Islamic Perspectives on the Principles of Biomedical Ethics presents results from a pioneering seminar in 2013 between Muslim religious scholars, biomedical scientists, and Western bioethicists at the research Center for Islamic Legislation & Ethics, Qatar Faculty of Islamic Studies. By examining principle-based bioethics, the contributors to this volume addressed a number of key issues related to the future of the field. Discussion is based around the role of religion in bioethical reasoning, specifically from an Islamic perspective. (...) Also considered is a presentation of the concept of universal principles for bioethics, with a response looking at the possibility (or not) of involving religion. Finally, there is in-depth analysis of how far specific disciplines within the Islamic tradition -- such as the higher objectives of Sharia (maqāṣid al-Sharī'ah) and legal maxims (qawā'id fiqhīyah) -- can enrich principle-based bioethics. (shrink)

Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international (...) collaborative trials of drugs in developing countries, especially expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research. Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research. (shrink)

As the recent inaugural Ethical, Legal, and Social Issues 2.0 conference made clear, the effects of information communication technology are pervasive in biomedical research. Data initiatives are arising in all corners of biomedicine. Data sharing efforts already promised to surpass even the ambitious goals of the National Human Genome Research Institute, only 5 years after publication of its 10-year vision. ELSI research was established, in part, to address challenges of open data access and data sharing. However, (...) by and large, ELSI research projects address particular concerns of a given population, jurisdiction, type of research practice or type of data. This does not necessarily facilitate coherent data policy for sustainable data stewardship. Forward-looking, data friendly strategies need to be considered. Orchestration strategies are needed which overcome barriers to collective action. Here we present challenges policymakers face, and suggest three basics steps towards meeting them. First, policymakers must recognise the systematic change that occurs when ICT enables dataflow itself to become an organising principle of biomedical research. Second, methods for identifying and gathering types of metadata suitable for ELSI research ought to be developed and regulated. Third, policymakers need to organise in ways that mirror the new vision for data-enabled research that data technologies are making possible, as ELSI 2.0 encourages researchers to do. Taking these steps will help ensure research evolves in ways that warrants trust of the public while still supporting widespread ethical access to necessary data, research subjects, samples and findings. (shrink)

Background Cardiopulmonary resuscitation and subsequent care are subject to various ethical and legal issues. Few studies have addressed ethical and legal issues in post-resuscitation care. Objective To explore nurses’ experiences of ethical and legal issues in post-resuscitation care. Research design This qualitative study adopted an exploratory descriptive qualitative design using conventional content analysis. Participants and research context In-depth, semi-structured interviews were conducted in three educational hospital centers in northwestern Iran. Using purposive (...) sampling, 17 nurses participated. Data were analyzed by conventional content analysis. Ethical considerations The study was approved by Research Ethics Committees at Tabriz University of Medical Sciences. Participation was voluntary and written informed consent was obtained. For each interview, the ethical principles including data confidentiality and social distance were respected. Findings Five main categories emerged: Pressure to provide unprincipled care, unprofessional interactions, ignoring the patient, falsifying documents, and specific ethical challenges. Pressures in the post-resuscitation period can cause nurses to provide care that is not consistent with guidelines, and to avoid communicating with physicians, patients and their families. Patients can also be labeled negatively, with early judgments made about their condition. Medical records can be written in a way to indicate that all necessary care has been provided. Disclosure, withdrawing, and withholding of therapy were also specific important ethical challenges in the field of post-resuscitation care. Conclusion There are many ethical and legal issues in post-resuscitation care. Developing evidence-based guidelines and training staff to provide ethical care can help to reduce these challenges. (shrink)

This book provides an analysis of the debate surrounding cultural diversity, and attempts to reconcile the seemingly opposing views of "ethical imperialism," the belief that each individual is entitled to fundamental human rights, and cultural relativism, the belief that ethics must be relative to particular cultures and societies. The author examines the role of cultural tradition, often used as a defense against critical ethical judgments. Key issues in health and medicine are explored in the context of cultural (...) diversity: the physician-patient relationship, disclosing a diagnosis of a fatal illness, informed consent, brain death and organ transplantation, rituals surrounding birth and death, female genital mutilation, sex selection of offspring, fertility regulation, and biomedical research involving human subjects. Among the conclusions the author reaches are that ethical universals exist, but must not be confused with ethical absolutes. The existence of ethical universals is compatible with a variety of culturally relative interpretations, and some rights related to medicine and health care should be considered human rights. Illustrative examples are drawn from the author's experiences serving on international ethical review committees and her travels to countries in Africa, Asia, and Latin America, where she conducted educational workshops and carried out out her own research. (shrink)

The Ethics and Regulation of Research with Human Subjects, edited by Professors Carl Coleman of Seton Hall, Jerry Menikoff of the University of Kansas, Jesse Goldner of Saint Louis University, and Nancy Dubler of the Albert Einstein College of Medicine, is an up-to-date and authoritative collection of readings on ethical, legal, and policy issues in research with human subjects. The authors have modeled their text on the casebook style commonly used in law schools. At 746 pages, plus (...) front matter and an appendix, this book contains just about everything one needs to know for a thorough grasp on human subjects research, including federal and state regulations governing this research, interpretive guidance from federal agencies, international guidelines and codes, court decisions, historical documents and case studies, and selected readings from scholarly articles and books. The book includes written comments and questions to help students understand and interpret the readings. (shrink)

Autonomy is a vital principle in medical law and ethics. It occupies a prominent place in all medico-legal and ethical debate. But there is a dangerous presumption that it should have the only vote, or at least the casting vote. This book is an assault on that presumption, and an audit of autonomy's extraordinary status. This book surveys the main issues in medical law, noting in relation to each issue the power wielded by autonomy, (...) asking whether that power can be justified, and suggesting how other principles can and should contribute to the law. It concludes that autonomy's status cannot be intellectually or ethically justified, and that positive discrimination in favour of the other balancing principles is urgently needed in order to avoid some sinister results. 'This book is a sustained attack on the hegemony of the idea of autonomy in medical ethics and law. Charles Foster is no respecter of authority, whether of university professors or of law Lords. He grabs his readers by their lapels and shakes sense into them through a combination of no-nonsense rhetoric and subtle argument that is difficult to resist.' Tony Hope, Professor of Medical Ethics, Oxford University 'This book is unlikely to be in pristine state by the time you have finished reading it. Whether that is because you have thrown it in the air in celebration or thrown it across the room in frustration will depend on your perspective. But this book cannot leave you cold. It is a powerful polemic on the dominance of autonomy in medical law, which demands a reaction. Charles Foster sets out a powerful case that academic medical lawyers have elevated autonomy to a status it does not deserve in either ethical or legal terms. In a highly engaging, accessible account, he challenges many of the views which have become orthodox within the academic community. This will be a book which demands and will attract considerable debate.' Jonathan Herring, Exeter College, Oxford University 'This is a learned, lively and thought-provoking discussion of problems central to the courts' approach to ethical issues in medical law. What principles are involved? More significantly, which really underlie and inform the process of seeking justice in difficult cases? Charles Foster persuasively argues, and demonstrates, that respect for autonomy is but one of a number of ethical principles which interact and may conflict. He also addresses the sensitive issue of the extent to which thoughts and factors which go to influence legal decisions may not appear in the judgments.' Adrian Whitfield QC. 'Introducing the Jake La Motta of medical ethics. Foster is an academic street-fighter who has bloodied his hands in the court room. He provides a stinging, relentless, ground attack on the Goliath of medical ethics: the central place of autonomy in liberal medical ethics. This is now the first port of call for those who feel that medical ethics has become autonomized.' Julian Savulescu, Uehiro Chair in Practical Ethics, University of Oxford. "This important book offers a robust challenge to anyone, whether lawyer or 'ethicist', who sees respect for autonomy as the only game in town. It argues eloquently and effectively that, on the one hand, despite the reverence paid to it by judges, in practice the law, even in the context of consent, weaves together a number of moral threads of which autonomy is merely one, in the pursuit of a good decision. It argues on the other hand, that were the day-to-day practice of law to be guided primarily by respect for autonomy, this would be wrong. Foster concludes that whilst, 'any society that does not have laws robustly protecting autonomy is an unsafe and unhappy one', so too would be a society in which too much emphasis was placed on respect for autonomy at the expense of other important moral principles. This is essential reading for anyone interested in the role of autonomy and indeed of medical ethics, in the law." Michael Parker, Professor of Bioethics, University of Oxford. (shrink)

One of the core problems of scientific research authorship is honorary authorship. It violates the ethical principle of clear and appropriate assignment of scientific research contributions. The prevalence of honorary authorship worldwide is alarmingly high across various research disciplines. As a result, many academic institutions and publishers were trying to explore ways to overcome this unethical research practice. The International Committee of Medical Journal Editors (ICMJE) recommended criteria for authorship as guidance for researchers submitting manuscripts to biomedical (...) Journals. However, despite the ICMJE guidelines, honorary authorship is still significantly present across various health research disciplines. The aim of this study was to explore the perceptions and knowledge of health care researchers towards honorary authorship according to the ICMJE guidelines across different health care fields in Jordan, which to our knowledge was never explored before. Data from an electronic survey that was distributed among researchers working in different healthcare fields across several major universities in Jordan, revealed that most of the respondents were assistant professors working mainly in the schools of Medicine and Pharmacy. The majority of the respondents (65.5%) were not aware of the ICMJE authorship guidelines. And, around 37% reported the inclusion of an honorary author, in which the most common non-authorship task reported by 73% of the respondents was reviewing the manuscript. Our findings emphasize the need for national academic and research institutions to address the issue of authorship in their educational programs and internal policies. (shrink)

