Research incentives are rewards offered to people in exchange for their participation in a study. National Institutes of Health Office of Human Subjects Research. J, Thus, although it will be appropriate in most trials to compensate research participants for their time and burden in engaging with research tasks, further evaluations of incentives that are designed specifically to enhance enrollment are needed to understand the range of trials in which this practice represents money well spent. E, Grady C, Mercede As a secondary measure of undue inducement, we tested the significance of the interaction between RAQ-7 scores and incentives. For example, in the smoking trial, the data are compatible with an incentive-by-risk interaction OR of up to 1.15, and even that worst-case scenario would only represent an 8.7% absolute reduction in risk sensitivity among patients who were receiving vs not receiving incentives (eTable 4 in Supplement 2). Conflict of Interest Disclosures: Dr Hitsman reported nonfinancial support from Pfizer during the conduct of the study. Objectives: To determine the effects of risk and payment on subjects' willingness to participate, and to examine how payment influences subjects' potential behaviours and risk evaluations. The different results could also be because of unmeasured differences in the characteristics of the samples or differences in the interventions or recruitment settings of the 2 trials. Coordinators used scripted probes to assess whether patients had heard about the use of incentives in the trial. P. Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials. Error bars represent 95% CIs. Increasing incentives were not associated with patients perceptions of research risks in the smoking (OR, 0.85; 95% CI, 0.61-1.17) or ambulation trials (OR, 1.34; 95% CI, 0.70-2.69). SJ, Hansen J Bioeth Inq. More than 70% of participants in each smoking trial group perceived no coercion (P=.91), as did more than 93% of participants in each ambulation trial group (P=.48). Analyses adjusted for baseline patient characteristics, including demographic characteristics, financial well-being, and RAQ scores, revealed a significant effect of incentives on consent in the smoking trial (adjusted OR [aOR] for each increase in incentive, 1.70; 95% CI, 1.34-2.17; P<.001) (eTable 5 in Supplement 2) but not in the ambulation trial (aOR, 0.88; 95% CI, 0.64-1.22; P=.45) (eTable 6 in Supplement 2). In both trials, noninferiority tests suggested that incentives did not act as undue or unjust inducements, and these findings were robust to sensitivity analyses. Strategies for increasing recruitment to randomised controlled trials: systematic review. BE, Fernandez Lynch Terms of Use| Objective Randomized participants who verbalized disinterest in the parent trial before seeing the consent form were considered to have declined consent. After patients made their choice to consent to participate in the parent trial or not, we administered a questionnaire assessing the perceived risks of patients regarding the parent trial, as measured by a modified version of the compared riskiness scale.32,33 We assessed patients understanding of the parent trial using 6 questions regarding core trial elements mentioned in the consent form, such as its duration and purpose. C. official website and that any information you provide is encrypted Coordinators used scripted probes to assess whether patients had heard about the use of incentives in the trial. Offering research subjects financial incentives for their participation is a common practice that boosts recruitment but also raises ethical concerns, such as undue inducement, exploitation, and . Attitudes to Three Weight Maintenance Strategies: A Qualitative Study. Dr Schnoll reported nonfinancial support from Pfizer during the conduct of the study and consulting fees from Curaleaf and GSK outside the submitted work. 2022 Sep;19(3):395-406. doi: 10.1007/s11673-022-10192-w. Epub 2022 Jul 19. , Dickert Careers, Unable to load your collection due to an error. Within strata, variable block sizes of 3 and 6 were used. The https:// ensures that you are connecting to the However, the extent to which incentives increase enrollment is uncertain. , Karlawish Administrative, technical, or material support: Halpern, Chowdhury, Bayes, Cooney, Hitsman, Schnoll, Lubitz, Reyes, Greysen, Mercede, Reale, Volpp, Karlawish. Error bars represent 95% CIs. The primary outcome of each incentive trial was the proportion of people assigned to each recruitment strategy that consented to participate. Thus, although it will be appropriate in most trials to compensate research participants for their time and burden in engaging with research tasks, further evaluations of