Who ensures information regarding payments to subjects is documented in a written consent form?

The IRB/IEC is responsible for reviewing and approving the consent form, which must include any information about payments to participants. This ensures transparency and ethical compliance regarding compensation.

The answer is verified according to GCP guidelines, which mandate IRB/IEC review of consentforms, including payment details.

"IRB/IEC must ensure that the informed consent process is thorough and includes disclosure of any compensation or payment to participants."

Objectives:

Guaranteeing informed consent quality

Ensuring transparency about participant payments