Twelve tips to avoid ethical pitfalls when recruiting students as subjects in medical education research

Medical education research has unique characteristics that raise their own set of ethical issues, which differ significantly from those commonly found in clinical research. In contexts where researchers have a dual role as teachers, free consent to participate in research may be undermined and students’ data must be kept confidential from faculty who play any role in their academic or professional path. Faculty members who recruit students as research subjects within their institution for education research should pay particular attention to ensure students’ consent to participate is indeed free and continuous and that their privacy is adequately protected. A good understanding of ethical standards and of the appropriate strategies to fulfill them is essential to conduct ethical medical education research and to ensure ethics approval is obtained. These twelve tips draw from the Declaration of Helsinki, from the ICMJE recommendations and from the example of their application to medical education research in a Canadian and North American context. They aim to act as a reminder and as a guide to address the main ethical issues which should be given proper consideration when designing a study involving students as subjects for medical education research.     

In Loco Parentis: Minimal Risk as an Ethical Threshold for Research upon Children

To what risks may children participating in research be subjected? Institutional review boards can stand surrogate for parents by filtering out studies whose risk is unacceptably high.     

Revisiting ethical guidelines for research with terminal wean and brain-dead participants

Some research is too risky to be conducted on anyone with a life expectancy of more than a few hours. Yet under some circumstances, the research can still be carried out by using subjects who are either brain dead or are soon to undergo a terminal wean, and who have articulated values that inclusion in the study can honor. So argues a team of ethicists and researchers at M.D. Anderson Cancer Center, where such research was recently undertaken.     

The ethics wars. Disputes over international research

The effort to revise the Declaration of Helsinki and the CIOMS Guidelines has sparked a sometimes vitriolic debate centering on the use of placebo controls.     

HIV Vaccine Trial participation in South Africa - an ethical assessment

Trial participation in the proposed HIV Vaccine Trials in South Africa is discussed in the context of the ethical tension that exists between international ethical research standards and local standards of care and cultural norms in the Third World. The important concepts of informed consent, risk-benefit ratio and fair treatment of trial participants are interpreted differently in traditional, rural African communities, where a moderate form of communitarianism referred to as "Ubuntu" or "communalism" is still prevalent. Research is an altruistic endeavor that benefits communities and societies as a result of risks taken by individuals. Universal ethical guidelines that are highly individualistic and fail to emphasize communalism may represent serious problems for the sort of research needed in Africa today.     

How traditions of ethical reasoning and institutional processes shape stem cell research in Britain

This article aims to show how the traditions of ethical reasoning and policy-making shape stem cell research in Britain. To do so I give a detailed account of the earlier developments of regulations on embryo research and the specific scientific advances made in Britain. The subsequent regulation of stem cell research was largely predetermined by those structures and the different and partly opposing orientations of a utilitarian approach to policies on biomedicine. The setting up of the first stem cell bank and the directing of public funding into not only bioethical but also sociological guidance of the development of the new science field are aspects of the particular British way of supporting stem cell research. However, there is also an ongoing philosophical and juridical debate on the possible erosion of fundamental values caused by incremental regulatory weakening. Although I am highly sympathetic to the critical position that there is a need for a metaphysical anchor to secure individual human rights, one has to admit that the British mode of handling the inevitable ethical problems we face with biomedical progress is rather successful in terms of securing some of the basic needs and values of a modern democratic society.     

The private practicing physician-investigator: ethical implications of clinical research in the office setting

Drug companies are moving their research from academic medical centers to physicians' private offices. The shift brings in more subjects, and could mean faster and better results. It also changes the physician's relationship to patients, dangles monetary lures in front of physicians, and could produce subjects who don't understand what they're participating in and results that are unreliable.     

Justice and the human development approach to international research

The debate over when medical research may be performed in developing countries has steered clear of the broad issues of social justice in favor of what seem more tractable, practical issues. A better approach will reframe the question of justice in international research in a way that makes explicit the links between medical research, the social determinants of health, and global justice.     

Twelve tips to teaching (legal and ethical aspects of) research ethics/responsible conduct of research

Teaching research ethics is a requirement within modern health science, nursing and medical curricula. We have drawn on our experience of designing, developing and integrating the teaching of research ethics in a new, fully integrated medical school curriculum, delivered using Problem Based Learning and the recent literature relating to the teaching of research ethics to produce the following 12 Top Tips designed to encourage readers to seek opportunities to embed this teaching within a variety of curricula.     

