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.
A System of Men and Not of Laws: What Due Process Tells Us About the Deficiencies in Institutional Review Boards,
Northwestern Interdisciplinary Law Review,
Available at: https://scholarship.law.pitt.edu/fac_articles/92
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