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.

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.

U of Illinois Launches Ethics CORE

The University of Illinois at Urbana-Champaign has officially launched Ethics CORE (NationalEthicsCenter.org), an online resource for education in research ethics.

Fredericton to Host Summit on Research-Ethics Review Alternatives

Will C. van den Hoonaard, author of The Seduction of Ethics, is organizing a conference to be held next month in Fredericton, New Brunswick, entitled "Ethics Rupture: An Invitational Summit about Alternatives to Research-Ethics Review."

Could Guidance and Feedback Replace Rote Compliance?

Murray Dyck and Gary Allen, both of Griffith University in Australia, argue that "the review process should be an advisory and collegial one—not one that focuses on compliance, enforcement and gatekeeping."

[Murray Dyck and Gary Allen. “Is Mandatory Research Ethics Reviewing Ethical?” Journal of Medical Ethics (August 3, 2012), DOI: 10.1136/medethics-2011-100274.]

I Review van den Hoonaard, The Seduction of Ethics

Contemporary Sociology has published my review of Will C. van den Hoonaard's Seduction of Ethics, which I term "a powerful, combined-arms assault on the system of ethics review of the social sciences."

[Zachary M. Schrag, review of The Seduction of Ethics: Transforming the Social Sciences by Will C. van den Hoonaard, Contemporary Sociology: A Journal of Reviews 41, no. 5 (September 2012): 678–679, doi:10.1177/0094306112457769oo.]

OHRP Calls for 2013 SACHRP Nominations Without Announcing 2012 Appointments

OHRP is calling for nominations to fill two SACHRP positions that will open in 2013.

OHRP has not, to my knowledge, announced the new members for 2012, including replacements for two members whose terms expired in July.

How is the public to suggest appropriate names for 2013 when we do not know what qualifications the 2012 appointments will bring to the committee?

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.

AAUP Posts New IRB Report

The American Association of University Professors has posted "Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board," a report prepared by a subcommittee of the Committee A on Academic Freedom and Tenure. I served on that subcommittee, which was chaired by Professor Judith Jarvis Thomson of MIT.

The AAUP press release explains,

In July 2011, the federal government took what may be the first step toward the most substantial change in the regulations since 1981, issuing an advance notice of proposed rulemaking, or ANPRM. More than 1,100 individuals and associations have submitted formal comments.

The AAUP report notes that “out of respect for liberty, it is normally expected that government regulation of behavior will consist in listing what is forbidden, all else being permitted.” The report goes on to suggest ways in which the regulations could be rewritten along these lines.

The Association welcomes comments on the report through September 28.

REB Member: Make Review Process Educative, Not Regulatory

Dominique Rivière, an education researcher at the University of Toronto, reports that REB service left her somewhat less critical of the ethics-review process, but she still calls for significant reform.

[Dominique Rivière, "Looking from the Outside/In: Re-thinking Research Ethics Review." Journal of Academic Ethics 9, no. 3 (2011): 193–204. DOI: 10.1007/s10805-011-9139-y]