Ethical practices for health research in the Eastern Mediterranean region of the World Health Organization: a retrospective data analysis

Abstract

Background: Commentators have expressed concern regarding the existence of proper ethics review systems in developing countries. Our aim is to explore the extent with which investigators from countries in the Eastern Mediterranean (EM) Region consider several ethical practices in the conduct of their research.

Methodology/principal findings: Investigators from 12 countries in the EM region submitted 143 proposals involving Public Health and Biotechnology & Genomics to a grant scheme funded by the Eastern Mediterranean Regional Office of the WHO and the Organization of Islamic Conference Standing Committee for Science and Technological Cooperation in 2006. The grant application included a 1-page questionnaire that asked investigators 1) whether ethical clearance was obtained, 2) whether they plan to obtain informed consent, and 3) whether confidentiality of human subject data would be ensured. The methodologies of the submitted researches were categorized as to whether it involved 1) human subject research (e.g., the prospective collection of biological specimens or the performance of qualitative research), 2) research that could be exempt from ongoing ethics review, and 3) research not involving human subjects. A descriptive analysis was used to analyze the investigators' responses and a chi-square analysis was used to analyze categorical variables. Of the 79 submitted proposals determined to involve "human subjects", ethical clearance was not obtained in 29%; investigators thought that informed consent was not needed in 29%; and investigators did not mention that they would ensure confidentiality of the obtained data in 8% of the studies. The magnitude of these deficiencies was similar regardless of study design type, i.e., prospective collection of biological samples and qualitative research methods.

Conclusion/significance: These results suggest that attention to ethical safeguards is not optimal among investigators in the EM Region. Further guidelines for strengthening ethical review systems, as well as enhanced educational training in concepts of research ethics for investigators are warranted in this region.