UNDERSTANDING AND AGREEING TO PARTICIPATION
Obtaining informed permission from parents is a critical protection for children involved in research. Scientific evidence is limited regarding the age at which children can meaningfully take part in discussions and decisions about their own participation in research. But children as young as 7 can understand basic information about what will happen in a study, the report says. The process for seeking consent from older adolescents should be very similar to that for adults.
HHS policies allow parental permission to be waived when it is not a reasonable requirement to protect children for example, in cases of neglect or abuse and when other safeguards are provided. FDA should change its rules to allow parental waivers, and its rules should be consistent with the policy on HHS-supported research, the committee said. In the vast majority of cases, however, it is best for parents to be involved in decision-making.
Discussions with parents and, when appropriate, children should allow sufficient time for questions and explanations of research protocols, the report emphasizes. In addition, IRBs should adopt explicit written policies on payments for research participation. It is appropriate to reimburse families for expenses related to research, such as parking fees at research facilities, and to give tokens of appreciation. But it is never acceptable to offer higher payments for enrolling children in more risky research. To broaden access to research participation among all socioeconomic groups, investigators also should consider scheduling research visits so that the hours do not interfere with parents' job or family responsibilities.
REGULATORY COMPLIANCE AND QUALITY IMPROVEMENT