Institutional Animal Care and Use Committee

Policy No.0002: Timetable for IACUC and PI Responses to Protocol Submissions and Requests for Revisions

Approved by Animal Institute Committee: 8/16/2000

REVISED: 4/20/2005

Reapproved: 6/15/11

  1. Incomplete Protocols: A protocol which is incomplete at the time of submission will be returned to the Principal Investigator (PI) for completion within two (2) weeks of return receipt. No further review of the protocol will take place until a completed protocol form is submitted. Criteria for incompleteness include:
    • required items or addenda are left blank or are missing.
    • the PI signature is missing (at the reviewers’ discretion, the signatures from the department head and from Safety, if required, may be postponed until the final draft)
     
  2. Triage: When a complete protocol is received, it will be assigned to either the Review Subcommittee (RSC) with a final approval by members of the full Internal Animal Care and Use Committee (IACUC) or designated review as per the IACUC review policy. Any protocol not requiring full review can be reassigned to a full review by any member of the IACUC including the delegated reviewer (DR). Assignment of submitted protocols will take place within three (3) weeks of receipt of the completed protocol.
  3. IACUC Response:
    • Full Review: A protocol assigned to full review will be discussed at the next RSC meeting; RSC meetings are scheduled at least once per month. Any comments or requests for revisions will be sent to the PI within two (2) weeks following the RSC meeting. Comments from other IACUC members may be included if the protocol has been discussed at a full meeting of the IACUC during this time period; otherwise such comments will be sent separately.
    • Delegated Review: A protocol assigned to delegated review will be reviewed and any requests for revisions sent to the PI within two (2) weeks of assignment to a DR
     
  4. Response by PI: The PI is expected to respond to requests for revisions by either the RSC or a DR within three (3) weeks of such request. The chairperson of the IACUC or the DR should remind the PI of this responsibility if no response is received by the end of this period. If a PI has not responded to a request for revision within one (1) month, a final reminder will be sent indicating that the protocol will be considered withdrawn if revisions are not provided within two (2) more weeks.
  5. Subsequent Revisions: Any requests for further revisions should be made within two (2) weeks of receipt of the revised protocol. The PI is expected to respond to such request within two (2) weeks, or the protocol will be considered withdrawn. The elapsed time between the submission of an initial protocol and the receipt of a final revised protocol should be no longer than three (3) months.

NB: Inquiries about the status of a submitted protocol may be addressed to the IACUC office (Dr. S. Shrestha) Tel. 718.430.3563, e-mail: sshresth@einstein.yu.edu.

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