Suggestions to Bring Electronic Protocol System into Compliance

To the Editor:

The NIH Office of Laboratory Animal Welfare (OLAW) and USDA/APHIS, Animal Care (AC) have reviewed the September 2001 Contemporary Topics article, "A Novel Interactive Electronic Protocol System" by Lewis, et al [40(5): 14-16]. We recognize the many positive innovative and burden-reducing elements in the system. 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. Relatively minor modifications of the described system could be made to make it fully compliant and consistent with previous published guidance on the subject (see Lab Animal letter to the editor March 2001 http://www.labanimal.com/letters/garnett.html).

Because many readers of Contemporary Topics are subject to these federal requirements, we believe that clarification of these inconsistencies is essential. PHS-Assured institutions are reminded that failure to comply with PHS Policy IACUC review provisions could result in invalidation of IACUC approvals and constitute violation of the terms and conditions of PHS awards.

Under the PHS Policy and AWAR there are only two protocol review models: full-committee review and designated-member review. The "Novel Interactive Electronic Protocol System" (NIEPS) appears to be a hybrid of these two review methods, and fails to fully satisfy the requirements of either system.

The NIEPS 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). Further, the NIEPS article states that any member may call for full review, suggesting that the NIEPS itself is not intended to emulate the full review mode.

In the designated-member mode, reviewer(s) may only "approve, require modifications in (to secure approval), or request full committee review." Designated reviewers technically do not "vote." If the NIEPS 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 modifications occur at any stage of the review, all designated reviewers must see and approve them; otherwise reviewers could be approving substantially different protocols. In the NIEPS, it appears possible for a majority of members to approve the proposal early in the 5-day review period, preempting questions that might have been raised by other members later in the 5-day period.

In order to modify the NIEPS to conform to 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 (as described in PHS Policy and AWAR) 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.

For example, the NIEPS could meet the procedural requirements of the designated member mode if, instead of an online vote, an official designated reviewer, selected by the Chair, made the final approval decision. That person's approval would be informed by all of the electronic discussions and modifications that occurred. Alternatively, if all members are considered designated reviewers, and all have had the opportunity to call for full review, the approval of the final version of the protocol by all, without further modification, would satisfy federal procedural requirements.

Although technologically more difficult, the functional equivalent of a convened quorum in the full committee mode might be emulated through real-time, interactive, video-conferencing added to the end of the described electronic review process. This possibility, under exceptional circumstances, has been alluded to in the previously referenced ILAR publication.

We would be pleased to collaborate with institutions and organizations in the design of model electronic protocol review systems that are consistent with PHS/USDA requirements.

Nelson Garnett, DVM, Director, NIH, Office of Laboratory Animal Welfare

Chester Gipson, DVM, Acting Deputy Administrator, USDA, APHIS, Animal Care