Thursday, July 17, 2008

Political Scientists to the Rescue?

The final essay in the PS symposium is Sue Tolleson-Rinehart, "A Collision of Noble Goals: Protecting Human Subjects, Improving Health Care, and a Research Agenda for Political Science."

Tolleson-Rinehart addresses the question of quality improvement in health care, such as the checklist publicized by Atul Gawande. As she notes, her "essay is not about the influence of IRBs on political science research" and is therefore largely outside the scope of this blog. That said, she makes some observations relevant to the regulation of social science research.

While sympathetic to individual IRB members, Tolleson-Rinehart takes a dim view of the system as it now operates:

IRBs are understandably, and necessarily, driven by their limiting case: the possibility of invasive or dangerous procedures performed with vulnerable individuals or populations, without adequate regard for the hallmarks of protection, respect for persons, beneficence and nonmaleficence, and justice elucidated in what is widely known as the Belmont Report, and adopted from the time of the Belmont Report’s release as our fundamental ethical principles. It is not surprising, given IRBs’ role as the protector of the vulnerable, that the general IRB perspective on “minimal risk” and risk-benefit comparisons is a conservative one.

IRBs are also terrified. All IRB professionals I know work in real fear that their IRBs could be the next ones to cause an entire university’s research to be shut down. Shutdowns in recent years at Harvard, Duke, and Johns Hopkins give IRBs every reason to be fearful of making what OHRP considers to be an error. The reasonable suspicion that researchers regard IRBs as obstacles to, rather than facilitators of, research, must further IRB professionals’ sense of being embattled.

Reviewers on IRB committees are our very hardworking colleagues who are usually not given adequate release time to meet their committee responsibilities, and who are not able to benefit from truly extensive and nationally standardized training, nor do they have anything like a consensus metric for evaluating the spectrum of risk in different research contexts and for different populations.

All these sources of strain might determine the conservative approach to human subject protections. When social science research (including quality-improvement research) occurs in a biomedical context, or when health care and health policy require evaluation, the conservative stance can become dysfunctional. IRB assessments of my own students’ work provide a clear example of one of the ironic and unintended consequences of the absence of agreed upon and broadly understood metrics for assigning risk in different research contexts. IRBs have a comparative lack of familiarity with how social science methods— such as those used in quality-improvement research—may differ from some other methods of clinical research in the risks they pose to subjects. (508)

She adds that while her own students submit "substantially similar" protocols, their

IRB determinations range from declarations that the project is “not human subjects research” at all to “research that requires full consent,” with every intermediate determination. I frequently have students working simultaneously on very similar projects, one of whom must go through a tedious consenting process taking as much as four to five minutes of the beginning of telephone interviews (with the busy elites at the other end chafing at these long and unnecessary prefaces to the first question), while another student researcher is not required to secure any kind of consent at all. The single source of variation across these cases is not the research question or the method, but the IRB reviewers and their familiarity ~or lack thereof ! with in-depth interviewing and the unique protections already available, via one’s position, to the “powerful research subject.” (509)

This is damning enough, but Tolleson-Rinehart insists that the "point of this vignette is not to criticize IRBs." (509) Rather, she argues that

political science is well prepared to analyze and make normative (but evidence-based) recommendations about the politics of human subjects research. We can help define what it is, and the circumstances under which it is generalizable knowledge, even though it may not necessitate a conservative approach to protections. We can construct frameworks to achieve a more precise understanding of how to balance risks and benefits. Those frameworks might even lead us to formulate what would amount to a multidimensional risk scale. Finally, political science can contribute to the construction of theoretical and methodological underpinnings for the content of truly national standards for IRB training curricula. These would improve IRB reviewers’ understanding of different research methods to go beyond mere compliance with federal regulations and become real resources and decision aids for hard-pressed reviewers who may have to evaluate research they aren’t familiar with. (509)

Finally, Tolleson-Rinehart notes that while the Association for the Accreditation of Human Research Protection Programs and Public Responsibility in Medicine and Research mean well, both emphasize regulatory compliance over actual research ethics. She argues that political scientists can go beyond compliance questions to work on "a common epistemology of the philosophical, ethical, and political foundations of human subjects research." (510)

All of this sounds fine, and I hope that Tolleson-Rinehart and her colleagues get to work on her agenda. But as my recent exchange with Levine and Skedsvold suggests, the most immediate question for political scientists may be to figure out how to make the regulatory system more responsive to developments in research. We seem stuck with a 1974 law and 1991 regulations that cannot be changed, even when everyone agrees they need updating.

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