64 Food and Drug Law Journal 225-260 (2009).
Research that utilizes human subjects is a large and growing enterprise. Tens of millions of individuals have already participated as subjects in one or more research protocols, and millions more participate each year. Government and industry combined spend billions annually to support as many as 20,000 research studies, many of which are individually large and complex enterprises in their own right.
These numbers are, if anything, likely to increase even further. Besides the growth in research, two other trends are apparent. First, research-related litigation is on the rise and appears likely to become even more widespread. Sparked at least in part by recent widely publicized instances of harm befalling research subjects, plaintiffs’ attorneys are suing both more often and more creatively. Related to this is the second trend: public trust in research is declining and, as a result, at least some types of research are struggling to find adequate numbers of human subjects.
As a result of these trends, exposure to potential liability and public perception are both increasingly important. Concomitant with all of this research is the discovery and generation of tremendous quantities of data specific to individual subjects, including—but not limited to—genetic information. Much of this data is irrelevant to subjects’ interests because it lacks predictive value, has uncertain meaning, or is otherwise uninformative. Some, however, is different—some of the personal data learned during the course of research with human subjects bears directly on individuals’ health. Despite the fact that much individual data has already been generated and that both the quantity and the quality of data generated seem likely to increase, there is a lack of clear guidance for researchers regarding whether and when such information should be divulged to the subjects on whom it bears.
In this environment, the potential exists for litigation alleging that a researcher was negligent for failure to disclose to a subject an individual research finding of medical significance. Such litigation would raise a heretofore-unanswered question: should a researcher have a legal duty to disclose medically significant individual research findings to a subject?