SOCRA CCRP Practice Exam

Which is a requirement for research with children involving a minor increase over minimal risk without direct benefit?

1. The intervention must present experiences commensurate with those from the child's routine medical care and daily life

2. The research should provide direct benefit to the child

3. The risk assessment doesn't rely on the assent from the child

4. Parental consent is not required if the child assents

The correct answer is: The intervention must present experiences commensurate with those from the child's routine medical care and daily life

Research with children can sometimes involve a slight increase in risk, but it is important that this increase is minimal and does not result in direct harm to the child. Therefore, the intervention must be comparable to the child's routine medical care and daily life experiences. Option B is incorrect because direct benefit to the child is not a requirement for research involving a minor increase over minimal risk. Option C is incorrect because the assessment of risk cannot disregard the child's assent. Option D is incorrect because parental consent is still required, even if the child assents.