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Multiple Choice

What should participants be told about who to contact for trial information and their rights?

Participants must be told who to contact for trial information, their rights, and for reporting any suspected trial-related injuries. This ensures they have a clear, direct line to someone who can explain the study, reinforce their rights under the consent, and address safety concerns promptly. The designated contact is typically a site person (such as the investigator or a designated study staff member) who can provide answers about the trial and its rights and who can receive reports of injuries. Relying only on the principal investigator or providing no contact information isn’t sufficient, and a sponsor’s public relations department isn’t appropriate for handling participant questions or adverse-event reporting.

Participants must be told who to contact for trial information, their rights, and for reporting any suspected trial-related injuries. This ensures they have a clear, direct line to someone who can explain the study, reinforce their rights under the consent, and address safety concerns promptly. The designated contact is typically a site person (such as the investigator or a designated study staff member) who can provide answers about the trial and its rights and who can receive reports of injuries. Relying only on the principal investigator or providing no contact information isn’t sufficient, and a sponsor’s public relations department isn’t appropriate for handling participant questions or adverse-event reporting.