Clarification to the Interim
Agency Policy, NIH Research Involving Chimpanzees

Notice Number: NOT-OD-12-116

Update: The following update relating to this
announcement has been issued:

November
25, 2013 - See Notice NOT-OD-14-024. Update to the Interim Agency Policy,
NIH Extramural and Intramural Research Involving Chimpanzees.

January
23, 2013 - See Notice NOT-OD-13-026. Request for Information (RFI): Input
on Report from Council of Councils Working Group on Use of Chimpanzees in
NIH-Supported Research.

Key Dates
Release
Date: June 15, 2012

Issued by
National Institutes of Health (NIH)

Purpose

The National Institutes of Health (NIH) is issuing this Notice to communicate
to the research community a clarification to interim agency policy, NIH
Research Involving Chimpanzees (NOT-OD-12-025). This clarification:

Addresses the conditions under which applications proposing the use of
stored samples obtained from chimpanzees will be accepted for peer review, and

Clarifies that this policy applies to all competing applications,
including renewals, revisions, and resubmissions.

The NIH will issue a final policy after the NIH Council of Councils makes
recommendations on the use of chimpanzees in NIH-supported research, and after
the agency considers public comments on implementing the recommendations.
Further policy is expected to be issued in early 2013.

Background

In December 2010, the NIH commissioned a
study by the Institute of Medicine of the National Academies (IOM) to assess
whether chimpanzees are or will be necessary for biomedical and behavioral
research. The IOM issued its findings, with a primary recommendation that
the use of chimpanzees in research be guided by a set of principles and
criteria. On December 15, 2011, the NIH announced its acceptance of the IOM
recommendations with respect to the use of NIH-owned or –supported chimpanzees
in research.

As one of the first steps toward implementing the
recommendations, the agency issued a notice in the NIH Guide to Grants and
Contracts (NOT-OD-12-025)
on December 21, 2011 that, effective immediately, “NIH will not fund any new or
other competing projects (renewal and revisions) for research involving
chimpanzees and will not allow any new projects to go forward with NIH-owned or
-supported chimpanzees.” Among other things, the agency announced that it would
not accept applications for research proposing to use chimpanzees until the NIH
issued further policy implementing the IOM’s recommendations.

After
issuing NOT-OD-12-025 on December 21, 2011, the NIH received a number of
questions with respect to how this notice applies to stored samples and whether
applications proposing the use of stored samples from chimpanzees may be
accepted for peer review. The NIH notes that the IOM explicitly exempted from
its criteria biomedical, comparative genomics, and behavioral research using
stored samples.

Actions

Consistent
with the IOM recommendations on the use of NIH-owned or

–supported
chimpanzees in research, the NIH will accept for peer review competing
applications proposing the use of samples obtained from chimpanzees on or
before December 15, 2011 – the date the NIH accepted the IOM recommendations.

In a cover letter attached to an incoming application and in
the Vertebrate Animal section of the application, investigators should describe
the source of the sample and affirm the collection date was on or before
December 15, 2011.

Applications that proposed the use of stored samples
but were withdrawn after December 21, 2011, may be reinstated. For these
specific cases, the investigator must provide the NIH with a letter containing
the information above along with an updated Vertebrate Animal section. The
request for reinstatement, cover letter, and updated Vertebrate Animal section
should be sent to:

Division of Receipt and Referral
Center for
Scientific Review, NIH
Rockledge II, Room 2130
6701 Rockledge Drive
MSC-7720
Bethesda, MD
20892-7720 (Post Office)
20817 (Overnight
Mail)
Phone: 301-435-0715
FAX: 301-480-1987
E-mail:  [email-masked]

Implementation

Applications proposing to
use stored samples obtained from chimpanzees on or before December 15, 2011 will
be accepted for peer review. For the purposes of this Notice, the following
definitions apply:

“Stored” refers to samples obtained from the
chimpanzee before 11:59 p.m. Eastern Standard Time on December 15,
2011.

“Sample” is defined to include biological specimens obtained from a
chimpanzee or collected during post-mortem procedures, habitat cleanup, or some
other circumstance. Examples of samples include tissue, blood, bone marrow,
urine, feces, saliva, hair, and other sources of biological material. Samples
need not have been processed, tested, or analyzed on or before December 15,
2011, to meet the definition. They need only have been obtained on or before
December 15. In effect, the creation of cell lines, isolation of DNA and other
cellular components, or collection of data from stored samples can occur after
December 15, 2011, as long as the samples were collected on or before that
date.

Nothing in this Notice revises or reverses existing NIH
policy that applies to the use of chimpanzees in ongoing NIH-supported research,
submitted competing applications, or competing applications pending submission.
Until the NIH issues further policy implementing the IOM’s recommendations,
the agency will not accept applications for research proposing to use
chimpanzees, or applications proposing the use of specimens obtained from the
chimpanzee after December 15, 2011.

Inquiries

For questions regarding a specific application please contact the NIH
program officer associated with the application or proposal. General inquires
about this interim policy may be directed to: E-mail: [email-masked].

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