After review of a new protocol, the Board will notify the submitting party of its decision about the study. Each study will be given one of the following designations:
* Approval will last for one year unless a shorter period is noted; an "Expiration Date" will be noted in the approval letter. The Board has the authority to revise the submitted consent document(s). (See 21 CFR 56.109 and FDA Information Sheets Frequently Asked Questions, #42.) The Board will fax or email the revisions to the submitting party for review prior to issuing an approved informed consent document and approval letter.
** If the study is Conditionally Approved, On Hold, or is Not Approved for any reason, an explanation will be sent via email, memorandum, or letter. If the Board does not approve the study, the submitting party can appeal the Board's decision in writing within 30 days 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 Frequently Asked Questions, #26.)