​​​Research Ethics :

In light of the necessity to establish unified standards for bioethical and medical research, a royal decree (No. 7/B/9512) was issued on 18/5/1422 AH to form a national committee named the National Committee for Bioethics and Medical Ethics. This committee aims to set and implement standards and ethics for bioethical and medical research, as well as to monitor compliance.

To complete the integrated system for regulating research from an ethical standpoint, a Cabinet Resolution (No. 321) was issued on 13/9/1431 AH approving the system of research ethics on living organisms. Subsequently, the National Committee for Bioethics issued the executive regulations for this system in the year 1433 AH.

Accordingly, a local research ethics committee was established at Princess Nourah bint Abdul Rahman University. The local bioethics committee at Princess Nourah bint Abdul Rahman University was registered with the National Committee for Bioethics on 18/09/1437 AH under registration number 059-01-H. It is currently known as the Institutional Review Board, in compliance with the ministerial decision requiring research institutions and centers to register local research ethics committees under the supervision of the national committee.

Instructions for Researchers Seeking Ethical Approval :

• ​All studies and research conducted at Princess Nourah bint Abdulrahman University must undergo ethical review by the Institutional Review Board (IRB) and be approved. The research project proposal, along with all supporting documents, must be submitted via email to IRB@PNU.EDU.SA, noting the importance of using the appropriate forms.
• Failure to comply with the relevant instructions and regulations of the IRB may result in the suspension of the research project and accountability for the research team.
• No research activity is allowed to commence before the issuance of the IRB approval decision.
• Annual renewal of the IRB approval must be submitted if necessary.
• All forms must be signed by the principal investigator or the research/graduate supervisor.
• The research team is required to submit the research project proposal, along with the questionnaire or data collection form, and the following documents as appropriate to the type of research:Exempt research path forms : For studies with minimal risk, such as surveys and interviews, the principal investigator must submit a periodic report at the midpoint of the research project.
• Expedited research path forms: For research with no more than minimal risk, such as blood sample collection, the principal investigator must submit a periodic report twice during the research project as specified in the IRB approval decision.
• Detailed review research path forms: For research involving human subjects for experimental drug or device trials, the principal investigator must submit a quarterly periodic report.​

The principal investigator must monitor the risk level and keep it to a minimum while regularly updating the IRB. The concept of "minimal risk" refers to the probability of harm or risk to research participants being no greater than what they would encounter in daily life or during routine medical exams. Examples of minimal risk include:

1.  Studies involving activities with a risk probability no greater than that experienced in daily life, such as blood sample collection or routine physical exams.
2. Studies involving no interventions, such as behavior observation or dietary studies.
3. Studies based on questionnaires.
4. Studies involving the collection of registry data or use of stored samples.

Application Process for Ethical Approval :

- The research proposal document, along with all supporting documents, must be submitted via email to IRB@PNU.EDU.SA, including the following attachments:

  1. Curriculum Vitae of Researchers

  2. Research Plan** (a brief description of the research objectives, methodology, and sample of participants)

  3. Questionnaire/Data Collection Tool** (to be included on the cover page of the questionnaire)

  4. Application Form for Exempt/Expedited/Full Review Research Pathways

  5. Certificate of Completion of the Research Ethics Training Program

• ​Please note that the approval process for research studies takes approximately 5-7 working days after all attachments are completed, whether the research is exempt or expedited. For studies requiring full review, the process may take up to 20 working days.
• The principal investigator must respond within 2-3 days after receiving feedback from the committee.
• The principal investigator is required to fill out the forms correctly and include the signatures of the participating researchers.
• The deadline for submitting applications is Wednesday, 14th Dhul-Qi'dah 1445 AH, corresponding to May 22, 2024 CE.
• The committee will resume accepting applications, God willing, at the beginning of the next year on Sunday, 14th Safar 1446 AH, corresponding to August 18, 2024 CE.
• For inquiries and more information, please contact the Research Ethics Committee at the Institutional Review Board via email at irb@pnu.edu.sa or call the following numbers: 42106 - 01182, 28994 - 01182.