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.]

The details of the case are murky. The official retraction states that
This article has been retracted at the request of the Editors-in-Chief.

The article is based on work that was undertaken without obtaining prior informed consent to conduct human subjects research from the Author's institution. The scientific community takes a very strong view on any ethical infringement in the conduct of research and apologies are offered to readers of the journal that this was not brought to our attention prior to publication.
IRB aficionados know that one secures informed consent from one's subjects or participants, not one's institution. So whoever wrote the retraction notice appears unfamiliar with regulatory terminology.

To add to the puzzle, the authors of the piece seem to have been aware of IRB rules, for the article clearly states that "Ethical approval for the research was obtained from the Institutional Review Board at the University of Arizona," where Goldade earned her PhD. Retraction Watch explains that
The editors of the journal tell us that while the notice says the retraction was their request, Goldade — whom we have not been able to reach for comment — asked for it first. We’ve asked the University of Arizona how the lack of IRB approval became clear, and will update with anything we learn.

Goldade’s co-author, Kola Okuyemie, who leads the University of Minnesota’s program in health disparities, said through the university that he only interpreted the data and developed the manuscript, so did not have anything to do with the work related to the IRB approval.

Finally, while it's hard to read the article with the word "RETRACTED" pasted in big red letters across the text, nothing that I could find explained why this project would not be exempt from IRB review under 45 CFR 46.101(b)(2). The interviewers seem to have asked health care providers about their views of "state responsibility for non-citizens within its territory," with such question as “What services do you think that migrants deserve even if they are undocumented?”

Had the investigators sought information about health care providers' decision to offer more or less care than was legally permissible or required, I can see how the answers "could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation." But interviews with competent adults about their political beliefs should not trigger IRB jurisdiction.


Brian Borchers said...

I don't know anything about the political situation in Costa Rica, and I'm not making any statement about what might have happened in this case, but I can certainly imagine situations in which a regime was so repressive and/or xenophobic that it might take action against any of its citizens who responded to a survey on a politically sensitive topic. In that situation you would be creating a risk for your survey respondents, and there really would be a serious ethical issue to be considered.

At another level, it's a clear ethical violation to claim that IRB approval was obtained when it had not in fact been obtained. If I were the editor of the journal, I'd be comfortable defending the decision to retract the paper on that basis alone.

As an IRB member, I'd be very upset if someone claimed that our IRB had approved a proposal when we hadn't actually approved it.

Zachary M. Schrag said...

Thanks for this message.

Costa Rica is a stable democracy that in 2013 earned Freedom House's highest scores for both political rights and civil liberties.

I agree that a false claim of IRB approval is grounds for retraction. But the facts as stated make me wonder if the explanation for the false statement might be a confusion between approval and exemption.