Policy ID:
Date Instituted: December 5, 2001
Last Revised: December 5, 2001
Policy Description
Any research project, class activity, or
testing procedure involving the use of
animals must be reviewed and approved by the IACUC before initiation.
Procedure for Submission of a New Protocol
- Obtain an Animal Protocol Review Form. The
Animal Protocol Review Form can be obtained from the Chair of the IACUC
or downloaded by clicking here.
- Submission to IACUC. The
investigator will submit 3 copies of the Animal Protocol Review Form to
the Chair of the IACUC. The Chair will send acknowledgment of the
receipt of the protocol.
- First Reviews. The first reviews serve as
an initial check to ensure that the protocol is complete and prepared
correctly. The submitted protocol will be sent to two members of the
IACUC for review. They have 10 business days to review for
completeness and correctness. At the end of the 10 days, they should
send a written concurrence or comments to the Chair through campus mail
or by e-mail. If a reviewer has questions, recommendations, or
concerns, the submitter will be notified by the Chair and asked to
respond to the questions by submitting written responses to the Chair.
The protocol is held until a response is received. The Chair will send
the investigator’s response back to the reviewer and the reviewer has 5
days to send written concurrence of completeness and correctness or
further comment.
- Second Reviews. Assuming 1st review
concurrence, the Chair will send the rest of the IACUC the submitted
protocol. The committee members have 10 business days for review.
At the end of the 10 days, they should send written comments to the
Chair through campus mail or by e-mail. If a reviewer has
questions, recommendations or concerns, the submitter will be notified
and asked to respond to the questions by submitting written responses
to the Chair. The protocol is held until a response is received. The
Chair will send the investigator’s response back to the reviewer and
the reviewer has 5 days to send written recommendation for approval or
further comment. If necessary, the investigator will be asked to submit
a revised protocol incorporating the recommendations from the first and
second reviews.
- Formal Approval. The final submitted
protocol is presented at a convened quorum of the IACUC for a full
committee review and vote. The committee’s decision to approve or
disapprove the protocol is noted in the minutes.
- Notification of Approval. Assuming approval by a
convened quorum of the IACUC, the Chair will assign a protocol number
and send the investigator a written letter stating approval of the
protocol. No protocol may ever be initiated, including the
ordering of animals, until written approval is received.
- Notification of Disapproval. The reasons
for disapproval will be given to the investigator who may request a
meeting of a convened quorum of the IACUC or resubmit a revised
protocol.
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Proposed Significant Changes to an Active Protocol
Proposed significant changes to an active protocol must go through the
same protocol approval process as described for the new protocol
submissions.
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Protocol Renewals and Annual Review of Active Protocols
- All protocol renewals are treated as a new protocol and
must go through the standard protocol review process.
- Regulations (9 CFR, Subchapter A) issued by the U.S.
Department of Agriculture (USDA) under the Animal Welfare Act,
2.31(d)(5), specifies that institutions “...shall conduct continuing
reviews of activities...not less than annually.” Thus, at the end
of each year all investigators with active protocols will be asked to
confirm that their protocols are active and that no changes have been
made without the review and approval of the IACUC.
- PHS Policy requires a complete new review every 3 years
using all the criteria for initial review
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