What must be included in an informed consent form to comply with GCP?

• A. Purpose of the research, risks/benefits, voluntary participation, alternatives, confidentiality, contact details, and right to withdraw.
• B. Potential compensation and trial duration only
• C. Personal preferences of the investigator
• D. Government sponsorship details

Answer: (A)

Informed consent forms are designed so participants can make a voluntary, well-informed decision about joining a study. Under GCP, the form must present the essential elements that allow that decision: the purpose of the research, the expected duration, the procedures involved, the reasonably foreseeable risks and benefits, the alternatives to participation, how confidentiality will be protected, whom to contact with questions, and the participant’s right to withdraw at any time without penalty. This combination ensures transparency, respects participant autonomy, and provides clear pathways for questions or concerns. The other options miss critical pieces (for example, focusing only on compensation or duration, or including investigator preferences or sponsorship details), so they do not satisfy the required content for informed consent.