Regulating the Production of Knowledge: Research Risk-Benefit Analysis and the Heterogeneity Problem

Scholars and lawmakers expend much effort determining optimal incentives to innovate, but almost entirely neglect the regulation of knowledge-producing activities themselves. This Article critically examines 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). It 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.