The First Amendment Right to Speak About the Human Genome.

This article explores whether laws that restrict the communication of genetic test results may, under certain circumstances, violate the First Amendment to the U.S. Constitution. The focus is whether investigators have a right to return results from non-CLIA-certified laboratories in situations where a research participant requests the results and the investigator is willing to share them but is concerned that doing so may violate regulations under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA"). This article takes no position on whether investigators can be compelled to return results when they do not wish to do so. It examines only whether investigators may, not whether they must, return results to a willing research participant. The article: (1) surveys state and federal laws that block communication of genetic test results to research participants; (2) examines the historical use of speech restrictions as a tool for protecting human research subjects; (3) traces how First Amendment doctrine has evolved since the 1970s when foundations of modern research bioethics were laid; (4) inquires whether recent bioethical and policy debate has accorded due weight to the First Amendment. The article applies two common methods of legal analysis, textual and constitutional analysis. It concludes that the CLIA regulations, when properly construed, do not treat the return of results as an event that triggers CLIA's certification requirements. Moreover, there is a potential First Amendment problem in construing CLIA's research exception in a way that bans the return of results from non-CLIA-certified laboratories.