Introduction

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These rules derive their regularity from one of the objectives of the Saudi Health Council, which includes raising coordination and integration between all health authorities, in order to achieve the maximum benefit from the available capabilities contained in the health system issued by Royal Decree No. (M/11) dated 23/03/1443 AH, as well as item (3) of paragraph (eleventh) of the Council of Ministers Resolution No. (11) dated 12/01/1434 AH, which defined the tasks and competencies of the Center for Health Research and Studies, it includes that the center may propose professional and ethical regulations and rules governing the activity of national health research, and follow up their implementation after their approval by the Saudi Health Council.

In preparing these rules, the Center started from its mission, which works to build an effective and sustainable system for health research and studies that helps to find and implement evidence-based national health strategies in partnership, coordination and integration between the relevant sectors.

Pursuant to this, a scientific committee has been formed for this purpose to prepare these rules of representatives from all health sectors, members of the Saudi Health Council, the Saudi Food and Drug A​uthority, the Council of Cooperative Health Insurance, the National Bioethics Committee, the National Center for Health Information, and the Center for Health Research and Studies, to achieve these objectives.

Therefore, these rules came as one of the tasks and roles of the Saudi Health Council and the Center for Health Research and Studies, in order to regulate the preservation and exchange of health data and its sharing for research purposes.