Public health practice is not research.

Abstract

Scientific and clinical activities undertaken by public health agencies may be misconstrued as medical research. Most discussions of regulatory and legal oversight of medical research focus on activities involving either patients in clinical practice or volunteers in clinical trials. These discussions often exclude similar activities that constitute or support core functions of public health practice. As a result, public health agencies and practitioners may be held to inappropriate regulatory standards regarding research. Through the lens of the Departments of Defense and Veterans Affairs, and using several case studies from these departments, we offer a framework for the adjudication of activities common to research and public health practice that could assist public health practitioners, research oversight authorities, and scientific journals in determining whether such activities require regulatory review and approval as research.