Managing Non-Compliance: Systematic Approach that Improves Human Subject Research Protections


Non-compliance occurs when human subjects research is conducted in a manner that disregards or violates federal regulations, the policies or procedures of the IRB, or institutional policies. An unapproved or otherwise non-compliant research activity may place a research participant at unnecessary risk. Incorporating a strategic plan for handling reports of non-compliance is an integral component of any HRPP. The IRB has developed a comprehensive approach to the evaluation of and response to reports of non-compliance. Diligent quality processes have helped improve turnaround time (TAT) from the time of notification of an event that may constitute non-compliance to reporting to the appropriate institutional officials and/or regulatory agencies. 

Process Improvement 
Prior to 2013, the IRB’s approach to address reports of non-compliance was not focused. Despite an existing, detailed policy and procedure, potential non-compliance reports could be handled by multiple members of the IRB staff and, therefore, the handling of such cases lacked consistency. In order to improve consistency, the IRB implemented a more systematic approach to review reports of possible serious and/or continuing non-compliance. The streamlined process for the IRB’s management of such reports promotes a thorough review, including: a) An administrative and scientific pre-screening conducted upon realization that an event is a possible non-compliance; b) Prompt determination regarding the necessity of convened board review; c) Solicitation of additional information to facilitate review by the convened IRB review, allowing the IRB to make appropriate determinations; d) An assessment of any corrective and preventative action (CAPA) plan proposed; e) A method to ensure prompt reporting to institutional officials and external federal agencies; and f) Follow-up action by the IRB including re-training of the research team and quality assurance audits to ensure that CAPA plans are followed through.

The IRB’s current procedures for handling events of non-compliance are reconsidered periodically. During this review, system-wide changes that are needed to respond to incidents of non-compliance and their implementation are discussed. In addition, the IRB director monitors ongoing non-compliance events on a bi-weekly basis. 

The data for the last two years (January 2013-January 2015) show significant improvement in overall processing time, with an average of 62 days in 2013, and 22 days in 2014. This application of consistency throughout the process has facilitated a more efficient and timely review process. We will continue to monitor these reports closely and ensure that the systematized approach adopted by the IRB ensures the most challenging and complex issues receive the timely review needed for human subjects’ protection.