CITI Training Practice Exam

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Which guideline requires that the potential benefits and risks of alternatives should be included in the consent form?

FDA
ICH GCP
EU Directive
HIPAA

The correct answer is: ICH GCP

ICH GCP (Good Clinical Practice) requires that the potential benefits and risks of alternatives be included in the consent form. This guideline ensures that participants are fully informed about the potential risks and benefits of participating in a clinical trial. Option A, FDA guidelines, primarily focus on regulating drug and medical device safety and efficacy and may not require specific details about alternatives in the consent form. Option C, EU Directive, also has similar focuses and may not necessarily require detailed information about alternatives. Option D, HIPAA, is a regulation that protects the privacy of individuals' health information and does not directly address the content of consent forms. Therefore, ICH GCP is the most appropriate guideline for including information about potential alternatives in the consent form.