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Using Animals in Research: Grant Application and Protocol Review
Checklist for submitting a PHS grant application when using laboratory animals:
- NIH Face Page: Item 5 = yes, Item 5b = A3292-01. Status and date
of approval are no longer required. If you have an approved protocol,
you may enter the approval date.
- Make sure you have completed the Vertebrate Animal Section of
the Research Plan, addressing the 5 points specified in the instructions.
- At least 60 days before you are required to submit verification
of IACUC approval to NIH, submit an completed Animal Use Protocol
to the UCAR office (click here for form)
for review. Note: the office cannot provide a "pending" letter until forms have been submitted.
- If the reviewers have questions, please respond as soon as possible
to prevent delays in approval and subsequent funding.
- When you receive your approval letter, send it to the appropriate
NIH office.
Other Agencies
Other agencies and organizations may have other rules about submission
of the verification of approval. It is up to the investigator to determine
when verification is required, and to submit forms to the UCAR office
at least 60 daysin advance. The office cannot provide "pending"
letters until the protocol has been submitted.
- At least 60 days before you are required to submit verification
of IACUC approval to the agency, submit an completed Animal Use
Protocol to the UCAR office (click here
for form) for review.
- If the reviewers have questions, please respond as soon as possible
to prevent delays in approval and subsequent funding.
- When you receive your approval letter, send it to the appropriate
reviewing agency.
UCAR review process:
- Upon receiving a protocol, the UCAR office staff logs it into
the system, and checks that it is appropriately signed, that it
matches a specific research application, that any necessary appendices
(recovery surgery, etc.) are appended, and that appropriate
contact information for the investigator is included.
- The protocol is then sent to a designated review team consisting
of at least one veterinarian and 4 other UCAR members for review.
Each reviewer either approves the application, asks questions of
the PI to help clarify the protocol, or provide missing information,
or requests that the protocol be reviewed at a convened meeting
of the UCAR.
- A description of each protocol submitted during the week is sent
to all UCAR members each Friday. The members have until the following
Wednesday to request to be added to the protocol review team.
- Questions from the reviewers are complied by the UCAR office staff
and sent to the PI for response. Failure of the PI to respond to
these questions effectively halts the review process.
- The response of the PI to all questions asked by the reviewers
is sent to all members of the review team for further review, and,
if necessary, more questions.
- Once all members of the review team approve the protocol, the
PI must incorporate all suggestions and revisions into an updated
protocol and provide it to the UCAR office in both hardcopy and
electronic versions. After the updated protocol is received by UCAR,
a letter verifying approval is generated and sent to the PI, who
must send it to the appropriate granting agency.
Protocol activation
Before any animals may be used or ordered, an approved protocol must
be activated. A protocol may be activated and animals ordered when
the following conditions are met:
- Protocol is reviewed and approved, and an updated version (both
hardcopy and electronic version) addressing all reviewer concerns
and questions is provided to UCAR Office.
- All personnel working on protocol must have attended the Animal
Resource Orientation, completed mandatory species specific trainin and obtain any relevant training from DLAM/Vivarium
(e.g., micro-isolator training, non-human primate handling, appropriate
tours of facilities as required).
- Personnel on the protocol are enrolled in the Occupational Health
Program if required (e.g., users of non-human primates, bats, sheep).
If you have questions call the UCAR Office, extension 5-1693).
- If you are using hazardous chemicals or biohazards, (e.g., tumor
cell lines, recombinant DNA, and viruses -- check the Environmental
Health and Safety website http://www.safety.rochester.edu).
Approval from EH&S must be received by the UCAR Office before approval letter will be provided..
- You must be able to provide evidence that your grant was peer
reviewed. If it has not gone to an agency that provides peer review
or if it will not be peer reviewed before you want to start work,
you must have the work reviewed and approved by the Deans
Research Advisory Committee (DRAC) and approval provided to
the Committee.
- When all of these conditions have been met you may call the UCAR
Office to activate the protocol. Please allow 24-hours to activate.
- In general, it is a good idea to contact the Vivarium Supervisor
before ordering animals to make sure that they can be adequately
housed. This is particularly important if you are a new investigator
without animals in house, are ordering an unusually large number,
a new species, have special housing requirements (micro-isolators,
one rodent per cage), are using hazardous substances, or are acquiring
animals from a non-routine vendor.
updated 4/20/07
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