Establishing Training Programs for Research Ethics Committees

Abstract

Over the last few years there has been an increase in research activity, including clinical trials, in many of the countries in the Arab region (Ahmad 2003). Such activity warrants a corresponding increase in the establishment of Research Ethics Committees (RECs) to ensure that the ethical aspects of research comply with international standards. There have been concerns, however, regarding the lack of regulatory and oversight mechanisms for RECs in low and middle income countries, including many countries in the Arab region (Ahmad 2003; Bhutta 2002; Hyder et al. 2004), as many of these RECs continue to face challenges in their capacity to review research. One challenge emanates from members with insufficient training. In a recent survey involving 15 research ethics committees in the Eastern Mediterranean region, Abou-Zeid and colleagues found that only 25% of the members and 20% of the chairs of the RECs received training in research ethics (Abou-Zeid et al. 2009). Other studies involving RECs in Egypt revealed that among the main barriers to effective REC functioning included insufficient member training and lack of continuing education in research ethics (Matar and Silverman 2013; Sleem et al. 2010).

Appendix XI

Provisional timetable for a two day workshop for training in research ethics

Day one		Day two
08:00–08:30	Registration & inauguration	08:00–08:30	Ethics of clinical trials
08:30–9:00	Ice breaking session	08:30–9:00	Case study
9:00–9:30	Pre-test	9:00–9:30	Vulnerability
9:30–10:00	Introduction to research ethics	9:30–10:00	Coercion and undue inducement
10:00–10:30	What makes research ethical?	10:00–10:30	Responsible conduct of research
10:30–11:00	Risks and benefits	10:30–11:00	Therapeutic misconception
11:00–11:15	Break	11:00–11:15	Break
11:15–11:45	Categories of research review	11:15–11:45	Reviewing national guidelines for research in human subjects
11:45–12:15	Research ethics committees; functions and operations	11:15–12:45	Protocol review
12:15–12:45	Informed consent	12:45–1:30	Break
12:45–1:30	Break	1:30–2:30	Protocol review
1:30–2:30	Protocol review	2:30–3:00	Open discussion
2:30–3:00	Waiver of informed consents	3:00–4:00	Post-test and certificates
3:00–4:00	Protocol review

Provisional time table for a four day workshop

Day one		Day two
08:00–08:30	Registration & inauguration	8:00–8:30	Informed consent
08:30–9:00	Ice breaking session	8:30–9:00	Case study on informed consent
9:00–9:30	Pre-test	9:00–9:30	Waiver of informed consent
9:30–10:00	Introduction to research ethics	9:30–10:30	Protocol review
10:00–10:30	What makes research ethical?	10:30–11:00	Research designs
10:30–11:00	Risks and benefits	11:00–11:30	Break
11:00–11:30	Break	11:30–12:00	Vulnerability
11:30–12:00	Case on risk and benefit	12:00––12:30	Case study
12:00–12:30	Categories of research review	12:30–1:00	Coercion and undueinducement
12:30–1:00	Exercises on categories of research review	1:00–1:30	Break
1:00–1:30	Break	1:30–2:30	Protocol review
1:30–2:30	Protocol review	2:30–3:00	Discussion
2:30–3:00	Discussion

Day three		Day four
8:00–8:30	Informed consent	8:00–8:30	Responsible conduct of research
8:30–9:00	Case study on informed consent	8:30–9:00	Case study
9:00–9:30	Waiver of informed consent	9:00–9:30	Research on human tissues and stored samples
9:30–10:30	Protocol review	9:30–10:30	Protocol review
10:30–11:00	Research designs	10:30–11:00	Ethics of genetic research
11:00–11:30	Break	11:00–11:30	Break
11:30–12:00	Vulnerability	11:30–12:00	Ethics of globalization of research
12:00––12:30	Case study	12:00–1:00	Protocol review
12:30–1:00	Coercion and undueinducement	1:00–1:30	Break
1:00–1:30	Break	1:30–2:00	Reviewing national guidelines that govern human subjects research
1:30–2:30	Protocol review	2:00– 3:00	Wrap up and certificates
2:30–3:00	Discussion