The “Guidelines for Responsible Conduct of Clinical Studies and Trials” advocates and describes the best practice in research for researchers and institutions, promotes integrity in research and explains what is expected from researchers, and assists researchers, administrators and the community on how to manage breaches from best research practice. It is addressed not only to researchers, but also to ethics review committees, investigational institutes, pharmaceutical manufacturers, sponsors of research drug regulatory authorities, the general public and those who have interest in clinical trials in Oman. This guideline not only serves the interests of the parties actively involved in the research process, but also protects the rights and safety of subjects, including patients, and ensures the investigations are directed to the advancement of public objectives of citizens.
This document provides information on how to manage research data and materials; ethics on how to publish and disseminate research findings (including proper attribution of authorship); obligations in peer review; and how to manage conflicts of interest. It is based on international standards but with an Islamic perspective and is a first time initiative by the Ministry of Health. Future revisions will take into consideration the evolving research guidelines and standards that are suitable to the situation and context in Oman.