Regulating Human Research
IRBs from Peer Review to Compliance Bureaucracy
Sarah Babb


Contents and Abstracts
chapter abstract

Institutional review boards (IRBs) are federally mandated committees that have for many decades protected human research subjects from ethical abuses. Sometime around the turn of the twenty-first century, IRBs were transformed from academic committees into compliance bureaucracies: nongovernmental offices where specialized staff oversee, define, and apply federal regulations. This book traces this historical evolution to reflect on the role of compliance bureaucracy in American organizations today, as well as its intended and unintended consequences.

1 The Federal Crackdown and the Twilight of Approximate Compliance
chapter abstract

This chapter traces the origins and demise of a period I call the "era of approximate compliance," which lasted until roughly the late 1990s. During this time, IRBs were typically run by faculty volunteers who, while taking their ethical duties seriously, often paid little attention to the letter of the regulations. The regulatory system left ethical decisions to local boards and relied on the labor of unpaid faculty volunteers. It was overseen by federal offices with limited authority and resources. As the world of biomedical research became larger, more commercialized, and more complex, this framework became increasingly inadequate and outdated. This created the conditions for an outbreak of research scandals—and for a disciplinary crackdown on research institutions.

2 Leaving It to the Professionals
chapter abstract

This chapter describes the circumstances that gave rise to the IRB profession, a new category of expert worker. By sanctioning institutions for noncompliance while failing to fully define what it meant to comply, federal authorities created high levels of uncertainty. Research institutions responded in two ways. First, they adopted the most conservative reading of the regulations, thereby launching what I call the "era of hypercompliance." Second, they hired skilled staff to interpret and apply these regulations, leading to the emergence of a nationwide human research protection profession.

3 Organizing for Efficiency
chapter abstract

This chapter shows how IRB offices responded to powerful pressures to become more efficient. During the era of hypercompliance, the review process came to pose an unacceptable obstruction to the biomedical research enterprise. In response, IRB offices deployed bureaucratic routines to lower the cost of compliance. The rationalization of these offices definitively shifted the locus of IRB decision making from faculty volunteers to full-time administrators and was the defining characteristic of the "era of compliance with efficiency." This reorientation had unintended consequences, including frictions around the exercise of bureaucratic authority over research design and goal displacement.

4 Ethics Review, Inc.
chapter abstract

This chapter shows how the IRB world came to adopt the dynamics, practices, and rhetoric of a private industry. This trend was uneven and was most visible in independent IRBs: boards run as for-profit enterprises, mostly reviewing privately sponsored biomedical research. Yet standards set in the most industrialized sector spread throughout the human research protections world, fueled by the forces of market competition, private accreditation, and professionals' inclination to borrow widely accepted best practices.

5 The Common Rule and Social Research
chapter abstract

This chapter analyzes the expansion of IRB oversight to social and humanities research. With the federal crackdown, these researchers suddenly became enmeshed in a regulatory system designed around the routines of biomedical and other experimental studies. The shift was produced not by new rules, but by changed interpretations of these rules by local institutions during the era of hypercompliance. These interpretations pulled unfunded and exempt research projects into the orbit of the regulations, as filtered through their most conservative reading. Later, however, a social movement among IRBs and other research administrators promoted a more flexible approach, providing some researchers in disciplines like sociology and anthropology with much-needed relief.

6 Varieties of Compliance
chapter abstract

This chapter compares across three different varieties of compliance bureaucracy: Equal Employment Opportunity (EEO), IRBs, and financial services. In all three fields, organizations hired compliance professionals to help them conform to complex and ambiguous rules. However, there was one revealing difference. Both IRB and financial services compliance offices came to embrace efficiency goals, as exemplified by the widespread use of compliance software and outsourcing to external vendors. In contrast, EEO offices did not adopt efficiency-enhancing innovations. I argue that this difference can be attributed to distinct varieties of compliance—those defined by a logic of confidence, assessed by courts that reward recognizable gestures of good faith, and those governed by a logic of auditability, assessed in regulatory inspections that place a premium on meticulously recorded procedural details. The relatively high cost of the latter creates efficiency pressures, which are reflected in the rhetoric and norms of compliance professionals.

chapter abstract

In the conclusion I revisit the major findings of the book, discuss the 2018 revisions to federal regulations governing IRBs, and contemplate the American model in the context of other national systems. Although the new regulations contained some significant changes, they did not represent a major departure from the system's workaround logic. There are numerous benefits to having a more centralized government role in human research protections, as illustrated by the British case. Yet in the American context, there may also be some advantages to a privatized system that provides protections beyond the reach of antiregulatory politics.