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Institutional Review Board (IRB)

Home Institutional Review Board (IRB)

Institutional Review Board (IRB)

The IRB committee consists of scientists, community representatives and health care professionals forming a committee with varying backgrounds to promote, and adequate review of research activities commonly conducted by the institution. It reviews research studies protecting the rights, safety and well-being of research participants and ensures the integrity and confidentiality of their information.

Research Proposal Guidelines

Purpose: This aims to provide guidance in the process of application and conducting a research in Sultan Bin Abdulaziz Humanitarian City.

Prior to approval of human research study, research protocols must be submitted to the IRB. You need to get a formal approval letter from the IRB before you can begin your research, including any data collection, or research participants' recruitment.  Once a research proposal is on hand, it is advised to get an appointment with the Director of Research and Scientific Center thru Research Nurse Coordinator +966-11562-0000 ext. 1708 to discuss the study for initial evaluation.
Upon discussion of the research study proposal, the Director will notify the Researcher to complete the required SBAHC requirements/checklist and forms for IRB approval. The Researcher will then be referred to Research Nurse Coordinator to complete the project submission. One will be providing the SBAHC requirements/checklist and forms to be sent to the researcher’s email address for completion.

All researchers are required to complete the following training courses according to the type of study:
Researcher NCBE Registration and Online Course http://bioethics.kacst.edu.sa/
Good Clinical Practice training course https://gcp.nidatraining.org.sa/

All documents should be sent by e-mail to: research@sbahc.org.sa for initial checking. Incomplete requests will not be processed and will be returned to investigators for completion. And once double checked by the research coordinator, researcher will be advised to submit all the final required documents affixing the signatures of the Principal Investigator and Co-Investigators with the original and soft copy at the SBAHC Research and Scientific Center.
Once received with complete application it will be evaluated again by the Director to determine whether it meets the definition of Human Research (link to definition) and if it does, it will be evaluated to determine the appropriate level of IRB review in accordance with regulations. 

Note: Make sure to submit all required documents, at least one month before the anticipated start day of research. If evaluated by the Director that the study needs most comprehensive IRB evaluation, the Institutional Review Board will discuss during the monthly meeting for the approval/disapproval/ or require modification by the board.
Note: Researcher will be notified via email by the RSC Coordinator if the research study will be included in the IRB meeting.
Researcher will be notified for the final IRB decision (at least 5 days from the board meeting).
Changes in approved research may not be initiated without IRB review and approval except when they are necessary to eliminate apparent immediate hazards to participating subjects. Researcher should report any unexpected serious harm to participants or unanticipated problems involving risks to participants or others.
If Researcher will plan to extend the pre-approved research period, they should renew for IRB approval while submitting the Amendment forms and notification letter at least 2 months to the study expiry.

IRB Committee Meeting Schedule for the Year 2024

Time: 10:00AM to 11:00AM

Venue: Microsoft Online Team Meeting/IRB Conference Room, Research Center.

Meeting No. Month/Year Date Month/Year Date Submission Deadline
1 January 2024 04 Jumada Al-Thani 1445 22 December 21, 2023
2 February 2024 01 Rajab 1445 20 January 18, 2024
3 March 2024 07 Shaban 1445 26 February 22, 2024
4 April 2024 04 Ramadan 1445 25 March 21, 2024
5 May 2024 02 Shawwal 1445 23 April 18, 2024
6 June 2024 06 Dhul-Qaadah 1445 29 May 23, 2024
7 July 2024 04 Dhul-Hijjah 1445 28 June 20, 2024
8 August 2024 01 Muharram 1446 26 July 18, 2024
9 September 2024 05 Rabi Al-Awwal 1446 02 August 22, 2024
1 January 2024 04 Jumada Al-Thani 1445 22 December 21, 2023
10 October 2024 03 Rabi Al-Awwal 1446 30 September 19, 2024
11 November 2024 07 Jumada Al-Awwal 1446 05 October 24, 2024
12 December 2024 05 Jumada Al-Thani 1446 04 November 21, 2024

IRB Review Fee:

1. Initial Submission:

  • Company Sponsored – SAR 15,000.00
  • Non-funded Studies SAR 500.00
  • IRB Fee is non-refundable after the study review.
  • Government Funded or PI Initiative with minimal funding – SAR 5,000.00
  • Post-Graduate students – SAR 1000.00

2. Renewal/Amendments: Any amendments should be stated in the Clinical Trial.

Agreement signed by PI and sponsor.

  • Renewal – SAR 2,000.00 starting on the 3rd year after the study
  • Amendment – SAR 1,000.00.
Checklist for New Researcher (Category of Research: Pre-Requisite Checklist)

Internal Employee Researcher: (Sultan bin abdulaziz humanitarian city)

  • Final version of research proposal
  • Final Case Report
  • GCP and NCBE Certificates
  • Final Informed Consent Form
  • Signed and Dated Curriculum Vitae of people involved in the study

External Researcher

  • Final version of research proposal
  • Final Case Report
  • Cover Letter from PI
  • Letter from researcher’s supervisor (If Applicable)
  • GCP and NCBE Certificates
  • Final Informed Consent Form
  • Signed and Dated Curriculum Vitae of people involved in the study
  • Letter from researcher’s affiliating Organization / College (If Applicable)
  • IRB Fee – SAR 500 (Non-refundable after IRB Review)

Post Graduate Researcher

  • Final version of research proposal
  • Final Case Report
  • Cover Letter from PI
  • Letter from researcher’s supervisor (If Applicable)
  • GCP and NCBE Certificates
  • Final Informed Consent Form
  • Signed and Dated Curriculum Vitae of people involved in the study
  • Letter from researcher’s affiliating Organization / College (If Applicable)
  • Letter of Confirmation for the acceptance of Local Supervisor from the researcher’s supervisor.
  • IRB Fee – SAR 500 (Non-refundable after IRB Review)