A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). Your IRB has determined that assent of children age 8 and older is required for the study. A 10-year-old firmly declined to participate in the study described above. Which of the following procedures best describes the action to be taken by the investigator?
The Correct Answer and Explanation is:
Correct Answer:
Respect the child’s decision and do not include the child in the study.
Explanation
In research involving children, ethical standards and federal regulations place a strong emphasis on protecting their autonomy and welfare. When a study involves minors, both parental permission and, when appropriate, child assent are required. Assent refers to a child’s affirmative agreement to participate in research. It is not simply the absence of objection; rather, it is a knowledgeable, voluntary decision made by the child to take part in the study.
In this case, the Institutional Review Board (IRB) has determined that assent is required for children aged 8 and older. A 10-year-old child has firmly declined participation. Regardless of whether the child’s parents or guardians have given their permission, the child’s decision must be respected.
According to federal regulations (45 CFR 46, Subpart D), specifically designed to protect child participants, research investigators are ethically and legally obligated to honor a child’s refusal to participate if assent is a requirement. The rationale behind this is that children, especially those aged 8 and above, typically have the developmental capacity to understand the basic purpose of the research and what it entails. Forcing participation against their will can cause distress, violate personal autonomy, and undermine the integrity of the research process.
Respecting dissent also reinforces the principle of respect for persons, one of the three ethical principles outlined in the Belmont Report. Even in minimal-risk research, if a child is competent to understand the study and decides not to take part, this decision must be honored.
Therefore, the appropriate procedure is for the investigator to exclude the child from participation in the study and document the child’s refusal. Any effort to override the child’s decision would be unethical and potentially in violation of both institutional and federal research guidelines.
