors.

A consideration of the ethics of brain death--what are the ethical guidelines for physician, family and society in dealing with brain death?

PubMed

Brooks, C M

1985-06-01

There is at present considerable confusion with respect to ethical guidelines that should govern the behavior of society and the physician confronted by problems resulting from recent attainments of medicine and science. The use of life supporting devices raises the problem of determining when death has occurred and what is proper ethical procedure in dealing with the deficient half life caused by "Brain Death." Some guidance is obtained from a consideration of the nature of life, the nature of death, the nature of man, and the essence lost in death of man. A parallel consideration of the nature of ethics, the bases of ethics and of ethical decision can be helpful. An individual may have ideals which control behavior, even elevate ethical standards; others entertain concepts that destroy social ethics. Ethics control and direct social interactions; ethics determine the quality of social behavior--ethics are established by societies not by individuals. Numerous commissions have endeavored to define the requirements of physicians for diagnosing brain death and for appropriate subsequent actions. The rationales presented, however, are not invariably accepted by lay society. The problem is created by numerous trends. Among them are the "rightest" movement which, though possessing many virtues, has its excesses such as expressed in the "right to life movement." These have not been beneficial and have necessitated "right to death movements." Opposition is also due to the fact that society's concepts of the medical profession have changed. The practice of organ transplantation has created problems. Finally, the concept of death as other than evil is no longer generally accepted. As more biological manipulations are possible ever more difficult ethical problems will arise. It is a certainty, however, that when brain death has occurred life of man and that of the individual has ended. Although others might not agree, our ethic requires us to use life assist techniques to preserve the vegetative man, the individual who can still breathe spontaneously though lacking consciousness and behavioral ability. All the codes of medical ethics state that a physician shall not kill--this does not mean he cannot permit the terminal phases of death when the essence of human life is lost. A major question is the ethical responsibility of one society toward another. Can an affluent society squander its resources in the preservation of ineffectual life in the body after "brain death" when others are without the medical assistance which would permit total living?

Professional Ethics for Digital Age Psychiatry: Boundaries, Privacy, and Communication.

PubMed

Sabin, James E; Harland, Jonathan Clark

2017-09-01

Internet and social media use continue to expand rapidly. Many patients and psychiatrists are bringing digital technologies into the treatment process, but relatively little attention has been paid to the ethical challenges in doing this. This review presents ethical guidelines for psychiatry in the digital age. Surveys demonstrate that patients are eager to make digital technologies part of their treatment. Substantial numbers search for professional and personal information about their therapists. Attitudes among psychiatrists about using digital technologies with patients range from dread to enthusiastic adoption. Digital technologies create four major ethical challenges for psychiatry: managing clinical boundaries; maintaining privacy and confidentiality; establishing realistic expectations regarding digital communications; and upholding professional ideals. Traditional ethical expectations are valid for the evolving digital arena, but guidance must be adapted for actual application in practice.

Ethics and methods for biological rhythm research on animals and human beings.

PubMed

Portaluppi, Francesco; Smolensky, Michael H; Touitou, Yvan

2010-10-01

This article updates the ethical standards and methods for the conduct of high-quality animal and human biological rhythm research, which should be especially useful for new investigators of the rhythms of life. The editors of Chronobiology International adhere to and endorse the Code of Conduct and Best Practice Guidelines of the Committee On Publication Ethics (COPE), which encourages communication of such updates at regular intervals in the journal. The journal accepts papers representing original work, no part of which was previously submitted for publication elsewhere, except as brief abstracts, as well as in-depth reviews. The majority of research papers published in Chronobiology International entails animal and human investigations. The editors and readers of the journal expect authors of submitted manuscripts to have made an important contribution to the research of biological rhythms and related phenomena using ethical methods/procedures and unbiased, accurate, and honest reporting of findings. Authors of scientific papers are required to declare all potential conflicts of interest. The journal and its editors endorse compliance of investigators to the Guide for the Care and Use of Laboratory Animals of the Institute for Laboratory Animal Research of the National Research Council, relating to the conduct of ethical research on laboratory and other animals, and the principles of the Declaration of Helsinki of the World Medical Association, relating to the conduct of ethical research on human beings. The peer review of manuscripts by Chronobiology International thus includes judgment as to whether or not the protocols and methods conform to ethical standards. Authors are expected to show mastery of the basic methods and procedures of biological rhythm research and proper statistical assessment of data, including the appropriate application of time series data analyses, as briefly reviewed in this article. The journal editors strive to consistently achieve high standards for the research of original and review papers reported in Chronobiology International, and current examples of expectations are presented herein.

