HHS Issues New Guidance on GINA

HHS Issues New Guidance on GINA

Biomedical researchers who want to learn more about the Genetic Information Nondiscrimination Act of 2008 (GINA) — and what it means for their research and the informed consent process — should check out a new guidance document from the U.S. Department of Health and Human Services (HHS).

Entitled Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards (IRBs) [hhs.gov], the document developed by the HHS Office for Human Research Protections (OHRP) offers the first formal guidance on this topic. The guidance applies to genetic research involving human subjects that is conducted or supported by HHS. Unless specific regulatory requirements are cited, the guidance simply represents OHRP's current thinking on the topic and should be viewed as recommendations.

GINA, which prohibits discrimination in health coverage and employment based on genetic information, was signed into federal law on May 21, 2008. The section of the law relating to health coverage generally will take effect between May 22, 2009 and May 21, 2010. The sections relating to employment will take effect on Nov. 21, 2009.

In addition to the guidance document, HHS has developed a list of Frequently Asked Questions (FAQ), Information for Researchers and Health Care Professionals, that touch upon aspects of GINA that are of particular interest to researchers and health-care professionals. Among the questions addressed are: "Does GINA have specific research provisions?", "Is GINA retroactive?" and "How will the law be enforced?"

"We strongly encourage investigators and IRB members to look over the new guidance and the FAQ. This information may prove helpful in discussions related to GINA that may arise as part of the research review or informed consent processes," said Laura Lyman Rodriguez, Ph.D., who is the acting director for the National Human Genome Research Institute's Office of Policy, Communications and Education.

Because GINA has implications regarding actual or perceived risks of genetic research and may affect a person's willingness to take part in such research, investigators should be aware of the protections that the law provides. They should also be familiar with the limitations in the law's scope and effect.

Members of Institutional Review Boards (IRB) should consider the provisions of GINA when assessing whether genetic research satisfies their criteria for approval, particularly whether risks are reasonable in relation to anticipated benefits and whether adequate provisions are in place to project research participants' privacy and maintain data confidentiality. GINA is also relevant to informed consent. According to the HHS guidance, when investigators develop and IRBs review consent documents and processes, they should consider whether those documents and processes reflect the protections provided by GINA.

Comments on the HHS guidance documents are welcome at any time. They may be sent by e-mail to ohrp@hhs.gov; by Fax to 240-453-6909; or by mail to: GINA Guidance Comments, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

HHS notes that comments received, including any personal information, will be made available to the public upon request.

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Last Reviewed: February 26, 2012