Certification for IRB Professionals (CIP) Practice Exam 2025 - Free CIP Practice Questions and Study Guide

The responsibility of the Institutional Review Board (IRB) in relation to informed consent is primarily to ensure that the informed consent process is ethical and compliant with regulations. The IRB plays a crucial role in protecting the rights and welfare of research participants. This includes reviewing the informed consent process to make sure that participants are fully informed about the research, including any potential risks, benefits, and the nature of their participation.

By overseeing the informed consent process, the IRB ensures that participants understand what they are agreeing to and that their choice to participate is based on adequate information. This oversight is essential in maintaining ethical standards in research and ensuring compliance with applicable laws and regulations, such as the Common Rule in the United States.

While the IRB may review informed consent documents, it does not typically draft them or sign them on behalf of researchers, nor does it collect consent. The responsibility for these tasks generally rests with the researchers conducting the study. Furthermore, while documentation of consent is important for legal purposes, it is not the primary function of the IRB to handle or record these documents. The focus of the IRB is fundamentally on the ethical governance of the research involving human subjects.