One particularly sensitive issue is when adolescents should be free to consent to research participation without parental permission. Certain studies that are important to adolescent health and well-being will not be feasible without such a waiver. The research reviewed here suggests that the DHHS regulations appropriately provide for waivers, including a requirement that a suitable mechanism is provided to protect children when parental permission is waived. FDA should revise its rule on the waiver of parental permission to be consistent with DHHS rules (Recommendation 5.4).
Ethical standards for participation in research require that the agreement to participate be freely given; that is, it should not be either coerced or unduly influenced by psychological, financial, or other pressure. The major concern about payments related to research participation is that they may unduly influence and distort decisions about research participation made by individuals in their own right or by parents on behalf of their child.
Survey and other information available to the committee suggested that many IRBs and research institutions do not have written policies to guide reviews of research payment practices. By developing written policies on payments to parents and children, IRBs can consider ethical issues outside of the context of an individual protocol. Such deliberation will help achieve a fairer and more consistent approach to making decisions on appropriate payments. In general, these policies should provide that payment be discussed during the process of seeking parents’ permission and the child’s assent to participation in research.
Recommendation 6.1: Institutional review boards, research institutions, and sponsors of research that includes children and adolescents should adopt explicit written policies on acceptable and unacceptable types and amounts of payments related to research participation. These policies should specify that investigators
disclose the amount, the recipient, the timing, and the purpose (e.g., an expense reimbursement or a token of appreciation to a child) of any payments as part of the process of seeking parents’ permission and, as appropriate, children’s assent to research participation;
avoid emphasis on payments or descriptions of payments as benefits of participating in research during the permission or assent process; and
obtain institutional review board approval for the disclosure of information about payments in advertisements and in permission and assent forms and procedures.