The foibles of 'electronic IACUCs' never seem to stop. Perhaps they result from the relative novelty of the concept or because there are no definitive guidelines on what is or is not acceptable. Consider what happened to the Great Eastern University IACUC during an evaluation of the procedures necessary to approve or request modifications to a protocol that was sent for Designated Member review. At Great Eastern, each Designated Reviewer (DR) received an electronic copy of the protocol along with a request to evaluate it. The DRs could communicate with each other, if they chose to, by any means they preferred. The reviewers emailed written comments to a previously selected 'primary reviewer' (PR), who would ensure that all the other reviewers were speaking with unanimity to the Principal Investigator (PI). For example, if all reviewers agreed to approve the study, they would then email this information to the PR. In turn, the PR emailed the IACUC office and informed the IACUC administrator that all reviewers were in agreement to approve the protocol. If there was no agreement to approve the study, then the PR would synthesize the comments of the other reviewers and email the PI (via the IACUC office) with the requested modifications to help secure approval. The other reviewers received a copy of all emails. If, after two interactions with the PI, no agreement could be reached for approving the protocol, then it was automatically sent for Full-Committee review at the next scheduled meeting. Of course, any DR could request Full-Committee review at any point in the process.

The problem facing Great Eastern was not the general process but the specific means of indicating approval. The IACUC Administrator was cautious about any process in which the PR claimed that all DRs approved a protocol, yet there was no documentation from the other reviewers to prove that. After a discussion at an IACUC meeting, one member suggested that the easiest solution was to use the voting feature on the email program. Unfortunately, the school had more than one email program, not all reviewers had the voting feature, and, in any case, they could not agree on the details. Someone then suggested that the PR continue to copy all other DRs on the approval email that he or she sent to the IACUC office. With this approach, members reasoned, any reviewer who believed that he or she did not truly approve a protocol could immediately raise objections. The IACUC Administrator was not happy with that suggestion, because it was the same system they were currently using. Furthermore, because the approval would have already been recorded and any dissent would require that it be negated, it was a process that she did not want to incur. Her preference, under the circumstances, was to have each reviewer send her an email signifying approval. Nevertheless, the Committee voted to maintain the status quo. The rationale was that, not only was it easy to do, but there was also nothing to suggest that it was not in compliance with any existing federal regulation for approving an IACUC protocol by the Designated Member review process.

Do you agree with the actions and logic of the Great Eastern University IACUC?

Response to Protocol Review Scenario: No Vote

Response to Protocol Review Scenario: The More Emails, the Better

Response to Protocol Review Scenario: KISS and Redesign

Response to Protocol Review Scenario: A Word from OLAW and USDA