Regulatory Considerations in Human Subjects Research

  • H. Richard AlexanderJr.Email author
  • Howard S. Hochster
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 the U.S. 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.

Further Reading

  1. Brown SR. Scurvy: how a surgeon, a mariner, and a gentleman solved the greatest medical mystery of the age of sail. New York, NY: St. Martin’s Press; 2003. ISBN 0-312-31391-8.Google Scholar
  2. Goodyear MDE, Krleza-Jeric K, Lemmens T. The Declaration of Helsinki. BMJ. 2007;335(7621):624–5. Scholar
  3. Jones J. Bad blood: the Tuskegee syphilis experiment. New York, NY: Free Press; 1981. ISBN:0-02-916676-4.Google Scholar
  4. Rockwell DH, Yobs AR, et al. The Tuskegee study of untreated syphilis; the 30th year of observation. Arch Intern Med. 1964;114:792–8. PMID 14211593.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  • H. Richard AlexanderJr.
    • 1
    • 2
    Email author
  • Howard S. Hochster
    • 1
    • 2
    • 3
  1. 1.Rutgers Cancer Institute of New JerseyNew BrunswickUSA
  2. 2.Division of Surgical Oncology, Department of SurgeryRutgers Robert Wood Johnson Medical SchoolNew BrunswickUSA
  3. 3.Division of Medical Oncology, Department of MedicineRutgers Robert Wood Johnson Medical SchoolNew BrunswickUSA

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