Elsevier

Contemporary Clinical Trials

Volume 41, March 2015, Pages 55-61
Contemporary Clinical Trials

Payment expectations for research participation among subjects who tell the truth, subjects who conceal information, and subjects who fabricate information

https://doi.org/10.1016/j.cct.2014.12.004Get rights and content

Abstract

Multiple models guide researchers' payment practices but few studies have assessed subjects' expectations for payment. Payments in excess of subjects' expectations may result in undue inducement, while payments below these expectations may be associated with exploitation. Data on subjects' payment expectations will help inform practices to avoid undue inducement and exploitation. This study examined subjects' expectations for payment for common research procedures and explored the relationship between subjects' honesty and payment expectations.

One-hundred subjects who participated in two or more studies in the last year reported the minimum payment they expect for completing study procedures. They were also asked about their use of deception while screening for studies.

Subjects expected $20 on average to complete the least risky and least burdensome procedure. Subjects' expectations for payment consistently increased with greater procedure risks. Subjects who denied using deception to enroll in studies refused more procedures than subjects who reported using deception. Among subjects who used deception, the rate of procedure refusal increased with procedure risks, suggesting that these subjects have some risk aversion and may act to protect themselves from undue inducement. Although subjects expect greater payments for more risky procedures, ethical considerations for limiting undue inducement may prevent researchers from meeting subjects' expectations. Subjects who use deceptive practices appear to be more risk-tolerant than subjects who deny using deception; nonetheless, these deceptive subjects also exercise some risk aversion when they refuse higher-risk procedures. These subjects may be able to protect themselves from undue inducement by refusing procedures that exceed their risk tolerance.

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.

References (13)

There are more references available in the full text version of this article.

Cited by (9)

  • Effects of financial incentives on volunteering for clinical trials: A randomized vignette experiment

    2021, Contemporary Clinical Trials
    Citation 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 Trials
    Citation 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 Philosophy
View all citing articles on Scopus
View full text