A Seventh-day Adventist Organization

AWP: Review Process

IACUC REVIEW PROCESS

IACUC meetings are held on the 3rd Wednesday of the month. An application may be reviewed outside of the regularly scheduled meeting when the committee chair determines the need to call a special meeting or when he decides to use the Designated Member Review Process. The review process is as follows:

Administrative Prescreening

The RPP receives the application and performs a check for completeness. Each protocol is given a serial number, which identifies the study during its entire lifespan. The PI is notified of any additions or corrections needed, makes the corrections, and returns the revised form to RPP.

Full Committee Review (FCR)

Protocols

The IACUC Chair assigns each protocol to a primary reviewer. The primary reviewer is an IACUC member with appropriate expertise. The reviewer will introduce the study to the committee by presenting the rationale, the main objectives, and the experimental designs. All members present discuss the protocols and, by a majority of the quorum, vote to either approve the study as written for up to one year, require modifications (to secure approval), or withhold approval of the protocol.

The PI is notified in writing about the outcome of the review no later than the Monday following the IACUC meeting. Any issues not resolved during the review are sent to the PI, who responds in writing through the RPP.

Amendments

Significant amendments are reviewed in a manner similar to the one described for new protocols.

Designated Member Review (DMR)

LLU IACUC uses the FCR for all new applications unless there is a compelling reason for the DMR process, such as anticipated loss of quorum for the scheduled meeting, the urgency of the submitted protocol, or an amendment that cannot wait until the next scheduled monthly meeting. In these cases, the chair determines whether the protocol or amendment is eligible for a DMR and appoints a designated reviewer from among the IACUC members based on relevant expertise and experience. All IACUC members are notified of this decision and are given the opportunity to call for a Full Committee Review.

Following expiration of the committee notification and in the absence of a request for an FCR, the designated member reviewer either approves the protocol or amendment if he or she is satisfied that the approval criteria are met, requests revisions if outstanding issues are present, or requests a full committee review if further review of the protocol or amendment is warranted.

Once the review is performed, any unresolved issues are routed through the RPP to the PI. The PI's responses to the review are returned to the reviewers through RPP.

Annual Reviews

Federal regulations require that IACUC reviews each protocol on an annual basis. Investigators will be sent a reminder two months before the anniversary of the original approval date. Updated information and any changes in the animal use protocol must be supplied on the Research Report Form. Approvals will be extended for another year if there are no major changes in the protocol.

Submitting a Modification (Amendment) to an Approved Protocol

If there are any changes to the protocol during the course of the research project or upon annual renewal, an amendment must be submitted to the IACUC for approval using an appropriate form. Requested procedures must be approved prior to their implementations. Minor changes can be reviewed administratively by the IACUC chair or his or her designee. Significant changes are reviewed and approved by the full committee or designated member reviewer as described above.

Examples of minor changes:

  • Addition or deletion of an investigator
  • Protocol title change
  • Change in funding source
  • Change or addition of minor procedures
  • Change in use site/location between approved sites
  • Change of animal strain

Examples of significant changes:

  • Increase in animal numbers with justification
  • Change of research facility (new site)
  • Change in the method of euthanasia
  • Change in anesthetic or drug dosage
  • Change in surgical procedures
  • Change in husbandry procedures
  • Change in pain classification

IACUC or the IACUC chair may request a submission of a new application (protocol) following major changes. The following may be considered major changes:

  • Change of species, with different aims and procedures
  • Change of a classification of a drug that will be administered to animals

Addition of a major procedure (i.e., survival surgical manipulation, procedures requiring anesthesia with recovery, and procedures involving hazardous or infectious agents.)