OHRP Draft Guidance on Oral History; No Mention of Examples

OHRP has posted draft guidance on “Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements.”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Unlike the June 22 video, the draft guidance offers no examples of projects that would or would not be regulated. We are left with a video that offers examples inconsistent with the Federal Register announcement and the official draft guidance from OHRP.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.”

Strangers on a Train

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.]

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.

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.

QI Focus Groups: Ditch Generalizability Criterion

Focus groups of professionals engaged in quality improvement (QI) or comparative effectiveness research (CER) report that the Common Rule's "generalizable knowledge" standard does not provide clear guidance.

[Whicher, Danielle, Nancy Kass, Yashar Saghai, Ruth Faden, Sean Tunis, and Peter Pronovost. “The Views of Quality Improvement Professionals and Comparative Effectiveness Researchers on Ethics, IRBs, and Oversight.” Journal of Empirical Research on Human Research Ethics, Published online before print, February 23, 2015, doi:10.1177/1556264615571558.]

Most IRB Chairs Can't Recognize Exempt Research or Non-Research

A study of criminal justice researchers' knowledge of IRB rules has found that IRB chairs can't agree on what makes a project exempt from review and think that IRB review is needed for public records. The authors of the study, one of whom is an IRB chair, seem not to realize the significance of these findings.

[Tartaro, Christine, and Marissa P. Levy. "Criminal Justice Professionals' Knowledge of Institutional Review Boards (IRBs) and Compliance with IRB Protocol." Journal of Criminal Justice Education 25, no. 3 (2014): 321–41. doi:10.1080/10511253.2014.902982.]

NRC Report: Liberate Oral History

For historians, the most exciting passage in the new National Research Council report—the passage that had me cheering out loud—is the recommendation that the Common Rule be amended to explicitly exclude historical interviews, as well as other forms of information gathering that do not constitute “human-subjects research specifically in the biomedical, behavioral, and social sciences.”

George Mason University Adopts Shelton Definition, Solicits Faculty Advice

My own institution, George Mason University, has adopted two significant IRB reforms: clarifying the regulatory definition of research, and establishing a faculty advisory board to help shape IRB policies.

Puglisi: ANPRM Is Stalled; Write Your Own Common Rule

Tom Puglisi, director of the Office of Research Oversight in the Department of Veterans Affairs and former director of human subject protections at OHRP, writes that the Common Rule needs reform but believes that the ANRPM is "stalled." He offers the Veterans Health Administration's interpretation of the Common Rule as a partial fix, but he does not address the implications of letting agencies rewrite the Common Rule for their specific needs.

[Puglisi, Tom. “Reform Within the Common Rule?” Hastings Center Report 43, no. s1 (2013): S40–S42. doi:10.1002/hast.140.]

Faden et al. Question Research-Treatment Distinction

Writing in a special report of the Hastings Center Report, a team of prominent ethicists and researchers "argue that conceptual, moral, and empirical problems surround the received view that we can and should draw sharp distinctions between clinical research and clinical practice." Yet they decline to detail the implications of any regulatory change for IRB review of medical research, much less research in the social sciences and humanities.

[Kass, Nancy E., Ruth R. Faden, Steven N. Goodman, Peter Pronovost, Sean Tunis, and Tom L. Beauchamp. "The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight." Hastings Center Report 43, no. s1 (2013): S4–S15. doi:10.1002/hast.133. h/t Yashar Saghai]

British Government Denies Conducting Research

I have reported in the past on the ability of U.S. federal officials to avoid IRB review of their work by asserting that they are not conducting research, even as university scholars doing the same kind of work face sanctions if they proceed without IRB approval.

It turns out that British officials take similar positions:

Having considered these guidance notes, their definitions of social research and the report in question, I can confirm that I do not consider ‘Listening to Troubled Families’ as being within the definition of Government social research and thus the scope of the guidance. My rationale for this is that this report falls more properly within the description ‘dipstick/informal information gathering’.

(Reply from Jane Todorovic, Head of Profession for the Government Social Research (GSR) service at DCLG, 3 October 2012)

[“Policy Based on Unethical Research.” Poverty and Social Exclusion. Accessed January 25, 2013. http://www.poverty.ac.uk/news-and-views/articles/policy-built-unethical-research. h/t Robert Dingwall]

What Is This Thing Called Research?