Ethical problems in an era where disasters have become a part of daily life: A qualitative study of healthcare workers in Turkey.

PubMed

Civaner, M Murat; Vatansever, Kevser; Pala, Kayihan

2017-01-01

Natural disasters, armed conflict, migration, and epidemics today occur more frequently, causing more death, displacement of people and economic loss. Their burden on health systems and healthcare workers (HCWs) is getting heavier accordingly. The ethical problems that arise in disaster settings may be different than the ones in daily practice, and can cause preventable harm or the violation of basic human rights. Understanding the types and the determinants of ethical challenges is crucial in order to find the most benevolent action while respecting the dignity of those affected people. Considering the limited scope of studies on ethical challenges within disaster settings, we set upon conducting a qualitative study among local HCWs. Our study was conducted in six cities of Turkey, a country where disasters are frequent, including armed conflict, terrorist attacks and a massive influx of refugees. In-depth interviews were carried out with a total of 31 HCWs working with various backgrounds and experience. Data analysis was done concurrently with ongoing interviews. Several fundamental elements currently hinder ethics in relief work. Attitudes of public authorities, politicians and relief organizations, the mismanagement of impromptu humanitarian action and relief and the media's mindset create ethical problems on the macro-level such as discrimination, unjust resource allocation and violation of personal rights, and can also directly cause or facilitate the emergence of problems on the micro-level. An important component which prevents humanitarian action towards victims is insufficient competence. The duty to care during epidemics and armed conflicts becomes controversial. Many participants defend a paternalistic approach related to autonomy. Confidentiality and privacy are either neglected or cannot be secured. Intervention in factors on the macro-level could have a significant effect in problem prevention. Improving guidelines and professional codes as well as educating HCWs are also areas for improvement. Also, ethical questions exposed within this study should be deliberated and actualized with universal consensus in order to guide HCWs and increase humane attitudes.

More Than Meets the Eye

ERIC Educational Resources Information Center

Parrish, Fred

1975-01-01

Concludes that the manipulation of photojournalism situations poses a problem for professional and student photographers, and suggests an ethical basis for developing guidelines for photojournalists. (RB)

Understanding bureaucracy in health science ethics: toward a better institutional review board.

PubMed

Bozeman, Barry; Slade, Catherine; Hirsch, Paul

2009-09-01

Research involving human participants continues to grow dramatically, fueled by advances in medical technology, globalization of research, and financial and professional incentives. This creates increasing opportunities for ethical errors with devastating effects. The typical professional and policy response to calamities involving human participants in research is to layer on more ethical guidelines or strictures. We used a recent case-the Johns Hopkins University/Kennedy Kreiger Institute Lead Paint Study-to examine lessons learned since the Tuskegee Syphilis Study about the role of institutionalized science ethics in the protection of human participants in research. We address the role of the institutional review board as the focal point for policy attention.

Understanding Bureaucracy in Health Science Ethics: Toward a Better Institutional Review Board

PubMed Central

Bozeman, Barry; Hirsch, Paul

2009-01-01

Research involving human participants continues to grow dramatically, fueled by advances in medical technology, globalization of research, and financial and professional incentives. This creates increasing opportunities for ethical errors with devastating effects. The typical professional and policy response to calamities involving human participants in research is to layer on more ethical guidelines or strictures. We used a recent case—the Johns Hopkins University/Kennedy Kreiger Institute Lead Paint Study—to examine lessons learned since the Tuskegee Syphilis Study about the role of institutionalized science ethics in the protection of human participants in research. We address the role of the institutional review board as the focal point for policy attention. PMID:19608947

Taking Ownership of the ITC's Guidelines for Computer-Based and Internet-Delivered Testing: A South African Application

ERIC Educational Resources Information Center

Foxcroft, Cheryl D.; Davies, Caroline

2006-01-01

The increased use of computer-based and Internet-delivered testing has raised a number of ethical and legal issues. The International Test Commission's (this issue) Guidelines for Computer-Based and Internet-Delivered Testing represent the most recent attempt to provide test users, publishers, and developers with guidance regarding the appropriate…

Implications of the ethical-legal framework for adolescent HIV vaccine trials--report of a consultative forum.

