After either the office or the committee has reviewed a protocol, the office will send the investigator notice of one of the following outcomes via e-mail from firstname.lastname@example.org:
If the protocol is determined to be Exempt from regulatory review, the researcher will receive an Exemption Notice e-mail. This email is to be regarded as approval to begin research. The protocol will not expire, but changes to the research may require review.
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. The date of approval will be the same as the date of the full committee meeting at which the research was approved.
Contingent Approval (most common result for non-exempt research)
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.
The final letter of approval to the investigator will be dated the same date as the convened committee issued contingent approval, regardless of when the revisions are received and approved. To state this differently, the expiration date will be one year from the date of the full committee meeting at which contingent approval was granted.
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 in a second full meeting. Approval date will be the date of the second full committee meeting at which the approval is granted. The expiration date will be one year from the date of this convened meeting.
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.