According to FDA regulations, what specific document must an IRB keep copies of?

According to FDA regulations, what specific document must an IRB keep copies of?

• A. Trial protocol amendments
• B. All research proposals reviewed
• C. Investigator's brochure
• D. Curriculum vitae of each investigator

Answer: (B)

The specific document that an Institutional Review Board (IRB) must keep copies of, as per FDA regulations, is all research proposals reviewed. This requirement is in place to ensure that the IRB can effectively monitor and evaluate the ethical considerations associated with the research being conducted. Keeping copies of all reviewed research proposals allows the IRB to establish a comprehensive record of the studies it has evaluated, enabling them to uphold their oversight responsibilities and ensure compliance with federal regulations. This documentation serves critical purposes, including facilitating future reviews, supporting the institution's adherence to ethical standards, and providing necessary information in the event of audits or investigations. By maintaining comprehensive records of proposals, the IRB can also ensure that informed consent, potential risks, and the scientific validity of the research are consistently addressed across all evaluations.

The specific document that an Institutional Review Board (IRB) must keep copies of, as per FDA regulations, is all research proposals reviewed. This requirement is in place to ensure that the IRB can effectively monitor and evaluate the ethical considerations associated with the research being conducted. Keeping copies of all reviewed research proposals allows the IRB to establish a comprehensive record of the studies it has evaluated, enabling them to uphold their oversight responsibilities and ensure compliance with federal regulations.

This documentation serves critical purposes, including facilitating future reviews, supporting the institution's adherence to ethical standards, and providing necessary information in the event of audits or investigations. By maintaining comprehensive records of proposals, the IRB can also ensure that informed consent, potential risks, and the scientific validity of the research are consistently addressed across all evaluations.