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Ethical Conduct of Clinical Research Involving Children
(if they are interpreted as recommended in Chapter 4) substantially limit the amount of risk to which children can be exposed in research without the prospect of direct benefit. The potential for harm must be minimal or only slightly more than minimal. Given this appropriate conservatism, the committee believed that it would be inappropriate—even within these narrow boundaries—to allow financial encouragement for children’s participation in research based on the level of risk involved. The recommendation above allows, however, for reasonable, age-appropriate compensation for those whose research participation is associated with more time or inconvenience (e.g., for adolescents who must take time away from a job).
Payment for Research-Related Injuries
Consistent with the recommendations of an earlier IOM committee and other groups, this committee also recommends compensation for child participants who are injured in the course of research. Depending on their medical condition, children who are permanently injured as a result of research participation may live with the consequences of an injury for a far longer period than an adult so injured. The committee also agrees that DHHS should collect data on the incidence of research-related injuries and should analyze their costs.
Recommendation 6.3: Research organizations and sponsors should pay the medical and rehabilitation costs for children injured as a direct result of research participation, without regard to fault. Consent and permission documents should disclose to parents (and adolescents, if appropriate) the child’s right to compensation and the mechanisms for seeking such compensation.
Payments to Investigators or Others
As described in Chapter 2, FDA and NIH have adopted policies to encourage investigators and research sponsors to include children in research. Chapter 2 also described the challenges that pediatric investigators face, including recruiting sufficient numbers of children for many kinds of studies. Given the combination of government policies and existing recruitment problems in some areas of research, policymakers, research institutions, and IRBs should be attentive to the recruitment practices proposed in pediatric protocols and should strongly discourage or forbid bonuses or similar financial incentives to physicians for enrolling their pediatric patients in research.
Recommendation 6.4: Investigators and their staffs may appropriately be reimbursed for the costs associated with conducting research. Pay-