E9-7782. Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards

AGENCY:

Office for Human Research Protections, Office of Public Health and Science, Office of the Secretary, HHS.

ACTION:

Notice.

SUMMARY:

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a guidance document entitled, “Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards.” The guidance document provides OHRP's first formal guidance on this topic. The document, which is available on the OHRP Web site at http://www.hhs.gov/​ohrp/​humansubjects/​guidance/​gina.html and http://www.hhs.gov/​ohrp/​humansubjects/​guidance/​gina.pdf, is intended primarily for investigators who conduct, and institutional review boards (IRB) that review, non-exempt human subjects research involving genetic testing or collection of genetic information (hereinafter referred to as “genetic research”). The guidance document provides background on protections provided by the Genetic Information Nondiscrimination Act of 2008 (GINA) and discusses some of the implications of GINA for investigators who conduct, and IRBs that review, genetic research, particularly with respect to the criteria for IRB approval of research and the requirements for obtaining informed consent under the Department of Health and Human Services (HHS) regulations for the protection of human subjects (45 CFR part 46).

DATES:

Comments on OHRP guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the guidance document entitled, “Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards,” to the Division of Policy and Assurances, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-402-2071. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance document. Submit written comments to GINA GUIDANCE COMMENTS, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to [e-mail] or via facsimile at 240-453-6909. Comments received, including any personal information, will be made available to the public upon request.

FOR FURTHER INFORMATION CONTACT:

Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

OHRP, Office of Public Health and Science, is announcing the availability of a guidance document entitled, “Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards.” The guidance document provides OHRP's first formal guidance on this topic. The document applies to non-exempt human subjects research conducted or supported by HHS and is intended primarily for investigators who conduct, and IRBs that review, genetic research.

The guidance document provides some general background information regarding GINA and discusses some of the implications of GINA with respect to the 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).

II. Electronic Access

Persons with access to the Internet may obtain the guidance document on OHRP's Web site at http://www.hhs.gov/​ohrp/​humansubjects/​guidance/​gina.html and http://www.hhs.gov/​ohrp/​humansubjects/​guidance/​gina.pdf.

III. Request for Comments

Interested persons may submit comments regarding this guidance document to OHRP at any time. Please see the ADDRESSES section for information on where to submit written comments.

Dated: April 1, 2009.

Jerry Menikoff,

Director, Office for Human Research Protections.