The words and phrases mentioned below – wherever they appear in these organizational arrangements – shall have the meanings specified next to each of them, unless the context requires otherwise:

The Institute: The National Institute for Health Research.

The Organizational Arrangements: The organizational arrangements of the Institute.

The Council: The Board of Directors of the Institute.

The President: The President of the Council.

The Chief Executive Officer: The Chief Executive Officer of the Institute.

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

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 health.

Translational Health Research: Health research that works to transfer knowledge and discoveries gained from the outputs of basic sciences – scientific disciplines such as biology, chemistry, physics, and 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 methods of healthcare.

Clinical Trials in Health: Health research related to research studies conducted on humans by identifying participants, such as: intervention with drugs, or medical devices, or surgical or diagnostic or preventive procedures, or placebo, and so forth.

The institute is organizationally linked to the Minister of Health, enjoys public legal personality, and has financial and administrative independence. Its main headquarters is located 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 community health, well-being, and quality of life.

2- Funding translational research and clinical trials in the field of health, 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 in them in coordination with relevant entities.

4- Contributing to the unification of efforts among stakeholders involved in translational research and clinical trials in the field of health.

The institute is the entity responsible for supervising translational research and clinical trials in the field of health, and it has – without prejudice to the competencies and responsibilities of other entities – the authority to do everything necessary to achieve its objectives, including the following:

1- Working to identify areas and programs for research, development, and innovation in the field of translational research and clinical trials in health.

2- Proposing appropriate environmental standards for conducting translational research and clinical trials in health, and submitting them for further necessary action.

3- Proposing investment opportunities and mechanisms in translational research and clinical trials in local and international health that are highly feasible by funding them – either fully or partially – and supporting their capabilities, and submitting them for further necessary action.

4- Proposing strategic plans related to the technical, professional, and academic development of human resources, including the development of 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 further necessary action.

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 funding translational research and clinical trials in health.

7- Supervising the implementation of translational research and clinical trials in health funded by the institute, and evaluating them according to the relevant regulations, rules, and policies.

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

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, and supporting its growth and directing it in areas of national priority; in accordance with the relevant regulations.

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

11- Conducting studies and information monitoring related to the development areas of the institute's work.

12- Forming research partnerships with international organizations and entities to promote collaborative, multi-institutional, and interdisciplinary research to support research entities within the Kingdom in the areas of the institute's specialization, in accordance with the relevant regulations.

13- Representing the Kingdom in regional and international bodies and organizations in the areas of the institute's specialization.

14- Engaging in scientific communication tasks, including publishing, holding workshops, training sessions, and local and international conferences, related to the institute's competencies.

15- Enhancing research collaboration and knowledge exchange with internationally prominent peer entities, and strengthening relationships with them through participation in conferences, forums, discussion circles, and international events they organize.

16- Providing studies, recommendations, consulting 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 guidelines for building outstanding competencies of scientists and consultants in translational research and clinical trials in health, and developing, attracting, and recruiting them.

The institute shall have a Board of Directors chaired by the Minister of Health, with the membership of:

1- A representative from the Council of Universities Affairs.

2- A representative from the Ministry of Health.

3- A representative from the Ministry of Investment.

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

5- A representative from the Public Health Authority.

6- A representative from the Research Development and Innovation Authority.

7- A representative from the Saudi Food and Drug Authority.

8- The Chief Executive Officer.

9- Two individuals with expertise and specialization in the work of the institute, appointed by a decree from the President of the Council of Ministers based on a proposal from the President.

The rank of the representatives of government agencies must not be less than the (fourteenth) rank or its equivalent. Except for the Chief Executive Officer of the institute, the term of membership in the council shall be (three) years, renewable once.

The Council is responsible for overseeing the management of the Institute's affairs and conducting its matters, and it makes all necessary decisions to achieve the Institute's objectives within the limits set by the organizational arrangements. In particular, it has the following responsibilities:

1- Approving the strategic plan for the Institute, in coordination with the Ministry of Health.

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

3- Proposing possible policies for translational research and clinical trials in health, and submitting them for further necessary actions.

4- Proposing draft laws and regulations related to the Institute's competencies, suggesting amendments to those in effect, and submitting them to the Supreme Committee for Research, Development, and Innovation, in preparation for completing the legal procedures.

5- Proposing regulations for grants and funding for translational research projects and clinical trials in health, and submitting them for further necessary actions.

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

7- Approving the internal policies and operational plans for the Institute and overseeing their implementation.

8- Approving the organizational structure of the Institute.

9- Approving the administrative and financial regulations that govern the Institute, along with other necessary regulations for its operations, provided that the approval of administrative regulations is in agreement with the Ministry of Human Resources and Social Development, and that the approval of financial regulations and provisions with financial implications in other regulations is in agreement with the Ministry of Finance.

