Action on any of the options listed below requires a majority vote of the quorum. Action to require revision of an application may be initiated by any reviewing IRB member upon initial review of an application if the Board member determines that such revisions are (a) needed to determine the level of risk to participants and/or (b) needed to complete an application.
Actions Regarding Approval of Applications:
- Approve application as submitted.
- Approve pending changes. The IRB determines the changes that are required for approval and these are communicated in writing to the PI. The PI submits the changes to the IRB Chairperson. The Chairperson (or designated IRB member) may approve the application on behalf of the IRB if the changes meet the requirements described in the written communication with the PI.
- Require modifications and resubmission to the IRB.
- Request consultant review. At any point, the IRB Chairperson or the IRB may determine that someone not on the IRB with relevant expertise needs to be consulted to address research issues, as they relate to the protection of human research participants. The consultant shall not be involved in the proposed project. In some cases, the identity of the consultant may need to remain confidential if there is any question that there could be problems should the PI know the identity of the consultant.
- Disapprove the application as submitted: When a project is disapproved, the PI may revise the proposal in accordance with IRB recommendations; discuss the project with the IRB Chairperson or respond in writing; or withdraw the proposal application.
Additional Actions and Authority of the IRB:
- Consult with the OSRP concerning matters of development and implementation of policies and procedures regarding the protection of human participants and the training of University employees and students regarding the conduct of research involving human participants.
- Monitor projects having received a full Board review for adherence to an approved protocol.
Suspend or terminate approval of research that is not being conducted in accordance with Federal Regulations and University policy or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval shall include a written statement of the reasons for the IRB’s action and shall be reported promptly to the OSRP, the PI’s Department Head, and the funding agency (if applicable).