Human Subjects’ Protection

  • Arthur L. Caplan
  • Barbara K. Redman


Federal regulations for protection of human subjects in biomedical and behavioral research have been in place since 1974. Preceded by the Belmont Report, which described ethical principles for human research, regulations known as the Common Rule (common across federal agencies) followed. They may be found at 45 CFR 46 and are administered by the Office of Human Research Protections (OHRP). Updated regulations have been approved and are expected to be in effect by early 2018.


Human subjects protection Institutional review board Data-safety monitoring board 


  1. DeMets DL, Ellenberg SS. Data monitoring committees – expect the unexpected. N Engl J Med. 2016;375(14):1365–71.CrossRefPubMedGoogle Scholar
  2. Grady C. Institutional review boards; purpose and challenges. Chest. 2015;148(5):1148–55.CrossRefPubMedPubMedCentralGoogle Scholar
  3. Hallinan A, Forrest A, Uhlenbrauck G, Young S, McMinney R. Barriers to change in the informed consent process: a systematic literature review. IRB. 2016;38(3):1–10.PubMedGoogle Scholar
  4. Nicholls SG, Hayes TP, Brehaut JC, McDonald M, Weijer C, Saginur R, Fergusson D. A scoping review of empirical research relating to quality and effectiveness of research ethics review. PLoS One. 2015;10(7):E013639.Google Scholar

Additional Suggested Reading

  1. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. 1979. (This is a foundational document which describes the ethical basis for human subjects protection in research.)Google Scholar
  2. Grady C. Institutional review boards; purpose and challenges. Chest 2015;148(5):1148–1155. (Provides a clear description of institutional review boards and the policies under which they operate.)Google Scholar
  3. Hallinan Z, Forrest A, Uhlenbrauck G, Young S, McKinney R. Barriers to change in the informed consent process: A systematic literature review. IRB. 2016 ;38(3):1–10. (Reviews research on informed consent in research and suggests steps to make it more robust.)Google Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Arthur L. Caplan
    • 1
  • Barbara K. Redman
    • 1
  1. 1.New York University Langone Medical CenterNew YorkUSA

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