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Introduction: The tremendous advances in the field of modern medicine have while on the one hand, brought immense benefits for human kind, on the other increased the potential for harm many folds also. To minimize harm and protect the interest of individuals, guidelines and mechanisms need to be put in place within the Health Systems of countries. The issue of ethics in health research is being given increasing recognition and importance internationally. The International community and donors are now not willing to recognize and fund research, which has not been put up to ethical scrutiny and received ethical clearance. In Pakistan no system for ethical clearance was in place and as a result researchers from within country seeking international funding and researchers from abroad linking with researchers and institutions, were facing lot of problems in getting the required ethical clearance for their projects. Further, to protect the interests of people of Pakistan from harm and exploitation in the name of research, there was a need that the Health Research System of the country develops standards, procedures and guidelines for the scrutiny of the ethical aspect of all health research being undertaken within the country. The Ministry of Health constituted a National Bioethics Committee (NBC) according to international guidelines formulated for such committees in consultation with a group of professionals who met under the chairmanship of the Director General Health. The committee is truly multidisciplinary and multi-sectoral in compositions with relevant expertise from across many disciplines of medicine, along with well-respected ‘non medical’ people representing the interests and concerns of the community. There is also a mix of age and gender to ensure equitable representation on the committee. The Committee has been established in accordance with applicable laws and regulations of the country and in accordance with values and principles of the community it serves. The committee was approved by the Ministry of Health, Government of Pakistan and notified in the Gazette of Pakistan on January 28, 2004.