Review of national research ethics regulations and guidelines in Middle Eastern Arab countries
1 King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, Box: 22490, Riyadh 11426, Saudi Arabia
2 Centre for Biomedical Ethics and Law, Faculty of Medicine KU Leuven, Kapucijnenvoer 35 Box 7001, Leuven B-3000, Belgium
BMC Medical Ethics 2012, 13:34 doi:10.1186/1472-6939-13-34Published: 12 December 2012
Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents.
Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others.
This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics.
Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines.