IRB Policies and Procedures

Investigators are responsible for using the most current versions of official policies and protocol submittal forms.  Please check the IRB Forms page for the current approved version of all forms.

Subject: Outcome of Proposal Reviews By Convened IRB (Full Review)

The IRB may choose from four different outcomes when reviewing human subjects' protocols at a convened meeting (more than minimal risk, full review protocols):

• Protocol is Granted Approval

The full board chairperson, or designee has approved this protocol, for a period not to exceed one year. The study may commence only upon written notice of approval from the Office of Research Compliance (ORC). While the ORC will send a reminder notice to Principal Investigators (PIs) approximately 2 months prior to protocol expiration, the PI is responsible for conducting research under valid protocols.

• Contingent Approval

The proposed study requires minor changes that must be rectified before final approval is granted. The proposed study may not commence under these conditions. Minor changes may include such things as typographical errors, re-wording of the consent form, or clarification of statistical methods.

The PI is responsible for addressing the concerns of the IRB before final approval can be granted. Once these changes are submitted, the chair or designee may grant final approval if the changes are satisfactory. If the IRB requests are not adequately addressed within 60 days, the protocol may be administratively withdrawn and it must be resubmitted as a new protocol for full IRB review. For full review protocols, the PI must attend the IRB meeting.

• Protocol is Tabled

This protocol is in need of major revisions – usually needing additional information or clarification of significant issues. This study may not commence until IRB approval has been granted in writing. The ORC will notify the PI in writing (letter or e-mail) indicating the issues being raised. The PI is responsible for addressing the concerns of the IRB before contingent or final approval can be granted. These changes must be submitted in writing to the Office of Research Compliance. If the IRB requests are not adequately addressed within 60 days, the protocol may be administratively withdrawn and it must be resubmitted as a new protocol for full IRB review.

• Protocol is Disapproved

  A protocol will be disapproved by the IRB for any of the following reasons:

  • the protocol lacks key information to evaluate its objectives, methods, endpoints, benefits, or risks;
    
  • protection of the research subjects is not addressed
    
  • the risks to the research subjects appear to outweigh the benefits of the research study; or
    
  • the protocol lacks merit or is designed such that the methodology is unlikely to yield useful data toward meeting the stated objectives.
    
    
  The ORC will notify the PI in writing, outlining the reasons for rejection. The protocol must be revised and resubmitted as a new protocol.