During my participation at the PRIM&R conference held in Boston, November 12-15, I attended a pre-conference program dedicated to Quality Assurance and Quality Improvement (QA/QI) programs in human subjects’ research.
The first part of the workshop was dedicated to discussing general aspects of QA/QI activity. This is a cornerstone component of any Human Research Protection Program (HRPP) established at an internal level in research institutions. The aims of such an activity are to ensure regulatory compliance and promoting ethical and responsible conduct of research in general. Key activities of QA/QI programs include ensuring regulatory compliance, improving the performance of the investigator and the Research Ethics Committee (REC) through auditing and education, and measuring the overall quality, effectiveness, and efficiency of the Human Research Protection Program (HRPP). The speaker, Delia Wolf, then discussed prerequisite elements that warrant the success of a QA/QI program, which included selection of goals, institutional support, and sufficient human and financial resources. She then presented and discussed different examples of QA/QI programs that have been successful.
The next part of the workshop was dedicated to methodological aspects of those programs. This included an overview of the audit process, which consists of four major steps: preparation, onsite engagement, report and resolution, and follow-up. This was followed by a discussion of more specific methods necessary for QA/QI programs, such as: the tools for effective communication and interaction, opportunities and methods that may be used to educate stakeholders and finally, specificities of quality assurance and quality improvement of RECs.
I found this session very interesting, because it showed theoretically and practically how a QA/QI program allows combining ethical principles and regulatory requirements to promote research compliance and oversight quality; and thus enhance human subjects’ protection at the institutional level. Two key elements were of particular interest to me: First, there should be an emphasis on the relevance of establishing HRPPs to ensure optimal research oversight at the institutional level that cannot be achieved only by establishing an REC. Second, when considering QA/QI programs, quality assurance constitutes a first level that needs to be implemented before efforts at quality improvement; QA is thus, a prerequisite for QI activities.