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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| Published in | Contemporary clinical trials Vol. 76; pp. 1 - 8 |
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| Main Authors | , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
01.01.2019
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| Subjects | |
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| Abstract | 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. |
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| AbstractList | 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. 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.INTRODUCTIONThe 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.METHODS AND ANALYSESWe 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. |
| Author | Polsky, Daniel Patel, Mitesh S. Karlawish, Jason Stephens-Shields, Alisa J. Krutsinger, Dustin C. Reyes, Celine Brooks, Steven Lubitz, Su Fen Ryan Greysen, S. Reale, Catherine Schnoll, Robert A. Volpp, Kevin G. Halpern, Scott D. Hitsman, Brian L. Mercede, Ashley McMahon, Jacqueline Bayes, Brian Barg, Fran |
| AuthorAffiliation | 5 Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA 10 Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania, USA 9 Department of Health Care Management, The Wharton School, University of Pennsylvania, Philadelphia, Pennsylvania, USA 7 Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA 11 Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 1 Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA 3 Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA 12 Department of Anthropology, University of Pennsylvania School of Arts and Sciences, Philadelphia, Pennsylvania 13 Department of Medical Ethics and H |
| AuthorAffiliation_xml | – name: 12 Department of Anthropology, University of Pennsylvania School of Arts and Sciences, Philadelphia, Pennsylvania – name: 3 Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA – name: 13 Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA – name: 4 Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania, USA – name: 10 Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania, USA – name: 2 Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA – name: 1 Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA – name: 7 Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA – name: 6 Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA – name: 15 Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA – name: 14 Penn Memory Center at the Penn Neuroscience Center, Philadelphia, Pennsylvania, USA – name: 8 Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA – name: 5 Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA – name: 9 Department of Health Care Management, The Wharton School, University of Pennsylvania, Philadelphia, Pennsylvania, USA – name: 11 Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania |
| Author_xml | – sequence: 1 givenname: Dustin C. surname: Krutsinger fullname: Krutsinger, Dustin C. email: Dustin.Krutsinger@uphs.upenn.edu organization: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 2 givenname: Jacqueline surname: McMahon fullname: McMahon, Jacqueline organization: Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 3 givenname: Alisa J. surname: Stephens-Shields fullname: Stephens-Shields, Alisa J. organization: Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 4 givenname: Brian surname: Bayes fullname: Bayes, Brian organization: Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 5 givenname: Steven surname: Brooks fullname: Brooks, Steven organization: Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 6 givenname: Brian L. surname: Hitsman fullname: Hitsman, Brian L. organization: Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA – sequence: 7 givenname: Su Fen surname: Lubitz fullname: Lubitz, Su Fen organization: Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 8 givenname: Celine surname: Reyes fullname: Reyes, Celine organization: Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA – sequence: 9 givenname: Robert A. surname: Schnoll fullname: Schnoll, Robert A. organization: Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 10 givenname: S. surname: Ryan Greysen fullname: Ryan Greysen, S. organization: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 11 givenname: Ashley surname: Mercede fullname: Mercede, Ashley organization: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 12 givenname: Mitesh S. surname: Patel fullname: Patel, Mitesh S. organization: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 13 givenname: Catherine surname: Reale fullname: Reale, Catherine organization: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 14 givenname: Fran surname: Barg fullname: Barg, Fran organization: Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 15 givenname: Jason surname: Karlawish fullname: Karlawish, Jason organization: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 16 givenname: Daniel surname: Polsky fullname: Polsky, Daniel organization: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 17 givenname: Kevin G. surname: Volpp fullname: Volpp, Kevin G. organization: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA – sequence: 18 givenname: Scott D. surname: Halpern fullname: Halpern, Scott D. organization: Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA |
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| ContentType | Journal Article |
| Copyright | 2018 Elsevier Inc. Copyright © 2018 Elsevier Inc. All rights reserved. |
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| Keywords | HUP Incentives DSMB RETAIN Behavioral economics RAQ-7 Randomized controlled trials MOVE IT Ethics BASC RCTs IRBs Nudge |
| Language | English |
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| Notes | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 JM, AJS, BB, SB, BLH, RAS, RRG, MSP, FB, DL, JK, KGV, and SDH contributed to the study design and protocol. DCK, JM and SDH drafted the protocol manuscript. AJS, BLH, RAS, RRG, MSP, DL, JK, and KGV provided critical feedback and revisions. All authors have provided final approval of the study protocol. Author’s Contributions |
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| SubjectTerms | 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 |
| Title | Randomized evaluation of trial acceptability by INcentive (RETAIN): Study protocol for two embedded randomized controlled trials |
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