Wednesday, January 18, 2017

United States of America Frees Oral History!

detail of sheet music for 'Victory' by  M. K. Jerome, Jack Wilson, Ben Bard, 1918

This morning sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects, effective 19 January 2018. The final rule preserves and clarifies the NPRM’s deregulation of oral history. This is a great victory for freedom of speech and for historical research.

Saturday, January 7, 2017

Common Rule reform still in suspense

A proposed final rule on human subjects protections made it to the Office of Management and Budget on Wednesday, January 4.


Jeannie Baumann of Bloomberg thinks this means that we’ll see it in the Federal Register before January 20. But she also quotes Lisa Nichols, director of research and regulatory reform for Council on Governmental Relations, predicting that Congress will overturn the reform, since it appears on the House Freedom Caucus hit list.


Wake me up when it’s over.


[Jeannie Baumann, “White House Takes Final Steps to Revamp Medical Research Rule,” Bloomberg BNA, January 6, 2017.]

Monday, January 2, 2017

Reforms for “21st century science” would have been good for the 20th too

A group of 11 researchers and IRB professionals, most of them affiliated with the University of California, San Diego, report on a brainstorming session from early 2015. They argue that readable consent forms, expert review, a less punitive system, and more exemptions would better serve researchers and participants. While they present their ideas as “a human research protections system that is responsive to 21st century science,” the measures they propose are equally valid for research as it has been practiced for decades.


[Cinnamon Bloss et al., “Reimagining Human Research Protections for 21st Century Science,” Journal of Medical Internet Research 18, no. 12 (2016): e329, doi:10.2196/jmir.6634.]

Thursday, December 15, 2016

Calls for Ethical Pluralism

In separate essays, Nathan Emmerich and Igor Gontcharov argue for more flexible systems that would avoid imposing biomedical ethics on the social sciences. Emmerich calls for an emphasis on professional ethics, while Gontcharov seeks “a set of ethical principles that would better reflect the position of [social sciences and humanities] researchers and participants.” I am left unsure what either proposed reform would look like in practice.


[Nathan Emmerich, “Reframing Research Ethics: Towards a Professional Ethics for the Social Sciences,” Sociological Research Online 21, no. 4 (2016): 7, DOI: 10.5153/sro.4127; Igor Gontcharov, “A New Wave of Positivism in the Social Sciences: Regulatory Capture and Conceptual Constraints in the Governance of Research Involving Humans,” SSRN Scholarly Paper (Rochester, NY: Social Science Research Network, October 31, 2016), DOI: 10.2139/ssrn.2861908.]

Monday, December 12, 2016

Ten Years of Blogging

The Institutional Review Blog launched ten years ago today. I would like to think that with or without a new Common Rule, it’s done some good, but I would dearly love to see oral history liberated in the next 39 days.


Zach's cat trying to get in from the screen porch, with the humorous caption, 'Can I Has Regz?'

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.]