The National Committee of Bioethics organizes a workshop on the ethics of early phases clinical trials and gene therapy
His Excellency the General Supervisor of Research and Innovation Support, the Chairman of the National Committee of Bioethics, Dr. Abdulaziz bin Malik Al-Malik, gave the opening speech in which he welcomed the participants and speakers and stressed on the importance of this workshop to come up with scientific recommendations that will lay the foundations and ethical controls for these studies.
The program of the workshop included two sessions, where the first session included three lectures and was chaired by Dr. Omar bin Abdul Hamid Al Mazrou, Director of the Benefit and Risk Assessment Department at the Food and Drug Authority. The first lecture dealt with a presentation of the scientific approach to clinical studies and gene therapy presented by His Excellency Professor Muhammad Zuhair Al-Qawi, Director of the Research Ethics Monitoring Office at the National Committee of Bioethics at King Abdulaziz City for Science and Technology. The second lecture dealt with the ethics of conducting clinical studies, presented by His Excellency Prof. Jamal bin Saleh Al-Jarallah, Chairman of the Clinical Ethics Committee at King Saud Medical University. Moreover, the SFDA's controls and requirements for clinical studies were discussed In the third lecture presented by His Excellency the pharmacist Faisal bin Ali Al-Daghim from the SFDA's Clinical Trials Department.
The second session, entitled Gene Therapy, included three lectures and was chaired by His Excellency Dr. Abdullah bin Surur Al-Judi, Consultant of Community Medicine and Secretary General of the Saudi Society for Jurisprudence Studies. The first lecture of this session dealt with the types of gene therapy and its applications, presented by His Excellency Dr. Hamad bin Ibrahim Al-Zaidan, a genetics consultant at King Faisal Specialist Hospital and Research Centre. The second lecture came to address the aspects of the ethics of conducting gene therapy research, presented by His Excellency Professor Omar Hassan Kasoli, Chairman of the Local Committee at Princess Nourah bint Abdulrahman University, King Abdullah University Hospital. The third lecture of this session dealt with the experiences of countries in gene therapy legislation, presented by His Excellency Dr. Abdullah Adlan Awad Adlan, Executive Director of the Ethics and Compliance Department at the National Institute for Health Research and Chairman of the National Committee for Health Ethics in the Saudi Health Council.
The third session devoted to discussion and recommendations was chaired by His Excellency Prof. Zuhair bin Nasser Al-Hasnan, Consultant of Genetic Diseases at King Faisal Specialist Hospital and Research Centre. The first lecture of this session dealt with the role of the National Committee of Bioethics in staving off the legal vacuum, presented by His Excellency Dr. Ghayath bin Hassan Al-Ahmad, Deputy Head of the Bioethics Department at the King Abdullah International Center for Medical Research. The session concluded with a discussion of a number of recommendations, the most important of which are setting controls for the initial clinical studies for the safety of the participants, the importance of involving the community in planning research and gene therapy, as well as the need to share developments related to such research with Sharia scholars to ensure that it does not violate Sharia regulations.
More than 380 researchers in the field of medical sciences, doctors, faculty members of universities and research centers and university students attended this workshop.
