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What criteria must be met for children to be involved in greater than minimal risk research with a prospect of benefit?

  1. Risks are minimal and benefits are unknown

  2. Risks are justified by the anticipated benefits and assent + consent is obtained

  3. Only parental consent is required

  4. Research can proceed without any ethical review

The correct answer is: Risks are justified by the anticipated benefits and assent + consent is obtained

Children involved in greater than minimal risk research with a prospect of benefit must have risks that are justified by the anticipated benefits and assent + consent must be obtained. This means that there must be a balance between the potential risks and potential benefits in the study, and both the child and their parents must give consent for the child to participate. Options A and C are incorrect because they do not mention the need for assent from the child and only mention parental consent, which is not enough for minors to participate in research. Option D is incorrect because all research involving human subjects must undergo ethical review before it can proceed.