IACUC- University of Arizona -Protocol flow chart

SUBMISSIONS TO THE IACUC COORDINATOR - 1st year protocols, 3rd. year re-reviews, Revised Protocols
ROUTING SHEETS SIGNED AND APPROVAL PENDING FORM PROVIDED ON REQUEST - Granting Agency and Sponsored Projects materials are forwarded by the Investigator (PI).
NOTIFICATION OF SUBMISSIONS FORWARDED TO THE IACUC - Species, Pain Category, Study Type, and recommended review type is noted. The Committee is given the opportunity to request a change of review category for a specific protocol. A Quorum Review may also be requested.

REVIEW TYPES:
ACCELERATED (See A. below)
FULL REVIEW (See B. below)
QUORUM REVIEW: Identical in procedure to FULL REVIEW but must have quorum of full committee voting
CONVENED REVIEW WITH PI: Identical to FULL or QUORUM REVIEW, but the PI is invited to personally address IACUC concerns.

RECOMMENDED OR REVISED REVIEW PROCESS FOLLOWED (See A, B below)
PI NOTIFIED OF FINAL DISPOSITION:

FULL APPROVAL: Verification of Review with Approval Date and Expiration date forwarded.

DISAPPROVED: PI notified of reasons for disapproval and given recommended course of action.

PROTOCOL ENTERED INTO COMPUTER SYSTEM - This allows for animal ordering and implementation of project.

A. ACCELERATED REVIEW

1) PRIMARY REVIEWER (PR) ASSIGNED - Must be a Veterinary Member of the IACUC

2) REVIEW SHEET COMPLETED - Primary Reviewer provides brief overview of project and makes recommendation for Approval, Approval with Revision, Revision, Disapproval. The Primary Reviewer may also request a change of review category for a specific protocol. A Quorum Review may also be requested. If Full Review or a Quorum Review is requested, the protocol will be moved to the Full Review track.

** PRIMARY REVIEWER COMMENTS AND RECOMMENDATION **

APPROVED1) IACUC NOTIFICATION

The IACUC is informed that Approval has been recommended and given a week to request further review.

2) FULL APPROVAL

APPROVE/REVISION1) PI NOTIFIED

The PI is forwarded minor revision or information requests and the protocol is held until a satisfactory response is received.*

2) IACUC NOTIFICATION

3) FULL APPROVAL

REVISION1) PI NOTIFIED

2) PR REVIEWS RESPONSE

The PI response is forwarded to the PR who will make further comment and Approval Recommendation.*

3) IACUC NOTIFICATION

4) FULL APPROVAL

DISAPPROVE1) PI NOTIFIED

The reasons for Disapproval are given to the PI who may request Full Review or may submit a Revised Protocol.

B. FULL REVIEW

PRIMARY REVIEWER (PR) ASSIGNED - May be Scientific or Veterinary Member of the IACUC or an invited "Expert" Reviewer.
REVIEW SHEET COMPLETED - This section is identical to the procedures listed above for ACCELERATED REVIEW, differing in that instead of IACUC NOTIFICATION being forwarded to the Committee, the protocol is taken to a convened IACUC Protocol Review Sub-Committee comprised of approximately half of the full IACUC.
FULL REVIEW - The PR presents their review and any revisions that have been made prior to the meeting. The Sub-Committee makes their comments and recommendations.

** IACUC COMMENTS AND RECOMMENDATION **

APPROVED

1) FULL APPROVAL

APPROVE/REVISION

1) PI NOTIFIED

The PI is forwarded minor revision or information requests. The protocol is held until a satisfactory response is received.*

2) FULL APPROVAL

REVISION

1) PI NOTIFIED

2) IACUC REVIEWS RESPONSE

The PI response is forwarded to the Review Subcommittee who will make further comment and Approval Recommendation.*

3) FULL APPROVAL

DISAPPROVE

1) PI NOTIFIED

The reasons for Disapproval are given to the PI who may request Quorum Review or may submit a Revised Protocol.

* Further routing depends on satisfactory responses from the PI.
NOTE: Any revisions requested during the review process become a part of the official protocol file.

Accelerated Review/Protocol - Some protocols involving little or no pain to the animals involved may qualify for accelerated review. These include field observations, tissue harvest only, antibody production, and some injections. This review requires the authorization of a veterinary Primary Reviewer. (The IACUC is notified of the PR’s recommendation for approval and is granted one week during which to request full review.) Accelerated review generally takes 1-2 weeks to accomplish depending on the overall review load.

SIRIUS - This refers to the Computer database employed by University Animal Care to generate USDA reports, billings, cage cards and to track animal usage/orders. All approved protocols are entered into the SIRIUS system.

Amendments - Forms or memos sent to change aspects of a given protocol, such as animal numbers, species, addition/deletion of personnel, addition/deletion of procedures, etc. NOTE: Amendments, unless specifically requesting an extension of the expiration date are authorized only for the duration of the protocol’s approval period. (IACUC review required).

Annual Updates - Forms are sent to PIs annually at the anniversary of the protocol approval date. These forms inform the PIs how many animals are still available under a specific Control Number and ask for a statement of status of the protocol (i.e., "No changes have been made to the protocol since it was last reviewed" or "I have forwarded the appropriate forms to amend my protocol") and ask for a current listing of participating personnel.

Approval Date - The date upon which final approval is granted for a specific protocol.

Approval Period - Protocols are granted 3-year approvals. NOTE: Approval dates for protocols may not coincide with funding periods.

Control Number - This 5-digit number is assigned upon receipt of the protocol. The first two digits (before the hyphen) indicate what year the protocol was received in, and the last three digits (after the hyphen) indicate what order the protocol was received in. (EXAMPLE: #96-008 was the 8th protocol received in the calendar year 1996). NOTE: Cage cards and the CIRIUS computer system reflect a third set of numbers. These indicate the month and year the protocol expires in. (EXAMPLE: #96-008-39 expires in the 3rd. month of 1999).

Expiration Date - Three years from the approval date, at which time the protocol is not longer considered "valid". Work described in the protocol may not be continued past the approval date without the submission of an extension request or a re-review protocol.

Extension Request - PIs may request up to a 6-month to extension to the approval period. (IACUC review required)

Final Approval - Final Approval is granted after a majority of the IACUC review committee (or Primary Reviewer for Accelerated Protocols) is satisfied with all aspects of the protocol and the PI has complied with all requests for revisions or additional information.

New Protocols - First time submissions of a specific protocol. (IACUC review required)

Primary Reviewer (PR) - A scientific or veterinary member of the IACUC assigned the initial responsibility of reviewing a protocol. The Primary Reviewer may request revisions or information which will help in the review of the protocol. The Primary Reviewer serves as the protocol advocate and presenter at IACUC Protocol Review Meeting.

Principal Investigator (PI) - The individual who is responsible for the work being done under a specific protocol.

Protocol - This refers to the actual Animal Protocol Review Form (APRF) submitted for IACUC review which outlines specific procedures that will be conducted on a specific set of animals. This word is often used interchangeably to refer to the specific procedures outlined in the APRF.

Regular (Full) Review - All protocols which do not fit the criteria for accelerated review much undergo a Regular Full Review. This involves a preliminary review by the Primary Reviewer followed by a review by at least one of the IACUC Protocol Review Sub-Committees. Regular Full Review may take up to 60 days depending on the overall review load, however, most can be accomplished within 4 weeks of submission if no revisions or additional information is requested.

Re-Reviews Protocol - This refers to the submission of an APRF requesting the continuation of a project which has already been approved, but has come to its expiration date. This is treated as a new protocol. (IACUC review required)