Despite the prominence of healthcare-relatedconcerns in public debate, the ground remainsinfertile for the idea of conscripting citizensinto medical research. Reluctance to entertainthe thought of a system where nearly everyonecould be selected for service might reflectuncertainty about what the project wouldinvolve. There might also be a fear that themore crucial issue is how to protect researchsubjects within current, voluntary systems. Nodoubt reluctance to explore a system ofuniversal service results from the common hopethat each of us might avoid research in anycapacity (...) besides researcher. A system of fullcivic participation might, however, avoid manyof the usual objections. Ethics regulations,including informed-consent guidelines, couldfor the most part remain in force. Though thesystem would compel people to serve, it couldremain responsive to principles of autonomy andjustice if it centered on broad publiceducation, community representation, and alottery-type selection process. The systemcould draw from the largest possiblecross-section of society, and offer conscriptsthe widest possible range of service. In thisway, a compulsory system might reconcile theexpectations about healthcare with researchneeds. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause (...) the research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

BackgroundThis study presents an empirical investigation of the ethical reasoning and ethical issues at stake in the daily work of physicians and molecular biologists in Denmark. The aim of this study was to test empirically whether there is a difference in ethical considerations and principles between Danish physicians and Danish molecular biologists, and whether the bioethical principles of the American bioethicists Tom L. Beauchamp and James F. Childress are applicable to these groups.MethodThis study is (...) based on 12 semi-structured interviews with three groups of respondents: a group of oncology physicians working in a clinic at a public hospital and two groups of molecular biologists conducting basic research, one group employed at a public university and the other in a private biopharmaceutical company.ResultsIn this sample, the authors found that oncology physicians and molecular biologists employed in a private biopharmaceutical company have the specific principle of beneficence in mind in their daily work. Both groups are motivated to help sick patients. According to the study, molecular biologists explicitly consider nonmaleficence in relation to the environment, the researchers' own health, and animal models; and only implicitly in relation to patients or human subjects. In contrast, considerations of nonmaleficence by oncology physicians relate to patients or human subjects. Physicians and molecular biologists both consider the principle of respect for autonomy as a negative obligation in the sense that informed consent of patients should be respected. However, in contrast to molecular biologists, physicians experience the principle of respect for autonomy as a positive obligation as the physician, in dialogue with the patient, offers a medical prognosis based upon the patients wishes and ideas, mutual understanding, and respect. Finally, this study discloses utilitarian characteristics in the overall conception of justice as conceived by oncology physicians and molecular biologists from the private biopharmaceutical company. Molecular biologists employed at a public university are, in this study, concerned with allocation, however, they do not propose a specific theory of justice.ConclusionThis study demonstrates that each of the four bioethical principles of the American bioethicists Tom L. Beauchamp & James F. Childress – respect for autonomy, beneficence, nonmaleficence and justice – are reflected in the daily work of physicians and molecular biologists in Denmark. Consequently, these principles are applicable in the Danish biomedical setting. (shrink)

BackgroundStreet-connected children and youth in low- and middle-income countries have multiple vulnerabilities in relation to participation in research. These require additional considerations that are responsive to their needs and the social, cultural, and economic context, while upholding core ethical principles of respect for persons, beneficence, and justice. The objective of this paper is to describe processes and outcomes of adapting ethical guidelines for SCCY’s specific vulnerabilities in LMIC.MethodsAs part of three interrelated research projects in western Kenya, (...) we created procedures to address SCCY’s vulnerabilities related to research participation within the local context. These consisted of identifying ethical considerations and solutions in relation to community engagement, equitable recruitment, informed consent, vulnerability to coercion, and responsibility to report.ResultsSubstantial community engagement provided input on SCCY’s participation in research, recruitment, and consent processes. We designed an assent process to support SCCY to make an informed decision regarding their participation in the research that respected their autonomy and their right to dissent, while safeguarding them in situations where their capacity to make an informed decision was diminished. To address issues related to coercion and access to care, we worked to reduce the unequal power dynamic through street outreach, and provided access to care regardless of research participation.ConclusionsAlthough a vulnerable population, the specific vulnerabilities of SCCY can to some extent be managed using innovative procedures. Engaging SCCY in ethical research is a matter of justice and will assist in reducing inequities and advancing their health and human dignity. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests (...) for the sake of society and science. This is the principle of precedence of individual. But there is a problem with how to interpret the principle of precedence of individual in the context of research without prospect of future benefit involving children. There are proposals trying to reconcile non-beneficial research involving children with the concept of the best interests. We assert that this reconciliation is flawed and propose an interpretation of the principle of precedence of individual as follows: not all, but only the most important interests of participants, must be guaranteed; this principle should be interpreted as the secure participant standard. In consequence, the issue of permissible risk ceiling becomes ethically crucial in research with incompetent subjects. (shrink)

Stay up-to-date on the ethical and legal issues that affect your clinical and professional decisions! Ethical and Legal Issues for Mental Health Professionals: A Comprehensive Handbook of Principles and Standards details the ethical and legal issues that involve mental health professionals. Respected authorities with diverse backgrounds, expertise, and professional experience discuss contemporary theories emphasizing professional ethics, the ramifications of professional actions and decisions, and ethical standards on teaching, training, research, (...) and publication. This informative handbook provides invaluable up-to-date information and guidelines vital for every mental health professional. This book is a thorough examination of ethical behavior which can be used as a reference source for the professional or a textbook for graduate students. The handbook itself is divided into five sections. The first section is a detailed introduction of ethics, law, and licensing. The second section presents general ethical principles like competence, integrity, and respect for individual rights and dignity. The third section examines confidentiality, privilege, consent, and protection. The fourth section focuses on general ethical standards in practice, including sexual contact, multiple relationships, and bartering. The fifth section presents the ethical principles and standards in teaching, training, and research. Appendices include the Ethical Principles of Psychologists and Code of Conduct (American Psychological Association, 2002) and the Code of Ethics of the National Association of Social Workers (National Association of Social Workers, 1999). Ethical and Legal Issues for Mental Health Professionals: A Comprehensive Handbook of Principles and Standards discusses: the history of basic approaches and issues in ethical philosophy five fundamental areas in the process of developing competence the necessary ingredients for the mental health professional's practice of integrity aspirational versus enforceable standards of ethics concern for the welfare of others as a core ethical principle the notion of social responsibility in the ethics codes of psychologists and social workers ethical principles, statutes, and case law protecting privacy and confidentiality issues involving the therapist-patient privilege the "duty to protect" doctrine and relevant legal issues the dynamics of multiple relationships and boundary violations sexualized dual relationships between psychologists and patients possible conflict of interest in bartering for services the requirements and implementation of maintaining patient records to avoid ethical and legal problems possible ethical dilemmas involving referrals and fees much, much more This Handbook is an essential resource for all mental health professionals, including psychologists, psychiatrists, social workers, counselors, therapists, and graduate students in mental health and the related fields. Ethical and Legal Issues for Mental Health Professionals: A Comprehensive Handbook of Principles and Standards is the first of three volumes under this title. The following volumes will focus on forensic settings and special populations/special treatment modalities. (shrink)

ABSTRACT This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze – as an example – the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, (...) either in the US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non‐uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries. (shrink)

BackgroundThe concept of benefit sharing to enhance the social value of global health research in resource poor settings is now a key strategy for addressing moral issues of relevance to individuals, communities and host countries in resource poor settings when they participate in international collaborative health research.The influence of benefit sharing framework on the conduct of collaborative health research is for instance evidenced by the number of publications and research ethics guidelines that require prior engagement between stakeholders to (...) determine the social value of research to the host communities. While such efforts as the production of international guidance on how to promote the social value of research through such strategies as benefit sharing have been made, the extent to which these ideas and guidelines have been absorbed by those engaged in global health research especially in resource poor settings remains unclear. We examine this awareness among stakeholders involved in health related research in Kenya.MethodsWe conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups.ResultsOur study suggests that although people have a sense of justice and the moral aspects of research, this was not articulated in terms used in the literature and the guidelines on the ethics of global health research.ConclusionThis study demonstrates that while in theory several efforts can be made to address the moral issues of concern to research participants and their communities in resource poor settings, quick fixes such as benefit sharing are not going to be straightforward. We suggest a need to pay closer attention to the processes through which ethical principles are enacted in practice and distil lessons on how best to involve individuals and communities in promoting ethical conduct of global health research in resource poor settings. (shrink)

