[Federal Register: April 7, 2009 (Volume 74, Number 65)]
[Notices]
[Page 15726-15727]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap09-47]
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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 ohrp@hhs.gov 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 Michael.Carome@hhs.gov.
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]
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