PubMed

Slack, Catherine; Strode, Ann; Grant, Catherine; Milford, Cecilia

2005-09-01

The ethical-legal framework in South Africa is in a period of transition, with a number of new developments changing the substantive principles and procedures for health research in the country. Some of the changing dynamics include both law reform and the review of ethical guidelines. This changing environment poses many complexities for researchers, research ethics committees and participating communities involved in planning, implementing and reviewing research with child participants, including HIV vaccine trials. This paper presents the major themes and outcomes of a consultative meeting convened by the HIV AIDS Vaccines Ethics Group in July 2004 for key stakeholder groups. At this forum participants discussed the complexities posed by a transitional and sometimes contradictory ethical-legal framework and how the framework could be improved to simultaneously promote critical research and the welfare of child participants.

[Current Practice of Pre- and Postnatal Screening and Future Developments for Evidence Based Guidelines].

PubMed

Hebebrand, J; Hamelmann, E; Hartmann, A; Holtmann, M; Jöckel, K-H; Kremer, U; Legenbauer, T; Lücke, T; Radkowski, K; Reinehr, T; Wand, K; Mühlig, Y; Föcker, M

2017-01-01

Objectives: In this selective review we provide an overview of the current pre- and postnatal screenings up to 18 years established in Germany to inform physicians of different medical fields (gynecologists, pediatricians, general practitioners, other medical specialists who treat children, adolescents or pregnant females). Current State: Research on screening for different types of cancer has frequently failed to show any benefit. Thus, there is a need to broaden the evidence basis related to medical screenings especially for children and adolescents. Outlook: Potential future developments of pre- and postnatal screenings are illustrated including their social impact. The lack of an early detection of mental health problems is pointed out. An interdisciplinary collaboration and research is required to accumulate evidence with regard to medical screenings and to consider health economic and ethical aspects. © Georg Thieme Verlag KG Stuttgart · New York.

Remote monitoring for active cardiovascular implantable electronic devices: a European survey.

PubMed

Halimi, Franck; Cantù, Francesco

2010-12-01

This survey sampled today's European practices in the use of remote monitoring (RM) for the follow-up of active cardiovascular implantable electronic devices. Eighty-five per cent of the responding centres are currently using RM. For the majority, RM is expected to increase importantly within 5 years, and it has already led to a new organization of care based on dedicated allied professionals and/or the creation of RM units. There are still major limitations for the development of RM, such as ethical and legal aspects, reimbursement issues, and the lack of specific national- and European-updated guidelines which need to be informed.

Ethics in practice: the state of the debate on promoting the social value of global health research in resource poor settings particularly Africa.

PubMed

Lairumbi, Geoffrey M; Michael, Parker; Fitzpatrick, Raymond; English, Michael C

2011-11-15

Promoting the social value of global health research undertaken in resource poor settings has become a key concern in global research ethics. The consideration for benefit sharing, which concerns the elucidation of what if anything, is owed to participants, their communities and host nations that take part in such research, and the obligations of researchers involved, is one of the main strategies used for promoting social value of research. In the last decade however, there has been intense debate within academic bioethics literature seeking to define the benefits, the beneficiaries, and the scope of obligations for providing these benefits. Although this debate may be indicative of willingness at the international level to engage with the responsibilities of researchers involved in global health research, it remains unclear which forms of benefits or beneficiaries should be considered. International and local research ethics guidelines are reviewed here to delineate the guidance they provide. We reviewed documents selected from the international compilation of research ethics guidelines by the Office for Human Research Protections under the US Department of Health and Human Services. Access to interventions being researched, the provision of unavailable health care, capacity building for individuals and institutions, support to health care systems and access to medical and public health interventions proven effective, are the commonly recommended forms of benefits. The beneficiaries are volunteers, disease or illness affected communities and the population in general. Interestingly however, there is a divide between "global opinion" and the views of particular countries within resource poor settings as made explicit by differences in emphasis regarding the potential benefits and the beneficiaries. Although in theory benefit sharing is widely accepted as one of the means for promoting the social value of international collaborative health research, there is less agreement amongst major guidelines on the specific responsibilities of researchers over what is ethical in promoting the social value of research. Lack of consensus might have practical implications for efforts aimed at enhancing the social value of global health research undertaken in resource poor settings. Further developments in global research ethics require more reflection, paying attention to the practical realities of implementing the ethical principles in real world context. © 2011 Lairumbi et al; licensee BioMed Central Ltd.

