The Ethical Imperialism of the NAS

The National Academies of Sciences, Engineering, and Medicine’s Committee on Federal Research Regulations and Reporting Requirements has released the second part of its report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The new part includes a chapter on “Ethical, Legal, and Regulatory Framework for Human Subjects Research.” While presenting valid critiques of the NRPM, the chapter ignores the voices of scholars in social sciences and the humanities. Its proposals are unlikely to be adopted, and if they were they would continue the half-century history of marginalizing those disciplines.

Bioethicists learn from history

Now that I’ve had my rant about the Belmont Report’s year of publication, I can turn to the more substantive arguments of Barron Lerner and Arthur Caplan’s recent essay, “Judging the Past: How History Should Inform Bioethics." These scholars wisely argue against simplistic condemnations of past behavior, yet they also reject the other extreme of attributing all past misbehavior to the age rather than the individual. By understanding what choices were open to actors in the past, we can better assess the morality of their actions and the choices that we ourselves face.

[Barron H. Lerner and Arthur L. Caplan, “Judging the Past: How History Should Inform Bioethics,” Annals of Internal Medicine 164, no. 8 (April 19, 2016): 553–57, doi:10.7326/M15–2642.

Medical researchers call for IRB clarity

Two medical researchers and a bioethicist, all affiliated with the UC Davis Center for Healthcare Policy and Research, call for IRBs to “reduce researchers’ frustrations and foster greater trust” by offering “transparency and accountability around IRB decisions.”

[Stephen G. Henry, Patrick S. Romano, and Mark Yarborough, “Building Trust Between Institutional Review Boards and Researchers,” Journal of General Internal Medicine, May 2, 2016, 1–3, doi:10.1007/s11606–016–3721–3.

NPRM Comments Focus on Biospecimens

The Council on Governmental Relations (COGR), with support from the Association of Public and Land-grant Universities (APLU), has reviewed and analyzed (they don’t say “read”) all 2,186 public comments submitted in response to the 2015 NPRM. The analysis suggests that the debate over biospecimens is crowding out discussion of other proposed reforms.

[Council on Governmental Relations, “Analysis of Public Comments on the Common Rule NPRM,” May 2016. h/t Michelle Meyer.]

NSF Officer Misstates Belmont and Common Rule Standards

In the final contribution to the PS symposium, Lee Demetrius Walker, currently serving as program officer for the Political Science Program at the National Science Foundation, acknowledges the problems of applying a biomedical review system to social science. But he misstates the Belmont and Common Rule standards for assessing research.

[Lee Demetrius Walker, “National Science Foundation, Institutional Review Boards, and Political and Social Science,” PS: Political Science & Politics 49, no. 02 (April 2016): 309–12, doi:10.1017/S1049096516000263.]

Schrag Reviews Klitzman, Ethics Police?

Just in time for the NPRM comment period, Society has published my review of Robert Klitzman’s book, The Ethics Police?: The Struggle to Make Human Research Safe (New York: Oxford University Press, 2015). I note that “By offering the subjective worldview of IRB members, Klitzman shows how good intentions combine with ethical ineptitude to produce arbitrary decisions.”

Per my agreement with Springer, what follows is the accepted manuscript of the review. The final publication is available at Springer via http://dx.doi.org/10.1007/s12115–015–9935-x.

Elliott Still Wants to Scrap IRBs

Writing in the New York Times about a series of scandals at the University of Minnesota, bioethicist Carl Elliott calls for the IRB system to be abandoned and replaced with “a full-blown regulatory system.” This is essentially the same argument he made in the New York Times in 2011, when the ANPRM was issued.

[Carl Elliott, “The University of Minnesota’s Medical Research Mess,” New York Times, May 26, 2015.]

Research Ethics Scales and Measures

Dr. Elizabeth Yuko kindly points me to Research Ethics Scales and Measures http://researchethicsmeasures.org/, a website run by Fordham University's Center for Ethics Education.

The website features a bibliography of publications about empirical assessments of researchers' and participants' experiences with human subjects research. Many concern medical research, particularly dealing with HIV, but they may be of interest to social researchers as well.

For additional pieces on this theme, please search this blog for the tag "empirical research."

Report from the National Academies Workshop

Last week I attended the Revisions to the “Common Rule” in Relation to Behavioral and Social Sciences Workshop sponsored by the National Academies.

I live-tweeted the event on my @IRBblog account, and I have collected those tweets on Storify.

What follows are what I consider some of the key messages from selected presenters. The statements following each name represent my summary of the remarks, not necessarily a quotation or paraphrase.

On Signing the Markingson Petition

By April 1942, the Pentagon was 40 percent over budget, partly because it had been enlarged since first approved, but mostly because the original estimate of $35 million had never been realistic. Lieutenant General Brehon Somervell delayed telling Congress, but in June he finally sent Colonel Leslie Groves to appear before a House Apppropriations subcommittee.

National Academies Run Workshops on Common Rule Revisions

The National Academies are running workshops on "Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences." I was unaware of the first two meetings in January, but I hope to attend the upcoming meetings on March 21 and 22.