Conducting marine mammal research can raise several important ethical issues. For example, the continuation of whaling for commercial purposes despite the international moratorium provides opportunities for scientists to obtain data and tissue samples. In 2021 we analysed 35 peer-reviewed papers reporting research based on collaborations with Icelandic whalers. Results highlighted little consideration or understanding of the legal and ethical issues associated with the deliberate killing of whales amongst those researchers, funding bodies, universities and journals involved. (...) Ethical statements were rarely provided. Those that were written were incomplete. Whilst research using whaling data may seem acceptable to some, it often becomes hard to justify when subject to scrutiny by the media and the public. Thus, there is a particular danger of reputational harm for early career researchers who may become unwittingly involved in such activities. Here we also consider the broader variety of ethical issues raised by non-lethal research (both historical and recent) on marine mammals including tagging and biopsy. We discuss instances where study animals were harmed or even killed and where the public mistook tags for harpoons. Without clear guidelines, reviewers and journal editors are put in an impossible position when considering whether to reject papers on ethical grounds. We propose that for such studies, universities, funders, journals, and permit issuers must require ethical assessments and that journals more effectively implement their existing policies on publishing ethical statements. The professional marine mammal societies need to work together to produce modern ethical guidance. Such guidance should require transparency in the provenance of data and samples while including advice on law, welfare issues, involvement of local scientists, and offshoring. Furthermore, it should require appraisal of and justification for the absolute necessity of invasive procedures. As is already the case in biomedical disciplines, ethical statements should be required in marine mammal science. (shrink)

Although the International Committee of Medical Journal Editors has published clear guidance on the authorship of scientific papers, short-term contract research workers, who perform much of the research that is reported in the biomedical literature, are often at a disadvantage in terms of recognition, reward and career progression. This article identifies several professional, ethical and operational issues associated with the assignment of authorship, describes how a university department of primary care set about identifying and responding to (...) the concerns of its contract research staff on authorship and describes a set of guidelines that were produced to deal with the ethical and professional issues raised. These guidelines include directions on how authorship should be negotiated and allocated and how short-term researchers can begin to develop as authors. They also deal with the structures required to support an equitable system, which deals with the needs of short-term researchers in ways that are realistic in the increasingly competitive world of research funding and publication, and may offer a model for more formal guidelines that could form part of institutional research policy. (shrink)

Public opinion surveys and polls have a long history as tools for the reportage of public sentiment. Born in the “straw polls” of nineteenth century politics, their use expanded in the last century to include a range of commercial and social subjects. In recent decades, these have included issues of medico-legal uncertainty including, in a partial list, abortion, fetal tissue research, and the propriety of medical termination. Because public opinion surveys are assumed to be “scientific,” and (...) thus unbiased, there has been little discussion of either their suitability in areas of complex, medico-legal uncertainty or the ethics of their use in these areas. This paper reviews their general history and then their use in the debate over medical termination, often called “medical aid in dying.” In this review, two problems are highlighted. First, there is the ambiguous nature of polls and the manner of their construction. Second, there is the manner in which they are deployed as simple and definitive statements in areas of complex medico-legal debate. The result calls for caution in their use by ethicists and a clear duty by both academics and journalists to understand the limits of the medium in areas of medico-legal debate and discussion. (shrink)

This article examines the global and worsening problem of research misconduct as it relates to bio-medico-legal education. While research misconduct has serious legal implications, few adequate legal remedies exist to deal with it. With respect to teaching, research ethics education should be mandatory for biomedical students and physicians. Although teaching alone will not prevent misconduct, it promotes integrity, accountability, and responsibility in research. Policies and law enforcement should send a clear message that researchers should adhere (...) to the highest standards of ethics in research. It is vital that researchers and physicians understand basic aspects of law and the legal system in order to develop understanding of the medico-legal issues not just in the legal context, but with a sound grounding in ethics, social and theoretical contexts so that they can practice good medicine. Routine and holistic research ethics education across the curriculum for medical students and resident physicians, and continuing medical education for practicing doctors, are probably the best ways to accomplish this goal. (shrink)

The raison d'etre of this dissertation is the Muslim dilemma when confronted with some of the biotechnological innovations which relate to the precautionary measures to prevent the birth of children, technological manipulation in order to overcome infertility and the termination of fetal life. All of these issues are directly related to human life and thus pose serious problems. The Muslim is one whose life is regulated by the teachings of the Qur'an and Sunnah of the Prophet. Hence, his action (...) is considered proper or right if it conforms to their broad teachings and improper or wrong if it contra-dicts the very spirit of their teachings. This study is thus focused on the teachings of the Qur'an and the relevant ahadith pertaining to the beginning of human life, the sanctity of married life, and the sanctions for the termination of human life. The objective is to analyze the relevant injunctions and present them in a systematic way to prepare ground for the assessment of such biotechnological issues so as to ascertain their legality under the Shari'ah. ;In order to comprehend the ethical system envisaged by the Qur'an and Sunnah vis-a-vis the biomedical issues it is essential that we acquaint ourselves with the fundamental concepts pertain- ing to health care, medical treatment and medical ethics. Thereafter, a detailed discussion follows on reproductive control, biotechnical parenting and abortion. Each of these issues are elaborately analyzed in the light of the spirit and principles envisaged by the relevant injunctions. ;Proper grasp of the implications of these issues within the Islamic framework is expected to provide the perplexed Muslims with the necessary guidelines in the event that circumstances demand that they opt for either the contraceptive devices or the modern tech-niques to overcome infertility or abortion. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

The phenomenon of the New Genetics raises complex social problems, particularly those of privacy. This book offers ethical and legal perspectives on the questions of a right to know and not to know genetic information from the standpoint of individuals, their relatives, employers, insurers and the state. Graeme Laurie provides a unique definition of privacy, including a concept of property rights in the person, and argues for stronger legal protection of privacy in the shadow of developments in (...) human genetics. He challenges the role and the limits of established principles in medical law and ethics, including respect for patient autonomy and confidentiality. This book will interest lawyers, philosophers and doctors concerned both with genetic information and issues of privacy; it will also interest genetic counsellors, researchers, and policy makers worldwide for its practical stance on dilemmas in modern genetic medicine. (shrink)

Throughout much of the world, universities have driven towards industrial partnerships. This collaboration, which, in the biochemical field at least, has to continue if potential benefits for patients are to be realised, has brought with it a number of problems. These include the neglect of long-term research in favour of short-term projects, the curtailing of free dissemination of research information within university departments and the biasing of results of clinical trials by the financial interests of the investigators.It is very important (...) that governments, universities, and industry itself address these problems. Universities should monitor the amount of basic, curiosity-driven research that is being carried on, compared with that which is more short-term goal orientated. PhD students and post-doctoral fellows should be exposed to the principles of bioethics early on in their careers. Further work is necessary on the terms of research contracts to protect, on the one hand, the rights of individual scientists and, on the other, industry from rogue scientists. Where problems arise, procedures should be in place for independent reviews to be conducted by bodies such as the Medical Research Council in the UK or the National Institutes of Health in the USA. The conflict-of-interest rules recently introduced for publication in medical journals should be extended to all branches of science. (shrink)

Guidelines for clerkship training at one Canadian medical school – Western University’s Schulich School of Medicine and Dentistry – did not state the ethical principles associated with the decision to suspend and eventually resume clinical training during the COVID-19 pandemic. The absence of stated ethical principles was notable considering the impact these decisions had on various stakeholders, and since ethics plays a large role in the practice of medicine. This study assessed these guidelines (...) using an ethical lens approach to identify ethical principles and tensions implicit in the guidelines. Clerkship is defined as the third year of training at this medical school, which consists of clinical rotations. While ethical principles were not documented, it was hypothesized that these could be identified within the guidelines. A literature search was conducted, which yielded a gap in knowledge concerning ethical considerations of clerkship clinical training. The guidelines were analyzed and ethical principles and tensions between conflicting principles were identified. The most prevalent principles were beneficence and non-maleficence. It is recommended that in the future, the ethical principles associated with guidelines responding to significant issues affecting undergraduate medical education be stated, in order to increase transparency to all parties involved, enhance communication with students, and to serve as an example of how ethics is applied in a medical education setting. One limitation of this study was the use of internal guideline documents, which were circulated internally but are not published. (shrink)

There have been serious controversies in the latter part of the 20th century about the roles and functions of scientific and medical research. In whose interests are medical and biomedical experiments conducted and what are the ethical implications of experimentation on subjects unable to give competent consent? From the decades following the Second World War and calls for the global banning of medical research to the cautious return to the notion that in controlled circumstances, (...) class='Hi'>medical research on human subjects is in the best interest of the given individual and the broader population, this book addresses the key implications of experimentation on humans. This volume covers major ethical themes within biomedical research providing historical, philosophical, legal and policy reflections on the literature and specific issues in the field of research on human subjects. Focusing on special populations (the elderly, children, prisoners and the cognitively impaired) it represents the most up-to-date review of the special ethical and legal conflicts that arise with relation to experimentation on subjects from these groups. In the light of current initiatives for law reform pertaining to research ethics the world over, this volume provides a timely, comprehensive and provocative exploration of the field. The volume has been carefully organized to present important philosophical perspectives on organizing principles that should underlie any practical application. A forward-looking historical review of the regulatory regimes of principal jurisdictions, including of the legal controls already in place, provides the backdrop for future policy initiatives. Additionally, in the light of global restructuring of health care systems, several chapters have been devoted to epidemiological research and related issues. (shrink)

