SOCRA CCRP Practice Exam

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What criteria must be met for children to be involved in research that presents more than a minimal risk without direct benefit?

Risks are high and no assent is required
Risks are a minor increase over minimal and assent + consent is obtained
Intervention can be unrelated to the child's medical condition
Research is directly beneficial to the child only

The correct answer is: Risks are a minor increase over minimal and assent + consent is obtained

The correct criteria for children to be involved in research that presents more than a minimal risk without direct benefit is for there to be a minor increase in risks over minimal and for both assent and consent to be obtained. Option A is incorrect because high risks without any required assent are not ethical. Option C is incorrect because the intervention should be related to the child's medical condition in order to provide accurate results. Option D is incorrect because research should not only benefit the child, but also contribute to scientific knowledge. Therefore, option B is the best choice as it includes both necessary criteria for children to be involved in this type of research.