The following words and phrases - wherever they appear in this Statute - shall have the meanings indicated opposite each of them, unless the context requires otherwise:

• 1- Institute: The National Institute for Health Research.

• 2- Statute: The Institute's Statute.

• 3- Council: The Institute's Board of Directors.

• 4- President: The President of the Council.

• 5- Minister: The Minister of Health.

• 6- Chief Executive Officer: The Institute's Chief Executive Officer.

• 7- Health: A state of complete physical, mental, and social well-being, not merely the absence of disease or infirmity.

• 8- Health Research: Research that follows scientific methodologies for the purpose of collecting, studying, analyzing, comparing data, and drawing conclusions in the field of health, including translational research and clinical trials in the health field.

• 9- Translational Health Research: Health research that works on transferring knowledge and discoveries derived from basic sciences outputs - scientific disciplines such as biology, chemistry, physics, mathematics, which explain natural and biological phenomena - to the application stage in clinical and community practices; to contribute to improving human health through the development of new drugs, technologies, and healthcare methods.

• 10- Clinical Trials in the Health Field: Health research related to research studies conducted on humans by identifying participants in them, such as: intervention with drugs, medical devices, surgical procedures, diagnostic, preventive, placebo treatments, and the like.

• 11- Saudi Clinical Trials Registry in the Health Field: A database that systematically and governably collects clinical trial data in the Kingdom, ensuring the completeness and accuracy of the data submitted to the registry.

The institute enjoys public legal personality and financial and administrative independence, and it is organizationally linked to the Minister. Its main headquarters is in the city of Riyadh, and it may establish branches within the Kingdom as needed.

The institute aims to achieve the following:

• 1- Contributing to the improvement of human health, well-being, and quality of life.

• 2- Funding translational research and clinical trials in the field of health, and ensuring the quality and efficiency of their outputs.

• 3- Transforming the results of translational research and clinical trials in the field of health into health and economic benefits, including investing them in coordination with relevant authorities.

• 4- Contributing to the unification of efforts of entities concerned with translational research and clinical trials in the field of health.

The Institute is the entity responsible for supervision and support of translational research and clinical trials in the field of health, and it shall - without prejudice to the competencies and responsibilities of other entities - undertake all necessary actions to achieve its objectives, including the following:

• 1- Working on identifying the fields and programs of research, development, and innovation in the field of translational research and clinical trials in health.

• 2- Proposing standards for the appropriate environment to conduct translational research and clinical trials in health, and submitting them for completion of the necessary procedures.

• 3- Proposing investment methods and mechanisms in translational research and clinical trials in local and international health with high feasibility by financing them - fully or partially - and supporting their capabilities, and submitting them for completion of the necessary procedures.

• 4- Proposing strategic plans related to the development of human resources technically, professionally, and academically, including developing clear and motivating career paths for researchers and trainees in the field of translational research and clinical trials in health in coordination with relevant entities, and submitting them for completion of the necessary procedures.

• 5- Monitoring the implementation of professional, ethical, and regulatory policies and standards related to translational research and clinical trials in health.

• 6- Establishing procedural and executive rules for financing translational research and clinical trials in health.

• 7- Supervising the implementation of translational research and clinical trials in health funded by the Institute, supporting and evaluating them, in accordance with the relevant laws, regulations, policies, and rules.

• 8- Establishing mechanisms to benefit from the results of translational research and clinical trials in health, and supervising their implementation.

• 9- Contributing to enabling the utilization of infrastructure related to translational research and clinical trials in health, making it available and facilitating access to it, supporting its growth, and directing it towards areas of national priority; all in accordance with the relevant laws.

• 10- Contributing to the establishment and activation of incubators and accelerators for translational research and clinical trials in health with scientific and research institutions and centers across all public, private, and non-profit sectors.

• 11- Conducting studies and informational monitoring related to the fields of developing the Institute’s work.

• 12- Establishing research partnerships with international organizations and entities to advance collaborative research to support research entities within the Kingdom in the fields of the Institute’s specialization, in accordance with the relevant laws.

• 13- Representing the Kingdom in regional and international bodies and organizations in the fields of the Institute’s specialization.

• 14- Undertaking scientific communication tasks including publishing, organizing workshops, training sessions, and local and international conferences, in relation to the Institute’s specializations.

