Margaret Foster Riley

Federal Funding and the Institutional Evolution of Federal Regulation of Biomedical Research

Harvard Law & Policy Review

UVA Law Faculty Affiliations


This paper examines the institutional evolution of the federal regulation of biomedical research and the effect that federal funding has had—or has not had—on that evolution. Biomedical research is a term that includes basic scientific research into human biology as well as its application to medical procedures and clinical treatments. Federal funding created the system of academic medical research that blossomed and enjoyed unrivaled dominance in the second half of the twentieth century. A change in the focus of federal funding, at least in large part, also brought on the eclipse of that academic dominance by industry in the last decades of the twentieth century. The current regulations for biomedical research, however, are largely based on that earlier academic model. Those regulations have not changed even though the academic model has itself changed beyond the recognition of its creators. As a result, the regulatory structure of oversight for biomedical research is based on a model of medical research that still exists in part but has been greatly complicated by industry relationships, new funding sources, and a global character. There are therefore gaps in oversight: the IRB model does not work as effectively with industry sponsored or international research, the current regulations do not deal with many of the new conflicts of interest, there is likely much research that is not subject to any oversight, and the incentives for biomedical research are profit based more than science based.


Margaret Foster Riley, Federal Funding and the Institutional Evolution of Federal Regulation of Biomedical Research, 5 Harvard Law & Policy Review 265-287 (2011).

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