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

Abstract

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.

Keywords: Radiopharmaceutical; clinical research; clinical trial; institutional review board.