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.
The IRB Committee consists of the following members:
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. 8828 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:
2. Renewal/Amendments: Any amendments should be stated in the Clinical Trial.
Agreement signed by PI and sponsor.
Checklist for New Researcher (Category of Research: Pre-Requisite Checklist)
Internal Employee Researcher: (Sultan bin abdulaziz humanitarian city)
External Researcher
Post Graduate Researcher