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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

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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.

Journal of Investigative Medicine : the Official Publication of the American Federation for Clinical Research

|October 2, 2020

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.

Keywords:

biomedical research emergency service hospital public policy research research design

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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.