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Revising a Proposal

If a researcher is making substantial revisions to an approved proposal, the entire proposal should be resubmitted.  It is possible that the revisions will require reconsideration of the proposal, either by the expedited process or the full review process.  Sometimes a change in the subject population will necessitate reconsideration of the proposal.  For example, if a researcher decided to add minors to the subject population of an already-approved proposal, the proposal would require review by the convened IRB, even if the original proposal had been approved using the expedited process.

When a researcher is revising an already approved proposal, it is helpful to explain the requested revisions in an email to the IRB Chair and to highlight revisions in the revised proposal.

When submitting a revised proposal, the researcher should take care to update any sections of the proposal that are date sensitive.  For example, recruiting materials or consent forms may have dates in them that need to be refreshed.

When considering revisions to a proposal, the researcher should take into consideration the time frame for which the amendment is being proposed.  If the proposal is near the required renewal date (one year from the previous IRB approval), the researcher should consider submitting the proposal for renewal instead of amendment.

If renewing a proposal, the revised proposal should be transmitted to the IRB Chair via an email which addressed the following questions.

It is possible that the IRB will require additional information to conform with OHRP Guidance on Continuing Review.