Research ethics governance will never be the most popular subject in health law, but its importance is hard to overestimate. A significant amount of scientific research involves human participants, whether directly (interviews, observations, or experiments on human subjects) or indirectly (use of human tissue or data). In the absence of such research, our knowledge of human health would be much worse, and so too would our individual lives and collective well-being. Medical progress is contingent on scientific research.
Before almost all forms research involving human participants can take place, though, investigators must submit their project to a committee for review on the basis of ethical soundness and compliance with rules, standards, and principles (found in laws, guidelines, and other regulatory instruments). This committee is known as a Research Ethics Committee (REC) in some countries, like the United Kingdom. In the United States, it is known as an Institutional Review Board (IRB), as the board is connected to a particular institution, be it a university, hospital, or private organization.
Sarah Babb, Professor of Sociology at Boston College, recently contributed to this niche area with a short, empirically informed monograph on IRBs in the United States, entitled Regulating Human Research: IRBs from Peer Review to Compliance Bureaucracy. Babb’s interest in the subject was sparked by her own time serving on Boston College’s IRB. As she writes, she was surprised to learn that she was expected to not only “apply” the classic “Belmont principles” of research ethics, but also to apply guidelines from the “Common Rule” on the regulation of human subjects research and from other sources:
Over time, I came to understand that the image of IRBs as committees charged with weighing ethical dilemmas captured the tip of a much larger iceberg of activities. I could see that there was a more routine form of regulatory decision making that was important, but not widely understood or even acknowledged. (P. 3.)
Her book makes a quick read (indeed, there are only 117 pages of text), and an enjoyable one.
Babb’s central thesis is that IRBs have transformed since the late 1990s from committees of peer reviewers – fellow academics making ethical judgements on the basis of scholarly expertise, but paying little attention to the letter of the regulations—to “compliance bureaucracies,” wherein full-time IRB administrators do much of the heavy lifting, often behind the scenes. Babb defines compliance bureaucracy as “a nongovernmental office that uses skilled staff—compliance professionals—to interpret, apply, and oversee adherence to government rules” (P. 5.) In this transformed governance environment, faculty board members still participate in terms of voting on whether to approve a project or expedited research protocols, but their work is simply not possible without IRB staff. This transformation, Babb argues, was due primarily to the growth in IRB scrutiny in the late 1990s by the Office for Human Research Protections (OHRP), which is situated in the federal Department of Health and Human Services. In turn, there was consequential growth in funding from research institutions to invest in IRB administration to better manage the risk associated with OHRP audits and enforcement actions. IRBs today are led not by peer reviewers, then, but rather a professionalized service of research administrators who know the nuances of IRB management. Babb’s case is summarized thusly:
…human research protection bureaucracies supplanted amateur IRBs both because they could make sense of the rules and because they were better equipped to manage the demands of auditable compliance. They could meet regulators’ demands for precisely recorded, auditable indicators, while addressing organizations’ need for efficacy, as compliance became increasingly intrusive and expensive. (P. 11.)
A second thesis that Babb advocates is that independent IRBs—IRBs disconnected from an academic institution and run for-profit – have proliferated in the last two decades, in large part due to two reasons: (1) the high cost now associated with running an IRB at an academic medical center or institution, and (2) the perceived high competence and fast turn-around time that private IRBs offer. Independent IRBs now review the majority of privately sponsored biomedical research, such as research sponsored by pharmaceutical companies). These independent IRBs have influenced the whole IRB apparatus in recent years, foremost those still situated at universities and at affiliated academic medical centers. The standards set by independent IRBs have spread by way of market competition, private accreditation, and the desire to adopt widely accepted best practices. There are plenty of concerns one may have about independent IRBs—and Babb does share her own concerns and acknowledges the benefits of a centralized government role in human research protections (as in the United Kingdom). Yet she rightly points out that a market-driven, privatized system can carry some advantages depending on legal and socio-political context. In the United States, a key advantage is that it can provide protections beyond the reach of antiregulatory politics, which are more pronounced than in almost any other country. As Babb writes, “In the case of our protections for human research subjects, it is important to clearly understand the imperfections—but also to acknowledge that our workaround framework is a great deal better than nothing. In this day and age, there is something to be said for that”. (P. 117.)
Babb’s central thesis is, on the whole, convincing. In large part, it is evidenced by the corpus of empirical data she has gathered through interviews over many years. I somewhat agree with her claim that this transformation is largely an example of the quirkiness of American governance, whereby in the absence of strong centralized government activity, governance is delegated (and strongly decentralized) to local, private actors, sometimes with specialized offices staffed by skilled workers. I would note, however, that professional staff have proliferated in other countries that have research ethics governance structures similar to the United States’, such as Canada, which has “Research Ethics Boards” (REBs) at local institutions. Based on my personal experience, these are also largely run and managed by full-time staff. Similar instances may also be found in other federal systems with decentralized research ethics governance structures, such as Australia.
While Babb may overplay the American-ness of the story, it remains the case that a transformation has indeed taken place in how IRBs function in the United States, and that the growth of independent IRBs, many of which lack adequate transparency and accountability, is cause for concern. Babb’s book makes for an interesting comparison to work done by ethics committees in other countries, such as the National Health Service RECs in the United Kingdom, which I recently investigated. I found that while professional staff are also crucial for the work that is done by NHS REC members, the members still very clearly play the central role. While I didn’t investigate the transformation question per se that is at the heart of Babb’s book, I would venture to say that there has been some shift over time in NHS RECs from peer review to a limited form of compliance bureaucracy, but it is not nearly as pronounced as it is in the United States. What is certainly the case, though, is that ethics committees should be seen as regulators in their own right.
In sum, Babb’s book is a welcome addition to the scholarship on research ethics governance. For those interested in this area of health law, it is a must-read.