title: 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.
authors: Jean Lin Otto is with the Henry M. Jackson Foundation for the Advancement of Military Medicine, contracted to work at the Armed Forces Health Surveillance Center, Silver Spring, MD. Mark Holodniy is with the Office of Public Health, Department of Veterans Affairs, Washington, DC. Robert F. DeFraites is with the Uniformed Services University of the Health Sciences, Bethesda, MD.
authors: Jean Lin
authors: JL
authors: Otto
authors: Mark
authors: M
authors: Holodniy
authors: Robert F
authors: RF
authors: DeFraites
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence; D004196:Disease Outbreaks / Q000517:prevention & control; D033161:Government Regulation; D006801:Humans; D011159:Population Surveillance; D015397:Program Evaluation; D011634:Public Health / Q000331:legislation & jurisprudence; D011635:Public Health Administration / Q000331:legislation & jurisprudence; D014481:United States; D059030:United States Department of Defense; D014493:United States Department of Veterans Affairs