I have posted the paper I prepared for the May 2012 Petrie-Flom conference as "What is this Thing Called Research? (May 7, 2012), http://ssrn.com/abstract=2182297.

A shorter version will appear in a book to be published by the MIT Press, tentatively entitled The Future of Human Subjects Research Regulation.

Here is the abstract:

Palys and Lowman on Boston College: "Be Suspicious of Universities"

Ted Palys and John Lowman of the School of Criminology at Simon Fraser University provide a helpful overview of the Boston College Belfast Project oral history legal case while condeming Boston College's actions before and after the arrival of the subpoena. Though the article is marred by an incomplete understanding of U.S. human subjects regulations, it makes a strong case that universities need to practice "ethical and legal due diligence" before promising confidentiality to research participants.

[Ted Palys and John Lowman. “Defending Research Confidentiality ‘To the Extent the Law Allows:’ Lessons From the Boston College Subpoenas.” Journal of Academic Ethics 10, no. 4 (2012): 271–297. doi:10.1007/s10805-012-9172-5.]

Berkeley Historian Defends IRB Review of Oral History

Martin Meeker, a historian with the Regional Oral History Office (ROHO) at the University of California, Berkeley, argues that "Historians of the recent past, many of whom use interviews as a source, need to be more systematic about doing oral histories as a form of research [and] that cooperation with IRBs offers one way to do that." What he really means, I think, is that cooperation with IRBs may help historians get legal help from their universities.

[Martin Meeker, "The Berkeley Compromise: Oral History, Human Subjects, and the Meaning of 'Research,'" in Doing Recent History: On Privacy, Copyright, Video Games, Institutional Review Boards, Activist Scholarship, and History That Talks Back, edited by Claire Bond Potter and Renee C. Romano (Athens: University of Georgia Press, 2012).]

Beauchamp and Saghai on the Mystery of Generalizable Knowledge

Philosophers Tom L. Beauchamp and Yashar Saghai find that although never defined, "the criterion of generalizable knowledge . . . is the foundation stone of the [National] Commission's conceptual and moral scheme in Belmont and beyond.

[Tom Beauchamp and Yashar Saghai. "The Historical Foundations of the Research-Practice Distinction in Bioethics," Theoretical Medicine and Bioethics 33, no. 1 (2012): 45–56. DOI 10.1007/s11017-011-9207-8. h/t Nathan Emmerich.]

Happy New Year, OHRP!

I started 2009, 2010, and 2011 with complaints that OHRP had failed to act on two reform initiatives it had undertaken in 2007.

In February 2007, Bernard Schwetz promised that by the end of 2007, OHRP would issue new guidelines that would give a lot of examples and will give more guidance on how to make the decision on what is research and what is not." And in October 2007, OHRP formally requested "written comments on a proposed amendment to item 5 of the categories of research that may be reviewed by the institutional review board (IRB) through an expedited review procedure, last published in the Federal Register on November 9, 1998 (63 FR 60364)."

OHRP has yet to issue Schwetz's promised examples and guidance, or to amend the expedited review list. But July's ANPRM goes so far toward honoring both of these promises that I can say with full voice, Happy New Year, OHRP! I look forward to a cooperative and productive 2012.

ANPRM Question 25: Read the Statute

It is September 26, the original comment deadline for the ANPRM, and the beginning of the final 30 days of the extended comment period. Here I offer my latest draft comments on the crucial Question 25. (This is adapted from my August 5 post.)

Aristotle: History Is Not Generalizable

I stumbled across the following passage from Aristotle's Poetics:

It is not the function of the poet to relate what has happened, but what may happen--what is possible according to the law of probability or necessity. The poet and the historian differ not by writing in verse or in prose. The work of Herodotus might be put into verse, and it would still be a species of history, with meter no less than without it. The true difference is that one relates what has happened, the other what may happen. Poetry, therefore, is a more philosophical and a higher thing than history: for poetry tends to express the universal, history the particular.

So history is not subject to the Common Rule, but poetry is.

ANPRM: It's Time to Redefine Research

In an earlier posting, I warned that the ANPRM's proposed "Excused" category could expand rather than diminish IRB interference with research in the social sciences and humanities.

Another option mentioned in the ANPRM--a redefinition of the scope of the Common Rule--could do more to achieve the ANPRM's goals of "better protect[ing] human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators." It could even the regulations with the statutes they claim as their basis.

I see several options here.