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.
Am J Public Health. 2014 Apr;104(4):596-602. doi: 10.2105/AJPH.2013.301663. Epub 2014 Feb 13.
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.
公共卫生机构开展的科学和临床活动可能会被误解为医学研究。大多数关于医学研究监管和法律监督的讨论都集中在涉及临床实践中的患者或临床试验中的志愿者的活动上。这些讨论通常排除了构成或支持公共卫生实践核心职能的类似活动。因此,公共卫生机构和从业人员可能会被要求按照不适当的研究监管标准行事。通过国防部和退伍军人事务部的视角,并使用这些部门的几个案例研究,我们提供了一个用于裁决常见于研究和公共卫生实践的活动的框架,这可以帮助公共卫生从业人员、研究监督机构和科学期刊确定这些活动是否需要作为研究进行监管审查和批准。