GINA Guidance for Researchers

The Department of Health and Human Services has published guidance related to the Genetic Information Nondiscrimination Act (GINA) and its effect on researchers.

“Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards” provides background on protections provided by GINA and discusses GINA’s impact on investigators who conduct genetic research and the institutional review boards that review it, particularly on criteria for IRB approval of research and the requirements for obtaining informed consent under the HHS regulations for the protection of human subjects (45 CFR part 46).

Final GINA regulations are expected in May.

To review GINA’s provisions, see the July 2008 “Word from Washington” column “Getting to Know GINA.”

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