Experts in medicine and the law at the University of Minnesota and Vanderbilt University Medical Center (VUMC) are leading a national effort to analyze and recommend improvements in genomic law.
Many current laws and regulations governing genomic science and its application to improving human health are “misunderstood, uncertain or unclear,” said Ellen Wright Clayton, M.D., J.D., CraigWeaver Professor of Pediatrics at VUMC and a nationally recognized expert on ethics, law and medicine.
There is uncertainty, for example, about how far the U.S. Food and Drug Administration can go in regulating the quality of genetic testing.
To provide some clarity, Clayton and her colleagues at the University of Minnesota, Susan Wolf, J.D., and Frances Lawrenz, Ph.D., will convene a working group to build a searchable public online database of current laws and regulations, and recommend improvements in the legal framework.
The working group will consist of 22 legal and scientific experts from academia, industry, government, professional societies and clinical care. The goal of the study, supported by a three-year, $2 million grant from the National Institutes of Health, is to optimize the successful translation of genomics into clinical use.
Wolf is the McKnight Presidential Professor of Law, Medicine and Public Policy and chair of the University of Minnesota’s Consortium on Law and Values in Health, Environment and the Life Sciences. Lawrenz, an associate vice president for research, is an expert in qualitative and quantitative research methods.
