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Proposals to Conduct Randomized Controlled Trials Without Informed Consent: a Narrative Review
James H Flory1, Alvin I Mushlin2, Zachary I Goodman2
1Department of Healthcare Policy and Research, Weill Cornell Medical College, 425 East 61st Street, 301, New York, NY, 10065, USA. jaf9052@med.cornell.edu.
Journal of General Internal Medicine
|July 8, 2016
Summary
This review surveys methods for randomization without consent (RWOC) in clinical trials. While some RWOC approaches like cluster randomization are common, others raise ethical concerns about patient autonomy.
Area of Science:
- Clinical Trials Methodology
- Research Ethics
- Informed Consent
Background:
- Informed consent is standard for randomized clinical trials (RCTs).
- Exceptions exist, such as emergency research, where consent procedures are modified.
- Systematic review of randomization without consent (RWOC) approaches is lacking.
Purpose of the Study:
- To survey and synthesize published proposals for randomization without consent (RWOC).
- To analyze different strategies for randomizing participants without explicit consent for randomization.
- To understand the ethical considerations and practical applications of RWOC.
Main Methods:
- Systematic literature review and narrative synthesis of published RWOC proposals.
- Defined RWOC to include studies omitting consent for randomization, for specific groups, or post-randomization.
- Excluded consent processes that obtain consent before randomization.
Main Results:
- Identified ten distinct RWOC proposals.
- Included cluster randomization, Zelen designs, consent to postponed information, two-stage randomized consent, cohort multiple RCT, emergency research, prompted optional randomization, and low-risk pragmatic RCTs.
- Only cluster randomized designs and emergency research are routinely used.
Conclusions:
- Cluster randomization and emergency research are justified by infeasibility of consent.
- Other RWOC designs raise concerns regarding patient autonomy.
- Future RWOC designs should prioritize patient engagement, transparency, and accountability within learning health care systems.