• 15- Enhancing research cooperation and knowledge exchange with prominent international peer entities, and strengthening relations with them through participation in conferences, forums, discussion panels, and international events they organize, in accordance with the applicable regulatory procedures.

• 16- Providing studies, recommendations, consultancy services, and research publishing services specialized in the field of translational research and clinical trials in health.

• 17- Establishing specialized training programs in the field of translational research and clinical trials in health.

• 18- Developing guidance manuals for building, developing, attracting, and recruiting distinguished competencies in translational research and clinical trials in health.

• 19- Establishing the Saudi Clinical Trials Registry in the field of health.

• 20- Promoting the culture related to translational research and clinical trials in health.

1- The Institute shall have a Board of Directors chaired by the Minister, and membership shall include:

• A- A representative from the Council of Universities Affairs.

• B- A representative from the Ministry of Health.

• C- A representative from the Ministry of Investment.

• D- A representative from the Ministry of Industry and Mineral Resources.

• E- A representative from the Public Health Authority.

• F- A representative from the Research Development and Innovation Authority.

• G- A representative from the Saudi Food and Drug Authority.

• H- The Chief Executive Officer.

• I- Two individuals with expertise and specialization relevant to the Institute's work.

2- The two members referred to in subparagraph (I) of paragraph (1) of this article shall be appointed by an order of the Council of Ministers based on a proposal from the President.

3- The rank of representatives of government agencies shall not be less than (fourteenth) rank or its equivalent.

4- Except for the Chief Executive Officer, the membership term on the Board shall be (three) years, renewable once.

The Council is the supreme authority of the Institute, responsible for supervising it and managing its affairs, and it makes all necessary decisions to achieve its objectives within the provisions of the statute. In particular, it has the following powers:

• 1- Approving the Institute's strategy.

• 2- Approving the fields and programs of research, development, and innovation in the field of translational research and clinical trials in health.

• 3- Proposing possible policies for translational research and clinical trials in health, and submitting them for completion of the necessary procedures.

• 4- Proposing draft laws and regulations related to the Institute's competencies, proposing amendments to existing ones, and submitting them for the completion of statutory procedures.

• 5- Proposing grant and funding regulations for translational research and clinical trial projects in health, and submitting them for completion of the necessary procedures.

• 6- Approving the funding of translational research and clinical trials in health, in accordance with relevant laws and regulations.

• 7- Approving the internal policies, operational plans, and governance of the Institute, and supervising their implementation.

• 8- Approving the organizational structure and organizational manual of the Institute.

• 9- Approving the administrative and financial regulations governing the Institute, and other regulations necessary for managing its affairs, provided that the approval of administrative regulations is in agreement with the Ministry of Human Resources and Social Development, and the approval of financial regulations and provisions with financial impact in other regulations is in agreement with the Ministry of Finance.

• 10- Determining the financial fees for the services provided by the Institute within its areas of competence.

• 11- Approving the Institute's draft budget, final account, auditor's report, and annual report; in preparation for submitting them according to statutory procedures.

• 12- Reviewing periodic reports submitted on the progress of work at the Institute and taking necessary actions regarding the outcomes thereof.

• 13- Appointing an internal financial auditor.

• 14- Accepting gifts, donations, grants, bequests, and endowment revenues, in accordance with statutory procedures.

• 15- Approving the establishment of branches of the Institute within the Kingdom.

• 16- Approving the conclusion of agreements, protocols, and contracts, in accordance with statutory procedures.

• 17- Approving the Institute's performance measurement indicators.

• 18- Approving the investment of the Institute's funds in a manner that achieves its objectives and missions, in accordance with relevant laws, instructions, and mechanisms.

To achieve its competencies and without prejudice to its assigned duties, the Council may form permanent or temporary committees from among its members or others, authorize them with tasks it deems appropriate, and specify in the decision forming each committee its chairperson, members, and competencies. The committee may also seek assistance from whomever it deems necessary to perform its assigned tasks. The Council may also delegate some of its competencies—except for the competencies listed in paragraphs (1), (2), (4), (8), (9), (10), (11), (12), (13), and (15) of this article—to the President, the CEO, or whomever it deems from its members or the Institute's staff.

1- The Council meetings shall be held at the Institute's headquarters, chaired by the President or his delegate from among the members representing government agencies. They may also be held at another location within the Kingdom.