A Credible Social Assurance

I am reading Alex John London's claims that IRBs help to "provide a 'credible social assurance' to the American people that social institutions, funded by their tax dollars and empowered to advance their health and well-being, work to: respect and affirm the moral equality of all community members; prevent the arbitrary exercise of social authority; and help create a 'market' in which the diverse stakeholders, often working to advance diverse ends, collaborate in a way that advances the common good."

I am reading Carl Elliott's accounts of the difficulties he has faced trying to use the IRB system at a public university to achieve any accountability for the burying of a drug study after it did not deliver the results a drug company wanted.

And I am re-reading Allan Brandt's Cigarette Century, which explains how tobacco companies reacted to early findings that cigarette smoking causes lung cancer. They promoted the use of filter tips, which didn't trap carcinogens but did turn brown as the cigarette burned. In 1966, Philip Morris executives noted that "the illusion of filtration is as important as the fact of filtration."

Faden et al. Question Research-Treatment Distinction

Writing in a special report of the Hastings Center Report, a team of prominent ethicists and researchers "argue that conceptual, moral, and empirical problems surround the received view that we can and should draw sharp distinctions between clinical research and clinical practice." Yet they decline to detail the implications of any regulatory change for IRB review of medical research, much less research in the social sciences and humanities.

[Kass, Nancy E., Ruth R. Faden, Steven N. Goodman, Peter Pronovost, Sean Tunis, and Tom L. Beauchamp. "The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight." Hastings Center Report 43, no. s1 (2013): S4–S15. doi:10.1002/hast.133. h/t Yashar Saghai]

Armchairs vs. Evidence in the Journal of Law, Medicine & Ethics

Last week I promised some comments on the Winter 2012 issue of the Journal of Law, Medicine & Ethics, which features a symposium entitled "Research Ethics: Reexamining Key Concerns."

The contributions reinforced my sense that the IRB debate is in part a contest between evidence-based approaches and armchair ethics.

Journal of Law, Medicine & Ethics Symposium Reexamines Research Ethics

The Winter 2012 issue of the Journal of Law, Medicine & Ethics features presented at a November 2011 Wake Forest University Center for Bioethics, Health, and Society presented a conference entitled "Research Ethics: Reexamining Key Concerns."

Is Ethics Review Like a Building Permit?

In the course of his response to Dyck and Allen, David Hunter also challenges claims by Whitney and Schneider that ethics review costs lives by delaying research for months or years. I am unpersuaded by Hunter's claims.

Health Researchers Learn that Ethics Review Really Is Creepy

Three Canadian scholars with backgrounds in various approaches to health research and bioethics find that, contrary to their expectations, many REB members and staffers believe that "ethics creep" is real. The authors have collected interesting thoughts from REB staff and members, but the authors' analysis and their own proposals for reform are unclear.

[Adrian Guta, Stephanie A. Nixon, and Mike G. Wilson, "Resisting the Seduction of 'Ethics Creep': Using Foucault to Surface Complexity and Contradiction in Research Ethics Review," Social Science & Medicine available online 25 September 2012, DOI: 10.1016/j.socscimed.2012.09.019.]

SACHRP Still Lacks Social Scientists

OHRP has announced new members of the Secretary's Advisory Committee on Human Research Protections (SACHRP):

• Chair Designate: Jeffrey R. Botkin, M.D., M.P.H., Professor of Pediatrics and Medical Ethics, Associate Vice President for Research, University of Utah. Term: October 15, 2012 - October 15, 2016
• Thomas Eissenberg, Ph.D., Professor, Department of Psychology and Institute for Drug and Alcohol Studies; Director, Clinical Behavioral Pharmacology Laboratory, Virginia Commonwealth University. Term: October 9, 2012 - October 9, 2016
• Owen Garrick, M.D., M.B.A., President and CEO, Bridge Clinical Research, Inc. Term: October 15, 2012 - October 15, 2016
• Pilar Ossorio, J.D., Ph.D., Associate Professor of Law and Bioethics, University of Wisconsin-Madison. Term: October 15, 2012 - October 15, 2016

Eissenberg's PhD is in Experimental Psychology, and his "primary area of research is the behavioral pharmacology of drugs of abuse, focusing primarily on nicotine/tobacco." Ossorio's PhD is in Microbiology and Immunology. So that's four new members with background in biomedical research of one kind or another, none whose primary interests are in non-medical research.

Can an IRB Ban a Researcher?

In July, the Sacramento Bee reported that the University of California, Davis, had ordered two doctors--J. Paul Muizelaar and Dr. Rudolph J. Schrot--"to halt all human research activity 'except as necessary to protect the safety and welfare of research participants.'" Schrot told the Bee that "To be banned from clinical research makes a career in academic medicine challenging, to say the least."

The Common Rule (45 CFR 46.113) empowers IRBs to "suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects," but it does not explicitly empower them to ban a researcher from all research.

IRBs Impeded Harvard Dissertation on Addiction and Incarceration

Kimberly Sue, a medical anthropologist in Harvard's MD/PhD program, reports that IRB review can seem "a hassle, a nuisance or a stumbling block, as we seek to enact a more relevant and engaged era of anthropology."

[Kimberly Sue "Are IRBs a Stumbling Block for an Engaged Anthropology?" Somatosphere, 9 August 2012, http://somatosphere.net/2012/08/are-irbs-a-stumbling-block-for-an-engaged-anthropology.html . h/t Michelle Meyer]