OHRP Draft Guidance on Oral History; No Mention of Examples

OHRP has posted draft guidance on “Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements.”

The draft reiterates the distinctions made in the January 2017 Federal Register announcement of the new Common Rule, stating:

It is not the particular field that removes the activity from the definition, but rather that the purpose and design of the particular activity is to focus on specific individuals and not to extend the activity’s findings to other individuals or groups. 

Unlike the June 22 video, the draft guidance offers no examples of projects that would or would not be regulated. We are left with a video that offers examples inconsistent with the Federal Register announcement and the official draft guidance from OHRP.

OHRP Video: Oral History of "Specific Leaders" Would Qualify as Research

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.”

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.”

Revised Common Rule Delayed at Least 6 Months

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.

Final Rule, three months later

It’s been three months since the announcement of the new Common Rule. Some reactions so far:

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.

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 TCPS2 Improvements Reach Researchers?

Canadian oral historian Nancy Janovicek applauds the ways that TCPS2 improves over TPCS’s treatment of oral history, but she warns that historians still must devote time to bureaucratic strategy that might be better spent exploring ethics and interviewing narrators.

[Nancy Janovicek, ,“Oral History and Ethical Practice after TCPS2,” in The Canadian Oral History Reader, ed. Kristina R. Llewellyn, Alexander Freund, and Nolan Reilly (Montreal and Kingston: McGill-Queen’s Press, 2015), 73–97.]

Oral Historians as Ethical Proofreaders

Kevin Bradley and Anisa Puri of the Australian Generations Oral History Project explain that the ethical challenges they faced came after they had conducted the interviews.

[Kevin Bradley and Anisa Puri, “Creating an Oral History Archive: Digital Opportunities and Ethical Issues,” Australian Historical Studies 47, no. 1 (2016): 75–91, doi:10.1080/1031461X.2015.1122072.]

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.

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

George Mason University Frees Oral History

George Mason University, my employer and my home, has issued a new Standard Operating Procedure (SOP) on Histories and Journalism, modeled closely on the excellent policies at Columbia and University of California, San Diego.

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: 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.

Cliff Kuhn, 1952-2015

I am sorry to learn of the death of Clifford M. Kuhn, executive director of the Oral History Association. Among his many other contributions to the study of the past, Cliff was concerned with freeing oral historians from inappropriate regulation while championing ethical standards for their work. In recent weeks I had the pleasure to talk with him about our hopes for regulatory reform, and I deeply regret that those conversations cannot continue.

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!

NPRM: Freedom for Historians, If They Can Keep It

The notice of proposed rulemaking (NPRM) promises long-sought relief for historians, journalists, and biographers. For these groups, the goal will be to ensure that the proposed rules are enacted as currently written.

[This post has been cross-posted to the Petrie-Flom Center's Bill of Health, which is conducting an online NPRM Symposium.]

11 September 2015: See update at the bottom of this post.

NPRM Proposes Freedom for Historians!

The long awaited Notice of Proposed Rulemaking: Federal Policy for the Protection of Human Subjects, released today, suggests the complete deregulation of “oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected.”

In the coming 90-day comment period, historians will need to insist that this remains an unqualified exclusion. Still, despite this last peril, we have much to celebrate.

"Great joy in camp we are in View of the Ocian, this great Pacific Octean which we been So long anxious to See."

UCSD Frees Oral History and Journalism

The University of California, San Diego, has determined that most projects by historians and journalists need not be submitted to the IRB.