Establishment & Achievements of The Faculty of Medicine Research Ethics Committee
Establishment
The Faculty of Medicine Research Ethics Committee have been established in October 2007, under the authority of the Head of the Ain Shams University and the Dean of Faculty of Medicine.
The overarching objective of clinical research is to develop generalizable knowledge to improve health and/or increase understanding of human biology Ethical requirements for clinical research aim to minimize the possibility of exploitation by ensuring that research subjects are not merely used but are treated with respect while they contribute to the social good
These 7 requirements for considering the ethics of clinical research provide a systematic framework to guide researchers and IRBs (Institutional Review Boards) in their assessments of individual clinical research protocols. Like a constitution, these requirements can be reinterpreted, refined, and revised with changes in science and experience. Yet these requirements must all be considered and met to ensure that clinical research— wherever it is practiced—is ethical.
Scope and Purpose
The purpose of the REC is to protect the rights, safety, and welfare of all research subjects. To achieve this, the REC must advise investigators in designing research projects in a manner to minimize potential harm to human subjects, review all planned research involving human subjects prior to initiation of the research, approve research that meets established criteria for protection of human subjects, and monitor approved research to ascertain that human subjects are indeed protected.
REC responsibility and authority
All human subjects research carried out at [state name of Faculty or Institution] must be reviewed and approved or determined exempt by the REC prior to the involvement of human subjects in research.
Accordingly, the REC has the following responsibilities and authority:
· The REC shall review and have authority to approve, require modifications in (to secure approval), or disapprove initial and continuing reviews of all research activities;
· The REC shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the REC’s requirements or that has been associated with unexpected serious harm to subjects.
· The REC must report to the [Dean or President] unanticipated problems involving risks to subjects and others or serious or continuing noncompliance by investigators.
Constitution of the REC
Members of the Research Ethics Committee (REC) Full Board:
· Total of 13 members, comprising
· One non affiliated non medical member , a Moslem religious man
· One non affiliated medical member, a Christian religious female
· Both male and female members
Members of the Research Ethics Committee (Reviewers):
· 200 Reviewers comprising subcommittees of the main REC in different faculty departments
Researches reviewed by the committee:
· International projects
· National projects
· Free researches
· MD research
· Master research
· Students’ research
Training courses and Continuous Education for the REC members
1. January 2018 Phase I
2. November 2017 Phase I
3. May 2016 Phase I
4. March 2013 Phase II
5. June 2012 Phase II
6. March 2012 Phase I
7. February 2011 Phase I
8. June 2010 Phase I
9. March 2010 Phase I
10. January 2010 Phase I
11. June 2009 Phase I
12. March 2009 Phase I
13. January 2009 Phase I
14. Staff members of Clinical Pathology Department in Faculty of Medicine Ain Shams Unversity
15. In cooperation with the National Research Center in December 2007
Stem Cell Research:
· Establishment of Stem Cell Research Policy, 2010
· Establishment of Stem Cell Research
WorkShops:
1. Impending Problems Facing Research Ethics Committees, 28th December 2016
2. In collaboration with European Union (EUNAM) project September 9th 2012
3. In collaboration with European Union (EUNAM) project February 7th 2012
Stem Cell Research:
· Establishment of Stem Cell Research Policy
· Establishment of Stem Cell Research
