ABSTRACT

Ethical and scientific standards have been developed for conducting biomedi-cal research in human subjects. They provide assurance not only concerning the rights, dignity, safety, and well-being of human subjects in research but also the production of accurate information. After reviewing the suitability for ethical and scientific standards of a research project, the ethics committee (EC) may accept or reject the protocol or require modifications. All provisions in The Declaration of Helsinki and statutory laws must be met for approval. In Turkey, research involving human subjects is regulated by a number of pieces of legis-lation including the Constitution, Turkish Penal Code, European Convention on Bioethics, Regulation on Patient’s Rights, Regulation on Clinical Drug Trials, and Guidelines for Good Clinical Practice (GCP). The structure and functio-ning of ECs are specified by law and regulations of the Ministry of Health in accordance with the GCP guidelines as well as The Operational Guidelines for Ethics Committees produced by the World Health Organization. The establish-ment of a national ethics network providing independent and efficient review and evaluation of biomedical research projects is of utmost importance for the adoption of ethical principles in the scientific community and the production of accurate information that can contribute to scientific knowledge.