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High-impact RCTs without prospective informed consent: a systematic review.
Roma Dhamanaskar1, Jon F Merz2
1Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Summary
Approximately 9% of high-impact randomized controlled trials (RCTs) were conducted without full informed consent. This prevalence remained stable over five years, often involving emergency situations or pragmatic trial designs.
Area of Science:
- Clinical Research Ethics
- Medical Research Methodology
Background:
- The ethical conduct of randomized controlled trials (RCTs) requires informed consent from all participants.
- The prevalence of RCTs conducted without fully informed prospective consent is not well-established.
Purpose of the Study:
- To estimate the prevalence of high-impact RCTs performed without informed consent from all subjects.
- To determine if the prevalence of such trials has changed over time.
Main Methods:
- Systematic review of English-language RCTs published from 2014-2018, identified via Scopus.
- Identification of the top 100 most highly cited RCTs per year.
- Independent review and coding of informed consent practices for each RCT.
Main Results:
- 8.8% (44 of 500) of high-impact RCTs did not obtain informed consent from all subjects.
- No significant change in prevalence was observed over the five-year study period (p=0.44).
- The majority of these trials (66%) involved emergency situations, pragmatic designs, or cluster randomization.
Conclusions:
- A significant proportion of high-impact RCTs are conducted without universal informed consent.
- Waiving informed consent in RCTs is often associated with emergency settings and specific trial designs.
- Further qualitative analysis is needed to understand justifications for waiving informed consent.
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