Photo ID 222412412 © US Navy Medicine | Dreamstime.com ABSTRACT In a non-military setting, the answer is clear: it would be unethical to treat someone based on non-medical considerations such as nationality. We argue that Battlefield Triage is a moral tragedy, meaning that it is a situation in which there is no morally blameless decision and that the demands of justice cannot be satisfied. INTRODUCTION Medical resources in an austere environment without quick recourse for resupply or casualty evacuation (...) are often limited. The shortage extends not only to supplies like blood products and drugs, but physicians and other medical personnel. In the midst of a mass casualty scenario, such as a battle that includes intense ground fighting, the medical staff will stretch scarce resources and triage casualties according to specific criteria. Typically, they proceed by providing care for the most severely wounded first, referred to here as conventional triage. At times, though, the staff may reverse the triage so that soldiers with minor wounds can return to the fight. In a mass casualty situation, when medical personnel apply conventional triage and treat casualties from opposing forces, a dilemma may arise. We argue that it can be permissible for military physicians to prioritize their own soldiers over enemy combatants in a mass casualty triage, where reverse triage does not apply. The case we will focus on is as follows: Battlefield Triage: During combat operations on a remote island in the Pacific Ocean, a compatriot soldier and an enemy combatant arrive at the compatriot soldier country’s medical treatment facility. Both have similar gunshot wounds to the abdomen, and they arrive with similar conditions. Both have low oxygen saturation and excessive blood loss. The sole physician only has enough time to stabilize one person. The scenario is brief, and we are aware that medical rules of eligibility will most often dictate how the physician proceeds,[1] but this scenario is useful in setting up the question we focus on in this paper: would it be wrong to favor the stabilization of a soldier just because the soldier is the physician’s compatriot? In other words, can nationality serve as an ethically justified tiebreaker in a situation such as Battlefield Triage?[2] In a non-military setting, the answer is clear: it would be unethical to treat someone based on non-medical considerations such as nationality. The AMA’s Code of Medical Ethics asserts that physicians have “ethical obligations to place patients’ welfare above their self-interest and above obligations to other groups.”[3] The World Medical Association’s Declaration of Tokyo affirms that “no motive, whether personal, collective or political, shall prevail against this higher purpose” of alleviating distress.[4] Physicians are taught early on that triage decisions must be medically indicated and made without consideration of factors such as race, ethnicity, religion, social status, and nationality. They are taught that public trust and obligations of justice grounded in equality demand that only medical indications be considered. But military physicians in a military setting are beholden to obligations, duties, and responsibilities as members of the military, and when these obligations, duties, and responsibilities conflict, as they do in Battlefield Triage, which loyalties win out and why?[5] Critics of partiality on national grounds argue that partiality undermines public trust in medicine and justice because everyone should be treated equally regardless of nationality.[6] Proponents of partiality argue that military obligations supersede equality and that justice requires partiality in such cases.[7] Despite the critics’ disagreement, both agree that there is a morally right, perhaps even blameless, course of action. Drawing on insights from virtue ethics, we argue that Battlefield Triage is a moral tragedy in which justice is unattainable and there is no action without moral cost. The assumption that there is a morally right choice is flawed. We argue that while no decision in this scenario is free from moral blame, there are reasons to favor treating one’s soldiers over enemy combatants. I. The Case Against Partiality There is a common assumption that there is a morally right or just decision in Battlefield Triage. A number of organizations and scholars claim that it is wrong for military physicians to favor their own soldiers on the grounds of nationality or some form of ‘group membership.’ (In a conflict involving service members from multiple nations working as a coalition, a soldier from an allied country may receive the same priority as the US service member due to ‘group membership.’) The World Medical Association’s WMA Declaration of Lisbon on the Rights of the Patient, which was reaffirmed in 2015, posits that, “[i]n circumstances where a choice must be made between potential patients for a particular treatment that is in limited supply, all such patients are entitled to a fair selection procedure for that treatment. That choice must be based on medical criteria and made without discrimination.”[8] This echoes what was set forth in Article 12 of the Geneva Conventions, which states that “[o]nly urgent medical reasons will authorize priority in the order of treatment to be administered.”[9] The argument for impartiality in Battlefield Triage is that every person is morally equal, and equality entails that medical distribution is, “based on a combination of medical need and urgency.”[10] This is in keeping with the bioethical principles that are generally applied.[11] II. The Case for Partiality On the other side, there are arguments that favoritism is the ethically right decision in Battlefield Triage.[12] The argument asserts that members of the military form a morally significant community of friends and participation in these relationships demands partiality. Just as parents have strong ethical duties to their children and not just any children, military personnel have ethical duties to their group, a group that involves an affirmation of mutual aid and support. Some have termed these ‘associative duties. According to Michael Gross, obligations of friendship, care, and solidarity “leave very little room for generally applicable principles of justice that would obligate a medic to treat enemy or non-compatriot wounded ahead of their compatriots.”[13] This is true in Battlefield Triage, but it may also be true even if the enemy’s soldier were more seriously wounded: “the ethics of small group cohesion, largely an ethics of care, mostly replaces the demands of impartial justice.”[14] In a more recent article, Gross explains that preferential treatment is ethically justified based on fighting capability and “the special obligations people owe friends, family, and, no less, comrades-in-arms.”[15] To not show partiality to the US soldier would be morally wrong on the grounds of friendship and mutual care.[16] III. The Moral Tragedy of Battlefield Triage Defenders and critics of Battlefield Triage favoritism based on nationality both frame their position as just or fair. For example, Justin List argues that physicians are “bound to practice medical neutrality,”[17] Marcus Adams denies that physicians “possess special ethical obligations” to enemy combatants because of their profession.[18] These perspectives assume that there is a morally right decision and that justice is attainable. The assumption that there is or can be a morally right Battlefield Triage decision, and we need to put our heads together to figure it out, remains strongly entrenched. However, the facts of the situation should give us pause; there are too many people and too few resources, and this demands a decision-making process that determines who will receive scarce resources. By its very nature, a battlefield triage decision has to be made based on some characteristic or value, a characteristic or value that will inevitably favor some at the expense of others. This is precisely why competing analyses “in the military context struggle to resolve these conflicts satisfactorily.”[19] Drawing on the insights of virtue ethics, we suggest that Battlefield Triage is a moral tragedy. Virtue ethics suggests that morality is about acting virtuously, which is to say that we should do what a virtuous person would do in the situation. Ethics is about figuring out how a just, wise, compassionate, loving, and fair person would act, and then doing that, as one grows in virtue. But life is not always clear cut, and it is possible that virtuous people may find themselves in a moral tragedy, a situation in which, through no fault of one’s own, a person must make a morally objectionable decision. After the action the virtuous person “emerges having done a terrible thing, the very sort of thing that the callous, dishonest, unjust, or in general vicious agent would characteristically do.”[20] Stated differently, a moral tragedy presents a virtuous person with two or more courses of action, all of which have a moral cost.[21] In Battlefield Triage, no matter how the physician goes about deciding, there is going to be defensible concern from those not saved. The fact that there are more people than can be helped fosters competing values in battlefield triage: maximize lives saved, treat people equally, treat the worse off, and support the war effort. Treating people equally may create tension between treating the worse off, maximizing lives saved, and supporting the war effort. Reverse triage is a case in point, as supporting the war effort conflicts with treating the worse off first, as is a fair lottery system since deploying a lottery may not maximize lives saved or support the war effort. There can be reasons why one person is selected over another, to be sure. Yet, there are reasons for making a decision, and that the decision is subject to legitimate moral concern is another. To recognize the moral tragedy of Battlefield Triage is to recognize the impossibility of acting blamelessly in the situation. In this situation, the virtuous military physician is going to have to sacrifice important values such as justice, compassion, and respect for others, even with a defensible criterion in hand. The physician will grieve this sacrifice accordingly. The physician may find her decision difficult or stressful, and rightly so, because of what her circumstances require of her. This kind of moral tragedy results “in actions which betray and violate the rights of persons to whom there may be a strong duty of care. When this happens, it properly triggers an appropriate moral emotion since our moral integrity has been violated and this affects how we think of ourselves and what we have become.”[22] Rather than view her triage decision as the morally superior choice, the virtuous military physician will view her decisions in these circumstances in a different light: it is the least bad option in a terrible situation, and she did something ethically problematic, something that is contrary to her moral character. She deeply regrets the circumstances in which she had to act. IV. Virtue Ethics A virtue ethicist has insight into how one should go about deciding what to do in a moral tragedy, although virtue ethics may not be as helpful as one may hope. The goal of the virtuous military physician in Battlefield Triage is to adopt the best course of action or the action that she feels she ought to do, all things considered. This does not make her choice devoid of serious wrongdoing—a decision must be made, but that does not make it just. The virtuous military physician will approach the situation with courage, responsibility, and insight. She will think about the decision carefully, wisely, and conscientiously; she will weigh the goods and harms of the choices before her, in conjunction with a proper conception of the good life, human worth, and understanding of her obligations to others—including chain of command, fellow soldiers, and the medical community. She is attuned to the value of human life and has a reasonable idea of the various ways her decisions will affect others. She recognizes that she is in this non-ideal situation through no fault of her own: she is not the one fighting in battles; she is serving her country as a physician, whose job it is to save lives, treat everyone justly, and promote military objectives. She regrets the decision she is forced to make in battlefield triage, acting “with immense regret and pain,” Hursthouse explains, “instead of indifferently or gladly.”[23] This is because, no matter what decision is made, the virtuous military physician “does something terrible or horrible,” something she otherwise would not do and is contrary to her values.[24] V. A Resolvable Moral Tragedy Instead of asking whether there is a morally right decision, in which a decision is morally blameless and above reproach, the virtue ethicist asks whether there is a decision with a convincing rationale, knowing that a decision can have a clear rationale but still be morally tragic. It is perfectly reasonable to think that different virtuous persons will arrive at different courses of action: “two virtuous agents, in the same situation,” Hursthouse writes, “may act differently” in irresolvable moral tragedies, in cases in which there is no clear course of action.[25] Because a person must act in a moral tragedy, one goal is to identify reasons for choosing the chosen action. Some decisions are clearly indefensible—treating neither the compatriot soldier nor the enemy combatant in Battlefield Triage would be wrong—and some decisions are more problematic than others. If the military physician selects to treat the soldier because she does not like the enemy combatant’s skin color, such a reason would be deeply problematic. But much of the debate over how to act in a moral tragedy is not over clearly indefensible or problematic criteria. Instead, the literature is largely about different standards or implementations of justice. Some scholars defend nation-impartial triage as right, while others defend nation-aware triage as right, and each argues that the other side is promoting an unjust or otherwise wrong solution to Battlefield Triage. We suggest that Battlefield Triage is a resolvable moral tragedy and that virtue ethics offers convincing reasons to prefer the treatment of the compatriot soldier rather than the enemy combatant on the grounds of national identity. Virtues are integral to living a good life, a flourishing life, but as Aristotle observed long ago, human beings are inherently social, interdependent and interconnected in profound ways.[26] This goes beyond the obvious fact that we need each other to survive day to day (one person makes clothes, another farms, and another makes tools); the claim is that a good or flourishing life depends in large part on one’s social network or community. This is why many of Aristotle’s moral virtues are other facing: justice, friendship, generosity, and magnanimity, to name a few. Courage, a typically self-facing virtue, is understood by Aristotle to be the virtue that regards one’s fear of death in battle, a battle fought on behalf of one’s city.