All decisions of the Board will be communicated to the Principal Investigator, Co-PIs, Faculty Advisor, and/or MHC Liaison, as applicable. The Board will either approve a project, request changes to the research protocol so that it can be approved, not approve the project, or delay a decision and inform the Principal Investigator how long it will take to review the proposal. If the project is not approved by the Board, the proposal may be revised and resubmitted, or the decision may be appealed. Board approval of a project is for a specified time period, typically one year. If additional time is needed to complete the project an extension may be requested. If the scope of an approved project changes (for example, if a new experiment is designed and implemented, or if additional human subjects are enrolled in the study), an amendment to the protocol must be submitted for IRB review.
In unusual circumstances the IRB may determine that a project requires review more often than annually and/or it may also determine a project requires verification from other sources other than the investigator that no material changes have occurred since previous IRB review.
After a proposal is underway, it is expected that PIs will promptly report to the Board, and other appropriate institutional officials, any unanticipated problems that pose risks to subjects or others. Further, complaints or questions regarding compliance with this Policy should be directed to the Board. Such reports will lead to an investigation and may be cause for suspension or termination of IRB approval for the project. If a PI needs to make any changes to the research protocol, they should submit an amendment to the IRB outlining the changes. No changes may be initiated until the IRB has approved such changes.
The decision of the Board may be appealed. The Principal Investigator(s) initiates the appeal in writing to the IRB. The PI may submit information pertinent to the proposal and may request a meeting with the Board. The Board may request additional information relevant to the proposal from either the investigator or others. The appeal will be considered by the Board and the decision will be determined by the majority vote of all members of the Board.