SOCRA CCRP Practice Exam

What is a requirement for IRB approval of research in children with more than minimal risk and no prospect of direct benefit?

1. High risk, high reward

2. Risk must be a minor increase over minimal

3. Children must receive some form of compensation

4. Parental consent is enough for approval

The correct answer is: Risk must be a minor increase over minimal

Research with children requires special precautions as they are considered a vulnerable population. IRB approval is necessary for research involving children who are at more than minimal risk with no prospect of direct benefit. This ensures that the potential risks to participants are carefully evaluated and minimized to the greatest extent possible. Option A is incorrect because high reward is not a requirement for IRB approval and may introduce undue influence on the children. Option C is incorrect because compensation is not a requirement for IRB approval and may also introduce undue influence. Option D is incorrect because parental consent alone is not enough for approval, as children are considered a separate and protected population with specific requirements for research involving them. Option B is the correct answer, as it emphasizes the importance of keeping risks minimal and carefully evaluating them to protect the well-being of child participants.