[27] All of this remains true today. Namely, there is an important sense in which our community matters to our lives: it is easier to live a good, flourishing life if one is part of a good, flourishing community. Our community is made up of smaller groups, and it is more accurate to say that we are simultaneous members of different groups within a broader community. A person may be part of a family, friend group, research team, large state university, city, state, and nation. Groups can function well or not, as we all have experienced, and this suggests that there are virtues or excellences that groups can instantiate. Good groups are unified in purpose, with each member doing their duty alongside others for the attainment of that purpose. Good groups manifest solidarity among their members. Although Aristotle does not list solidarity as a virtue, a number of modern-day virtue ethicists have begun examining how group solidarity can be a virtue that contributes to a good or flourishing life.[28] Solidarity is not conceptualized as an individual virtue, a virtue possessed by a person in isolation of others; instead, it is a collective virtue, a virtue that is shared among members of a defined group with particular ends.[29] “A group has solidarity to the extent that its members are disposed to: (1) share values, aims, or goals; (2) care about those values, aims, or goals; (3) act in accordance with those values, aims, or goals; (4) trust the testimony of other group members with respect to those values, aims, and goals; and (5) feel a sense of belonging to the group.”[30] The virtue of collective or group solidarity involves individuals having special concern for each other, shared aims and values, trust, loyalty, and a sense of belonging with these specific others. There is a oneness to the group in the pursuit of a definite goal or purpose, involving mutual support and affirmation of each member. As such, the group has ends and goods above and beyond the good of each individual person. Sometimes solidarity requires personal sacrifice for the collective (for example, a father sacrificing food so his child can eat). The virtue of collective or group solidarity is important to the military and medical community at every level, and for clear reasons. In the military, there is a clear hierarchy of command, unity of purpose and end, mutual trust and support in complex settings, and so on. Soldiers need to know they can count on one another, and solidarity grounds a soldier’s ability to trust others and be assured of mutual aid. In medicine, solidarity maintains self-regulation of the profession, shared values and goals, as well as public support, not to mention that day-to-day operations require physician trust, engagement, and effort toward the ends of clinical care. Physicians need to work together, along with others, in pursuit of health, and disunity is sowed when there is mistrust, selfishness, or disengagement among the healthcare team and organization. Importantly, just as we are all members of various groups and hence may manifest group solidarity in different settings, the virtuous military physician instantiates collective solidarity with both the medical profession and the military. Her dual loyalty contributes to the moral difficulty of acting in Battlefield Triage. The military physician has competing obligations to distinct groups and cannot satisfy all obligations in Battlefield Triage. Solidarity with the military supports the consideration of favoring the soldier for reasons of national identity, whereas solidarity with the medical community does not. Something has to give, which is why it is a moral tragedy. The virtuous military physician, therefore, must weigh the costs of each course of action. To fulfill her obligations to the medical community would require that she does not use nationality and other non-medical considerations in Battlefield Triage. Since the soldier and enemy combatant are equally injured, justice would demand a random process, perhaps a flip of the coin. Although this may satisfy obligations the military physician has to the medical community, this would be costly to the physician’s military group. If word gets out that the physician decides who to treat based on a coin toss, soldiers, families, and citizens may become frustrated and angry. Soldier morale may go down if it becomes known that a coin flip led to the preventable death of a soldier and the saving of an enemy combatant who had killed (or attempted to kill) other soldiers. As Gross highlights, military solidarity involves a mutual aid promise that military personnel promise to help one another.[31] A military physician is part of the military and, as such, is part of the mutual aid promise, which would appear to be violated if the physician flips a coin. Treating a member of one’s own team may be psychologically more beneficial than treating an enemy combatant and may lead to less moral distress.[32] Finally, treating soldiers rather than enemy combatants promotes broader military and social aims, including returning soldiers to health, maintaining unity of purpose, and minimizing community suffering from a soldier’s death. Favoring members of one’s group, that is, triage based on nationality in Battlefield Triage, would fulfill obligations of military group loyalty, which is contrary to the values and duties of medicine. It does not seem as though showing favoritism in this particular situation is very costly to the medical community or general public, but this is because there is recognition that the physician is in the military. Medicine is impartial to non-medical indications partly because of fairness and to promote public trust in medicine. However, Battlefield Triage is unique, as medicine is being practiced in a non-public, wartime setting. In ordinary circumstances, a patient’s identity is irrelevant, and physicians ought not play favorites. Since Battlefield Triage is not an ordinary circumstance, decisions based on patient identity may not undermine public trust in medicine. In addition, it is contestable that fairness in Battlefield Triage requires that no consideration be paid to one’s nationality. Fairness is about giving each person their due, what is owed to them, and the case can be made that soldiers who place themselves in danger for the sake of the common good or a just cause are owed special attention when they suffer harm in the line of duty. In other words, soldiers voluntarily undergo risk to themselves for the greater good, and society owes them for this sacrifice. This plausibly includes preferential treatment in a situation such as Battlefield Triage. So, while the medical community affirms justice demands non-preferential treatment, the military community can affirm the opposite. The demands of fairness are unclear at best or in conflict in this situation: demands of physician justice decry favoritism, while demands of military justice support favoritism. Triage not based on nationality is arguably unfair and triage based on nationality may not undermine public trust, after all. All things considered, there is a clear rationale for favoring nationality-based preferential treatment in Battlefield Triage. Adopting a nationality-based preference in this situation is more defensible than not. This does not make such a decision ethically right or just. Preference based on nationality is the least bad decision, but it is not morally blameless. It involves one in a serious moral wrong, a wrong otherwise avoided and contrary to one’s character. The virtuous military physician is in a situation in which obligations conflict, and we disagree with Gross, who posits that care of fellow soldiers “is important to the near exclusion of all else.”[33] Gross fails to appreciate the collective virtue of solidarity as applied to those in medicine. The military physician has duties to fellow soldiers but also to fellow physicians, to the medical community, and humanity. To favor a soldier on grounds of nationality violates her duties and responsibilities to this latter group. She is involved in a moral tragedy and can only seek the most just action given the circumstances, yet, at least in virtue ethics, the action remains far from blameless. CONCLUSION We argue that Battlefield Triage is a moral tragedy, meaning that it is a situation in which there is no morally blameless decision and that the demands of justice cannot be satisfied. As such, the virtuous military physician incurs a moral cost to acting as she does—there is a moral residue. However, despite being a moral tragedy, there are clear reasons to act in favor of treating one’s own, considering group solidarity. As such, these kinds of tragedies are resolvable: virtuous military physicians should favor treatment of their own, although they would do so with sorrow. - [1] Militaries set forth medical rules of eligibility or guidelines used to determine whether a person qualifies for specific medical interventions or treatments in certain circumstances, and these guidelines are binding for a military physician. For example, despite opposition from medical organizations, militaries have adopted reverse triage guidelines for military physicians to follow. For ethical discussion, see Falzone, Elisabeth, P. Pasquier, C. Hoffmann, O. Barbier, M. Boutonnet, A. Salvadori, A. Jarrassier, J. Renner, B. Malgras, and S. Mérat. "Triage in military settings." Anaesthesia Critical Care & Pain Medicine 36, no. 1 (2017): 43-51. https://doi.org/10.1016/j.accpm.2016.05.004 [2] There are issues that are related to this, including the triage of civilians and allied soldiers. We set related issues aside for purposes of this paper [3] American Medical Association, Code of Medical Ethics: Current Opinions with Annotations, 2004–2005 ed. (Chicago, IL: AMA, 2004), 300. [4] American Medical Association, Code of Medical Ethics: Current Opinions with Annotations, 2004–2005 ed. (Chicago, IL: AMA, 2004), 300. [5] This is termed the “dual loyalty” dilemma in military medicine and has been described at length elsewhere: Institute of Medicine (US) Board on Health Sciences Policy. Military Medical Ethics: Issues regarding Dual Loyalties: Workshop Summary. Washington (DC): National Academies Press (US); 2008. Toward a Framework for Resolving Dual Loyalties. Available from: https://www.ncbi.nlm.nih.gov/books/NBK214853/ [6] See Kenneth G. Swan and K.G. Swan, Jr., “Triage: The Past Revisited,” Military Medicine 161:8 (1996): 448–452. https://doi.org/10.1093/milmed/161.8.448; Jerome A. Singh, “American Physicians and dual loyalty obligations in the ‘war on terror,’” BMC Medical Ethics 4.4 (2003): 1–10. https://doi.org/10.1186/1472-6939-4-4; Beam, Thomas E. "Medical Ethics on the Battlefield." Military Medical Ethics: Sect. IV. Medical ethics in the military. Medical ethics on the battlefield: the crucible of military medical ethics 2 (2003): 369-402; Hereth, Blake. "Health justice for unjust combatants." Journal of Military Ethics 20, no. 1 (2021): 67-81. https://doi.org/10.1080/15027570.2021.1949782. [7] See Adams, Marcus P. "Triage priorities and military physicians." In Physicians at war: The dual-loyalties challenge, pp. 215-236. Dordrecht: Springer Netherlands, 2008. Gross, Michael L. "Comradery, community, and care in military medical ethics." Theoretical medicine and bioethics 32 (2011): 337-350. https://doi.org/10.1007/s11017-011-9189-6. Gross, Michael L. "The limits of impartial medical treatment during armed conflict." In Military medical ethics for the 21st century, pp. 71-84. Routledge, 2016. [8] World Medical Association, WMA Declaration of Lisbon on the Rights of the Patient. 5 December 2022, https://www.wma.net/policies-post/wma-declaration-of-lisbon-on-the-rights-of-the-patient/ [9] Geneva Convention for the Amelioration of the Condition of Wounded, Sick in Armed Forces in the Field. 12 August 1949. https://www.un.org/en/genocideprevention/documents/atrocity-crimes/Doc.30_GC-I-EN.pdf. [10] List, Justin M. "Medical neutrality and political activism: physicians' roles in conflict situations." In Physicians at war: The dual-loyalties challenge, pp. 237-253. Dordrecht: Springer Netherlands, 2008. 240 [11] Beauchamp, T., and J. Childress. 2013. Principles of Biomedical Ethics, 7th ed. Oxford, United Kingdom: Oxford University Press. [12] Adams, Marcus P. "Triage priorities and military physicians." In Physicians at war: The dual-loyalties challenge, pp. 215-236. Dordrecht: Springer Netherlands, 2008. [13] Gross, "Comradery, community, and care in military medical ethics," 347. [14] Gross, “Comradery, community, and care in military medical ethics,” 349. [15] Gross, Michael L. "When medical ethics and military ethics collide." Narrative inquiry in bioethics 13, no. 3 (2023): 199-204. 202 https://dx.doi.org/10.1353/nib.2023.a924191 [16] Our argument draws on virtue ethics, from which care ethics derives, and it is worth clarifying how our argument relates to Gross’s. We do not think that the virtue of friendship grounds triage decisions, for we think it is unlikely that the physician and wounded soldier are friends. Instead, as explained below, we think the collective virtue of group solidarity better captures the moral significance of group loyalty and that Gross would agree with us. But since military physicians are part of distinct groups, with competing obligations, the military physician will be forced to sacrifice a value in battlefield triage cases. In other words, we think Gross downplays the dual group membership of a military physician. [17] List,”Medical neutrality and political activism,” 250. [18] Adams,”Triage priorities and military physicians,” 235. [19] London, Leslie, Leonard S. Rubenstein, Laurel Baldwin-Ragaven, and Adriaan Van Es. "Dual loyalty among military health professionals: human rights and ethics in times of armed conflict." Cambridge Quarterly of Healthcare Ethics 15, no. 4 (2006): 381-391. 383. [20] Hursthouse, R. On Virtue Ethics. OUP 1999. 74 [21] Nussbaum, Martha C. "The costs of tragedy: Some moral limits of cost-benefit analysis." The Journal of Legal Studies 29, no. S2 (2000): 1005-1036, 1007. [22] De Wijze, S. (2005). Tragic-remorse–the anguish of dirty hands. Ethical theory and moral practice, 7(5), 453-471, 457. https://doi.org/10.1007/s10677-005-6836-x [23] Hursthouse, 73 [24] Hursthouse, 81 [25] Hursthouse, 72 [26] Aristotle, Politics 1253a8. Reeve, C. D. C., Indianapolis: Hackett Publishing Co., 2017 [27] Aristotle, Nicomachean Ethics. III.6.114a, 34-35. 2002, Nicomachean Ethics, Christopher Rowe (trans.), Oxford: Oxford University Press [28] Byerly, T. Ryan, and Meghan Byerly. "Collective virtue." The Journal of Value Inquiry 50, no. 1 (2016): 33-50. https://doi.org/10.1007/s10790-015-9484-y; Federico, Veronica. "Conclusion: solidarity as a public virtue." Solidarity as a Public Virtue (2018): 495-542. https://doi.org/10.5771/9783845290058. Rehg, William. "Solidarity and the common good: An analytic framework." Journal of Social Philosophy 38, no. 1 (2007): 7-21. https://doi.org/10.1111/j.1467-9833.2007.00363.x [29] Byerly and Byerly. "Collective virtue." 43 [30] Battaly, Heather. "Solidarity: Virtue or vice?." In Social virtue epistemology, pp. 303-324. Routledge, 2022. 304 [31] Ibid., 2011: 341 [32] It might be thought that displaying altruism by helping an enemy combatant at the expense of one’s fellow soldier may be psychologically satisfiying. For evidence that military physicians find it difficult to treat enemy combatants, see Lundberg, Kristina, Sofia Kjellström, Anders Jonsson, and Lars Sandman. "Experiences of Swedish military medical personnel in combat zones: adapting to competing loyalties." Military medicine 179, no. 8 (2014): 821-826. https://doi.org/10.7205/MILMED-D-14-00038. Lamblin, Antoine, Clément Derkenne, Marion Trousselard, and Marie-Ange Einaudi. "Ethical challenges faced by French military doctors deployed in the Sahel (Operation Barkhane): a qualitative study." BMC Medical Ethics 22 (2021): 1-13. https://doi.org/10.1186/s12910-021-00723-2 [33] Ibid., 2011: 344. (shrink)

