Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform.

When the clinical center of the National Institutes of Health (NIH) opened more than a half a century ago, its director required that independent committees review any research that posed high or unusual risks for its human subjects. In 1966 the requirement for independent review was extended to all human subjects research funded by the NIH, and in 1974, this was codified as federal law by the National Research Act. The law required organizations seeking funding from the U.S. Public Health Service to form committees that would review the adequacy of protections for human subjects. The committees—which came to be known as “institutional review boards,” or IRBs—were specifically charged with assessing the safety of the proposed research and the adequacy of the consent to be obtained from the research participants. A survey conducted the year after the new law was enacted found overwhelming support for IRBs among researchers, with 91 percent of the respondents agreeing that IRBs protect patients and 70 percent supporting the statement that IRB review improves the overall quality of research (Gray, Cooke, and Tannenbaum 1978). The researchers did have some reservations, however. Approximately half the respondents (43 percent of biomedical and 54 percent of behavioral and social scientists) believed that the need to obtain IRB review impeded their research to some extent, and a small number (8 percent) even concluded that the difficulties associated with IRB review outweighed its benefits. In the time since that survey, both the volume of research and the number of IRBs have grown. Between 1995 and 2009, the NIH's research budget increased almost fourfold, from $7.7 billion to almost $30 billion (US DHHS 2009), while the number of IRBs grew at more than double that rate, from 491 in 1995 to almost 4,000 by 2008 (Catania et al. 2008). During this interval, there also were a number of government-commissioned evaluations of IRBs, as well as the wider system for protecting human research participants, which largely concluded that reforms were necessary to ensure adequate protections (Bell, Whiton, and Connelly 1998; Federman et al. 2003; NBAC 2001; US DHHS 1998; US GAO 1996). Although there has not been any broad-based effort to examine the corollary impacts that IRB review might have on research, the U.S. Department of Health and Human Services (US DHHS) recently announced its intention to reform the regulations that govern such review (US DHHS 2011). Editorials and commentaries from a wide range of clinical and research disciplines characterize IRBs as “slow and cumbersome [and] inconsistent” (Straight 2009, 376) and claim that they unduly delay research (Marsh et al. 2008), create disincentives for research participation (Infectious Diseases Society of America 2009), do not have the requisite expertise needed for review (Emanuel et al. 2004), and, more generally, impose a “staggering” cost on the research (Gordon et al. 2003). More pointedly, some people have argued that even though many of the costs and constraints resulting from IRB review are necessary, other costs constitute an unnecessary “burden” because they do not increase the research participants’ protections.