OHRP Draft Guidance on Oral History; No Mention of Examples

OHRP has posted draft guidance on “Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements.”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Unlike the June 22 video, the draft guidance offers no examples of projects that would or would not be regulated. We are left with a video that offers examples inconsistent with the Federal Register announcement and the official draft guidance from OHRP.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

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 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.

IRB Chair: "Nobody Really Knows" If IRBs Do Any Good

A former chair of the University of Wisconsin-Madison Education and Social/Behavioral Science IRB guesses that IRB review “most likely” protects subjects from harm, but concedes that “nobody really knows.” He also notes that it consumes tens of thousands of hours of work, mostly by researchers, at his university each year.

[Kenneth R. Mayer, “Working through the Unworkable? The View from Inside an Institutional Review Board,” PS: Political Science & Politics 49, no. 02 (April 2016): 289–93, doi:10.1017/S1049096516000226.]

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.

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.

OHRP Inaction Leaves IRBs Reliant on Gut Feelings

Theresa Defino’s Report on Research Compliance describes an April 14 webcast by Robert Klitzman about his new book, The Ethics Police.

[“Books, Bioethics Panel Say OHRP Inaction Weakens Protection System, Thwarts Trials,” Report on Research Compliance, May 2015.]

Most of the excerpts from Klitzman concern the way that OHRP silence hampers IRBs:

When they reach out to OHRP for support, IRB officials reported getting nowhere. In the chapter titled, “Federal Agencies vs. Local IRBs,” Klitzman wrote that one chair told him, “Many times when you call for advice, they essentially just read back the regulations.”

One recounted waiting two years to hear from OHRP on changes it had made. When federal officials respond, “they often refrain from doing so in writing, or say that the clarification does not apply more generally,” Klitzman was told.

Without assurance that they are acting correctly, IRBs act arbitrarily:

IRB chairs and members, according to Klitzman, “relied on gut feelings, intuition, the sniff test. People wanted to feel comfortable….They wanted peace of mind” about the studies they approved. Decisions were influenced by “pet peeves” and the “prudishness” of IRB members and chairs. Some IRBs are “user-friendly” or “pro-research,” he said.

In truth, such arbitrariness serves neither researchers nor research participants. Defino quotes Alice Dreger’s new book Galileo’s Middle Finger, which argues that “in practice, protections for people who become subjects of medical research may be their weakest in decades.”

The IRB system is premised on the notion that, at times, researchers and subjects have competing interests. Thanks to OHRP, they also have a common enemy.

Was OHRP Ever an Independent Watchdog?

Public Citizen is upset that NIH will get to write much of the NPRM. I don't understand why that matters.

Internal E-Mails Suggest NPRM is Coming

According to an open letter to HHS secretary Sylvia Mathews Burwell, Public Citizen obtained "very recent internal emails" among officials at the Office of Management and Budget and the Department of Health and Human Services, showing that the latter is actively working on a Notice of Proposed Rulemaking (NPRM) to revise the Common Rule.

I'll write separately about the substantive issue raised by Public Citizen. For now, the news is that as of November 13, 2014, senior officials were actively working to write an NPRM.

Well I, for one, am very interested to see what's going to happen next.

OHRP Claims to Be "Working Very Hard" on NPRM

Writing for the Chronicle of Higher Education, Christopher Shea notes that though two years passed between the 2012 Future of Human Subjects Research Regulation conference at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the publication of the conference volume in July 2014, the delay of the next step in regulatory reform--a notice of proposed rulemaking (NPRM)--means that the book remains timely.

[Shea, Christopher. “New Rules for Human-Subject Research Are Delayed and Debated.” Chronicle of Higher Education, November 3, 2014.]

One also hopes that it won't be timely forever. Shea writes,

A spokesman for the Office for Human Research Protections, which is part of the Department of Health and Human Services, could not provide a timetable but told The Chronicle late last month, "I can assure you that this continues to be an HHS priority, and all the relevant parties are still working very hard on this."

Or, as they might have put it, "We have top men working on it right now."

David Wright: OASH "is secretive, autocratic and unaccountable."

David Wright has resigned as director of the Department of Health and Human Services' Office of Research Integrity. In his letter of resignation, obtained by Science Insider, Wright blames a dysfunctional Office of the Assistant Secretary for Health (OASH), which also houses OHRP.

[Kaiser, Joceyln. "Top U.S. Scientific Misconduct Official Quits in Frustration With Bureaucracy." Science Insider, March 12, 2014.]

Happy New Year, National Academy of Sciences!

As longtime readers of this blog will know, I used to begin each year by mocking OHRP for failing to issue "a lot of examples and will give more guidance on how to make the decision on what is research and what is not" by the end of 2007, as promised by a former director. That trope got a bit old after a few years, and I didn't recycle it in 2013.

I will note that the National Academy of Sciences pledged to issue a summary of its March 2013 workshop "in summer 2013" and that "the study report will be issued in early winter 2013."

Anyone seen either of those?

On Signing the Markingson Petition

By April 1942, the Pentagon was 40 percent over budget, partly because it had been enlarged since first approved, but mostly because the original estimate of $35 million had never been realistic. Lieutenant General Brehon Somervell delayed telling Congress, but in June he finally sent Colonel Leslie Groves to appear before a House Apppropriations subcommittee.

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.]

Should We Expect an NPRM in April?

The Report on Research Compliance notes that the December 21 Current Regulatory Plan and the Unified Agenda of Regulatory and Deregulatory Actions projects a Notice of Proposed Rulemaking (NPRM) in April 2013 as the next step in a revised Common Rule.

RRC also cautions that "federal agencies are notorious for missing specified dates," so I won't hold my breath.

What Has OHRP Told Huron It Hasn't Told Me?

The Huron Consulting Group is advertising a free webinar on November 7 entitled "OHRP Regulatory Interpretations That You Need To Know, But Have Never Been Told." The press release explains:

The Health and Human Services (HHS) human subjects regulations aren't always clear-cut and often times Institutional Review Boards (IRBs) and researchers struggle with how to interpret them. During this webinar, the presenters will share the knowledge Huron has gained through communications with Office for Human Research Protections (OHRP) about topics such as:

• How to handle "protocol exceptions for a single subject"
• When an unanticipated problem involving risks to subjects or others does not have to be reported to OHRP
• Whether the IRB has to require the submission of the names of all study staff on a research study
• When Subpart C does not apply to a subject who becomes incarcerated

I am troubled by the premise of this webinar: that OHRP has passed on important information to a private consulting firm without posting it for public use. For some topics, this may be puffery by Huron. For example, OHRP has issued public guidance on "What happens if a human subject becomes a prisoner during the course of a research study?" But I don't know of similar guidance on topics like "protocol exceptions for a single subject." If OHRP has in fact made such regulatory interpretations, why aren't they on its website?

OHRP Calls for 2013 SACHRP Nominations Without Announcing 2012 Appointments

OHRP is calling for nominations to fill two SACHRP positions that will open in 2013.

OHRP has not, to my knowledge, announced the new members for 2012, including replacements for two members whose terms expired in July.

How is the public to suggest appropriate names for 2013 when we do not know what qualifications the 2012 appointments will bring to the committee?

IRB Chair Denies Being a Vampire

Patricia Price, a geographer and IRB chair at Florida International University, assures us that her board is not "a malevolent, vampirish entity."

[Patricia L. Price, "Geography, Me, and the IRB: From Roadblock to Resource," Professional Geographer 64, no. 1 (2012): 34-42, DOI:10.1080/00330124.2011.596789]

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).]