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Erschienen in:
01.10.2014 | Original Research Article
Ethics and Governance of Clinical Research in a Developing Country: A Cross-Sectional Survey Among Resident Physicians in Nigeria
Erschienen in: Pharmaceutical Medicine | Ausgabe 5/2014
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Background
Research on human subjects is a public trust; therefore, there is a need to ensure that research coming out of Africa is conducted to the highest ethical standards. Ethics codes ensure that participants in research projects are treated with dignity and respect while they contribute to the social good. History of past abuse of human participants in research and the need for a body to be responsible for ensuring adherence to the principles of ethics in clinical research has necessitated the formation of ethics committees. This study assessed the knowledge of resident doctors, who are medical specialists in training, on their understanding of ethical issues involved in clinical research and their perception of the working and operations of ethics committees.
Methods
The study took place at the Lagos State University Teaching Hospital, Ikeja, among resident doctors from all the clinical and laboratory departments of the hospital. The study design was a cross-sectional survey with the use of structured self-administered questionnaires among respondents who volunteered to participate. Qualitative variables were summarised as count and percentages and continuous variables expressed as mean ± standard deviation.
Results
In total, 102 resident doctors took part in the survey; two-thirds of whom had had previous research experience. Observational studies were the most common type of research activity among the responders, only 7 % had had previous experience with clinical trials. About 50 % believed that statistics and science of study protocol studies should not be reviewed by an ethics committee.
Conclusion
Many of the residents in the study were involved with clinical research but only a few of them had had previous contact with an ethics committee. There was a gap in the knowledge of the resident doctors about the operations of the ethics committee and some ethical principles that guide clinical research.