Outsourcing Ethics

Regulating Human Research: IRBs from Peer Review to Compliance Bureaucracy by Sarah Babb. Stanford, CA: Stanford University Press, 2020.

According to its website, the Office for Human Research Protections (OHRP) in the US Department of Health and Human Services “provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research. . . by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.” In reality OHRP consists of a handful of professionals confined to a small office suite in Rockville, Maryland. There are too few staff to maintain oversight of the thousands of research projects proceeding at any one time, and they are too circumspect to provide useful clarification and guidance.

As sociologist Sarah Babb explains, the consequence of such government incapacity is not freedom but privatization. OHRP may be tiny, but it retains the power to withhold millions of research dollars from a university or a hospital, a power its predecessor at the National Institutes of Health, the Office for Protection from Research Risks, ruthlessly exercised in a spree of enforcement actions from 1998 to 2002. No institution that depends on federal funding and drug approval wants to risk such penalties, but they do not rely on federal guidance to keep them out of trouble. Instead, drug companies, hospitals, and universities have turned to an overlapping set of nongovernmental “compliance bureaucracies” that offer some hope of a clean audit should federal inspectors come knocking. Basing her findings on a sociologist’s understanding of bureaucracy—a term she uses in the nonpejorative sense that Max Weber characterized as rational and efficient—Babb offers an instructive tour of the privatized research ethics industry that has stepped in where government falls short.

The most important compliance bureaucracy, Babb explains, is an institution’s own administrative staff. According to federal law, research with human subjects should be overseen by institutional review boards (IRBs), imagined to be composed mostly of active researchers who provide a form of ethical peer review. Since the late 1990s, however, these boards— composed largely of faculty members—have been unable to keep up with the complexity of the regulations, especially as they are interpreted by zealous federal officials. Administrative staff, often with advanced degrees and long experience in the field, now vet applications far earlier and more scrupulously than the boards themselves. They judge applications not as peer reviewers or ethicists but as bureaucrats who can quickly compare an application to a series of standardized checklists.

Backing up these administrators is a set of interlocking professional institutions. Public Responsibility in Medicine and Research (PRIM&R), a nonprofit, hosts training sessions for administrators and credentials them as “Certified IRB Professionals.” The Collaborative Institutional Training Initiative (CITI) Program provides online certification for researchers. Researchers may get only the most superficial instruction, which warns them not to commit atrocities like those committed by Nazi doctors but fails to explore current ethical debates in the wide range of disciplines that form a university. But institutions get what they want: an audit trail. Ambitious universities can pay heavily—in time and money—for accreditation by the Association for the Accreditation of Human Research Protection Programs, Inc. Or they can outsource all of this work by sending their most valuable research applications to for-profit IRBs for approval. Together, these institutions comprise what Babb calls a “workaround state,” in which the government delegates important functions to nongovernment actors.

Babb interviewed dozens of players in the research world to explain why they rationally embrace this system. Pharmaceutical companies, hospitals, and major research universities prefer a high but predictable expense for compliance to the unpredictable risk of federal penalties. If they act in concert, they can test out minor reforms (such as reviewing ongoing projects every two years instead of annually) with less individual exposure should federal regulators take offense. The competition from for-profit IRBs spurs university offices to greater efficiency. Congress gets to believe that human-subjects research is being monitored without the budget or big-government optics of a larger regulatory structure. And many people make steady livings, or even fortunes, working in the IRB industry. Because the system works so well for so many, a major reform effort under President Obama fizzled into only modest changes.

The system works less well for smaller colleges and universities that lack the resources to staff large ethics review offices. And it may not work well for the human subjects who participate in research. Based on an apparent absence of “biomedical research scandals” in recent decades, Babb thinks the system is working to protect participants. But scandal is a matter of opinion. This century has seen its share of bad outcomes for participants in research trials, including the deaths of some research participants and the discovery that trials in a dirty, overcrowded facility were overseen by an IRB owned by the spouse of one of the testing center’s executives.

Today’s compliance regime also threatens social scientists whose work is potentially controversial. While Babb, a sociologist, secured exemption from IRB review for her research on this book, she is unsure that a graduate student today would be allowed to do what she did in the 1990s: travel to a semiauthoritarian country and quote professionals by name about their views on government policy. “Whereas a contract research organization (CRO) overseeing a risky biomedical experiment may be treated as a valued client,” she explains, “an unfunded anthropologist who wants to do participant observation may be put through the third degree.” IRB administrators freely told Babb that they believe themselves duty bound to help their institutions avoid negative newspaper headlines, which does not bode well for scholars seeking to explore such topics as social justice or sexuality. While the Obama reforms did free oral historians and journalists from the jurisdiction of the IRB, most scholars will need to find a way to live with the system as it now exists.

As Babb notes, these challenges are similar to those that faculty encounter with other compliance bureaucracies, such as offices governing nondiscrimination. Provosts hire compliance administrators not to make life hard for the faculty but because compliance is hard work, because experts do that work most efficiently, and because the price of noncompliance is steep. Regulating Human Research, among its many contributions, makes this logic clear.

Although she does not say so explicitly, Babb’s insights also point to a strategy for researchers seeking to do their work within a compliance regime. Rather than focus on the IRB itself, which is steadily becoming a less important component of a typical institution’s human subjects protection program, faculty need to shape the compliance bureaucracy. My university established a faculty board that helped to choose the IRB manager and reviews procedures as they are developed or revised. At Australia’s Macquarie University, anthropology faculty developed an ethics training system specific to their discipline to compete with the medically oriented CITI Program. As Australian research ethics scholars Gary Allen and Mark Israel have documented, in Canada, the United Kingdom, and Australia, scholarly organizations have begun to develop standards and practices that may be more comprehensible to the institutional mindset than are pleas from individual researchers. Now that Babb has explained how bureaucracies think about researchers, it is up to researchers to learn to think like bureaucrats.

Zachary M. Schrag is professor of history at George Mason University and author of Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009. In 2012, he served on an AAUP subcommittee on academic freedom and the institutional review board. His email address is [email protected].