Email and electronic communications, in general, are transforming the way the world does business. Therefore, it should come as no surprise that many IACUCs are using electronic communications for part or all of the protocol review process. The Great Eastern University IACUC was using email to expedite its work, but mostly to have a veterinarian 'pre-review' the protocol so as to find and correct significant problems before it went to the full Committee for general review at a convened meeting. That system worked well, but the continued increase in the number of protocols discussed at each meeting led the researchers on the IACUC to demand that the entire protocol review process be handled electronically. They were all on the same campus, but it seemed to them that they were spending too much time at IACUC meetings. The Chair of the IACUC was a researcher and saw a decreased workload for himself, so he strongly favored the idea. The veterinarian was skeptical, thinking that the entire process might become perfunctory, but he was willing to try it. The other members did not object.
The process they agreed upon was not to have Designated Member review, but to continue with the veterinarian's pre-review, and then to have the corrected protocol sent electronically to all IACUC members. Two members would serve as the primary and secondary reviewers who had the obligation of reading all protocols and commenting on them, while other members were only encouraged to do so. Members sent any comments to the IACUC office, which in turn forwarded them to all the members. Thus, all members were able to see and respond to any other person's comments if they chose to do so. The process continued until the primary reviewer considered that the Committee had no further significant comments, and advised the IACUC office to collate any requested clarifications or modifications and send them directly to the investigator for final consideration and corrections. The full Committee then received the revised protocol from the investigator. They then voted electronically to approve, approve if specific modifications were made, or withhold approval. Committee members emailed their votes to the IACUC office, where they were tallied.
The process seemed to work reasonably well; nevertheless, it was questioned during an AAALAC site visit. The site visitors wanted to know how the IACUC complied with the PHS Policy and Animal Welfare Act (AWA) regulation, which called for approval “at a convened meeting of a quorum of the IACUC and with the approval vote of a majority of the quorum present.” The Chair of the IACUC responded that all members had the opportunity to vote, and no approval could occur without the approval of a majority of all the IACUC members. That, he said, was comparable to having a quorum present. Still, it did not seem quite right to the site visitors, because they suspected that some, perhaps many protocols, were receiving little if any review by most of the IACUC members, who just arbitrarily voted to approve any protocol that the primary reviewer had concluded was ready for a vote. On the other hand, they reasoned, this situation wasn't much different from what happens with many IACUC meetings attended by all members. However, the issue of needing a convened meeting was still bothersome.
Was Great Eastern University acting appropriately with the methods they chose to use for protocol review, or were the AAALAC site visitors on the right track with their concerns?