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International
Policies
on Research Ethics |
The 10 principles of the Nuremberg Code were written by the judges who presided over the tribunal of Nazi physicians who conducted pseudoscientific experimentation on inmates at various concentration camps. Since then, various national and international guidelines on ethics of human experimentation have evolved.
Adopted by the World Medical Association (WMA) 18th General Assembly held in Helsinki, Finland in 1964. The current version is based on the amendment made at the 59th WMA General Assembly in Seoul, Korea in 2008.
The Declaration of Helsinki is a statement of 25 ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.
Prepared by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, this report consists of three main sections: boundaries between practice and research, basic ethical principles and applications.
The report describes three "basic ethical principles" - respect for persons, beneficence and distributive justice. It also covers the subject of assessment of risks and benefits in the context of medical research ethics.
International
Conference on Harmonisation-Good Clinical Practice
(ICH-GCP)
ICH-GCP is an international ethical and scientific quality standard encapsulating the design, conduct, recording and reporting of clinical trials involving the participation of human subjects. Compliance with this standard ensures the rights, safety and well-being of human subjects are protected in accordance to the principles stipulated in the Declaration of Helsinki.
Section 3 on "Institutional Review Board / Independent Ethics Committee (IRB/IEC)" contains guidance on responsibilities; composition, functions and operations; procedures and records pertinent to IRB/IEC.
Directive
2001/20/EC of the European Parliament and of the Council of 4 April 2001
This document is on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
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Last update: 16 December 2009