During a recent monitoring visit to a site, I was witness to an IRB in action. Going in, I knew that this site had multiple issues. Three monitors were at the site during this time as there was an incredible amount of data to review. As I began looking at the data for the study, it was apparent that there were many inconsistencies at this particular site.
While I was at the site, it came to my attention that the site had undergone a recent IRB audit. To the chagrin of the site and the sponsor, the findings of this audit were not in their favor. The IRB took action based on their finding and shut the site to enrollment. Was the IRB justified in its actions? Of course the study staff and sponsor disagreed. But based on the overwhelming documentation of several issues the IRB was carrying out its obligation to protect the subjects enrolled in the studies it represented. According to 21 CFR 56.113, the IRB has the authority to suspend or terminate approval of research that is not being conducted according to its policies. In this case, the site was very delinquent in data entry as well as not having all regulatory requirements up-to-date. Although the site may not have been jeopardizing subject safety on this particular study, they were jeopardizing the quality and legitimacy of the data. Because this site was engaged in multiple research activities, it was likely an assumption of the IRB that if the site was so delinquent in their data entry and regulatory requirements for this particular study, they would also be running all their studies in a similar fashion.
It was interesting to see the various reactions regarding the cessation of enrollment handed down by the IRB. As a monitor, we are often caught in the “cross-fire” of what happens between a sponsor and a site. Both parties were in a panic and were under definitive timelines to correct all violations noted by the IRB.
It is our goal to work with a site to make sure that they are compliant with all aspects of the:
- Investigator Agreement
- Investigational Plan
- IRB policies
But first and foremost, we must ensure that the site is following all Federal Regulations.
It was encouraging to witness an IRB doing exactly what it was established to do. It was also refreshing to know that much of the IRBs information came from well-prepared and detailed monitoring reports. It was from those reports that the IRB saw consistent issues and was propelled to step in and take action. Did the site have a blatant disregard for the IRB policies and Federal Regulations? No, but they did have issues with completing study tasks and completing regulatory requirements in an efficient and timely manner.
We all no doubt have seen sites that struggle with staff change issues, the inability to enter data in a timely manner, and not keeping up with the filing and maintaining of regulatory documents. But do these sites warrant a cease to enrollment by the IRB? You be the judge. Let us know your thoughts and comments.
Photo Credit: bmills