Board Response
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 (1) year.
Conditionally Approved: The Board conditionally approves the study based upon the expected responses from the Principal Investigator (PI) and/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 and/or the Principal Investigator (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 authority to require revisions to the submitted Informed Consent(s) (IC[s]). (See 
21 CFR 56.109 and FDA Information Sheets dated September 9, 1998, page 2, question 42 and page 5 “Consent Document.”) Schulman will e-mail suggested revisions to the IC(s) to the submitting party for review and approval prior to issuing an approval letter and approved IC(s).
Approval will last for one year unless a shorter period is noted; an "Expiration Date" will be noted in the approval letter. The Schulman approved IC(s) will be included with the initial study approval documents.
If the study is Disapproved, the Board will issue a formal letter of disapproval. The recipient has the right to appeal, in writing, the Board’s decision within thirty (30) calendar days of receipt of the Board’s decision. If the protocol is submitted to a second IRB after disapproval by Schulman, the subsequent IRB must be notified of the disapproval. (Refer to FDA Information Sheets dated September 9, 1998, page 9, question 26. See also FDA Guidance for Institutional Review Boards, Clinical Investigators and Sponsors.)