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CTSA Institution

University of California, San Francisco

Disclaimer Please cite the appropriate authors/contacts when using or adapting these materials.
Acknowledgment Bernard Lo, M.D.
Professor of Medicine
Director, Program in Medical Ethics
Contacts Bernard Lo, M.D.
Format Links
URL http://www.ctspedia.org/do/view/ResearchEthics/WhatDoRegulatorsClassifyasResearch
Materials Provided Link to article
Title What Do Regulators Classify as "Research"?
Topics Description This addresses the question of what is considered “Research.” If it is contributing to generalizable knowledge it is "research"; however, if a clinician decides additional tests are needed to improve patient care, that would not be considered "research".
Keywords Common Rule; Confidentiality; Data; Empirical Research Studies; Exempt; Federal Regulations; Food and Drug Administration (FDA); Generalizable Knowledge; Health Insurance Portability and Accountability Act (HIPAA); Informed Consent; IRB Review; Medical Records; Professional Meetings; Publish; Quality Improvement (QI); Regulators; Research; Retrospective Case Series; Standard Clinical Care; Systematic Investigation
See Also

Topic Human Subjects, Other
Topic revision: r4 - 14 Feb 2012 - 11:26:20 - MaryBanach
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