High-intensity interval training versus moderate-intensity steady-state training in UK cardiac rehabilitation programmes (HIIT or MISS UK): study protocol for a multicentre randomised controlled trial and economic evaluation

PubMed Central

McGregor, Gordon; Nichols, Simon; Hamborg, Thomas; Bryning, Lucy; Tudor-Edwards, Rhiannon; Markland, David; Mercer, Jenny; Birkett, Stefan; Ennis, Stuart; Powell, Richard; Begg, Brian; Haykowsky, Mark J; Banerjee, Prithwish; Ingle, Lee; Shave, Rob; Backx, Karianne

2016-01-01

Introduction Current international guidelines for cardiac rehabilitation (CR) advocate moderate-intensity exercise training (MISS, moderate-intensity steady state). This recommendation predates significant advances in medical therapy for coronary heart disease (CHD) and may not be the most appropriate strategy for the ‘modern’ patient with CHD. High-intensity interval training (HIIT) appears to be a safe and effective alternative, resulting in greater improvements in peak oxygen uptake (VO2 peak). To date, HIIT trials have predominantly been proof-of-concept studies in the laboratory setting and conducted outside the UK. The purpose of this multicentre randomised controlled trial is to compare the effects of HIIT and MISS training in patients with CHD attending UK CR programmes. Methods and analysis This pragmatic study will randomly allocate 510 patients with CHD to 8 weeks of twice weekly HIIT or MISS training at 3 centres in the UK. HIIT will consist of 10 high-intensity (85–90% peak power output (PPO)) and 10 low-intensity (20–25% PPO) intervals, each lasting 1 min. MISS training will follow usual care recommendations, adhering to currently accepted UK guidelines (ie, >20 min continuous exercise at 40–70% heart rate reserve). Outcome measures will be assessed at baseline, 8 weeks and 12 months. The primary outcome for the trial will be change in VO2 peak as determined by maximal cardiopulmonary exercise testing. Secondary measures will assess physiological, psychosocial and economic outcomes. Ethics and dissemination The study protocol V.1.0, dated 1 February 2016, was approved by the NHS Health Research Authority, East Midlands—Leicester South Research Ethics Committee (16/EM/0079). Recruitment will start in August 2016 and will be completed in June 2018. Results will be published in peer-reviewed journals, presented at national and international scientific meetings and are expected to inform future national guidelines for exercise training in UK CR. Trial registration number NCT02784873; pre-results. PMID:27852718

Code of Ethics in a Multicultural Company and its Legal Context

NASA Astrophysics Data System (ADS)

Odlerová, Eva; Ďurišová, Jaroslava; Šramel, Bystrík

2012-12-01

The entry of foreign investors and simultaneous expansion of different national cultures, religions, rules, moral and ethical standards is bringing up problems of cooperation and coexistence of different nationalities, ethnicities and cultures. Working in an international environment therefore requires adaptation to a variety of economic, political, legal, technical, social, cultural and historical conditions. One possible solution is to define a code of ethics, guidelines which find enough common moral principles, which can become the basis for the adoption of general ethical standards, while respecting national, cultural differences and practices. In this article, the authors pay attention not only to the analysis of the common ethical rules in a multicultural company, but also to the legal aspects of codes of ethics. Each code of ethics is a set of standards, which, like the legal norms, regulate the behaviour of individuals. These standards, however, must simultaneously meet certain statutory criteria that define the boundaries of regulation of employee’s behaviour.