BackgroundIn 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. In this manuscript, we attempted to (...) do just that.MethodsWe 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.ResultsWe 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. Of the 12 clusters, Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least.ConclusionThere 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. (shrink)

Throughout much of the world, universities have driven towards industrial partnerships. This collaboration, which, in the biochemical field at least, has to continue if potential benefits for patients are to be realised, has brought with it a number of problems. These include the neglect of long-term research in favour of short-term projects, the curtailing of free dissemination of research information within university departments and the biasing of results of clinical trials by the financial interests of the investigators. It is very (...) important that governments, universities, and industry itself address these problems. Universities should monitor the amount of basic, curiosity-driven research that is being carried on, compared with that which is more short-term goal orientated. PhD students and post-doctoral fellows should be exposed to the principles of bioethics early on in their careers. Further work is necessary on the terms of research contracts to protect, on the one hand, the rights of individual scientists and, on the other, industry from rogue scientists. Where problems arise, procedures should be in place for independent reviews to be conducted by bodies such as the Medical Research Council in the UK or the National Institutes of Health in the USA. The conflict-of-interest rules recently introduced for publication in medical journals should be extended to all branches of science. (shrink)

This study investigated the circumstances and problems that departments of forensic medicine encounter with bereaved families regarding samples obtained from medico-legal autopsies. A questionnaire was posted to all 76 departments of forensic medicine performing medico-legal autopsies in Japan, and responses were received from 48 . Of the respondents, 12.8% had approached and communicated with bereaved families about collecting samples from the deceased person during an autopsy and the storage of the samples. In addition, 23.4% of these (...) had informed families that samples might be used in research. Eighteen departments had received enquiries and requests from families about the samples, with most requests concerning their return. The response to such requests varied according to the department. Few departments interacted with the bereaved families regarding the procedure for obtaining autopsy samples, and their methods for handling family concerns differed depending on the person within the department authorised to contact the family. Moreover, the procedures for engaging in such communication have long been unclear, and no legal or ethical consensus or agreement with the general public has been established. It is important for researchers to further discuss the correct way for forensic medicine departments to communicate with bereaved families. (shrink)

This book discusses feature films that enrich our understanding of doctor-patient dilemmas. The book comprises general clinical ethics themes and principles and is written in accessible language. Each theme is discussed and illuminated in chapters devoted to a particular film. Chapters start with a discussion of the film itself, which shares details behind the making of the film; critical reception; casting and other facts about production. The chapter situates the film in a history of medicine and medical sociology (...) context, analyzes ethical issues raised in the film from a clinical ethics lens, and explains to readers how to use each film as a teaching aid for clinical ethics. Readers will understand how each film in this collection served to bring particular clinical ethics issues to the public’s attention, or reflected medico-legal issues that were part of the public discourse. The book is a perfect instructor's guide for anyone teaching bioethics, healthcare ethics, medical sociology, medical history, healthcare systems narrative medicine, or nursing ethics. (shrink)

