Southern African Research Ethics Network -SAREN- held a workshop to develop a reference book for African RECs in Stellenbosch, South Africa on the 12th and 13th of August 2011. Prof. Dr Mariana Kruger, the Executive Head of the network and a professor of pediatrics and child health in Stellenbosch’s faculty of Health Sciences, chaired the event.
Dr Hany Sleem, a member of MRERTI program, the co-coordinator of the Egyptian Network of Research Ethics Committees (ENREC) and the chair and a member of several RECs in Egypt, attended the workshop. He gave a presentation on the current status of RECs and the Egyptian Network of Research Ethics Committees (ENREC) and a speech on ‘Self-Assessment of the Operations and Functions of Research Ethics Committees in Developing Countries’
The workshop aimed to boost the ethics review capacity of members and assist in long term sustainability of REC in Africa. It provided a platform for face to face meeting of chairpersons and REC members from more than 11 African countries who discussed the common problems and challenges faced by RECs in Africa and initiated a steering committee to plan and write a detailed review book for RECs in Africa.
Much care and consideration were spent to ensure that the reference would incorporate issues only relevant to Africa, such as the challenge of adopting a western model of informed consent in communitarian and patriarchal societies and issues specific to the review of both public health research and clinical trials in the areas of HIV, malaria and tuberculosis. A hard copy of the reference book as well as a PDF online version will be made available for distribution to attendees
Some of the most important topics discussed in the workshop included:
1- Challenges faced by RECs in Africa such as:
- The ethical challenges of clinical research in Africa
- A brief overview of South Africa regulatory framework
- Overview of MARC project (Mapping African Research Ethics Review )
- The main obstacles preventing optimal REC functioning in Africa and possible solutions.
- The challenges of RECs and international collaborative research and possible solutions.
- The selection criteria and minimum training requirements for REC membership.
- The regulatory framework, its SOPs and the quality control needed
2- Informed consent and Vulnerable Research Populations in Africa
- The ethical issues of paediatrics clinical trials in developing countries
- The challenges of informed consent and its guidelines
- The issues and guidelines for vulnerable populations
- Are universal guidelines for informed consent and vulnerable populations applicable in Africa?
3- Storage and export of biological samples; Risk-benefit assessment
4- Risk-benefit assessment in paediatric research
5- African REC Guidebook
- What are the essential components of an African REC Guidebook for members?
- What chapters should be included in the guidebook?
Written by Dr Hany Sleem