Following review of a new study submission, the Board will notify the submitting party of its decision.
Each study will be given one of the following designations:
Approved: The Board approves the study as submitted for no longer than one year.
Conditionally Approved: The Board conditionally approves the study based upon the expected responses from the Principal Investigator (PI) or Sponsor/CRO to the Board’s request for additional information.
On Hold: The Board defers a decision on the study in order to seek information or opinions from consultants, the Sponsor/CRO, or the PI.
Disapproved: The Board cannot approve study and will issue a formal letter of disapproval stating the basis for its decision.
In the case of an Approved, Conditionally Approved, or On Hold decision, the submitting party will be notified via an e-mailed Study Status Notification.
The Board has the responsibility and authority to determine the adequacy and appropriateness of all of the wording in the consent. (See 21 CFR 56.109 and FDA’s A Guide to Informed Consent.) Schulman will either e-mail proposed consent revisions to the submitting party prior to issuing an approval letter and final consent, or approve the consent as revised by the Board.
Approval for studies and sites will last for the period specified in the approval documentation, but will not exceed one year. We will specify the expiration date in your approval letter. The Schulman approved consent will be included with the initial approval documents.
The Board will issue a formal letter if the study is disapproved. The recipient has the right to submit a written appeal to the Board within 30 calendar days of receiving the letter. See Appealing a Board Decision for more information. If you submit the study to a second IRB after disapproval by Schulman, you must notify the other IRB of Schulman’s disapproval. (Refer to FDA’s Institutional Review Boards Frequently Asked Questions, question 26. See also FDA’s Sponsor – Investigator – IRB Interrelationship.)