Council
| Saudi Health Council.
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Center
| Center for Health Research and Studies at the General Secretariat of the Saudi Health Council.
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Rules
| Rules governing the activity of health research data exchange.
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Data Sharing Agreement (DSA)
| It is an agreement concluded between the data requester and the controller or controllers of the data regarding the sharing of that data or information that includes everything related to the researcher's obligation to share the data after the completion of its processing.
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Data Management
| It is all administrative and technical procedures through which data is obtained from databases and their integrity is maintained, collected and shared.
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Research/Study
| It is an empirical methodological investigation (i.e., data collection and analysis), aimed at advancing the biological sciences, or enriching or developing general knowledge using the living creature or parts of it.
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National Bioethics Committee (NCBE)
| The National Bioethics Committee contained in the Code of Research Ethics on Living Creatures, issued by Royal Decree No. (M/59) dated 14/09/1431 AH.
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Data Controller
| It is a natural or legal person which is determined alone or jointly with others by determining the objectives and means of data processing.
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Source
| Is the patient and/or the correct person from whom the consent to give a sample of biomaterial or to provide his/her data in his/her individual capacity or on behalf of others/others for research purposes.
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Biomaterials
| Material collected from living creatures without registered objection from the source (where applicable) for further research, including but not limited to cell strains or viruses, bacteria, expired blood donation bags, or old umbilical cord blood stored (in blood banks). The concept of biomaterials may include any data that can be used, now or in the future.
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Health Research Data (RD)
| Research data related to health research, previously collected by licensed researchers.
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Data Management and Sharing Plan (DMSP)
| A plan that describes how research data is managed, saved, shared, and made available to interested professionals
(such as researchers and government agencies).
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Local Committee (IRB)
| The Research Licensing Committee formed in the facility in accordance with the Research Ethics System on Living Creatures issued by Royal Decree No. M/59 dated 14/09/1431 AH.
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Data processor
| It is a natural or legal person who processes data on behalf of the data controller. The researcher can also be considered a data processor.
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Data processing
| Any operation or set of operations performed on data or on data sets (e.g., use of processing methods such as collection, recording, organization, installation, storage, adaptation, alteration, retrieval, consultation, use, disclosure by transmission or publication) or otherwise made available, combination, collection, restriction, erasure, or destruction.
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Data Protection Officer (DPO)
| It is the one who is appointed by the data controller to advise on compliance with the applicable laws and regulations and these rules.
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Data Sharing
| Enable finding, accessing, utilizing, and reusing research data and biosamples for research purposes.
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Observer for the sharing and protection of research data and biomaterials
| It is a legal person that performs the task of monitoring research data and vital materials in acting as an independent supervisory body in full coordination and cooperation with the National Bioethics Committee.
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Protection period
| It is the period requested by the researcher to protect data from sharing for the purposes of benefiting from that protected data as requested in the Data Management and Sharing Plan (DMSP) accompanying the new research proposal.
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New Research Proposal
| It is the proposal submitted by the researcher to benefit from the health research data collected from previous research/studies.
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The Four Empowerment Principles (FAIR)
| The basic principles that must be followed by all organizations that collect data for health research purposes are enabling data finding, enabling data access, enabling data interoperability, and enabling data reuse. |
