PEDIATRICS Vol. 118 No. 4 October 2006, pp. 1546-1552 (doi:10.1542/10.1542/peds.2006-0821)
ARTICLE |
Payments to Children and Adolescents Enrolled in Research: A Pilot Study
a Center for Health Care Ethics
b School of Public Health
c Department of Research Methodology, St Louis University, St Louis, Missouri
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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OBJECTIVES. The goal was to identify current payment practices in research involving children.
METHODS. A 4-page survey was mailed to the first author or corresponding author of pediatric research studies. Questions concerned whether children enrolled in research and/or their parents received any form of payment, values and types of remuneration, federal categories of pediatric research under which studies were approved, institutional policies regarding payments to children and/or their parents, institutional review board review of payment plans, factors that influenced payment decisions, prorating of payments, purposes of payments, perceived effects of payments on recruitment, and investigators' attitudes toward payments and the perceived risks and discomforts of studies.
RESULTS. Payment practices varied, and the reasons for which investigators adopted particular payment practices varied. Approximately one half offered payment. The most popular form of payment was cash. The number of institutions with policies addressing directly payments for children enrolled in research has increased, but still only approximately one half of institutions studied had such policies in place.
CONCLUSIONS. Awareness of the variations in payment practices and policies and additional study of the ethical issues surrounding payments for research participation are essential for building consensus and developing the guidelines the Institute of Medicine has said are necessary. Additional research also is needed to understand why parents enroll their children in research, how payments affect research participation decisions, and what the relationship between a study's risks and discomforts and payment should be.
Key Words: incentives • payments • pediatric research ethics • research subjects
Abbreviations: IRB—institutional review board • IOM—Institute of Medicine
In 2004, the Institute of Medicine (IOM) issued a report evaluating the current system of oversight intended to protect children who might or do participate in research.1 One issue that has received significant attention in the research ethics literature and in the IOM report is payments to children and/or parents of children enrolled in research.1,2 The IOM recommended that institutional review boards (IRBs), research institutions, and sponsors "adopt explicit written policies on acceptable and unacceptable types and amounts of payments related to [children's] research participation."1 Despite the focus on this issue, surprisingly little is known about practices and policies related to payments.
The limited data available concerning payments generally address only adult research participants or do not distinguish between payments made to adult and child participants.3 Other studies focused on motivations for participation, often for hypothetical subjects, without documenting actual payments made in research involving human subjects.4–8 An extensive Medline search conducted twice in 2005 and again in January 2006 for studies documenting payments to children participating in research or their parents identified only a study published in 2003 with data from 1999 on payments to adolescents9 and a study published in 2002 in which IRB chairs were surveyed regarding their payment practices for research involving children.10
This study was undertaken to document contemporary practices regarding payments to children (from birth through adolescence) participating in health research and/or their parents. Secondary aims were to assess the feasibility of conducting such a study, to refine the study design, and to identify current institutional policies concerning payments to children enrolled in research and/or their parents.
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METHODS |
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Instrument
A 4-page survey was designed by the principal investigator (A.S.I.) and a research methodologist (H.M.), in consultation with Dillman11 and Berdie et al.12 The survey asked open- and closed-ended questions to gather data on whether children enrolled in research and/or their parents received any form of payment, the magnitude of payments, the types of remuneration offered, whether studies were sponsored and if so by whom, the federal category of pediatric research under which studies were approved (ie, 45CFR46.404/405//406/407), whether institutional policies were in place regarding payments to child subjects or their parents, whether IRBs required changes in payment plans, the factors that influenced decisions about payment, whether payments were prorated, the purpose of payments (eg, reimbursement or incentive), and the perceived impact of payment levels on recruitment. Questions also addressed investigators' attitudes toward payment and the perceived risk and discomfort level of the study. The study was approved by the St Louis University IRB.
Sample
The first or corresponding author of studies meeting the following criteria were contacted: (1) results were published in 2003 in Pediatrics, Archives of Pediatrics and Adolescent Health, 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 (eg, studies that included only chart or literature reviews were excluded); and (5) some research was conducted with children (ie, information was gathered from children or about children or procedures were performed on children). In cases in which 1 individual was the first or corresponding author for >1 study that met the inclusion criteria, separate surveys were sent regarding each study. The first 2 journals listed were selected because their focus is children and we expected the research published there to include significant numbers of children and often to include only children. The latter 2 were chosen with the expectation that at least some studies would include children and adults. We sought to have studies including only children and studies including children and adults represented in our survey.
