What must be provided to the IRB/IEC to obtain its favorable opinion?

• A. The current copy of protocol, informed consent form, and any other written information to be provided to subjects
• B. The sponsor's marketing plan
• C. A list of investigators' educational certificates
• D. The trial's annual budget

Answer: (A)

IRBs review the study plan and the information that will be given to participants to ensure that risks are reasonable and that participants can make an informed choice. To obtain a favorable opinion, investigators must provide the current protocol, the informed consent form, and any other written information that will be presented to subjects. This allows the IRB to assess the study design, safety protections, and how information about risks, benefits, procedures, and rights will be communicated to participants.

The sponsor’s marketing plan, investigators’ educational certificates, and the trial budget are not the materials the IRB uses to grant initial approval. They may be relevant for other reasons, but they’re not the basis for the favorable opinion focused on participant protection and informed consent.