incentives that are designed specifically to enhance enrollment are needed to understand the range of trials in which this practice represents money well spent. AJ, SD, Courtright We chose noninferiority analyses rather than traditional superiority tests of these terms because concerns about undue and unjust inducement commonly limit the use of incentives in research, meaning that the burden of proof for practice to change requires establishing that such unintended consequences are unlikely to arise. Both of these concerns have been challenged on conceptual grounds,19,20,25,28,29 and studies that assess how willing people are to participate in hypothetical RCTs have provided limited empirical support for the view that incentives increase enrollment without yielding either of these unintended ethical consequences.30-32 However, evidence of how real incentives affect decisions to participate in real trials is needed to optimally inform research regulations and international practice. Any monetary or gift incentive that they receive is secondary to their altruistic reason for participating. Strategies for increasing recruitment to randomised controlled trials: systematic review. Jr, Wendler , Man , Jonckheere sharing sensitive information, make sure youre on a federal C, Abadie R, De Vries , Kim Dr Volpp reported grants from the National Cancer Institute during the conduct of the study and being a partial owner of VAL Health and grants from Humana, WW, Vitality/Discovery, and HMSA outside the submitted work. The remaining patients were invited to attend an in-person assessment to read and potentially sign the informed consent form and to confirm full eligibility for the smoking trial. We used 2 and Jonckheere tests45 for trend to compare binary and continuous outcomes, respectively, across ordered incentive arms. Two RCTs of incentives that were embedded in 2 parent RCTs, 1 comparing smoking cessation interventions (conducted at smoking cessation clinics in 2 health systems) and 1 evaluating an ambulation intervention (conducted across wards of the Hospital of the University of Pennsylvania) included all persons eligible for the parent trials who did not have prior knowledge of the incentives trials. A, Volpp , Piaggio Investigators conducting data analyses (M.C. Krutsinger DC, OLeary KL, Ellenberg SS, Cotner CE, Halpern SD, Courtright KR. Critical revision of the manuscript for important intellectual content: Halpern, Bayes, Hitsman, Schnoll, Lubitz, Reyes, Patel, Greysen, Mercede, Barg, Volpp, Karlawish, Stephens-Shields. RETAIN comprised 2 RCTs. Controversy over providing financial incentives to research participants has a long history and remains an issue of contention in both current discussions about research ethics and for institutional review bodies/human research ethics committees which are charged with the responsibility of deciding whether such incentives fall within ethical guidelines. There were no significant effects of incentive size on the secondary outcomes in either trial, including time spent reviewing the risk sections of consent forms, perceived research risks, trial understanding, perceived coercion, or therapeutic misconceptions. Effectiveness and Ethics of Incentives for Research Participation: 2 Randomized Clinical Trials. and A.S.) were unmasked to group assignment once data collection for both trials was complete to enable tests for trend and noninferiority, but the statistical analysis plan was finalized before unmasking. However, the findings that incentives did not modify the relationships between research attitudes and enrollment in either trial supports the conclusion that incentives did not unduly influence trial enrollment decisions. , Martin The .gov means its official. Noninferiority methods were used to test whether the data were compatible with these 2 effects of incentives and superiority methods to compare the primary and other secondary outcomes. The embedded smoking trial ended when the parent trial closed, and the embedded ambulation trial ended when the target sample size with complete risk assessment data for RETAIN was achieved. There is considerable confusion regarding the ethical appropriateness of using incentives in research with human subjects. In the ambulation trial, the 5th percentile=$10 to $19000, 25th percentile=$30 to $49000, 50th and 75th percentiles both=$50 to $99000, 95th percentile=$100000 or more, and mean=$30 to $49000. Risk perception did not modify the relationships between incentives and enrollment in either trial (upper confidence limits of interaction ORs, 1.15 and 0.99; both P<.001) (eFigures 1-2 in Supplement 2). J, Stephens-Shields J, Bower A nudge toward participation: Improving clinical trial enrollment with behavioral economics. approaches to payment for research participation. examining the ethics of incentives first, then the ethics of human subjects research, and, finally, the areas where the use of incentives either introduces an ethical problem into a medical research setting or aggravates an ethical problem already implicit in it. