Academic Excellence
Professors often ask students to write papers on current food and drug law issues. If you would like to have FDLI consider the top papers required for a particular course for publication on our website, please contact the Editor-in-Chief, Michael Levin-Epstein at (202) 222-0897 or mdl@fdli.org
The first postings in this section are two papers from a course entitled Human Subject Research: Law, Science & Public Health, taught by Professor Sheila Shulman at the University at Buffalo Law School, State University of New York. (Eight students in Professor Shulman’s class also attended FDLI’s first Colloquium, Whose Life Is It, Anyway? in Washington, DC, Feb. 27, 2007.)
Please note: This is not intended to discourage any student from participating in the A. Thomas Austern Writing Competition. Indeed, papers can be submitted to both if they meet the requirements.
Student Papers
Human Subject Research and Developing Countries:
Beneficence and Protection of Human Rights
by Julia Brylinski
This paper reviews sources of historical guidance embodied in regulation and ethical codes, and examines relevant guidelines adopted more recently by academic institutions in the U.S. that sponsor or conduct research in developing countries. It reports on the results of a survey commissioned by the former National Bioethics Advisory Commission that probed the experiences and views of researchers in developing countries with respect to externally-sponsored clinical trials, and reports on international ethical guidelines formulated to address problematic ethical issues. Finally, the paper raises the irreconcilable difficulty inherent in ethical mandates requiring that host populations have access to the experimental therapy following the conclusion of the study, assuming safety and effectiveness have been established, with the economic disincentives that exist for pharmaceutical manufacturers first, to conduct research on conditions unique to the host country, and second, to provide a needed therapy to countries lacking economic resources.
Due Process Predictions:
The Likely Outcome of Abigail Alliance v. Von Eschenbach
by Andrea Ott
This paper examines the substantive and procedural similarities between Washington v. Glucksberg and Abigail Alliance v. Von Eschenbach. In both cases, the appellants sought constitutional protection for novel fundamental rights. The Glucksberg appellants were unsuccessful in their attempt to secure a protected liberty interest in assisted suicide. In Abigail Alliance,the U.S. Court of Appeals for the D.C. Circuit will soon rule on a substantive due process right for the terminally ill to access investigational drugs. By analyzing precedent, populations involved and judicial recommendations, this paper concludes that the Court will deliver a holding in Abigail Alliance consistent with that in Glucksberg: there is no fundamental liberty interest deserving of substantive due process protection.