All research studies that do not meet the criteria for Expedited Review or Exemption from IRB Review as listed below will be reviewed by a full board at a convened IRB meeting with a quorum present. Principal investigators are encouraged to attend meetings at which their proposals are being presented to answer any questions or concerns that may arise.
The actions taken by the IRB will be provided to investigator within ten days after the convened meeting at which the specific research application was discussed. IRB actions for initial or continuing review of research will include the following:
- Approved with no changes. The research may proceed once the approval letter and, if applicable, the consent form with the IRB signature stamp is received.
- Approved with minor changes that are clearly delineated by the IRB so the investigator may simply concur with the IRB’s stipulations. The research may proceed after the required changes are verified and the project is approved by the IRB Chair.
- Tabled. Tabled research applications are approvable but require substantive changes or additional substantive information that must be reviewed at a convened meeting of the IRB. The research may proceed only after the convened IRB meeting has reviewed and approved the required changes to the research or the information provided.
- Disapproved. The IRB has determined that the research cannot be conducted by investigator at Bridgeport Hospital.
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