Determining when a clinical activity should be classified as research requiring institutional review board review

Ernest D. Prentice, Bruce G. Gordon, Melody H. Lin

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

The boundary between therapy and research may at times be difficult to distinguish, and it is, therefore, important for health care professionals to recognize when a clinical activity should be properly classified as research. Research may be subject to federal regulations which require advance review and approval by an Institutional Review Board (IRB) in order to protect the rights and welfare of patients who serve as human subjects. This paper will discuss the criteria health care professionals can use to distinguish between therapy, innovative therapy, and therapeutic or clinical research.

Original languageEnglish (US)
Pages (from-to)88-91
Number of pages4
JournalJournal of Extra-Corporeal Technology
Volume29
Issue number2
StatePublished - Jun 1997

Keywords

  • Federal regulations
  • Human subjects
  • Institutional Review Board
  • Research

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Health Professions (miscellaneous)
  • Cardiology and Cardiovascular Medicine

Fingerprint Dive into the research topics of 'Determining when a clinical activity should be classified as research requiring institutional review board review'. Together they form a unique fingerprint.

  • Cite this