|Main themes||Critical Analysis of the Dominant View||Gaps in the Literature|
• 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?|
• 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?
• 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?
• 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?|