Approvals of protocols are for one year at a time. Protocols can be renewed up to a total of five years maximum. Once a protocol has reached the five-year maximum number of approvals, a new application must be submitted and approved prior to the sixth year if that protocol is still ongoing.
NOTE: The IRB and investigators must plan ahead to meet required continuing review dates. If an investigator has failed to provide continuing review information to the IRB or the IRB has not reviewed and approved a research study by the continuing review date specified by the IRB, the research must stop. Enrollment of new subjects cannot occur after the expiration of IRB approval.
The Fort Peck IRB Administrator will send out renewal forms approximately one (1) month prior to the renewal date. The approval number assigned to the protocol is indicated in brackets after the title of the protocol. The approval number is usually two letters (PI's initials) followed by six numbers, which is the date the protocol was approved. So, if John Doe's protocol was approved on October 24, 2008, his assigned approval number would be JD102408. This way you know when your renewals are due. If you know that your protocol is nearing the expiration date and you have not received the renewals forms from our office, please contact our office as soon as possible so that your approval does not lapse. It is ultimately the responsibility of the PI to maintain compliance with these regulations. There is a 30-day window in which protocols can be renewed (not more than 30 days prior to renewal date and absolutely not after the renewal date).
Click here here for OHRP guidance documents for renewals.
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