Remote consent may be considered under which condition?

• A. For all trials
• B. Only when the participant is hospitalized
• C. Where appropriate
• D. Only for minors

Answer: (C)

Remote consent is allowed when it is appropriate to the trial and the participant’s situation. This reflects the flexible, patient-centered approach of GCP: you can obtain informed consent remotely if doing so preserves the participant’s rights and welfare and still meets all elements of consent (purpose, risks, benefits, alternatives, voluntary nature, and right to withdraw). The appropriateness is determined by the investigator in consultation with the ethics committee/IRB and depends on factors like the trial design, participant access, and ability to ensure comprehension, identity verification, and proper documentation. It’s not mandated for every trial, nor is it restricted to hospitalized individuals or to minors only.