How to Review a Protocol
Full committee review of protocol applications requires a convened meeting of a quorum of the IACUC members (half of the committee membership plus one). Each protocol is assigned to a primary and secondary reviewer; these individuals are responsible for an in-depth review of the protocols to which they have been assigned. All members in attendance at the convened meeting receive a copy of all protocol applications on the agenda, and are welcome to add their comments to the discussion as well.
A protocol for the use of live animals in research, testing or teaching must address, at minimum, the following issues:
- The scientific rationale of the study must be clearly stated in language understandable to someone unfamiliar with the scientific discipline involved.
- Use of live animals must be justified, based on the scientific design of the study. Alternatives to the use of live animals, if they exist, must be considered. There must be some valuable return in exchange for the lives of the animals used in the study.
- The number of animals needed for the study must be justified, based on the experimental design.
- Alternatives to the use of live animals and painful or distressful procedures must be considered and determined to be scientifically unacceptable for the study. Consideration of alternatives includes:
- Replacement of live animals with an in-vitro model alternative, computer modeling, etc.
- Reduction in the overall number of animals used, without increasing the level of pain, distress and discomfort.
- Refinement of procedures to minimize pain, distress and discomfort in the animals.
Animal welfare regulations and policies (USDA) consider the search of appropriate scientific literature databases to be the most effective method for documenting the consideration of alternatives.
- Humane endpoints must be identified for all animals in the study. An AVMA-approved method of euthanasia must be described in the protocol.
- All research personnel must have relevant experience and/or appropriate training to perform all procedures in live animals, including euthanasia.
- All surgical and non-surgical procedures must be clearly and completely described, consistent with the experimental design outline. Clinical signs that may present in the animals due to the procedures must be described as well.
- Use of analgesics or anesthesia must be used whenever procedures are expected to produce more than momentary pain, discomfort or distress, unless a scientific justification is provided for withholding such agents.
- There must be an appropriate plan for monitoring animals for pain, discomfort and distress, including criteria for determining early euthanasia.
- All locations where animal work will be performed must be listed.
The points listed above should be considered when reviewing requests for modification of an already approved protocol as well. In addition, reviewers should consider whether it is appropriate to the proposed modification as an extension of the existing project, or whether a new, stand-alone protocol application should be submitted.
Before the Full Committee Meeting
- Pre-review all assigned materials as soon as possible after you receive them, approximately 2 weeks before the scheduled meeting. UCI utilizes a primary-secondary reviewer system; therefore if you are assigned as either the primary or secondary reviewer it is your responsibility to thoroughly review the IACUC application materials and provide pre-review comments and recommendations in advance of the meeting.
- Get all questions answered before the meeting. IACUC Members are not expected to be the absolute experts about the protocols they are assigned to review. Talk with others as needed. Feel free to contact the:
- IACUC Chair
- Co- reviewer
- IACUC Administrator
- Ad-hoc Consultation*
* Ad-hoc consultations can be arranged through the IACUC Administrator.
Committee members are bound by the Members Standards to maintain all committee proceedings and documents that contain personal, confidential and proprietary information in strict confidence. Such information may not be disseminated or used for any purpose other than the IACUC review and may not be disclosed to anyone outside of the IACUC unless permission is granted in writing by the Vice Chancellor for Research. - Complete the Pre-review checklist, providing comments and recommendations for pre-meeting revisions and clarifications and return it to the IACUC Administrator by the specified date.
- Contact the IACUC Chair and Administrator if you have serious concerns about the protocol.
At the Meeting
The primary reviewer should:
- Provide a brief summary of the study and its scientific rationale
- Briefly summarize the pre-review comments
- Indicate whether the LR has made all changes requested during pre-review.
- Recommend a committee action (see below)
The secondary reviewer should then:
- Indicate agreement or disagreement with the primary reviewer's recommended committee action
- Discuss any additional issues as appropriate
Please refer to the Streamlining IACUC Meetings page for more information about the conduct of IACUC meetings.
Before the final vote on any protocol or modification, all members should consider the following questions:
- Are the specific aims, hypotheses and research questions clearly identified?
- Is there sufficient preliminary data to justify the research?
- Does the protocol adequately justify the use of live animals?
- Does the animal model make sense for the research project?
- Have the "Three Rs" (replacement, reduction and refinement) been adequately addressed?
- Are the members of the research team qualified and experienced in the procedures to be performed?
- Has pain, discomfort and distress to the animals been minimized or avoided to the fullest extent possible?
Possible Committee Actions
- Approval - All IACUC concerns and administrative and veterinary issues have been adequately addressed in the application as written. No changes are necessary.
- Tabled Administratively - Minor administrative details are required before approval can be released. The concerns are minor and do not alter the content of the protocol itself.
- Tabled to Subcommittee - Animal welfare issues have been adequately addressed, but additional information, details or clarifications of a scientific nature are necessary before approval can be granted.
- Resubmission Required - Either there are serious animal welfare concerns associated with the project that have not been adequately addressed, or a reasonable judgement cannot be made regarding the experimental design or scientific merit of the proposed work, based on the information supplied. In modification requests, the new part of the project is beyond the scope of work described in the original protocol and must be resubmitted as a new stand-alone protocol.
Adapted from: OLAW/ARENA Institutional Animal Care and Use Guidebook, 2002
