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Which statement is true about the criteria for involving children in greater than minimal risk research with prospect of benefit?

  1. Benefits do not need to be justified

  2. The relation of anticipated benefit must be favorable compared with alternative approaches

  3. Parental consent isn't necessary

  4. Children's assent isn't considered important

The correct answer is: The relation of anticipated benefit must be favorable compared with alternative approaches

When involving children in research, it is important to consider the level of risk and potential benefits. Benefits do not need to be justified as they always need to outweigh the risks. Parental consent is absolutely necessary as children cannot legally give their consent. Children's assent is also important but not considered as crucial as parental consent. Therefore, the most important consideration is whether the anticipated benefits outweigh the risks and if the chosen approach is favorable compared to alternative methods. This ensures that the research is ethical and in the best interest of the child.