Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

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What should the informed consent form (ICF) include when there is no expected clinical benefit for a research subject?

  1. A detailed explanation of risks involved

  2. Wording indicating that there is no expected benefit

  3. An overview of the study's scientific goals

  4. A summary of compensation for participation

The correct answer is: Wording indicating that there is no expected benefit

The informed consent form (ICF) must include clear wording indicating that there is no expected benefit to the research subject when this is the case. This transparency is crucial in maintaining ethical standards and ensuring that participants fully understand the nature of the study. It helps to set appropriate expectations and allows individuals to make an informed decision about their participation. Informing subjects about the lack of anticipated clinical benefit aids in protecting their autonomy and ensuring they are not misled about what participation in the study might provide. This element is especially important in studies that might involve risks or inconveniences, as it emphasizes that participation is more about contributing to scientific knowledge than receiving direct personal benefits.

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