A growing proportion of clinical research funded by pharmaceutical companies, high-income country research agencies, and not-for-profit funders is conducted in low- and middle-income settings. Disparities in wealth and access to healthcare between the populations where new interventions are often tested and those where many of them are ultimately marketed raise concerns about exploitation. This chapter examines several ethical requirements frequently advanced as mechanisms for protecting research subjects in underserved communities from exploitation and evaluates the effectiveness of those mechanisms as responses (...) to exploitation worries. It goes on to highlight where the conceptual frameworks relied upon by research ethicists must be improved if we are to fully understand the nature of the moral claims and obligations that arise in research conducted in underserved communities. (shrink)

Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because these assessments often involve value (...) judgments for which there are no agreed-upon objective standards, we rely on deliberative procedures thought to have the greatest likelihood of producing the right or best outcomes. Concerns about the potential for improperly functioning IRBs to waste scarce human and institutional resources and impede biomedical progress have motivated a surge in empirical research assessing their procedures and outcomes. Yet within this literature, there has been minimal attention paid to the social scientific evidence regarding how individuals and deliberating groups make decisions, nor how those data might inform IRB practice. This essay seeks to fill that gap, locating recent empirical data on IRB composition and process within the context of data regarding what I call “deliberative pathologies,” or instances when deliberation fails to live up to one or more aspect of the deliberative ideal because of systematic biases in the ways participants interact. The paper goes on to make evidence-based recommendations to reduce the vulnerability of IRB deliberations to the kinds of pathologies discussed and indicate directions for future research. (shrink)

Since the 1988 Cartwright Inquiry, lay members of ethics committees have been tasked with ensuring that ordinary New Zealanders are not forgotten in ethical deliberations. Unlike Institutional Review Boards in North America, where lay members constitute a fraction of ethics committee membership, 50% of most New Zealand ethics committees are comprised of lay members. Lay roles are usually defined in very broad terms, which can vary considerably from committee to committee. This research queries who lay representatives are, what they do, (...) and what if anything they represent. Our findings are based on data collection with 12 participants: eight semi-structured interviews with lay members from diverse types of ethics committees who described their roles, and commentary from four ethics committee chairs, three of these lay members who commented on this article’s final draft. Findings indicate that the role of New Zealand lay persons – although distinctively valued – is otherwise similar to the documented role of lay persons within North American ethics committees. Lay members see their role as primarily protecting the research participant and at times offering a corrective to non-lay members’ views and the interests of their institutions. However, in spite of their numbers, most lay members do not see themselves as representing any particular constituent groups or institutionally unaffiliated areas of concern. On tertiary education committees especially, there is a good deal of ambiguity in the lay role. (shrink)