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Does the FDA require a description in the consent if research provides no expected benefit?

  1. Yes, detailed description is required

  2. No, only an explanation of the research's expected benefits

  3. Yes, but only the risks involved

  4. No, description is not required at all

The correct answer is: No, only an explanation of the research's expected benefits

The FDA only requires a description in the consent if the research provides expected benefits. Any additional information beyond this requirement may be provided, but is not mandated by the FDA. Therefore, options A and C are incorrect since they suggest that a detailed description or risks are required regardless of whether there are expected benefits. Option D is also incorrect because a description is still required if there are expected benefits.