Feds Say New Common Rule Will Reduce Burdens and Offer Guidance—But Not Yet

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.”

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.

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.]

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.

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.

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.

The Ethical Imperialism of the NAS

The National Academies of Sciences, Engineering, and Medicine’s Committee on Federal Research Regulations and Reporting Requirements has released the second part of its report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The new part includes a chapter on “Ethical, Legal, and Regulatory Framework for Human Subjects Research.” While presenting valid critiques of the NRPM, the chapter ignores the voices of scholars in social sciences and the humanities. Its proposals are unlikely to be adopted, and if they were they would continue the half-century history of marginalizing those disciplines.

NPRM Comments Focus on Biospecimens

The Council on Governmental Relations (COGR), with support from the Association of Public and Land-grant Universities (APLU), has reviewed and analyzed (they don’t say “read”) all 2,186 public comments submitted in response to the 2015 NPRM. The analysis suggests that the debate over biospecimens is crowding out discussion of other proposed reforms.

[Council on Governmental Relations, “Analysis of Public Comments on the Common Rule NPRM,” May 2016. h/t Michelle Meyer.]

Political Scientists Complain about Lost Exemption

Political scientists and law professors are protesting the proposed elimination of the current exemption for research about public officials and candidates for office. The drafters may have eliminated the exemption by mistake, thinking that such research was exempted by other provisions of the proposed rule, which turns out not to be the case.

My NPRM Comments

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.

NPRM: How to Exclude Journalism?

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.

PRIM&R and SACHRP Attack Social Science Exclusion

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.

I Agree With PRIM&R on Something

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.

Yes, indeed.

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.”

In NPRM Comments, Historians Applaud Proposed Rule

In addition to the formal comments from the National Coalition for History, endorsed by other scholarly associations, individual historians have begun submitting comments on the notice of proposed rulemaking. Without exception, they endorse the proposal to free oral history from IRB review. The only opposition comes from a professor of education and psychology who seems to suggest that tribal governments should hold veto power over oral history research.

Here are some of the highlights, alphabetical by last name. I have edited some for brevity. Full comments can be found at http://www.regulations.gov/#!documentDetail;D=HHS-OPHS–2015–0008–0001

Blog Day

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.

My NPRM Response. Draft 1.

Though the deadline for commenting on the NPRM has been extended until January 6, I post here a draft of my comments in the hopes that they may help others craft theirs and send me feedback on mine.

NPRM Comment Deadline Extended to January 6

OHRP has extended the deadline for NPRM comments until January 6, 2016. As a teacher with papers to grade, I applaud this extension.

NPRM: Will Political Science Interviews Require Review?

What do we know about interview research under the NPRM?

Whatever its final provisions, the new Common Rule seems bound to be much harder to follow than, say, Canada’s TCPS2. The proposed rule is full of cross references from one section to the next, and often to other documents, such as Subpart D or the Belmont Report. This makes it hard to figure out what it says about any given form of research.

Here’s what I’ve been able to figure out about one form: interview research. My sense is that the NPRM proposes to eliminate IRB review for the vast majority of conversations between consenting adults, but it may unintentionally impose review on projects that do not merit it.

Does the NPRM Exclude or Exempt Ethnography?

Though I could not attend the October 20 Public Town Hall Meeting on the Federal Policy for the Protection of Human Subjects (Common Rule) Notice of Proposed Rulemaking (NPRM), I’ve now watched the whole thing on YouTube. Much of the day was spent discussing procedures for biospecimens, which is outside the scope of this blog. But I was interested to see Julia Gorey of OHRP reply to questions that had been sent in by two anthropologists, Lise Dobrin, co-author of the American Anthropological Association’s 2011 comment on the ANPRM, and Edward Liebow, the AAA’s executive director. Gorey frankly admitted OHRP’s lack of expertise on ethnography but held out hope that ethnography may be exempt or even excluded under the NPRM’s proposals.

Historians Love the NPRM

Fifteen scholarly organizations, including the American Council of Learned Societies, the American Historical Association, the American Political Science Association, the Oral History Association, and the Organization of American Historians, have signed a letter endorsing the NPRM’s proposed exclusion of “oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected."

The letter (whose authors kindly consulted me in its early stages) is unequivocal:

We concur with this recommendation of full exclusion of such activities from IRB oversight. It reflects an appreciation that these activities should not be evaluated under frameworks originally designed with the sciences in mind. It recognizes the value and attributes of these forms of scholarship. It eliminates any ambiguity about review, regulation and enforcement, and thus removes an enormous and contentious burden for both scholars and IRBs.

Don’t change a thing!