Table 3 Critical analysis of the major themes and gaps identified
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? |