Invited Speaker

Local Ethics Committees and Research: the Tunisian Experience
Majed ZEMNI
TUNISIA

With the increased recognition of the potentially harmful effects of research on clinical trials, it is now routine practice for a researcher to gain ethical approval before a study is commenced. In Tunisia, Most University hospitals conducting research have a local ethics committees.

Before submitting a study protocol for ethical review, it is necessary to have clear study protocols, information sheets and consent forms that can be easily understood.

The mission of local committees as defined by the Tunisian National Committee of Medical Ethics is an advisory and educational mission. The local committees missions are threefold: decision support, education and training in ethics and the study of biomedical research protocols.

While the majority of University Hospitals have local ethics committees, their role is limited to giving local opinions on research protocols and provide decisions support for many issues in médical practice. Their role in ethics education and training is limited. they remain without legal status and in fact regarded as sub committees emanating from the hospital medical committee. it is composed in the majority of cases only of hospital practitioners. Finlay, they are no established process for reviewing research proposals by these committees.

Currently, the Tunisian National Committees of Medical Ethics with the support of Public Health Ministry works on a law project to ensure the organisation and the activities of Local Ethic’s committees.