How (and When) Will I know that a Protocol has been Approved?
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Once a protocol has been reviewed and approved, a formal written notice of approval will be sent to the Principal Investigator.
A written “Board Action” will be sent to the Principal, Investigator as soon as possible after the convened IRB meeting, describing the Board’s findings and determination, along with description of the needed changes (if any). In most cases, this notice will be sent within 48 hrs of the convened meeting.
If the protocol is APPROVED “as is”:
If the protocol was APPROVED “as is”, the Principal Investigator will receive a Board Action notice from the IRB Chair specifying the terms and conditions of the approval, as well as the continuing review period (6 months, 12 months). The project is then ready for initiation.
If the protocol was Approved (but contingent on minor modifications):
In some cases, the Board, during its review, may require changes or clarifications to elements of a protocol, consent document, or other project related materials. This happens when the protocol is APPROVED contingent on specific minor modifications. The Principal Investigator makes the necessary changes and re-submits the revised protocol for subsequent review by the IRB Chair. If all changes are appropriate, the IRB Chair may then Approve the protocol as previously authorized by the convened Board that had contingently approved the protocol.
If the protocol was DEFERRED (requiring substantive modifications):
In other cases, the Board, during its review, may require significant or numerous changes or clarifications to elements of a protocol, consent document, or other project related materials. Under these circumstances, the protocol cannot be approved, even on a contingent basis. The protocol is “tabled” or Deferred for major revision and re-submission to the Full Board. This happens when significant or numerous changes are required for the consent form, or the protocol itself, to address issues of risk, scientific merit, safety and clarity for the subjects likely to be involved in a project.
For DEFERRED protocols, the Principal Investigator makes the necessary changes and re-submits the revised protocol for subsequent review. In this case, however, the review must be conducted by a convened IRB, and not only the IRB Chair. For that reason, investigators are strongly encouraged to appropriately respond to the Board Action notice specifying needed changes, and be able to submit a properly corrected protocol application in time for the next IRB meeting deadline. Investigators are also encouraged to seek additional guidance from ORC – IRB administrative staff managing that protocol to assist them in preparation of an appropriate and timely re-submission to avoid subsequent deferrals or delays.
This page was last modified on December 22, 2017