Vexed Again: Social Scientists and the Revision of the Common Rule, 2011-2018

Abstract

In revising the Federal Policy for the Protection of Human Subjects (Common Rule) between 2009 and 2018, regulators devoted the vast bulk of their attention to debates over biomedical research. They lacked both expertise in and concern about the social sciences and humanities, yet they imposed their will on experts in those fields. The revision process was secretive, spasmodic, and unrepresentative, especially compared to rulemaking in Canada, where social scientists participate in the process, and revisions take place every few years. The result was a final rule that offers some wins for social science and the humanities, but that fails to solve the problems identified by Ezekiel Emanuel and in the 2011 advance notice of proposed rulemaking.

Process, Power, and Impact of the Institutional Review Board in Criminology and Criminal Justice Research

“…If interviews are utilized, a deeper understanding of experiences and recommendations may emerge. Additionally, with recent revisions of the Common Rule in 2018, it is clear that social science researchers continue to be left out of the conversations and criticism of IRBs as the revisions neither ameliorate the concerns of researchers who conduct qualitative research nor require IRBs to implement appeals processes for their decisions that researchers could pursue (Schrag, 2019). Perhaps future research could more intimately explore the impact of the revised Common Rule on various types of criminology and criminal justice research.…”

Implications of the Revised Common Rule for Qualitative Health Research: Opportunities, Concerns, and Recommendations

“…Under the RCR, both qualitative and quantitative noninterventional research and "benign" behavioral interventions involving adults (where no deception is involved) are now exempt from IRB oversight (Schrag, 2019). However, the RCR recommends that investigators not be given the authority to determine their own exempt status.…”

“…In some ways, the RCR addresses longstanding debates about the appropriateness of federal oversight in relation to humanities and social sciences research, particularly noninterventional, qualitative research typical of anthropology and sociology. Critics have argued that the Common Rule, and the subsequent system of IRB review and approval, was developed for and by biomedical researchers and imposed on research fields with no representation in its development and for which it has limited applicability (Peled-Raz et al, 2020;Schrag, 2019). Arguments to limit or eliminate IRB oversight have centered on three key domains: the limited potential harms associated with such research (Dingwall, 2007(Dingwall, , 2008, the challenges of IRB oversight given the nature of qualitative research (Hodge, 2013;Metro, 2014), and the barriers to research created by the bureaucratic nature of the IRB process (Katz, 2006;Lederman, 2006;Lincoln & Tierney, 2004;Shweder, 2006;Wax, 1995;Wynn & Israel, 2018).…”

Research ethics committees, ethnographers and imaginations of risk

“…Likewise, in 2015-2017, Australia's National Health and Medical Research Council undertook to revise the section of its National Statement on Ethical Conduct in Human Research ("the National Statement") pertaining to qualitative research, convening a working group that included an anthropologist and criminologist as representatives from two disciplines that had heavily criticized previous versions of the National Statement for bias toward clinical and quantitative research. In the US context, the Office of Human Research Protections also revised its Federal Policy for the Protection of Human Subjects ("the Common Rule") in 2018, partly in response to longstanding criticisms regarding the over-regulation of social and behavioral research, although many social scientists -and anthropologists, in particular -were disappointed with the extent to which the problems with the original legislation have been addressed (Schrag, 2019).…”