The Return of Results in Genetic Testing: Who Owes What to Whom, When, and Why?

Abstract

The field of genetic research has revolutionized modern medicine and will continue to do so in the years to come. For the people whose biological materials form the basis for this research, however, the research process may also lead to personal discoveries — namely, it may expose information about their health, genetic predispositions, and other gene-linked characteristics. Researchers who uncover this kind of personal genetic information are likewise confronted with the question of whether they should — or must — provide their subjects with feedback about their results. For subjects and researchers alike, the answer is unclear. Presently, there is little guidance as to these parties’ rights and responsibilities when it comes to the return of genetic results in a research setting. As a result, neither party has a clearly defined understanding of what to expect from the research relationship. This Article draws on recognized ethical and legal foundations to propose that genetic researchers should owe three limited legal duties to their research subjects regarding planning for, acquiring informed consent about, and reporting certain genetic findings. Considering the wide variation among individuals in terms of what genetic information they would like to know, this Article balances concerns for individual autonomy with the right to acquire personal health information, and it weighs those interests against the potential cost to socially beneficial genetic research. In balancing these considerations, this Article’s proposals for a limited set of duties offer a careful step toward clearly defining the rights and responsibilities of genetic researchers and their subjects.