Ethical Guidelines for Clinical Trials

Abstract

Introduction: According to importance of respect the human subjects’ rights in clinical trials, many nationals and international ethical guidelines have been developed in the world, to enforce researchers to respect codes of research ethics in this type of study. During recent years, regarding to the increasing number of medial researches in Iran, the necessity of developing ethics codes for special types of research such as clinical trial has became more cleared. Medical ethics and History of medicine research center did a project based on a grant from the National Medical Research Center, on development of ethical guidelines for six domains of medical research. One of them presented in this paper is ethical guideline for clinical trials.Methods and Materials: After a broad search and review of literature on international or national ethics guidelines and clinical trial research regulations in other countries, draft of the guideline was written. Then the draft was evaluated for the practical and cultural aspects in several meetings with cooperation of some researcher who had experience in clinical trial and some research ethics committee members. Next it was appraised for agreement with law and Islamic jurisprudence by some experts. Finally it was edited for Farsi syntactic rules. Discussion: This guideline is a big step toward teaching ethical standards to medical researcher and guiding research ethics committees to systematize their ethical evaluation. Definitely this guideline needs to be evaluated and revised periodically to fit best to practical matters raised in clinical trial, so authors welcome to all readers’ appraisal comments.

Keywords

• clinical trial
• code of ethics
• ethics committee