The Illinois White Paper

Abstract

Our system of research self-regulation, designed to provide internal checks and balances for those who participate in research involving human subjects, is under considerable stress. Much of this crisis has been caused by what we call mission creep, in which the workload of IRBs has expanded beyond their ability to handle effectively. Mission creep is caused by rewarding wrong behaviors, such as focusing more on procedures and documentation than difficult ethical questions; unclear definitions, which lead to unclear responsibilities; efforts to comply with unwieldy federal requirements even when research is not federally funded; exaggerated precautions to protect against program shutdowns; and efforts to protect against lawsuits. We recommend collecting data. We also call for refinements to our regulatory system that will provide a set of regulations designed for non-biomedical research. This will enable IRBs to direct attention to the areas of greatest risk while intentionally scaling back oversight in areas of lesser risk. We recommend removing some kinds of activity from IRB review altogether. Our system, if not broken, is seriously straining at the seams. It is imperative that we have a respected and effective system in place to protect human research subjects, so that much-needed research into the causes and prevention of disease and other research expanding the boundaries of knowledge can proceed. We hope that this White Paper will further the discussion about what reasonable procedures can be instituted to help get IRBs back on track and do what they were originally meant to do—protect the rights and welfare of human subjects while allowing the research enterprise to progress and its benefits to society to accrue.

Sexual Health Research With Young Black Men Who Have Sex With Men: Experiences of Benefits and Harms

“…The findings from this study provide empirical data for regulatory boards, including local IRBs, about the nature of the potential benefits and harms of participating in qualitative research focused on sexual health and may assist IRBs in evolving from subjective to an evidence-based risk and benefit assessment (Gunsalus et al, 2007; Mustanski, 2011; Wendler, Belsky, Thompson, & Emanuel, 2005). Findings from this study suggest that sexual health research can provide a safe space for YBMSM to share their experiences, express their sexuality, and assist with overall adolescent and sexual development.…”

Spotlight on ethics: institutional review boards as systemic bullies

“…An estimated 3000-5000 IRBs (Brown, 1998;Hamilton, 2005) oversee the research involving human subjects conducted by academics and professional researchers in the US. Though the focus of these IRBs was originally intended to be the oversight of medical research (Brown, 1998), including food and drug trials, their reach has expanded to encompass social science and humanities research (Gunsalus et al, 2007;White, 2007), even when such research involves no or minimal risk to participants. Academics (Bledsoe, Sherin, Galinsky, & Headley, 2007;Gunsalus et al, 2007;Librett & Perrone, 2010;White, 2007) and oversight boards (Brown, 1998) alike have expressed concerns regarding this overextension of IRBs beyond their explicated purpose and, as the opening quotation from the Inspector General of the Department of Health and Human Services acknowledges, have called for IRBs to restrict their oversight to focus resources on addressing the safety and protection of human subjects in higher-risk medical, food and drug research, rather than expending limited resources on policing and policy-making for minimal-or no-risk research.…”

From anonymity to “open doors”: IRB responses to tensions with researchers

“…In the US and elsewhere, IRBs have been increasingly faulted for several reasons, including extension of their review into the social sciences [1], and discrepancies in reviews of the same protocol in multi-site studies, delaying research, and impeding comparison of data [2]. Critics contend that IRBs have become overly bureaucratic, focused on the ethics of documentation [3], and may be “dyfunctional” [4].…”

“…Importantly, though PIs’ complaints about IRBs have been described [1,2,6,10,11], little, if any, attention has been given to whether IRBs respond to these critiques, and if so, how. Yet researchers’ beliefs that IRBs are unfair may dissuade these researchers from fully adhering to research ethics guidelines [12].…”