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:

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:

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:  csrdrr@mail.nih.gov

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: dpcpsi@od.nih.gov.


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