Table 1 Sumary of major themes
Main Themes | Associated Question | Majority View |
|---|---|---|
Research-Practice Distinction | Is research morally distinct from clinical practice? | • Rejects the distinction between research and practice • Rests on an empirical claim that research often introduces risks that are unrelated to a patient’s clinical care • Problematic assumption that research automatically involves higher risks than clinical practice. |
Consent | Is consent required, and if so how extensive must the consent process be for low-risk pragmatic RCTs? | • Low-risk pragmatic RCTs may proceed without consent (i.e., waiver of consent) • Limited to cases in which risk of participation is low and other consent options are unworkable • Altered informed consent models may strike a balance between autonomy and burden for researchers. |
Disclosure | What aspects of research must be disclosed to research participants of low-risk pragmatic RCTs? | • Information should only be disclosed if research participation adds risks over and above clinical practice • Disagreement whether to disclose randomization • No disclosure required in an ethically robust learning health care system. |
Oversight | What level of oversight is required for low-risk pragmatic RCTs? | • Oversight is time consuming, costly and complex • Burdens stem from the faulty research-practice distinction and the lack of inter-institutional standardization • Review process for low-risk pragmatic RCTs should be streamlined. |