The Recruitment of Normal Healthy Volunteers: A Review of The Literature on the Use of Financial Incentives

Abstract

Unresolved issues of ethical, methodological, and legal concerns in the use of normal healthy volunteers persist. Financial incentives in their recruitment offer a unique ethical dilemma because of questions surrounding payment. A review of literature was conducted to obtain research systematically examining volunteer motivation and the role offinancial incentives. The primary selection criterion was motivation and payment to volunteers; seven studies met the criterion for review. Studies that have systematically investigated volunteer motivation have found financial rewards to be an important motivator among normal healthy volunteers in their decision to participate in clinical trials. Also evident is that differences based on demographic characteristics exist in the motivation and rates of volunteerism. Ethical issues surrounding the use of normal healthy volunteers are discussed, with attention to the issue offinancial incentives (e.g., economically vulnerable volunteers, undue inducements). Regulations, guidelines, and recommendations are discussed with regard to volunteers and financial incentives.

Methods and Strategies to Recruit African Americans into Cancer Prevention Surveillance Studies

“…Not unexpectedly, incentive-based strategies, including the promise of an incentive, yielded the highest responses, regardless of approach letter. Many, but not all studies, have similarly shown that both monetary and nonmonetary incentives increase study participation across various participant subgroups (16,21,24,25). Incentives were equally effective across all demographic subgroups, in contrast to other investigations that have reported greater effectiveness of incentives in some demographic groups (25,26).…”

“…Many, but not all studies, have similarly shown that both monetary and nonmonetary incentives increase study participation across various participant subgroups (16,21,24,25). Incentives were equally effective across all demographic subgroups, in contrast to other investigations that have reported greater effectiveness of incentives in some demographic groups (25,26). Nonetheless, we note that some studies have also found that factors such as altruism, personal satisfaction, and learning about diet and health are much stronger motivations for participation than incentives (27,28).…”

Payment of clinical research subjects

“…Similarly, people participate in clinical research for multiple reasons, and money may be one among those reasons or even the main reason. Limited data suggest that the offer of money is one factor in the decision making of some, but not all, potential participants (21,24,(36)(37)(38)(39)(40).…”

“…Healthy subjects are often motivated by money to participate in research, receive little or no benefit from participation, and may appropriately be considered independent contractors in research (40). Paying money to healthy volunteers is widely accepted, although concerns about undue inducement and distributive justice may still pertain.…”

Patient recruitment and experiences in a randomised trial of supervised exercise training for individuals with abdominal aortic aneurysm

“…24 However, the ethics of such an approach needs to be 11 considered, as argued by Tishler. 25 The two main concerns are undue inducement and taking 12 advantage of economically vulnerable patients. As well as the ethical issues of undue inducement, 13 financial incentives also have the potential to encourage false information from whomever the 14 inducement is aimed.…”