Big Data researchers call for IRB review, based on shaky premises

Jacob Metcalf of the Data & Society Research Institute and Kate Crawford of Microsoft Research, MIT Center for Civic Media, and New York University Information Law Institute (I think those are three different things) want to subject Big Data research to IRB review, at least in universities. Their argument rests on shaky premises.

[Jacob Metcalf and Kate Crawford, “Where Are Human Subjects in Big Data Research? The Emerging Ethics Divide,” Big Data & Society 3, no. 1 (January–June 2016): 1–14, doi:10.1177/2053951716650211.]

Ethics of big data research are unsettled, and so are mechanisms

Sarah Zhang of WIRED uses the OKCupid data dump to explore the unsettled state of big data research ethics and mechanisms to promote them.

[Sarah Zhang, “Scientists Are Just as Confused About the Ethics of Big-Data Research as You,” WIRED, May 20, 2016.]

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.]

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.

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]

UNC Stops Pretending that IRBs Understand Data Encryption

The Chronicle of Higher Education reports that the University of North Carolina at Chapel Hill and Harvard are asking their IT departments, rather than their IRBs, to design data security protocols for human subjects researchers.

[Voosen, Paul. “Researchers Struggle to Secure Data in an Insecure Age.” Chronicle of Higher Education, September 13, 2013. http://chronicle.com/article/Researchers-Struggle-to-Secure/141591/. (gated)]

Against Armchair Ethics: Some Reflections from Petrie-Flom

As followers of my Twitter feed will know, I spent Friday and the first half of the Saturday at The Future of Human Subjects Research Regulation, a conference sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

The conference organizers, led by Professor Glenn Cohen, did a magnifent job bringing together participants with varied views and backgrounds, and as a group we discussed ideas ranging from treating research subjects as workers to including adolescents on IRBs. Those who want the full story should be able to watch videos of the presentations before too long.

I was struck, however, by one recurring theme: the distinction between evidence-based approaches and armchair ethics.

Emanuel: ANPRM Will End Reliance on Worthless Gut Reactions

I watched the webcast of this morning's appearance by Ezekiel Emanuel before the Presidential Commission for the Study of Bioethical Issues. There were no huge surprises in Emanuel's presentation; much of it repeated points he had made in the New England Journal of Medicine. But I found some of his remarks, and the Commission's response, noteworthy.

Will ANPRM Limit the Use of Published Data?

Despite the ANPRM's general goal of "reducing burden, delay, and ambiguity for investigators," the proposed policy for the re-use of pre-existing data threatens to increase all of those by expanding the current definition of human subjects research.