The critique of vulnerability offered by Levine et al. (2004) affirms recent discussions about the disutility of this imputed characteristic of individuals and groups for protecting research subjects. Being “too broad,” vulnerability stereotypes whole categories of individuals, and everyone might be considered vulnerable. Being “too narrow,” vulnerability’s focus on group characteristics diverts attention from features … Read more

There are increasing expectations about the potential of medical research to produce clinically significant benefits. And the increasing public demand to participate in clinical research reflects expectations that individuals can directly benefit from research participation. At the same time, there is growing concern about the adequacy of the system of institutional review boards (IRBs) to … Read more

Over the past decade, the number of clinical trials registered with the Food and Drug Administration (FDA) has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of … Read more

On 2 October 1996 the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) each published a final rule allowing emergency research to proceed without the consent of its participants in a strictly limited circumstance. This waiver of informed consent applies to “research activities that may be carried out in … Read more

Somewhere near the end of a consent form, script, recruitment letter, or brochure, researchers usually state that they will keep information “confidential.” But how is this promise evaluated by the Institutional Review Board (IRB) and kept by the researchers? Given the researchers’ confidentiality plan, the IRB must assess the risks related to participation, including risks … Read more

Background. Over the past decades there have been tremendous efforts to improve the ethical conduct of research involving humans throughout the world. As a one-size-fits-all philosophy can no longer work, most countries have developed specific legal and ethical guidelines for research, tailored to their own context. We reviewed South African (SA) ethical guidelines and Health … Read more