Zachary M. Schrag, PhD, a history professor at George Mason University in Fairfax, VA, is the author of the 2010 book Ethical Imperialism, in which he argued, in part, that IRBs have an undue “chilling effect” on research in the social sciences and humanities.

IRB Advisor asked him to weigh in on his past concerns in light of the revised changes to the Common Rule.

IRB Advisor: Discussing the extensive research you performed for your book, you say you found an “arbitrariness and inconsistency [that] is less the fault of any one IRB than a design flaw in the system as a whole.” Can you elaborate on your opinion that the 2011 Advance Notice of Proposed Rulemaking (ANPRM) offered “relatively timid proposals” to address these problems?

Schrag: It proposed no mechanisms to require IRBs to base their decisions on empirical evidence, or to share knowledge across institutions. And the 2017 revisions abandoned one of the boldest proposals from 2011: “a requirement that every institution must provide an appropriate appeal mechanism.” The 2017 revisions offer relief to those scholars whose work will now fall wholly out of the scope of regulation. But for those still in the system, I see little protection from arbitrariness and inconsistency.

IRB Advisor: You have mentioned innovative policies at some universities to free social research from IRB entanglements. Could you cite any current examples of these types of policies, perhaps an approach that suggests a way forward for IRBs and researchers in the social sciences?

Schrag: Several institutions, including my own, have explicitly acknowledged that oral history does not require review. The new Common Rule makes this national policy, so I hope that such statements will no longer be necessary once the rule goes into effect.

In 2011, a number of institutions formed the Flexibility Coalition to explore ways that they could offer alternative procedures for research not directly funded by a Common Rule agency, provided their institutions had not promised to regulate all research to Common Rule standards; i.e., had not “checked the box.” Now that the new Common Rule eliminates the box, all U.S. institutions will have the option of exploring such procedures. For social scientists, a particularly important step would be allowing researchers to determine if their projects are exempt from review, rather than requiring them to submit applications for approval by IRB staff. Ideally, we can return to the 1980s, when exempt meant exempt.

IRB Advisor: You have made the historical point that the Belmont Report is widely interpreted as applying to “all human subject research,” but when consulting the document it actually suggests it does not apply to at least some social science research. Is this a continuing concern, and was there any clarification on this matter in the recently finalized Common Rule?

Schrag: In 1974, Congress passed the National Research Act, which requires funded institutions to establish IRBs “to review biomedical and behavioral research involving human subjects.” The same act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, best remembered today for producing the Belmont Report. But neither the act nor the commission defined “behavioral research,” leading to decades of confusion about the scope of the law. The 2017 revision of the Common Rule continues this failure. It claims to apply to “behavioral and social science research,” even though the Department of Health and Human Services lacks statutory authority to regulate social science.

IRB Advisor: It is intuitive that human medical research entails risk to subjects and warrants ethical protections and informed consent. What risk or ethical imperatives are at stake in interviews by historians or other aspects of social science research? Is this a case of complete overreach, or are there some principles that warrant oversight in the social sciences?

Schrag: Scholars in the social sciences and the humanities have long recognized ethical obligations, including the duties to seek the truth, to honor promises, and to avoid inappropriate invasions of privacy. Scholarly associations in anthropology, sociology, history, and other disciplines have embraced these obligations in their codes of ethics. Professors have taught them to their students, and universities have censured scholars who breach those codes. But prospective review of research plans — IRBs’ primary tool — was developed for quantitative experimentation, and it is not the right tool for ensuring the ethical conduct of evolving qualitative research.