1. Evaluation of Ethics Review Procedures for Research in Egypt Hany Sleem 1 Henry Silverman 2 1 National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt 2 University of Maryland School of Medicine, Baltimore, Maryland, USA © Dr. Hany Sleem 2007

2. 2700 BCE - before Oath of Hippocrates : Papyrus showed the first medical ethics guideline ever written (Have an expectant attitude and trust in nature's healing. Be observant of the patient's condition). 12th c. CE - Moses ben Maimon in his Daily Prayer of a Physician stated: –Don't let desire for profit, fame, or admiration interfere with your work. – Help the rich and the poor, enemy and friend equally. –Care for the lives and health of all creatures. In Egypt there is a rich history of medical ethics

3. Research ethics is an emergent concept in Egypt The role of research ethics and more specifically, research ethics committees (RECs), is developing in Egypt. Several RECs exist in Egypt, but many lack essential resources for effective functioning.

4. Lack of national ethical guidelines. Few REC members with adequate training in research ethics Insufficient resources (equipment, space and personnel) (leads to loss of members motivation). No local accreditation for the RECs Problems facing Egyptian RECs

5. Problems facing Egyptian RECs (cont.) Cultural challenges ( consent form is unpopular even in medical practice). Absence of a network to ensure communication between different RECs. Lack of regulations. (no punishment for unethical researcher)

6. We don't have legal mandates Egyptian Constitution (1970) Article (43) Any medical or scientific experiment may not be performed on any person without his free consent Although the Egyptian constitution states the need for informed consent in research, what is missing is the power of a specific legislation

7. There are little data from Egyptian RECs regarding their: Structure and function Resource needs

8. Study Proposal Our aims:  Understand better the role of RECs in Egypt  Identify perceived resource & capacity building needs of Egyptian RECs for the review of research protocols

9. We developed a survey tool that will collect data on the following domains:  Demographic information  Membership composition  Training needs  Perceived challenges for effective functioning  Workload Methods

10. Survey Tool  Use of research ethics guidelines  Use of standard operating procedures  Process of REC review  Necessary financial and material resources. We will incorporate open ended questions in the survey tool

11. Contact details of RECs in Egypt will be obtained from –previously held workshops –internet searches –website of the U.S. Office for Human Research Protections We will select RECs that have been active for at least one year. Surveys will be distributed to REC chairpersons Identification and Selection of RECs

12. Surveys will be completed without the use of the names of individual REC members. Identifiable details of each REC will initially be coded but made anonymous after all information collected. Assurances of confidentiality enhance: –accuracy of reporting without fear of being seen as lacking capacity to review research proposals Confidentiality

13. We will evaluate the quantitative data set using basic descriptive statistics. Responses to open-ended questions will be coded for basic themes and analyzed using basic techniques of qualitative data analysis. Analysis

14. The results of our study will help institutional officials and policy-makers to better understand the resource capacity needs of a strong human subject protection program. Conclusion

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