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.

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

After Lawsuit, Arizona State IRB Hindered Native American Interviews

Kimberly TallBear, assistant professor of science, technology, and environmental policy at Berkeley, describes her encounters with IRBs there and at Arizona State University. At the latter, the IRB imposed conditions that made her abandon plans to interview Native Americans.

["Interview with Kimberly TallBear," GeneWatch, May/June 2010.]

As she puts it:

IRBs vary from university to university, and some are much stricter than others. For example, the Arizona State University IRB is, after the Havasupai lawsuit, incredibly strict where tribes are concerned. If you're going to do research with native populations, whether it's biological research or even social science research, you have to get approval from the tribal council before the university will even look at your protocol. On the other hand, I'm doing a project at Berkeley where I'm interviewing both genetic scientists and tribal government people, and Berkeley didn't look twice at my interview with indigenous people. I asked if they require some sort of documentation that I got approval from the tribe, and they said, "No, no, no, that's not a problem." So there are differences between IRBs as well as between disciplines . . .

I'm not an expert on IRBs, but I can speak from personal experience—I have worked at both Arizona State and Berkeley, so I have seen the huge differences in IRBs. In short, the difference is that ASU has been sued. Before the Havasupai suit, ASU was lax as well.

I was at ASU in 2006 and 2007. As a social scientist, I was interviewing a range of people—native people, scientists, regulators—and the IRB was very strict about allowing me to talk to tribes. I had interviewees at five or six tribes, which meant I would have had to go through each one of those tribes to get approval for those interview questions. So, in order to get approval for my science piece, I backed out of the Native American community member questions.

This was also really interesting: I study the culture and politics of genetic science, and I think they should have been more strict and careful about my research questions for scientists. In my work, scientists are potentially vulnerable subjects. Now, I don't actually think they are very vulnerable—I think they actually have a lot more cultural authority than I do in the broader world—but I'm a potential critic. While the native populations were seen as potentially vulnerable subjects, it didn't seem to have crossed the IRB's minds that scientists could be potentially vulnerable subjects, too.

It was the opposite at Berkeley, actually: they were much, much more concerned about my questions for scientists and protecting their confidentiality, and they seemed not at all concerned about my questions for indigenous people, at least from my perspective.

TallBear does not appear angry that the the ASU IRB's strictness forced her to "back out" of planned interviews. Rather, she seems to wish that IRBs were even stricter: "What IRBs require is a bare minimum of the standards that you have to meet to conduct ethical research. IRB approval doesn't constitute a thorough process." And, later, "you see people who have just decided they don't want to work with tribes, because they don't want to have to go through a tribal research review board, they don't want to let a tribal council or a tribal IRB have a say over whether they can publish something or not. I think that's a good thing . . . Go do something else!"

It is not clear from the published interview whether she believes that such discouragement is appropriate only for geneticists and other biomedical researchers, or if she is happy to let tribal governments control the writings of social scientists and journalists as well.

Report from SACHRP, Part 3: When Consent Means Censorship

A third item of interest from this month's SACHRP meeting concerns rules about research on Indian reservations.

According to a handout provided at the meeting, in March 2008, Dr. Francine Romero--an epidemiologist and former member of SACHRP--proposed that the Common Rule be amended to specify that

For human subject research to be conducted wtihin the jurisdiction(s) of federally recognized American Indian or Alaska native (AIAN) Tribal government(s), the IRB shall require documentation of explicit Tribal approval for the research. This approval shall come from the Tribal Council or other agency of the Tribal government to whom such authority has been delegated by the Council.

The Subpart A Subcommittee decided that while amending the Common Rule was neither "efficacious, expeditious, nor appropriate," it apparently thought the overall idea a good one, and recommended that OHRP develop guidance to assure that researchers get permission from Tribal governments to do research within their jurisdiction. In the general discussion, various SACHRP members and other federal officials debated whether OHRP was the right office to handle the task, and they modified the recommendation to include other HHS agencies.

As I pointed out during the public comment period, similar rules in Canada have deterred historians from including First Nations Canadians in their research, and give Band Councils veto power over who in their communities gets to talk with a university researcher. And in California, a Tribal government used an IRB to suppress research on labor conditions in casinos. But at no point during the SACHRP discussion did anyone consider the effect the recommendation would have on social science research.

Since 1966, IRB policies have been determined by bodies dominated by medical researchers, and SACHRP is just the latest in a long list. However much medical researchers and administrators may want the trust and respect of social researchers, they simply cannot keep in mind the rights and responsibilities of social scientists when something like this comes up. For medical researchers, it seems, more consent is always better, and they forget that one person's consent is another's censorship.

In related news, today's New York Times reports that the U.S. military has suppressed photographs of American casualties in Iraq by insisting that photojournalists obtain written consent from the troops they photograph:

New embed rules were adopted in the spring of 2007 that required written permission from wounded soldiers before their image could be used, a near impossibility in the case of badly wounded soldiers, journalists say . . . Two New York Times journalists were disembedded in January 2007 after the paper published a photo of a mortally wounded soldier. Though the soldier was shot through the head and died hours after the photo was taken, Lt. Gen. Raymond T. Odierno argued that The Times had broken embed rules by not getting written permission from the soldier.

[Michael Kamber and Tim Arango, "4,000 U.S. Deaths, and Just a Handful of Images," New York Times, 26 July 2008]