Oversight on the borderline: Quality improvement and pragmatic research.

Oversight on the borderline: Quality improvement and pragmatic research. Clin Trials. 2015 Sep 15; Authors: Finkelstein JA, Brickman AL, Capron A, Ford DE, Gombosev A, Greene SM, Iafrate RP, Kolaczkowski L, Pallin SC, Pletcher MJ, Staman KL, Vazquez MA, Sugarman J 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 activities. When activities have attributes of both research and quality improvement, confusion often arises about what ethical oversight is, or should be, required. For routine quality improvement, 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 quality improvement to first determine whether such non-routine activities constitute research or quality improvement 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 that (1) health care organizations should have systematic policies and processes for designating activities as routine quality improvement, non-routine quality impro...
Source: Clinical Trials - Category: Research Authors: Tags: Clin Trials Source Type: research