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Institutional Review Board

 

Princess Nourah bint Abdulraman University – Institutional Review Board - PNU IRB

(Research Ethics Committee)

 

Brief Summary

The Institutional Review Board (IRB), formerly called Local and Permeant Committee of Research Ethics, at Princess Nourah bint Abdulrahman University (PNU) has been registered with the National Committee of BioEthics (NCBE) at King Abdulaziz City for Science and Technology (KACST) with reference No. (H-01-R-059), in compliance with the Council of Ministers' decision, which requires entities and research centers in the Kingdom to form a Local Committee of Research Ethics in each institution under the supervision and monitoring of NCBE.

Instructions for researchers applying for IRB review:

-       Please note that all research projects that are going to be conducted at PNU must be reviewed and approved by PNU Institutional Review Board (IRB). Research proposal along with required supporting documents must be submitted electronically to: IRB@pnu.edu.sa. Please use appropriate forms available at form section.

-       Failure to adhere to the IRB Committee roles and regulations may subject the project to suspension and research team will be subjected to disciplinary actions.

-       All research-related activities must not be initiated until the IRB decision letter is released.

-       The exempt forms are used for research that involves less than a minimal risk such as questionnaires or interview research. The expedited forms are used for research that involves not greater than minimal risk, such as taking a blood sample. 

-       Minimal Risk: Requires ongoing monitoring by the Principal Investigator (PI) and Institutional Review Board (IRB) 

-       Minimal Risk to subjects means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical and psychological examinations or tests and that confidentiality is adequately protected, examples of Minimal Risk are:

• Study poses no more risk than expected in daily life (e.g., blood draw, physical exam, routine psychological testing).

• Non-interventional studies (e.g., observational studies of behavior or nutrition).

• Survey/Questionnaire studies of a non-sensitive nature.

• Research involving the collection or meta-analysis of existing data, documents, records, pathological specimens, or diagnostic specimens to understand basic bio-behavioral processes.

-       The full-board review forms are used for research that involves human intervention using drugs or devices.

-       All forms must be ink signed by the researcher and the immediate supervisor.

 

For further information on the research that involves human subject; please review: 

OHRP Expedited Review Categories (1998) | HHS.gov  

 

Note: IRB review decision letter must be renewed annually, if needed. Status report must be submitted towards midway of the project for exempt research. For expedited research, the progress report should be submitted twice as per the IRB decision letter. For full board review research, status report must be submitted quarterly. 

The researchers have to submit the research proposal/protocol along with the questionnaire or data collection instrument.

 

 Documents to be submitted; as appropriate, are:

·       Request for exempt status form

·       Consent Form for Exempt Studies (Questionnaire or Interview) - Arabic 

·       Consent Form for Exempt Studies (Questionnaire or Interview) - English 

·       Research Registration Form

·       Amendment Request Form

·       Request for Expedited Review Form

·        Consent Form for Expedited Studies

·        Request for Full Review

·        Consent Form for Full Review Studies

·        Study Status Report Form - required 

·        Final Report for IRB Termination or Study Completion

·        Adverse Events and Protocol Deviations/Violations Data Reporting

 

Attachments 

·       Updated Curriculum Vitae – for the researchers and the principal researcher

·       Questionnaire and/ or data collection form

·       Declaration of conflict of interest 

·       Other forms available

·       Ethics Training Certificate certification of training in research ethics obtainable by taking a short online course and passing the test. These can be found at the following sites:

Links for Ethics Training Courses:

National Institute on Drug Abuse, National Institutes of Health

The Good Clinical Practice (GCP) course:  https://gcp.nidatraining.org/

 

Note: The processing time shall be within 5-7 working days for exempt and expedited research and one month for full review research.

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IRB Administration 

The PNU IRB is administratively supported by the Deanship of Scientific Research

Deanship of Scientific Research

Dean

Professor Kholoud S. AlMoqrin


PNU IRB Administrator

Ms. Sarah Wedhaya, LL.M.

Swedhaya@pnu.edu.sa

 

 

Committee email:

For further information, please contact the IRB email 

irb@pnu.edu.sa

 

Committee website:

https://www.pnu.edu.sa/en/Deanship/Research/Pages/Scientific-Research-Ethics-Committee.aspx

 

Chairman and Members of the IRB Committee

 

NamePosition
1.    Prof. Omar H. KasuleProfessor, Epidemiology and Bioethics, Faculty of Medicine, King Fahad Medical City
2.    Dr. Huda Ibrahim AlMohammed Associate Professor, College of Health and Rehabilitation Sciences, PNU
3.    Prof. Dr. Kholoud Saad Hamad AlMuqrinAssociate Professor, College of Sciences, PNU
4.    Prof. Dr. Anwar Abdulkarim El KamaryProfessor, College of Art and Design, PNU
5.    Prof. Dr. Hazzaa bin Mohammed Al-HazzaaHead of the Lifestyle and Health Research Center, PNU
6.    Dr. Amel Ahmed Fayed Associate Professor, College of Medicine, PNU
7.    Dr. Sireen Abdulrahim ShilbayehProfessor, College of Pharmacy, PNU
8.    Dr. Jehan Saleh Lardhi Assistant Professor, College of Social Work, PNU
9.    Dr. Reem Abdulwahab AbdulwahabAssistant Professor, College of Education, PNU
10.    Dr. Najla Saad Ali AlMasoudAssistant Professor, College of Sciences, PNU
11.    Dr. Maad bin Faisal Al-SaatiConsultant, Orthopedic Surgery, KAAUH
12.    Dr. Najwa Abdulkarim Al-GhamdiExternal Member
13.    Mrs. Rufaidah A. ShalabyCommunity Representative
14.    Ms. Sara A. WedhayaLegal advisor and Administrative Officer of the Committee
15.    Reem Faris al-FaqeerCommittee Coordinator/Secretary

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