Randomized evaluation of trial acceptability by INcentive (RETAIN): Study protocol for two embedded randomized...

Area of Science:

• Bioethics
• Clinical Trials
• Informed Consent

Background:

• Ethical concerns regarding financial incentives in research include undue inducement (blunting risk perception) and unjust inducement (preferential enrollment of the poor).
• Previous studies have not assessed these concerns in real-world randomized clinical trials (RCTs).

Purpose of the Study:

• To evaluate the ethical implications of financial incentives in real randomized clinical trials (RCTs).
• To assess whether incentives unduly influence risk perception and informed consent.
• To determine if incentives lead to unjust preferential enrollment among socioeconomically disadvantaged populations.

Main Methods:

• Conducting parallel randomized trials with 576 participants each, assigned to one of three incentive groups.
• Assessing participant attitudes, demographics, perceived risks, consent document review time, and comprehension.
• Supplementing quantitative data with semi-structured interviews to explore participant motivations.

Main Results:

• The trials are designed with adequate statistical power to detect undue and unjust inducement.
• Exploration of potential benefits, such as increased attention to research risks and cost-effectiveness, is ongoing.

Conclusions:

• This research directly addresses the ethical concerns of financial incentives in real clinical trial settings.
• Findings will inform best practices for using incentives while safeguarding participant welfare and ensuring equitable research participation.