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. Key measures obtained at this stage included income, financial well-being,36 and score on the Research Attitudes Questionnaire7 (RAQ-7),37 a measure with high internal consistency and factorial validity38,39 in which higher scores indicate more favorable views of research. Further, because of ethical concerns, 18-20 their use and size are highly variable among otherwise similar studies 11 and are variably regulated by institutional review boards (IRBs). Questions and scoring of the financial well-being scale, eTable 4. C, Dickert MeSH C, Tariot XE, Herman A. We acknowledge the outstanding guidance we received from our ethics advisory board members: Tim Coetzee, PhD (National Multiple Sclerosis Society), Ezekiel Emanuel, MD (University of Pennsylvania), David Festinger, PhD (Philadelphia College of Osteopathic Medicine), Christine Grady, RN, PhD (NIH Clinical Center Department of Bioethics), Steven Joffe, MD, MPH (University of Pennsylvania), Scott Kim, MD, PhD (NIH Clinical Center Department of Bioethics), Barbara Langloss (Patient Representative), and Leslie Wolf, JD, MPH (Georgia State University College of Law). In the smoking trial, the upper confidence limit of 1.15 must be cubed to account for the 3-unit difference between the 25th and 75th percentiles of the risk perception distribution (eTable 7 in Supplement 2), yielding an upper limit of 1.52 (eTable 4 in Supplement 2). Social complexities of informed consent and assent among young males undergoing voluntary medical male circumcision in Eswatini. , Krutsinger G, Emanuel Sensitivity analyses for ruling out undue inducement using lower non-inferiority margins, eTable 9. RG, Kieburtz However, balance for incentive types and amounts can be difficult to . RETAIN indicates the Randomized Evaluation of Trial Acceptance by Incentive study. , Viens et al. We chose noninferiority analyses rather than traditional superiority tests of these terms because concerns about undue and unjust inducement commonly limit the use of incentives in research, meaning that the burden of proof for practice to change requires establishing that such unintended consequences are unlikely to arise. Primary analyses used logistic regression, which was adjusted for site and prespecified patient characteristics (Supplement 1), to evaluate the main effects of incentives on consenting to participate in the parent trial and the 3 interaction terms of interest: between incentive and perception of research risk (as the measure of undue inducement) and between incentive and income and incentive and financial well-being (as 2 measures of unjust inducement).31,33 In the primary analysis, to maximize power, we entered incentives into logistic models as a continuous variable with values 0, 1, and 2 to promote consistency between the 2 trials. Reinhoudt-den Boer L, van Wijngaarden J, Huijsman R. Health Expect. The different results could also be because of unmeasured differences in the characteristics of the samples or differences in the interventions or recruitment settings of the 2 trials. SS, Cotner Fair payment or undue inducement? Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement, Measuring change in personal economic well-being. Ethical implications of economic compensation for voluntary medical male circumcision for HIV prevention and epidemic control. These factors emphasize the need for ethical incentive decision-making guidelines, especially in biomedical HIV research. Recruitment to randomised trials: strategies for trial enrollment and participation study. 2010 Oct;10(10):19-36. doi: 10.1080/15265161.2010.519233. PN. Funding/Support: This work was supported by the National Cancer Institute, R01CA197332 and R01CA184211. Clinical research with economically disadvantaged populations. Thus, research regulators should relax restrictions on the use of incentives that are designed to improve enrollment in low-risk trials. The recruitment strategy for the RETAIN trial that was embedded within the ambulation trial was changed after the first 30 patients were enrolled (Supplement 1). For example, an incentive-by-risk interaction OR of 2.0 would be found if enrollment dropped from 40% to 25% with increasing risk perception among patients who were not assigned to incentives, but remained constant at 40% across levels of risk perception among patients who