Which items should be included in submissions to the IRB/IEC?

• A. Protocol and amendments only.
• B. Informed consent materials only.
• C. Protocol and amendments, informed consent materials, Investigator's Brochure, trial-related information, recruitment advertisements, compensation plans, ongoing safety updates, and investigator qualifications.
• D. Investigator qualifications only.

Answer: (C)

Submitting to the IRB/IEC requires a complete set of documents that let the board assess risk, protect participants, and ensure proper study oversight. The protocol and any amendments establish the study design, procedures, timelines, and eligibility criteria, providing the framework the IRB uses to judge risk and conduct. Informed consent materials are essential so participants can understand what they are agreeing to, including risks, benefits, and rights, and to ensure consent is truly informed. The Investigator's Brochure consolidates current safety and pharmacology information to help investigators assess risk, monitor for potential harm, and manage participant safety. Trial-related information, such as data collection plans, monitoring procedures, and safety reporting processes, demonstrates how the study will be conducted and how information will be managed and reviewed. Recruitment advertisements show how participants will be approached and ensure messaging is appropriate and non-coercive. Compensation plans clarify reimbursement and care for trial-related injuries, addressing participant rights and welfare. Ongoing safety updates keep the IRB informed of new risks or adverse events as the trial progresses. Investigator qualifications verify that the team has the appropriate training and experience to conduct the study safely. Because each of these elements contributes to a thorough ethical and safety review, all are typically required in submissions. Omitting any of them can hinder the IRB’s ability to protect participants and properly oversee the trial.