Have you ever heard the phrase “proper preparation prevents poor performance?” That refrain echoed in my mind as I enjoyed three of the many 2021 Advancing Ethical Research Virtual Conference (AER21) sessions. These sessions featured guidance for IRB professionals for implementing OHRP (45 CFR 46) and FDA (21 CFR 56) regulations. In each session, the featured presenters dismantled any fear I had surrounding interaction with regulatory entities by offering rubber-meets-the-road application of regulatory requirements and resources to be properly prepared.
One session was cleverly titled “Knock, Knock, FDA Is Here.” As an IRB professional, the looming possibility of a visit by the FDA for an audit can be a daunting thought. However, the presenters offered a practical breakdown of inspection preparation, resources to be familiar with such as the investigator’s operations manual or Office of Regulatory Affairs field manual as applicable to understand the FDA focus and intent for visits, and recommended post-inspection responses. I valued the highlights for IRB audit awareness—initial and continuing review of research, minutes content, membership compilation/roster, and implementation of internal standard operating procedures (SOPs). As the presentation went on, I was able to associate the recommendations with the written processes and resources we have in place at our institution, and I felt confident that our IRB business practices and SOPs have positioned us to be well-prepared.
One jointly-presented session by OHRP and the FDA, “Essential Documentation: IRB Record Keeping, Written Procedures, Minutes, and More,” centered on properly capturing accurate, compliant IRB documentation. Their lively discussion touched on record-keeping for board reviews/determinations, details for clear concise meeting minutes, and importance for internal written procedures. I enjoyed the focus on the “may” or “should” language, differentiating requirements for documentation with aspects of the regulations that afford flexibility. The speakers presented the material in a way that was tangible and accessible for newcomers, as well as a welcome refresher for seasoned IRB professionals. The presenters featured practical resources and guidance documents as part of the “take home” message and facilitated interactive questions/scenarios to gate check understanding!
The session “The IRB’s Critical Role in Understanding Sponsor and Investigator Responsibilities for Investigational New Drug Application (IND) Safety Reporting in Order to Assure the Protection of Human Subjects ” was eye-opening and challenged my current understanding of the FDA guidance on investigational new drug safety reporting and the corresponding IRB responsibilities. The speakers summarized how and when sponsors, investigators, and IRBs should implement the safety reporting information in the guidance (2012 Final guidance, and 2021 draft guidance) and FDA/OHRP Joint Guidance on IRB Written Procedures. Conversely, there were admonitions to prevent overreporting, to elicit only the most meaningful reports, and to sort out what information the IRB needs to receive about the events.
The session featured elements from the new draft guidance from the FDA, while underscoring existing guidance, for sponsor requirements to notify the FDA and all participating investigators via an investigational new drug safety report of potential serious risks. And by extension, since these investigational new drug safety reports are received by the investigator and are considered unanticipated problems (containing serious and unexpected adverse reactions), these events must be reported by investigators to the IRB of record. I appreciated the clarification by the presenters that this expectation for reporting to the IRB of record also includes external SUSAR reports that local sites/investigators receive from the sponsor, while participating in a multisite research project. As the session came to a close, I was able to raise valuable conversations with my institution’s Director of the Human Research Protections Program and IRB, to evaluate how our internal written procedures reflect the current guidance and ways they may need to be updated based on the new draft guidance.
I will confidently say that the speakers for all three of these sessions were not only professional and expert in their field, but authentically desired that attendees understand and apply this knowledge to make their research programs better. I appreciated the approachable tone of the sessions and the speakers’ clever, thoughtful responses to the active question and answer portions. For a virtual conference, there was a surprising level of interaction and openness with speakers and attendees alike, which helped build unity and dismantle the fear that may be associated with a visit from the FDA. I’d like to extend my thanks to the PRIM&R conference organizers and each of the speakers for their contributions to make the experience valuable!
Rebecka (Becky) Snyder is the IRB Coordinator for Ascension Healthcare in Wisconsin, one of the leading nonprofit and Catholic health systems in the United States. She has been with Ascension Wisconsin for three years, first as a Regulatory Specialist for industry-funded clinical trials and then as the IRB Coordinator for almost two years. She also served as the IACUC Coordinator at the Medical College of Wisconsin for about eight years, with a brief pause on her professional career in between to enjoy four years as a stay-at-home mom to her wonderful son.
Want to know more about navigating FDA regulatory requirements and how they differ from the Common Rule? Join us on April 26 for our upcoming webinar Un-Common Rules: Navigating FDA-Regulated Research and the IRB.