Saturday, January 25, 2014

Willingham Denies Misleading UNC IRB

Mary Willingham, accused by the University of North Carolina at Chapel Hill of diverging from the protocol she showed her IRB, states that the IRB always knew her plans.

[Wilson, Robin. “Chapel Hill Researcher’s Findings on Athletes’ Literacy Bring a Backlash.” Chronicle of Higher Education, January 24, 2014.]

Quebec Court Shields Confidential Interview from Police

A Quebec court has quashed a search warrant for an interview given in confidence by accused killer Luka Magnotta to University of Ottawa researchers. The court agrees with the professors that "the public interest in protecting researcher-participant confidentiality in general, and in the specific circumstances of this case, clearly outweighs what minimal contribution, if any, the release of the seized items will make to the prosecution of the accused in the criminal proceeding." (2)

[Parent c. R., 2014 QCCS 132. h/t Will C. van den Hoonaard]

Friday, January 24, 2014

Should IRBs Monitor Research Safety?

Susanne Bahn, Michelle Greenwood, and Harry Van Buren argue that "universities have a legal (and an ethical) duty of care for the safety of their employees and it is therefore reasonable to expect that all risks are identified, disclosed and adequately controlled" and that "highly risky research requires additional safeguards for the protection of the research subjects and researchers alike."

Their article offers scant details on what such safeguards might look like.

[Bahn, Susanne, Michelle Greenwood, and Harry J. Van Buren. “The Nexus of Employee Safety, Professional Integrity and Ethics: Applying Stakeholder Theory to University Researchers.” Research in Ethical Issues in Organizations 9 (2013): 13–29. DOI: 10.1108/S1529-2096(2013)0000009007]

Tuesday, January 21, 2014

UNC Accuses Critics of Unauthorized Research

As I noted briefly before, the UNC-Chapel Hill has accused Mary Willingham of violating human subjects rules in her study of the scholastic abilities of student athletes. Willingham has yet to offer a detailed account of her side of the story, and the university's account remains vague as well.

Saturday, January 18, 2014

Exemptions Don't Come to PRIM&R's Mind

In October, PRIM&R hosted a webinar on "Protecting Human Subjects in Qualitative Research: Ethical Considerations for IRBs and Researchers," hosted by Julie Simpson, director of research integrity services at the University of New Hampshire.

A follow up question, just posted the PRIM&R Blog, suggests that Simpson is unfamiliar with the Common Rule:

AS: Under what circumstances might qualitative research not require IRB review?
JS: None come to mind at this time. If the activity is research and it involves human subjects, then it needs IRB review.

Of course, 45 CFR 46.101 lists several circumstances in which human subjects research does not require IRB review, some of them--particularly (b)(2) and (b)(3)--of enormous importance to qualitative researchers.

To be sure, OHRP is primarily responsible for discouraging institutions from recognizing the exemptions. But it is a pity to see PRIM&R spread such misinformation.

Friday, January 17, 2014

Caught Between an IRB and the Provost

The UNC-Chapel Hill IRB has suspended research on student-athlete literacy after former learning specialist Mary Willingham of UNC-Chapel Hill complied with her provost's demands for the data.

[Kane, Dan. “UNC Board Suspends Whistle-Blower’s Research on Literacy Level of Athletes.” News & Observer, January 16, 2014]

Thursday, January 16, 2014

University of Utah Plans Symposium on IRB Policy

On March 20 and 21, the University of Utah Political Science Department will host a symposium, Field Research and US Institutional Review Board Policy.

I will give the keynote address, "'The Freedoms We are Committed to Protect': Political Science, Academic Freedom, and Institutional Review Boards in Historical Perspective."

Tuesday, January 14, 2014

NRC Report: Where's the Freedom?

My biggest disappointment with the new NRC report is its silence on the question of academic and personal freedom.

Sunday, January 12, 2014

NRC Report: Assess Risk Empirically

One theme running throughout the NRC report is the need to replace the worthless gut reactions decried by Ezekiel Emanuel with a system that would base its judgments on the latest empirical evidence. But the report does not present a clear set of reforms that would effect this change without scrapping the current system of local IRB review.

Saturday, January 11, 2014

NRC Report: Liberate Oral History

For historians, the most exciting passage in the new National Research Council report—the passage that had me cheering out loud—is the recommendation that the Common Rule be amended to explicitly exclude historical interviews, as well as other forms of information gathering that do not constitute “human-subjects research specifically in the biomedical, behavioral, and social sciences.”

Friday, January 10, 2014

National Research Council Issues IRB Report

The National Research Council has issued its long awaited report, Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences.

[National Research Council. Committee on Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences. Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences. Washington, D.C.: The National Academies Press, 2014.]

Tuesday, January 7, 2014

Happy New Year, National Academy of Sciences!

As longtime readers of this blog will know, I used to begin each year by mocking OHRP for failing to issue "a lot of examples and will give more guidance on how to make the decision on what is research and what is not" by the end of 2007, as promised by a former director. That trope got a bit old after a few years, and I didn't recycle it in 2013.

I will note that the National Academy of Sciences pledged to issue a summary of its March 2013 workshop "in summer 2013" and that "the study report will be issued in early winter 2013."

Anyone seen either of those?