In legal scholarship and education, innovation law and policy is virtually synonymous with intellectual property in general, and with patent law in particular. This is curious and, I think, misguided. We expend considerable effort designing optimal incentives for innovation. We expend similar effort ensuring that socially useful knowledge, once produced, is widely and accurately disseminated. But if knowledge-producing activities themselves are suboptimally regulated, neither upstream incentives to engage in them nor downstream mechanisms to disseminate their fruits will much matter.
In Regulating the Production of Knowledge: Research Risk-Benefit Analysis and the Heterogeneity Problem, I
critically examine[] that regulatory framework, adopted by more than one dozen federal agencies in the U.S. and many other countries, which governs the vast majority of those knowledge-producing activities that have the greatest potential to affect human welfare: research involving human beings, or “human subjects research” (HSR). [The Article] focuses on the primary actors in the regulation of HSR — licensing committees called Institutional Review Boards (IRBs) which, before each study may proceed, must find that its risks to participants are “reasonable in relation to” its expected benefits for both participants and society. It argues for a particular interpretation of this risk-benefit standard and, drawing on scholarship in psychology, economics, neuroscience and other fields, argues that participant heterogeneity prevents IRBs from carrying out their regulatory duty. Instead, the regulatory system implicitly responds to the heterogeneity problem with risk aversion that is costly not only to researchers and society but, critically, to would-be research participants. The Article concludes by laying out the policy options that remain in the wake of the heterogeneity problem’s intractability: continuing the legal fiction of risk-benefit analysis, honestly embracing the heterogeneity problem and its costs, or jettisoning IRB risk-benefit analysis. A companion Article develops the possibility of the third option.
HSR is not, of course, unknown to the legal academy. But in the law school curriculum, HSR tends to be relegated to the final weeks of courses in health law or FDA law (themselves often inexplicably marginalized in the curriculum). This curricular choice rests on a conflation of HSR with biomedical research in general, and with pharmaceutical drug trials in particular. Viewing “human subjects research” (except for the obligatory nod to the evils of Milgram and Zimbardo) as virtually synonymous with clinical trials doesn’t remotely match the regulatory reality. Virtually every research methodology (not only randomized, controlled trials but also data collection and analysis, online Stroop tests, surveys, interviews, and even simple observation) and virtually every academic discipline (not only biomedicine and psychology but every social science, many humanities — and, yes, empirical legal studies) is subject to federal regulation, including prospective review by an IRB.
And so the regulations governing HSR should be of concern to scholars of innovation law and policy (because HSR is a critical link in the innovation chain), to many, many other scholars (because their work is, or easily could be, considered HSR and thus subject to regulation, even if many of them don’t realize it), to citizens (because most of us presumably want the laws and policies to which we are subject to be evidence-based, and that depends on being able to conduct well-designed, generalizable HSR without undue delay, cost, or restriction), and — perhaps counterintuitively — to would-be research participants themselves, whose welfare, I argue in The Heterogeneity Problem and its companion, Research Contracts, is just as often served by participating in research as it is by being protected from offers to participate.
In a series of posts cross-posted here and at The Faculty Lounge, I’ll be unpacking The Heterogeneity Problem and Research Contracts. I’ll be talking about the broad scope of the regulations and their legislative history, arguing that the regulatory requirement of prospective, third-party risk-benefit analysis was unresponsive to the abuses in HSR that Congress and the public sought to redress. I’ll be discussing the ways in which the regulations are suboptimal (and making a claim about what we’re trying to optimize), and what might be done about this. (Next up in the series: Expedited and Exempt IRB Review: Curb Your Enthusiasm, Or, IRB Review: Step Zero.)
I’ll also be making the case that the same neglected regulatory framework governing HSR that I critique in those articles seriously undermines evidence-based practice in health care, public health, legal services, and in any number of other realms of law- and policy-making, from the criminal justice system to education. On that front, I’ll be blogging about a March 1, 2012, workshop (and, I hope, subsequent edited volume) that I’m organizing, Legal Experimentation: Legal and Ethical Challenges to Evidence-Based Law and Medicine, to be held at Harvard Law School and sponsored by the Petrie-Flom Center.
For now, let me note that the American Association of University Professors (AAUP) has recently issued Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board, a draft update of its 2006 report on this issue. H/T George Mason history prof. Zach Schrag, whose Institutional Review Blog and book, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1960–2009, are must-reads in this area (as is co-blogger Laura Stark‘s book, Behind Closed Doors: IRBS and the Making of Ethical Research, about which I hope she’ll blog). Zach co-authored the AAUP report along with five others, including philosopher Judith Jarvis Thomson (she of the famous violinist abortion hypo, and much additional, fame) and Illinois law prof. David Hyman.
The AAUP will be accepting comments on its report until September 28. Comment early and often. Academic freedom — but also human welfare — depend on it.
Portions of this post were adapted from a July 11, 2012, post at The Faculty Lounge.
As someone who may soon be needing the services of an IRB or providing such services to others, I’m very interested. I’m organized with some colleagues to do clinical trials of dietary supplements, but we’ve also offered our service as an IRB to others. Whether an IRB is legally required mostly is going to depend on where the findings go. Most journals require IRB review, so if a client wants a study submitted for publication, that increases cost and time. However, the Federal Trade Commission does not require businesses to submit their findings on their products, only that they satisfy themselves that their advertising claims are correct, so studies only to that end don’t require IRB review.