SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer—Regulatory Process, Part II: The Role of the Institutional Review Board in Food and Drug Administration–Regulated Radiopharmaceutical Research

CE credit: For CE credit, you can access the test for this article, as well as additional JNMT CE tests, online at https://www.snmmilearningcenter.org. Complete the test online no later than June 2025. Your online test will be scored immediately. You may make 3 attempts to pass the test and must answer 75% of the questions correctly to receive Continuing Education Hour (CEH) credit. Credit amounts can be found in the SNMMI Learning Center Activity. SNMMI members will have their CEH credit added to their VOICE transcript automatically; nonmembers will be able to print out a CE certificate upon successfully completing the test. The online test is free to SNMMI members; nonmembers must pay $15.00 by credit card when logging onto the website to take the test. The goal of clinical research is to advance medical knowledge in hopes of improving patient care. At the core of clinical research is the need to perform research on human volunteers. This is absolutely required for the eventual approval of drugs and certain therapies. Unfortunately, history is replete with stories involving exploitation and abuse of individuals in research. Clinical research using radiopharmaceuticals introduces additional apprehension. Although the past few decades have witnessed significant improvements in safety and ethics, there remain indelible images seared into the psyche of the general population. Those new to clinical research may find themselves asking questions such as, What are the ethical guidelines and regulations for clinical research, How are they enforced and by whom, and How do we ensure the safety of participants? The answer, in large part, is the oversight and actions of the institutional review board. This article will focus on familiarizing the reader with the institutional review board and its role in protecting the rights and welfare of humans participating as subjects in Food and Drug Administration–regulated radiopharmaceutical research.