An enhanced approach to distinguishing public health practice and human subjects research

Research output: Contribution to journalReview article

23 Scopus citations

Abstract

This article discusses the conceptual, legal, and practical distinctions between public health practice and human subjects research, proposing a two-stage process to better classify activities that involve the collection of individually identifiable health information as public health practice or research. Public health authorities, institutional review boards, and others must determine whether public health activities are classified as research or public health practice to comply with the federal Common Rule governing human subjects research, the HIPAA Privacy Rule, and other federal, state, and local laws.

Original languageEnglish (US)
Pages (from-to)125-141
Number of pages17
JournalJournal of Law, Medicine and Ethics
Volume33
Issue number1
DOIs
StatePublished - Jan 1 2005
Externally publishedYes

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health Policy

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