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Research ArticleContinuing Education

SNMMI Clinical Trials Network Research Series for Technologists: Ethical Issues and Regulations in the Medical Workplace

Sarah Frye, Regan Butterfield and John M. Hoffman
Journal of Nuclear Medicine Technology December 2021, 49 (4) 303-310; DOI: https://doi.org/10.2967/jnmt.121.263100
Sarah Frye
1Department of Clinical Health Sciences, St. Louis University, St. Louis, Missouri;
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Regan Butterfield
2Center for Quantitative Cancer Imaging, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah; and
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John M. Hoffman
3Huntsman Cancer Institute, University of Utah School of Medicine, Salt Lake City, Utah
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    TABLE 1

    Regulatory Policies and Governing Bodies

    NameResponsibilities
    U.S. FDAProtects public health by ensuring safety, efficacy, and security of human and veterinary drugs, biologic products, and medical devices
    CFROrganizes rules published by U.S. federal government departments and agencies; is divided into 50 titles
    NRCEnsures safe use of radioactive materials
    Joint CommissionSets standards and accredits health-care organizations in United States
    HIPAAProvides data privacy and security for safeguarding medical information
    OSHASets and enforces workplace safety
    OHRPProtects human subjects and provides leadership in biomedical and behavioral research
    WHOPromotes healthy lives and well-being for all people
    ICHPromotes public health safety through international harmonization
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    TABLE 2

    Research Ethical Standards

    StandardDescription
    Nuremberg CodeSet of research ethical principles for human experimentation from Nuremberg trials
    Declaration of HelsinkiGeneral guiding principles for researchers when working with human subjects
    Belmont ReportBasic ethical guidelines on human subject research (respect for persons, beneficence, and justice)
    GCPDescription of clinical trial design and responsibilities of investigator, sponsor, and institution
    Common Rule (title 45 of CFR, part 46, subpart A)Rule for creating uniform regulations across U.S. agencies involved in human subject research
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Journal of Nuclear Medicine Technology: 49 (4)
Journal of Nuclear Medicine Technology
Vol. 49, Issue 4
December 1, 2021
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SNMMI Clinical Trials Network Research Series for Technologists: Ethical Issues and Regulations in the Medical Workplace
Sarah Frye, Regan Butterfield, John M. Hoffman
Journal of Nuclear Medicine Technology Dec 2021, 49 (4) 303-310; DOI: 10.2967/jnmt.121.263100

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SNMMI Clinical Trials Network Research Series for Technologists: Ethical Issues and Regulations in the Medical Workplace
Sarah Frye, Regan Butterfield, John M. Hoffman
Journal of Nuclear Medicine Technology Dec 2021, 49 (4) 303-310; DOI: 10.2967/jnmt.121.263100
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  • Article
    • Abstract
    • REGULATORY AGENCIES
    • HISTORICAL EXAMPLES OF MISTREATMENT
    • ETHICAL CODES
    • DISCUSSION
    • CONCLUSION
    • DISCLOSURE
    • ACKNOWLEDGMENTS
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Keywords

  • ethics
  • ethical regulation
  • clinical research
  • informed consent
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