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A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley
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 …
Big (Gay) Love: Has The Irs Legalized Polygamy?, Anthony C. Infanti
Big (Gay) Love: Has The Irs Legalized Polygamy?, Anthony C. Infanti
Articles
Within days in December, a federal judge in Utah made news by loosening that state’s criminal prohibition against polygamy and the Attorney General of North Dakota made news by opining that a party to a same-sex marriage could enter into a different-sex marriage in that state without first obtaining a divorce or annulment. Both of these opinions raised the specter of legalized plural marriage. What discussions of these opinions missed, however, is the possibility that the IRS might already have legalized plural marriage in the wake of the U.S. Supreme Court’s decision last June in United States v. Windsor, which …