اخلاق در پژوهشهاي زيست پزشكي بر روي آزمودني هاي انساني

Ethics in Biomedical Research Involving Human Subjects

Background: Research involving human subjects should deal with health issues of the population or community in which the research is carried out. Ethical expedients, would be achieved only when the successful interventions or other beneficences are provided to the society as a results of such research. Thus, to supply ethical expedients, a planning and management process must be established prior to implementation of the research and monitoring and evaluation along the study to the end and even communication of the results to the authorities and also the population in which the research is carried out. Investigatorsʹ commitment and skills and safety of research environment should be verified by ethical review committees prior to study and its process must be ceased upon diverting from protocol obligations or human rights. Obtaining the voluntary informed consent of the prospective subject and assurance that they would have the right of unconditional withdraw from the study, is considered as part of the investigatorsʹ commitments. Such an intricate, which would be occurred along conducting the research supported by sponsors, is bias distortion in performing and communicating the study results. Thus the investigator is obligated with his/her commitments, free from exclusive relations, particularly socio-economic, to the sponsors and in case of conflict of interests he/she must disclose it to the ethical review committees and even when communicating the study results. Conclusion: This article represents a review of different ethical aspects of biomedical research involving human subjects and essential guidelines protecting their rights.