Over the past 6 months, coronavirus-induced disease has spread across 212 countries, affecting millions of people. As it has no known cure, social distancing is highly recommended for prevention of spread of the disease. Here, we have described the impact of the social distancing measures implemented by the Government of India on various sections of the society, especially the vulnerable sections. Furthermore, we have presented an analysis of these measures, according to the World Health Organization´s Guidance for Managing Ethical (...) Issues in Infectious Disease Outbreaks ; we have also applied principles, as applicable, from the Indian Council of Medical Research’s National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. Finally, we have presented several measures that should have been adopted before and in addition to implementing the lockdown to improve its effectiveness. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Ethics and the Allocation of Organs for TransplantationJames F. Childress (bio)A quarter of a century ago, in my second year of teaching at the University of Virginia, I began to explore the emerging field of biomedical ethics through a seminar on “Artificial and Transplanted Organs,” which included both faculty and students from law, medicine, and the humanities. My paper for the seminar was entitled “Who Shall Live When (...) Not All Can Live?” This experience drew me into biomedical ethics, because of the complex mix of ethical, legal, and medical issues and the fruitfulness of interdisciplinary and interprofessional dialogue.Several of the major problems confronting that seminar have persisted, often in altered form. In the area of organ transplantation, two significant issues continue to require society’s attention: (1) how can the organ supply be increased, and (2) how should the available organs be allocated? I want to make a few points about ethical criteria in the allocation of donated organs, as a way to indicate some directions for organ allocation policies in the twenty-first century. I will focus on the second question because I believe that a tremendous and ever-widening gap will persist between the need for transplantable organs and the supply of human cadaveric organs.Community Ownership of Donated Organs and Public ParticipationSince the mid-1980s, the operative conception of the ownership of donated organs has shifted, with major implications for the procedures used to formulate policies for organ allocation. As vice-chair of the federal Task Force on Organ Transplantation in the mid-1980s, I did not immediately realize that debates about allocation policies often reflected different conceptions of the ownership of donated organs. More specifically, organ allocation policies largely presupposed that donated organs belonged to, or were under the dispositional authority of, transplant surgeons, with only limited public accountability. However, the Task Force (1986) held that donated organs belong to the community, and that transplant professionals are only trustees and stewards of those organs for the [End Page 397] community’s welfare. This conception of ownership implies that the public should participate in setting the criteria for organ allocation.According to Jeffrey Prottas (1994), another member of the Task Force, these shifts represent the “socialization” of organ transplantation. Although professional dominance, through knowledge and power, continues in the United Network for Organ Sharing (UNOS)—the national organ procurement and transplantation network that was established in the late 1980s—that dominance is now more circumscribed and accountable, particularly because UNOS, in developing any allocation policy, has to respond “to public criticisms with public answers.” Not only is organ allocation policy now in the public domain—and thus a matter of public ethics rather than medical ethics—the terms of the debate have changed, as Prottas further notes, so that equity must be considered along with efficiency.Balancing Several Ethical Principles or ValuesThe main ethical criteria for organ allocation express principles that are prominent in the major competing theories of justice, particularly libertarian, egalitarian, utilitarian, and communitarian theories. The principles of liberty, equality, utility, and community all play important roles, and organ allocation policies often seek to balance these competing principles, which frequently are specified or circumscribed—for instance, utility is specified as medical utility. Just or equitable policies are found in the process of balancing.UNOS (1994) attempts to develop an equitable organ allocation system in light of a “set of basic principles” and “specific measurable objectives” that have been derived from these principles. It uses the metaphor of “balance” for its efforts to relate these different principles and objectives. For instance, it holds that balancing requires that “equal consideration” be given to both medical utility and to justice, so that neither can be ranked a priori over the other. However, it may not be possible to “give equal weight to [both] medical utility and justice” (UNOS 1994, p. 123) because trade-offs appear to be unavoidable in many policies and are consistent with the metaphor of balancing.Medical Utility and EqualityMedical utility—maximizing the welfare of patients suffering from end-stage organ failure—includes, at a minimum, attention to the factors that influence both graft and patient survival, as well... (shrink)

Recent technological developments have considerably transformed the supply, storage, and transportation processes of cadavers, creating new and previously unforeseen ethical challenges regarding cadaver usage. In this study, we analyzed two aspects of the cadaver processing system—cadaver supply and its use in research. Thereafter, we highlighted the major ethical concerns underlying these stages and correlated our search results with the ethical principles outlined in the Declaration of Helsinki (DoH), or Helsinki Declaration. To ensure the reliability and continuity (...) of medical progress, human—especially cadaver—research depends on the ethical priorities as outlined in the DoH: respect for autonomy, privacy/confidentiality, risks/burdens/benefits, and the protection of vulnerable groups. According to our ethics analysis, which also corresponds with the ethics guidelines of the Consensus Panel on Research with the Recently Dead, the most ignored values were respect for autonomy and privacy/confidentiality issues. Based on these ethical concerns, we provide recommendations to address these challenges in anatomy research. (shrink)

The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, since post-disaster research is essential to the improvement of the humanitarian response, it is important that adequate research ethics oversight be available. We aim to answer the following questions: 1) what do research ethics committee members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries perceive as the (...) key ethical concerns associated with disaster research?, and 2) in what ways do REC members understand these concerns to be distinct from those arising in research conducted in non-crisis situations? This qualitative study was developed using interpretative description methodology; 15 interviews were conducted with REC members. Four key ethical issues were identified as presenting distinctive considerations for disaster research to be implemented in LMICs, and were described by participants as familiar research ethics issues that were amplified in these contexts. First, REC members viewed disaster research as having strong social value due to its potential for improving disaster response, but also as requiring a higher level of justification compared to other research settings. Second, they identified vulnerability as an overarching concern for disaster research ethics, and a feature that required careful and critical appraisal when assessing protocols. They noted that research participants’ vulnerabilities frequently change in the aftermath of a disaster and often in unpredictable ways. Third, they identified concerns related to promoting and maintaining safety, confidentiality and data security in insecure or austere environments. Lastly, though REC members endorsed the need and usefulness of community engagement, they noted that there are significant challenges in a disaster setting over and above those typically encountered in global health research to achieve meaningful community engagement. Disaster research presents distinctive ethical considerations that require attention to ensure that participants are protected. As RECs review disaster research protocols, they should address these concerns and consider how justification, vulnerability, security and confidentially, and community engagement are shaped by the realities of conducting research in a disaster. (shrink)

BackgroundGenetics and genomics research (GGR) is increasingly being conducted around the world; yet, researchers and research oversight entities in many countries have struggled with ethical challenges. A range of ethics and regulatory issues need to be addressed through comprehensive policy frameworks that integrate with local environments. While important efforts have been made to enhance understanding and awareness of ethical dimensions of GGR in Africa, including through the H3Africa initiative, there remains a need for in-depth policy review, at (...) a country-level, to inform and stimulate local policy development and revision on the continent.MethodsTo identify and characterize existing ethics-related guidelines and laws applicable to GGR across much of Africa, we conducted a scoping review of English language policy documents identified through databases, repositories, and web searches. Thirty-six documents were included and coded using a framework that contained a range of themes across five analytical categories: (1) respect, (2) beneficence, (3) justice, (4) independent oversight, and (5) bans and prohibitions. Data analysis software (NVivo 12) was used to organize, code, and tabulate information according to document characteristics and topics. Illustrative examples of policy requirements were selected for inclusion.ResultsDocuments that met inclusion criteria spanned 20 years; published between 1996 and 2018, with the majority (58%) published after 2009. About two-thirds were denoted as “guidelines,” and slightly more than half were non-exclusive to GGR. Very few (six) country-level documents identified were specific to GGR. Requirements related to the principle of “respect” appeared most often across all documents, relative to other principles and processes. The most commonly stated ban was on reproductive cloning. Other prohibitions applied to germline editing, undue inducements in research, sample use for commercial purposes, employee mandatory DNA testing, fetal sex selection, stem cell use, eugenics, and research without public health benefits.ConclusionsEnforceable policies that are indispensable to the ethical conduct and review of GGR are either deficient or missing in many African countries. Existing international, GGR-specific ethics guidelines can be used to inform GGR policy development at a country-level, in conjunction with insight from country specific ethics committees and other local stakeholders. (shrink)

In research ethics there is a canon regarding what ethical rules ought to be followed by investigators vis-à-vis their treatment of subjects and a canon regarding what fundamental ethical principles apply to the endeavor. What I aim to demonstrate here is that several of the rules find no support in the principles. This leaves anyone who would insist that we not abandon those rules in the difficult position of needing to establish that we are nevertheless justified (...) in believing in the validity of the rules. I conclude by arguing that this is not likely to be accomplished.The rules I call into question are the rules requiring:– that studies be designed in a scientifically valid way– that risks to subjects be minimized– that subjects be afforded post-trial access to experimental interventions– that inducements paid to subjects not be counted as a benefit to them– that inducements paid to subjects not be ‘undue’– that subjects must remain free to withdraw from the study at any time for any reason without penaltyBoth canons, the canon on principles and the canon on rules, are found in the overlap among ethical pronouncements that are themselves canonical: the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, CIOMS's International Ethical Guidelines for Biomedical Research Involving Human Subjects, and NBAC's 2001 report, Ethical Issues in International Research: Clinical Trials in Developing Countries. (shrink)

