- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
1.2 Ethical principles
All research involving human subjects should be conducted in accordance with the ethical principles contained in the current version of the Declaration of Helsinki (see Appendix 1). Three basic ethical principles should be respected, namely justice, respect for persons, and beneficence (maximizing benefits and minimizing harms and wrongs) and non-maleficence (doing no harm) as defined by the current revision of the International Ethical Guidelines for Biomedical Research Involving Human Subjects1 or the laws and regulations of the country in which the research is conducted, whichever represents the greater protection for subjects. All individuals involved in the conduct of any clinical trial must be fully informed of and comply with these principles. (See chapters 3 and 4).
1 These guidelines are updated regularly by the Council for International Organizations of Medical Sciences (CIOMS); the most recent update was published in 1993 (2)