Research implications of the Genetic Information Nondiscrimination Act (GINA) on secondary data research uses

Advances in laboratory techniques and bioinformatics are making it possible for researchers and health care organizations to collect and store greater amounts of genetic data about patients and clinical research participants for longer periods than ever before. At the same time, improvements in computer hardware and medical information systems (e.g., electronic health records) have made it possible to store and transfer large quantities of medical data efficiently. Sophisticated databases and high-capacity storage devices facilitate sharing of identifiable medical information among multiple physicians, researchers, and institutions. The ability to aggregate large quantities of genetic data can facilitate development of better diagnostic tools, new medical treatments, and more accurate prognostic models, all of which offer benefits to patients and society as a whole. However, when individuals consent to the collection and storage of genetic information, they typically have no way to determine what happens to the information derived from the sample(s) provided. In particular, they cannot determine who has accessed their personal information, how information about them is being used, and whether personal information has been sufficiently de-identified to protect their privacy. To protect patients from potential harm resulting from inappropriate disclosure or unintended use of genetic information, in 2008 the United States Congress passed the Genetic Information Nondiscrimination Act. This presentation outlines briefly the provisions of GINA, discusses how research-related secondary data collection and use have changed since GINA went into effect in May 2009, and identifies potential opportunities and challenges for the future.