Friday, December 9, 2016

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.]

Wednesday, December 7, 2016

Will Cures Act Replace Common Rule Reform?

As of November 15, POLITICO thinks that Common Rule reform is dead:

HHS’s controversial revision of the Common Rule, the regulations that protect participants in clinical research, still hasn’t been sent to OMB for review. That’s not likely to get finished under Obama’s watch.

(David Pittman, “Obama’s HHS, Congress at Potential Odds over Pending Rule,” POLITICO, November 15, 2016)

On the other hand, Congress just passed the 21st Cures Act, which includes a provision for a Research Policy Board designed, as Science puts it, to “examine excessive regulation of research.”

In his September 29 testimony before the Subcommittee on Research and Technology, James Luther of Duke University suggested that the congressional effort could replace the executive one. He complained “that HHS is still trying to move forward with a final rule [for human subjects research] for which many of the proposals remain unchanged from the ANPRM despite overwhelmingly negative comments” about its provisions on biospecimens. And he suggested that a Research Policy Board might do a better job.

Perhaps such a board would attend to questions of concern to the social sciences and humanities, but I am not hopeful. Luther’s testimony cites the May 2016 analysis by the Council on Governmental Relations (COGR) and the Association of Public and Land-grant Universities (APLU) and the June report by the National Academies of Sciences, Engineering, and Medicine’s Committee on Federal Research Regulations and Reporting Requirements. Both of those documents mostly ignored the social sciences and humanities.

The sun never sets on the Ethical Empire.

Monday, October 31, 2016

Qualitative Sociologists Find Standard Randomness

Sociologists Sarah Babb, Lara Birk, and Luka Carfagna surveyed qualitative sociologists about their IRB experiences and heard many of the usual horror stories, from insistence on inappropriate consent forms to the dribbling out of concerns over several rounds of comments. Few of their respondents are happy with the present system, though getting the right people in key positions can help.

[Sarah Babb, Lara Birk, and Luka Carfagna, “Standard Bearers: Qualitative Sociologists’ Experiences with IRB Regulation,” American Sociologist, October 6, 2016, 1–17, doi:10.1007/s12108–016–9331-z. Note: I read a version of this article in manuscript and am so credited in the article.]

Tuesday, October 25, 2016

Final Rule in 2016?

Theresa Defino reports that OHRP “hopes to get ‘something’ out by year end.”

If OHRP were to liberate oral history on the 10th anniversary of this blog, that would be OK with me.

Sunday, October 2, 2016

Brazil calls for "equitable representation from the Social Sciences and Humanities"

Brazil is revising its research ethics standards in ways that will help tailor them to research in the social sciences and the humanities. The standards provide for greater representation by scholars in those fields when policies and decisions are made, and they decenter some of the medical assumptions that had previously governed all research. But they do not go as far as the Canadian TCPS2 in recognizing the legitimacy of critical inquiry.

[Iara Coelho Zito Guerriero, “Approval of the Resolution Governing the Ethics of Research in Social Sciences, the Humanities, and Other Disciplines That Use Methodologies Characteristic of These Areas: Challenges and Achievements,” Ciência & Saúde Coletiva 21, no. 8 (August 2016): 2619–29, doi:10.1590/1413–81232015218.17212016.]

Saturday, October 1, 2016

"One more impediment to getting a worthwhile project done"

A final horror story posted in response to Patricia Aufderheide’s essay, “Does This Have to Go Through the IRB?."

Brian Abel Ragen writes,

Eventually you will probably find a reasonable person to stop the nonsense. That was my experience when one of my graduate students was told that his plan to interview a writer for the New York Review of Books meant he was using “human subjects” and therefore needed to submit his thesis proposal to the IRB after filling out all the appropriate forms and applications. A student asking a professional literary critic why he had championed the reputation of a certain novelist was, quite rightly, seen as an interaction WITH a fellow human being, not research ON a human subject. But that should have been obvious from the beginning. What the whole process did for me as an English professor and my student in the humanities was to create just one more impediment to getting a worthwhile project done—this new obstacle laced with fear of getting in trouble with the Federal government if we made a mistake. It also protected a writer from hearing from someone who admired his work and wanted to explore it with him for a few weeks. So I would say that the limits of the IRB’s powers need to be more clearly drawn, so as to remove one more hazard from the already obstacle-strewn path to completing a degree or a research project. I won’t say that i can’t imagine projects in literary studies that don’t involve using people as actual “human subjects,” but I think the default assumption should be that any project that involves neither deception nor asking the interlocutor to do anything but talk about something is beyond the scope of an IRB.

An IRB need not block a project to discourage curiosity.

Friday, September 30, 2016

IRB consent form spooked respondents

Commenting on Patricia Aufderheide’s essay, “Does This Have to Go Through the IRB?,” a writer with the screen name “reinking” relates:

I was investigating a routine instructional intervention in a school district serving a large hispanic population. IRB required, not just that the consent form be translated into Spanish (not unreasonable if a consent form was necessary), but also that I develop several versions in different dialects. Nonetheless, when sent to parents, remarkably few were returned, and I eventually determined why. The standard template for IRB consent (modeled on far riskier medical research) indicated that any questions or concerns should be directed to me as “principal investigator.” “Investigator” was apparently a term (in English or Spanish) that set off alarm bells among parents in this hispanic community.

So much for IRB sensitivity to local conditions.

Monday, September 19, 2016

More failures of "local precedents"

Laura Stark’s 2012 book, Behind Closed Doors: IRBs and the Making of Ethical Research, devotes a chapter to what Stark calls “local precedents,” her term for “the past decisions that guide board members’ evaluations of subsequent research.” “By drawing on local precedent,” Stark claims, “board members can read new protocols as permutations of studies that they have previously debated and settled based on members’ warrants. The result is that IRBs tend to make decisions that are locally consistent over time.” (47)

But I keep getting stories about IRBs that are locally inconsistent.

Tuesday, September 6, 2016

A satisfied customer at American University

Patricia Aufderheide, University Professor of Communication Studies at American University, reports her satisfaction with the IRB at that institution. It’s great to hear some good news, and Aufderheide’s essay points to the importance of having the right people in positions of power. But it also raises questions about how good and how replicable AU’s experience is.

[Patricia Aufderheide, “Does This Have to Go Through the IRB?,” Chronicle of Higher Education, August 17, 2016.]

Thursday, August 11, 2016

"Vulnerable" participants may have the most to gain from talking

Seven qualitative researchers forcefully argue that IRBs mislead research participants when they demand consent forms stating that interview research has “no known benefits.” In fact, people labeled “vulnerable” by IRBs often gain a great deal by participating in projects the IRBs deem “risky.”

[Tara Opsal, Jennifer Wolgemuth, Jennifer Cross, Tanya Kaanta, Ellyn Dickmann, Soria Colomer, and Zeynep Erdil-Moody, “‘There Are No Known Benefits …’ Considering the Risk/Benefit Ratio of Qualitative Research,” Qualitative Health Research 26, no. 8 (July 2016): 1137–50, doi:10.1177/1049732315580109.]