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IACUC REVIEW PROCESS (rev August 2007, February 2005, May 2003)

Approval Period

Federal regulations mandate a maximum of one year for study approvals. The IACUC will send courtesy reminders to PIs approximately 75 and 45 days before the expiration date of an approved study to allow sufficient time for renewal processing. Note: If renewal applications are not renewed and approved by the expiration date, animals will be immediately transferred to the LARC Holding Protocol for routine care. The Principal Investigator and his/her staff will not have access to the animals until the application has been approved.

Types of Review

UCSF-IACUC has adopted formalized procedures, known as “Designated Reviewer”, approved by the USDA and PHS. This process allows for review of proposed activities (protocols) by less than a full Committee.

Full Committee Review: Initial applications, every three years thereafter, and major changes (see below) in approved protocols are reviewed by the full committee and require completion of the Full Committee Application.

Designated Subcommittee Review: Applications for annual review, second and third year after initial review and approval, are reviewed by an IACUC subcommittee and require completion of the Annual Application (unless a major modification to the protocol is involved - see Types of Modifications for requirements.)

Urgent Reviews: Under certain rare circumstances the IACUC Chair may designate a reviewer for urgent reviews. The investigators must provide compelling reasons for these types of reviews.

Tissue Collection: The IACUC Chair may designate a reviewer for Category C protocols proposing tissue collection only.

Modification Review: If the PI wishes to make modifications to the approved protocol during its one-year approval period, these changes must be approved before they are initiated. Approval for a modification does not change the existing expiration date.

Loss of Quorum: If a quorum is lost during a convened meeting of the Full Committee due to the early departure of one or more Committee members, the IACUC Chair may call for a vote by the Full Committee (before any members are excused) to review the remaining protocols on the agenda via the designated member review process.

Investigators Attending IACUC Meetings

Typically, the PI is not asked to attend the IACUC meeting at which his/her protocol is being reviewed; a thorough application is sufficient. On occasion, however, the IACUC may require more information or the PI may wish to appear to address specific problems or questions in person, particularly when Category E studies are involved, or in cases such as follow-up of apparent protocol violation. Attending a IACUC meeting can be arranged by calling the IACUC office at 476-2197. Regardless of conversations or oral presentations at a meeting, responses and resolutions must always be documented in writing.

Types of Review Outcome

After IACUC review, one of the following determinations is made for each application:

Full Approval is granted when the Committee has no concerns about the application. The investigator is sent a letter with a IACUC approval number, valid for one year, and may begin the project.

Revisions Requested prior to approval is given when the members require a written response from the investigator. The members may ask the investigator to clarify a point, provide further information, or make revisions in the protocol. The investigator's response is normally reviewed by the IACUC Chair. No approval is given until the questions and/or concerns of the Committee have been satisfactorily addressed and approved by the Chair.

Returned for Additional Information prior to committee re-review is requested when serious concerns are raised and the members agree that additional information and/or justification is needed before approval can be reconsidered. The investigator's response must include a point-by-point letter addressing all concerns, as well as a revised application. The response is then reviewed by the Full Committee.

Disapproval is given when the Committee completely refuses to approve a protocol.

On rare occasions, the Committee may encounter major difficulty in making an assessment and an outside reviewer may be asked to consider the protocol.