2- The Council shall hold its meetings regularly at least (twice) a year, and whenever necessary as determined by the President, or if requested by at least (one-third) of the members.

3- The invitation to the meeting shall be issued in writing by the President sufficiently in advance of the meeting date as determined by the President, provided that the invitation is accompanied by the meeting agenda.

4- The Council meeting shall be valid if attended by a majority of the members - at least - including the President or his delegate from among the members representing government agencies. Decisions shall be issued by the majority of the votes of those present at least. In the event of a tie, the side voted for by the meeting President shall prevail.

5- The Council's deliberations and decisions shall be recorded in minutes signed by the meeting President and the members present.

6- If necessary, in urgent cases, and according to the President's discretion, meetings may be held and decisions voted on remotely through the use of technology means. Decisions may be made by circulation among the Council members, and signed to indicate that all members have been informed. Decisions issued in this manner shall not be considered valid unless circulated to all members, voted on by them, and approved by at least a majority of their votes.

7- A Council member shall not abstain from voting, nor delegate another member to vote on his behalf in his absence.

The objecting member has the right to record his objection and the reasons for the objection in the Council meeting minutes.

8- A Council member shall not disclose any of the Institute's secrets he has become aware of even after the termination of his membership in the Council.

9- The Council may invite specialists and consultants whom it deems necessary to attend its meetings, without granting them the right to vote.

The Institute shall have a Chief Executive Officer, who is appointed and relieved by a decision of the Council, and is the primary person responsible for managing the affairs of the Institute. His responsibilities and authorities are concentrated within the limits of the statute and what the Council decides. In particular, he shall have the following competencies:

• 1- Supervising the preparation of the Institute's strategy and submitting it to the Council.

• 2- Proposing the Institute's key performance indicators and submitting them to the Council.

• 3- Supervising the preparation of the Institute's programs and policies, submitting them to the Council, and overseeing their implementation after approval.

• 4- Proposing the internal policies, operational plans, and governance of the Institute, and submitting them to the Council.

• 5- Proposing the organizational structure and organizational manual of the Institute, and submitting them to the Council.

• 6- Proposing the administrative, financial, and technical regulations governing the Institute, proposing amendments to the applicable ones, supervising their preparation, and submitting them to the Council for approval and implementation after approval.

• 7- Supervising the workflow in the Institute in accordance with its approved regulations, plans, and programs.

• 8- Proposing the financial fees for the services provided by the Institute within its areas of specialization, and submitting them to the Council.

• 9- Approving the organization of conferences, seminars, scientific forums, and events related to the Institute's activities, in accordance with the statutory procedures.

• 10- Supervising the preparation of the Institute's draft budget, final account, auditor's report, annual report, and periodic reports submitted on the progress of work in the Institute; and submitting them to the Council.

• 11- Proposing the establishment of branches of the Institute within the Kingdom, and submitting the proposal to the Council.

• 12- Signing agreements, protocols, and contracts after the Council's approval, or according to the authorities granted to him by the Council.

• 13- Appointing the Institute's employees in accordance with the applicable laws and regulations, and supervising them.

• 14- Approving plans and programs related to training, scholarship, and deputation of the Institute's employees in all fields of the Institute's work, in accordance with the relevant laws and regulations.

• 15- Representing the Institute before the judiciary, government agencies, institutions, authorities, relevant organizations, and other entities or conferences or events inside and outside the Kingdom, and he may delegate others to do so.

• 16- Any other competency assigned to him by the Council.

The Chief Executive Officer may delegate some of his competencies to whomever he deems appropriate from the Institute's employees.

1- The financial resources of the institute consist of the following:

• A- The financial appropriations allocated to it in the state budget.

• B- The returns on investments of its available financial resources.

• C- The financial consideration it receives for the services it provides.

• D- Donations, grants, bequests, and endowment revenues accepted by the Council.

• E- Any other resource approved by the Council, provided it does not conflict with laws and regulations.

2- The institute's funds shall be deposited in the Ministry of Finance's current account at the Saudi Central Bank.

3- The institute shall open an account at the Saudi Central Bank, and it may open accounts at any licensed banks operating within the Kingdom. Disbursements from these accounts shall be in accordance with the institute's approved budget and its financial regulations.