The workshop was declared open by the Honourable Secretary of State for Health and Social Welfare, Dr Malick Njie. In his opening remarks, Dr Njie stressing the need for locally-based ethics review bodies commented: ‘It is…imperative that African ethics review bodies, aware of the sensitivities of each ethnic and cultural group, formulate ethical review standards cogniscent of these challenges.’ Dr Njie also commended the commitment of H E The President of The Gambia, Alh Dr Yahya A J J Jammeh to the development of science in the country, which is reflected in many areas including the establishment of the Faculty of Medicine (University of The Gambia) and a number of scholarships in the sciences.
The Gambia Government/MRC Ethics Committee was established 28 years ago and is held to be one of the most successful and effective medical research regulatory committees in Africa. MRC (UK) The Gambia’s Unit Director Professor Tumani Corrah remarked that the goal of the Committee is ‘to ensure that unethical biomedical research is not permitted in The Gambia and to protect individuals and communities taking part in biomedical research.’ He added ‘The standard of biomedical research must be the same regardless of whether it is carried out in the developing or developed world. The general ethical principles related to healthcare research all over the world are the same: to alleviate suffering, to respect the individual, not to exploit the poor and vulnerable while respecting cultural differences.’

Presenting a brief history of the ethics of biomedical research, Professor Sarah Rowland-Jones, Director of Research, MRC (UK) The Gambia began by citing Hippocrates (5th century BCE) whose golden rule for healers was to “first, do no harm”. She concluded by mentioning some of the recommendations that were made by the Nuffield Council on Bioethics which published ‘The ethics of research related to healthcare in developing countries’ in 2004. The Nuffield Council’s recommendations state that research should not be imposed on developing countries by the developed world; research should meet local priorities; new treatments should be tested against the best available; and cultural issues surrounding informed consent should be addressed.

Professor Hilton Whittle, Emeritus Scientist, in his overview of scientific and ethical governance at MRC (UK) The Gambia argued that conducting research in a developing country is a ‘civic duty’ and serves to improve treatments and vaccines where the disease occurs. He outlined the history of formal research regulation at the unit, which began in 1980 with the creation of the MRC Scientific Coordinating Committee (SCC) and the Gambia Government/MRC Ethics Committee. The SCC reviews projects to ensure that they are scientifically sound and once approved, they are passed to the Ethics Committee which examines issues such as protecting participants from too much research, safety and the relevance of projects to the people of The Gambia. In 1998 an independent chairman, Mr Malcolm Clarke, was appointed to the Gambia Government/MRC Ethics Committee. Professor Whittle commended Mr Clarke’s contribution, commenting that he has been a ‘successful and honorable Chairman’

Some of the major issues which have been discussed by the Gambia Government/MRC Ethics Committee over the years include blood sampling (the amount taken is almost never harmful); the ethics of HIV testing and disclosure; and communicating the concept of a randomized control trial to communities. Another recurring theme is that of informed consent. Commenting on this, Professor Tumani Corrah said ‘This is a must if biomedical research is to be ethically acceptable. Information to participants must be relevant and presented in a simple and comprehensible manner and the participant must give his/her willingness to participate freely. Participants must not be led to equate willingness to participate in research with the provision of free health care, which is a possibility in the developing world. Hence the need to emphasize to potential recruits that refusal to participate will not exclude them from benefiting from medical care provided for study participants.’ Professor Whittle also stated that consent has political, community, family and individual dimensions, which must be taken into account when research proposals are being formulated. He commented that consent forms are legally binding and protective to donors, but are often meaningless to participants, an issue debated at length during the workshop.

Mr Sekou Omar Toure, Director, Directorate of Planning and Information at the Department of State for Health gave a synopsis at the workshop of recent developments with regard to national health research in The Gambia. He commented that health research, identified as the most efficacious interventions to prevent existing and emerging diseases, has been given higher priority by DoSH during recent times, and a more proactive stance is being taken towards planning. A Health Research Strategic Plan has been compiled, resulting from consultation between DoSH, NGOs, MRC and the private sector and its development has been strongly supported by CIAM and the WHO. The policy, which is based on Vision 2010 and the Poverty Reduction Strategy II 2007-11, aims to support planning, implementation, monitoring and evaluation of health services in The Gambia, building on encouraging trends such as the recent decline in infant mortality rates and a rise in life expectancy in the country to 64 years. The strategy also advocates the creation of a ‘cross-cutting’ ethics committee, which would include the University of The Gambia, MRC, DoSH and other partners.

The issue of the composition of the Gambia Government/MRC Ethics Committee was highlighted during a presentation by Mr Malcolm Clarke. Reporting back from a meeting on Health Research Ethics for Ethics Committees and Review Boards in Africa (Addis Ababa, September 2007), Mr Clarke shared some of the recommendations that were made: that committees should be multidisciplinary/multi-sectoral; balanced in terms of age and gender representation; contain lay persons representing community interests; and operate according to applicable laws and values of communities. The voluntary nature of consent and the confidentiality of study participation were also stressed.

