OLAW Clarifies Use of Animals in NIH Grants
News Posted: June 30, 2010
Share thisIn late April 2010, OLAW published the following three clarifications to its policies on grants involving animals.1
Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section (VAS) in NIH Contract Proposals 2
On April 21, 2010, OLAW posted “New Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section (VAS) in NIH Contract Proposals” in the NIH Guide for Grants and Contracts.
On April 21, 2010, OLAW posted “New Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section (VAS) in NIH Contract Proposals” in the NIH Guide for Grants and Contracts.
The purpose of this Notice is to:
a. Clarify the information that must be included in a separate section of the Technical Proposal titled the Vertebrate Animal Section (VAS) of contract proposals for biomedical and behavioral Research and Development (R&D), research training, and biological testing activities that use live vertebrate animals, and
b. Explain how the VAS is evaluated as part of the NIH technical evaluation process for award of a contract. Distinction is made between the oversight role of the Institutional Animal Care and Use Committee (IACUC) and review responsibility of the NIH Scientific Review Group (SRG).
Update of Sample Animal Welfare Assurance for Foreign Institutions 3
On April 16, 2010, OLAW released an “Update of Sample Animal Welfare Assurance for Foreign Institutions,” published in the NIH Guide for Grants and Contracts, NOT-OD-10-083. This Notice informs Public Health Service (PHS) grantee institutions regarding revisions to the sample Animal Welfare Assurance for Foreign Institutions document (Foreign Assurance) formerly known as the Statement of Compliance for Foreign Institutions. The revised sample is available for download on the OLAW webpage for Foreign Assurances.4
On April 16, 2010, OLAW released an “Update of Sample Animal Welfare Assurance for Foreign Institutions,” published in the NIH Guide for Grants and Contracts, NOT-OD-10-083. This Notice informs Public Health Service (PHS) grantee institutions regarding revisions to the sample Animal Welfare Assurance for Foreign Institutions document (Foreign Assurance) formerly known as the Statement of Compliance for Foreign Institutions. The revised sample is available for download on the OLAW webpage for Foreign Assurances.4
Guidance on Confirming Appropriate Charges to NIH Awards during Periods of Noncompliance for Activities Involving Animals
Released on April 15, 2010, OLAW published a new “Guidance on Confirming Appropriate Charges to NIH Awards during Periods of Noncompliance for Activities Involving Animals” in the NIH Guide for Grants and Contracts, NOT-OD-10-081. This Notice provides additional clarification in reference to Notice NOT-OD-07-044 regarding the grantee’s responsibilities when animal activities have been conducted which do not meet the terms and conditions of grant award.
Released on April 15, 2010, OLAW published a new “Guidance on Confirming Appropriate Charges to NIH Awards during Periods of Noncompliance for Activities Involving Animals” in the NIH Guide for Grants and Contracts, NOT-OD-10-081. This Notice provides additional clarification in reference to Notice NOT-OD-07-044 regarding the grantee’s responsibilities when animal activities have been conducted which do not meet the terms and conditions of grant award.
This guidance in more detail here, in order to emphasize the significance of its often-misunderstood requirements.
Guidance on Confirming Appropriate Charges to NIH Awards during Periods of Noncompliance for Activities Involving Animals
A. 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.
A. 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.
B. Specific situations under which charges are not allowable are:
a. The conduct of animal activities in the absence of a valid Assurance on file with OLAW.b. 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)
C. 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.
D. 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/noticefiles/NOT-OD-05-034.html)
E. A grantee under consortium (subaward) agreements in which the grantee collaborates with one or more other organizations, 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.
F. 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).
G. 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.
H.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).
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600251).
References
- OLAW Highlights. http://grants.nih.gov/grants/ola w/olaw.htm.
- Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section (VAS) in NIH Contract Proposals. Released April 19, 2010. Posted April 21, 2010. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-049.html. (NOT-OD -10-049).
- Update of Sample Animal Welfare Assurance for Foreign Institutions. Released 16 April 2010, Posted April 20, 2010.
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-083.html (NOT-OD-10-083). - Sample Animal Welfare Assurance for Foreign Institutions. http://grants.nih.gov/grants/ola w/sampledoc/foreign.htm.
Veterinarian Moshe Shalev, MSc (Genetics), VMD, is a Diplomate of the American College of Laboratory Animal Medicine. A recognized expert in medicine, management, and facility designs of small, farm, and exotic laboratory animals, he publishes regularly on animal welfare regulations.