Ethics in clinical research—roles of ethical guidelines—

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  • Usui Noriko
    Department of Transfusion Medicine, and Department of Clinical Oncology and Hematology, The Jikei University Daisan Hospital

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  • 臨床研究で求められる倫理とは—倫理指針をふまえて—

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The aim of clinical research is to obtain and to generalize knowledge that elucidates mechanisms, causes and/or pathology of a disease or improves treatments and/or prophylaxis of a disease, in order to develop medical science. Researchers should conduct valuable and ethical study along with to protect human rights and welfare of people who participate in clinical research. Based upon the ethical guidance such as Nuremberg Code, Declaration of Helsinki, or Belmont Report that were primarily a response past abuses of research participants, seven main principles have been described as guiding the conduct of ethical research : 1) Social and clinical value, 2) Scientific validity, 3) Fair subject selection, 4) Favorable risk-benefit ratio, 5) Independent review, 6) Informed consent, 7) Respect for potential and enrolled subjects. The newly revised ethical guideline in our country named “Ethical Guidelines for Medical and Health Research Involving Human Subjects” proposes basic principles and rules of clinical research according to these seven principles. How to comply these ethical guidelines in clinical research has been considered in this review.

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