During the consent process, what must the investigator ensure regarding participant identity?

• A. Identity verification is optional
• B. Identity verified by sponsor
• C. Identity verification is not required if the participant is over 65
• D. The investigator should assure themselves of the identity of the participant or their legally acceptable representative in accordance with applicable regulatory requirements

Answer: (D)

During consent, the investigator must confirm the identity of the participant or their legally acceptable representative, in line with applicable regulatory requirements. This ensures that the person providing consent is indeed the intended participant or someone authorized to consent on their behalf, which is essential for valid consent, safety, and proper protection of the participant’s rights and data. The exact verification method depends on local regulations and may involve government-issued identification or appropriate authorization documentation. This responsibility rests with the investigator, not the sponsor, and there are no age-based exemptions.