Undue worry about paying research participants?

Abstract

Why do we keep worrying about paying research subjects? Offering payment to research participants is a longstanding and widespread practice, similar to paying people in other kinds of transactions, yet disagreement persists about the appropriateness and practice of paying participants [1]. At the same time, money has a pervasive presence in the conduct of clinical research. The estimated total spending on health-related research and development by the drug industry and the Federal government has tripled since 1990 [101]. Conducting clinical research is expensive; estimated per patient costs for a clinical trial can exceed US$47,000 [102]. Pharmaceutical and biotech sponsors, although they spend millions conducting research, are among the most profitable companies globally. Private and public research sponsors pay large amounts of money to clinical researchers, contract research organizations, data managers, recruiters and others to help conduct efficient and quality trials. Significant recent attention has focused on potential conflicts raised by investigator and institutional financial interests [2]. In spite of this large and growing research enterprise, available estimates suggest that the average payment per participant for a research study – when they receive any payment – is usually quite modest, although there is a range of dollar amounts and details about payment are limited [3]. Timely and adequate recruitment, vital for successful clinical research, can be difficult and cause delays in study completion. Offering money to research participants may be critical for recruitment, and could save money overall. Evidence suggests that payment is an important recruitment incentive for healthy volunteers [4], improves response rates in social science research [5], and increases willingness to participate in hypothetical studies [6]. There are more limited data on the effectiveness of payment in recruiting patients into clinical research studies [7]. Patients often enroll in research because they are seeking treatment for their condition, want access to treatment otherwise unavailable, or are following the recommendations of their physician. More research is needed to evaluate the effect and acceptability of monetary incentives for recruitment into clinical research. Accumulating data from the use of monetary incentives for adherence and behavioral change may offer some insights [8]. Even more limited data exist on the effectiveness of payment for retention in clinical studies, also critical to successful trial completion. Although money may motivate people to participate in research, participants are offered payment for reasons beyond recruitment. Commonly, money is offered as reimbursement for travel and other expenses in order to simply make participation “It is time to stop worrying and move forward on developing guidance for determining reasonable amounts of money to offer research participants in different studies and settings.”