NOT-OD-07-044: NIH Policy on Allowable Costs for Grant Activities Involving Animals when Terms and Conditions are not Upheld

NIH Policy on Allowable Costs for Grant Activities Involving Animals when Terms and Conditions are not Upheld

Notice Number: NOT-OD-07-044

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

April 15, 2010 - See Notice NOT-OD-10-081 Guidance on Confirming Appropriate Charges to NIH Awards during Periods of Noncompliance for Activities Involving Animals.

Key Dates
Release Date: January 26, 2007

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

The purpose of this Notice is to clarify that no costs for activities with live vertebrate animals may be charged to NIH if there is not a valid Animal Welfare Assurance and Institutional Animal Care and Use Committee (IACUC) approval. This notice is applicable to grants and cooperative agreements involving activities with live vertebrate animals.

Background

Terms and conditions applicable to all grant awards that involve live, vertebrate animals - including research, research training, experimentation, biological testing, custom antibody preparation, or related purposes - require a valid Animal Welfare Assurance (Domestic, Foreign, or Inter-institutional Assurance, as applicable) approved by the NIH Office of Laboratory Animal Welfare (OLAW), and valid IACUC approval. IACUC approval must be dated within the last three years in order to be valid. IACUCs are not authorized to administratively extend approval beyond three years. Foreign grantees receiving direct support are not required to provide IACUC approval, but must have a valid Foreign Assurance on file with OLAW (see http://grants.nih.gov/grants/olaw/assurance/500index.htm for list of foreign institutions with approved Assurances).

Policy

The Office of Management and Budget Cost Principles and the NIH Grants Policy Statement (NIHGPS) do not permit charges to grant awards for the conduct of animal activities during periods of time that the terms and conditions of the NIHGPS are not upheld. Specific situations under which charges are not allowable are:

The conduct of animal activities in the absence of a valid Assurance on file with OLAW.
The conduct of animal activities in the absence of valid IACUC approval of the activity. Absence of IACUC approval includes failure to obtain IACUC approval, expiration, or suspension of IACUC approval. Suspension is described in the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy) at section IV.C.6. (http://grants.nih.gov/grants/olaw/references/phspol.htm)

Institutions are required to report such situations to the Institute/Center (IC) supporting the award. NIH expects grantees to continue to maintain and care for animals during the periods described above. Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis.

Additionally, these situations constitute serious noncompliance with section IV.F.3. of the PHS Policy and as such must be promptly reported to OLAW in accord with the PHS Policy. See NOT OD-05-034, Guidance on Prompt Reporting to OLAW (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-034.html)

Grantees are reminded that under consortium (subaward) agreements in which the grantee collaborates with one or more other organizations, the grantee, as the direct and primary recipient of NIH grant funds, is accountable for the performance of the project, the appropriate expenditure of grants funds by all parties, and all other obligations of the grantee as specified in the NIHGPS. The animal welfare requirements that apply to grantees also apply to consortium participants and subprojects. The prime grantee is responsible for including these requirements in its agreements with collaborating organizations, and for ensuring that all sites engaged in research involving the use of live vertebrate animals have an appropriate Animal Welfare Assurance and that the activity has a valid IACUC approval. (see http://grants.nih.gov/grants/olaw/assurance/300index.htm for a list of domestic institutions with Assurances). If the prime grantee does not have an Animal Welfare Assurance and the animal work will be conducted at an institution with an Assurance, the grantee must obtain an Inter-institutional Assurance from OLAW. When the grantee is a domestic institution and there is a foreign performance site using animals, the grantee must ensure that the performance site has an appropriate Foreign Assurance and must provide verification of IACUC approval by the domestic grantee’s IACUC, certifying to NIH that the activity as conducted at the foreign performance site is acceptable to the grantee. (See NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements, http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600251).

Inquiries

Questions concerning this Notice should be directed to:

Office of Policy for Extramural Research Administration
National Institutes of Health
Telephone: 301-435-0938
Email: [email protected]

Questions about Assurances or IACUC approval of animal activities should be directed to:

Office of Laboratory Animal Welfare
Division of Assurances
National Institutes of Health
Telephone: 301-496-7163
Email: [email protected]