chapter  1
12 Pages

Rules, Roles, and Responsibilities

Clinical research is a complex, multidisciplinary industry that integrates science, business, law, ethics, and health care. It is regulated by multiple government agencies and is conducted for a variety of purposes. As such, the roles of individuals within the industry are diverse and multifaceted. However, overall, the clinical research environment is divided into four areas that have distinct but overlapping responsibilities and goals. These areas or roles include regulatory agencies, sponsors, investigators, and ethical/institutional review boards (IRBs). Each encompasses a scope of responsibilities intertwined with regulations, ethics, best practices, and professional standards.