Risk and supervised exercise: the example of anorexia to illustrate a new ethical issue in the traditional debates of medical ethics

PubMed Central

Giordano, S

2005-01-01

Sport and physical activity is an area that remains relatively unexplored by contemporary bioethics. It is, however, an area in which important ethical issues arise. This paper explores the case of the participation of people with anorexia nervosa in exercise. Exercise is one of the central features of anorexia. The presence of anorexics in exercise classes is becoming an increasingly sensitive issue for instructors and fitness professionals. The ethics of teaching exercise to anorexics has, however, seldom, if ever, been addressed. Codes of ethics and legislation do not offer guidelines pertinent to the case and it is left unclear whether anorexics should be allowed to participate in exercise classes. It is shown by this paper that there are strong ethical reasons to let anorexics participate in exercise classes. However, the paper also explains why, despite these apparently cogent ethical reasons, there is no moral obligation to allow a person with anorexia to take part in exercise/sports activities. PMID:15634747

A principled and cosmopolitan neuroethics: considerations for international relevance.

PubMed

Shook, John R; Giordano, James

2014-01-03

Neuroethics applies cognitive neuroscience for prescribing alterations to conceptions of self and society, and for prescriptively judging the ethical applications of neurotechnologies. Plentiful normative premises are available to ground such prescriptivity, however prescriptive neuroethics may remain fragmented by social conventions, cultural ideologies, and ethical theories. Herein we offer that an objectively principled neuroethics for international relevance requires a new meta-ethics: understanding how morality works, and how humans manage and improve morality, as objectively based on the brain and social sciences. This new meta-ethics will simultaneously equip neuroethics for evaluating and revising older cultural ideologies and ethical theories, and direct neuroethics towards scientifically valid views of encultured humans intelligently managing moralities. Bypassing absolutism, cultural essentialisms, and unrealistic ethical philosophies, neuroethics arrives at a small set of principles about proper human flourishing that are more culturally inclusive and cosmopolitan in spirit. This cosmopolitanism in turn suggests augmentations to traditional medical ethics in the form of four principled guidelines for international consideration: empowerment, non-obsolescence, self-creativity, and citizenship.

A principled and cosmopolitan neuroethics: considerations for international relevance

PubMed Central

2014-01-01

Neuroethics applies cognitive neuroscience for prescribing alterations to conceptions of self and society, and for prescriptively judging the ethical applications of neurotechnologies. Plentiful normative premises are available to ground such prescriptivity, however prescriptive neuroethics may remain fragmented by social conventions, cultural ideologies, and ethical theories. Herein we offer that an objectively principled neuroethics for international relevance requires a new meta-ethics: understanding how morality works, and how humans manage and improve morality, as objectively based on the brain and social sciences. This new meta-ethics will simultaneously equip neuroethics for evaluating and revising older cultural ideologies and ethical theories, and direct neuroethics towards scientifically valid views of encultured humans intelligently managing moralities. Bypassing absolutism, cultural essentialisms, and unrealistic ethical philosophies, neuroethics arrives at a small set of principles about proper human flourishing that are more culturally inclusive and cosmopolitan in spirit. This cosmopolitanism in turn suggests augmentations to traditional medical ethics in the form of four principled guidelines for international consideration: empowerment, non-obsolescence, self-creativity, and citizenship. PMID:24387102

Ethical considerations in industry-sponsored multiregional clinical trials.

PubMed

Ibia, Ekopimo; Binkowitz, Bruce; Saillot, Jean-Louis; Talerico, Steven; Koerner, Chin; Ferreira, Irene; Agarwal, Anupam; Metz, Craig; Maman, Marianne

2010-01-01

During the last several decades, the scientific and ethics communities have addressed important ethical issues in medical research, resulting in the elaboration and adoption of concepts, guidelines, and codes. Ethical issues in the conduct of Multiregional Clinical Trials have attracted significant attention mainly in the last two decades. With the globalization of clinical research and the rapid expansion to countries with a limited tradition of biomedical research, sponsors must proactively address local ethical issues, the adequacy of oversight as well as the applicability and validity of data, and scientific conclusions drawn from diverse patient populations. This paper highlights some core ethical principles and milestones in medical research, and, from an industry perspective, it discusses ethical issues that the clinical trial team may face when conducting Multiregional Clinical Trials (MRCT, clinical trials conducted at sites located across multiple geographic regions of the world). This paper further highlights the areas of consensus and controversies and proposes points to consider. Copyright © 2010 John Wiley & Sons, Ltd.

Ethics and clinical trials.

