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Ethical Conduct of Clinical Research Involving Children
regardless of how minimal the risk may be” (Children’s Hospital Boston, 2003, unpaged).
STATEMENTS OF PROFESSIONAL ORGANIZATIONS
In its 1995 statement on the ethical conduct of drug studies with pediatric populations, the Committee on Drugs of the American Academy of Pediatrics (AAP) stated that remuneration, compensation, and indemnification are ethical payment practices based on current societal standards. It also observed that “serious ethical questions arise when payment is offered to adults acting on behalf of minors in return for allowing minors to participate as research subjects” (AAP, 1995, p. 293). As noted and questioned earlier in this chapter, the statement recommended that investigators refrain from discussing gifts or appreciation payments with children until after the research is completed.
In its 2003 statement to the Institute of Medicine (IOM) committee, AAP emphasized that “parents should not profit from placing their child in research,” even when the research does not present “significant risk” (AAP, 2003, p. 12). In contrast, for research that involves no burden to the child beyond inconvenience (i.e., no discomfort, unpleasantness, or tangible risk), “remuneration may be a major incentive for participation and completion of the study and it is appropriate in this context to compensate children for their efforts in a manner comparable to compensating adult research subjects,” as long as the payment is not used to coerce (unduly influence) children or their parents into agreeing to participation (p. 12). Research projects may also waive treatment costs if the IRB and investigators judge that such payment-in-kind will not “be coercive of participation.”
Other organizations presented statements to the IOM committee in which they indicated that it is appropriate to reimburse expenses or compensate for time or inconvenience. These organizations include the Association of Medical School Pediatric Department Chairs, the Cystic Fibrosis Foundation, the Society for Pediatric Research (which mentioned only “expenses”), the Allergy & Asthma Network/Mothers of Asthmatics, Public Citizen’s Health Research Group, and the Genetic Alliance. None of these groups explicitly endorsed incentive payments to parents or children.
OTHER CONCERNS ABOUT PAYMENT RELATED TO CHILDREN’S RESEARCH PARTICIPATION
Compensation for Research-Related Injuries
If an adult or child suffers a research-related injury that is not the result of malfeasance or negligence, that person has no legal avenue to recover