Which items are included in the standard submissions to the IRB/IEC?

• A. Protocol and amendments, informed consent materials, Investigator's Brochure, trial-related information, recruitment advertisements, compensation plans, ongoing safety updates, and investigator qualifications.
• B. Sponsor's business plan.
• C. Marketing plan only.
• D. Trial's internal budgets.

Answer: (A)

These submissions focus on documentation that protects human subjects and allows the ethics committee to assess risk and ensure proper oversight. The items typically included are the protocol and any amendments, informed consent materials and the consent process, the Investigator’s Brochure, trial-related information (such as data collection procedures and safety monitoring plans), recruitment advertisements, compensation plans for injuries or participation, ongoing safety updates (like adverse event reports and yearly safety summaries), and evidence of investigator qualifications. Together, these materials enable the IRB/IEC to evaluate risks, ensure informed consent is truly informative and voluntary, verify that the study is scientifically sound, and confirm that the personnel conducting the trial are qualified.

Other options don’t fit because they pertain to the sponsor’s business or marketing aspects, not to the ethical and participant-protective review required by the IRB/IEC.