Essentials for IACUC Members - Refresher Course

Case Study 1.  Investigations of non-compliance

Dr. M. Bigdolah is the PI on a multimillion dollar project at Big Time University (BTU), sponsored by medical device maker Northeast Medical Equipment Inc. (NMEI), to test new vascular stents developed by NMEI, first in dogs and then in non-human primates . The company, NMEI, was started by 3 faculty members in the BTU Department of Surgery, including the PI and the Chair of the Department (Dr. Lyons). The University and the 3 faculty members jointly own patents on several devices including the one under study. The arrangement was reviewed by the Technology Transfer Office and by the CoI committee and they concur that potential financial conflicts of interest are well managed.

Dr. Bigdolah's protocol calls for the creation of an aortic aneurism and then, at predetermined times after creating the pathology, the stent is implanted through the femoral artery using a minimally invasive procedure. Dr. Bigdolah's team has a great amount of experience with the procedures in dogs and humans.

During a period of several weeks the team has problems implanting the new stent device by the femoral artery route. Dr. Bigdolah is busy with his patient load and with his commitments to presenting the group's data at various conferences sponsored by NMEI. Dr. Kutter, a co-investigator on the project decides that due to the limitations of the dog model, another method must be used for the placement of the stents. Because this is initially a proof of principle or pilot study to show the efficacy of the stent, Dr. Kutter decides that for the next 4 animals, they will implement a major survival surgery procedure to implant the stent.

A Major Survival Surgery to place the stent was conducted with the next 3 dogs.

Is it permissible for the team to modify the conduct of the protocol in this way?      No  |  Yes  Please select one to continue: