What Is Compliance? How Audits Change Ethics and Organizational Fields

In 1995, Sarah Babb was a graduate student at Northwestern University in the Department of Sociology. She had recently arrived in Mexico City for dissertation research on economic planning and had never heard of an Institutional Review Board (IRB). ¹ In 2017, in the waning days of the Obama Administration, the federal government announced the first major overhaul of human-subjects regulation in more than four decades. In the years between her dissertation research and the regulatory overhaul, Babb was hired at Boston College, promoted through to full professor, and tasked with chairing the college’s own IRB—the local iteration of the peculiar, pervasive, and mostly reviled American structure mandated by federal regulations. Babb’s aim in the brisk, smart new book Regulating Human Research: IRBs from Peer Review to Compliance Bureaucracy is to characterize the period when IRBs went from being a vague notion in the lives of most social scientists to an active presence that was impossible to miss.

The book is about how IRBs came to be oriented toward regulatory compliance rather than toward ethically protecting research participants, as they were imagined in their earliest, most righteous (and hopeful) moments. It joins a shelf of books that document and explain precisely why the U.S. administrative state has been incapable of supporting thick public discussions and decision-making practices around moral questions. Those books have come from either economic and organizational sociologists (such as Wendy Espeland, Carol Heimer, Sarah Quinn, and Viviana Zelizer) or from sociologists of science, including John Evans, Sheila Jasanoff, Shobita Parthasarathy, and Stefan Sperling. Babb’s book cross-indexes to each of these subfields, as well as to medical sociology and research methods, making it broadly relevant for the field of sociology. (Pick Chapter Five for a quick, current take on IRBs to assign in a methods course.)

In 1974, the U.S. Congress passed the National Research Act on the heels of public revelations about the horrific Tuskegee Syphilis Studies—long-standing, government-funded, racist research on African American men in Alabama. Researchers’ abuses had been going on for decades, but they were exposed at that historical moment because of the (alas, incomplete) successes of the U.S. Civil Rights Movement. The revelations were an occasion for high-ranking federal bureaucrats to lift the U.S. government’s own internal research review system to the law of the land. The government’s aim was to deflect legal and financial responsibility for the researchers it funded to the universities and hospitals that employed them. Until the 1970s, legal responsibility for ethical transgressions in research was essentially unlegislated and untested in courts (Stark 2012).

The laws have changed little since 1974, but the extent of federal enforcement has careened. Methodologically, Babb makes the wise choice, then, to treat changes in federal enforcement of laws, rather than changes in the laws themselves, as the relevant inflection points for the story. Although the book is mostly historical (in the mode of “recent history”), Babb includes quotations from interviews with 54 people in the IRB world (including federal regulators, local IRB staff members, ethics consultants, and well-placed others) to amplify what she finds in published sources and knows from personal experience as an IRB chair. But the changing intensity of enforcement is only part of the story.

The particular technique the federal government has used to enforce the regulations has made all the difference in producing the current, packaged flavor of IRB offices. The government’s enforcement technique of choice—the audit—is a convenient option for an agency that has never been properly funded nor had enough staff members, in Babb’s view. To the extent that universities and hospitals comply with the regulations, they do so because federal regulators reserve the right to stop by for a site visit, poke around in IRB files, scroll through records, and more. Yet there is a range of ways that the federal government could enforce regulations. Equal Employment Opportunity regulations, for example, are enforced through threat of litigation and court precedent. Financial regulations, like human-subjects rules, have been enforced primarily through audits. Babb’s excellent final chapter (Chapter Six) compares enforcement techniques and their consequences for these three types of regulation and in doing so makes the chapter useful for organizational sociologists, legal studies scholars, and many others.

