Investigator Responsibilities

Living reference work entry


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.


Belmont Report The Common Rule Delegation of tasks Drug accountability Good clinical practice Informed consent process Institutional review board (IRB) Investigator Noncompliance Scientific misconduct 


  1. Baer AR, Devine S, Beardmore CD, Catalano R (2011) Clinical investigator responsibilities. J Oncol Pract 7:124–128. Scholar
  2. Emanuel EJ, Wendler D, Grady C (2000) What makes clinical research ethical? JAMA 283:2701–2711. Scholar

Authors and Affiliations

  1. 1.The ECOG-ACRIN Cancer Research GroupPhiladelphiaUSA
  2. 2.Massachusetts General HospitalBostonUSA
  3. 3.Department of Medical OncologyUniversity of PretoriaPretoriaSouth Africa

Section editors and affiliations

  • Eleanor McFadden
    • 1
  1. 1.Frontier Science (Scotland) LtdKingussieUK

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