Payment expectations for research participation among subjects who tell the truth, subjects who conceal information, and subjects who fabricate information
Introduction
Payment is a critical component of clinical research, yet most of the discussion of payment practices has focused on ethics and policies without including the subjects' payment perspectives. High levels of reimbursement could compromise subjects' ability to consent [1] and induce subjects to take risks that they would ordinarily refuse [2]. Because financial inducement may be more compelling to economically disadvantaged populations, overpaying research subjects may lead one segment of the population to assume disproportionate risks [3]. Multiple models exist as to guide payment practices: the Wage Payment Model provides subjects with a fair wage; the Market Model provides subjects with payments that are sufficient to enroll subjects given local market conditions; the Reimbursement Model provides reimbursement for expenses; the Token of Appreciation Model provides a small gift; and the Fair Share Model proposes paying subjects a percentage of the money that is owed to the investigator team [4], [5], [6]. Although following these models may provide some assurance that research subjects are appropriately compensated, debate has centered on which model of payment should be used, considering study characteristics (e.g., burden, potential for direct benefit), patient characteristics (e.g., vulnerability, socioeconomic status, age), and geographic characteristics (e.g., prevailing wage). What remains unaccounted for in this debate, however, are subjects' expectations regarding appropriate payments. Understanding subjects' perspectives could be instrumental in determining appropriate payments. Payment greatly above expectations may increase the risk of undue inducement while payment greatly below expectations of wage may result in feelings of exploitation [5]. Understanding expectations for payment could also provide some information about how subjects gauge study risks and apportion reimbursement expectations based on risk. Subjects' payment expectations are likely to increase for procedures involving higher levels of perceived risk.
Very few studies have directly assessed subjects' expectations for payment. Among the published studies that have assessed payment expectations, Slomka [7] found that low socioeconomic status, cocaine-using subjects expected at least $20 (US) to take part in any research study. Breitkopf and colleagues [8] reported that women enrolling in a sexual health study expected reimbursement to be linked to inconveniences of participation, study risks, and the invasiveness of study procedures. Czarny et al. [9] found that when healthy volunteers were asked about reimbursement for four hypothetical studies, they expected greater payments for the burden of a study than for the risks of a study. Scherer et al. [10] reported that adolescents with no previous research experience expected lower payments for an asthma study than adolescents with previous study participation.
With such limited information about research subjects' expectations of payment, the present study was conducted to assess subjects' expectations for payment to undergo commonly used procedures that vary in risk. The present study was designed to explore subjects' willingness to identify a payment amount that would induce them to undergo these procedures vs. refusing to undergo the procedures at any payment amount. The present study also examined the relationship between the subjects' payment expectations and the subject's use of deceptive practices when enrolling in research.
Section snippets
Methods
One hundred subjects were recruited through newsprint advertisements and an online posting. An advertisement seeking ‘experienced research subjects’ was placed in two major newspapers in Boston (Boston Herald and Boston Globe) as well as a free newspaper (Boston Metro) distributed to bus and train commuters in Boston. This advertisement was also placed in the “volunteers” section of Craigslist. Clinical researchers across major academic institutions use all four of these media outlets when
Analytic procedures
Values for reimbursement expectations and age are presented as mean values (± standard error) unless otherwise indicated. The proportions for gender groups and rates of refusal are shown as percentage values. Based on subjects' reported use of deceptive practices to enroll in studies, three “Subject Deception” groups were created to represent the different categories of lies that subjects use to improve the possibility of meeting study eligibility. Subjects who denied lifetime use of any
Results
Demographic characteristics of subjects are shown in Table 1. The mean age of this sample was 53. Greater than half of the sample was male (58% male, 42% female), and most subjects were either white (55%) or African American (37%). Roughly one-quarter (28%) of subjects reported completing a bachelor's degree or higher. Nearly two-thirds (62%) of subjects were retired, disabled, or unemployed, and more than half (58%) of subjects reported a household income below $30,001. Based on questions
Discussion
Consistent with Slomka's findings [7], subjects in this study expected no less than $20 on average to take part in any study procedure. Rates of reimbursement for some procedures are greater than the recommendations made by Dominguez et al. [12], who published payment guidelines based on historical rates of payment at a large NIH Clinical Center. For example, subjects in the present study expected an average payment of $31 for a blood sample; Dominguez and colleagues recommended an average
Limitations
The scope of research procedures that were presented to subjects may limit the generalizability of these findings. For studies that use specialized procedures or other variations of procedures that were not assessed in the present study (e.g., MRI with contrast), expectations for payment reported in this study may not be relevant to inform future payment practices. Future studies of payment expectations should include a wider range of commonly used research procedures. It is possible that
Funding
This work was supported by a grant R01 AA015923 awarded to D.A.C.
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Cited by (9)
Effects of financial incentives on volunteering for clinical trials: A randomized vignette experiment
2021, Contemporary Clinical TrialsCitation Excerpt :Researchers may often feel limited in knowledge about intended participants' perception of risk/burden from the intended research population [18–20] and participants' expectations [21]. Some data also suggests that the appropriate amount of financial incentive, as defined by prospective participants, can vary by factors such as respondent income or age and the perceived risk of the study [13,22,23]. Furthermore, researchers may need to contend with variability in institutional review board (IRB) assessments of acceptable incentives and avoidance of coercion [20].
Deception in clinical trials and its impact on recruitment and adherence of study participants
2018, Contemporary Clinical TrialsCitation Excerpt :A range of 36–40% of experienced research participants admitted in a survey that they had shared or received information from others to gain admission into clinical studies [4]. Our systematic review has several limitations, including scarcity of data; few studies have investigated deceit in research participants [4,8,10,13], and fewer studies have examined deceit as a primary objective. Most of the deceptive practices highlighted in our review were incidentally detected.
The ethical anatomy of payment for research participants
2022, Medicine, Health Care and PhilosophyComparing Payments Between Sociobehavioral and Biomedical Studies in a Large Research University in Southern California
2021, Journal of Empirical Research on Human Research Ethics