Exchanging genetic data for public health practice and human subjects research: implications for health practitioners

Advances in genomic science and medicine require collaboration between healthcare providers, researchers and public health practitioners to improve individual and communal health. However, broader collaboration raises significant privacy and other concerns about acquisitions, uses and disclosures of identifiable genetic data. Corresponding legal requirements vary extensively if data are to be used in clinical practice, human subjects research, or public health surveillance. Distinguishing between practice and research activities is not easy. We introduce an enhanced methodology to distinguish public health practice from human subjects research to: help providers, researchers, and public health practitioners navigate the legal requirements underlying the exchange of genetic information; determine when public health data use crosses over to research, thereby triggering differing legal and ethical regulations; and to protect individual and group privacy from the unintended misuse of genetic information.