Law Commons^™

Modeling Through, Ryan Calo

Articles

Theorists of justice have long imagined a decision-maker capable of acting wisely in every circumstance. Policymakers seldom live up to this ideal. They face well-understood limits, including an inability to anticipate the societal impacts of state intervention along a range of dimensions and values. Policymakers cannot see around corners or address societal problems at their roots. When it comes to regulation and policy-setting, policymakers are often forced, in the memorable words of political economist Charles Lindblom, to “muddle through” as best they can.

Powerful new affordances, from supercomputing to artificial intelligence, have arisen in the decades since Lindblom’s 1959 article …

Encouraging Maternal Sacrifice: How Regulations Governing The Consumption Of Pharmaceuticals During Pregnancy Prioritize Fetal Safety Over Maternal Health And Autonomy, Greer Donley

Articles

Pregnant women are routinely faced with the stressful decision of whether to consume needed medications during their pregnancies. Because the risks associated with pharmaceutical drug consumption during pregnancy are largely unknown, pregnant women both inadvertently consume dangerous medications and avoid needed drugs. Both outcomes are harmful to pregnant women and their fetuses. This unparalleled lack of drug safety information is a result of ill-conceived, paternalistic regulations in two areas of the law: regulations governing ethical research in human subjects and regulations that dictate the required labels on drugs. The former categorizes pregnant women as “vulnerable” and thus precludes them from …

A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley

Articles

Governmental regulation of human subjects research involves unique agency action. It delegates power to non-expert committees, Institutional Review Boards, to decide whether research protocols are "ethical" according to vague federal regulations. Without IRB approval, the protocol cannot be investigated. The empirical evidence regarding this system demonstrates that IRBs render deeply inconsistent and inaccurate outcomes. This Article argues that the lack of due process in the IRB system is to blame for such arbitrary agency action. By juxtaposing the levels of process required for IRB approval or research with FDA new drug approval--agency action involving similar interests--this Article highlights that IRBs …