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Ethical Consideration in Orthopedic Research

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Basic Methods Handbook for Clinical Orthopaedic Research

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Abstract

Concern for the ethics of human subject research has existed since the earliest days of scientific discovery. Respect for a participant’s well-being and autonomy is of utmost importance. From this early understanding of patient autonomy, further principles emerged, and in the modern era, this was further accelerated and formalized, particularly after revelation of atrocities committed by Nazi “scientists.” This leads to documents like the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report, the formation of institutional review boards, and legislation passed by multiple legislatures, all in order to help ensure researchers abide by guiding principles of ethics. Specific to orthopedic surgery, there has been rising concern for conflict of interest due to the role of industry funding. The goals of this chapter are the following:

  • Understand the historical basis for the development of regulations and governing bodies reviewing human subject research.

  • Identify and understand ethical principles that guide human subject research.

  • Understand how to navigate the current regulatory environment for human subject research.

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Author information

Authors and Affiliations

  1. Department of Orthopaedic Surgery, NorthShore University Health System, Evanston, IL, USA

    Jason L. Koh & Diego Villacis

  2. Northshore Orthopedic Institute, Evanston, IL, USA

    Jason L. Koh & Diego Villacis

  3. Pritzker School of Medicine, University of Chicago, Chicago, IL, USA

    Jason L. Koh & Diego Villacis

Authors
  1. Jason L. Koh
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  2. Diego Villacis
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Corresponding author

Correspondence to Diego Villacis .

Editor information

Editors and Affiliations

  1. UPMC Rooney Sports Complex, University of Pittsburgh, Pittsburgh, PA, USA

    Volker Musahl

  2. Department of Orthopaedics, Sahlgrenska Academy, Gothenburg University, Sahlgrenska University Hospital, Gothenburg, Sweden

    Jón Karlsson

  3. Department of Orthopaedic Surgery and Traumatology, Kantonsspital Baselland (Bruderholz, Laufen und Liestal), Bruderholz, Switzerland

    Michael T. Hirschmann

  4. McMaster University, Hamilton, ON, Canada

    Olufemi R. Ayeni

  5. Hospital for Special Surgery, New York, NY, USA

    Robert G. Marx

  6. Department of Orthopaedic Surgery, NorthShore University HealthSystem, Evanston, IL, USA

    Jason L. Koh

  7. Institute for Medical Science in Sports, Osaka Health Science University, Osaka, Japan

    Norimasa Nakamura

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Koh, J.L., Villacis, D. (2019). Ethical Consideration in Orthopedic Research. In: Musahl, V., et al. Basic Methods Handbook for Clinical Orthopaedic Research. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-58254-1_4

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  • DOI: https://doi.org/10.1007/978-3-662-58254-1_4

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  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-662-58253-4

  • Online ISBN: 978-3-662-58254-1

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