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Investigator Responsibilities

In: Principles and Practice of Clinical Trials

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  • Bruce J. Giantonio

    (The ECOG-ACRIN Cancer Research Group
    Massachusetts General Hospital
    University of Pretoria, Department of Medical Oncology)

Abstract

The research atrocities committed during World War II using human subjects prompted the development of a body of regulations, beginning with the Nuremberg Code, to ensure that human subjects’ research is safely conducted and prioritizes the rights of the individual over the conduct of the research. The resultant regulations guiding human subjects’ research affect protocol design, the selection of participants, safety reporting and oversight, and the dissemination of research results. The investigator conducting research on human subjects must be familiar with those regulations to meet his/her responsibility to protect the rights and welfare of research participants.

Suggested Citation

  • Bruce J. Giantonio, 2022. "Investigator Responsibilities," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 6, pages 85-95, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_29
    DOI: 10.1007/978-3-319-52636-2_29
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