Prior to the trial, what must be obtained regarding the consent forms?

• A. The written informed consent form and any other written information to be provided to subjects should be revised and receive IRB/IEC approval in advance of use.
• B. The IRB/IEC's approval is not required.
• C. The sponsor's approval is sufficient.
• D. The investigator's personal approval is sufficient.

Answer: (A)

Before starting a trial, the written informed consent form and any other written information given to potential subjects must be revised as needed and receive IRB/IEC approval in advance of use. This ensures that the materials clearly, accurately, and completely describe the study, its risks and potential benefits, and the rights of participants in language that is understandable. The IRB/IEC provides independent ethical review to protect subjects, and their approval is required before these documents are used to obtain consent. Sponsor or investigator approval on its own does not substitute for the IRB/IEC’s approval, and any changes to the consent materials after initial approval generally require re-approval before use.