Federal regulations require that all NIH grants involving vertebrate animals be reviewed by the Institutional Animal Care and Use Committee (IACUC). The IACUC approval date on the grant application must be listed as "pending" until the Committee has had an opportunity to formally conduct a grant comparison with the IACUC protocol application and provide approval.
The grant application must address the following five points in Section F:
- Provide a detailed description of the proposed use of the animals in the work outlined in the Research Design and Methods section. Identify the species, strains, ages, sex, and numbers of animals to be used in the proposed work.
- Justify the use of animals, the choice of species, and the numbers to be used. If animals are in short supply, costly, or to be used in large numbers, provide an additional rationale for their selection and numbers.
- Provide information on the veterinary care of the animals involved.
- Describe the procedures for ensuring that discomfort, distress, pain, and injury will be limited to that which is unavoidable in the conduct of scientifically sound research. Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices, where appropriate, to minimize discomfort, distress, pain, and injury.
- Describe any method of euthanasia to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the Panel on Euthanasia of the American Veterinary Medical Association. If not, present a justification for not following the recommendations.
Please be aware that approval must be granted prior to award of funds. Some agencies may require earlier notification of approval. Once notified by NIH of the funding status, investigators must follow one of the following procedures:
Funding for already approved protocols
If using an IACUC approved protocol on the paper application, please submit copies of the following with a cover letter indicating the protocol number:
- the grant face page
- the project summary (page 2)
- Section F Vertebrate Animals
- the IACUC approved protocol
If using an IACUC approved protocol approved through the eSirius system submit your request as an amendment to the approved protocol. Please refer to the eSirius User's Guide for Investigators for submitting an amendment to protocols approved through the system.
Funding for new protocol submissions:
If the grant is being submitted with the new IACUC protocol please provide the above items when submitting your new protocol. Instructions for attaching these documents are clearly provided in the eSirius system.
NOTE: If the project involve collaboration with an investigator at another institution and that investigator will be conducting the animal work, you may qualify for expedited review. Please review the Policy for Collaborative Projects Involving the Use of Live Animals and contact the IACUC Coordinator (646-962-8186) for clarifications.
Upon approval of a grant, the investigator will receive a Verification of Approval form that is to be sent to the funding agency with the grant number that was assigned by NIH.
If the grant involves the use of rDNA or transgenic animals, the form "Certificate of Registration for Research Using Recombinant DNA or Transgenic Animals" must be completed. The form can be obtained from the IBC website.
***Protocols that utilize recombinant DNA (rDNA) or transgenic animals must not begin until Institutional Biosafety Committee (IBC) approval is obtained. The National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA (rDNA) Molecules gives the IBC oversight on the generation of transgenic animals, including rodents. Therefore, use of these animals requires registration with the IBC. In an effort to ensure that investigators comply with this policy, work on portions of the protocol involving the use of recombinant DNA and transgenic animals (whether purchased or generated) should not commence until IBC approval is attained. For further assistance on the process of registering transgenic animals and rDNA molecules, please contact the IBC Coordinator at (646) 962-8192 or send an email inquiry to firstname.lastname@example.org.