received incentives (eTable 4 in Supplement 2). PLOS Glob Public Health. We find that, in the vast majority of situations, the use of incentives in medical . Inclusion in an NLM database does not imply endorsement of, or agreement with, Recruitment to randomised trials: strategies for trial enrollment and participation study. FOIA , Halpern JA, Asch Second, although many ethicists and research regulators have worried that research incentives may unduly induce participation by masking participants to risk and preventing fully informed consent,18,23,28,29,46,47,48,49,50,51 in these 2 trials, incentives were not associated with patients perceptions of research risks and did not significantly modify patients sensitivity to increased risks as a factor that governed their willingness to enroll. All other elements of the consent processes for the parent trials were identical across incentive groups. Paying people to participate in research: why not? 2023 Feb;26(1):268-281. doi: 10.1111/hex.13653. Unable to load your collection due to an error, Unable to load your delegates due to an error. We equalized payments to reward people identically for their contributions to the parent RCTs. RD, Two scales for measuring patients perceptions for coercion during mental hospital admission, A distribution-free k-sample test against ordered alternatives. Hypertensive patients willingness to participate in placebo-controlled trials: implications for recruitment efficiency. PubMed. Paying research subjects: an analysis of current policies. Incentives in research: ethical issues The participation of some subjects in research may be association with their receiving some compensation for their time and effort. The EWG provides ethics advice for research carried out by the HPTN. approaches to payment for research participation. A, Craig DR. In 2 randomized clinical trials (including 1296 total participants) of real incentives for participation in 2 separate real parent trials, we found that incentives increased enrollment considerably in 1 trial but did not affect enrollment in the other. M, Cook sharing sensitive information, make sure youre on a federal Critical revision of the manuscript for important intellectual content: Halpern, Bayes, Hitsman, Schnoll, Lubitz, Reyes, Patel, Greysen, Mercede, Barg, Volpp, Karlawish, Stephens-Shields. Measuring change in personal economic well-being. Table 2 presents secondary outcomes for both trials, all of which were evaluated with traditional superiority tests. We acknowledge the outstanding guidance we received from our ethics advisory board members: Tim Coetzee, PhD (National Multiple Sclerosis Society), Ezekiel Emanuel, MD (University of Pennsylvania), David Festinger, PhD (Philadelphia College of Osteopathic Medicine), Christine Grady, RN, PhD (NIH Clinical Center Department of Bioethics), Steven Joffe, MD, MPH (University of Pennsylvania), Scott Kim, MD, PhD (NIH Clinical Center Department of Bioethics), Barbara Langloss (Patient Representative), and Leslie Wolf, JD, MPH (Georgia State University College of Law). , Treweek Both of these concerns have been challenged on conceptual grounds,19,20,25,28,29 and studies that assess how willing people are to participate in hypothetical RCTs have provided limited empirical support for the view that incentives increase enrollment without yielding either of these unintended ethical consequences.30,31,32 However, evidence of how real incentives affect decisions to participate in real trials is needed to optimally inform research regulations and international practice. All 659 eligible participants in the smoking trial who presented during the RETAIN collaboration were randomized, as were 646 of 652 eligible participants (99.1%) in the ambulation trial. Relationship between risk perception and enrollment by incentive stratum in the ambulation trial, eMethods 1. Dr Volpp reported grants from the National Cancer Institute during the conduct of the study and being a partial owner of VAL Health and grants from Humana, WW, Vitality/Discovery, and HMSA outside the submitted work. The site is secure. The https:// ensures that you are connecting to the Inducement in research. EA, Timpson KR. The influence of risk and monetary payment on the research participation decision making process. , Rosenstone Data Sharing Statement: See Supplement 3. Third, although the generalizability of our results is strengthened by conducting 2 embedded trials within different parent trials that differed in their true risks, neither of these parent trials posed particularly high risks. The protocols for the 2 embedded trials33 that moved forward are also described in Supplement 1 and were approved by IRBs at the University of Pennsylvania