Consistent with federal regulations, it is the policy of the University of Miami IRB that all human subject research activities (with the exception of 'exempt' studies and studies given multi-year approval by the IRB under IP3R policies) under its jurisdiction be reviewed at least annually with the period appropriate to the degree of risk [45 CFR 46.109(e), 21 CFR 56.109(f)]. This continuing review is additional to the review required for all changes, amendments, serious adverse events and sponsor notifications.
The IRB must determine at the time of initial approval and also at the time of each continuing report whether future continuing reports are to be submitted on an annual basis or whether it is necessary for continuing reports to be submitted more frequently[45 CFR 46.103(b)(4), 21 CFR 56.108(a)]. This is based on whether the risks are of a sufficient magnitude that annual review is inadequate. Although the magnitude of the risks is in part determined by the study procedures, other factors that pertain to the study (e.g., age of participants) may also be considered.
Regulations make no provision for any grace period extending the conduct of research beyond the date that IRB approval expires. Regulations also make no provision for retroactive approval of studies that have expired. Therefore, Principal Investigators have the responsibility to avoid lapses in IRB approval by submitting applications for continuing review and re-approval of a study with sufficient time for review prior to the previously assigned IRB expiration date. If IRB approval is not granted by the expiration date, the research is automatically suspended. Suspension for lapse in IRB approval means that new subjects can no longer be enrolled (see below) and research may not be conducted unless/until approval is granted.
If a study is suspended for lapse in IRB approval, the HSRO shall inform the Principal Investigator of this suspension and of related policies. Included in this policy information shall be the following:
a) It is the responsibility of the Principal Investigator to immediately submit either a continuing report or a final report
b) If IRB approval for continuance of the study is not granted before the close of `the 90th calendar day following the lapse in IRB approval, the study shall be administratively closed unless this closure is waived by the Associate Vice Provost for Human Subject Research.
c) If the Principal Investigator wishes to continue the study, the continuing report should be immediately submitted but in no case should it be received by the HSRO later than 45 calendar days following lapse in IRB approval. This provides the IRB with 45 days to conduct its review prior to the 90th day and administrative closure of the study
Continuing reports and their reviews should be substantive and meaningful with concentration upon the summary of the current state of the research, (number subjects enrolled, number subject withdrawn and the reasons why, amendments, etc.) including whether the risk/benefit ratio has changed, whether there are unanticipated findings involving risks to human subjects and/or others, whether any new information regarding risks and benefits should be provided to subjects and other information the institution and/or IRB deems necessary to conduct a meaningful review. An application to continue an active study shall be reviewed based on approval criteria that are the same as for initial (i.e. new) studies (c.f. Policy 7.3).
If the IRB is conducting continuing review in multi-center trials monitored by a DSMB, DMC, or other similar body or sponsor where relevant data/information may not be readily available to local investigators, the IRB may request/require and rely upon a current statement from the DSMB or sponsor indicating that it has reviewed study-wide adverse events, interim findings, and any recent literature that may be relevant to the research (in lieu of requiring that this information be submitted directly to the IRB and in addition to reports of local, on-site events and unanticipated problems).