Paying Clinical Research Participants: One Institution's Research Ethics Committees' Perspective

Abstract

REGULATORY GUIDELINES LEAVE determination of coercion and undue influence of research participants open to interpretation. A web-based survey was conducted of the research ethics committees members at Virginia Commonwealth University (VCU) to evaluate their perspectives on paying participants in clinical research via general questions, as well as 8 short cases involving hypertension placebo-controlled trials, a pilot exercise study, a survey of substance abusers, a healthy-volunteer pharmacokinetic study, a twin study involving DNA samples, and an asthma medication study in children. Research ethics committee members were asked to state what payment they would consider appropriate for a given type of protocol. The results suggest that risk, time required, reimbursement for expenses, and inconvenience were important in determining appropriate payment, while income and funding source were not. The case studies revealed wide variation in recommended payments both within type of study and between studies.

Commonly performed procedures in clinical research: A benchmark for payment

“…Further support for using these numbers as possible benchmarks comes from their concordance with a few other available lists of per procedure payment amounts [14, 15] as well as one research study that asked investigators to propose a payment amount for common procedures [16, 17]. Although not all of the same procedures are included, each of these list similar payment amounts for some commonly performed procedures (Table 2).…”

Why Do We Pay? A National Survey of Investigators and IRB Chairpersons

“…The surveys were piloted locally with Virginia Commonwealth University (VCU) IRB members and investigators (Ripley et al, 2008; Ripley et al, 2006) and nationally utilizing a web-based survey of Western IRB (WIRB) members. Both surveys in this study asked similar questions.…”

“…In reporting this Australian study, Fry et al (2005) called for empirical research to identify how ethics committees and investigators make decisions about participant payment practices. Data from two single United States (US) institution studies by Ripley et al (2008) and Ripley, Macrina, & Markowitz (2006) showed variable opinions regarding payment among and between investigators and IRB members at a single institution, but there was a consensus that risk was a major determinant of payment. These studies looked at pragmatic answers to payment at one institution.…”

Who's Doing the Math? Are We Really Compensating Research Participants?

“…The survey asked best answer, multiple choice, and open text questions. The surveys had previously been piloted locally (Ripley et al, 2008; Ripley, Macrina, & Markowitz, 2006). Descriptive statistics were used where appropriate and are reported as percentage or mean ± SD.…”