IRB (institutional review board)

Institutional Review Board (IRB)

The institutional review board (IRB) committee was established on June 12, 2017, to regulate medical research only.

Vision

SEMA IRB will be the guardian of all research, to ensure strict adherence of any research conducted at SEMA’s affiliated facilities to the established ethics in the field of medicine and research.

Missions

  • Support and guide researchers to conduct advanced, safe, and ethical medical studies, and get published in international journals.
  • Protect research participants according to Helsinki’s Declaration (Appendix 1)

Objectives

  • To improve the quality of research conducted at SEMA-affiliated centers
  • To ensure adherence to research ethics
  • To educate SEMA members about research methodology
  • To spread principles of scientific research between medical staff
  • To ensure the dignity of participating individuals by taking proper, informed consent.

Essential regulations (related to researchers)

First: No research, unless specified in this document, should be conducted in SEMA affiliated medical centers without a previous IRB approval.

Second: All types of studies require completing the application form by the principal investigator (PI) that include the study proposal and the consent process or waiver as required. Proposals submitted to the IRB committee will only be accepted in English or Arabic. All research proposal should be submitted with the completed required forms to the IRB chairman directly at: [email protected]

Third: IRB classifies studies into 3 categories (this determine the level of internal review):

  1. Exempt: include case reports, case series, or retrospective chart reviews (if they are part of a previously approved project), or studies that involve the collection of publicly available, existing records. For such studies, the IRB chair may make the decision on this category alone. 
  2. Expedited: includes observational, cohort studies, case-control studies, cross-sectional studies (e.g., prevalence studies) using surveys or questionnaires, and retrospective studies (if it is not part of a previously approved project). For such studies, the IRB chair will ask 2 to 3 members of the committee to review the proposal and all will participate in making the decision. 
  3. Full review: typically randomized controlled trials or any interventional studies that are not necessarily randomized or not including control groups, or any study that the IRB chair may feel needs a more extensive review. This category requires full committee review.

Studies and manuscripts that do not require IRB approval are: opinions, commentary, letters-to-the-editor, review articles, systematic reviews, and meta-analysis.

Fourth: RESPONSIBILITIES OF THE PRINCIPAL INVESTIGATOR

The principal investigator (PI) is the main researcher in the study and the one who will be responsible for conducting the study. The PI is usually the most senior researcher in the team and usually becomes the corresponding author in the final manuscript.

  1. The PI is required to send the IRB a study progression report every 6 months that includes:
    1. Number of patients recruited
    2. Expected time for study completion
  2. The PI is required to inform the IRB and get their approval at any time a study protocol modification occurs, and before implementation occurs
  3. The PI is required to inform the IRB when the study is completed or stopped within 3 days,
  4. The PI is required to submit a complete report to the IRB of any adverse events happening within 24 hours
  5. The PI is required to use the consent form that the IRB determines after the IRB review the completed consent form template and approve it. The PI is not allowed to use any other form than what SEMA IRB committee approve
  6. The PI is required to save the patients’ consents for up to 5 years and make them available to the IRB at any time they asked for
  7. The PI is responsible for protecting all patients’ information, and not sharing any identification information with any other party or person, outside the research team, under no condition
  8. The PI is advised to avoid discussing political issues and avoid using controversial terminology (e.g,. civil war in Syria)
  9. The PI is required to send the IRB a copy of the manuscript before submitting it to the journal
  10. The PI is required to clearly mention the hospital’s affiliation with SEMA
  11. The PI is required to send a PDF copy of the final published manuscript
  12. Starting January 1st, 2019, the PI is required to review the IRB assigned materials and pass the online test. The test certificate is valid for 3 years from the day the PI passes the exam.

Fifth: Failure of the PI to comply with the above-mentioned duties, may result in suspending the IRB approval and not giving the PI any further research approval. By starting the study after obtaining the IRB approval the PI becomes responsible for all the above conditions, and in case the research team violates any of the above terms and conditions the IRB committee has the rights to withdraw the approval. The above-mentioned PI responsibilities will be included in any IRB approval letter. 

Sixth: We will apply the Saudi research ethics (National Committee of BioEthics (NCBE)) regulations to research conduction, review, and approval. The regulations are available in both Arabic and English languages. We will make them available to all applicants for IRB approval. (see appendix 2).

Appendix

1- Helsinki`s Declaration

2- Saudi research ethics (National Committee of BioEthics (NCBE)) regulations

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