This Law aims at setting the general principles and controls necessary for dealing with living things, parts thereof or their genetic material in research in light of applicable professional ethics not conflicting with Sharia.

No establishment may conduct research on a living thing except upon fulfilling procedures required under this Law. Research shall be subject to periodic inspection by the National Committee in accordance with the Regulations.

• 1. A national committee of bioethics shall be formed at KACST comprising specialists nominated by the competent minister or head of an agency for a renewable term of 3 years, as follows:

  • − A representative of KACST, Chairman.

  • − A representative of the National Guard, Member.

  • − A representative of the Ministry of Defense and Aviation, Member.

  • − A representative of the Ministry of Interior, Member.

  • − A representative of the General Presidency of Religious Research and Ifta', Member.

  • − Two representatives from the Ministry of Higher Education (Universities), Members.

  • − A representative of the Ministry of Health, Member.

  • − A representative of the Ministry of Education, Member.

  • − A representative of the Ministry of Agriculture, Member.

  • − A representative of the Saudi Wildlife Commission, Member.

  • − A representative of the Food and Drug General Authority, Member.

  • − A representative of King Faisal Specialist Hospital and Research Center, Member.

  • − A representative of Human Rights Commission, Member.

  • − The Director of Research Ethics Monitoring Office, Member.

  • − A representative of the private sector selected by the Chairman of the Council of the Chambers of Commerce and Industry, Member.

  • − A legal counselor selected by the President of KACST, Member.

• 2. The President of KACST shall issue the committee-formation decision, and said committee shall report to him.

• 3. The President of KACST shall appoint a secretary for the committee.

• 4. Committee members shall elect from among themselves a vice president.

The National Committee shall convene periodically upon the Chairman's call or as necessary. The committee shall convene upon a call by its Chairman or upon a written request by one third of its members. Committee meetings shall not be valid unless attended by two thirds of its members. Committee resolutions shall pass by majority vote of attending members. In case of a tie, the Chairman shall have the casting vote. The Regulations shall determine committee work procedures and meetings as well as remuneration of members in accordance with applicable laws, resolutions and directives.

• The National Committee shall set standards for biological research ethics and oversee enforcement thereof. It shall be the authority regarding overseeing research ethics and monitoring implementation thereof. It shall particularly undertake the following:

• 1. Prepare bioethics research regulations and review them in accordance with recent developments.

• 2. Propose amendment to the Law and its Regulations.

• 3. Form specialized subcommittees for conducting detailed studies on research fields within the jurisdiction of the National Committee.

• 4. Set controls for sending biological samples to laboratories outside the Kingdom.

• 5. Oversee local committees and monitor compliance with Sharia and statutory rules when dealing with biological material.

• 6. Set ethical controls and monitor implementation thereof to safeguard rights of human subjects during research and ensure confidentiality and security of research information.

• 7. Establish a database for saving and retrieving national information on genetic material of Saudi society.

• 8. Coordinate between the Kingdom and other countries as well as Arab and international organizations with regard to its jurisdiction, in accordance with applicable legal procedures.

• 9. Set bylaws for the National Committee.

• 10. Propose annual budget of both the National Committee and the Research Ethics Monitoring Office.

• 11. Oversee and monitor the central information system for national genetic material banks and set controls for documentation and retrieval thereof.

• 12. Set rules and principles for ethical recognition of research laboratories working in biomedical fields.

• 13. Conduct periodic ethical evaluation and monitoring of national laboratories, and monitor medical research and experiments conducted on living things to ensure legitimacy.

• The Committee may seek consultation from experts, associations, scientific centers or specialized agencies within the Kingdom and abroad.