and Northwestern University using a waiver of the requirement for informed consent (eMethods 3 in Supplement 2). Question Questions and scoring of the compared riskiness (i.e., risk perception) scale, National Library of Medicine These documents indicated the payment for research participation in the trial summary on the first page and in all subsequent sections that described the costs to participate. Assuming that 50% of RETAIN patients would choose to enroll in each parent trial, a true interaction OR of 1, and using a 1-sided significance level of P=.04 following 2 interim analyses such that the upper 95.73% confidence limit on the observed OR would have to fall below the noninferiority threshold to rule out undue inducement, we calculated that 576 patients in each embedded trial would provide at least 80% power to conclude that undue inducement did not manifest. Acquisition, analysis, or interpretation of data: Halpern, Chowdhury, Bayes, Cooney, Hitsman, Schnoll, Lubitz, Reyes, Patel, Greysen, Mercede, Reale, Barg, Karlawish, Stephens-Shields. We followed the guidelines for reporting embedded recruitment trials5 and several aspects of the Consolidated Standards of Reporting Trials extension for noninferiority trials35 because portions of the analytic plan entail tests of noninferiority. JA. E. Trial Registration Undue inducement: nonsense on stilts? We repeated all analyses of secondary outcomes after weighting for the inverse probability of response. The recruitment strategy for the RETAIN trial that was embedded within the ambulation trial was changed after the first 30 patients were enrolled (Supplement 1). Similar power would exist to conclude that incentives did not represent unjust inducements, as indicated by an interaction OR of 2.0 or greater between either (1) income and incentive amount or (2) financial well-being and incentive amount. We thank Casey Whitman, MS, for assistance preparing analyses for presentation in this manuscript and Jacqueline McMahon, MSW (University of Pennsylvania Perelman School of Medicine) for her leadership, perseverance, and diligence as we launched, implemented, and monitored these trials. Patients who indicated any prior familiarity were deemed ineligible for RETAIN. , Krutsinger G, Elbourne Rethinking the Ethics of Clinical Research. BGO, Julious Second, although many ethicists and research regulators have worried that research incentives may unduly induce participation by masking participants to risk and preventing fully informed consent,18,23,28,29,46-51 in these 2 trials, incentives were not associated with patients perceptions of research risks and did not significantly modify patients sensitivity to increased risks as a factor that governed their willingness to enroll. et al. Supervision: Cooney, Hitsman, Schnoll, Reale, Barg, Stephens-Shields. , McNeill Carroll R, Antigua J, Taichman D, et al.. Halpern SD, Karlawish JHT, Casarett D, Berlin JA, Asch DA. et al. Paying people to participate in research: why not? HM, Reale but this raises complex accounting issues and the payment arrangements must be agreed with Finance. However, the findings that incentives did not modify the relationships between research attitudes and enrollment in either trial supports the conclusion that incentives did not unduly influence trial enrollment decisions. VW; Sandra Eldridge on behalf of MRC START Group and Gordon Forbes on behalf of the START Expert Consensus Group. If U-M researchers wish to conduct a as a form of incentive payment, or as a part of research with human subjects, they must comply with federal policy and State of Michigan Act 382 of 1972. All 659 eligible participants in the smoking trial who presented during the RETAIN collaboration were randomized, as were 646 of 652 eligible participants (99.1%) in the ambulation trial. Incentives did not increase consent among those in the ambulation trial: 98 of 216 (45.4%), 102 of 212 (48.1%), and 92 of 214 (43.0%) in the $0, $100, and $300 groups, respectively (aOR, 0.88; 95% CI, 0.64-1.22; P=.45). and A.S.) were unmasked to group assignment once data collection for both trials was complete to enable tests for trend and noninferiority, but the statistical analysis plan was finalized before unmasking. Similarly, the data were not compatible with incentives operating as unjust inducements in either trial because neither income (upper confidence limits of ORs, 1.21 and 1.26; P=.01 and P<.001) (Figure 2) nor financial well-being (upper confidence limits of ORs, 1.17 and 1.04; P=.003 and P<.001) (Figure 3) modified the effect of incentives. Second, we could not measure certain secondary outcomes, including therapeutic misconception and perceived coercion, among patients who chose not to