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Ethical Conduct of Clinical Research Involving Children
Certain types of payments to parents or adolescents are usually, if not always acceptable, for example, reimbursement for reasonable expenses that are necessary for participation in research. Other payments are never appropriate, for example, paying parents for permitting their child to be exposed to a greater research risk. Compensation to parents for lost wages or time may be appropriate under carefully scrutinized circumstances. One objective of IRB and institutional policies on payments related to children’s participation in research should be to encourage equal access to study participation, regardless of a family’s economic status, while avoiding practices that risk exerting undue influence over the parents’ and children’s consideration of the child’s participation in research (Recommendation 6.2). To respond to the diverse barriers to children’s participation in research, nonfinancial alternatives that equalize participation opportunities should also be considered, for example, adjusting the times or places for research visits for parents who cannot take time off from work.
REGULATORY COMPLIANCE, QUALITY IMPROVEMENT, AND ACCCREDITATION
The dearth of information about human research protection programs in general and about protections for child research participants in particular makes it impossible to describe adequately the implementation and enforcement of federal regulations and, likewise, hinders evaluation and improvement efforts. As one of its recommendations for strengthening the system for protecting human participants in research, the 2003 IOM report Responsible Research proposed that DHHS commission studies to gather basic information about the current system as needed to identify problems and track improvements. This committee agrees.
Recommendation 7.1: To help identify what further guidance, education, or other steps may be needed to protect child participants in research, the U.S. Department of Health and Human Services—with direction from the U.S. Congress, if necessary—should develop and implement a plan for gathering and reporting data on
research involving children, including the categorization of studies by the relevant section of federal regulations (45 CFR 46.404 to 407 and 21 CFR 50.51 to 54), and
implementation of the regulations that govern research involving children, including data from the Office for Human Research Protections and the Food and Drug Administration on their inquiries, investigations, and sanctions related to such research.