Incomplete submission documents: Please refer to the submission form to ensure you are submitting all required documents for review.The following list reflects common reasons for delays in the IRB review process: Turnaround time is dependent upon complete and accurate submission of study documents, and may be extended if the IRB, upon review, requires further information.Īdditionally, site approval will not be provided until the study has been approved and the informed consent finalized. IRB standard turnaround times apply only when a submission is complete and follow-up activities resolved as appropriate. If you submit the study to a second IRB after disapproval by Advarra, you must notify the other IRB of Advarra’s disapproval. The recipient has the right to submit a written appeal to the IRB. The IRB will issue a formal letter if the study is disapproved.

The Advarra-approved consent will be included with the initial approval documents. Advarra will specify the expiration date in your approval letter. (See 21 CFR 56.109 and FDA’s A Guide to Informed Consent.) Advarra will provide proposed consent revisions to the submitting party.Īpproval for studies and sites will last for the period specified in the approval documentation but will not exceed 1 year (not applicable for studies that do not require continuing review under the revised Common Rule). Advarra’s IRB has the responsibility and authority to determine the adequacy and appropriateness of all the wording in the informed consent form. In the case of an approved, approved with modifications, or deferred decision, the submitting party will be notified.

Disapproved: The IRB cannot approve the study and will issue a formal letter of disapproval stating the basis for its decision.

Deferred: The IRB defers a decision on the study to seek additional information from the PI, sponsor/CRO, or a consultant.Approved with Modifications: The IRB may approve research with modifications, also known as a “Conditional Approval,” with IRB-required restrictions or alterations of specific elements and/or documents.This is not applicable for studies that do not require continuing review under the revised Common Rule. Approved: The IRB approves the study as submitted for up to 1 year.Each study will be given one of the following designations:

Ib insync