What is one responsibility of the IRB according to ICH guidelines?

What is one responsibility of the IRB according to ICH guidelines?

• A. To approve marketing applications for drugs
• B. To obtain relevant documents for the trial
• C. To ensure all subjects are compensated
• D. To provide training for investigators

Answer: (B)

One of the key responsibilities of the Institutional Review Board (IRB) according to the ICH E6 guidelines is to ensure the protection of the rights, safety, and well-being of trial subjects. This involves a thorough review of all relevant documents related to the clinical trial, such as the study protocol, informed consent forms, and any other materials that could impact participants' understanding and participation in the trial. The IRB must assess whether these documents provide adequate information to potential participants, ensuring transparency and helping them make informed decisions about their involvement. While obtaining relevant documents is critical for the IRB's review process, the other responsibilities listed do not fall under the purview of the IRB. For instance, approving marketing applications for drugs is typically the role of regulatory authorities rather than the IRB. Similarly, issues related to compensation for subjects, while important, are not primarily handled by the IRB, which focuses on ethical considerations rather than financial stipulations. Providing training for investigators, though essential for the conduct of clinical trials, is usually managed by sponsors or other training organizations, rather than the IRB. Hence, the IRB's responsibility to obtain and review relevant documents is central to its function in upholding ethical standards in research involving human subjects.

One of the key responsibilities of the Institutional Review Board (IRB) according to the ICH E6 guidelines is to ensure the protection of the rights, safety, and well-being of trial subjects. This involves a thorough review of all relevant documents related to the clinical trial, such as the study protocol, informed consent forms, and any other materials that could impact participants' understanding and participation in the trial. The IRB must assess whether these documents provide adequate information to potential participants, ensuring transparency and helping them make informed decisions about their involvement.

While obtaining relevant documents is critical for the IRB's review process, the other responsibilities listed do not fall under the purview of the IRB. For instance, approving marketing applications for drugs is typically the role of regulatory authorities rather than the IRB. Similarly, issues related to compensation for subjects, while important, are not primarily handled by the IRB, which focuses on ethical considerations rather than financial stipulations. Providing training for investigators, though essential for the conduct of clinical trials, is usually managed by sponsors or other training organizations, rather than the IRB. Hence, the IRB's responsibility to obtain and review relevant documents is central to its function in upholding ethical standards in research involving human subjects.