Abstract
BackgroundResearch 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.MethodsThirteen 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.ResultsThis 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.ConclusionsRecently, 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.
Highlights
Research ethics guidelines are essential for conducting medical research
We reviewed the relevant guidelines, regulations, and ethical codes of the Arab countries in the Middle East; investigated whether each country had national regulations or guidelines on research ethics; determined whether ethical principles are stated in these guidelines and, if so, which ones; and compared them with each other and with the major international guidelines
Historical overview After the establishment of the first international and Western clinical research guidelines, it required a few decades for decision makers in the Arab countries in the Middle East to begin thinking about their own guidelines
Summary
Research ethics guidelines are essential for conducting medical research. Numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. There has been increased awareness of ethical issues because of the extensive expansion of clinical research and trials. There has been growing debate over the ethical challenges faced by different societies. Scholars have begun to consider how to offer protection to the research community, resulting in the creation of research ethics guidelines in many countries [1]
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