Wednesday, August 11, 2010

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.

Friday, August 6, 2010

More Universities Uncheck Their Boxes

In 2006, the American Association of University Professors filed a Freedom of Information Act request for a list of all U.S. colleges and universities whose Federalwide Assurances (FWAs) did not check the box on the form pledging to apply federal regulations to all human subjects research, regardless of funding. The list contained 174 entries, though 12 of those were duplicates. (See "IRB Documents" for these lists._

In March 2010, I reported that OHRP estimated that 26 percent of U.S. institutions had unchecked their boxes, up from only about 10 percent in the late 1990s. Curious about this trend, I requested an updated list, and in April 2010 I received a spreadsheet showing all institutions (including hospitals, health departments, commercial labs, and other health institutions) with unchecked boxes.

Making sense of this list took some processing, which accounts for the delay between my receiving the spreadsheet and this post. I did my best to extract institutions of higher learning, and came up with a list of 207 colleges and universities. Then I compared that list to the 2006 list sent to the AAUP.

Only 60 institutions appear on both the 2006 and 2010 lists. One hundred and two had unchecked boxes in 2006 but not 2010, while 147 unchecked their boxes between 2006 and 2010.

Major research universities appear on both lists. Between 2006 and 2010, William & Mary, Johns Hopkins, Princeton, and the University of Connecticut, went from unchecked to checked. Meanwhile, those unchecking boxes included Arizona, Boston University, Brandeis, Emory, George Washington University, Illinois at Urbana-Champaign, Indiana, Michigan State, Minnesota, Northwestern, Notre Dame, Ohio State, University of Pennsylvania, Texas at Austin, Tufts, UCLA, and the University of Southern California. This suggests that the trend is for major research institutions to uncheck. (Apologies to major universities not mentioned; this is my eyeball list, not an effort to correlate the list to Carnegie rankings or anything.)

An unchecked box minimizes a university's exposure to federal oversight and sanction. It does not, however, necessarily change anything for a university's researchers. My own institution, George Mason University, unchecked its box sometime between 2006 and 2010, but the administration has told faculty that it intends to apply all federal regulations to all research, regardless of funding. I imagine the same is true at many of the institutions that have unchecked their boxes.

Update, 15 May 2012, to fix link to "IRB Documents."

Monday, August 2, 2010

Like the blog? You'll love the book!

I am proud to announce the publication of my book, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009.

The book and the blog are complementary. The former traces the history of IRB review of research in the social sciences and humanities from its origins in the mid-1960s through last year, while the latter documents the ongoing debate over such review. I hope that everyone with an interest in the present debate will share my interest in its past.

The Johns Hopkins University Press has graciously offered a 25 percent discount to readers of this blog: please download the "Now Available" flyer. Books should begin shipping by the end of next week.