- Institutional Review Board
- Institutional Review Board (IRB)
- The IRB is a committee of scientists, non-scientists, community representatives and health care professionals. It reviews research studies in an effort to protect the rights, safety and well-being of research participants and ensure the integrity and confidentiality of their information. In addition to documenting information needed by patients or healthy volunteers to enable them to make informed decisions on whether to participate in a research or not.
- The Institutional Review Board at Prince Sultan Military College of Health Sciences is registered locally by the Saudi National Commission for Bioethics (NCBE) with the number HA-05-D-046 and dated 07/10/1435 AH. It operates according to NCBE regulations and Good Clinical Practice Guideline (GCP).
- We are pleased to serve you, please note:
1- Prior approval of human research study protocols by the IRB is mandatory. 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.
2- 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.
3- You should report any unexpected serious harm to participants or unanticipated problems involving risks to participants or others.
4- If you plan to extend your pre-approved research period, you should renew your IRB approval.
5- 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/
- 6- All documents should be sent by e-mail to: email@example.com
- 7- Make sure to submit all required documents, at least one month before the anticipated start day of research.
- 8- Make sure to submit complete applications. Incomplete requests will not be processed and will be returned to investigators for completion.
- 9- Upon receiving a complete application, it will be evaluated 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.
- 10- This evaluation classifies research into one of three categories:
- - eligible for exemption from periodic review;
- - qualified for expedited review; or
- - subject to the most comprehensive IRB evaluation at one of the committee’s monthly meetings.
You will be notified of the specific review level, the approximate time required to complete your application review, and the final IRB decision.
- IRB Office
- Email: firstname.lastname@example.org
- Tel: 966-3-8440000, Ext. 6288
- Prince Sultan Military College of Health Sciences (PSMCHS)
- King Fahd Military Medical Complex
- Bldg. 80, First Floor, Office 1039
- Important Links
- National Committee of BioEthics (NCBE): http://bioethics.kacst.edu.sa/About.aspx?lang=en-US
- Good Clinical Practice training course: https://gcp.nidatraining.org/
- The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for
- Human Use (ICH): https://www.ich.org/products/guidelines.html
- Collaborative Institutional Training Initiative (CITI) training program: https://about.citiprogram.org/en/homepage/
- The Program for Readability In Science & Medicine (PRISM): https://www.kpwashingtonresearch.org/about-us/capabilities/research-communications/prism/
- Definition of Human Subject Research