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). JP A. Recruitment and consent scripts. 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. But incentives can also be viewed as one way to get others to do what they otherwise . J, McCurdy The EWG provides ethics advice for research carried out by the HPTN. We designed the 2 embedded trials such that each was independently powered to determine that incentives did not represent undue inducements, defined by the interaction between incentive size and perceived trial risk,31 using a noninferiority margin of 2.0 for the interaction odds ratio (OR). Effect of Income on Relationships Between Incentives and Trial Enrollment, Figure 3. However, balance for incentive types and amounts can be difficult to . Macklin MS, Rick 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. A piece of my mind: subject to payment? Research coordinators administering the consent processes in both parent trials were unmasked to the incentive information but adhered to IRB-approved communication scripts. Med Care. Key elements and risks of the trial were then described, and the assigned incentive was revealed (eMethods 1 in Supplement 2). Patients approached for the smoking trial were randomized to receive $0, $200, or $500 for participation. An official website of the United States government. A more likely explanation is that the benefits of the ambulation trial relative to the risks were perceived to be high, yielding higher baseline consent rates and fewer patients whose decisions could be altered by incentives. Relationship between risk perception and enrollment by incentive stratum in the smoking trial, eFigure 2. Trial protocol and statistical analysis plan, eTable 1. Federal government websites often end in .gov or .mil. Therapeutic misconception, misestimation, and optimism in participants enrolled in phase 1 trials. The findings from these 2 RCTs of financial incentives embedded within parent trials with different sample characteristics provide real-world confirmation of hypothetical studies that also had not identified ethical problems with incentives for research participation. Drafting of the manuscript: Halpern, Chowdhury, Cooney, Reale. Research coordinators administering the consent processes in both parent trials were unmasked to the incentive information but adhered to IRB-approved communication scripts. , Carroll The site is secure. The higher incentive sizes in the smoking trial are unlikely to explain the different results because the $300 incentive in the ambulation trial was ineffective, whereas the $200 incentive in the smoking trial increased enrollment. DA. Recruitment occurred from September 2017 to August 2019 for the smoking trial and January 2018 through May 2019 for the ambulation trial; data were analyzed from January 2020 to July 2020. but this raises complex accounting issues and the payment arrangements must be agreed with Finance. et al. JA, Asch SD. EJ. We equalized payments to reward people identically for their contributions to the parent RCTs. a response to Wilkinson and Moore. We therefore undertook the Randomized Evaluation of Trial Acceptance by Incentive (RETAIN) study to examine, in 2 separate RCTs embedded within different parent trials, the extent to which incentives produced several intended and unintended influences on the decision for patients to enroll.33 Our primary goals were to evaluate whether incentives increase trial enrollment among eligible patients and whether incentives constitute either undue or unjust inducements. The https:// ensures that you are connecting to the 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). Socio-economic status and inducement to participate. 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. The integrity of researchers is paramount. The https:// ensures that you are connecting to the Sensitivity analyses for ruling out unjust inducement using lower non-inferiority margins, eTable 10. Statistical analysis: Chowdhury, Bayes, Stephens-Shields. Research Incentive Guidelines | Research Ethics & Compliance 11,12 The most commonly cited 19,21 concern with incentives for research participation is that incentives may represent undue inducements by diminishing peoples . Percentile distributions of perceived riskiness scores in smoking and ambulation trials, eTable 8. Financial incentives for research participation: empirical questions, available answers and the burden of further proof. 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Payment of clinical research subjects - PMC - National Center for The primary outcome of each incentive trial was the proportion of people assigned to each recruitment strategy that consented to participate. However, the extent to which incentives increase enrollment is uncertain. the contents by NLM or the National Institutes of Health. Would you like email updates of new search results? G, Elbourne 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. Background. If a specific charity is named, this . Two scales for measuring patients perceptions for coercion during mental hospital admission, A distribution-free k-sample test against ordered alternatives. Older adults attitudes toward enrollment of non-competent subjects participating in Alzheimers research. All Rights Reserved, Challenges in Clinical Electrocardiography, Clinical Implications of Basic Neuroscience, Health Care Economics, Insurance, Payment, Scientific Discovery and the Future of Medicine, 2021;181(11):1479-1488. doi:10.1001/jamainternmed.2021.5450. 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). Interventions Strategies to improve recruitment to randomised trials. Conflict of Interest Disclosures: Dr Hitsman reported nonfinancial support from Pfizer during the conduct of the study. Motivations of patients with pulmonary arterial hypertension to participate in randomized clinical trials. K. W, Hoge Could providing financial incentives to research participants be Cryder CE, John London A, Volpp KG, Loewenstein G. Informative inducement: study payment as a signal of risk. 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. We find that, in the vast majority of situations, the use of incentives in medical . This is a necessary limitation in evaluating incentives within real RCTs because the risks of real trials are not malleable. 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. Table 1 presents the characteristics of patients enrolled in the 3 groups of each trial. S, Williams Paying people to participate in research: why not? KL, Ellenberg Administrative, technical, or material support: Halpern, Chowdhury, Bayes, Cooney, Hitsman, Schnoll, Lubitz, Reyes, Greysen, Mercede, Reale, Volpp, Karlawish. This study has limitations. In neither trial was there evidence of undue or unjust inducement (upper confidence limits of ORs for undue inducement, 1.15 and 0.99; P<.001 showing noninferiority; upper confidence limits of ORs for unjust inducement, 1.21 and 1.26; P=.01 and P<.001, respectively). Medicine series on research integrity that examines issues affecting the ethics of health research worldwide. 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). Third, incentives did not function as unjust inducements, as they were not preferentially motivating across groups with different income levels or financial well-being in either trial. Careers. 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. Effectiveness and Ethics of Incentives for Research - PubMed Ethical implications of economic compensation for voluntary medical male circumcision for HIV prevention and epidemic control. 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. , Cryder 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. In the $0 arms, these sections stated that participants would not be paid for enrolling. , Bentley 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. Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group . Is psychiatric research stigmatized? 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. Error bars represent 95% CIs. Guidelines for reporting embedded recruitment trials. 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). In the smoking trial, consent rates were 21.8%, 35.9%, and 47.1% in the $0, $200, and $500 arms, respectively (P<.001).
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