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What must research involving children with greater than minimal risk and the prospect of direct benefit meet to be IRB-approved?

  1. Only risk is justified by anticipated benefits

  2. Benefits are provided to all participants

  3. Risk is related to the benefit and is at least as favorable as any alternative

  4. Parental consent is not required

The correct answer is: Risk is related to the benefit and is at least as favorable as any alternative

One option that is incorrect is A, which only requires that the risks are justified by anticipated benefits, but it does not specify that the risks must be at least as favorable as any alternative. Another incorrect option is B, which states that benefits must be provided to all participants, but it does not mention anything about risks or how they relate to the benefits. D is also incorrect because parental consent is always required for research involving children, regardless of the level of risk or potential benefit. C is the correct answer because it specifies that the risks must be related to the benefits and must be at least as favorable as any alternative. This ensures that the potential benefits outweigh the potential risks and that the research is ethically sound in regards to children.