 Some links will work for NIAID staff only.
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Standard Operating Procedure Table of Contents
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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.
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 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 the NIH Office of Laboratory Animal Welfare (OLAW) to resolve bars to
award during most of the fiscal
year. For a code 44, for example, investigators send program staff a revised Vertebrate Animal section of the Research Plan.
OLAW determines whether an applicant has adequately addressed reviewer concerns so it can remove a bar. If so, OLAW changes the code in IMPAC, lifts the bar, notes any restrictions, and notifies program and grants 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 staff must request a temporary lifting of it
to issue a restricted award.
The NIH 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 Animals in Research on the NIAID Research Funding Web site.
If an institution that does not have an animal welfare assurance from OLAW, NIAID will withhold funding until an assurance is in place.
Read more in NIAID's Animals in Research SOPs, Vertebrate Animals in Research questions and answers, and on our Research Animals portal.
Applicants and Grantees
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 staff notifies the Office
of Laboratory Animal Welfare (OLAW) that an award is pending.
- If no animal assurance exists, OLAW will contact the grantee. If an application is likely to be funded, grants management
staff should contact OLAW as soon as possible and request that OLAW
negotiate
an
assurance.
- OLAW will notify NIAID when a grantee has submitted the required
information and a bar is lifted.
- NIH may also 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 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 modifications to a 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 fiscal year.
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. To temporarily lift a bar to award so we can fund an application at the end of a fiscal year:
- Grants staff emails OEP requesting a temporary lift of the 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 restores the bar to award.
- Grants management staff remind 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 |
