1. ASSESSMENT OF SELF-PERCEIVED RISK- BENEFIT DECISION PATTERNS BY RESEARCH ETHICS COMMITTEE MEMBERS IN EGYPT Samia Hassan Rizk, MD, MPH, MSc in clinical research* Professor of Clinical Pathology, Cairo University, Egypt Certified Research Ethics Trainer Micheal Guirguis, PhD, University of Liverpool, U.K. PRIM&R Advancing Ethical Research Conference December 4-6, 2012 San Diego, CA

2. ABSTRACT AIM : To explore the self-perception of research ethics committee (REC) members in Egypt to risk-benefit issues METHODS: A structured quantitative close-ended questionnaire RESULTS: the main findings were – 78.3%-84.2% agreed for most risk issues and 86.9% to100% for all benefit issues. – A high satisfaction with information about the type of benefit to participating patients (89.1%)& the importance of research to science (88.2%). – Estimation of risks & benefits& scientific validity have a substantial degree of difficulty. – “Self-participation in the trial” was considered an important way to judge risk-benefit balance, while systematic analysis was rarely used. – “Benefits to patients” and “offering the trial based therapy” were the most critical determinants of risk-benefit balance (86.9%). CONCLUSION: Data from this study could be used to prioritize areas for further research and education.

3. METHODOLOGY A cross-sectional quantitative survey design was used to study the self-perceived responses to a set of risk-benefit assessment issues by research ethics committee (REC) members in Egypt. The questionnaire was based on a survey designed by Van Luijin et al. (2002) in phase II cancer clinical trials protocols’ review. RESULTS MinMaxmed # of Resp* Age30824838 Years of review1405.537 protocols/year12001136 Table 1: Average Age, Number of Review Years& # of Protocols Reviewed/Year

4. Table 2: Frequency Distribution of Research Ethics Experiences of Respondents: Number%No of respondents* SPECIALTY Clinical2668.438 Social science00 Others12 31.6 How often do you receive training in research ethics? start REC membership2054.137 each REC meeting12.7 1-3 times/year718.9 3-5 times/year410.8 >5 times/year25.4 No regular training821.6 Experience in research methodology None37.938 introductory923.7 Deep1950 Skilled513.2 Research ethics education MSc0038 PhD00 Certificate1539.5 Short course1539.5 In-job training1744.7

5. Figure 1: Frequencies of Participants’ Opinions Towards Research Risk Issues Questionnaire statement: “I consider each of the following risk/benefit factor as the most relevant in assessing a clinical study protocol”:- 1-Medication side-effects, 2- Length of hospital stay, 3- Psychological/social impact, 4- Decrease in QOL, 5- International settings, 6- Use of genetic material, 7- Use of innovative therapy Figure 2: Frequencies of Participants’ Opinions Towards Research Benefit Issues

6. Figure 3: Frequencies of Participants’ Opinions Towards Risk/Benefit Information Provided In The Study Protocol 1-benefits received by the patient,2-likelihood that the patient will receive the benefit,3-degree of benefit received by the patient,4-duration of the benefit to the patient,5-type of risks to the patient,6-likelihood of risks to the patient,7- seriousness of risks to the patient,8-duration of the risks to the patient,9-reversibility of risk to the patient,10- importance of the research to future patients,11- importance of research for science Figure 4: Frequencies of Participants’ Opinions Towards Easiness of Estimating Risk/Benefit In Research Protocols

7. Figure 5: Frequencies of Participants’ Opinions Towards Easiness of Estimating Scientific Validity In The Research Protocols Figure 6: Frequencies of Participants’ Opinions Towards Methods of Assessing Risk To Benefit Balance In The Study Protocols

8. Figure 7: Frequencies of Participants’ Opinions Towards The Importance of Risk- Benefit Balance Determinant Issues CONCLUSIONS Homogeneous acceptance of most risk& benefit issues. Unexpectedly; low agreement for drug toxicity& genetic research& a high agreement for social& psychological benefits; require further clarification Estimation of various aspects of risks& benefits as well as the scientific validity of research has substantial degree of difficulty. No special method for evaluating risk- benefit balance Benefits to participating patients& offering the trial therapy after the end of the study were the most important determinants in evaluation. On-job acquired experience was the main source of training. for many respondents. The majority lack continuous training.

9. Table 3: Summary of Risk-Benefit Assessment Issues with Consensus and Weakest Agreement Rates CONSENSUS* (80-100%) RISK-BENEFIT FACTORS : 1.Length of hospital stay 2.Psychological/ social risks 3.Decrease in quality of life 4.Increase in quality of life 5.Possible treatment effect 6.Psychological benefit SUFFICIENT PROTOCOL INFORMATION 1.Benefits to patient 2.Importance of research for science IMPORTANT DETERMINANTS IN EVALUATION: 1.Benefits to patients 2.Offering the trial-treatment to patients after the study end WEAK AGREEMENT *(20-40%) COMMONLY USED EVALUATION METHOD : 1.Systematic analysis of risks and benefits

10. RECOMMENDATIONS Further in-depth interview of REC members Comparing decisions& comments of few selected RECs to common protocols with known risk or benefit concerns Findings from this study could be used to prioritize areas of risk-benefit judgment which contribute a special difficulty ACKNOWLEDGEMENT This work represents the dissertation study done through the MSc in Clinical Research at the University of Liverpool. Deep thanks to all Egyptian research ethics committee chairs and members who participated in this survey Great appreciation to advisors of this thesis; Micheal Guirguis& Jill Weisberg for their sincere mentorship