Genomics Big Data and Broad Consent: a New Ethics Frontier for Prevention Science

摘要

Emerging technologies for analyzing biospecimens have led to advances in understanding the interacting role of genetics and environment on development and individual responsivity to prevention and intervention programs. The scientific study of gene-environment influences has also benefited from the growth of Big Data tools that allow linking genomic data to health, educational, and other information stored in large integrated datasets. These advances have created a new frontier of ethical challenges for scientists as they collect, store, or engage in secondary use of potentially identifiable information and biospecimens. To address challenges arising from technological advances and the expanding contexts in which potentially identifiable information and biospecimens are collected and stored, the Office of Human Research Protections has revised federal regulations for the protection of human subjects. The revised regulations create a new format, content, and transparency requirements for informed consent, including a new mechanism known as broad consent. Broad consent offers participants a range of choices regarding consent for the storage and future use of their personally identifiable data. These regulations have important implications for how prevention scientists and oversight boards acquire participant consent for the collection, storage, and future use of their data by other investigators for scientific purposes significantly different from the original study. This article describes regulatory changes and challenges affecting traditional informed consent for prevention research, followed by a description of the rationale and requirements for obtaining broad consent, and concludes with a discussion of future challenges involving ongoing transparency and protections for participants and their communities.