Thanks very much to Dan and the other loungers for having me, and to Al for that very generous introduction. Owing to other projects, I’ll be posting a bit more sporadically, but hanging out a bit longer, than some other guests.
I have varied interests, but of late, I’ve been obsessed with what is generally known as “human subjects research” (HSR) and with the institutional review boards (IRBs) that review it. I’ll talk about some of my own work in this area in later posts, but for now let me explain why readers of The Faculty Lounge care about HSR and IRBs — even if you don’t know it.
In legal scholarship and education, innovation law and policy is almost synonymous with intellectual property in general, and with patent law in particular. This, I think, is a mistake.
We can all agree that incentives to engage in knowledge-producing activities are important, even as we disagree about whether the current patent system in fact provides optimal incentives and about what values we should be trying to maximize when we establish those incentives. But one of the things that gets lost in our focus on patents, technology transfer, and so on is the next step in the innovation chain: optimal incentives to engage in knowledge-producing activities will be of little use if the regulation of knowledge-producing activities themselves is suboptimal.
Innovations with the potential to affect human welfare at some point generally have to involve human beings. That’s where HSR comes in. In the law school curriculum, HSR tends to be relegated to the final weeks of courses in health law or FDA law (themselves often marginalized in the curriculum, if they are offered at all). But this curricular choice rests on a conflation of HSR with biomedical research in general, and with pharmaceutical drug trials in particular.
This narrow focus doesn’t remotely match the regulatory reality, which is that 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 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.
In later posts, I’ll have more on the breadth of the current regulatory framework, what that framework entails, how we got here, what’s wrong with the current system, and what might be done about it. For now, let me suggest that 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 virtually all 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), and — most importantly — to citizens (because you presumably want the laws and policies to which you are subject to be evidence-based, and that depends on being able to conduct well-designed, generalizable HSR without undue delay, cost, or restriction).
Thanks again to Dan, Al, and the other loungers for letting me hang around the lounge. I look forward to the conversation.