Oversight on the borderline: Quality improvement and pragmatic research

Abstract

Pragmatic research that compares interventions to improve the organization and delivery of health care may overlap, in both goals and methods, with quality improvement (QI) activities. When activities have attributes of both research and QI, confusion often arises about what ethical oversight is, or should be, required. For routine QI, in which the delivery of health care is modified in minor ways that create only minimal risks, oversight by local clinical or administrative leaders utilizing institutional policies may be sufficient. However, additional consideration should be given to activities that go beyond routine, local QI to first determine whether such non-routine activities constitute research or QI and, in either case, to ensure that independent oversight will occur. This should promote rigor, transparency, and protection of patients’ and clinicians’ rights, well-being, and privacy in all such activities. Specifically, we recommend: 1. Health care organizations should have systematic policies and processes for designating activities as routine QI, non-routine QI, or QI research, and determining what oversight each will receive. 2. Health care organizations should have formal and explicit oversight processes for non-routine QI activities that may include input from institutional QI experts, health services researchers, administrators, clinicians, patient representatives, and those experienced in the ethics review of health care activities. 3. QI research requires review by an IRB; for such review to be effective, IRBs should develop particular expertise in assessing QI research. 4. Stakeholders should be included in the review of non-routine QI and QI-related research proposals. Only by doing so will we optimally leverage both pragmatic research on health care delivery and local implementation through QI as complementary activities for improving health.

Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation

“…Most authors believe that the review process must be streamlined [ 40 – 44 ]. Some authors focus on steps to improve the current review process across the board, including transparent policies, safeguards and stakeholder participation [ 51 , 52 ]. Some suggest the need for a case-by-case approach to determine when streamlined review is both needed and appropriate, depending on the level of risk posed [ 44 , 53 , 54 ].…”

Quality improvement into practice

“…Research aims to generate new generalisable knowledge, while QI typically involves a combination of generating new knowledge or implementing existing knowledge within a specific setting 32. Unlike research, including pragmatic research designed to test effectiveness of interventions in real life, QI does not aim to provide generalisable knowledge.…”

Online randomized controlled experiments at scale: lessons and extensions to medicine

“…There is a push towards having more trials that are simple and which compare usual care modifications that are already implemented somewhere or would be implemented anyway without ethical approval [49]. The evaluation of minor usual care modifications may be seen more as quality improvement than research [50] and using randomization alone may not necessarily define an evaluation as research [20].…”