ABSTRACT The demand for basic research ethics training has grown considerably in the past few years. Research and education organizations face the challenge of providing this training with limited resources and training tools available. To meet this need, Family Health International (FHI), a U.S.‐based international research organization, recently developed a Research Ethics Training Curriculum (RETC). It was designed as a practical, user‐friendly tool that provides basic, up‐to‐date, standardized training on the ethics of human research. The curriculum can easily be adapted (...) to different audiences and training requirements. The RETC was reviewed by a group of international experts and field tested in five countries. It is available in English, French, and Spanish as a three‐ring binder and CD‐ROM, as well as on the Web. It may be used as either an interactive self‐study program or for group training. (shrink)

Clinical and research practices designed by developed countries are often implemented in host nations of the Third World. In recent years, a number of papers have presented a diversity of arguments to justify these practices which include the defence of research with placebos even though best proven treatments exist; the distribution of drugs unapproved in their country of origin; withholding of existing therapy in order to observe the natural course of infection and disease; redefinition of equipoise to a more bland (...) version, and denial of post-trial benefits to research subjects. These practices have all been prohibited in developed, sponsoring countries, even though they invariably have pockets of poverty where conditions comparable to the Third World prevail. Furthermore, the latest update of the Declaration of Helsinki clearly decries double ethical standards in research protocols. Under these circumstances, it does not seem appropriate that First World scholars should propose and defend research and clinical practices with less stringent ethical standards than those mandatory in their own countries. Recent years have witnessed frequent reports of less stringent ethical standards being applied to both clinical and research medical practices, for the most part in the field of drug trials and drug marketing, initiated by developed countries in poorer nations. Still more unsettling, a number of articles have endorsed the policy of employing ethical norms in these host countries, which would be unacceptable to both the legislations and the moral standards of the sponsor nations. Also, these reformulations often contravene the Declaration of Helsinki or one of its updates. This paper is not so much concerned with the actual practices, which have been subjected to frequent scrutiny and publicly decried when gross misconduct occurred. Rather, my concern relates to the approval and support such practices have found in the literature on bioethics from authors who might be expected to use their energy and scholarship to explore and endorse the universalisability of ethics rather than to develop ad hoc arguments that would allow exceptions and variations from accepted moral standards. To this purpose, issue will be taken with arguments in three fields: medical and pharmaceutical practices, research strategies, and local application of research results. (shrink)

There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects.

What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in bioethics? A simple answer to both questions is that vulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. This analysis is limited to two areas. First is the context of multinational research, in which vulnerable people can be exploited even if they are not harmed, and harmed even if they are not exploited. Second is the situation of women, who are (...) made vulnerable in cultural settings or in entire countries in which they are oppressed and powerless. (edited). (shrink)

The aim of this article is to analyse the contemporary ‘futility discourse’ from a constructivist perspective. I will argue that bioethics discourse typically disregards the con text from which controversies emerge and the processes that inform and constrain such discourse. Constructivists have argued that scientific knowledge is expressive of the dominant paradigm within which a scientific community is working. I will outline an analysis of ‘medical futility’ as a construction of biomedical and bioethical communities (and their respective paradigms). I will (...) trace the emergence and utilization of futility in the literature. My analysis of the context (i.e. the historical circumstances, the particular actors involved) within which the futility discourse emerged suggests that medical futility was constructed, in part, as a means of enhancing physician domination of a context wherein medical authority was threatened. The actors in this debate express widely divergent frameworks of ‘the good’, arguing from distinctive representations of moral agency. At times, this controversy has been argued from incommensurate moral horizons wherein the discussants debate incomparable problems. This discussion is related to a study of the ‘practice’ of futility in the clinical context. Further studies on the construction of bioethical problems are a necessary condition for supporting the truth claims of bioethical arguments. (shrink)

Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. (...) A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research. (shrink)

The fourth edition of this bestselling title is designed to help you think critically and thoughtfully about ethical decisions you'll face in practice-in any health care discipline. Utilizing a unique 6-step decision making process designed by the author, this multi-disciplinary text provides an expert framework for making effective choices that lead to a professional and caring response to patients and clients.

Who should decide? In When Doctors Say No, philosopher and bioethicist Rubin examines this controversial issue.

In Wrong Medicine, Lawrence J. Schneiderman, M.D., and Nancy S. Jecker, Ph.D., address issues that have occupied the media and the courts since the time of Karen Ann Quinlan. The authors examine the ethics of cases in which medical treatment is offered--or mandated--even if a patient lacks the capacity to appreciate its benefit or if the treatment will still leave a patient totally dependent on intensive medical care. In exploring these timely issues Schneiderman and Jecker reexamine the doctor-patient relationship and (...) call for a restoration of common sense and reality to what we expect from medicine. They discuss economic, historical, and demographic factors that affect medical care and offer clear definitions of what constitutes futile medical treatment. And they address such topics as the limits on unwanted treatment, the shift from the "Age of Physician Paternalism" to the "Age of Patient Autonomy," health care rationing, and the adoption of new ethical standards. (shrink)