Standard Operating procedure for Protocol and Amendment Review

IACUC Guideline: Revised October 12, 2007

Four Tiers of AVAU and Amendment Review:

First Tier of Review:

• New protocols (Applications for Vertebrate Animal Use; AVAUs) and amendment requests for approved protocols (amendments) are received in the IACUC office by the IACUC Regulatory Compliance Administrator. Protocol amendment requests are processed and reviewed the same as new protocols (see http://www.ncsu.edu/iacuc/sops.html - “Significant Changes in Approved AVAU”).
• The IACUC Compliance Coordinator checks the names of the individuals named in the application against the list of names of individuals who have completed the required animal care and use training. The date of completion of animal care training must be within three years of the date of receipt of the application. The names of individuals listed on the protocols must also be checked against the names of faculty, students and personnel who are in compliance with the Occupational Health and Safety program. If listed individuals are not in compliance with the training and/or Occupational Health and Safety program requirements, the IACUC Compliance Coordinator sends a notification to the applicant regarding the requirements, informing them that IACUC approval will be withheld if the requirements are not met.
• The IACUC Regulatory Compliance Administrator conducts an administrative review of the AVAU or amendment to pick up gross omissions before continuing the review process. In cases where need for significant revision is apparent, the Administrator may recommend that the Principal Investigator (PI) seek immediate assistance from a Committee member in revising the AVAU or amendment.
• The Administrator assigns the AVAU a designation of “non-agricultural,” “agricultural,” or “teaching,”  using the definition of “animal” included in 9 CFR 1.1 as a guideline to identify which projects are subject to USDA reporting.  The designation is subject to change during the review process. This designation is not final until the protocol is approved (after the fourth tier of review).

NOTE: All correspondence related to all veterinary and primary reviews of an AVAU or amendment will be copied to all reviewers identified in the original review assignment email, including the IACUC Regulatory Compliance Administrator and IACUC Compliance Coordinator.

Second Tier of Review

To facilitate the PI’s submission of the AVAU or amendment, the Administrator assigns a veterinary reviewer and a primary reviewer (PR). The veterinary reviewer will conduct the initial review with regard to veterinary issues and copy all correspondence with the PI to the PR. The veterinarian will usually be a current IACUC member; however, other veterinary reviewers may be utilized. The PR will usually be a current IACUC member, but other consulting reviewers may be utilized. The veterinary reviewer should contact the PI within ten (10) working days, if changes are necessary. If the veterinary reviewer recommends revisions, the PI will return the revised application directly to the veterinary reviewer. Upon finding the application satisfactory with regard to veterinary issues, the veterinary reviewer then releases the revised AVAU or amendment to the primary reviewer for the next tier of review, making sure to copy the correspondence to the IACUC Regulatory Compliance Administrator and IACUC Compliance Coordinator.

Third Tier of Review

Upon receipt of the revised AVAU or amendment from the veterinary reviewer, the primary reviewer will be responsible for reviewing the entire AVAU or amendment for IACUC concerns and coordinating revisions to be presented to the full committee. There are special considerations for Category E protocols and amendments (see Third Tier of Review, below). The primary reviewer should contact the PI within ten (10) working days after receipt of the revised AVAU or amendment. The PI should return the revised application directly to the primary reviewer for review and recommendation to the full committee. As noted for the second tier of review, all correspondence should be copied to the IACUC Regulatory Compliance Administrator and the IACUC Compliance Administrator.

Fourth Tier of Review (Final Review)

The NCSU IACUC conducts full committee reviews of all non-Category E protocols under the Designated Member Review process, with the IACUC Chair acting as Designated Reviewer. It should be noted that once a non-Category E protocol has been distributed to the full committee in Designated Review mode, and a quorum of responses has been received by the IACUC Regulatory Compliance Administrator with no responding member requesting further discussion of the protocol at a convened quorum, the IACUC Chair may sign approval of the protocol. If the IACUC Chair is on leave, the following individuals may act as Designated Reviewer in his or her stead, in this order: 1) the IACUC Vice Chair, 2) the University Attending Veterinarian, or 3) the IACUC Regulatory Compliance Administrator.

Non-Category E protocols:

• If the primary reviewer is satisfied that the application requires no further revision, the PR will recommend, by email to the Administrator, approval of the application without further discussion.

If the PR is not satisfied with AVAU or amendment revisions and is unable to recommend approval of the protocol or amendment, the AVAU or amendment is placed on the agenda for discussion at the next convened quorum. “Quorum” is defined as a majority (>50%) of the voting members of the IACUC. For reasons other than conflict of interest, abstentions from voting do not alter the quorum or change the number of votes required.

