Regulating Human Research
IRBs from Peer Review to Compliance Bureaucracy
Published by: Stanford University Press
184 pages, 140.00 x 216.00 mm
- ISBN: 9781503611221
- Published: January 2020
Institutional review boards (IRBs) are panels charged with protecting the rights of humans who participate in research studies ranging from biomedicine to social science. Regulating Human Research provides a fresh look at these influential and sometimes controversial boards, tracing their historic transformation from academic committees to compliance bureaucracies: non-governmental offices where specialized staff define and apply federal regulations. In opening the black box of contemporary IRB decision-making, author Sarah Babb argues that compliance bureaucracy is an adaptive response to the dynamics and dysfunctions of American governance. Yet this solution has had unforeseen consequences, including the rise of a profitable ethics review industry.
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.
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research became larger, more commercialized, and more complex, this framework became increasingly inadequate and outdated.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.
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.
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.
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.
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.
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.
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.
"It sounded so good: colleagues reviewing each others' projects to ensure that human research subjects were properly protected. And yet that project, like many, went badly off the rails. Sarah Babb's exceptionally lucid book explains how a flexible, locally controlled system morphed into a quasi-legal body of arcane rules, spawned a new profession, and split into private and for-profit branches that do more to protect research institutions than research subjects. Rounding out her story and seamlessly stitching together several fields, Babb explains why the pressures of ambiguous federal rules nevertheless led to quite different compliance bureaucracies in other fields such as financial services and equal employment law. If you have time for only one piece on IRBs—or indeed on responses to federal regulation—this book should be your hands-down choice. Or you could just read it because it's a fantastic and elegant piece of scholarship." ~Carol A. Heimer, Northwestern University and American Bar Foundation
"Beautifully done. Sarah Babb adroitly explains IRBs as but one expression of a general feature of distributed governance in the United States. Like it or not, this is what happens to ethics in complex systems." ~Mitchell Stevens, Stanford University
"Scientific research has long been portrayed as self-regulating, governed by practices of peer review and professionalism. But in recent decades, this self-regulation has been brought into question by research gone drastically wrong and transformed by federal policy. Focusing on institutional review boards, Regulating Human Research uses this case to document how the American state relies on private organizations to interpret and implement policy. In this succinct and insightful account, Sarah Babb illuminates policy developments and organizational changes that have been felt by a wide range of researchers, in academic and commercial institutions alike." ~Elisabeth S. Clemens, Civic Gifts: Voluntarism and the Making of the American Nation-State