Randomized evaluation of trial acceptability by INcentive (RETAIN) : Study protocol for two embedded randomized controlled trials
Copyright © 2018 Elsevier Inc. All rights reserved..
INTRODUCTION: 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.
METHODS AND ANALYSES: 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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:76 |
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| Enthalten in: |
Contemporary clinical trials - 76(2019) vom: 03. Jan., Seite 1-8 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Krutsinger, Dustin C [VerfasserIn] |
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| Links: |
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| Themen: |
Behavioral economics |
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| Anmerkungen: |
Date Completed 11.03.2020 Date Revised 20.03.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.cct.2018.11.007 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM290475287 |
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| 245 | 1 | 0 | |a Randomized evaluation of trial acceptability by INcentive (RETAIN) |b Study protocol for two embedded randomized controlled trials |
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| 520 | |a Copyright © 2018 Elsevier Inc. All rights reserved. | ||
| 520 | |a INTRODUCTION: 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 | ||
| 520 | |a METHODS AND ANALYSES: 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 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Behavioral economics | |
| 650 | 4 | |a Ethics | |
| 650 | 4 | |a Incentives | |
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| 650 | 4 | |a Randomized controlled trials | |
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| 700 | 1 | |a Stephens-Shields, Alisa J |e verfasserin |4 aut | |
| 700 | 1 | |a Bayes, Brian |e verfasserin |4 aut | |
| 700 | 1 | |a Brooks, Steven |e verfasserin |4 aut | |
| 700 | 1 | |a Hitsman, Brian L |e verfasserin |4 aut | |
| 700 | 1 | |a Lubitz, Su Fen |e verfasserin |4 aut | |
| 700 | 1 | |a Reyes, Celine |e verfasserin |4 aut | |
| 700 | 1 | |a Schnoll, Robert A |e verfasserin |4 aut | |
| 700 | 1 | |a Ryan Greysen, S |e verfasserin |4 aut | |
| 700 | 1 | |a Mercede, Ashley |e verfasserin |4 aut | |
| 700 | 1 | |a Patel, Mitesh S |e verfasserin |4 aut | |
| 700 | 1 | |a Reale, Catherine |e verfasserin |4 aut | |
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| 700 | 1 | |a Polsky, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Volpp, Kevin G |e verfasserin |4 aut | |
| 700 | 1 | |a Halpern, Scott D |e verfasserin |4 aut | |
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