Consent and Assent in Pediatric Research

The process of soliciting a minor's assent has moral import, even if it is not always required by the current regulations. Ethically, the process provides for the child's opinion to be heard, for respecting their developing capacity and involving the child as a participant in research. Of course, the extent to which a child should be involved in the assent process depends on the age, experience, and maturity of the child. This put the onus on researchers to enable a minor's understanding of a research protocol by providing the trial information in a developmentally appropriate way. Although a minor's assent is an important process, their dissent may not be determinative. Instead, researchers and parents should engage in a discussion about the dissent. During this conversation, it is important to ensure that the child and the parents understand the risks and benefits of participation and do not conflate the research process with clinical care (ie, cause therapeutic misconception). Returning, then, to our case, the researcher should first facilitate a conversation with Sonya and her parents. Her parents may be misunderstanding the purpose of research, conflating Sonya's participation with another clinical option. This therapeutic misconception should first be resolved by providing the appropriate risk and benefit information to Sonya and her family and by explaining the purpose of the trial, namely that it is to generate generalizable knowledge. After this conversation, the researcher should solicit both Sonya and her parents' understanding and perspective. During this conversation, it will be important to highlight shared values and perspectives as well as understand the nature of any remaining disagreement. The purpose of this conversation is to ensure both that the parents and Sonya understand the research and that Sonya herself feels heard. However, despite the ethical need for this conversation, the case describes a research trial that likely has atrue prospect of direct benefit for Sonya. Thus, Sonya's affirmative agreement to participate in the trial would likely not be required by the IRB, leaving final decision-making authority to her parents. Research with pediatric populations carries certain ethical considerations. Regulations, including The Common Rule, attempt to put procedures in place to ensure that ethical processes are followed and that the vulnerabilities of children are protected. These include requirements for including pediatric populations in all phases of research, including the consent/assent process. The ethical importance of inclusion of pediatric populations in both research and the assent/consent process ensures that despite children's vulnerabilities, they are recognized as human participants with developing autonomy and values. Thus, it is important for researchers, clinicians, and IRBs to recognize both the vulnerabilities of this special population and the ways that inclusion of pediatric populations can advance scientific discovery.