|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.