Certification for IRB Professionals (CIP) Practice Exam

What document do IRBs primarily rely on to ensure ethical research standards are met?

1. The researcher's proposal

2. The IRB's bylaws

3. The Belmont Report

4. The funding agency's requirements

The correct answer is: The Belmont Report

The Belmont Report is a foundational document that outlines key ethical principles and guidelines pertinent to the conduct of research involving human subjects. It emphasizes three core principles: respect for persons, beneficence, and justice. These principles guide the ethical decision-making process in research involving human participants and are essential for Institutional Review Boards (IRBs) as they review research proposals. IRBs utilize the Belmont Report as a benchmark when evaluating whether a proposed study upholds the ethical standards necessary for protecting participants’ rights and welfare. This document informs IRB considerations regarding informed consent processes, the assessment of risks versus benefits, and fair participant selection. Thus, the Belmont Report serves as the primary ethical framework to which IRBs refer to ensure that research not only complies with regulatory standards but also aligns with ethical considerations that promote the dignity of individuals participating in research. In contrast, while a researcher's proposal, the IRB's bylaws, and the funding agency's requirements contain relevant information, they do not provide the comprehensive ethical guidelines necessary for IRB decision-making that the Belmont Report offers.