The increasing possibilities for using tissue for research and development in genetics and biotechnology have made stored human biological materials more important than ever. Using stored human biological materials raises many legal and ethical questions. On an international level however, the use of these materials has not been regulated in a detailed manner so far. The Council of Europe recently declassified the text of the proposal for an instrument on the use of archived human biological materials in (...) class='Hi'>biomedical research for public consultation. The purpose of this paper is to comment on this document regarding its primary goal, which is to protect the rights and fundamental freedoms of the individual whose biological materials could be included in a research project. The guidelines offer good basic protection for sources of identifiable human biological materials but, surprisingly, offer no protection to sources of anonymous or anonymised materials. (shrink)

This open access book presents an ethical approach to utilizing personal medical data. It features essays that combine academic argument with practical application of ethical principles. The contributors are experts in ethics and law. They address the challenges in the re-use of medical data of the deceased on a voluntary basis. This pioneering study looks at the many factors involved when individuals and organizations wish to share information for research, policy-making, and humanitarian purposes. -/- Today, (...) it is easy to donate blood or even organs, but it is virtually impossible to donate one’s own medical data. This is seen as ethically unacceptable. Yet, data donation can greatly benefit the welfare of our societies. This collection provides timely interdisciplinary research on biomedical big data. Topics include the ethics of data donation, the legal and regulatory challenges, and the current and future collaborations. -/- Readers will learn about the ethical and regulatory challenges associated with medical data donations. They will also better understand the special nature of using deceased data for research purposes with regard to ethical principles of autonomy, beneficence, and justice. In addition, the contributors identify the key governance issues of such a scheme. The essays also look at what we can learn in terms of best practice from existing medical data schemes. (shrink)

BackgroundMany 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.MethodsThe 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.ResultsThe 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.ConclusionThe 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. (shrink)

Background Generally, there is unanimity about the value of community engagement in health-related research. There is also a growing tendency to view genetics and genomics research (GGR) as a special category of research, the conduct of which including community engagement (CE) as needing additional caution. One of the motivations of this study was to establish how differently if at all, we should think about CE in GGR. Aim To assess the perspectives of genetics and genomics researchers in Uganda on CE (...) in GGR. Method A cross-sectional qualitative study was conducted at Makerere University and Uganda Virus Research Institute. Twenty-five individuals participated, the majority being male (sixteen). Participants included nineteen genetics and genomics researchers (researchers and research coordinators), two CE officers, three nurses and one nursing counsellor. Data were collected using in-depth interviews and analyzed in a thematic manner using NVivo version 12 Plus. Study findings Thirteen of the respondents had conducted CE in their GGR in either a geographical and disease-specific community. Some respondents said CE principles are the same and there is no need for special consideration for CE in GGR. Others gave ethical issues in GGR that require special consideration for CE in such research and these were categorized into six themes: GGR is new to communities, Difficulty in communicating GGR by the researchers, Genes are shared in communities, Cultural sensitivities against GGR, Community attitude toward GGR, Some GGR studies take long to end, and Negotiation of research benefits. Special considerations for CE when conducting GGR were suggested and categorized into seven themes: creating awareness of GGR in communities, obtaining both community acceptance and individual consent, CE team composition, involve communities in solving GGR challenges, prolong CE in some GGR, develop guidelines for CE in GGR, and legal considerations on GGR. Conclusion GGR was characterized by special issues that require special CE considerations for such research. (shrink)

In this era of globalization, as the health problems of poor countries and rich countries become increasingly intertwined, medical research is being conducted at the international level. For example, a research study may be sponsored by a developed country and conducted in a resource-poor country to address health problems faced by both nations. The globalization of medical research is, in effect, quickly outpacing the development of internationally accepted ethical guidelines for the conduct of research. For many (...) medical researchers working in resource-poor countries, ethical decision-making is like sailing in the days before modern navigation; one is never quite sure where one is, or in what direction one is headed. Our aim in this article is to fix a few navigational points on an ethical compass to guide biomedical researchers from developed countries working in resource-poor countries.Just as one of the principles underlying the Hippocratic Oath is “First, do no harm,” a principle underlying medical research ethics may be “First, do not exploit.”. (shrink)

Informed consent is one of the foundational ethical and legal requirements of research with human subjects. The Nuremberg Code, the Helsinki Declaration, the Belmont Report, the Common Rule and many other laws and codes require that research subjects make a voluntary, informed choice to participate in research.12345 Informed consent is based on the moral principle of respect for autonomy, which holds that rational individuals have a right to make decisions and take actions that reflect their values and preferences. (...) 6 Whereas most guidelines and codes also require that informed consent be properly documented, informed consent is much more than signing a piece of paper: It is a continuous process of communication between the investigator and the research subject. 7 Because the body of knowledge impacting a study frequently changes, subjects should receive information from investigators after they have enrolled in a study, such as significant new findings that may affect their decision to participate in research or clinically useful tests results. 8910 In large studies, some investigators use newsletters to update subjects on the progress of research and other developments.11Most of the ongoing communications between investigators and subjects involve little more than information sharing, without revisiting the decision to participate in research or signing any additional documents. Sometimes, however, it may be necessary for subjects to reaffirm their decision to participate, to re-consent, or to sign or re-sign a document. 8 Re-consent can be defined as an action in which a subject makes the decision to participate in research once again. Re-consent is different from reaffirming a commitment to participate in a study, because in re-consent one actually reconsiders the information necessary to make decision, whereas in reaffirmation one simply expresses …. (shrink)

BackgroundEthics in biomedical research is still a fairly new concept in Africa. This work aims to assess the knowledge, attitude and experiences of Beninese researchers with regard to the national ethical regulatory framework of biomedical research in Benin.MethodsThis was a cross-sectional and descriptive study, involving all the researchers fulfilling the inclusion criteria. Data were collected through a face-to-face interview using a questionnaire and analysed. Proportions and means were calculated with their confidence intervals and standard deviations, respectively.ResultsOf the (...) 110 participants included in the study, 40.9% were medical lecturers and 71.1% had been involved in more than 10 biomedical research as researcher. Less than three quarters were able to correctly quote the basic principles from Belmont report. The quarter of them knew the attributions of the National Ethics Committee for Health Research and 38.2%, the content of the legislation on health research ethics in Benin. The common ethical rules were known by 69.1% of the participants. A quarter of participants said they always present the study’s briefing note to their study participants and 62.7% said they systematically request informed consent. For those who do not present the briefing note to participants, the main reasons provided were the researchers’ difficulties in writing the note in plain language and the participants’ limitation in understanding it.ConclusionsThe foundations of a good ethical framework for health research exist in Benin. However, the deployment and use of the various legal texts deserve to be improved. (shrink)

Globalization is a major challenge not only for marketing, but also for marketing ethics. Is it possible to delineate a conceptual framework that helps identify some major issues in this unchartered field? This paper assumes that the development of such a framework needs both serious reflection on the very concept of marketing and a thorough exploration of universal ethical values. Among a number of competing concepts of marketing, those concepts seem preferable which go beyond a merely 'instru (...) mental' or 'value free' understanding of marketing and are open to ethical questions. As for universal ethical values, it is proposed to start from four broad areas marketing is involved in: communication, people, culture and nature; and to explore major global reports and declarations (which reflect a certain global consensus) for ethical guidance. Four guidelines are identified. Furthermore, an attempt is made to combine the insights from the conceptual discussion of marketing with the ethical guidelines in order to develop 'mid-level principles' for international marketing ethics, which are illustrated by a few examples. (shrink)

Large-scale linkage of international clinical datasets could lead to unique insights into disease aetiology and facilitate treatment evaluation and drug development. Hereto, multi-stakeholder consortia are currently designing several disease-specific translational research platforms to enable international health data sharing. Despite the recent adoption of the EU General Data Protection Regulation, the procedures for how to govern responsible data sharing in such projects are not at all spelled out yet. In search of a first, basic outline of an ethical governance framework, (...) we set out to explore relevant ethical principles and norms. We performed a systematic review of literature and ethical guidelines for principles and norms pertaining to data sharing for international health research. We observed an abundance of principles and norms with considerable convergence at the aggregate level of four overarching themes: societal benefits and value; distribution of risks, benefits and burdens; respect for individuals and groups; and public trust and engagement. However, at the level of principles and norms we identified substantial variation in the phrasing and level of detail, the number and content of norms considered necessary to protect a principle, and the contextual approaches in which principles and norms are used. While providing some helpful leads for further work on a coherent governance framework for data sharing, the current collection of principles and norms prompts important questions about how to streamline terminology regarding de-identification and how to harmonise the identified principles and norms into a coherent governance framework that promotes data sharing while securing public trust. (shrink)

The meaning of justice can be defined according to a juridical, human, theological, ethical, biomedical, or social perspective. It should guarantee the protection of life and health, personal, civil, political, economic, and religious rights, as well as non-discrimination, inclusion, protection, and access to care. In this review, we deal with three theoretical concepts that define justice in all its aspects. (1) The utilitarian theory, which justifies moral statements on the basis of the evaluation of the consequences that an (...) action produces, elaborating a pragmatic model of medical science. (2) The libertarian theory, which considers freedom as the highest political aim, thus absolutizing the rights of the individual; here, the principle of self-determination, with respect to which the principle of permission/consent is the fundamental presupposition, plays a central role in the definition of the person. (3) The iusnaturalist theory, in which man’s moral freedom is identified with the ability to act by choosing what the intellect indicates to him as good; the natural moral law that drives every conscience to do good is therefore realized in respect for the person in the fullness of his rights. In conclusion, different forms and conceptions of justice correspond to different organizations of society and different ways of addressing ethical issues in the biomedical domain. (shrink)