PubMed

Chassany, O; Duracinský, M

1999-01-01

The current reference guideline about ethics in clinical trials is the Declaration of Helsinki of human rights in medical research. Three major principles are emphasised: respect of the patient to accept or not to participate in a trial, the constraints and the presumed risks must be acceptable for patients included in a study, and vulnerable subjects should not participate in studies. The investigator is responsible for obtaining a free and well-informed consent from patients before their inclusion in a study. Where possible, a new drug should always first be compared to placebo in order to prove its superiority. Else, a small-sized trial comparing a new drug versus a reference treatment can lead to an erroneous conclusion of absence of difference. Moreover, good results or improvement are obtained in at least 30% of cases with placebo, whatever the disease. The use of placebo is unethical in life-threatening diseases and when an effective proved drug exists. The use of placebo is ethical in severe diseases with no efficient drug, in some severe diseases even when an active reference treatment is available, and in all moderate and functional diseases. In order to detect flawed studies, most journals now ask for any manuscript submitted and reporting results of a randomised clinical trial to join a checklist in order to verify the quality of the trial. Finally, it remains the responsibility of the doctor to decide whether or not a protocol is ethical, to participate or not and to include patients or not.

Legal and ethical implications in the evaluation and management of sports-related concussion.

PubMed

Kirschen, Matthew P; Tsou, Amy; Nelson, Sarah Bird; Russell, James A; Larriviere, Daniel

2014-07-22

To examine the ethical and legal issues physicians face when evaluating and managing athletes with sports-related concussions, and to offer guidance to physicians as they navigate these situations. This position paper reviews and compares the components of sports-related concussion laws, including education, removal from play, and clearance for return to play. It highlights the challenges privacy laws present relevant to providing care to concussed athletes and suggests ways to help physicians overcome these obstacles. The report also explores the ethical considerations physicians should bear in mind as they evaluate and manage concussed athletes, addressing them through a framework that includes considerations of professionalism, informed decision-making, patient autonomy, beneficence, nonmaleficence, conflicts of interest, and distributive justice. Physicians caring for concussed athletes have an ethical obligation to ensure that their primary responsibility is to safeguard the current and future physical and mental health of their patients. Physicians have a duty to provide athletes and their parents with information about concussion risk factors, symptoms, and the risks for postconcussion neurologic impairments. Physicians should facilitate informed and shared decision-making among athletes, parents, and medical teams while protecting athletes from potential harm. Additionally, including concussion evaluation and management training in neurology residency programs, as well as developing a national concussion registry, will benefit patients by the development of policies and clinical guidelines that optimize prevention and treatment of concussive head injury. © 2014 American Academy of Neurology.

Ethical dilemmas in community-based participatory research: recommendations for institutional review boards.

PubMed

Flicker, Sarah; Travers, Robb; Guta, Adrian; McDonald, Sean; Meagher, Aileen

2007-07-01

National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of "knowledge production" is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework more suitable for CBPR, and we propose alternative questions and procedures that may be utilized when assessing the ethical appropriateness of CBPR.

Ethical Dilemmas in Community-Based Participatory Research: Recommendations for Institutional Review Boards

PubMed Central

Travers, Robb; Guta, Adrian; McDonald, Sean; Meagher, Aileen

2007-01-01

National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of “knowledge production” is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework more suitable for CBPR, and we propose alternative questions and procedures that may be utilized when assessing the ethical appropriateness of CBPR. PMID:17436114

Ethical Guidelines for Structural Interventions to Small-Scale Historic Stone Masonry Buildings.

PubMed

Hurol, Yonca; Yüceer, Hülya; Başarır, Hacer

2015-12-01

Structural interventions to historic stone masonry buildings require that both structural and heritage values be considered simultaneously. The absence of one of these value systems in implementation can be regarded as an unethical professional action. The research objective of this article is to prepare a guideline for ensuring ethical structural interventions to small-scale stone historic masonry buildings in the conservation areas of Northern Cyprus. The methodology covers an analysis of internationally accepted conservation documents and national laws related to the conservation of historic buildings, an analysis of building codes, especially Turkish building codes, which have been used in Northern Cyprus, and an analysis of the structural interventions introduced to a significant historic building in a semi-intact state in the walled city of Famagusta. This guideline covers issues related to whether buildings are intact or ruined, the presence of earthquake risk, the types of structural decisions in an architectural conservation project, and the values to consider during the decision making phase.