The U.S. government’s use of audits prompted the emergence of the defining feature of ethics review as an organizational field since the 1990s: that is, corporatization. Conventionally, the field has been imagined in terms of relationships between state agencies and research institutions. Regulating Human Research implicitly shows, however, that the organizational field has expanded in the types of corporations present. Most directly, the organizational field now includes independent commercial IRBs whose products are decisions and whose price tags are steep. Historically, ethics review had been exclusively an in-house job. IRBs operated as what sociologist of law Susan Shapiro (1987) calls “trustees”—units within organizations whose purpose was to anticipate outside critics (including regulators) in an effort to stave off actual criticism in the future. Since the 1990s, however, private industry and private foundations have continued to exceed the research spending of the U.S. government, which has largely and shamefully abdicated its responsibilities to robustly fund (social) scientific knowledge in the global public interest. (Consider, for example, the Bayh Dole Act [see Fisher 2020; Robinson 2019].) Research institutions, both public and private, now stand to gain substantially from privately funded (typically) biomedical research, which requires IRB approval before it can begin. The in-house IRBs at busy hospitals and universities proved ill-equipped for the task. In this context, hospitals and universities outsourced decision-making to for-profit independent IRBs, which sold quicker and more “cost-effective” decisions on contract—all with better “customer service.” Such business-speak is noteworthy, as Babb keenly points out in Chapter Four. It is the lingua franca of IRB offices today, regardless of their institutional location, and an import from the for-profit corporate world from which commercial IRBs emerged.

IRB offices located within universities and hospitals adopted the practices of corporate bureaucracies because federal regulations were enforced by audit. Irregularities in record-keeping could (and did) shut down all research at an institution, not only the study in which a problem was found. In the logic of the audit, any surface imperfection was the visible evidence of a system potentially flawed to the core. In spot-checks, regulators were unable to judge the quality of decisions—all matters of context, trust, and circumstance, the theme of sociologist Adam Hedgecoe’s work on research ethics committees in the United Kingdom (2012), which Babb notes in a brief, useful closing section on comparative ethics review. U.S. regulators knew they had neither the capacity nor the skill to assess experts’ deliberations about the moral implications of research in a nearby community, for example. Instead, audits were successful to the extent that local IRB offices could produce evidence that regulatory procedures had been followed. As John Evans (2000) has crisply shown, the wager of ethics regulation is that if procedures are followed, any person will arrive at an appropriate decision. Thus, auditors wanted files full of completed study applications, standardized consent forms, and meeting minutes that cited the section of federal code on which decisions were based—preferably spell-checked.

Producing this kind of evidence was beyond the ken of vintage IRB offices, which were typically “offices” only in name. IRBs were committees of at least five faculty members (or doctors, depending on the institution)—plus a volunteer community member because it was required and a secretary because it was convenient. This work was a nibble of professors’ and doctors’ labor time; it was not a location where they went. Vintage IRB offices fulfilled the requirements of the law “approximately,” as Babb puts it, like cooks who make a successful meal by following the recipe more or less.

Call most IRB offices today, however, and a full-time office staff member, likely a Certified IRB Professional (CIP), will answer the phone in a dedicated physical space (COVID dependent). The audit-logic’s demand that offices produce documents and records, coupled with a growing portfolio of top-dollar research, prompted most universities and hospitals to hire full-time, specialist administrative staff members. Babb documents the invention of this new profession—namely, the CIP—which was underwritten by a new nonprofit corporation in the field of ethics review that trained and credentialed IRB staff. (Although Babb insists that expert members of IRBs are “amateurs” and only CIPs are “professionals,” there is a fascinating project still to be done on how professional jurisdiction is negotiated when a new profession enters a field, akin to the negotiation of doctors and pharmacists in medicine.) In Chapter Two, Babb crystalizes what students of this topic have only suspected and researchers known anecdotally: IRB office staff (not experts in researchers’ areas) make consequential judgments in the course of doing administrative work. These judgments alter the research process and therefore what can (and cannot) be known in the name of (social) science. Laws on paper are always matters of interpretation in practice, as Michèle Lamont (2012), Marion Fourcade (2011), and others describe in their important studies of (e)valuation.

A bounty of ethics-adjacent corporations emerged starting in the 1990s to make products that IRB offices especially valued. These products helped keep the relationship between research institutions and regulators happy, or at least manageable, given that the relationship was now oriented around the audit technique. It was also unfolding in the context of massive private funding for research and, sadly, when it was clear that the survival of American universities and hospitals depended on that private research money. The products included online training platforms (like the loathsome CITI platform), protocol management software, and other “tools” (forms, checklists, and templates), as well as accreditation certifications and professionals themselves. These corporate products, along with their “best practices” and “standard operating procedures,” promised to make the ethics review process speedier and cheaper: that is to say, mass-producible.

