This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.
Some links will work for NIAID staff only.
Purpose
To prevent NIAID from making an award before resolving scientific review group concerns about the care or use of research animals.
Procedure
To receive a PHS award, investigators working with research animals must base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals and abide by the PHS Policy on Humane Care and Use of Laboratory Animals. There are no exemptions from the PHS policy.
PHS policy is summarized in the brochure What Investigators Need to Know About the Use of Animals. Applicants must follow NIH application instructions.
Missing or insufficient animal care and use information may adversely affect an application's overall impact score.
Peer review recommendations may prevent NIAID from making an award before animal care and use documentation is in place and concerns are resolved.
- A bar concerning the protection of research animals is indicated by a code 44 on the summary statement and in the IMPAC database.
- A bar concerning euthanasia method is indicated by a code 46 on the summary statement and in the IMPAC database.
- A bar for administrative issues, including the lack of an assurance, is indicated by a code 20.
- Find a list of codes at Research Animals Involvement Codes.
Bars to award must be resolved before we can fund animal research.
NIAID staff work with applicants and the NIH Office of Laboratory Animal Welfare (OLAW) to resolve animal-related bars to award.
- OLAW determines whether an applicant has adequately addressed reviewer concerns so it can remove a bar.
- If so, it changes the code in IMPAC, lifts the bar, notes any restrictions, and notifies program and grants management staff. This procedure usually takes a few weeks but may take longer.
- If an application still has a bar at the end of a fiscal year, grants management staff may ask OLAW for permission to issue a restricted award.
- OLAW does not allow this for applications with a code 44 or 46.
- See the End of Year section below for more details.
If an institution does not have an animal welfare assurance from OLAW, NIAID will withhold funding until an assurance is in place.
Find more information on animal research requirements at Animals in Research for Grants SOP.
Applicants and Grantees
- Contact your program officer if you see a problematic code. To find out what the codes mean, see Research Animals Involvement Codes.
- Using the just-in-time module in eRA Commons, send all material that your program officer requests.
Program and Grants Management Staff
An animal welfare code 20 indicates that the application requires administrative review, e.g., for a lack of an animal welfare assurance or a change of institutions.
To get this bar lifted:
- Grants management staff notify OLAW that an award is pending.
- If no animal assurance exists, OLAW contacts the grantee.
- An assurance must be in place for each performance site where live vertebrate animals will be used. Production of custom antibodies is considered use of live vertebrate animals.
- If an application is likely to be funded, grants management staff should contact OLAW as soon as possible and request that it negotiate an assurance.
- When a grantee has submitted the required information, OLAW lifts the bar and notifies NIAID.
- For a change of institution.
- Grants management staff ensure that the new grantee has submitted the three points in the Vertebrate Animal section of the Research Plan.
- Program staff review and approve the grantee's response.
- Grants management staff ensure that the new grantee has an animal welfare assurance on file with OLAW and an approved Institutional Animal Care and Use Committee (IACUC) certification.
- Grants management staff email the face page from the new application to OLAW Contact for NIAID Staff. OLAW will lift the bar.
An animal welfare code 44 indicates a bar due to scientific review group concerns.
To lift this bar
- Program staff request from the investigator a revised and dated Vertebrate Animal section of the Research Plan to resolve any comments or concerns indicated in the summary statement.
- Program staff request a letter signed by the investigator and business official documenting how the concerns were resolved.
- Program staff verify that applicant has sufficiently resolved the concerns.
- Program staff prepare a memo to OLAW requesting that the bar to award be lifted. The request should include a copy of the application and summary statement as well as correspondence from the applicant addressing the concerns.
- Program staff send the information listed above to Contact for NIAID Staff.
- When OLAW agrees that a concern is resolved, it changes the code in IMPAC to code 54 (concerns resolved) or 10 (no live vertebrate animals). OLAW then emails the program officer and grants management specialist, lifting the bar and noting any remaining restrictions. This procedure usually takes a few weeks.
Verification of IACUC review and approval is required for any application involving use of live vertebrate animals. Submission of an IACUC approval date is not required before review but is a just-in-time requirement before award.
Note that the resolution of vertebrate animal concerns may result in protocol modifications that require re-review by the IACUC and an updated verification of IACUC approval. NIAID does not issue a restricted award when vertebrate animal concerns are unresolved, except at the end of the fiscal year with permission from OLAW.
An animal welfare code 46 indicates a bar due to the method of euthanasia.
To lift this bar
- Program staff request a change from code 46 (unacceptable; euthanasia method not consistent with AVMA guidelines) to either a code 54 (concerns resolved) or code 10 (no live vertebrate animals) by contacting OLAW Division of Assurances.
- Provide the grant number in the subject line of the email and include the reason for request – code change; grant number; project title; principal investigator; grantee institution; performance site(s), if applicable; names of the program official and grants management specialist, and any other staff that should be notified of OLAW actions.
- For applications that also have animal welfare concerns provide: correspondence from the investigator addressing the concern and, if necessary, a revised, dated, Section F. Vertebrate Animals (this must be approved by the AOR); and program's official approval of the resolution of concerns.
Note, the resolution of concerns over the method of euthanasia or the proposed use of vertebrate animals may result in modifications to the animal study protocol that requires re-review by the IACUC. NIAID does not issue a restricted award when vertebrate animal concerns are unresolved, except at the end of the fiscal year with permission from OLAW.
End of year. At the end of a fiscal year, NIAID may make restricted awards to institutions that lack animal welfare assurances or IACUC approvals. However, OLAW does not permit NIAID to award applications with code 44 or 46 bars to award.
To make restricted awards at the end of a fiscal year, grants management staff do the following:
- Confirm with a branch chief that NIAID will issue the restricted award.
- Email OLAW at Contact for NIAID Staff to request a restricted award.
- Add the restriction to the Notice of Award and remind the grantee to address all concerns.
- After the grantee submits all required paperwork, issue a revised Notice of Award to lift the restriction.
Contacts
Applicants should contact their program officer to discuss bars to award.
Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.
Links
Animals in Research for Grants SOP
Guide for the Care and Use of Laboratory Animals
Public Health Service Policy on Humane Care and Use of Laboratory Animals