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 Scientific Research Ethics Committee

Local Committee (PNU IRB) Registration
As a result of the Ministerial Resolution No. 180 dated 9/6/1425H mandating the establishment of local committees for medical & bioethics, that has to be supervised by the National Committee of Medical & Bioethics. Moreover, as per the request of HE Dr. Huda Al-Ameel, the Princess Nourah bint Abdulrahman Rector, to have IRB registration.


The Objectives of National Committee of Bio-ethics (NCBE)
Seeking to improve and enhance all health, preventive, diagnostic, therapeutic, psychosocial and living aspects of life, while preserving human dignity, promoting charity, justice, individual and societal rights, in a way consistent with the Islamic Sharia (law), and the traditions and essence of the culture of the Kingdom of Saudi Arabia, royal decree no. 7/B/9512 dated 18/5/1422H ordered the creation of a national committee (the National Committee of Bio and Medical Ethics), to develop and monitor compliance with bio/medical research ethics and standards. Committee interests would include bio/medical research ethics, and related applications in hospitals, universities and research institutes. The committee would be under the supervision and authority of King Abdulaziz City for Science & Technology (KACST), 1 [Online]; >http://bioethics.kacst.edu.sa/About.aspx?lang=ar-SA<


IRB PNU – Administration
The PNU IRB is supported administratively by the Health Sciences Research Center’s Office of Regulatory Affairs at KAAUH that includes the IRB Administrator and other associated research administrative staff. The PNU IRB is linked administratively to the Health Sciences Research Steering Committee, Chaired by the CEO of King Abdullah bin Abdulaziz University Hospital (KAAUH). The IRB reports and research project approvals and recommendations are sent regularly to the HE PNU Rector. 

PNU IRB By-Laws
In application to the NCBE legislation, the Princess Nourah bint Abdul Rahman University is developing its IRB By-Laws, to coordinate the relation between the IRB and the other sub-committees in the universities’ colleges. This By-Laws will determine the mechanism of action to assist the faculty staff and researchers, and disseminate the culture of research ethics at the university. It will then be submitted to HE PNU rector for approval.


PNU IRB - Duties and Responsibilities
The members of the PNU IRB will be sufficiently competent to deal with the following responsibilities: 
1) Review research proposals in terms of regulations, applicable laws and standards of professional conduct and practice, and PNU’s commitments. The IRB members’ background will be diverse, and will include consideration of specialties, understanding cultural, social and religious backgrounds, clinical and scientific experience, and sensitivity to issues as community attitudes, to be able to assess and judge correctly on the submitted research project.
2) Members of the PNU IRB will commit to a three (3) year term and to fulfill their duties during that time.
3) All members must be fluent in the English language, and must read and review each research proposal and associated materials that are submitted to the PNU IRB for review.  
4) Including monthly meetings and preparation time for those meetings, it is anticipated that typically the PNU IRB member will be required to spend eight (8) hours monthly in fulfilling the obligations of their membership. Membership on the PNU IRB accompanies the opportunity to contribute to the success of human subject research at Princess Nourah bint Abdulrahman University.
5) It also entails significant responsibility and accountability for the protection of the human rights of individuals participating in the research.

Attachments:
1) IRB GUIDELINES:
Describes policies and guidelines for research involving human subjects conducted at PNU, ethical principles and the organization of the IRB.
2) Informed consent:
The informed consent for participation is required document in term of human subject research. There are two informed consents, one for Adult and the other for Assent /minor.
3) Request for Expedited status:
Request for research that may be reviewed by an expedited review process (By IRB Chairman) must NOT involve more than minimal risk and may NOT involve more than a minor change in a research project.
4) Request for Exempt status:
Some very specific forms of research may be exempt from IRB review.