THE IACUC REVIEW PROCESS
Faculty and student Principal Investigators (PI) submit complete Animal Use Clearance forms to the IACUC. (Clearance forms are available on the university's website.) An investigator may consult with the attending veterinarian or the IACUC Chairperson during protocol development or may request a preliminary review before submitting a proposal.
Once submitted, copies of the Clearance form are forwarded to all IACUC members along with notification of the required response period, which will ordinarily be not less than two days nor more than 14 days (typically 9 days). [A longer response period may be required due to member unavailability such as during university breaks.] Committee members will review the protocol and determine whether it should be reviewed in a convened meeting of the IACUC (for full committee review). Requests for full committee review must be made to the Chairperson within the response period. If any one committee member makes such a request, full committee review will be scheduled. Otherwise, the protocol will undergo designated reviewer review. Committee members not requesting a full committee meeting may nevertheless respond with comments.
Pursuant to review by committee or designated reviewer, if clarifications or changes are required to secure approval, the PI is notified of the concerns in writing by IACUC staff. The PI's response is forwarded to the committee or designated reviewer. A record of correspondence is kept with the original clearance form in the file. This process continues until the committee or designated reviewer is satisfied that concerns have been addressed and the protocol is approved. If this process does not reach a satisfactory conclusion, the designated reviewer may refer the protocol to the full committee, or the full committee may withhold approval.
The IACUC Chairperson notifies the PI of approval status in writing. If the protocol is not approved, reasons are explained.
B. FULL COMMITTEE REVIEW
If a full committee review is requested, review of the protocol is scheduled for the next meeting of the IACUC and the PI is notified. This would normally be the semi-annual meeting, but a special meeting could be called if the next semi-annual meeting would not occur until after the anticipated commencement of the project.
If the IACUC desires more scientific and technical expertise to evaluate aspects of a proposal it may contact outside consultants to provide information. Such consultants may not vote. The responsibility lies with the PI to justify and explain his or her proposed experiments to the satisfaction of the IACUC.
- The PI may, but is not required to, attend the meeting in order to be available to clarify protocol issues that arise. The PI will leave the meeting prior to final discussion and voting on approval.
- In order to complete the review, a quorum (simple majority of members) must be present at the meeting in person or by conference call.
- A simple majority of those present is required to approve the protocol.
- The committee may approve, require modifications to secure approval, or withhold approval.
C. DESIGNATED REVIEWER REVIEW
If a full committee review is not requested, a designated reviewer is assigned to formally review the protocol. The designated reviewer may approve, require modifications to secure approval, or send the protocol to full committee. The designated reviewer does not have authority to deny approval.
The designated reviewer will apply the same criteria in review as the full committee would.
D. IACUC REVIEW CRITERIA
he IACUC shall review protocols considering the criteria for review listed in the PHS Policy on Humane Care and Use of Laboratory Animals, the Federal Animal Welfare Act regulations, and the U.S. Government Principles for the Utilization and Care of Vertebrate Animals in Testing, Research, and Training.
E. CONFLICTS OF INTEREST
IACUC members who have a conflict of interest with respect to a protocol should notify the IACUC Chair and may not participate in the review or approval except to provide information if requested by the IACUC. They cannot be counted toward a quorum and may not vote. In the event that a conflict of interest exists with the Chair of the IACUC, the Chair must designate another member to act in his or her place for the purpose of reviewing the relevant protocol.
If the PI believes that an IACUC member has a potential conflict, the investigator may request that the member be excluded.
Some possible examples of conflict of interest include:
- A member is a co-investigator on this research project or is involved in a potentially competing research program;
- Funding or other financial ties exist or place the member in a competitive position;
- A member's personal biases may interfere with impartial judgment.
F. APPEAL OF IACUC DECISIONS
The author of a protocol may appeal decisions of the IACUC to the Associate Vice President of Graduate Studies, Research & Continuing Education . However, Federal law prohibits administrative approval of an activity not approved by the IACUC. Nevertheless, the Associate Vice President of Graduate Studies, Research & Continuing Education may work to facilitate the communication between the PI and the IACUC ensuring that the protocol has been fully presented and reviewed.