Supplemental Table 1. Rationale for identical regulatory requirements for clinical practice, quality improvement and clinical research. Table is adapted from (42, 43).
1. Usual clinical practice is not conducted solely to improve patient outcomes.
2. Obtaining generalizable knowledge is an important and inextricable component of clinical practice, quality improvement and clinical research.
3. Systematic data collection to monitor and improve health care is now an important, component of good clinical practice as well as quality improvement and clinical research.
4. The current double standard for obtaining informed consent for unproven therapies in clinical research, but not in clinical practice, is illogical.
5. The risk of administering an unproven therapy is not greater in clinical research than clinical practice. In fact it is likely that the total number of patients harmed from wellmeaning use of unproven therapies is orders of magnitude greater in usual clinical practice than in clinical research.
6. Providing labels for the activities of ‘research’ and ‘clinical practice’ are poor proxies for what should be central moral concerns.