Regulatory Considerations in Human Subjects Research

  • H. Richard AlexanderJr.
  • Edward Sausville
  • Shannon Decker
Part of the Success in Academic Surgery book series (SIAS)


Biomedical research can be broadly defined as the systemic collection and analysis of data for the purposes of generating new knowledge that will relieve suffering and cure disease. Today, we understand that human subjects research must be conducted in compliance with federal statutes that are in place to ensure that all research activity is conducted ethically and follows the principles articulated in historical treatises such as the Nuremberg Code, the Helsinki Declaration, and the Belmont Report. For research involving drugs or devices, investigators also must comply with all US Food and Drug Administration (FDA) regulations relating to such research. This chapter will review the historical context under which these regulations were developed, provide an overview of the current regulatory requirements that must be met to perform human subjects research, and offer some practical considerations for new academic investigators.


Human Subject Research Protected Health Information Belmont Report Military Tribunal Nuremberg Code 
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Copyright information

© Springer-Verlag London 2014

Authors and Affiliations

  • H. Richard AlexanderJr.
    • 1
    • 2
  • Edward Sausville
    • 3
  • Shannon Decker
    • 3
  1. 1.Division of General and Oncologic Surgery, The Department of Surgery, Marlene and Stewart Greenebaum Cancer CenterUniversity of Maryland School of MarylandBaltimoreUSA
  2. 2.Division of General and Oncologic Surgery, Department of SurgeryUniversity of Maryland School of MedicineBaltimoreUSA
  3. 3.Division of Medical Oncology, The Department of Medicine, Marlene and Stewart Greenebaum Cancer CenterUniversity of Maryland School of MarylandBaltimoreUSA

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