Institutional Review Board mission creep: the common rule, social science, and the nanny state.

• Author: White, Ronald F.

In this article, I scrutinize the process by which scientific research on human subjects is regulated by Institutional Review Boards (IRBs). At the outset, let us agree that at least some biomedical scientific research on human subjects must be externally monitored and that whether government should sometimes be involved in that process is at least an open question. We simply cannot forget the lessons learned from Nuremburg and Tuskegee. My argument, however, is that although the IRB process may have been at least marginally well suited to serve its original mission (to protect federally funded biomedical research subjects from physical harm), that process has become buried in an avalanche of new and unrelated socially constructed mandates. Today, the IRB process consumes an inordinate amount of time, energy, and resources in attempting to prevent a growing list of imagined harms, minor harms, or highly unlikely harms. Consequently, IRBs no longer serve their original mandate well. Worse, they have surreptitiously undermined legitimate and useful social science, science education, and freedom of inquiry. Despite a growing body of scholarly criticism, seasoned with IRB horror stories, the beat goes on ("Communications Scholars' Narratives" 2005).

Mission drift denotes a devolutionary process familiar to most scholars who study the history of public institutions: the process of co-opting a successful and well-conceived process (or in this case a marginally successful process), then gradually and mindlessly expanding it until it is no longer capable of performing its original function--the familiar Peter Principle, as applied to institutions (Peter and Hull 1969) The gradual expansion of public schools from relatively simple, locally administered educational institutions to complex socioeconomic institutions remotely controlled by a web of local, state, and federal agencies is a prime example of mission drift. Mission creep, the term I prefer here, signifies a more deliberate, sneaky, and nefarious form of devolutionary change than the more unintentional, randomized "drift" evident in other government institutions.

During the past thirty years, the IRB has devolved to become an ineffective means of regulating the diverse activities that the government ambiguously calls "scientific research on humans." Moreover, the government's continued reliance on monopolistic, one-size-fits-all institutionalized solutions, such as the IRB process, clearly threatens the future of behavioral science, if not of biomedical science, by overloading the system with paperwork and by wasting the time, effort, and resources of everyone involved, including researchers, board members, students, teachers, and government officials. Even more troubling, the process undermines science education and the last vestiges of "academic freedom."

We may well recognize that some IRBs at some institutions are less overworked, more efficient, and less intrusive than others, and therefore are less likely to elicit controversy (Ferraro et al. 1999). Some colleges and universities focus more on teaching than on research, and many of those institutions do not rely on the IRB process to regulate students' behavioral research. In addition, significant puzzles surround the social dynamics that emerge between local IRBs and researchers (Keith-Spiegel 2005). Finally, across the board, many researchers imperceptibly employ IRB avoidance and deliberately design their own research and their students' research to minimize IRB scrutiny. In light of the foregoing considerations, it is difficult to assess scientifically either researchers' satisfaction with the IRB process or the costs and benefits associated with the process as a whole. Prevention of imaginary harms can be especially tough to quantify!

Nevertheless, I argue from a utilitarian standpoint that the protection afforded research subjects across the social-science disciplines by the IRB program is now far outweighed by the costs of implementing it. These costs include not only sacrificed time and energy on the part of government, researchers, and IRB members, but also a variety of long-term, hidden costs, most notably, the undermining of the teaching of social science in colleges and universities.

History of IRB Mission Creep

The history of IRB mission creep is wrought with mind-boggling complexity. The 1960s marked the first rumblings of committee review of federally funded scientific research on human beings. In 1966, Surgeon General William Stewart issued the first federal policy statement on the protection of research subjects in research funded by the Public Health Service. This policy called for "prior review of the judgment of the principle investigator or program director by a committee of his institutional associates" (Levine 1988, 353). This peer review was to monitor the investigators' "judgments" about whether a research project might harm research subjects.

Since 1966, numerous revisions and emendations of that original concept have come forth. In the 1970s, the need for large-scale governmental oversight of biomedical research seemed justified by a series of highly publicized scandals, such as the one related to the Tuskegee Syphilis Study. Back in 1963, behavioral research had it own quasi-scandals, most notably Stanley Milgram's highly deceptive, but nevertheless harmless experiment on obedience and individual responsibility. In 1974, amidst a firestorm of research-related concerns (including fetal research), Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and ultimately passed the National Research Act. This law required the Department of Health, Education, and Welfare (which later became the Department of Health and Human Services [DHHS]) to issue regulations via IRBs for all research the department funded. It also created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Chadwick and Dunn 2000). This regulatory net would gradually be extended to research not funded by government.

Indeed, one of the early symptoms of mission creep is the proliferation of these politically charged "fact-finding commissions" and their subsequent "findings," which, most often, lead to new bureaucratic flow charts that merely reshuffle the structural relationships among watchdog agencies, commissions, and committees within the various levels of government. (The most recent example of such "flow-chart reform" in the United States was the creation of the Department of Homeland Security.)

During the congressional hearings held in the early 1970s, considerable debate occurred concerning the locus of control over scientific research involving human subjects. Would it be at the federal level or at the institutional level? The compromise solution to the control problem was to empower local IRBs to regulate research within their own respective institutions, with the DHHS providing "guidance." Federal "guidance" was initially supplied by the Belmont Report (1979), which stipulated a rights-based moral structure designed to focus IRB concerns on securing the informed consent of research subjects. That moral framework gradually devolved into a mechanical checklist of "do's and don'ts" expressed in increasingly more complex verbiage and convoluted rules. Hence, we have the initial phase of IRB mission creep from the application of deontological moral principles to institutionalized interpretation of those principles embedded in codified rules and procedures.

Meanwhile, the Food and Drug Administration (FDA) developed its own IRB structure that extended not only to federally funded research but to any research involving drugs, biologics, and eventually medical devices. Henceforth, there would be two separate sets of IRB guidelines: one administered by the FDA, the other by the DHHS. In 1981, some of the major differences between these agencies were ironed out, but only the FDA regulations specifically defined the IRB's role: to "assure the protection of the rights and welfare of the human subjects" (21 Code of Federal Regulations, sec. 56. 102 [g]; Chadwick and Dunn 2000). Today, that mandate has been obscured by numerous "flow chart reforms" and the persistent inability of the National Institutes of Health, the FDA, institutions in general, and researchers to communicate effectively with one another.

Beginning in 1991, seventeen federal agencies adopted the "Common Rule" as the basis for their regulation of research. This rule was stated in the text of 45 Code of Federal Regulations Pt. 46, with references to numerous internal documents of the various agencies. As Hamilton observes, "The contrasting language and organization of these documents demonstrates that between 1979 and 1991, regulation became much more specific yet less decipherable, less doable, and even less discoverable" (2005, 192).

Nevertheless, throughout the 1990s, most colleges and universities voluntarily adopted the Common Rule as the basis for regulating both federally funded and non-federally funded research at their institutions. Today, most have institutionalized their own IRBs, which oversee not only federally funded research but all research that produces "generalizable knowledge"--that is, not only biomedical research, but also harmless behavioral research, and not only faculty research, but also student research. Thus, we have the second major phase of IRB mission creep.

In December 2000, the National Bioethics Advisory Commission (NBAC) drafted a report that recommended sweeping changes in the structure and process of IRBs (NBAC 2001). These recommendations portended a whole new level of mission creep by proposing that all research involving human subjects be reviewed, regardless of the locus of funding; that all such regulation be brought under a single agency; and that IRB committee members be certified...