An Ethics Review Process for Quality Improvement Projects: An Overview of the Women’s College Hospital Approach

Delays at research ethics boards have become one of the most important impediments to the efforts of the increasingly large number of trainees and faculty members engaged in quality improvement (QI) work. For this reason, Kaveh Shojania, Vice-Chair,  Quality & Innovation, asked us to provide a brief account of the innovative approval process for QI projects we developed at Women’s College Hospital (WCH).

Quality improvement (QI) initiatives are integral to enhancing patient experience and safety, improving outcomes and reducing costs. It has been said that evidence based medicine focuses on, “doing the right things;” while QI focuses on, “doing things right.”[1] Scholarly QI work is often encumbered by Research Ethics Board Processes that are prohibitively long and onerous. The Women’s College Hospital Ethics Assessment Process for Quality Improvement Projects (WCH APQIP) is a process designed to foster, “doing the right things,” and “doing things right,” by encouraging scholarly QI projects essential to a learning healthcare organization. The APQIP is an expedited ethics review process that aims to address three key issues related to QI projects: 1) a need to relieve the research ethics board (REB) of the administrative burden associated with performing reviews of QI projects; 2) a need for an ethics review process that takes into account key methodological difference between QI and research; and 3) a need ensure oversight while balancing review turnaround time periods with the level of risk and burden associated with QI projects. Across these three aims was the goal to keep the process as streamlined as possible for applicants and reviewers.

In the spring of 2014, APQIP was developed over a three month stakeholder engagement process that included individuals from within and beyond the intuition with expertise in ethics, quality improvement, law, bioethics, innovation, research and medical practice. Stakeholders provided input on the design and operating procedures of the process and an evaluation committee was struck. Clinicians involved in QI projects at WCH were given an overview of the process and the APQIP process was piloted on the first ten submissions. The submissions themselves are comprised of an online on-boarding form containing many of the standard categories of a project protocol along with the scoring output from the ARECCI Tool – a risk and burden stratification tool created by Alberta Innovates Health Solutions.

In a three month pilot period, the APQIP process reviewed ten projects with an average review turnaround time of 7.6 days from time of submission through the online portal. While we’re unsure of how long a traditional REB review of similar projects would have taken, anecdotally we can assume at least a month from the moment of submission to the REB. In a blinded review of the process, reviewers completed ARECCI tools for each project. ARECCI scores by reviewers were consistently lower than applicants’ self-reported risk – suggesting applicants were being more sensitive to the potential risks or burdens to their QI participants.

As you can imagine, user satisfaction with this process has allowed it to continue and grow at WCH. Key to the overall success of the process design and implementation phases was the robust stakeholder engagement process at the outset coupled with strong buy-in from hospital leadership. As an innovative ambulatory care hospital, WCH has the distinct opportunity to implement and evaluate scholarly QI work in the field of ambulatory medicine and innovative processes such as APQIP medicine; and encourages that very work.

 

[1] Glasziou, P., Ogrinc, G. & Goodman, S. (2011). Can evidence-based medicine and clinical quality improvement learn from each other? British Medical Journal. 20(Suppl 1).