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. Study after study recently has reported that this is a system “in crisis,” “in jeopardy,” and in need of thoughtful re-examination.
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.
Honest IRB specialists admit that they operate under constant concern about the one case in a thousand that might slip through review — with the consequence that the other 999 receive exaggerated reviews and risk rejection in an effort to err on the side of caution.
As a consequence, mission creep is causing IRBs to lose the respect and “buy-in” of the very people they are meant to regulate; they are misdirecting their energies, threatening both academic and first amendment freedoms; and most importantly, mission creep is taking needed resources from the most risky research, which truly does need IRB oversight.
Following an invitational, national, interdisciplinary conference held at the University of Illinois, recommendations were formulated to strengthen and reinvigorate the functioning of the internal review boards (Institutional Review Boards or IRBs) at universities and research centers and to gather accurate data on the scope of the problem. Our recommendations focus on fields and methodologies of coverage, and they apply primarily to research outside the biomedical arena.
We recommend collecting data.
The greatest irony of the entire IRB debate is how little of it is informed by actual, reliable research about the facts of the problem. Experts from across the nation have identified very few studies that could even provide accurate descriptive national data (numbers of cases reviewed; numbers of serious abuses; etc.), let alone a more systematic examination of effort and effectiveness of the IRB system. We propose gathering information, both examples of good practices and examples of poor practices. We suggest the latter because the rumors and stories that make their way through the academic or national grapevine are, of course, the most sensationalistic or outrageous — cases where abuses have been most egregious and the punishments or censure have been particularly severe. Such a clearing house of information will ensure that the examples of practices that reduce bureaucratic overhead in ways that still comply with ethical and regulatory mandates are shared and will provide information helpful to other institutions seeking to improve procedures as well as substantive ethical oversight.
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.
IRBs need examples of methodologies that have warranted IRB oversight and those that are exempt. These examples will enable IRBs to determine such things as what is meant by risk and harm, how practice differs from research, and when a subject needs to be kept anonymous and when that is not required. These refined regulations would provide appeal procedures, guidelines specific to social sciences and humanities proposals, and lists of approved exemptions, among other things. Universities might develop different tracks and methods by which to review research proposals, tailoring the review process depending on such criteria as the field and methods of research, as well as the vulnerability of the subjects. This process would allow us to discard the current “one-size-fits-all” approach that relies so heavily on criteria and procedures developed for biomedical research.
We recommend removing some kinds of activity from IRB review altogether.
We recommend focusing on those areas of research that pose the greatest risk, such as biomedical research, while removing or reducing scrutiny of many fields within the social sciences and humanities that pose minimal risk. Some fields, such as journalism and ethnography, and methods, such as oral history, have their own, well-established sets of ethical guidelines and appeal procedures. In addition, they pose virtually no risk to the subjects. In the case of journalism, where a subject might be harmed with the exposure of their activities, as in the case of President Nixon and Watergate, the goal is to benefit the greater good, not the individual. This is another argument for removing journalism and similar fields from IRB oversight.
In conclusion, members of the invited conference and others affected by the IRB system recognize that the 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.
