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Table 3 Critical analysis of the major themes and gaps identified

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

Main themes Critical Analysis of the Dominant View Gaps in the Literature
Research-practice distinction • The rejection of the research-practice distinction rests on a mistaken assumption that the classification turns solely on risk.
• Pragmatic RCTs are research, so a better starting place is oversight for other categories of low-risk and socially important research.
• Given that pragmatic RCTs are research, what are the implications for consent, disclosure, and oversight?
Consent • The central focus on risk leads to the spurious conclusion that consent need not be sought for all low-risk research.
• The ethical principle of respect for persons requires that consent be sought unless conditions for a waiver apply.
• When are waivers appropriate?
• What is meant by ‘impracticable’?
• Does cost, time and complexity count as sufficient justification?
Disclosure • Grounding the disclosure of information in risk is irrelevant to why information is disclosed.
• The ethical principle of respect for persons requires that information be disclosed for research participants to compare their values with the details of the research.
• What type of notification is best for disclosing information?
• Which approaches to notification uphold respect for persons to the highest degree?
Oversight • The level of scrutiny from RECs need not be proportionate to the level of risk of the research.
• Proportionate review ought to be based on several factors, including presence of vulnerable participants, degree of risk and methods.
• Multisite trials ought to be reviewed by a central REC.
• What models for centralized review of multisite pragmatic RCTs are successful, and why?