Dr. Romansky's protocol essentially expired, and therefore, in the eyes of the IACUC, the study came to an end. By setting a historic precedent allowing Romansky to continue activities after his protocol has expired, Great Eastern University has failed to comply with federal regulations. According to federal regulations1, Ms. Gates was working under the correct assumption and acted appropriately when she notified Dr. Romansky to cease and desist pending renewal of the expired protocol. Furthermore, while Ms. Gates's letter to Romansky on behalf of the IACUC interrupted the unapproved activities, it does not constitute an official suspension of activities as defined in the Animal Welfare Regulations2, which requires a review and decision by a quorum of the IACUC. The protocol simply expired.

While there is no federal regulation that prevents Romansky from requesting to add research animals that were assigned to the expired protocol to an approved one, the IACUC must determine whether or not Romansky's request constitutes a minor or major amendment to the protocol. Major changes typically include an increase in the number of animals or number of studies or treatment groups. If there is no increase in the number of animals used or procedures performed on each animal, and there is no change in the objectives of the proposed study, then Romansky's request may be considered a minor change by the IACUC. However, the additional treatment group may very well change the objectives of the study, and therefore will likely be considered a major change. This amendment will require review and approval by the IACUC prior to implementation3. The criteria for categorizing a change to activities proposed to an approved protocol must be delineated in the PHS Assurance for Great Eastern University, and should be in place prior to any further consideration of Romansky's request.

Provided he can supply adequate justification for the change in objectives, requiring an additional treatment group, while not illegal, may be considered unethical. Considering the ethical nature of Romansky's request, it appears to be one of convenience. The IACUC must determine that the changes in objectives are justified in the review process. Given the necessity of an IACUC review process, whether he submits his renewal or submits an amendment to an existing protocol, he has not saved time. Romansky has actually delayed the process by fighting the system in the first place. Covelli should advise Dr. Romansky of these facts and encourage him to comply, thus shortening the amount of time that the study is halted. Importantly, Dr. Romansky must be reminded that changes to existing protocols or renewal of expired protocols must be approved prior to implementation or the study will be suspended, and the suspension will be reported to regulatory and governmental funding agencies4.