Legal and ethical issues in the international transaction of donor sperm and eggs.

PubMed

Heng, Boon Chin

2007-04-01

Pertinent ethical and legal issues in the international transaction of donor sperm and eggs are discussed. Firstly, there may be legislative and ethical "contradiction" by the local health authority in permitting import of donor gametes, due to varying policies on donor reimbursement in different countries. This is particularly significant in countries where the underlying principle of gamete donation is altruistic motivation, and where reimbursement is given only for direct "out-of-pocket" expenses i.e. traveling costs. Secondly, there is a lack of clear and coherent internationally-binding legislation and regulatory guidelines overseeing the exchange of donor gametes across international borders. In particular, provisions should be made for donor traceability if gametes are sourced from abroad. Thirdly, in the case of "frozen-egg donation" from abroad, patients must rightfully be informed that current cryopreservation technology is still sub-optimal, and all studies have consistently shown that the chances of conception are always lower with "frozen-eggs" compared to freshly-retrieved eggs. Finally, regulatory safeguards should be put in place to prevent fertility clinics and medical professionals from "re-selling" imported donor gametes at a profit to the patient, since it would be thoroughly unprofessional for them to earn a profit simply through the 'brokerage' of donated human material.

[Research ethics committees: a necessary good].

PubMed

Riera, Alejandra V

2013-12-01

The Nuremberg Code, issued as the result of the deliberations of the Nuremberg Trials, which judged the atrocities carried out during Nazi Germany (1933-1945), was the first universal document that defined research ethics principles for human experimentation. This code served as the basis for the subsequent ethical codes and principles used today by the Research Ethics Committees. The Research Ethics Committee is a multidisciplinary body whose primary role is to protect the rights and welfare of research subjects through the review of research protocols, ensuring compliance with internationally and locally accepted ethical guidelines. Worldwide, there have been important improvements in order to promote and regulate bioethics in medical research. In Venezuela, several national organizations have been constituted with the aim of promoting the establishment of ethics committees; however, there has not been a significant progress in the quantity or quality of the functioning of Research Ethics Committees in the country. It is imperative for each research institution to establish and work to improve their ethics committee to ensure the quality of the clinical research conducted, making it adherent to ethical codes, and safeguarding the integrity and credibility of the investigators and the research institutions, and more importantly, the patient's rights.

Guidelines for stem cell science and clinical translation.

PubMed

Pandya, Sunil K

2016-01-01

The International Society for Stem Cell Research has released its updated guidelines for stem cell research in order to provide "assurance that stem cell research is conducted with scientific and ethical integrity and that new therapies are evidence-based." The guidelines were updated by a Guidelines Update Task Force consisting of twenty-five scientists, ethicists and experts in health care policy from nine countries. The chairpersons of this task force are Jonathan Kimmelman, George Daley and Insoo Hyun. There is no representative from India; the only person of Indian origin on it, Mahendra Rao, represents The New York Stem Cell Foundation.

The Social Work Ethics Audit: A Risk-Management Strategy.

ERIC Educational Resources Information Center

Reamer, Frederic G.

2000-01-01

Article integrates current knowledge on social work ethics and introduces the concept of a social work ethics audit to aid social workers in their efforts to identify pertinent ethical issues; review and assess the adequacy of their current ethics-related practices; modify their practices as needed; and monitor the implementation of these changes.…

Medical ethics in pediatric critical care.

PubMed

Orioles, Alberto; Morrison, Wynne E

2013-04-01

Ethically charged situations are common in pediatric critical care. Most situations can be managed with minimal controversy within the medical team or between the team and patients/families. Familiarity with institutional resources, such as hospital ethics committees, and national guidelines, such as publications from the American Academy of Pediatrics, American Medical Association, or Society of Critical Care Medicine, are an essential part of the toolkit of any intensivist. Open discussion with colleagues and within the multidisciplinary team can also ensure that when difficult situations arise, they are addressed in a proactive, evidence-based, and collegial manner. Copyright © 2013 Elsevier Inc. All rights reserved.

