Regulatory Affairs Certification (RAC) Practice Exam

What basis could an IRB use to approve a clinical trial involving children with no prospect of direct benefit?

1. A Knowledge gain about the condition

2. B Parental consent

3. C Risk minimization

4. D Financial compensation for subjects

The correct answer is: A Knowledge gain about the condition

The approval of a clinical trial involving children who may not receive direct benefits can be justified by the potential for knowledge gain regarding the condition being studied. In the context of pediatric research, this is particularly significant because research often seeks to improve understanding, treatment, and management of diseases that affect children. When an Institutional Review Board (IRB) evaluates such a trial, they consider the ethical implications of involving vulnerable populations like children. If the study has the potential to generate important data that could lead to improved treatments or outcomes for children with that condition in the future, this rationale can support the approval of the research. The emphasis on knowledge gain underscores the belief that the ultimate goal of research is to advance medical science, even if individual participants do not directly benefit. While parental consent and risk minimization are crucial components of the ethical review process, they cannot independently justify the approval of a study that lacks a direct benefit to participants. Financial compensation may also introduce ethical concerns regarding coercion or undue influence, particularly when it involves children. Thus, the primary basis for approval lies in the potential for knowledge gain that can contribute to the broader field of pediatric research.