The original mailing and a second mailing to nonresponders were sent from February to May 2005. An introductory letter from the principal investigator (A.S.I.), explaining the purpose and voluntary nature of the study, and a stamped envelope addressed to the principal investigator were enclosed. Each mailing was followed by an e-mail from the principal investigator (A.S.I.), reminding individuals that they had received the survey, describing the study, and requesting participation. Surveys were coded so that information from the surveys could be correlated with data collected from the publication and institutional policies that corresponded to individual surveys. For completed surveys, data were collected from the publication, including the affiliation of the IRBs listed as having approved the study. A total of 185 surveys were sent as part of the first mailing; 5 surveys were returned as undeliverable, and efforts to contact those authors were unsuccessful. Four individuals wrote to state that they would not participate. Sixty-nine completed surveys were received after the first mailing. A second mailing of 107 surveys (185 minus the 5 undeliverable surveys, the 4 refusals, and the 69 surveys received) was sent 
6 weeks after the first mailing. Seventeen surveys were received after the second mailing. A total of 86 completed surveys were received. Five surveys had to be excluded because the studies involved only retrospective data collection and did not meet the inclusion criteria; they were included erroneously in the original pool of eligible studies. Therefore, there were 180 eligible surveys mailed. Of the 180 eligible surveys, 5 were undeliverable, meaning that 175 eligible participants received surveys. Of the 175 eligible participants who received surveys, 81 returned completed surveys. Data were collected from 81 of the 175 eligible respondents, yielding a response rate of 46.3%.
Analysis
Data were analyzed by using descriptive statistics to identify payment practices, beliefs and opinions related to payment, and policy standards. Statistical analyses were performed with SPSS software (version 12.0; SPSS, Chicago, IL).
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RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Description of Studies
In reporting of the results, "subjects" represent persons enrolled in the studies whose payment practices were studied in this investigation and "respondents" represent persons who answered the survey. The number of subjects enrolled in studies ranged from a minimum of 4 to a maximum of 29762, with a mean of 1440.68 and a SD of 3997.10. Some of the studies involved both children and adults as subjects. The number of children in the studies ranged from 4 to 14972, with a mean of 1221.35 and a SD of 2891.90.
Respondents were asked to describe the protocols under study, including study procedures, sponsorship, and whether the study involved payment. Responses are summarized in Table 1.
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IRB Review and Policies
Our survey asked questions about the type of IRB that reviewed the protocol for the published study and about the IRB's impact on the payment plan for subjects, the federal category of pediatric research under which the study was approved, whether the IRB required changes in payment structure, and whether the institution had a policy regarding payments to children/parents of children enrolled in research when the study was conducted or when respondents completed the survey. One member of our team (S.D.) sought IRB policies for the primary IRB listed in each publication for which an eligible survey was returned (n = 81). Institutional Web sites were reviewed and IRB offices were contacted to determine whether the respondents' institutions had a policy regarding payments to children/parents of children enrolled in research at the time the study was conducted. Results are summarized in Table 2.
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We identified 43 surveys for which the primary IRB had a payment policy regarding children enrolled in research and/or their parents and 38 for which no policy could be located. Of those that had a policy, 6 (14.6%) were in place at the time the study was conducted and 35 (85.4%) were not.
Of the policies that were in place at the time the studies in question were conducted and that offered guidance about the relationship between risks and payments, 1 policy stated that higher payments could be offered to acknowledge the relative risk of study procedures and 1 policy stated that it was impermissible to pay subjects enrolled in medical studies that put subjects at risk. One policy also stated that it was permissible to increase payments in relation to anticipated discomfort associated with study participation. One policy stated that more payment could be offered when health benefits were remote. One policy stated that payments could be based on the time and inconvenience associated with study participation. Both policies that were in place at the time the original studies were conducted and that had information on prorating payments stated that payments should be prorated. One policy stated that payments could be offered for a number of purposes, namely, to compensate subjects for time and inconvenience, to compensate subjects for discomfort, or to reimburse subjects for actual expenses incurred. Three policies stated that payments should be offered as reimbursement for expenses incurred as a result of study participation. One policy recommended that payments be in the form of money or gift certificates. Two policies recommended that payments be either vouchers from a grocery store or savings bonds in the child's (subject's) name.
