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

The most common and conceptually sound ethical concerns with financial incentives for research participation are that they may (1) represent undue inducements by blunting peoples' perceptions of research risks, thereby preventing fully informed consent; or (2) represent unjust inducements by en...

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Bibliographic Details
Published in:Contemporary clinical trials 2019-01, Vol.76, p.1-8
Main Authors: Krutsinger, Dustin C., McMahon, Jacqueline, Stephens-Shields, Alisa J., Bayes, Brian, Brooks, Steven, Hitsman, Brian L., Lubitz, Su Fen, Reyes, Celine, Schnoll, Robert A., Ryan Greysen, S., Mercede, Ashley, Patel, Mitesh S., Reale, Catherine, Barg, Fran, Karlawish, Jason, Polsky, Daniel, Volpp, Kevin G., Halpern, Scott D.
Format: Article
Language:English
Subjects:
Attitude to Health
Behavioral economics
Coercion
Comprehension
Decision Making
Ethics
Humans
Incentives
Informed Consent
Motivation - ethics
Nudge
Patient Participation
Patient Selection - ethics
Perception
Randomized controlled trials
Randomized Controlled Trials as Topic
Research Subjects
Risk
Therapeutic Misconception
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Summary:The most common and conceptually sound ethical concerns with financial incentives for research participation are that they may (1) represent undue inducements by blunting peoples' perceptions of research risks, thereby preventing fully informed consent; or (2) represent unjust inducements by encouraging enrollment preferentially among the poor. Neither of these concerns has been shown to manifest in studies testing the effects of incentives on decisions to participate in hypothetical randomized clinical trials (RCTs), but neither has been assessed in real RCTs. We are conducting randomized trials of real incentives embedded within two parent RCTs. In each of two trials conducted in parallel, we are randomizing 576 participants to one of three incentive groups. Following preliminary determination of patients' eligibility in the parent RCT, we assess patients' research attitudes, demographic characteristics, perceived research risks, time spent reviewing consent documents, ability to distinguish research from patient care, and comprehension of key trial features. These quantitative assessments will be supplemented by semi-structured interviews for a selected group of participants that more deeply explore patients' motivations for trial participation. The trials are each designed to have adequate power to rule out undue and unjust inducement. We are also exploring potential benefits of incentives, including possible increased attention to research risks and cost-effectiveness.
ISSN:1551-7144
1559-2030
DOI:10.1016/j.cct.2018.11.007