Ethics and genetics: an international survey

Wertz and Fletcher briefly summarize the findings of their 1985-86 survey of responses to ethical dilemmas by medical geneticists in 19 countries. Geneticists identified six categories of ethical problems encountered in practice: (1) the duty to warn third parties of genetic harm vs. the duty to preserve patient confidentiality; and (2) full disclosure of sensitive information; (3) full disclosure of test results; (4) directive vs. nondirective counseling; (5) patient requests for prenatal diagnosis without medical indication; and (6) mandatory vs. voluntary screening programs and access by third parties to test results. Survey participants ranked issues that they believed would be of greatest ethical concern to their field within the next 10 to 15 years. The authors caution that issues seen as less problematic by medical geneticists may be those of most concern to the public.     

Levinas and the patient as other: the ethical foundation of medicine

The thesis of this paper is that because the significance of Western medicine lies in its ability to enhance the health of persons within a society, the practice of medicine is foremost an ethic and only thereafter a science. In support of the priority of an ethical perspective in medical practice, the paper explores the socio-cultural nature of knowledge, upon which science itself is constructed. Next, it draws from Levinas' philosophy, which illumines the problem of ontological and epistemological priority. Specifically, it examines Levinas' rendering of the human face and of language, as they found the case for the priority of justice, or ethics. Finally, the paper offers the practice of narrative discourse as one solution that elevates the status of ethics within the institution of medicine and that has the potential to counteract the tendency in medical practice to employ a universalizing methodology based in science's power to control the human Other.     

The ambiguity and the exigency: clarifying 'standard of care' arguments in international research

This paper examines the concept of a 'standard of care' as it has been used in recent arguments over the ethics of international human-subjects research. It argues that this concept is ambiguous along two different axes, with the result that there are at least four possible standard of care arguments that have not always been clearly distinguished. As a result, it has been difficult to assess the implications of opposing standard of care arguments, to recognize important differences in their supporting rationales, and even to locate the crux of the disagreement in some instances. The goal of the present discussion, therefore, is to disambiguate the concept of a 'standard of care' and to highlight the areas of genuine disagreement among different standards. In the end it is argued that one standard of care argument in particular is more complex than either its proponents or its critics may have recognized and that understanding this possibility opens up a potentially promising avenue of inquiry that remains to be carefully explored.     

Preparing students for the ethical challenges on international health electives: A systematic review of the literature on educational interventions

International health electives pose specific ethical challenges for students travelling from to low and middle income countries. We undertook a systematic review of the literature on interventions to prepare students to identify ethical issues addressed, educational approaches and to collate evidence on the effectiveness of different strategies. We searched nine electronic databases of peer-reviewed literature and identified grey literature through key word searches; supplemented through citation mapping and expert consultation. Articles that described ethical training conducted by universities or professional bodies were included for review. We reviewed forty-four full text articles. Ten sources of published literature and seven sources of grey literature met our inclusion criteria. We identified thirteen ethical situations that students should be prepared to manage and eight generic skills to support this process. Most interventions were delivered before the elective, used case studies or guidelines. Some suggested ethical principles or a framework for analysis of ethical issues. Only two papers evaluated the intervention described. Our paper collates a small but growing body of work on education to prepare students to manage ethical issues. Ethical training should have elements that are delivered before, during and after the elective. Interventions should include case studies covering thirteen ethical issues identified here, linked to ethical principles and a process for responding to ethical issues. We suggest that evaluations of interventions are an important area for future research.     

Building an environmentally accountable medical curriculum through international collaboration

Background: Global environmental change is associated with significant health threats. The medical profession can address this challenge through advocacy, health system adaptation and workforce preparedness. Stewardship of health systems with attention to their environmental impacts can contribute to mitigation of and adaptation to negative health impacts of environmental change. Medical schools have an integral role in training doctors who understand the interdependence of ecosystems and human health. Yet integrating environmental perspectives into busy medical curricula is not a simple task.

Content: At the 2016 Association for Medical Education in Europe conference, medical educators, students and clinicians from six continents discussed these challenges in a participatory workshop. Here we reflect on emerging themes from the workshop and how to plan for curricular change. Firstly, we outline recent developments in environmental health and associated medical education. Secondly, we reflect on our process and outcomes during this innovative approach to international collaboration. Thirdly, we present learning objectives which cover core content for environmentally accountable medical curricula, developed through a reflective process of international collaboration integrating current literature and the workshop outcomes.

Conclusions: International collaboration can bring together diverse perspectives and provide critical insights for the inclusion of environmental health into basic education for medical practitioners.