On Thursday, April 25, PRIM&R hosted a webinar titled Quality Assurance/Quality Improvement (QA/QI): Study Review from Conception to Completion. Kristen Burt, JD, interim director of the Michigan State University (MSU) Human Research Protection Program (HRPP), and Eunice Yim Newbert, MPH, manager of the Education and Quality Improvement Program (EQuIP) at Boston Children’s Hospital (BCH), participated as speakers, with Amy Davis, JD, MPH, senior director for program and publications at PRIM&R, as moderator.

Following the webinar, we connected with the presenters, and they kindly answered a few more questions that came in from webinar participants, for Ampersand.

Alexandra Shlimovich (AS): What triggered your institution to implement a QI program? Was it proactive, or due to/following an event?

Eunice Newbert (EN): A bit of both—prior to 2003, institutional review board (IRB) analysts initiated periodic QA/QI efforts; implementing a separate program was a proactive measure, but most likely expedited by publicized events from other institutions that emphasized the importance of having a program in place.

Kristen Burt (KB): Similarly, MSU IRB administrators had conducted periodic QA/QI efforts. We modeled our Human Research Liaison program after our Animal Care Program’s Animal Research Liaison program which has been successful.

AS: How do your institutions handle investigators that do not respond to reports?
EN: At BCH, our general policy is that principal investigators (PIs) have one month to respond to reports using the PI Response Form. We try to make it as easy as possible to respond (i.e. checkboxes) and extend the time frame upon request. If a PI does not respond within 30 days and they have not asked for an extension, reminders are sent by email first, then by phone and page. Reminders are also sent to the research coordinator or other contacts. Many of our PIs have requested extensions and some have needed reminders, but to date, all our PIs have eventually submitted their responses. In the event they do not, our policy is to notify the director of research compliance who will then notify the PI, and if there is still no response, the protocol is subject to suspension.

KB: At MSU, responses are typically due within 10 working days. Because the letter is sent by both the human research liaison and the IRB, the IRB manager follows up with investigators who do not respond by the date requested.

AS: I’d like clarification concerning the practice of NOT sharing reports with the IRB. Is this true if you identify protocol deviations or unanticipated problems?
EN: Yes, our reviews and reports are confidential between our office and the PI. The reviews focus not only on identifying deviations/areas for improvement, but on educating PIs about what, how, and to whom each deviation/unanticipated problem should be reported. By not sharing reports directly with the IRB, we find there is ultimately more openness between our office and the PI/staff.

But yes, there is a risk that a PI may not ultimately report the deviation after we leave, though we have not found this to be an issue, as most PIs ask us for assistance in reporting to the IRB and/or list us on the report (e.g. the following deviation was discovered during an EQuIP review).

If the event is significant, especially with immediate increased risk to subjects, we do make an exception—we would report to the director of research compliance, who would then determine what the next steps would be. However, even in these instances, the PI would be informed and would be encouraged to contact them as well.  In the last 10 years, we have only used this option a few times.

KB: MSU does share the reports with the IRB.

AS: How do you audit the IRB itself if your IRB administrator or staff do the auditing? Do you have outside people/customers volunteer to audit the IRB? I think it is important for the IRB to be audited, but I do not feel I can audit myself.
EN: At BCH, since we are separate from the IRB, this has not been an issue in terms of ensuring an unbiased review. However, since we are not part of the IRB, we have to be careful about how the reports are handled; if required, the IRB responds and implements corrective actions as necessary. IRB audit reports are reviewed by the director of research compliance who determines any follow-up action. We have limited access to the electronic IRB system, so if we need additional information (metrics, reports), we need to put in a special request.

KB: Similarly, the MSU Human Research Liaisons are separate from the IRB office.

If you’re interested in learning more about QA/QI and did not have a chance to participate in last week’s webinar, the archive is available for purchase. PRIM&R members can also access additional readings related to this topic on our Knowledge Center.