Introduction: National Regulations and Guidelines

Frameworks to guide the ethics of research are instrumental in enhancing the rights and welfare of research participants, thus promoting the public trust. Countries have issued some combination of legal regulations, guidelines, and codes governing human subject research. For countries that have not issued legal regulations, research ethics committees usually rely on the Declaration of Helsinki; CIOMS guidelines; and the International Conference on Harmonisation’s (ICH) Good Clinical Practices (GCP) guidelines. Reliance on international guidelines are not necessarily problematic and can be useful in providing a rich source of information. But international guidelines may not be applicable to the local context. There has been scarce analytical focus on the existence, substance, and operation of research regulations in individual countries in the Arab region.