A System of Men and Not of Laws: What Due Process Tells Us About the Deficiencies in Institutional Review Boards

Northwestern Interdisciplinary Law Review, Vol. 7, p. 197 (2014)

U. of Pittsburgh Legal Studies Research Paper

46 Pages Posted: 13 Aug 2018

See all articles by Greer Donley

Greer Donley

University of Pittsburgh - School of Law

Date Written: 2014

Abstract

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 lack even the most basic procedural safeguards. This conclusion indicates that one of two solutions must be pursued: IRBs must be injected with processes to become minimally competent or the IRB system should be abolished in favor of a better alternative. Because the cost of infusing these protections into IRB decision-making is unfeasible, I conclude that a combination of tort liability and licensing for medical researchers can protect research participants in a less burdensome and more equitable way.

Keywords: procedural due process, human subjects research, institutional review boards, IRBs, medical research, bioethics and the law, science and technology law, administrative law, health law and policy

Suggested Citation

Donley, Greer, A System of Men and Not of Laws: What Due Process Tells Us About the Deficiencies in Institutional Review Boards (2014). Northwestern Interdisciplinary Law Review, Vol. 7, p. 197 (2014), U. of Pittsburgh Legal Studies Research Paper, Available at SSRN: https://ssrn.com/abstract=3224662

Greer Donley (Contact Author)

University of Pittsburgh - School of Law ( email )

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HOME PAGE: http://www.law.pitt.edu/people/greer-donley

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