• The PI may be invited to address the committee concerning unresolved issues.
• The IACUC Regulatory Compliance Administrator (or IACUC Compliance Coordinator, in his or her stead) distributes non-Category E applications recommended for approval without further discussion to the full committee, with the IACUC Chair (or in his or her absence, the Vice Chair, UAV or IACUC Regulatory Compliance Administrator) acting as designated reviewer. Members are notified that they have five (5) working days to review the applications and flag them for discussion at the next scheduled meeting. Members are required to respond to the notice in order to document that they have had an opportunity to review the AVAU(s) and/or amendments and to indicate whether they want to flag the AVAU(s) and/or amendments for discussion at the next convened quorum. At the end of the review period, if a quorum of responses has been received, and the protocol(s) and/or amendment(s) has (have) not been flagged for discussion at the next convened quorum, the Chair (or in his or her absence, the Vice Chair, UAV or IACUC Regulatory Compliance Administrator) will act as designated reviewer, and approve the protocol(s) and or amendment(s), unless he/she has concerns about those submissions. As designated reviewer, the Chair (or in his or her absence, the Vice chair, UAV or IACUC Regulatory Compliance Administrator) may approve the AVAU or amendment, require modifications, or bring the AVAU or amendment to a convened quorum for further discussion.
• At any time during the committee review period, members may contact the IACUC Administrator with requests for minor revisions (i.e. revisions that would not require discussion at a convened quorum). Such requests will be forwarded to the primary reviewer for consideration and communication with the investigator or instructor. The PR and the IACUC member requesting the revision will review any changes made to the protocol. At the end of the review period, if these minor issues have been resolved, the Chair (or in the absence of the Chair, the Vice Chair, UAV or IACUC Regulatory Compliance Administrator) will act as designated reviewer, as above. If issues have not been resolved, the Chair (or in the absence of the Chair, the Vice Chair, UAV or IACUC Regulatory Compliance Administrator) may request further discussion at the next convened quorum.
• EXPEDITED REVIEWS: At times, the IACUC Administrator, in consultation with the IACUC Chair, will approve investigator requests for expedited committee review. The procedures are the same as above, with one exception. The committee will be allowed a shorter time to respond (1-4 working days), subject to determination by the IACUC Administrator. As with regular reviews, members are required to respond to the notice in order to document that they have had an opportunity to review the AVAU(s) and/or amendments and to indicate whether they want to flag the AVAU(s) and/or amendments for discussion at the next convened quorum. At the end of the review period, if a quorum of responses has been received, and the protocol(s) and/or amendment(s) has (have) not been flagged for discussion at the next convened quorum, the Chair (or in the absence of the Chair, the Vice Chair, UAV or IACUC Regulatory Compliance Administrator) will act as designated reviewer, and approve the protocol(s) and or amendment(s), unless he/she has concerns about the protocol.
• If an AVAU or amendment is flagged for discussion, the primary reviewer, veterinary reviewer, IACUC Regulatory Compliance Administrator, and the IACUC Compliance Coordinator are notified of the concerns raised, and the item is placed on the agenda for discussion at the next meeting. In the event that the concerns are resolved prior to the meeting, to the satisfaction of the member(s) raising the concerns, the AVAU or amendment is removed from the agenda and approved without further discussion.

Category E protocols:

• The PR should advise PIs that, in accordance with NCSU IACUC policy, all AVAUs involving Category E animal use must be presented for discussion at a convened quorum. The PR is asked to inform PIs that the IACUC requires a revised copy of the application at least one week prior to the scheduled meeting for distribution to the full committee. If the revised AVAU is not received in the proper time allocated it will be considered at the next convened quorum.
• Amendments to approved Category E protocols will only require discussion at a convened quorum if it involves additional procedures that are Category E animal use.
• When the PR is satisfied that the application requires no further revision, the PR will recommend, by email to the Administrator, that the application be placed on the agenda for the next meeting.

Convened Quorum Review

• AVAUs and amendments involving Category E animal use, those for which the primary reviewer or Designated Reviewer have requested discussion at the next meeting, and those that have been flagged for discussion by any voting member of the committee during final review are placed on the agenda for discussion at the next meeting.
• AVAUs and amendments discussed at a convened quorum are processed according to the approved motions resulting from the committee’s discussions. If an AVAU or amendment is not approved, the IACUC Regulatory Compliance Administrator contacts the investigator regarding the IACUC’s decision. If the committee requests further revisions, the original primary reviewer coordinates them, unless specified otherwise in the committee’s action.

Final Processing

Once approved, a signed copy of the AVAU or amendment is emailed to the PI as an attachment with a form email memo from the IACUC Compliance Coordinator or IACUC Regulatory Compliance Administrator. A copy of the approved AVAU or amendment is forwarded to the animal facility identified in the protocol as the location/site of the animal use. The University Attending Veterinarian is copied on all approval notices.