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The IRB is a committee providing a process for reviewing ethical considerations for research involving human subjects. All staff involving human subjects or social/behavioral research within the Ministry of National Guard – Health Affairs (MNG-HA) and all affiliated facilities, must comply with the IRB regulations and seek IRB approval before starting their research projects.
The IRB takes into consideration different international and national laws and regulations, such as the Law of Ethics of Research on Living Creatures, Declaration on Bioethics and Human Rights and others; as well the Islamic General Rules and Guidelines, and the general ethical principles like: Principle of ‘Beneficence’, the principle of ‘Justice’ and the principle of ‘Respect for Persons’.
The IRB committee is composed of the chairman, the co-chairman and the members. The IRB members include at least: two physicians, one affiliated academic staff, one nurse, one not affiliated member, one member with a nonscientific background and one member who is recognized as a reference in the application of Islamic principles. The gender of the board members must be inclusive of both males and females.
- The IRB is responsible for protecting the rights and welfare of human participants, through reviewing, approving, monitoring and suspending ongoing research projects when needed and as applicable.
- Reviewing all research projects involving human subjects or human biological material or social/behavioral sciences projects.
- Approving all research proposals including patients/volunteers recruitment and screening activities.
- The IRB reviews research proposals taking into considerations also the Sharia rules or applicable laws and legislations in the Kingdom that are compatible with international laws and regulations.
- Reviewing and approving different types of research proposals.
- Continuing the review of ongoing research projects
- Approving research amendments
- Taking action on information or reports received from any source that indicates any Adverse Events (AE)/ Serious Adverse Event (SAE)
- Taking action on any noncompliance that is either reported to the IRB or identified by the IRB.