FYI 

-----Original Message-----
From: [log in to unmask]
[mailto:[log in to unmask]] On Behalf Of Ccph
Sent: Monday, April 13, 2009 2:34 PM
To: [log in to unmask]
Subject: [Ccph-ethics] Guidance on the Genetic Information
NondiscriminationAct

Dear Community-Campus Partnerships for Health colleagues,

Guidance on the Genetic Information Nondiscrimination Act: Implications
for Investigators and Institutional Review Boards

The US Office of Human Research Protections has posted on its website a
finalized 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 website 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
(IRBs) that review, non-exempt human subjects research involving genetic
testing or collection of genetic information.  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 regulations
for the
protection of human subjects (45 CFR part 46).   The Federal Register
notice announcing the availability of this new guidance document can be
found at:
http://edocket.access.gpo.gov/2009/E9-7782.htm or
http://edocket.access.gpo.gov/2009/pdf/E9-7782.pdf

OHRP welcomes comments on this new guidance documents. Please send any
comments to OHRP by e-mail at [log in to unmask], with citation of the
specific document related to the comments in the subject line.

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