On November 9, I will join other scholars to discuss the revised Common Rule at a one-day conference hosted by Seton Hall University: Reimagining Human Subject Protection for the 21st Century: A Critical Assessment of the Revised Common Rule.
The agenda is online at https://law.shu.edu/docsnoncommonspot/images/events/human-subject-agenda.pdf
On June 22, OHRP posted a video to YouTube, dated March 2018 and entitled “When Does the Common Rule Apply?,” featuring Misti Ault Anderson, Senior Advisor for Public Health Education at OHRP. The video includes a passage stating that while an oral history interview of “one individual” will no longer be considered research under the new Common Rule, a project about “specific leaders” would still be regulated.
I consider this statement to be at odds with the 18 January 2017 Federal Register announcement of the revised rule. However, Anderson tells me the video is an “education tool,” not official guidance, and that “we will be seeking public comment for consideration before developing the final guidance.”
In a new notice of proposed rulemaking, published in the Federal Register on April 20, HHS and other Common Rule Agencies identify three provisions of the new Common Rule as “burden-reducing.” Among them is the redefinition of research to exclude historical research. Yet the notice gives institutions either three or nine months to implement the reforms.
[“Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period,” 83 Federal Register 17595 (April 20, 2018).
The “burden-reducing” label correctly implies that the corresponding provisions of the current Common Rule are unnecessarily burdensome. Yet rather than reducing the burdens immediately, the new NPRM gives institutions the choice of eliminating them in July 2018 or January 2019.
The notice presents this as a recognition of “entities’ possible inclinations to make all transitions at once.” To be sure, federal agencies seem to favor massive, comprehensive, and infrequent change to incremental improvement, but I wonder if research institutions feel the same. And it’s telling that the notice considers “entities” as the primary stakeholders in the decision. Recall that the 2011 ANPRM aimed at “Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” (Emphasis added.) The new notice does not speculate how investigators might feel about the pace of transition.
The notice also states,
We note that we intend to publish guidance on the carve-outs from the definition of research prior to July 2018, which may also impact an institution’s decision to elect to implement the three burden-reducing provisions or not.
In February 2007, OHRP promised such guidelines “by the end of the year.”
The new Common Rule was supposed to go into effect today, but OHRP has declared a six month delay in the implementation of most of its parts. This apparently includes a delay in the redefinition of research and the liberation of oral history.
It’s been three months since the announcement of the new Common Rule. Some reactions so far:
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.
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.
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.]
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.
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.]
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.
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.
In Patricia Highsmith’s novel, Strangers on a Train (adapted for the screen by Alfred Hitchcock), a sociopath plans to get away with murder. Rather than kill his own nemesis and risk arrest, he will kill the troublesome wife of a stranger, and expect that stranger to reciprocate by killing his detested father. Since each man could arrange to be out of town at the time of his relative’s murder, each alibi could be ironclad.
Ethnographers Staci Newmahr and Stacey Hannem think this is a good way to deal with the IRB. The idea might be stupid enough to work in some cases, but it is also a distraction from the hard work of regulatory reform.
[Staci Newmahr and Stacey Hannem, “Surrogate Ethnography Fieldwork, the Academy, and Resisting the IRB,” Journal of Contemporary Ethnography, May 10, 2016, doi:10.1177/0891241616646825.]
As has been widely not reported, today marks the fiftieth anniversary the issuance of U.S. Public Health Service Policy and Procedure Order (PPO) #129, which mandated that each recipient of a PHS grant involving human beings secure prior review by “a committee of his institutional associates.” From this document flowed all subsequent IRB policies, in the United States and in several other countries.
To honor the occasion, I have posted a PDF of the order on my page of IRB documents.
(Not really. A correspondent was looking for a copy, and I posted it for her.)
Perhaps 2016 will be the year when OHRP makes good on its 2007 promise to “give more guidance on how to make the decision on what is research and what is not,” in the form of a promulgated revision to the Common Rule. If so, Happy New Year, OHRP!
Wth these hopes, I have submitted my own comments on the NPRM. I have posted a copy of the PDF I submitted, and below is a web version with links.
Few if any argue that journalists should be required to submit their work to IRB review. Some IRB apologists think journalism is too important to bear restriction, while others consider it so full of “blatant bias and even hyperbole” that it doesn’t deserve the dignity of review. But all participants in the debate, at least in United States, seem uncomfortable with the idea of subjecting journalists to prior restraint.
The question, as always, is how to draw the line between journalism and regulated forms of conversation. The NPRM’s proposed rule attempts to do so with a specific exclusion for “Oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected.” Will that suffice?
Neither the NPRM's language nor SACHRP's proposed replacement is quite right, so let me suggest an alternative.
In their comments on the NPRM, SACHRP and PRIM&R oppose the proposed exclusion of “Research, not including interventions, that involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) uninfluenced by the investigators” (§ ll.101(b)(2)(i)); they want such research to be moved from the excluded to the exempt category. But they differ in what they think the consequences of such a move would be; SACHRP thinks that researchers would face low barriers, while PRIM&R sees a chance for its members to continue to exert more control than is authorized by regulations. Both groups fail to represent the researchers most likely to conduct these kinds of studies.
PRIM&R has posted its draft comments on the NPRM. I have found something to agree with.
PRIM&R writes:
Over the past 25 years, the difficulty of getting all of the agencies to agree on the Common Rule was cited as the grounds for concluding that changing any provisions would require a Herculean effort. It may well be that revising the entire Common Rule at once is a task that can only be undertaken once in a generation.
But if the current NPRM, issued four years after the ANPRM to revise the Common Rule (July 26, 2011), underlines how daunting a comprehensive revision can be, it also shows that the best, evidence-based revisions will not emerge from a process that tries to make all needed revisions at once. By perpetuating the view that regulations cannot be revised when needed, the current approach risks locking in place for another 25 years a number of provisions in the NPRM that even its most enthusiastic supporters admit are flawed in important ways.
Instead, we recommend that the relevant agencies pursue an issue-by-issue approach in which it is possible to “drill down” on an issue, to consider all the sections of the regulations where it arises and all the evidence that is available—and that is needed—to resolve it well. Further, the agencies should address each issue more openly, developing and relying upon evidence, and allowing consensus to emerge and revisions to be crafted that will work well for all stakeholders. This approach would not only produce better results, but would signal that, once adopted, any provision can be changed if it does not work as well as intended.
I don’t go so far as to agree with PRIM&R that the proposed rule should be scrapped. Historians have already waited too long for their freedom. But even the best rules deserve reexamination more frequently than once every 25 or 35 years.
I would also note that PRIM&R embodies the system’s longstanding failure to consult “all stakeholders.” If PRIM&R is serious about that phrase, it should endorse the American Anthropological Association’s call for “a commission constituted specifically of social scientists (e.g., sociologists and the like), humanistic social researchers (e.g., cultural anthropologists and the like), and humanists (e.g., historians, legal scholars, and the like) … tasked with developing alternative guidance appropriate for their fields.”
The Institutional Review Blog is nine years old today. It continues its original mission of aggregating news and commentary about IRB review of research in the humanities and social sciences, such as Wednesday’s report of an article from Feminist Studies. And it has never been closer to its goal of regulatory reform.
Posts
All Comments
