During a recent monitoring visit, I came across a scenario that challenged my efforts to ensure compliance with the Institutional Review Board’s (IRB) policies. For background, an East Coast University/Hospital has a new area of outsourcing for the studies that are being conducted at their institution. The local IRB reviews all Phase I/ II studies and all studies that are funded by the National Institutes of Health (NIH). Phase III and IV trials are outsourced to a central IRB.
This IRB, like most local IRBs, is completely inundated with the amount of study applications, serious adverse events, protocol deviations and amendments that are being submitted by the University/Hospital’s Principal Investigators. Anyone involved in the IRB review process understands the amount of time and effort exhausted even for a minor submission (for example, an addition of a Sub-Investigator). Additionally, there is an expense associated with all IRB related activities, and some budgets do not account for administrative costs of several protocol amendment submissions and other IRB-related activities. Therefore, at this particular IRB, Phase III and IV studies are handed over to a central IRB. The study coordinator noted that sponsors will foot the bill for these studies, which can often be $2500 for an initial submission! As the monitor, I noted that this “handover” is not haphazard, however.
First, the coordinator must begin the initial study submission to the central IRB. Next, the coordinator submits the same submission packet to the local IRB. This is not a small matter. The packet includes:
- Protocol and protocol summary
- Informed Consent Form (ICF) template
- Instructions For Use (IFU)
- Regulatory approvals
- CVs, Medical Licenses and Financial Disclosures of study staff
- Subject recruitment materials
The local IRB reviews the submission and then hands over responsibility of future IRB related activity to the central IRB. Only after, interestingly enough, the sponsor pays for the administrative cost of the initial submission. The IRB requires the budgeted submission cost before it will turn over responsibility to the central IRB (since sometimes the payment is not received until after the first patients are enrolled). The study coordinator picks up the task of communicating with the central IRB after the initial submission, and continues all future activities with the central IRB.
Although IRB oversight is provided by the central IRB, it was clear that the local IRB made significant contributions to getting the study approved. The question while monitoring at this site was the following: Whose reporting policies does the site adhere to? The extremely liberal central IRB’s policy only requires Serious Adverse Events (SAEs) that are unexpected and related to the study procedure/device or the comparatively conservative local IRB’s policies, which may include reporting all SAEs regardless of relationship or relatedness?
Have you worked with a combination local and central IRB? How did you answer this question? Please share your experiences with us!
Photo Credit: Horia Varlan