How does your organization view noncompliance investigations? Are they seen as an opportunity for learning and growth? If we are honest, many of us would not volunteer to learn or grow our HRPPs through a noncompliance investigation. We want to get through it and hope it does not occur again. That is wishful thinking and is not the wisest approach to addressing and mitigating noncompliance. The AER19 session, “How to Investigate, Mitigate, Report and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement” inspired me to believe that there can be a bright side through the process of noncompliance investigations.
Often, when attending these types of sessions, it is usually with some measure of trepidation. It is that feeling that most HRPP professionals have about noncompliance occurring within our HRPPs. We do not want it at our institution, and we definitely do not want to be reminded of it. I entered the session at AER19 thinking I would hear a few case studies, go over the definitions and be reminded of the federal reporting requirements. Thankfully, that was not what I encountered. The session was the most informative, thought-provoking one I attended this year. Both Robert Hood (Director of Accreditation, AAHRPP, Inc.) and Scott J. Lipkin, DPM, CIP (Managing Director, Health Solutions, Ankura Consulting) provided their insight, experience, and practical tools to improve this often-arduous process. Based on the amount of information given and conversation during the session, this session could honestly have been divided into two sessions: “Investigating and Reporting Noncompliance” and "Mitigating Noncompliance. “
Surprisingly, noncompliance is not defined in the federal regulations, which accounts for the variability in definitions and approaches among institutions. The presenters described varied institutional approaches for investigating noncompliance. An essential element of the investigation process is policy, specifically the definition of noncompliance. We were able to reflect upon our own institutional approach and determine if it was comprehensive. We also discussed some overlooked areas of concern like noncompliance that involves compromised data.
The discussion of noncompliance investigations included investigator and IRB noncompliance, which I thought was a much-needed discussion as well. There was an interesting dialog centered on which entity or group within an organization is most equipped to make noncompliance determinations and design Corrective and Preventive Action Plans (CAPA). For investigator noncompliance, is the reviewing IRB most equipped to make these determinations? Is the quality assurance staff better trained to make the decision, or should a separate executive committee be responsible for the determination process? For IRB noncompliance, what should an objective determination process look like and who should be involved?
The case studies were thorough and intriguing. There were a couple that included some familiar scenarios for us, but each case left the group debating and pondering what the right answer would be. A refreshing take-away from the session is “there is no right answer.” The approach to determinations should align with institutional policy with the goal of remaining compliant regarding reporting, while also using the noncompliance as an opportunity to grow and strengthen the HRPP.
Ivy Tillman, MS, CCRC, CIP, joined the Augusta University IRB Office in 2005 and is currently the Director. She serves as the primary liaison for the Augusta University Human Research Protection Program (HRPP), which is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Augusta University’s IRBs review research for Augusta University, Augusta University Medical Center, and the Charlie Norwood VA Medical Center. Ivy is responsible for overseeing the missions of the IRB Office, which include administrative support to the IRB committees, compliance and oversight of human research studies, and education and training for research team members and the IRB Committee members.
Ivy received her Master of Science in Management with a concentration in Healthcare Management from Troy University and her Bachelor of Arts in Biological Sciences and Modern Languages from Clemson University. A former educator, Ivy’s past roles in human research include working as a clinical research coordinator in pediatric sickle cell and adult neurology studies, and serving as the IRB Office Training Coordinator. She obtained certification as a Certified Clinical Research Coordinator in 2005 and Certified IRB Professional in 2008.
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