You know, it's very strange

On 19 January 2007, Inside Higher Ed reported the launch of this blog. Here is the kicker from that story:

Schrag said that the problems with IRBs will probably remain for some time. “I think the regulations themselves are poorly drafted, with terms that are not well defined, and I anticipate problems until they are amended,” he said. “Perhaps until then, I’m going to have to keep up the blog.”

Ten years later, to the day, the amended regulations are in the Federal Register.

You know, it’s very strange—I have been in the revenge business so long. Now that it’s over, I don’t know what to do with the rest of my life.

Should I consider piracy?

Why is Felice Levine satisfied?

Inside Higher Ed reports that Felice J. Levine, executive director of the American Educational Research Association, is happy with the final rule. I’m curious about why; it doesn’t seem to give her anything she asked for in 2011.

[Scott Jaschik, “U.S. Issues Final Version of ‘Common Rule’ on Research Involving Humans,” Inside Higher Ed, January 19, 2017.]

[Edited at 11:12AM to mention the normal educational practices in penultimate paragraph.]

A social scientist’s guide to the Final Rule

On 18 January 2017, sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects. As I noted earlier, this marks a huge victory for historians, who have spent the last 20 years working to end the inappropriate interference of IRBs with oral history research.

In addition, the final rule includes several provisions of note to scholars in the humanities and social sciences. Here are some of them; I don’t claim it is a complete list.

United States of America Frees Oral History!

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.

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.]

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.]

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.]

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.

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.]

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.