C. IRB Decisions

The IRB may take the following actions with respect to submitted research proposals (46.109d):

1. Approval: for a period of not greater than (and possibly less than) one year. After receiving written notification of approval, no further action is required from the investigator before beginning the study. If the study lasts longer than12 months the investigator should inform the IRB chair of the current status of the project, any changes in protocol, and whether any adverse events have occurred.
2. Revise and resubmit: The IRB may request written clarification and/or modification of one or more aspects of the proposal from the investigator. After receiving written notification of a revise and resubmit decision, the investigator should submit a revised application that clarifies the issues involved and/or answers the IRB’s questions, provides the requested documentation or agrees to make requested modifications. The revised and resubmitted proposal will be either approved or disapproved or asked for further modification/clarification if deemed necessary by the IRB.
3. Disapproval: because of the level of risk involved, the proposed research cannot be justified. Written notification of disapproval must include reasons for the decision and offer the investigator an opportunity to respond in person or in writing. When a proposal is disapproved investigators are encouraged to review and resubmit their proposal in accordance with the criteria for acceptance.