[Laura Stark, Review of Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 by Zachary Schrag, American Journal of Sociology 117 (November 2011): 1019-1021.]
Stark apparently rejects my conclusion that "IRB review of the social sciences and the humanities was founded on ignorance, haste, and disrespect." Instead, she claims that
research methods commonly used in the social sciences were included in the regulations because of contemporary concerns about social, legal, and financial risks—not only the (nonexistent) physical risks of sharing information with a social researcher. To understand how worries about nonphysical risks might have seemed legitimate to historical actors, readers should bring to the book a sense of broader political conversations at the time about civil rights, "privacy," and expert authority.
One can find some evidence to support such a thesis. For example, I report the 1967 recommendations of the Panel on Privacy in Behavioral Research, which supported the idea of institutional review out of concern with privacy. Yet that same panel concluded that
because of its relative inflexibility, legislation cannot meet the challenge of the subtle and sensitive conflict of values under consideration, nor can it aid in the wise decision making by individuals which is required to assure optimum protection of subjects, together with the fullest effectiveness of research . . . Institutions differ in their internal structures and operating procedures, and no single rigid formula will work for all. (Ethical Imperialism, 36)
Of course, Congress and the executive agencies ignored this advice, passing legislation imposing rigid formulae. Most of my book is a narrative of such disconnects between the people genuine concerned with the issues that Stark notes and those who had the power to pass rules over the objections of the former group.
Stark and I may disagree most on our understanding of the power of individuals and groups to shape the law. Back in 2007, I complained about Stark's use of the passive voice in describing the origins of the IRB system, and I am sorry to see her still relying on it: "research methods commonly used in the social sciences were included in the regulations because of contemporary concerns . . ." The active voice would have required her to explain who exactly was so concerned. Congress? The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research? NIH officials?
But Stark discounts the value of studying people, arguing that my "historical interpretations tend to be character assessments of individuals rather than reflections on how IRBs connected to broader social processes or how IRB debates fit into a wider political context." Indeed, I do study individuals, and small groups such as the National Commission. I do so in the belief that people, and not "broader social processes," write laws, regulations, and guidance. And I was unable to find anyone with the power to craft those rules who was also seriously interested in the problems of social science.
Stark also accuses me of crafting a narrative in support of a policy position, writing, "Schrag's concern is to justify the view that most social scientists' research should not be subject to the federal regulations."
As I explained in my preface,
I approached this project with as open a mind as I could, abandoning some of my preconceptions as my research progressed. In particular, I began my investigations expecting to find that the officials who wrote today's human subjects regulations had wholly failed to consider the impact of their work on nonbiomedical research, and I was repeatedly surprised to learn how frequently (if superficially) they debated the subject. I hope all those interested in the topic, regardless of their positions, will likewise let themselves be surprised by the facts in this account. (x)
Either Stark overlooked this passage, or she doesn't believe me.
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