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.
Was it human subjects research?
A January 17 university press release, “UNC-Chapel Hill leaders share facts on Willingham dataset, findings,” claims that Willingham departed from the plan she filed in 2008, which the IRB had determined not to constitute human-subjects research.
According to the press release,
Every research university is required by the federal government to have a campus body, such as an IRB, to oversee human subjects research. UNC-Chapel Hill’s IRB is an independent governing body comprised of faculty researchers, knowledgeable staff and community members. Willingham’s analysis contradicted information she provided in her formal application to the federally regulated IRB in 2008. At that time, based on information she provided, the IRB determined that their oversight was not needed because 1) the data were represented as secondary (not collected directly from subjects) and 2) individuals could not be identified. De-identified means that the researchers themselves do not know the identities of subjects—not that the researchers do not disclose their subjects’ identities as part of their work. As a result, the IRB allowed Willingham to proceed without direct IRB oversight. Willingham collected and retained identified data, as her public comments over the past two weeks have confirmed, and this was the basis of the IRB’s decision to rescind its earlier determination.
As noted by Inside Higher Ed, the press release does not specify which statements indicate access to identifiable data. Willingham’s co-investigator, Richard Southall, last week said he didn’t know what UNC meant by the charge. CNN Correspondent Sara Ganim notes that Willingham has not identified any students. (Ganim also accuses UNC of lying about CNN’s requests for data.)
If UNC is so sure that Willinghham used identifiable data, why doesn’t it share more facts to support that claim?
If so, was it exempt?
Making matters murkier, the press release uses the phrase, “federally regulated IRB,” and includes the bullet point, “IRB Review Triggered by Federal Rules Regarding Use of Protected Data.” But it UNC may be applying its own rules, not federal rules.
The provost, Jim Dean, told the News & Observer that Willingham “did not have the authority to use identifiable data because to do so would have required (review board) … approval, which she did not have.”
In fact, research with identifiable data may be exempt under 45 CFR 46.101(b)(4), so long as the investigator records the information in such a manner that subjects cannot be identified either directly or indirectly through identifiers linked to the subjects. For example, if a researcher has access to complete records, but just takes notes on select, non-identifiable data, such as test scores.
At UNC, however, there is no such thing as exempt research. Rather, all human subjects protocols must be reviewed by the IRB, which at most determine a project to be “exempt from continuing review.”
It is possible, then, that Willingham’s work was exempt under federal rules but not under UNC rules. If so, the press release’s claim about “federal rules” may be misleading.
What rights do university faculty and staff possess?
Michelle Meyer makes the good point that researchers shouldn’t fib on their protocols, at least not most of the time. But nor should university administrations make unsubstantiated accusations about such lapses (or about sexual harassment, intimidation, etc.)
What, after all, is the value of a vague accusation of violating research ethics? It protects no research participants, provides no guidance for other researchers, yet affords the accused no more dignity than a clear explanation of how the IRB concluded that a researcher has broken her pledge. Both Willingham and the public deserve better.