Current policies offered varied guidance on study risks and payments to subjects. Three policies specified that payments could be correlated with the risk level of a study, and 6 specified that payments to subjects should not be based on risk. Current policies also were divided regarding whether it is permissible to allow the anticipated discomfort associated with study participation to influence the amount of payment. Eight policies permitted increased payments for greater discomfort, and 3 policies stated that payments should not depend on the discomfort associated with studies. Most of the guidance in current policies regarding the relationship between payments and benefits focused on separating the discussion of benefits of study participation from the discussion of payments offered to subjects. Five policies stated that payment should not be treated as a benefit of study participation. Two policies stated that it was appropriate to pay subjects when it was not expected that they would obtain health benefits from study participation. All 19 current policies that offered guidance on the relationship between payments and time or inconvenience stated that compensation to subjects could be based on the time or inconvenience associated with study participation. One policy in particular stated that payments could be based on the duration of the study and the impact on work-related income. The policy made no reference to the possibility that such a practice could lead to different levels of compensation for different subjects because of varying wages/salaries. All current policies that offered guidance on prorating payments (n = 24) recommended (n = 5; 20.83%) or required (n = 19; 79.17%) that payments be prorated. Five policies specified that payments should not depend on completion of a study. One policy specified that payments should be prorated but the value of payments could be increased as a study progressed. Current policies offered various guidelines regarding the purposes payments to research subjects could serve, including reimbursement for time (n = 5; 20.83%), compensation for inconvenience (n = 9; 37.50%), compensation for discomfort (n = 3; 12.5%), compensation for risk (n = 1; 4.17%), reimbursement for expenses associated with study participation (n = 9; 37.5%), compensation for effort (n = 1; 4.17%), incentive (n = 2; 8.33%), and compensation for impact of study participation (n = 1; 4.17%). Current policies listed various forms of payments or compensation as acceptable. Seven policies permitted specifically compensation in the form of money; 4 others allowed for money to be given only as reimbursement for expenses incurred as a result of study participation. Six policies allowed payments to be given in the form of gift certificates or gift cards. Eight policies allowed for toys, books, or other items/merchandise to be given to subjects. Six policies permitted the use of vouchers (eg, for meals or parking). Two policies permitted the provision of services (eg, child care) as compensation. One policy permitted the use of lottery tickets or raffle tickets as compensation. Two policies specified that payments offered should be age-appropriate for the children enrolled in the research study, rather than being given to the parents.
Factors Affecting Payment Practices
Respondents who did not offer payments to children and/or their parents were asked their reasons for not offering payments. Responses are summarized in Table 3.
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Respondents who offered payments were asked to identify the factors that influenced the amount of payment they offered. Results are summarized in Table 4.
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Values and Types of Payments
Information about types and value of payments is summarized in Table 5. Those who offered payments were asked what percentage of the total value of all payments offered was meant to serve as reimbursement for expenses and what percentage was intended as an enrollment incentive. A total of 54.8% (n = 23) stated that no payment (0%) was meant as reimbursement for actual expenses incurred as a result of research participation, and 26.2% (n = 11) stated that all payment (100%) was meant as reimbursement; 35.7% (n = 15) stated that 100% of payment was meant as an incentive, 11.9% (n = 5) stated that 50% of payment was meant as an enrollment incentive, and 26.2% (n = 11) stated that 0% of payment was meant as an incentive.
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Payment and Recruitment
Respondents who did not offer payment were asked whether they thought that recruitment would have been easier if they had offered payment; 25.6% (n = 10) said yes, 64.1% (n = 25) said no, and 10.3% (n = 4) were unsure. Respondents who offered payment were asked if they thought that recruitment would have been easier if they had offered more payment; 23.8% (n = 10) said yes, 69% (n = 29) said no, and 7.1% (n = 3) were unsure.
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Discussions of payments/incentives in research usually focus on whether it ever is ethical to pay research subjects and, if so, when and how they may be paid.13–18 Little is known about how much child subjects and/or their parents are paid,19 what types of payments they are offered, and how investigators decide how much to pay subjects. The data presented here give new insight into how and how much children who participate in research and/or their parents are paid and how investigators make payment decisions. Approximately one half of the studies that were the subject of our investigation, all of which involved prospective data collection, offered some form of payment to children and/or their parents. These data confirm the existence of varying practices and beliefs about what payment practices are appropriate. To develop guidance on payments to children enrolled in research and their parents, as the IOM1 recommends, we need to know what the current standards of practice are and we must settle debates over which factors should be allowed to influence payment practices.
The answers to the survey questions concerning the factors that influenced decisions to pay and how much to pay or that influenced decisions not to pay merit additional consideration. Investigators who paid subjects overwhelmingly stated that the risks associated with study participation did not influence their payment decisions (92.9%); however, among those who did not pay subjects, 63.2% (n = 24) cited the fact that the study involved no more than minimal risk as a reason for not offering payment. Therefore, at least among those who decided not to pay subjects, consideration of risk played an important role in determining payment practices. It is worth noting that, although many hold that it is permissible to pay subjects on the basis of the time and inconvenience involved in study participation, only 47.4% (n = 18) of those who did not offer payment cited minimal time commitment as a reason for not offering payment. The fact that a study involved only minimal risk influenced more of those who did not offer payment, compared with the fact that a study involved a minimal time commitment.
