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Table 1 Sumary of major themes

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

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.