What legislation is relevant when conducting clinical drug trials?
International guidelines have been formulated to protect the rights of trial subjects. These include the Nuremberg principles, the Declaration of Helsinki and the Council for International Organizations of Medical Sciences (CIOMS) International Guidelines for Biomedical Research. Other guidelines are the Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (World Health Organization, WHO); the Buenos Aires Declaration on Ethics and Clinical Trials; the Universal Declaration on Bioethics and Human Rights (United Nations Educational, Scientific and Cultural Organization, UNESCO); and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Tripartite Guideline for Good Clinical Practice. In order to be admitted to the European market a drug has to have been tested in accordance with European Union guidelines called ‘directives’; if they were not, the pharmaceutical company can actually hav