10- Determining the financial compensation for the services provided by the Institute within its competencies.

11- Approving the holding of conferences, seminars, scientific forums, and events related to the Institute's activities, in accordance with the legal procedures.

12- Approving the draft budget of the Institute, its final account, the auditor's report, and the annual report; in preparation for submitting them according to the legal procedures.

13- Reviewing periodic reports submitted on the progress of work in the Institute and evaluating the performance of the executive management, and taking necessary actions based on the outcomes.

14- Appointing an external auditor (or more) and an internal financial controller.

15- Accepting gifts, donations, grants, bequests, and the proceeds of endowments, in accordance with the legal procedures.

16- Approving the establishment of branches of the Institute within the Kingdom.

17- Approving the conclusion of agreements, protocols, and contracts in accordance with the legal procedures.

18- Approving the performance measurement indicators of the Institute.

To achieve its competencies and without prejudice to the duties assigned to it, the Council may form permanent or temporary committees from its members or others, delegating them tasks it deems necessary. Each committee's formation decision specifies its chairperson, members, and competencies, and it may seek assistance from whomever it deems necessary to perform the assigned tasks. It may also delegate some of its competencies to the President, the Chief Executive Officer, or any of its members or staff of the Institute.

1- The Council meetings are held at the Institute's headquarters, chaired by the President or a member appointed by him from the representatives of government agencies. They may also be held at another location within the Kingdom.

2- The Council holds its meetings periodically, 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 is sent by the President in writing well in advance of the meeting date, as deemed appropriate by the President, and must be accompanied by the meeting agenda.

4- The Council meeting is valid if attended by the majority of the members – at least – including the President or a member appointed by him from the representatives of government agencies. Decisions are made by a majority of the votes of those present at least. In the event of a tie, the side that the meeting President voted with is favored.

5- The discussions and decisions of the Council are recorded in minutes signed by the meeting President and the attending members.

6- If necessary, in urgent cases, and as deemed appropriate by the President, meetings may be held and votes on decisions may be taken remotely using technological means. Decisions can be made by circulating among the Council members, and they are signed to indicate that all members have been informed of them. Decisions made in this manner are not considered valid unless they are circulated to all members, voted on, and receive at least a majority of their votes.

7- A Council member may not abstain from voting, nor delegate another member to vote on their behalf in their absence. An objecting member has the right to record their objection and the reasons for it in the minutes of the Council meeting.

8- A Council member may not disclose any information they have learned about the Institute's secrets even after their membership in the Council has ended.

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

The institute shall have an Executive President, appointed by a decision from the Council, which specifies his salary and other financial and functional benefits. He is responsible for managing the affairs of the institute, and his responsibilities are concentrated within the limits of the organizational arrangements and what the Council decides. He shall undertake the following responsibilities:

1- Supervising the preparation of the strategic plan for the institute and submitting it to the Council.

2- Proposing the key performance indicators for the institute and submitting them to the Council.

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

4- Proposing the internal policies and operational plans for the institute and their governance, and submitting them to the Council.

5- Proposing the organizational structure of the institute and submitting it to the Council.

6- Proposing the administrative, financial, and technical regulations that the institute operates under, suggesting amendments to the existing ones, overseeing their preparation, and submitting them to the Council for approval and implementation after approval.

7- Supervising the workflow in the institute according to its regulations, plans, and approved programs.

8- Proposing the financial compensation for the services provided by the institute within its competencies and submitting it to the Council.

9- Proposing the organization of conferences, seminars, scientific forums, and events related to the institute's activities, and submitting them to the Council.

10- Supervising the preparation of the institute's budget project, its final account, the auditor's report, the annual report, and the periodic reports submitted regarding the workflow in the institute, and evaluating the performance of the executive management; and submitting them to the Council.

11- Proposing the establishment of branches for the institute within the Kingdom and submitting it to the Council.

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

13- Appointing the institute's staff in accordance with the regulations and rules governing that, and supervising them.

14- Approving the plans and programs related to training the institute's staff, sending them for further studies, and dispatching them in all areas of the institute's work, in accordance with the relevant regulations and rules.

15- Representing the institute before the judiciary and with government agencies, institutions, bodies, organizations concerned, and other entities or conferences or events inside and outside the Kingdom, and he has the authority to delegate others in this regard.

The Executive President may delegate some of his powers to whomever he sees fit among the institute's staff.

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

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

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

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

• D- Any gifts, donations, grants, bequests, and endowment revenues accepted by the council.

• E- Any other resource approved by the council that does not violate the regulations and instructions.

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

3- The institute shall open an account with the Saudi Central Bank, and it may open accounts in any of the banks licensed to operate within the Kingdom, with disbursements from these accounts being in accordance with the institute's budget and its financial regulations.