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| Medical Trial Volunteers Equate Pay with Risk |
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| SciMed - Horizons | |||
| TS-Si News Service | |||
| Tuesday, 08 December 2009 10:00 | |||
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Fairfax, VA, USA. High-paying research studies raise a red flag for volunteers and signal high levels of risk, according to a new study. Research institutions view payments to volunteers as compensation for time and expenses, not as compensation for potential risks related to participating in the experiments. Volunteers have a very different view of compensation. A medical trial (or clinical or drug trial) tests a medical therapy or drug for potential benefits and threats. More than 15 million Americans participate annually in clinical trials, according to the Alliance for Human Research Protection (AHRP), and most will be compensated for their participation. Travel time, expenses and any medical exams or care may also be covered. Participants are expected be used as research cases in the clinical trial and record any information relative to the test. The reported decision of volunteers to equate higher compensation with elevated risk has implications for informed consent in human subjects research and the debate over research participation incentives. Cynthia Cryder, assistant professor of Marketing at the Olin Business School, Washington University in St. Louis, is the lead author. Her co-authors are Alex John London and George Loewenstein at Carnegie Mellon University and Kevin G. Volpp at the University of Pennsylvania School of Medicine and the Wharton School. Their paper appears in the journal Social Science and Medicine.
"At a big-picture level, what stands out from these results is that research participants do not just consider participation payments as an incentive to be traded off for their time." Cryder explains. "They actually infer information about the study itself from the participation payment." Cryder and colleagues conducted three experiments using an online nationwide sample or a sample from a northeastern U.S. city in 2007-2008. The researchers measured the interest of people toward participating in potentially risky research studies, their perception of the risk associated with those studies and how payment amounts affected their interest and perceptions. The study finds that while high pay is a real incentive for people to participate in clinical trials, it also increases the "perceived risk" of the trial and the time potential volunteers spend researching and viewing information about risks related to the trial. "Specifically in our experiments," Cryder explains, "they [participants] judge studies that offer high payments to be riskier than identical studies that offer low payments."
George Loewenstein, the Herbert A. Simon Professor of Economics and Psychology at Carnegie Mellon and co-author of the study, says these findings contradict some of the common guidelines used for establishing participation incentives. "Most organizations that do research prohibit participation payments that substantially exceed compensation for time and expenses. The fear is that people will be overly tempted by high payments to take excessive risks," says Loewenstein. "Our research challenges this common practice. It suggests that people assume that studies that don't pay much aren't risky." The study concludes that there is a "mismatch" between current research guidelines for setting compensation levels and the assumptions participants make about the levels of pay and risk. Loewenstein explains that "Contrary to the assumption that high payments are excessively tempting, our research suggests that they alert subjects to potential risk and make them more vigilant about protecting themselves. An added bonus of high payments is that it is ethically sensible for people to be adequately compensated when they do, in fact, incur risks." The authors of the study believe their findings should contribute to the debate over research participation incentives and informed consent. The way potential human subjects interpret payment, risk and information about clinical trials as documented in the Cryder et al paper sheds new light on the role of the human subjects in research. CitationInformative inducement: Study payment as a signal of risk. Cynthia E. Cryder, Alex John London, Kevin G. Volpp, and George Loewenstein. Social Science & Medicine 2009; ePub ahead of print. doi 10.1016/j.socscimed.2009.10.047
Abstract In research involving human subjects, large participation payments often are deemed undesirable because they may provide ‘undue inducement’ for potential participants to expose themselves to risk. However, although large incentives may encourage participation, they also may signal the riskiness of a study's procedures. In three experiments, we measured people's interest in participating in potentially risky research studies, and their perception of the risk associated with those studies, as functions of participation payment amounts. All experiments took place 2007–2008 with an on-line nationwide sample or a sample from a northeastern U.S. city. We tested whether people judge studies that offer higher participation payments to be riskier, and, if so, whether this increased perception of risk increases time and effort spent learning about the risks. We found that high participation payments increased willingness to participate, but, consistent with the idea that people infer riskiness from payment amount, high payments also increased perceived risk and time spent viewing risk information. Moreover, when a link between payment amount and risk level was made explicit in Experiment 3, the relationship between high payments and perceived risk strengthened. Research guidelines usually prohibit studies from offering participation incentives that compensate for risks, yet these experiments' results indicate that potential participants naturally assume that the magnitude of risks and incentives are related. This discrepancy between research guidelines and participants' assumptions about those guidelines has implications for informed consent in human subjects research. Keywords: risk, incentives, ethics, participant payments; human participants research; usa, informed consent.
 The TS-Si News Service is a collaborative effort by TS-Si.org editors, contributors, and corresponding institutions. Sources can include the cited individuals and organizations, as well as TS-Si.org staff contributions. Articles and news reports do not necessarily convey official positions of TS-Si, its partners, or affiliates. We welcome your comments. Use the form below to leave a public comment or send private correspondence via the TS-Si Contact Page. We will not divulge any personal details or place you on a mailing list without your permission.TS-Si is dedicated to the acceptance, medical treatment, and legal protection of individuals correcting the misalignment of their brains and their anatomical sex, while supporting their transition into society as hormonally reconstituted and surgically corrected citizens.
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