Overview on health research ethics in Egypt and North Africa.

Developing countries, including Egypt and North African countries, need to improve their quality of research by enhancing international cooperation and exchanges of scientific information, as well as competing for obtaining international funds to support research activities. Research must comply with laws and other requirements for research that involves human subjects. The purpose of this article is to overview the status of health research ethics in Egypt and North African countries, with reference to other Middle Eastern countries. The EU and North African Migrants: Health and Health Systems project (EUNAM) has supported the revision of the status of health research ethics in Egypt and North African countries, by holding meetings and discussions to collect information about research ethics committees in Egypt, and revising the structure and guidelines of the committees, as well as reviewing the literature concerning ethics activities in the concerned countries. This overview has revealed that noticeable efforts have been made to regulate research ethics in certain countries in the Middle East. This can be seen in the new regulations, which contain the majority of protections mentioned in the international guidelines related to research ethics. For most of the internationally registered research ethics committees in North African countries, the composition and functionality reflect the international guidelines. There is growing awareness of research ethics in these countries, which extends to teaching efforts to undergraduate and postgraduate medical students.

Evaluation of the diagnostic value of serum and tissue apoptotic cytokeratin-18 in patients with chronic hepatitis C.

BACKGROUND AND STUDY AIMS: Hepatitis C virus (HCV) is considered the most common aetiology of chronic liver disease (CLD) in Egypt. The disease severity ranges from mild illness to cirrhosis and hepatocellular carcinoma. A role for apoptosis in liver damage caused by HCV chronic infection has been suggested. Cytokeratin 18 (CK-18) is the major intermediate filament protein in the liver and is a known caspase substrate in hepatocyte apoptosis. Therefore, we analysed the serum and tissue levels of CK-18 in patients with chronic HCV infection to evaluate its role in hepatocyte apoptosis. We also correlated CK-18 expression with the severity of hepatic pathology. PATIENTS AND METHODS: This study examined 80 Egyptian patients with liver disease. There were 69 patients with chronic hepatitis C and 11 patients with hepatitis C-induced cirrhotic changes. Fifteen healthy controls were also included in the study. The levels of CK-18 fragment were quantified in paired serum and liver biopsy samples. RESULTS: The serum and tissue CK-18 levels were reduced in chronic HCV patients compared to early cirrhosis patients. This result indicates that serum levels of CK-18 and the hepatic expression of CK-18 might play an important role in disease progression. The serum and tissue levels of CK-18 were significantly increased and directly correlated with inflammation severity, stage of fibrosis, and ALT levels in the chronic HCV group and the cirrhotic liver group. There was no significant difference in viral load between patient cohorts. CONCLUSION: The serum level and the hepatic expression of CK-18 are related to disease activity and are directly correlated with METAVIR scoring. This result suggests that serum CK-18 levels may be useful for monitoring disease activity in chronic HCV and liver cirrhosis patients.

Curriculum guide for research ethics workshops for countries in the Middle East.

To help ensure the ethical conduct of research, many have recommended educational efforts in research ethics to investigators and members of research ethics committees (RECs). One type of education activity involves multi-day workshops in research ethics. To be effective, such workshops should contain the appropriate content and teaching techniques geared towards the learning styles of the targeted audiences. To ensure consistency in content and quality, we describe the development of a curriculum guide, core competencies and associated learning objectives and activities to help educators organize research ethics workshops in their respective institutions. The curriculum guide is divided into modular units to enable planners to develop workshops of different lengths and choose content materials that match the needs, abilities, and prior experiences of the target audiences. The content material in the curriculum guide is relevant for audiences in the Middle East, because individuals from the Middle East who participated in a Certificate Program in research ethics selected and developed the training materials (e.g., articles, PowerPoint slides, case studies, protocols). Also, many of the activities incorporate active-learning methods, consisting of group work activities analyzing case studies and reviewing protocols. The development of such a workshop training curriculum guide represents a sustainable educational resource to enhance research ethics capacity in the Middle East.