Increasing the amount of payment to research subjects

Abstract

This article discusses some ethical issues that can arise when researchers decide to increase the amount of payment offered to research subjects to boost enrollment. Would increasing the amount of payment be unfair to subjects who have already consented to participate in the study? This article considers how five different models of payment—the free market model, the wage payment model, the reimbursement model, the appreciation model, and the fair benefits model—would approach this issue. The article also considers several practical problems related to changing the amount of payment, including determining whether there is enough money in the budget to offer additional payments to subjects who have already enrolled, ascertaining how difficult it will be to re-contact subjects, and developing a plan of action for responding to subjects who find out they are receiving less money and demand an explanation.

Healthy volunteers and early phases of clinical experimentation

“…Among the proposed ways, those indicated by Iltis et al [21] and Resnick [29] appear to be quite interesting. Iltis et al [21] underline the conflict existing between the practice of providing appropriate payments that avoid undue influence and the requirements of justice when recruiting normal healthy volunteers for phase I clinical trials.…”

“…Several authors support the opportunity of a reimbursement to healthy volunteers [22][23][24][25][26][27][28][29][30][31][32] and propose different hypotheses to resolve this issue. Among the proposed ways, those indicated by Iltis et al [21] and Resnick [29] appear to be quite interesting.…”

Drug Experimentation in Healthy Volunteers

“…Several authors support the opportunity of a reimbursement to healthy volunteers and propose different hypotheses to resolve this issue (Pasqualetti et al, 2010). Among the proposed ways, those indicated by Iltis (2009) andResnick (2008) appear to be quite interesting. Iltis (2009) underlines the conflict existing between the practice of providing appropriate payments, thus avoiding undue influence, and the requirements of justice when recruiting normal healthy volunteers for phase I clinical trials.…”

“…The first two models represent a form of "compensated labour" and could motivate individuals to take part in a clinical trial merely to obtain consistent gains. By contrast, the remaining models reflect a "free and voluntary contribution" to community, but they can't embrace the actual motivations of healthy volunteers, who might be seeking free clinical tests or monetary gain (Resnick, 2008). The lack of international and local guidelines about some crucial aspects related to the recruitment of healthy volunteers in early phase clinical trials, such as the definition of healthy status, payments, advertisement, and participation of the same subject in different experimentations, stimulated a proposal by the Centre for Clinical Drug Experimentation of Pisa University Hospital to implement specific operative procedures (Pasqualetti et al, 2010), attempting to properly address the following issues: (1) advertising to healthy volunteers for recruitment in early phase clinical trials after approval by the local ethics Committee; (2) evaluation of the clinical and psychological status of a potential healthy volunteer; (3) creation of a database containing information on selected healthy subjects to be contacted for possible enrollment in a clinical trial, and allowing a proper monitoring of their participation in different experiments; (4) calculation of adequate reimbursements to healthy volunteers participating to clinical trials.…”

“…An alternative way to decrease or increase payments homogeneously is to offer reimbursements based on various and personalized contributions, which may differ according to the specific procedures required by trial protocols (Iltis, 2009). Resnick (2008) describes five distinct models of payments to research subjects: (1) free market model: subjects are paid for providing services (such as completing surveys and undergoing tests and procedures), goods (such as blood, tissue or other biological samples), and to cover potential risks; (2) wage payment model: participants earn a wage equivalent to that of a typical unskilled labourer; (3) reimbursement model: in this setting, participation in clinical research is regarded as a public service (altruism) and volunteers can be paid for their travel expenses, lost wages, baby sitting expenses, etc. ; (4) appreciation model: subjects are not compensated for the costs of participation, but they receive money or gifts, such as t-shirts, mugs, gift certificates, as a sign of the investigators' appreciation; (5) fair benefits model: subjects are neither paid labourers nor paid volunteers, but partners in research, sharing the benefits of research, including the economic ones.…”