An evaluation of the informed consent procedure used during a trial of a Haemophilus influenzae type B conjugate vaccine undertaken in The Gambia, West Africa
Introduction
The shocking abuses of human subjects involved in medical research during the Second World War led to the formulation of the Nuremberg Code (1948) to safeguard the rights of the individual. This code stated the now generally accepted principles of consent to medical research: that individuals should have a free choice and have sufficient knowledge and comprehension of the subject matter to make an informed decision.
It has been questioned whether in a multi-cultural world it is possible to have one internationally agreed standard of consent to medical research, or whether research ethics should be adapted to the cultural values of the community (Barry and Molyneux, 1992; Christakis, 1992; Levine, 1991; Smith et al., 1991; Taylor, 1979). A principle of Western ethics is that the individual behaves as an autonomous agent, whereas in many other cultures the individual is viewed in the context of the social group (Christakis, 1992; Levine, 1991; Hall, 1989). This has lead some authors to propose that, in societies in which decisions are traditionally taken at the level of the community, it is more appropriate to seek consent from respected leaders than from individuals (Barry and Molyneux, 1992, Hall, 1989). Others have warned that a change from the requirement for individual consent may allow people to be exploited by unethical researchers or community leaders (IJsselmuiden and Faden, 1992). There are also practical problems in achieving a consent that is truly informed in a poorly educated society with a traditional belief pattern. For example, comprehension of the purpose of vaccination relies on the prior acceptance of the germ theory of disease and this may conflict with locally held beliefs of disease causation (Ekunwe and Kessel, 1984; Hall, 1989).
In The Gambia, the Gambia Government/Medical Research Council Ethical Committee (established in 1978) has tried to implement the recognised international ethical standard of “informed consent” with sensitivity to the educational and cultural background of the community. In order to evaluate this approach, a study was undertaken of the effectiveness of the consent procedure used during a large efficacy trial of a Haemophilus influenzae type B (HIB) conjugate vaccine conducted in the western part of The Gambia (Mulholland et al., 1997). Current attitudes of the Gambian people to consent to medical research have also been investigated.
Section snippets
Study setting
The Gambia is a small West African country. The majority of the population are Moslem, live in rural areas and depend upon subsistence farming, which is supplemented by the cultivation of groundnuts as a cash crop. The urban agglomeration near the capital city is steadily increasing in size as a result of a high birth rate and migration to the towns. As in many other developing countries the diseases of poverty are common and the infant and child mortality rates are high. Pneumonia, of which
Results
All those asked to join the study agreed to participate, but whereas all of the acceptors were interviewed, 25% of the refusers gave incorrect addresses and could not be traced. In total, 189 interviews were made, 137 with acceptors (urban 64, rural 73) and 52 refusers (urban 44, rural 8). Two subjects in the refuser group had been enrolled erroneously into the trial and had received the first dose of vaccine. In both cases mothers had not been asked for consent.
In the rural areas, only 20% of
Discussion
This study has examined two questions: whether informed consent was desired by this community and whether it was successfully applied during an HIB vaccine trial. Each of the underlying principles of consent, that it was free, autonomous and informed, have been considered.
Consent should be given free of coercion, penalty or inducement. In this HIB vaccine trial this appears to have been achieved, very few mothers reported feeling pressurised to join by MRC workers, but some agreed to
Conclusions
The most striking result from this enquiry is that the principles of autonomous informed consent have been affirmed by the study community. It was agreed unanimously that each parent has the right to make a free choice. No one accepted that a community or religious leader could make a decision on their behalf. A good knowledge of the purpose of the vaccination was found and so doubts that this community would be able to understand the subject matter were unfounded. The parents themselves
Acknowledgements
We thank Caroline Barfoot, Felicity Cutts and Linda Williams for their comments on the manuscript.
References (14)
Ethics are local: engaging cross-cultural variation in the ethics for clinical research
Soc Sci Med
(1992)- et al.
Randomised trial of Haemophilus influenzae type-B tetanus protein conjugate for prevention of pneumonia and meningitis in Gambian infants
Lancet
(1997) - et al.
Ethical dilemmas in malaria drug and vaccine trials: a bioethical perspective
J Med Ethics
(1992) - et al.
Informed consent in the developing world
Hastings Center Report
(1984) Epidemiology of acute lower respiratory tract infection, especially those due to Haemophilus influenzae type B, in The Gambia, West Africa
J Infect Dis
(1992)Public health trials in West Africa: logistics and ethics
IRB
(1989)- et al.
Research and informed consent in Africa—another look
N Engl J Med
(1992)
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