Umm Al-Qura University

Umm Al-Qura University

Institutional Research Ethics Board IRB


- 2016/05/10

 

Institutional Research Ethics Board (IRB):

Dr. Abdul Haseeb M. Hanif
Assistant Professor
Department of Clinical Pharmacy
[email protected]
0568560776

UQU Affiliated Members

Dr. Raafat Abdallah
Associate Professor
Department of Pharmacology
[email protected]
0532708951

Dr. Muhammed Ahmed Masood
Assistant Professor
Department of Pharmacology

Dr. Ashraf Nabiel Abdalla Abdrabo
Assistant Professor
Department of Pharmacology
[email protected]
0538903316

Dr. Ihab Talat Ahmed Abdel- Raheem
Associate Professor
Department of Pharmacology
[email protected]
0596265466

Dr. Muhammed Tarique Imam
Lecturer
Department of Clinical Pharmacy
[email protected]

This email address is being protected from spambots. You need JavaScript enabled to view it.">0549166412

Dr. Amal Yousef
Assistant Professor
Department of Clinical Pharmacy


 

A. Goals & Objectives

Faculty of Pharmacy: Institutional review board was established in 2014. The Institutional Review Board (IRB) is responsible for review of all research projects including human subjects under the Faculty of Pharmacy, Umm Al Qura University. Aim of IRB is to provide standard of protection for human subjects in research. All research projects involving human subjects either funded by university funding bodies e.g. IRS, KAST or funded by other sources must be submitted for ethical approval by faculty IRB. All faculty members including students are required to submit complete description of their proposals and obtain IRB approval to initiate research projects. 

 

Unit Policies:

A. Projects Initial Approval Process

All proposed research projects involving human Subjects research should submit online Research Proposal Form to the IRB for initial review before initiating research project. All required fields must be filled and returned to the committee for appraisal. Proposals must include all required documents along with the supporting forms as applicable, e.g. written informed consent form, recruitment advertisements, and survey/questioners etc. In case of absence of such documents, there must be justification of such missing documents.

All applications must be submitted one week before meeting to be considered in the meeting. The committee will contact investigator in two weeks after submission about decision. Review process might delay during holidays and examination period. Further detail might be requested from the investigator in case of any further clarifications. Investigation cannot begin unless approved. Principle investigator will receive official copy of final decision letter for their record.

B. Projects Follow Up:

After initial approval any further changes in the research protocol must be submitted to IRB for approval before commencement. In addition IRB approval of study is valid for one-year period. Any delay in proposed duration must be informed to IRB for further continuation. Submitting Project renewal Form can facilitate this.

Finally, any adverse or unexpected consequence should be reported to the IRB as soon as possible. It includes not only physical injury to the study subject but also violation of research protocol and any patient personnel information disclosure. 

C. Exemptions:

There are some specific types of research project does not require IRB oversight after approval and needs to be clarified in proposal submission form. Board will decide about those exemptions based on research protocol submitted. When project is eligible for except, further communication with IRB regarding continuation and changes in protocol is not required.

Followings are the major categories allowing a project to be eligible for exception for IRB supervision.

  1. Research conducted in educational settings e.g. academic settings involving normal educational practices, like: (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of such techniques, curricula, or classroom managements. Research on prisoners is excluded from such exception.
  2. All qualitative and quantitative studies involving surveys, interview or observation of public behavior are exempted from IRB oversight after approval unless: (i) subjects can be identified through recordings or on data collection forms; and (ii) any release of subject response put him in civil or criminal liability or harm their employability or status. Research on prisoners is excluded from such exceptions. 

 

D. STUDENTS RESEARCH

IRB committee before any type of commencement should approve all student projects involving human subjects. Each student mentor must submit proposal submission form to IRB. All correspondence regarding students project will be made through their mentors only. All other requirement would be same for student’s research projects for appraisal.

E. Research involving other institutions, e.g. Ministry of Health

Projects including data collection at other institution e.g. universities and/or hospitals require further IRB approval of that organization.

1. Ministry of Health:

According to Ministry of Health all research project proposed to conduct in MOH hospitals must be initially approved by Training & Scholarship administration, Holy Makkah, and then approved by General Directorate of Health, Ministry of Health, Makkah region and later by individual hospital IRB. This is the responsibility of principal investigator to provide all such approvals in order to gain final approval from faculty Institutional Review Board.

2. Armed forces Hospitals including National guard Hospitals

All military hospitals have separate system of approval. Principal applicant must contact research centers of those specific institutions for review process. Once permission granted, Principle investigator must provide copy of approval letter to faculty IRB. As principal investigator relates to faculty, approval by faculty IRB is also required. 

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