All research studies require a continuing renewal (either annually or semi-annually depending on the level of risk to the subject). Studies that have been identified as exempt do not require a continuing renewal. As with initial reviews continuing renewals may be completed either by full board or in an expedited manner. The form to be used for these submissions is the Renewal Application. This form is used for all studies except the Humanitarian Use Device (HUD) and the National Cancer Institute Central Institutional Review Board (NCI CIRB) reviews. The HUD Renewal Application requires different information than that of the Renewal Application and therefore is a separate form. The HUD Renewal Application may be reviewed in an expedited manner. There isn't a Renewal Application for the NCI CIRB studies as the information is obtained through the NCI CIRB. All that the LBH IRB requires is a cover letter explaining what has occurred at a LifeBridge Health facility. All Renewal Submissions require that the SAE & SRs Annual Report (Serious Adverse Events and Safety Reports) be submitted at the time of the continuing renewal (annually or semi-annually) if any have been reported.
If there are any Adverse Events that occurred at a LifeBridge Health facility the Adverse Events Form is required to be completed at the time of the event and resubmitted when the continuing renewal is submitted.