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/priority score. Peer reviewer recommendations may prevent NIAID from making an award before animal care and use documentation is in place and scientific review group concerns are resolved.

When reviewers have concerns about the care or use of research animals, NIH places a bar to award on the application. The bar, indicated by a code 44 on the summary statement and in the IMPAC database, must be resolved before we can fund it.

When reviewers have concerns about administrative issues, including the lack of an assurance, NIH places a code 20 to indicate a bar. Find a list of codes at Research Animals Involvement Codes.

NIAID staff work with applicants and NIH's Office of Laboratory Animal Welfare (OLAW) to resolve bars to award during most of the fiscal year.

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 must request a temporary lifting of it to issue a restricted award. However, OLAW does not allow this for applications with a code 44.

OLAW lifts the bar just long enough for grants management staff to award the application with a restriction, and then restores the bar until it receives proper documentation. See End of Year for more details.

If an institution that 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 on the NIAID Research Funding Web site.

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.
Send all material that your program officer requests. See the section below for details.

Program and Grants Management Staff

An animal welfare code 20 indicates that the application requires administrative review, e.g., an lack of an animal welfare assurance or a change in institutions.

To get this bar lifted:

Grants management staff notify the Office of Laboratory Animal Welfare (OLAW) that an award is pending.
If no animal assurance exists, OLAW contacts the grantee. 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.
NIH may also assign an animal weflare code of 20 to a grant because of a change of institution.
- In this instance, grants management staff must ensure that the new grantee has submitted the five points in the Vertebrate Animals 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 IACUC certification.
- Grants management staff fax the face page from the new application to OLAW, and 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 agree that a concern is resolved, it changes the code in IMPAC to code 54 or 10. 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.

Note that the resolution of vertebrate animal concerns may result in protocol modifications that require re-review by the IACUC. An IC may not issue a restricted award when vertebrate animal concerns are unresolved, except at the end of the fiscal year with permission from OLAW.

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.

End of year. OLAW permits restricted awards for applications with bars unless the application has a code 44. The restrictions prevent grantees from spending funds on animal research until they submit all materials to have the bar lifted and receive a revised Notice of Award lifting the restriction.

To get OLAW approval to fund an application with restrictions:

Grants management specialists email OLAW to request a temporary lift of the bar.
- In the subject line, identify the award as a restricted award and include the grant number.
- In the body or as an attachment, provide grant number, project title, PI names, grantee institution, any performance sites, and any of the following reasons for request:
  - Animal Welfare Assurance (Please specify – domestic, foreign, or inter-institutional).
  - Delayed IACUC Approval Verification.
  - Delayed Animal Onset affecting Animal Welfare Assurance, IACUC Approval or both.
After OLAW lifts the bar, it sends a restriction to grants management staff.
Grants management staff add the restriction to the Notice of Award.
After the award is made, OLAW restores the bar to award.
Grants management staff remind grantees to complete all required paperwork and address all concerns before spending funds, as written in the terms and conditions of award.

Contacts

For research animal bars, Contact for NIAID Staff

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Animals in Research SOP

Bars to Grant Awards SOP

IMPAC and RePORTER SOP

Institutional Animal Care and Use Committee Guidebook

PHS OLAW policy on humane care and use of laboratory animals

OER Guidance for Issuing 2009 End of Fiscal Year Restricted Awards Involving Animals

Vertebrate Animals in Research questions and answers

Look It Up

animal welfare assurance
animals in research
bar to award
fiscal year (FY)
institutional animal care and use committee (IACUC)
IMPAC
just-in-time
Notice of Award
peer reviewer
Office of Laboratory Animal Welfare (OLAW)
overall impact/priority score
program officer
Research Plan
restriction
scientific review group (SRG)
summary statement
terms and conditions of award

See the Glossary for terms.