Preparation and Review of Animal Use Protocols

Last updated on April 10, 2002

Continuing reviews

PHS Policy demands that animal protocols be reviewed every 3 years, whereas USDA 9CFR regulations stipulate that they be reviewed at least annually. OLAW has decided that the PHS Policy means protocols must be reviewed de novo every 3 years. This can be accomplished by either: (a) assignment of a designated reviewer by the IACUC chair, who then has the authority to approve, ask for modifications, or request full committee review; or (b) full committee review, meaning that a quorum of the IACUC must meet and a majority of those present must vote for approval.

Criteria for approval of a project must address several factors, according to PHS policy. Projects must also adhere to the institution’s Assurance, the AWA and the Guide. Factors include:

a. Avoidance or minimization of pain/distress/discomfort

b. Use of sedation, analgesia or anesthesia for procedures that cause more than momentary or slight pain or distress

c. Euthanasia for animals that would otherwise experience severe or chronic pain or distress that can’t be relieved

d. Appropriate living conditions for the animals, directed by a DVM or other scientist trained in proper care, handling and use of the species

e. Provision of veterinary medical care by a qualified DVM

f. Qualification and training of personnel who conduct procedures on animals

g. Euthanasia methods consistent with the AVMA Panel on Euthanasia

The USDA has a different interpretation of the purpose for the continuing review. They consider it one form of monitoring the use of animals. A standardized form was suggested in 1996{3938} which reveals (a) the status of the project, (b) assurance that there are no current deviations from the approved protocol, and (c) any proposed departures from the protocol in the coming year. Any significant changes that are proposed must be approved by the IACUC prior to being implemented.

Current status includes the funding status, the number of animals that have already been used, and proposed amendments. A progress report is a good idea, but it should not be used as an evaluation "unless there is an indication that animal use is not consistent with good science."

Compliance with current regulations and policies is necessary because some changes may have occurred since the last review. The "state of the art" may also have changed in the animal procedures. One of the 3 Rs may need to be addressed in light of newly-available information.

An ethical cost-benefit analysis should be performed by the IACUC, meaning that any pain, morbidity or mortality must be balanced or outweighed by the potential benefits to human or animal health, advancement of knowledge or the good of society. Rather than taking the role of the NIH study section, however, the IACUC review should be a threshold level of review that documents the continued justification for the use of animals. Without this level of assessment, there is a lack of accountability, particularly in projects that are not funded by PHS or by agencies demanding peer review.{3938}

The continuing form that the University of Kentucky uses conforms to the one proposed as a model by authors from OLAW and USDA{3938}. The first section can usually be produced from the computerized database, containing names, addresses, numbers of animals used and approved, and the pain level and nature of the procedures. The source of funding and any changes in project personnel are listed next. Information in the progress report is used by the IACUC to document the "continued approvability" of the research; for example if 50 dogs have been used and the PI has no progress toward specific aims, then the IACUC could request clarification. Any problems that have been encountered are factored into the risk/benefit process. Alternatives to animal use, alternatives to painful procedures, and assurance that there is no unnecessary duplication are discussed. The PI is asked if there will be any future plans for changes in the approved protocol. A modification or amendment may need to be completed if the proposed changes are significant. The signature of the PI is intended to certify his or her understanding of the responsibilities they assume, the seriousness of the IACUC’s review process, and the importance of justifying the continuation of the research project for another year. The IACUC is held responsible through its designated reviewer.{3938}

The method of IACUC continuing review involves providing every member of the committee with a copy of the completed continuation form. The members must have access to the original protocol if they request it, and any member can request a full review. If no one requests such a review and the designated reviewer procedure has been used, that reviewer must review both the CR and the current protocol. This method satisfies both the USDA and PHS requirements for continuing review. It is recommended, however, that if a project will extend beyond six years, a complete new IACUC protocol be submitted, even though there is no federal requirement for it.{3938}

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