2nd Edition 2002 arena/olaw institutional Animal Care and Use Committee Guidebook

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Protocol Review Procedures

The procedural review requirements of the PHS Policy or the AWRs take precedence even though they may differ from some commonly used par-liamentary procedures. Institutions may develop their own meeting pro-cedures as long as the procedures do not contradict or are not inconsistent with the requirements of the PHS Policy or the AWRs.

If a proposed protocol may cause more than momentary or slight pain or distress to animals, the AWRs specifically require investigators to consult with the AV or his or her designee during protocol development. Some committees find it helpful to assign a member a given proposal for in-depth review and liaison with the investigator prior to committee review. Still other committees assign this task to professional IACUC staff. The investigator may choose to consult with these individuals and request a preliminary review before formally submitting a protocol.
The PHS Policy and AWRs recognize two methods of protocol review: full committee review and designated member review. The following pertains to review of initial protocols as well as to review of proposed significant changes in previously approved protocols.

  • Full committee review

Full committee review of protocols requires a convened meeting of a quorum of the IACUC members. The PHS Policy and AWRs are explicit that proposals reviewed by the full committee must receive the approval vote of a majority (>50%) of the quorum present in order receive approval (see A.2. Quorum requirements.)

Some committees designate a specific member or members to serve as primary or primary and secondary reviewers. These individuals, usually chosen for their expertise or familiarity with a given topic, are responsible for an in-depth review of a proposal and sometimes take responsibility for describing the proposal to the full committee and answering questions about the proposal during review by the Committee. Primary and secondary reviewers can also take the initiative to contact the investigator prior to the meeting for clarifications, additional information, or in anticipation of questions the IACUC may raise. The use of primary

reviewers facilitates full committee review by distributing the workload among IACUC members so that each member has responsibility for in-depth review of only a portion of the proposals the IACUC will review. It differs from designated member review (see below), which invests authority to approve a proposal in one or more members.

Review of proposals by the full committee method invokes a deliberative process, and the PHS Policy and AWRs require that minutes of IACUC meetings reflect committee deliber-ations. Minutes should include records of attendance, a sum-mary of the issues discussed and the resolution of issues, and the results of IACUC votes on protocols.
Participation by investigators in meetings in which their pro-posal is being reviewed is not addressed by either the PHS Policy or the AWRs. The participation of the investigator can facilitate the review in a number of ways. Obviously, questions can be addressed as they are raised rather than after the meeting, allowing the review process to proceed rather than be interrupted for this exchange of information. Another benefit is the opportunity for the investigator to give a broad overview of how the proposal under review fits into the larger research picture, thus providing additional information regarding the justification and scientific merit. Invariably, both the investigator and the IACUC benefit from such an ex-change. The greatest deterrents to participation by investigators in the IACUC meeting are that it may make the meeting last longer, and problems arise if this is an adversarial rather than collegial exchange of information. In any event, the investigator should leave before the final committee deliberations and if he or she is a committee member may not contribute to a quorum or vote.

  • Designated member review

To utilize designated member review, each IACUC member must be provided with at least a list of the proposed research protocols or proposed significant changes to previously approved protocols prior to the review. Most committees provide members with an abstract of proposals; in all cases, written descriptions of the research proposals must be made available to IACUC members upon request. All members

must have the opportunity to request full committee review of any proposal. If no member requests full committee review, the Chair designates one or more qualified members to review the proposal (or proposed amendment). These designated members have authority to approve, require modifications in (to secure approval), or request full committee review.
IACUCs with a large volume of proposals to be reviewed find the designated member review option may allow for efficient management of the IACUC workload as well as timely turn-around of requests from investigators for protocol review. Some committees prefer to reserve the designated member review option for certain classes of protocols or amendments; conversely, some IACUCs have devised categories of research activities that must be reviewed by the full committee, e.g., nonhuman primate studies, survival surgeries, etc. If the designated member review method is to be used by PHS-supported institutions then the IACUC's specific procedures for using the method should be described in its PHS Assurance.

Categories of IACUC Actions

As a result of their review of protocols, an IACUC may take one of several different actions depending upon the findings of the committee: approval, modifications required to secure approval, and withhold approval. An IACUC may also defer or table review if necessary.

The PHS Policy and AWRs require the IACUC to notify investigators and the institution in writing of its decision to approve or withhold approval, or of modifications required to secure approval. If approval is withheld the IACUC must provide the reasons for its decision and give the investigator an opportunity to respond.

  • Approval

When the IACUC has determined that all review criteria, based on the PHS Policy and AWRs, have been adequately addressed by the investigator, the IACUC may approve the project, thus providing the investigator permission to perform the experiments or procedures as described.

An IACUC-approved proposal may be subject to further appropriate review and approval by institutional officials due

to financial, policy, facility, or other institutional or adminis-trative considerations. However, those officials may not approve an activity if it has not been approved by the IACUC.

  • Modifications required to secure approval

An IACUC may require modifications to the protocol before granting approval. If the IACUC determines that a protocol is approvable contingent upon receipt of a very specific modification (e.g., receipt of assurance that the procedure will be conducted in a fume hood), or clarification of a specific point, the IACUC may handle these modifications or clarifications as administrative details that an individual, such as the Chair, could verify.

If a study is unusually complex or involves untried or contro-versial procedures the IACUC may wish to impose restrictions, (e.g., approval for the use of a limited number of animals as a pilot study with a written report of interim results, or close monitoring by veterinary or other qualified personnel.) If such modifications represent significant departures the IACUC can ask the investigator to revise the protocol to reflect the modifications imposed by the IACUC.
If the protocol is missing substantive information necessary for the IACUC to make a judgment, or the IACUC requires extensive or multiple modifications, then the IACUC can require that the protocol be revised and resubmitted. If the IACUC wishes to shift to the designated reviewer mode for the approval of the modified protocol, that shift should be explicitly noted in the minutes and the requirements for designated review must be met.
IACUCs sometimes use terms such as "conditional appro-val," "provisional approval" or "approved pending clarifica-tion." Anything less than full IACUC approval via one of the accepted methods described above is not adequate for initiation of animal activities or for submission of an IACUC approval date to PHS in conjunction with a grant application. Therefore, OLAW and USDA recommend that IACUCs either avoid using these terms, or describe them (e.g., in IACUC minutes, Assurance documents, etc.) in sufficient detail to be fully understood.

Withhold approval
When the IACUC determines that a proposal has not ade-quately addressed all of the requirements of the PHS Policy and AWRs as applicable, the committee may withhold approval. A designated reviewer may not withhold appro-val; this action may only be taken if the review is conducted using the full committee method of review.
As indicated above, a higher institutional authority may not administratively overrule an IACUC decision to withhold approval of a proposal.

If the protocol requires clarification in order for the IACUC to make a judgment, committee members with certain expertise are not present, the IACUC wishes to seek external consul-tation, or any of a number of other reasons prevent the IACUC from conducting its review, then the IACUC may wish to defer or table review. Good communication between the IACUC and the investigator can ensure that this action is needed infrequently. However, should it be necessary, the investigator should be informed so that he or she can respond or plan accordingly.

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