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Types of Submissions

Protocols and Amendments: The review of animal research protocols and amendment forms has been designed to help guide the investigator by requiring the specific information needed in order to comply with federal regulations. A protocol is submitted for new research and amendments are submitted to propose changes to an approved protocol.

Personnel Amendments: Any person that is to work with animals must be listed on an approved protocol and complete the IACUC requirements before beginning. Proposed additions to personnel are submitted by the Principal Investigator or an administrator on their behalf via personnel amendments (Supplement Ps).

Animal Transfers: animal protocol transfers, in which animals are moved from one Approved protocol to another, may be permitted in certain cases. Animals under one protocol may not be used for any work under another animal protocol until the transfer has received IACUC Approval.

Review of Protocols and Amendments

IACUC Approval is required prior to initiation of animal research and prior to changes to animal research. Requests for IACUC Approval are done via the submission of the appropriate form to the Submissions may be reviewed and Approved by Full Committee Review, Designated Member Review or Expedited Review.

Full Committee Review: The IACUC convenes monthly to discuss proposed animal research and practices of animal care and use at Tufts University and Tufts Medical Center. Protocols and significant amendments are typically reviewed by the full Committee. During the convened meeting, the IACUC votes for one of the following categorizations for each protocol submission:

1. Approval – no additional changes are required and approval can be granted.

2. Non-substantive Issues – non-substantive modifications are required in order to secure approval. The revision is submitted to the Designated Member Review. If all required modifications are made, the subcommittee can approve or require additional modifications in order to secure approval by selecting either Designated Member or Full Committee review of the required modifications. The designated reviewers cannot disapprove.

3. Substantive issues – If a protocol requires substantive modifications, the revised protocol or amendment must be submitted back to a Full Committee Review. The revision can either be approved or the Committee can require further modifications in order to secure approval by selecting either Designated Member or Full Committee review of the required modifications.

4. Disapproval – the research cannot be conducted at this time.

Expedited Review: The IACUC recognizes that in certain situations, it may be advantageous to attain Approval prior to the next scheduled convening of the Committee. Investigators are permitted to submit protocols and amendments under Expedited Review. Committee members are given a designated time frame in which to review the proposed animal work and vote for either Full Committee Review or Designated Review. If no member calls for Full Committee, the protocol or amendment will be reviewed by a designated team of members.

Designated Member Review: Two or more members of the Committee may be designated as a subcommittee to review proposed research. The designated reviewers can vote for Approval, require modifications or call for full Committee review. Designated Member Review may be used for non-significant amendments, after a vote of non-substantive issues during a full Committee Review or after non-contested submission through Expedited Review.

Some minor changes to animal work, such as the addition of personnel, can be reviewed and completed administratively.