|
Abstract: Some public health activities are easily classified as public health practice or human subjects research, but lost in a legal and ethical gray zone are a host of public health activities that are not neatly characterized as either. The issue constantly arises in the planning and performance of public health activities involving the acquisition and use of identifiable health information. Clearer distinctions are needed because the laws, standards, and ethical principles that may apply depend on whether the underlying activity is public health practice or research. In addition, widespread variation in distinctions between public health practice from research have led to confusion among institutional review boards (IRBs) and public health agencies, inefficient and duplicative reviews, and infringements on information sharing. An existing array of guidance is used by practitioners, researchers, and IRB members to decide whether a proposed activity is public health practice or research, but there is no national consensus.
This article proposes enhanced criteria to distinguish public health practice and research developed through analysis of existing laws, scholarship, and applied approaches. This article presents modern definitions of "human subjects research" and "public health practice," and their underlying legal frameworks and suggests defining principles to classify public health practice and research activities. An examination of key, foundational premises of public health practice and human subjects research helps unravel these activities to resolve simple cases. A set of enhanced guidelines applies to more difficult cases.
|