As part of the investigator's written application to the IRB/IEC, what must be provided?

• A. A copy of the sponsor's insurance certificate.
• B. A current copy of the Investigator's Brochure.
• C. A summary of subject recruitment methods.
• D. A payment authorization from the sponsor.

Answer: (B)

The key item is the current Investigator’s Brochure. This document compiles all essential information about the investigational product, including pharmacology, toxicology, prior human experience, dosing, and known risks, with updates as new safety data emerge. The IRB/IEC needs the latest IB to assess whether the potential risks to participants are justified by the potential benefits and to ensure that the informed consent language accurately reflects known risks. While other items like sponsor insurance certificates or summaries of recruitment methods may appear in some submissions, they do not replace the need for a current IB, which is the primary source the IRB uses to evaluate safety and risk.