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

Who is required to sign the Informed Consent Form according to ICH E6?

1. Only the subject

2. Only the legal representative

3. The subject and the person conducting the consent interview

4. All investigators involved in the trial

The correct answer is: The subject and the person conducting the consent interview

The correct response highlights the importance of ensuring that both the subject and the individual conducting the consent interview sign the Informed Consent Form, as outlined by the International Council for Harmonisation (ICH) E6 guidelines. This dual-signature requirement serves to validate that the subject has been adequately informed about the study, understands the implications of their participation, and voluntarily agrees to enroll. By having the person conducting the consent interview also sign the form, it provides a formal acknowledgment that they have fulfilled their responsibilities to communicate essential information effectively and that the subject's consent was given freely, with all relevant information considered. This practice not only safeguards the rights of the trial participants but also promotes ethical research conduct, ensuring transparency and accountability from the research team. The other options do not encompass the necessary elements of informed consent as mandated by regulatory guidelines. Only having the subject sign would overlook the responsibility of the investigator to ensure thorough understanding. If only the legal representative signed, it would disregard the subject's autonomy. Lastly, requiring all investigators to sign would create unnecessary logistical complications without enhancing the integrity of the consent process.