Ethical Considerations

  • Derek Pearson
  • Colin G. Miller


Whenever a clinical trial is being designed, the ethical implications have to be considered. All trials have to fulfill the general guidance issued in the declaration of Helsinki, Edinburgh Amendment 2000.1 This has been enshrined in Good Clinical Practice (GCP) guidelines that have been produced by the International Committee for Harmonization (ICH) and adopted by the Food and Drug Administration (FDA) for the USA2 and the Committee for Proprietary Medicinal Products (CPMP) within Europe.3 These cover issues that researchers must consider, such as:
  1. 1.

    The anticipated benefit of the trial to the individual subject and society must outweigh the foreseeable risks and inconveniences.

  2. 2.

    The protection of the trial subject, which should be the most important consideration.

  3. 3.

    The responsibilities of the Institutional Review Board/Independent Ethics Committee (IRB/IEC).

  4. 4.

    The responsibilities of the investigator and sponsor.

  5. 5.

    The informed consent of the trial subjects.

  6. 6.

    The study protocol and investigator’s brochure and the essential documentation required to undertake a clinical trial.



Hormone Replacement Therapy Trial Subject Patient Information Sheet Fracture Intervention Trial Lateral Spine Radiograph 
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© Springer-Verlag London 2002

Authors and Affiliations

  • Derek Pearson
  • Colin G. Miller

There are no affiliations available

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