[Federal Register Volume 74, Number 65 (Tuesday, April 7, 2009)]
[Notices]
[Pages 15726-15727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-7782]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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.

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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

[[Page 15727]]

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 <a href="/cdn-cgi/l/email-protection#6a0502181a2a020219440d051c"><span class="__cf_email__" data-cfemail="3b5453494b7b535348155c544d">[email protected]</span></a> 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 <a href="/cdn-cgi/l/email-protection#216c48424940444d0f6240534e4c44614949520f464e57"><span class="__cf_email__" data-cfemail="a3eecac0cbc2c6cf8de0c2d1cccec6e3cbcbd08dc4ccd5">[email protected]</span></a>.

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.
 [FR Doc. E9-7782 Filed 4-6-09; 8:45 am]
BILLING CODE 4150-36-P


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