Currents in contemporary ethics: ethical and practical concerns in developing payment policies for research involving children and adolescents.

An Institute of Medicine (IOM) panel charged with reviewing the system for overseeing research involving children concluded in 2004 that Institutional Review Boards (IRBs), institutions engaged in research, and study sponsors should “adopt explicit written policies on acceptable and unacceptable types and amounts of payments related to [children’s] research participation.”1 We previously reported data on practices and policies in the U.S. regarding payments to children who participate in research and their parents.2 Here, we report additional results from our study and identify some of the decisions that must be made in developing payment plans and on which payment policies will be expected to offer guidance. We conclude that further conceptual analysis and empirical research are necessary before IRBs, institutions, and sponsors can develop specific rules on numerous aspects of payment. Nevertheless, payment policies that promote the ethical treatment of children in research and their parents can be developed. We propose a structure for such policies. At the time the 2004 IOM report on pediatric research was issued, very little was known about practices and policies related to payments to either children who participate in research or to their parents. We conducted a study to document such policies and practices in research that enrolled children from birth through adolescence.3 We developed a four-page survey that included open- and closed-ended questions and contacted the first or corresponding author of studies that met the following criteria: results were published in 2003 in Pediatrics, Archives of Pediatrics and Adolescent Medicine, Journal of the American Medical Association, or New England Journal of Medicine; (2) studies were conducted solely in the United States; (3) the first author was listed at an institution in the United States; (4) the study involved some prospective data collection…and (5) some research was conducted with children.4 Of the 175 eligible participants who received surveys, 81 completed the survey, for a response rate of 46.3 percent. Approximately one-half (51.9 percent, n=42) paid subjects, and the others (48.1 percent, n=39) did not. Cash (42.9 percent, n=18) and gift certificates (39.1 percent, n=16) were the most common forms of payment. For all 81 returned surveys, we used institutional Web sites and made direct contact with IRB offices when necessary to determine whether the institution had a policy that addressed payments to either children who participate in research or to their parents and whether those policies were in place at the time the studies that led to the publications in question were conducted. In the fall of 2005, 43 institutions (53.1 percent) had such policies. Some policies were more specific than others, and some included requirements that conflicted with guidelines in other policies. For example, three policies said that it was acceptable to correlate payments with risk, six said this was unacceptable, and the others did not address the issue.5 Of those 43 institutions that had policies in fall of 2005, only six (14 percent) had a policy in place when the published study was conducted. Our survey asked a number of questions about why investigators paid particular amounts of money for study participation or why they did not pay subjects, as well as their beliefs about the relationship between payment, recruitment, and retention. Only 4.8 percent (n=2) of investigators who reported paying subjects stated that study risks played a role in determining the amount of payment offered while 61.5 percent (n=24) of those who did not pay stated that the fact that a study involved only minimal risk influenced the decision not to pay subjects. We have further investigated the relationship between risks and payment amount. We used the Kruskal-Wallis test, a non-parametric approach, to compare differences in the amount of payment offered among different risk factors, namely the following: the amount of physical risk, the amount of psychological/emotional risk, the amount of social risk, the amount of physical discomfort, the amount of psychological/emotional discomfort, and the funding source. The non-parametric test is used when the value of the dependent variable does not have a normal distribution, when the dependent variable is highly skewed, or when the sample size is small. Results are reported in Table 1. There were significant differences among the categories in the amount of physical risk (x2=10.444, df=3, p<0.05), the amount of social risk (x2=7.173, df=2, p<0.05), the amount of physical discomfort (x2=7.811, df=2, p<0.05), and the amount of psychological/emotional discomfort (x2=6.561, df=2, p<0.05). There were no statistically significant findings in the amount of psychological risk or the funding type. No physical risk received the highest mean of ranking (35.33), followed by more than a minor increase over minimal risk (28), minor increase over minimal risk (24.29), and minimal risk (16.19). The pattern for other variables appeared to be the same. In other words, if investigators offered any payment, they offered a relatively large sum for studies that they stated posed no risk. (All research that involves human subjects carries some risk, though perhaps that risk is minimal and some think negligible.) When a study involved a risk and the study paid, then, as the risk level increased, the payment also increased. This does not show that investigators paid more because of the increased risk, but it does raise questions about whether risk may have influenced the amount of payment directly or indirectly and about what level and types of payments are acceptable in higher risk research. Although there was no statistically significant difference in payment amount among studies with different funding sources, when investigators received funding from industry, federal government, or private foundations, they appeared to have paid more than when they were funded by local/state government or by their own institutions. Table 1 Comparison of Payment Amount among Studies with Different Risks, Discomforts, and Funding Sources Because our previous study found that investigators reported that the length of study and time required for study were the two major factors influencing the amount of payment offered,6 we investigated further the relationship between time and payment. As reported in Table 2, the Pearson product moment correlational analysis found a statistically significant positive correlation between the total amount of payment and the number of visits required (r=0.546, p<0.001). Although the correlation between the total amount of payment and the average length of visit was positive (r=0.165), it was not statistically significant. Table 2 Correlation of Payment with Number of Study Visits