Us Irbs Confronting Research in the Developing World

Abstract

Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear. METHODS I conducted in-depth interviews of 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%). RESULTS US IRBs face ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs’ quality, resources and training; and health systems in some countries may have long-standing practices of corruption. These IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures’ differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, ‘negotiate’ for maximum benefits for participants and fearing ‘worst-case scenarios’. CONCLUSIONS US IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice.

The Myth of Community Differences as the Cause of Variations Among IRBs

“…As described elsewhere, I interviewed 46 chairs, administrators, and members by telephone for 2 hours each (Klitzman 2011a; Klitzman 2011b; Klitzman 2011c; Klitzman 2011d). In brief, from the list of the top 240 U.S. institutions by National Institues of Health (NIH) funding, I e-mailed the IRB leaders of every fourth one ( n = 60).…”

“…Interviewees discussed how they defined, viewed, and addressed RI, based in part on how they interpreted and applied federal regulations, which they did in differing ways due to a variety of factors. Interviewees varied in how they saw and approached the roles and responsibilities of IRBs and conflicts of interest (Klitzman 2011b); how they viewed and interacted with researchers, federal agencies, institutions, industry funders, central IRBs (Klitzman 2011c), and developing-world IRBs (Klitzman 2011d); and how they were affected by histories of violations of RI and audits at their own and other institutions, and psychological and personality issues on their IRB. They described how and why their IRBs differed in these and other regards.…”

Barriers to Effective Deliberation in Clinical Research Oversight

“…Recent empirical research has examined several dimensions of IRBs governing clinical research. Studies have sought to characterize the composition of IRBs (Schuppli and Fraser 2007), differences in IRB process (Larson et al 2006), the nature and cause of outcome differentials (Abbott and Grady 2011;Klitzman 2011), how IRBs interact with their broader institutional settings (Klitzman 2013c), the extent to which IRBs successfully apply the Common Rule federal regulations for ethical research (Lidz et al 2012a), as well as how IRB members perceive and address a variety of different issues that arise during prospective review (Klitzman 2012b(Klitzman , 2013a(Klitzman , 2013b. Such research helps to highlight where oversight processes may break down or have room for improvement.…”

How IRBs view and make decisions about coercion and undue influence: Table 1

“…In these interviews, issues concerning coercion and undue influence frequently arose. Interviewees’ perceptions of RI were related to how they saw and addressed conflicts of interest,17 central IRBs,18 relationships with researchers19 and the so-called ‘community’ members,20 variations between IRBs21 and research in the developing world 22. Interviewees also discussed how they saw and approached issues related to coercion and undue influence.…”