The federal regulations and the Office for Human Research Protections Institutional Review Board Guidebook20 leave significant discretion to IRBs and investigators regarding payments to subjects. This study and others19 suggest that local guidance is limited, and this study confirms the need for more work in this area. It may be permissible to have amounts of payment vary according to location, because of economic differences, but the same factors should be considered for structuring payments regardless of locale. For example, although it may be permissible to vary the amount of payment depending on location, it does not seem reasonable to say that in some places the amount of risk a study poses should increase the amount of payment and in other places investigators may not pay subjects more for assuming greater risk. The appropriate relationship between risks and payments is debated in general21 and especially for research involving children, because children do not make their own participation decisions. There is some concern that unintentionally parents may expose their children to greater risk than they otherwise would deem appropriate because of offers of payment or intentionally they may enroll children in studies for personal gain.2
Approximately one third of the respondents to our survey (n = 26; 32.1%) stated that their institution had a policy in place regarding payments to children enrolled in research (and/or their parents) at the time the study we were investigating was conducted. Our team was able to locate only 6 policies that were in place at the time the studies in question were conducted. It is possible that our efforts to locate policies fell short, although all IRB Web sites were reviewed and all IRBs were contacted when the information on the Web site was insufficient. It also is possible that investigators who responded to our survey and said that their institution had a policy in place had in mind less formal policies (ie, accepted practices within their institutions) or were referring to a general payment policy, rather than one specific to children. We sought guidance specifically about payments to children and/or their parents because the IOM1 holds that policies specific to child subjects ought to be developed. It also is possible that some institutions had payment policies in place at the time the studies under investigation were conducted and those policies no longer are in place.
Approximately one fourth of those who paid thought that offering more payment would have made recruitment easier, and approximately one fourth of those who did not pay thought that offering payment would have facilitated recruitment. Very few empirical data exist regarding why parents choose to enroll their children in research. One study suggested that, when children are enrolled in a study about a disorder or condition they have, parents primarily are interested in learning more about the child's condition, advancing knowledge about the condition, and having access to treatment.22 Approximately one fourth of those we surveyed thought that money does influence parental decisions regarding enrollment of children in research.
The limitations of this study include the fact that it was a preliminary study with a small sample size. Surveys were sent regarding specific studies published in 2003. Those studies might have been conducted over a period of years, and payment practices might have changed during that time. In the case of multicenter studies, it is possible that participants in one location were paid differently from those in other locations. A future investigation could evaluate large multicenter studies to assess differences in payments for identical or nearly identical studies. It would not be surprising to find such differences, based on variations in costs in different places throughout the United States and on the circumstance that IRBs are known to review identical protocols differently at times.23–25 Because the surveys were sent only to authors of articles for studies that involved prospective data collection, these data regarding study procedures, number of children enrolled, and categories of federal regulatory approval do not describe the state of pediatric research as a whole. This survey did not seek input from IRBs reviewing studies; therefore, we do not know which factors played a role in the IRBs' determinations that the payment plans proposed were permissible, such that changes were required in very few cases. Finally, we do not know whether there is any bias in the sample of responders, compared with nonresponders.
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CONCLUSIONS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Payment practices in pediatric research vary, as do beliefs about what factors should influence decisions about whether and how much to pay subjects. A significant number of institutions do not have policies that address specifically payments to children enrolled in research and/or their parents. A number of areas require additional investigation, including the motivations for enrolling in research and the permissibility of using risk and discomfort levels of a study to determine payments. Institutions need to develop policies regarding payments to children or their parents and guidelines regarding how payment amounts should be determined. Greater awareness of these variations and additional study of the ethical issues surrounding payments for research participation are essential for building consensus and developing the guidelines the IOM has said are necessary.
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ACKNOWLEDGMENTS |
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This study was funded by the Beaumont Faculty Development Fund at St Louis University.
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FOOTNOTES |
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Accepted May 23, 2006.
Address correspondence to Ana S. Iltis, PhD, Center for Health Care Ethics, St Louis University, 221 N Grand Blvd, St Louis, MO 63103. E-mail: iltisas{at}slu.edu
The authors have indicated they have no financial relationships relevant to this article to disclose.
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PEDIATRICS (ISSN 1098-4275). ©2006 by the American Academy of Pediatrics
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