Before consenting participants, what must be in place regarding informed consent materials and process?

• A. The IRB/IEC's documented approval or favorable opinion of the informed consent materials and process.
• B. A signature from the sponsor.
• C. A preliminary patient questionnaire.
• D. A post-trial notification plan.

Answer: (A)

The key concept here is that the consent materials and the way consent is obtained must be reviewed and approved by an independent ethics body before any participant is enrolled. An IRB/IEC must provide a documented approval or favorable opinion of both the written consent form and the consent process. This ensures the information presented to potential participants is complete, understandable, and appropriate for the study, covering all required elements such as purpose, risks, benefits, alternatives, confidentiality, voluntary participation, and the right to withdraw.

Any changes to the consent documents or how consent is obtained require fresh IRB/IEC approval, and consent must be obtained only after that approval is in place. While investigator signatures on the consent form and the participant’s signature to indicate agreement are important parts of the process, the sponsor’s signature is not a regulatory substitute for IRB/IEC approval of the consent materials and process. Options like a preliminary screening questionnaire or a post-trial notification plan do not meet the requirement for prior IRB/IEC review.