After either the IRB has reviewed a protocol, the ORSP will send the investigator notice of one of the following outcomes:
- Full Approval
When the research is approved, the IRB will send an email with approval letter attached to the investigator. The letter will state the approval date, expiration date and terms of approval. IRB approval may be given for a maximum of one year. If a research project will last more than a year, the investigator may request continuation review before the approval expires.
- Contingent Approval (most common result)
A contingent approval is awarded if there are minor correctable problems found in the protocol and related documents. The investigator will receive a letter from the IRB office requesting the revisions or clarifications necessary for full approval. Research may not commence until the revisions have been addressed and accepted by the IRB chair, and a letter of approval has been issued to the investigator.
Approval of this type of protocol lasts one year from the date that contingent approval was given, regardless of when the revisions are received and approved. Again, continuation review should be requested before the approval expires if needed.
A protocol is deferred if there are substantive issues that require correction; major clarifications needed on risk or procedures; or information needed to continue review. Research activity may not commence until the investigator has provided the information clarifications or revisions, and the IRB committee has reviewed and approved the response.
If the research is disapproved, the investigator may not conduct the proposed research. However, the IRB will provide the investigator with the reason for its decision by email. The investigator must have the opportunity to respond to the committee in writing or in person. The investigator may resubmit a protocol to the IRB for review if the reasons given for disapproval can be corrected and addressed. Please note that disapproval is very rare.