The aim of this project is to explore the ethical and legal ramifications of the increasing use of racial and ethnic categories in the context of gene patenting and drug development. Spurred, in part, by directives from federal agencies to collect racial and ethnic data in clinical trials and drug development, medical researchers and drug companies are increasingly considering the relationship between race, ethnicity and genetics, particularly in the emerging field of pharmacogenomics. In this context, we see a new phenomenon emerging - the implicit use of race and as genetic categories to obtain patent protection and drug approval. ? ? The specific objectives of this project are the following: ? ? i. Identify and explore existing and on-going genetic research and drug development that uses race and/or ethnicity as central categories for seeking regulatory approval and/or patent protection. ? ? ii. Consider the evolving impact of patent and regulatory incentives to race and ethnicity as categories in basic research and drug development. ? ? iii. Develop a set of policy and practice guidelines for appropriate regulatory agencies to insure that categories of race and ethnicity are used responsibly and constructively in basic research, clinical interventions, and drug development. The guidelines will be employed when reviewing applications that use race and/or ethnicity in a manner that is premised upon an underlying assumption that such categories are somehow genetic. ? ? ?
| Kahn, Jonathan (2008) Race, Genes, and Justice: A Call to Reform the Presentation of Forensic DNA Evidence in Criminal Trials. Brooklyn Law Rev 74:325-375 |
| Ellison, George T H; Kaufman, Jay S; Head, Rosemary F et al. (2008) Flaws in the U.S. Food and Drug Administration's rationale for supporting the development and approval of BiDil as a treatment for heart failure only in black patients. J Law Med Ethics 36:449-57 |