Ethical dilemmas in genetic testing: examples from the Cuban program for predictive diagnosis of hereditary ataxias.

PubMed

Mariño, Tania Cruz; Armiñán, Rubén Reynaldo; Cedeño, Humberto Jorge; Mesa, José Miguel Laffita; Zaldivar, Yanetza González; Rodríguez, Raúl Aguilera; Santos, Miguel Velázquez; Mederos, Luis Enrique Almaguer; Herrera, Milena Paneque; Pérez, Luis Velázquez

2011-06-01

Predictive testing protocols are intended to help patients affected with hereditary conditions understand their condition and make informed reproductive choices. However, predictive protocols may expose clinicians and patients to ethical dilemmas that interfere with genetic counseling and the decision making process. This paper describes ethical dilemmas in a series of five cases involving predictive testing for hereditary ataxias in Cuba. The examples herein present evidence of the deeply controversial situations faced by both individuals at risk and professionals in charge of these predictive studies, suggesting a need for expanded guidelines to address such complexities.

Conflict of Interersts in Scientific Study and Bioethics as Professionalism

PubMed Central

Lee, Kyung-Hee

2013-01-01

Science in the 21st century does not consider participants’ welfare, safety and human rights in clinical studies, but modern science puts economic profits in its priority. This leads to a growing concern about social responsibility and professionalism ethics of companies, sponsors and scientists. Specifically, there is no way to control conflicts of participants’ welfare with economic profits, leading to simply relying on individual ethics, social responsibilities and audit. This paper helps relevant agencies and people involved understand conflict of interest. Also this study presents the guidelines as well as independence, autonomy, ethical imagination and phronesis required for scientists. PMID:25949165

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

PubMed

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

2011-06-01

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

Board oversight of community benefit: an ethical imperative.

PubMed

Magill, Gerard; Prybil, Lawrence D

2011-03-01

Board oversight of community benefit responsibility in tax-exempt organizations in the nonprofit health care sector is attracting considerable attention. Scrutiny by the IRS and other official bodies has led to stricter measures of compliance with the community benefit standard. But stricter compliance does not sufficiently engage the underlying ethical imperative for boards to provide effective oversight--an imperative that recent research suggests has not been sufficiently honored. This analysis considers why there is a distinctively ethical imperative for board oversight, the organizational nature of the imperative involved, and practical ways to fulfill its obligations. We adopt an organizational ethics paradigm to illuminate the constituent components of the ethical imperative and to clarify emerging benchmarks as flexible guidelines. As these emerging benchmarks enhance board oversight of community benefit they also can shed light on what it means to be a virtuous organization.

Physicians’ Professionally Responsible Power: A Core Concept of Clinical Ethics

PubMed Central

McCullough, Laurence B.

2016-01-01

The gathering of power unto themselves by physicians, a process supported by evidence-based practice, clinical guidelines, licensure, organizational culture, and other social factors, makes the ethics of power—the legitimation of physicians’ power—a core concept of clinical ethics. In the absence of legitimation, the physician’s power over patients becomes problematic, even predatory. As has occurred in previous issues of the Journal, the papers in the 2016 clinical ethics issue bear on the professionally responsible deployment of power by physicians. This introduction explores themes of physicians’ power in papers from an international group of authors who address autonomy and trust, the virtues of perinatal hospice, conjoined twins in ethics and law, addiction and autonomy in clinical research on addicting substances, euthanasia of patients with dementia in Belgium, and a pragmatic approach to clinical futility. PMID:26671961

Unfinished business: ongoing ethical exceptionalism in the oversight of human pluripotent stem cell research in Canada.

PubMed

Baylis, Françoise; Downie, Jocelyn

2012-01-01

In this article, we critically examine the arguments for and against the exceptional status given human pluripotent stem cell research in Canada (through the latest [December 2010] revision of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans), and conclude that this exceptionalism is unwarranted and ethically unsound. In our view, the three federal research granting agencies should honor their longstanding commitment that researchers, research sponsors, and Research Ethics Boards in Canada have access to "a single reference document for all research involving humans conducted under the auspices of institutions eligible for Agency funding." As well, responsibility for the development, interpretation, and implementation of Canada's research ethics guidelines should be under the authority of a single oversight body that is independent of the federal research granting Agencies.