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Seton Hall University

IACUC Review Process

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

  1. Obtain an Animal Protocol Review Form. The Animal Protocol Review Form can be obtained from the Chair of the IACUC or download the form »  and the instructions »
  2. Submission to IACUC.  The investigator will submit the completed Animal Protocol Review Form by email to the Chair of the IACUC. The Chair will send acknowledgment of the receipt of the protocol.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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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