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NIH

Data Sharing and Privacy

Genomic Data Sharing Policies and Controlled Access

Technological advances in DNA sequencing have made high-throughput sequencing methods significantly faster and cheaper, allowing researchers to generate larger datasets than ever before. These datasets can be used for genome-wide association studies (GWAS) that identify specific genomic factors associated with human health and disease. NIH implemented the GWAS Policy in 2008, requiring data from NIH-funded GWAS to be shared with the research community in a central data repository maintained by NIH, the database of Genotypes and Phenotypes (dbGaP). To protect research participants' privacy, access to sensitive data in dbGaP is through a controlled access policy, and NIH requires secondary use of data (i.e. use of existing data for a different study) to be consistent with the informed consent obtained from research participants during the initial study. 

To further expand genomic data sharing of all types, NIH released a Genomic Data Sharing policy that has been in effect since January 25, 2015. The policy states that NIH expects investigators to obtain consent for participants' data to be used for future research purposes and to be shared broadly through databases. NIH has the same expectations for informed consent for studies using genomic data from cell lines or clinical specimens that were created or collected after the effective date of the policy. Like the GWAS policy, the GDS policy includes numerous provisions to ensure the protection of human genomic data. See http://gds.nih.gov/ for more information.

The importance of controlling data access to protect research participant privacy has been highlighted by the HeLa Genome Data Use Agreement announced by NIH in August 2013. HeLa cells are used widely in research and were first taken and immortalized from a cancer patient named Henrietta Lacks. In collaboration with the Lacks family, NIH developed a controlled access policy through dbGaP specifically for genomic data generated from the HeLa cell line. The HeLa Genome Data Access Working Group reviews HeLa genome data requests from the research community, and f HeLa genome data generated from NIH-funded research is submitted to dbGaP. For further information, see: "Nature Comment: Family Matters."

Genetic Information Nondiscrimination Act

The Genetic Information Nondiscrimination Act (GINA) prohibits health insurers and employers from requesting or requiring genetic information from an individual or an individual's family members, and further provides legal protection against discrimination on the basis of a person's genetic information. This means that individuals who participate in research are protected from insurance and employment discrimination if they contribute their genetic information to studies. GINA does not protect against discrimination in some forms of insurance, however, including life insurance, long-term care insurance, and disability insurance. HHS has issued guidance on GINA for IRBs and investigators involved with Federally-supported human subjects research. In addition, NHGRI's Informed Consent for Genomics Research  resource contains model language for including information on GINA in informed consent forms. For further information on GINA, see: Genetic Discrimination

Re-identification and Privacy

DNA sequences can reveal health and other information about individuals and their families. Whether genomic information is being used for research, clinical or other uses, it is important to consider what measures are needed to ensure that individual privacy is respected. This includes issues around the use of clinical samples in research and uses in law enforcement. For more information about issues of privacy in genomics and the protections provided, please see Privacy in Genomics.

Posted: July 18, 2017 

See Also:

Participating in Genomics Research