Final Rule, three months later

It’s been three months since the announcement of the new Common Rule. Some reactions so far:

New Book: The Ethics Rupture

The University of Toronto Press has published The Ethics Rupture: Exploring Alternatives to Formal Research-Ethics Review, edited by Will C. van den Hoonaard and Ann Hamilton. My chapter is entitled, “Ethical Pluralism: Scholarly Societies and the Regulation of Research Ethics.”

PRIM&R and SACHRP Attack Social Science Exclusion

In their comments on the NPRM, SACHRP and PRIM&R oppose the proposed exclusion of “Research, not including interventions, that involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) uninfluenced by the investigators” (§ ll.101(b)(2)(i)); they want such research to be moved from the excluded to the exempt category. But they differ in what they think the consequences of such a move would be; SACHRP thinks that researchers would face low barriers, while PRIM&R sees a chance for its members to continue to exert more control than is authorized by regulations. Both groups fail to represent the researchers most likely to conduct these kinds of studies.

Dingwall Links Ethics Review to University "Command and Control"

Robert Dingwall argues that ethics regulation is just one part of a corporate model that threatens innovative research in universities.

[Dingwall, Robert. “How Did We Ever Get into This Mess? The Rise of Ethical Regulation in the Social Sciences.” Studies in Qualitative Methodology 12 (2012): 3–26. doi:10.1108/S1042-3192(2012)0000012004.]

Schrag Responds to Responses to Schrag

The June 2012 issue of Research Ethics features four responses to my December 2011 essay, "The Case Against Ethics Review in the Social Sciences." Three scholars based in Canada wrote a joint response, while three in Britain wrote individual replies. I am grateful to all of the respondents for their attention, kind words, and challenging critiques.

• Nicholls, Stuart G., Jamie Brehaut, and Raphae Saginur. “Social Science and Ethics Review: A Question of Practice Not Principle.” Research Ethics 8, no. 2 (June 2012): 71–78. doi:10.1177/1747016112445435
• Hedgecoe, Adam. “The Problems of Presumed Isomorphism and the Ethics Review of Social Science: A Response to Schrag.” Research Ethics 8, no. 2 (June 2012): 79–86. doi:10.1177/1747016112445437
• Jennings, Sean. “Response to Schrag: What Are Ethics Committees for Anyway? A Defence of Social Science Research Ethics Review.” Research Ethics 8, no. 2 (June 2012): 87–96. doi:10.1177/1747016112445423
• Bond, Tim. “Ethical Imperialism or Ethical Mindfulness? Rethinking Ethical Review for Social Sciences.” Research Ethics 8, no. 2 (June 2012): 97–112. doi:10.1177/1747016112445423

Since the responses overlap somewhat in their themes, I think it best for me to respond to them collectively.

Dingwall: UK May Enact Research Integrity Rules With Little Scholarly Input

Writing on social science space, Robert Dingwall warns that the United Kingdom's Economic and Social Research Council seems to be crafting burdensome regulations on research integrity without defining the problem to be solved, considering the costs of regulation, or consulting scholarly associations:

REC Forbids Dissertations on Lap Dancing

Robert Dingwall fears that "research ethics is co-opted to infantilize students who are legally adults but treated as if they should never be allowed to risk a bad experience."

[Robert Dingwall, "Better Drowned than Duffers…?," social science space, 19 February 2012.]

The Costs of Ethical Review, Part II

Researchers on both sides of the Atantic are trying to measure how the delay due to ethics review in medical research can harm or kill those who would benefit from innovative therapy.

[Ian Roberts, David Prieto-Merino, Haleema Shakur, Iain Chalmers, Jon Nicholl, "Effect of Consent Rituals on Mortality in Emergency Care Research," Lancet 377, no. 9771 (26 March 2011): 1071-1072, doi:10.1016/S0140-6736(11)60317-6; S. N. Whitney and C. E. Schneider, "Viewpoint: A Method to Estimate the Cost in Lives of Ethics Board Review of Biomedical Research," Journal of Internal Medicine 269, no. 4, (April 2011): 396-402, doi: 10.1111/j.1365-2796.2011.02351_2.x See also The Costs of Ethical Review. Hat tips to Rebecca Tushnet and Simon Whitney.]

The Costs of Ethical Review

In his article on "Regulatory Innovation," discussed here earlier, Scott Burris complains that

the core problem with the Common Rule is the IRB’s power to treat its insights and risk–benefit calculations as ‘‘right answers’’ that may be imposed at no cost to the IRB upon researchers whose own ethical reflection may have led to different, equally defensible conclusions.

Robert Dingwall concurs in his essay, "The Ethical Case Against Ethical Regulation in Humanities and Social Science Research," 21st Century Society 3 (February 2008): 1-12. Though Dingwall is British, he notes that the system there looks "very like US Institutional Review Boards, and their analogues in Canada and Australia." (4) British boards, and British rules in general, fail to account for the costs of ethical review.

This has real consequences. Dingwall relates his own experience:

A colleague and I were recently commissioned by the NHS [National Health Service] Patient Safety Programme to study the national incidence and prevalcence of the reuse of single-use surgical and anaesthetic devices, and to consider why this practice persisted in the face of strict prohibitions. Part of this involved an online survey, using well-established techniques from criminology to encourage self-reporting of deviant behaviour, so that relevant staff in about 350 hospitals could complete the forms without us ever needing to leave Nottingham. However, a change in NHS ethical regulation meant that we needed approval from each site, potentially generating about 1600 signatures and 9000 pages of documentation. Although we never planned to set foot in any site, it would also have required my colleague to undergo around 300 occupational health examinations and criminal record checks. As a result, we were unable to carry out the study as commissioned and delievered a more limited piece of work. Other estimates suggest that the practice we were studying leads to about seven deaths every year in the UK and a significant number of post-operative infections. The ethical cost of the NHS system can be measured by the lives that will not be saved because our study could not investigate the problems of compliance as thoroughly as it was originally designed to. (10)

This is a stark example, but Dingwall sees it as emblematic of a general drag on social research that has consequences for the future of free socieites. Ethical regulation of humanities and social science research, he argues, contributes to "a waste of public funds, serious information deficits for citizens, and long-term economic and, hence, political decline . . . " (10)

Dingwall discounts the need for oversight, arguing that humanities and social science researchers "do nothing that begins to compare with injecting someone with potentially toxic green stuff that cannot be neutralised or rapidly eliminated from their body if something goes wrong. At most there is a potential for causing minor and reversible emotional distress or some measure of reputational damage." (3) I think this takes the case too far. See Sudhir Venkatesh’s Gang Leader for a Day for a recent example of a social scientist who seriously hurt people by breaking their confidences. (The book is recent; the incident took place in the early 1990s.) Dingwall's own research, had it exposed a physician who was illegally re-using devices, would have done irreversible harm to that physician. Rather than arguing that such harms are impossible, Dingwall would be better off arguing that they are a) rare, and b) not likely to be prevented by the forms of prior review now in place.

The Belmont Report calls for "systematic, nonarbitrary analysis of risks and benefits . . . This ideal requires those making decisions about the justifiability of research to be thorough in the accumulation and assessment of information about all aspects of the research, and to consider alternatives systematically." If we were to hold regulatory regimes to the same standard, we would find ample risks, few documented benefits, and no consideration of alternatives.