participate in the parent trials. RETAIN comprised 2 RCTs. Similar conclusions that undue inducement was not present would have been reached using noninferiority margins as low as 1.6 and 1.8 in the smoking and ambulation trials, respectively (eTable 8 in Supplement 2). Accessibility Statement, Our website uses cookies to enhance your experience. J, Taichman Research coordinators administering the consent processes in both parent trials were unmasked to the incentive information but adhered to IRB-approved communication scripts. Patients were also no more likely to perceive being coerced when offered incentives. Relationship between risk perception and enrollment by incentive stratum in the smoking trial, eFigure 2. SJ, Evans The STEPS study, A nudge toward participation: Improving clinical trial enrollment with behavioral economics. Ending concerns about undue inducement. Accessibility In this paper I consider how these issues arose in a research project with lone mothers and the way in which offering payments might help with gaining access to . , McNeill CE, John London In the smoking trial, the 5th percentile=less than $10000, 25th percentile=$10 to $19000, 50th percentile=$20 to $29000, 75th percentile=$30 to $49000, 95th percentile=$100000 or more, and mean=$20 to $29000. S, Bierer doi: 10.1097/01.MLR.0000023958.28108.9C. , Caldwell There were low rates of possible and likely therapeutic misconceptions in both trials, which did not differ by incentive group. IG, Kornetsky J, McCurdy We repeated all analyses of secondary outcomes after weighting for the inverse probability of response. We followed the guidelines for reporting embedded recruitment trials5 and several aspects of the Consolidated Standards of Reporting Trials extension for noninferiority trials35 because portions of the analytic plan entail tests of noninferiority. In the ambulation trial, the significance of the corresponding interaction term (interaction OR, 0.83; 95% CI, 0.38-2.06; P = .048) was slightly greater than the adjusted threshold of P = .043 required to conclude that there was no evidence of undue inducement (eTable 10 in Supplement 2). C. RD, White 2022 May;7(5):e007918. , Pentz Am J Bioeth. In the $0 arms, these sections stated that participants would not be paid for enrolling. Research by Wharton management professor Maurice . Main Outcomes and Measures Michigan Penal Code Act 328 of 1931. Ak Narayan Poudel, D. Newlands, P. Simkhada. Participants eligible for RETAIN were those approached for informed consent to participate in the smoking or ambulation trials.33 Embedded RETAIN recruitment in these trials occurred from September 2017 through August 2019 and from January 2018 through May 2019, respectively. BMJ Glob Health. , Halpern This is a necessary limitation in evaluating incentives within real RCTs because the risks of real trials are not malleable. Key measures obtained at this stage included income, financial well-being,36 and score on the Research Attitudes Questionnaire7 (RAQ-7),37 a measure with high internal consistency and factorial validity38,39 in which higher scores indicate more favorable views of research. For the smoking trial, recruitment first entailed a telephone conversation with a study coordinator, during which initial eligibility was assessed and patient characteristics (Table 1) were measured. In contrast with prior hypotheses,53 incentives did not affect rates of therapeutic misconception, possibly because these rates were so low among patients who consent to participate in these 2 parent trials. SD, Karlawish R, Antigua The median percentage of correct responses to the 6 trial understanding questions was 67% in all smoking trial groups and 100% in all ambulation trial groups. In the ambulation trial, the significance of the corresponding interaction term (interaction OR, 0.83; 95% CI, 0.38-2.06; P = .048) was slightly greater than the adjusted threshold of P = .043 required to conclude that there was no evidence of undue inducement (eTable 10 in Supplement 2). , Bentley Relationship between risk perception and enrollment by incentive stratum in the ambulation trial, eMethods 1. JC. EJ, Currie We reasoned that if the relationship between patients favorable views of research and their odds of enrolling was modified by incentives, then incentives may unduly alter the nonfinancial motivations for people to participate. Bethesda, MD 20894, Web Policies We understand the ethical issue of undue influence as an issue, not of coercion, but of corruption of judgment. Med Care. , Shah Am J Bioeth. Results suggest incentives matter in achieving participation in qualitative research, but there may be diminishing returns.
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