There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences, the International Conference on Harmonization's standards for industry, and the CONSORT group's reporting norms, in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's body of regulations, and information sheets by the Department of (...) Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”. (shrink)

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

Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

In 2004 Emanuel et al. published an influential account of exploitation in international research, which has become known as the 'fair benefits account'. In this paper I argue that the thin definition of fairness presented by Emanuel et al, and subsequently endorsed by Gbadegesin and Wendler, does not provide a notion of fairness that is adequately robust to support a fair benefits account of exploitation. The authors present a procedural notion of fairness – the fair distribution of the benefits of (...) research is to be determined on a case-by-case basis by the parties involved in each study. The fairness of the distribution of benefits is not assessed against an independent normative standard. Emanuel et al.'s account of fairness provides a framework for objecting only to transactions that occur without the fully informed consent of the weaker party. As a result, a debate about exploitation collapses into a debate about consent. This is problematic because, as the proponents of the fair benefits framework acknowledge, neither the trial participants' consent nor the host community's consent preclude exploitation. Attempts to stipulate normative standards of fairness to protect research subjects in developing countries have been controversial and divisive, and it is therefore understandable that bioethicists would be tempted to develop accounts of exploitation that are independent of such prescriptive principles. I conclude, however, that the utility of the fair benefits model of exploitation as a policy tool will ultimately depend on whether a substantive principle of fairness can be developed to underpin it. (shrink)

At least since the seminal work of the (US) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s, a fundamental distinction between research and practice has underwritten both conceptual work in research ethics and regulations governing research involving human subjects. Notwithstanding its undoubted historical importance, I believe the distinction is problematic because it misrepresents clinical inquiry. In this essay, I aim to clarify the character of clinical inquiry by identifying crucial contextual constraints on (...) justification constitutive of clinical science. This analysis shows that, from an epistemological point of view, clinical research and clinical practice are not sharply distinct but intimately intertwined. This result is important in its own right—an enriched understanding of the epistemology of clinical research is valuable in and of itself. But this result is also important because it has profound implications for the ethics of human subjects research. (shrink)