IRB Review & Approval

 

The concluding step in the approval of a protocol submission is the approval by the Institution Review Board (IRB).  Approval is contingent upon approval of the IRB and all relevant ancillary committees. 

 

The IRB review process involves one or many board meetings, depending on the path that the HRO determines the protocol should take. The IRB board status is reported back to the HRO, based on the Board’s action, the HRO will approve the protocol, send the protocol back to the PI for modifications (requires modification) or to answer questions / provide clarifications (defer), or disapprove the protocol.

 

Expedited Review Process

In this business scenario, the application has been submitted to the HRO and the protocol office has determined, based on the nature of the study and the associated risk level, that the protocol meets the requirements for an expedited review.   An expedited review allows for review by a single IRB Chairperson or designee, as opposed to a full board of reviewers.  Protocols may be assigned to a specific IRB Chairperson or designee based on their workload balance and level of expertise.

 

Full Board Review Process

In this business scenario, the application has been submitted to the HRO and the protocol office has determined, based on the nature of the study and the associated risk level, that the protocol requires full board IRB review.  A full board review requires the review from a board of individuals.  Protocols are assigned to a specific full board review based on the availability of upcoming meetings.

 

The full board will make a determination of the next steps based on their review of the protocol.  They can take many actions including disapprove, approve, hold, defer or requires modification.