Protocol Review

Discussion Forum

Current Discussion


Innovative, But Not Compliant


To the Editor:

The NIH Office of Laboratory Animal Welfare (OLAW) and USDA/APHIS, Animal Care (AC) have reviewed the February 2001 Lab Animal article, "An Innovative IACUC Protocol System" by Katie Traxel [30(2):32-35]. We recognize the many positive innovative and burden-reducing elements in the system (for example, the Investigator's Web). We also recognize that there are circumstances under which the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy) and/or the Animal Welfare Act Regulations (AWAR) do not apply. Nevertheless, both OLAW and AC find elements of the system, as described, to be noncompliant with the federal requirements for protocol review.

Because many readers of Lab Animal are subject to these federal requirements, we believe that clarification of these inconsistencies is essential. Relatively minor modifications of the described system could be made to make it fully compliant.

Under the PHS Policy and AWAR there are only two protocol review modelsfull-committee review and designated-reviewer review. The "Innovative IACUC Protocol System" (IS) appears to be a hybrid of these two review methods, and fails to fully satisfy the requirements of either system.

The IS does not meet the full committee review model because full review must occur in real-time and with a convened quorum of the IACUC participating (see ILAR Journal 37(4):190-192; /guidance/articles/ilar95.htm).

Under the designated-reviewer model, all members must be given the opportunity to call for full-committee review of a given protocol. This step appears to have been omitted in the IS. Designated reviewer(s) may only "approve, require modifications in (to secure approval), or request full committee review" Designated reviewers do not vote. If the IS is attempting to follow the designated reviewer model, with all members being treated as designated reviewers, then every member must respond with one of the above three options. Under these circumstances, a quorum of designated reviewers approving the protocol is not sufficient and approval by all is required. If modification occurs at any stage of the review, all designated reviewers must see and approve the changes.

Other elements of the article require further clarification to determine whether they are compliant. It is unclear what role the IACUC Coordinator has in editing the IACUCs comments. Modification of the official record of review would seem to be highly inappropriate. Regarding the final approval role of the Coordinator, if it is simply administrative ("clicking the button"), then we recommend it be so stated.

The statement that the Coordinator may assign the protocol to veterinarians or safety personnel implies that these individuals might not be involved otherwise, and that the Coordinator would be referring the protocol to a veterinarian other than the one on the IACUC. Elsewhere, it is stated that protocols are not designated to specific reviewers. This appears to be contradictory.

In order to modify the IS to conform with federal requirements, it is first necessary to clearly recognize which mode of review (full or designated) is being emulated. The appropriate procedures, in the required sequence, can then be designed into the system. In this case, such modifications would appear to be minor and would not substantially diminish the intended benefits of the IS. We would be pleased to collaborate in the design of model electronic protocol review systems that are consistent with PHS/USDA requirements.

Nelson L. Garnett, DVM, Director, NIH, Office of Laboratory Animal Welfare W. Ron DeHaven, DVM, Deputy Administrator, USDA, APHIS, Animal Care

Editor's note: As stated above, the article in question was meant to showcase how one facility is attempting to reduce time and effort through an innovative online system. We regret that editing changes might have created the impression that the system is fully compliant, and appreciate that OLAW and USDA/APHIS took this opportunity to clarify federal policy and regulation regarding this important matter.

Director, Office of Laboratory Animal Welfare
Office of Extramural Research,
Office of the Director, National Institutes of Health
RKL 1, Suite 360
6705 Rockledge Dr .
Bethesda , MD 20892-7982
(For express or hand-delivered mail use zip code 20817)
Telephone (301) 496-7163

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