Thursday, February 28, 2013

Journal Retracts Interview-Based Article for Lack of IRB Approval

Retraction Watch reports that Social Science & Medicine has retracted an article based on interviews with Costa Rican healthcare providers, apparently because it did not receive the IRB approval it claimed.

[“Social Sciences Paper Retracted for Lack of Ethical Approval.” Retraction Watch, February 25, 2013.; Goldade, Kate, and Kolawole S. Okuyemi. “RETRACTED: Deservingness to State Health Services for South–South Migrants: A Preliminary Study of Costa Rican Providers’ Views.” Social Science & Medicine 74, no. 6 (March 2012): 882–886. doi:10.1016/j.socscimed.2011.06.045.]

Wednesday, February 27, 2013

Lecture at Brigham Young University

On Thursday, February 28, I'll speak at Brigham Young University. The talk, "Ignorance Is Strength: Pseudo-Expertise and the Regulation of Human Subjects Research," is an updated version of one I delivered at Virginia Tech in 2011.

George Mason University Adopts Shelton Definition, Solicits Faculty Advice

My own institution, George Mason University, has adopted two significant IRB reforms: clarifying the regulatory definition of research, and establishing a faculty advisory board to help shape IRB policies.

Tuesday, February 26, 2013

New Brunswick Declaration Seeks Respect for Researchers and Participants

Back in October, I participated in the Ethics Rupture summit, hosted by the University of New Brunswick and St. Thomas University of Fredericton, New Brunswick.

One product of that conference is the New Brunswick Declaration: A Declaration on Research Ethics, Integrity and Governance. It's only a page long and therefore hardly bears summarizing, but I would note its desire to "encourage regulators and administrators to nurture a regulatory culture that grants researchers the same level of respect that researchers should offer research participants." That shouldn't be a radical demand, but it is.

Saturday, February 23, 2013

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.]

Wednesday, February 20, 2013

Dreger Reviews Stark: It Is Lawyers All The Way Down

Alice Dreger reviews Laura Stark's Behind Closed Doors for the Journal of American History:

Contrary to the self-aggrandizing story bioethicists like to tell about how IRBs arose out of concern for human subjects of research, Stark shows that, when you dig into this history, it is lawyers all the way down . . . She argues that IRB work was decentralized not to make it more ethical, but to protect the NIH from lawsuits. Stark convincingly concludes that IRBs today do not primarily enact ethical principles; they manage procedures.

[Dreger, Alice. “Behind Closed Doors: IRBs and the Making of Ethical Research.” Journal of American History 99, no. 4 (March 2013): 1328–1328. doi:10.1093/jahist/jas666.]

Tuesday, February 12, 2013

Puglisi: ANPRM Is Stalled; Write Your Own Common Rule

Tom Puglisi, director of the Office of Research Oversight in the Department of Veterans Affairs and former director of human subject protections at OHRP, writes that the Common Rule needs reform but believes that the ANRPM is "stalled." He offers the Veterans Health Administration's interpretation of the Common Rule as a partial fix, but he does not address the implications of letting agencies rewrite the Common Rule for their specific needs.

[Puglisi, Tom. “Reform Within the Common Rule?” Hastings Center Report 43, no. s1 (2013): S40–S42. doi:10.1002/hast.140.]

Sunday, February 10, 2013

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]