Mrs Bertha Mboge (retired Chief Nursing Officer, DoSH and Gambia Government/MRC Ethics Committee member) commenting on the status of ethical committees in Africa, reported that following a survey conducted by WHO AFRO of 46 countries in Africa in 2003, a strategy for supporting countries with poor/no ethical committees had been evolved. Ethical regulation has become a priority due to the high disease burden on the continent; the need for more stringent regulations relating to the testing of new products; the increase in research on human subjects in Africa; concern for vulnerable groups; an increase in the abuse of human rights; poverty leading to potential exposure to exploitation; the need to share complex bioethical issues with a wide diversity of people; the necessity of providing a line of continuity between researchers and participants; the urgency of providing adequate information and safeguards to conducting research with no coercion. In recognition of the participatory nature of research, Mrs Mboge also stressed that research participants should not be referred to as ‘subjects’.

The sharing of human tissue among researchers was the focus of a talk by Professor Ousman Nyan, Deputy Vice Chancellor of the University of The Gambia, Provost of the School of Medicine and Scientific Adviser to the Gambia Government/MRC Ethics Committee. Professor Nyan made a presentation on the Malaria Genomic epidemiology network (MalariaGEN), a consortium formed in 2005 from more than 20 countries (including seventeen in Africa). The project, funded through a Bill and Melinda Gates Grand Challenges grant and the Wellcome Trust (UK) aims to identify critical mechanisms of protective immunity against malaria. Samples and core data are sent to the Sanger Centre in Oxford (UK) for DNA analysis and genotyping, with the hope that this research could lead to the development of a successful malaria vaccine in the future.

The issue of research involving children was explored by Dr Stephen Howie, Senior Research Clinician at MRC (UK) The Gambia. Dr Howie contended that specific research must be done on children as they are not small adults; children are physiologically and psychologically different from adults and may react differently to interventions from adults (EU Clinical Trials Directive 2001/20/EC). Research involving children can and should promote the rights of children (UN Convention on the Rights of the Child Article 24, 1989) but the question of consent is often a difficult one – from the point of view of the child’s understanding and sometimes from the perspective of identifying the child’s legally acceptable representative. Dr Howie argued that research conducted on children must acknowledge their vulnerability as a group and that the best interests of the child should be the primary consideration (UN Convention Article 3). He concluded that appropriate research was needed to promote the welfare of children, genuine consent must be obtained from an appropriate representative, assent from the child was required at an appropriate stage and that all research should be conducted according to the ‘minimal risk’ principle (US regulation 45 CFR 46; Declaration of Helsinki – 2000).

The globalization of clinical trials and drug development has led to the evolution of stringent regulations regarding the manufacturing, testing and marketing of new drugs. Dr Jenny Mueller, Clinical Trials Support Manager (MRC (UK) The Gambia) in her talk on ‘Biomedical Research on Medicinal Products’ gave a history of drug regulation, citing some of the cases which led to changes in the law including the tragedies of the antibiotic Sulfonimide in the USA in 1938 that claimed a hundred lives and the sleeping/anti morning sickness drug Thalidomide, that led to the births of ten thousand deformed babies in the late 1950s/early 1960s in Europe and the USA. Dr Mueller traced the history of regulation from the inception of the US Food and Drug Administration to the International Conference on Harmonization (1990), which drew up guidelines for conducting, designing, recording and reporting clinical studies.

Ethically conducted research is a condition of Good Clinical Practice, an international recognized set of guidelines for conducting clinical trials. Adherence to GCP includes the existence of qualified team members at research sites, proper documentation and safety reporting of clinical trials. Mrs Vivat Thomas-Njie, MRC UK The Gambia’s Clinical Trials Monitor, elucidated the basic principles of monitoring including ethical approval, monitoring for deviation from protocols, quality assurance and control.

The workshop was concluded by Dr Nestor Shivute, WHO Country Representative, who gave an overview of WHO’s standpoint on the ethics of biomedical research. Dr Shivute commented ‘WHO recognizes biomedical research as an important part of its work, but the evidence generated from it can only be meaningful if it is conducted in an ethically sound manner.’

Dr Shivute quoted the international ethical guidelines for biomedical research, which include

Detailed research protocols, to ensure the protection of human subjects involved in the study
The known benefits and risks or disadvantages for the subjects in the study must be provided
Exact description of the information has to communicated both orally and in writing to the subjects of the study
When appropriate, any special incentive or treatment that subjects will receive through their participation in the study must be indicated. The study should ensure that the subjects involved suffer no financial burden as a result of their participation
Information obtained from participants in the study should be kept confidential
Where appropriate, drugs, vaccines, diagnostic procedures, or instruments to be used have to be listed, whether they are registered, unregistered, new, or currently in use in the country
The inclusion, as appropriate, of children, the elderly, physically challenged, and pregnant women should be indicated and justified
A brief synopsis of how the research findings will be reported and delivered to the subjects involved in the study or to other interested parties should be provided
Informed consent form to be signed by persons participating in the study, has to be provided in advance.

Debates arising from this workshop are likely to contribute significantly to the continuing development of the Gambia Government/MRC Ethics Committee, which has already played such an important role in regulating medical research for over a quarter of a century in the country. Professor Tumani Corrah, commenting on the national and global influence of the Committee’s deliberations, stated that “the Committee’s interest in what happens to individuals and communities “after the research is over” has yielded significant benefits to the Gambia’s Extended Programme on Immunisation (EPI) which now includes the Hepatitis B and Haemophillus Influenzae Type B vaccines, following successful studies of these vaccines in The Gambia. And we are proud to say that The Gambia’s EPI was the first to incorporate these vaccines into its schedules in Africa.” The Gambia Government/MRC Ethics Committee is currently under review and it is envisaged that the Committee will continue to strengthen its contribution to the promotion of safe, relevant research in the country and region as a whole.