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 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
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