There is a fairly broad consensus among bioethicists and state and federal regulators that scientific investigators’ communication of genetic test results to research participants should be subject to prior review and content-based restrictions on what the participants can be told. The recommended restrictions often include outright bans on the return of results that are scientifically uncertain, that lack a well-established clinical or reproductive significance, or that reveal risks about which little can be done given the limitations of current medical knowledge. Yet, many research participants are curious about their genomes and want to know what researchers found out about them. Investigators may feel strongly inclined to answer their questions whether out of civility, fear of liability, or respect for the research participants, but they worry that doing so would violate a complex web of laws and regulations that restrict the return of experimental test results.
Part I of this Article surveys these laws. Part II surveys bioethical recommendations to limit or suppress the return of results and surveys the bioethical rationales that support those recommendations. These include a litany of concerns about the dangers of communicating complex and uncertain genetic findings to scientifically naïve research participants. Doing so, it is feared, may mislead participants and potentially lead them to seek needless medical treatments or may inflict psycho-social harms such as making them feel anxious or stigmatized. Moreover, putting scientific information into the hands of laypeople may bring about broader social and economic harms: for example, wasteful healthcare spending as participants seek follow-up care in a quest to make sense of their genomes; depletion of research budgets by the allegedly high cost of returning results, and the possibility that laypeople may propagate non-canonical understandings of the genome within the social networks they form during their search to decipher what their genomes mean.
Parts III–IV of this Article explore whether legal restrictions on the return of results from genomic research may violate the First Amendment to the U.S. Constitution. Past literature on the return of research results has focused heavily on investigators’ duties--that is, on identifying situations when an investigator has an ethical or legal obligation to inform a research participant of results that could have medical or other significance to the individual7 This Article examines a different question: whether investigators have a right to communicate results to a research participant who has expressed the desire to receive them. This discussion presumes that the research participant has requested return of results so that there is a consenting recipient. Moreover, the investigator is potentially willing to share the information but is concerned that the requested communication may violate a law or regulation. This situation sets up the inquiry: Is the return of results to a willing research subject a form of speech that is entitled to protection under the First Amendment, such that laws that block such speech may be unconstitutional?
The First Amendment Right to Speak About the Human Genome,
U. Pa. J. Const. L.
Available at: https://scholarship.law.upenn.edu/jcl/vol16/iss3/1