Regulating Human Research is best read as a set of linked essays. Though arranged chronologically, the book rewards time with the concepts self-contained in each chapter, rather than insistence on a satisfying causal account across the chapters. True to Northwestern roots, Babb is committed to applying Weber’s classic insights about bureaucracy and offers an uncomplicated reading of Economy and Society. For the most part, the aim is not to query or substantially refine the nineteenth-century ideal-type of German bureaucracy for twenty-first-century lived practice.

Babb updates Weber, however, with the marquee concept of the book, the “workaround state.” With this concept, Babb links out to sociologists seeking to characterize the modern administrative state. The notion of the “workaround” is presented as a fresh adjective to help sociologists understand how the state functions. There are generative links still to be made to sociologists of science who have theorized “the workaround”—understood as an improvised practice that allows an actor to accomplish a goal despite a structural incumbrance (physical, legal) that prevents them from accomplishing the goal through direct, conventional means. Owen Whooley, for example, analyzes workarounds that psychiatrists develop to allow patients to access treatments that would be inaccessible if practitioners followed official diagnostic criteria. Whooley (2010) builds on sociologists Geoffrey Bowker and Susan Star’s classic articulation (2000) of the concept, defining “workarounds” as ad hoc solutions and strategies “to problems arising when the official protocol is perceived as hindering the assigned task” (2010:456).

It will be important to link Babb’s concept with sociologists theorizing the workaround, not only theorizing the state, because it will help clarify Babb’s concept of “the workaround state.” In Babb’s use, “the state” is identified as the source of the constraint prompting the workaround; and at the same time “the state” is regarded as the agent doing the workaround. Thus, the state is both the incumbrance (e.g., the National Research Act) and the improviser (Office of Human Research Protections). In conceptualizing “the workaround state,” Babb wants to flag the fact that the federal government devolves substantial attention to ethics review to local institutions (as required by law) and that private organizations functionally define compliance for regulators who build these corporations’ standards back into their guidelines. Although it is easy to get the gist of Babb’s general meaning and to be convinced of the problem, the book’s conceptual promiscuity with “the state” suggests that readers should pack their own agile theory of the state—one that recognizes, as Babb no doubt agrees, that “the state” is far from a cohesive homogeneous agent, with agencies and individuals often working at cross purposes. Otherwise, some might wonder what is to be gained with the concept of the workaround state, especially when others might simply call this process of devolving responsibilities to the private sphere neoliberalism. It would be exciting to hear Babb’s critiques of the many varieties of neoliberalism and, by connecting to sociologists who have theorized the concept of “the workaround” at the individual level, to discover what we can learn from Babb’s innovative use of the concept at the organizational level.

As Babb was finishing the book, the U.S. government published a major overhaul of human subjects regulations. The new rules were six years in the making—the result of extensive deliberation, public commentary, and extra unplanned revisions to deal with criticisms. The book might seem, then, to compare a bygone era of “approximate compliance” with an era that is itself bygone. But Babb is having none of that. “Like the old rules,” Babb writes, the 2017 rules, despite many fundamental changes, are “complex, ambiguous, and difficult to summarize” (p. 107). Key troublesome continuities are that IRB staff, not topic experts, “would have a central role in interpreting the new regulations” and that “regulators would continue to provide noncommittal non-clarifications about what it meant to comply” (p. 108).

Regulating Human Research builds on the premise that the state is incapable of adequately responding to collective moral questions. The book establishes that the problems associated with standardization and routinization emerged from the U.S. government’s enforcement technique (the audit), which has expanded—and privatized—the organizational field of ethics review. It comes as a surprise, then, that the book doubles down on the need for federal policy fixes to address the problems of research regulation. The book ultimately asserts the superiority of the state whose ineffectuality it has just demonstrated.

Thus the book is an occasion to build alliances with sociologists of science working from feminist, anticolonial perspectives, who have outlined the problems with returning to exclusively state-centric approaches to research governance and documented how human research itself is often complicit in the corruptions and injustices of the administrative state. A good starting point to understand the governance concerns for human research is the inaugural piece from Catalyst on “Science and Justice” (2015) and the special issue from Science, Technology, and Human Values on “Entanglements of Science, Ethics, and Justice” (2013). The scholars behind this work have pushed against ethics governance based on the dominant structures already in place and instead have amplified existing alternatives to state-based governance, conjuring futures that involve truer research justice, in all its complications and inefficiencies. ² Babb’s marvelous book will be invaluable as part of this project for research justice because it precisely maps the surprising organizational terrain of ethics review today.