Ethics in Clinical Research

  • Naomi Roselaar
  • Niv Marom
  • Robert G. MarxEmail author


Historically, medical research was conducted without formal regulations, supervision informed consent, or recognition of patient rights and interests. Ethical oversight has been implemented through the development of international, federal, and institutional guidelines to protect human subjects in clinical research. When proposing and conducting experiments involving human subjects, researchers must comply with these guidelines. Clinical research on human subjects must consider the ethical representation of vulnerable and minority populations to avoid misrepresentation and improve generalizability. Responsibilities concerning the ethics of clinical research also fall to publishers and editors of medical journals. Conflict of interest disclosures as well as the awareness of self-citation and predatory journals contribute to the prevention of data fraud and misconduct.


Ethics Clinical Regulations Guidelines Consent Human subjects 


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Copyright information

© ISAKOS 2019

Authors and Affiliations

  1. 1.Orthopedic Surgery, Hospital for Special SurgeryNew YorkUSA

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