Gundersen Health System requires that the Research Committee review all proposed research protocols* to ensure that the study design is scientifically sound. Research Committee usually meets on the first and third Wednesdays of each month. In order to be put on the agenda, the following materials must be submitted to the Institutional Review Board (IRB) Coordinator at least one week before the meeting at which you intend to present your prospective protocol:
- a completed IRB questionnaire
- a copy of the informed consent form (if required)
- the Investigators brochure (if available - usually with clinical research and oncology protocols)
- any additional documentation (e.g., advertising, letters, adverse event reports)
At least one member of the Research Committee is assigned to review the protocol. At the Research Committee meeting, the protocol is summarized and discussed. The Committee then votes to approve, to approve pending changes, or to disapprove. If approved outright, the protocol moves on to Human Subject Committee/IRB review. If approved pending changes, once the changes have been made, the protocol then moves on to Human Subjects Committee/IRB review. The Human Subjects Committee/IRB usually meets the fourth Wednesday of every month.
* except for most oncology protocols, which are reviewed by the Director of Research and then go to IRB review.