Bars to Grant Awards -- Research Animals

Purpose

To prevent NIAID from making an award before study section concerns are resolved and documentation is in place for 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. PHS policy is summarized in the brochure What Investigators Need to Know About the Use of Animals. Applicants must follow NIH application instructions.

Animal research codes 20 or 44 in IMPAC and on an application's summary statement indicate a bar to award that must be resolved before funding. For a list of codes, go to Research Animals Involvement Codes.

Bars to award should be resolved before a fiscal year closes. If an application still has a bar at the end of a fiscal year, grants staff must request a temporary lift of the bar to award it. The Office of Extramural Programs (OEP) lifts the bar just long enough for grants staff to award the application with a restriction, and then OEP restores the bar. See End of Year for more details. Find more information on animal research requirements at NIAID research animal resources on the 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

Program and grants management staff should work with the investigator to ensure that all vertebrate animal concerns are resolved.

An animal welfare code of 20 indicates that the application requires administrative review. Instances that would incur a code 20 include the absence of an animal welfare assurance on file or a change in institutions. To get this bar lifted:

• Grants staff notifies the Office of Laboratory Animal Welfare (OLAW) that an award is pending.
• If no animal assurance exists, OLAW will contact the grantee. Note that when an institution does not have an animal welfare assurance, and an application is likely to be funded, grants management staff should contact OLAW as soon as possible and request that OLAW negotiate an assurance. When all performance sites where live, vertebrate animals will be used.
• OLAW will notify NIAID when a grantee has submitted the required information and a bar is lifted.
• NIH may assign an animal weflare code of 20 to a grant because of a change of institution.
  • In this instance, grants 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 staff ensure that the new grantee has an animal welfare assurance on file with OLAW and an approved IACUC certification.
  • Grants staff fax the face page from the new application to OLAW, and OLAW will lift the bar.

An animal welfare code of 44 indicates a bar due to scientific review group concerns. To lift this bar:

• Program staff requests 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 requests a letter signed by the investigator and business official documenting how the concerns were resolved.
• Program staff verifies that applicant has sufficiently resolved the concerns.
• Program staff prepares a memo 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 sends the information listed above to Contact for NIAID Staff.
• When OLAW agrees that a concern is resolved, it will change the code in IMPAC to code 54 or code 10 . OLAW will then send an email to 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 modifications to the protocol 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 year.

Verification of IACUC review and approval is required for each application involving use of live vertebrate animals. The submission of the IACUC approval date is not required before an application is reviewed at NIH, but is a just-in-time requirement before award.

End of year. To temporarily lift a bar to award so an application may be awarded at the end of a fiscal year:

• Grants staff sends an email to OEP requesting a temporary lift of the application's bar.
• After OEP lifts the bar, it will send a restriction for the award to grants staff.
• Grants staff adds the restriction to the Notice of Award.
• After the award is made, OEP will restore the bar to award.
• Grants staff reminds the grantee to read the terms and conditions of award, since there may be a restriction that prevents the grantee from spending funds until all required paperwork is complete and concerns have been addressed.

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 CRISP SOP

Institutional Animal Care and Use Committee Guidebook

PHS OLAW policy on humane care and use of laboratory animals

OER extramural intranet memorandum on end-of-year restricted awards