The Review Process

 

The review process begins with the pre-reviews by the Animal Care Manager and the Attending Veterinarian. The purpose of the pre-review is to identify issues that are either incomplete or unclear thereby preventing or delaying approval by the IACUC. Once these issues are identified, the investigator has the opportunity to respond to and/or revise the Protocol Form in advance of presentation to the IACUC during a convened meeting. Although this pre-review process will materially improve the probability that the protocol will be approved, it does not guarantee approval by the full Committee. It is to your advantage to follow this submission format to avoid delaying the review process, particularly since granting agencies do not take final action on research funding until they have received results of the IACUC review. Copies of final protocols and responses to issues raised at the pre-review are distributed to IACUC members in advance of the meeting. Submission deadlines have been established so IACUC members have the opportunity to review the materials thoroughly. Receipt deadlines are without exception and the IACUC is not obligated to conduct a review of a late submission even in light of funding deadlines. At the meeting, IACUC members discuss each individual protocol and evaluate it for adherence to animal welfare laws, regulations, and policies. IACUC approval voting is by consensus.

 

The possible actions taken by the IACUC are: Approved (self explanatory), Conditionally Approved (minor points require clarification or correction but the protocol is generally satisfactory), Deferred (there are some major areas of concern that may require in-depth discussion and resolution), and Disapproved (the protocol, as submitted, is not acceptable and must be extensively revised and resubmitted as a new application). After a convened meeting is held, committee actions are recorded in the IACUC minutes. The secretary of the IACUC sends written notification to the investigator of its decision. If the action taken by the Committee is other than full approval, a detailed descrition of the issues raised by the members is provided to the investigator along with the changes required to secure full approval. When approval is granted, a copy of the notification letter in addition to all IACUC records are placed on file in the Office of Sponsored Programs so that they may notify granting agencies and for review by Federal and State agencies responsible for animal welfare .

 

If the IACUC decides to withhold approval of an activity, . the investigator is given an opportunity to respond in person or in writing prior to or at the next convened meeting. Investigators may be contacted by Committee members to clarify points and/or negotiate changes in the protocol. For Conditional Approvals, once the IACUC secretary has received the investigator's response to the IACUC, approval may be granted before the next convened meeting. For Deferred protocols, the investigator's response must be reviewed by all members at the next Committee meeting. It is important to remember that the approval process is one of discussion and negotiation between the IACUC and investigators in order to promote research while maintaining high standards for animal welfare. It is important to remember that research involving animals cannot be initiated or continue until full approval is granted by the Committee.