Virtual Clinical Trials: One Step Forward, Two Steps Back

Virtual clinical trials have entered the medical research landscape. Today’s clinical trials recruit subjects online, obtain informed consent online, send treatments such as medications or devices to the subjects’ homes, and require subjects to record their responses online. Virtual clinical trials could be a way to democratize clinical research and circumvent geographical limitations by allowing access to clinical research for people who live far from traditional medical research centers. But virtual clinical trials also depart dramatically from traditional medical research studies in ways that can harm individuals and the public at large. This article addresses the issues presented by virtual clinical trials with regard to: (1) recruitment methods; (2) informed consent; (3) confidentiality; (4) potential risks to the subjects; and (5) the safety and efficacy of treatments that are approved

A Conceptual Framework for Genetic Policy: Comparing the Medical, Public Health, and Fundamental Rights Models

This Article presents the first attempt to develop a comprehensive legal framework governing the regulation of genetic information in the United States. Part II addresses the need for such legal framework. Part III analyzes three conceptual legal models that have been adopted in the past for regulating medical services: the medical model, the public health model, and the fundamental rights model. Part IV examines the results of medical and social scientific studies on the impact of genetic services. Part V addresses the impact of genetic services. Part VI revisits the three models to determine which is appropriate for genetics. Part VII discusses the legal justification for the fundamental rights model