This scenario invites deliberation of core issues brought forth by Wilson in the three assertions that comprised his formal request to the IACUC: (i) the justification of animal numbers, (ii) the function of Designated Member Review (DMR) and (iii) the right of an IACUC member to demand the re-review of an approved protocol.

Wilson disputed the number of animals requested by Ross because she had a previous protocol that utilized a similar assay but required only half as many animals. Institutions using animals regulated by the Animal Welfare Act and Animal Welfare Regulations1 and submitting applications to the Public Health Service (PHS) are obligated to assure that proposals contain a rationale for the number of animals to be used2. The direct application of animal numbers or group sizes from one protocol to another is inappropriate without giving consideration to the specifics of study design and statistics. Perhaps Ross' earlier protocol was a pilot study designed to arrive at a variance for application to future projects. Armed with that information, Ross might have requested additional animals in the current protocol to achieve statistical significance using that assay. Regardless, the reviewers were satisfied that the justification for the number of animals was scientifically sound, and their approval should be upheld.

Regarding Wilson's challenge of DMR approval, we presume that the IACUC acted within the procedures outlined in Great Eastern University's Assurance and that all IACUC members were given sufficient time to receive materials and request a full committee review2. The fact that Wilson's travel prevented him from responding in a timely manner is unfortunate, but his failure to respond within the consideration period given may be interpreted as approval to use DMR for review.

Wilson also requested a re-review of Ross' protocol, claiming that this was within his rights as an IACUC member. Indeed, the IACUC's involvement with a project does not end with protocol approval. Both the Animal Welfare Act and Animal Welfare Regulations1 and the PHS Policy on Humane Care and Use of Laboratory Animals3 require the IACUC to carry out continuing review of a protocol no less than annually1. Under certain circumstances, such as in situations of protocol non-compliance, the IACUC is also obliged to conduct an investigation. If warranted, the IACUC may convene to re-review the protocol and take appropriate action1. In this case, however, there is no such basis for Wilson's request for re-review of the protocol. Furthermore, granting his request would supplant the authority of the IACUC and DMR process. At the time of annual renewal, Wilson would be free to review Ross' progress report and express any reservations at that time.

In conclusion, we believe that Covelli acted within the word and spirit of existing federal regulations.

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