The institutional review board is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published (...) between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality and considerably fewer on the assessment of risks and potential harms, study design, and subject-selection procedures. (shrink)

The institutional review board is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published (...) between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality and considerably fewer on the assessment of risks and potential harms, study design, and subject-selection procedures. (shrink)

In this essay, I offer some reflections on how the topics were identified and approached by the Presidential Commission for the Study of Bioethical Issues, on which I had the honor to serve, in the hope that the reflections may be useful to future national bioethics commissions. In the executive order that established the bioethics commission, President Obama explicitly recognized the ethical imperative to responsibly pursue science, innovation, and advances in biomedical research and health care, and the importance of national (...) attention to these issues. The bioethics commission prioritized practicable, actionable, targeted recommendations. Like most earlier U.S. national bioethics commissions, President Obama's commission did not undertake projects on significant and troublesome issues related to health and health care that were not associated with new science or technology. Issues such as health care access, health care delivery, opioid addiction, end‐of‐life care, and physician‐aid‐in‐dying are topical and ethically complex areas of significance to bioethics, and they are also being discussed and debated by the public, the media, and policy‐makers. In my view, there are good reasons to select and prioritize projects as well as a justification for confining commission efforts to issues related to novel science and emerging technologies, when there is only one national‐level bioethics commission that has been established by the Office of the President. (shrink)