Wednesday, April 17, 2013

What Can One University Do?

A few weeks ago, a correspondent asked me what reforms individual universities can implement while awaiting systemic, regulatory reform. It's an excellent question, so here's a roundup from material previously covered on the blog.

No university has adopted all of these measures, and at least one of these measures has not been adopted by any. But most of them are in place already, and there's no reason they can't spread.

1. Uncheck the box

Current regulations do not require institutions to apply federal regulatory standards to research not directly funded by one of the Common Rule agencies, so universities have the option to "uncheck the box" on their federal assurances to avoid making such pledges. In 2006, Richard Shweder identified this unchecking as "a monumental (even if small) first step" toward defending academic freedom. While many universities have unchecked their boxes simply to avoid federal sanctions, rather than to free up research, some have in fact made life better for researchers and the participants in their projects.

2. Free oral history, journalism, and folklore

Several top research universities, including Columbia, Princeton, Texas at Austin, Michigan, Notre Dame, USC, and now George Mason, have acted on OHRP's 2003 advice that oral history does not constitute generalizable research, and have stopped requiring oral historians to seek IRB review. So have several government agencies. Often, such policies also liberate other forms of interviewing in which attribution by full name is the norm, notably journalism and folklore.

3. Accept evolving research

A common complaint among ethnographers and other interview researchers is that IRBs expect researchers to form questions in advance, rather than asking questions about what they observe. The University of Pennsylvania has addressed this in its policy on evolving research. Canada's TCPS2 takes a similar approach in its chapter on qualitative research.

4. Allow alternative training

Mortifyingly stupid CITI training can quickly destroy any goodwill a new researcher brings to the IRB process. Yet it is not required by the regulations. A university can still subscribe to CITI but offer researchers the opportunity to document in other ways that they are familiar with their responsibilities. Macquarie University has developed an online training course for ethnographers, and Princeton has crafted a research-ethics course for historians. Universities could allow researchers to complete such training in lieu of the CITI Program.

5. Offer alternatives to Belmont

45 CFR 46.103(b)(1) requires institutions to submit "a statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research," but gives them the choice of "an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution itself." The last I checked, no U.S. university had meaningfully used this flexibility to do anything but pledge allegiance to the Belmont Report. But a university could embrace greater pluralism by recognizing alternatives to Belmont, such as the ethical codes crafted by scholarly societies.

6. Allow researchers to determine exemptions.

As I document in my book, the framers of the regulations expected researchers to be able to determine for themselves whether their research is exempt under 45 CFR 46.101(b). OHRP has made clear that this remains permissible. Now, several universities are testing a computer program that would make exemption determinations in respose to inputs from researchers. If the test goes well, this reform could be quite easy for other universities to implement.

7. Adopt evidence-based review

I was most impressed by the recent article, Anderson and DuBois. “IRB Decision-Making with Imperfect Knowledge: A Framework for Evidence-Based Research Ethics Review,” Journal of Law, Medicine & Ethics 40, no. 4 (2012): 951–969. This offers step-by-step instructions for an IRB that wants to base its decision on evidence, rather than gut reactions. The Journal of Empirical Research on Human Research Ethics and The Ethics Application Repository are good resources for such an approach.

8. Establish an appeals process

The AAUP's 2013 report, "Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board," notes that many responses to the ANPRM called for an appeals process, and the AAUP did so as well. Current regulations make an appeals process cumbersome, but the AAUP suggests features of a good appeals process, some of which could be implemented under current regulations.

9. Create an advisory board

Allowing IRBs and IRB offices to set policies about research, as well as reviewing specific proposals, can create a dangerous concentration of power. Several universities, most recently Mason, have created faculty advisory boards, not to review cases or even hear appeals, but to offer guidance on such issues as when does a classroom project need review.

Universities with some kind of oversight include Michigan State, Ohio State, UCLA, the University of Michigan, and Virginia Commonwealth. I have seen references to others as well, but they may be defunct.

10. Learn

I haven't read much of the literature on organizational learning, but the basic idea is that experience should shape what organizations know and, better still, what they do.

Some university human research protections programs learn from experience. The University of Michigan seems particularly committed to continuously improving its program, sponoring surveys of investigator experiences, and trying out new policies (including unchecking the box, freeing oral history, providing oversight of the IRB, and trying out new exemption procedures). Not all universities have the resources of Michigan, but all can resolve to look for opportunities to make things better.

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