Randomized evaluation of trial acceptability by INcentive (RETAIN): Study protocol for two embedded randomized controlled trials.
Behavioral economics
Ethics
Incentives
Nudge
Randomized controlled trials
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
received:
15
08
2018
revised:
02
11
2018
accepted:
06
11
2018
pubmed:
12
11
2018
medline:
12
3
2020
entrez:
12
11
2018
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 30414865
pii: S1551-7144(18)30514-7
doi: 10.1016/j.cct.2018.11.007
pmc: PMC6354250
mid: NIHMS1512765
pii:
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
1-8Subventions
Organisme : NIA NIH HHS
ID : P30 AG010124
Pays : United States
Organisme : NCI NIH HHS
ID : R01 CA184211
Pays : United States
Organisme : NCI NIH HHS
ID : R01 CA197332
Pays : United States
Organisme : NHLBI NIH HHS
ID : T32 HL098054
Pays : United States
Informations de copyright
Copyright © 2018 Elsevier Inc. All rights reserved.
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