Documentation of ethical considerations in published articles in Sudanese medical journals
Guidelines for biomedical research involving human subjects require that research should be conducted in accordance with accepted ethical principles. The International Committee of Medical Journal Editors guidelines require authors to indicate that they have obtained ethical approval and informed consent. Sudanese scientific medical journals ask authors to declare informed consent and ethical approval by an ethics review committee (ERC) in published reports.
Methods. We reviewed 114 original research articles published in five peer-reviewed Sudanese medical and health journals to assess the extent to which ethical considerations had been reported.
Results. A subtitle indicating ‘ethical considerations’ was found in 5 (4.4%) articles, 35 (30.7%) stated that informed consent had been obtained from the study participants, and 13 (11.4%) stated that the study had been approved by an independent ERC. Although all five journals explicitly ask authors to document ethical approval and informed consent, 88.6% and 69.3% of the articles examined had failed to document ethical approval and informed consent, respectively.
Discussion. Failure to obtain or report ethical approval by an ERC and failure to obtain informed consent from study participants was the most prominent finding. Failure to report ethical approval or consent was seen to a similar extent in all study designs reported, so study design did not seem to influence the reporting of ethical considerations. However, failure to document ethical considerations, in particular ethics committee approval and obtaining of informed consent, does not necessarily mean that these were not done in the research reported.
Limitations. We reviewed only Sudanese journals, so do not know the practice of Sudanese authors in this regard when they publish in international scientific journals.