Review of National Research Ethics Regulations and Guidelines in Middle Eastern Arab Countries

Several ethics guidelines for clinical research have been developed recently in response to the increase of industry sponsored clinical trials in the Middle East. The rise in clinical trials in the region (recorded at 4% between 2006 and 2010) can be attributed to diversified patient populations, low operational costs, less government oversight and the availability of relatively good health facilities in the Middle Eastern Arab (MEA) countries. This article investigated whether MEA countries had national research ethics regulations and those identified were analyzed and compared to existing international guidelines.

The authors sought available online governmental official sources to identify research ethics guidelines and clinical research laws in MEA countries, namely; Egypt, Iraq, Saudi Arabia (SA), Yemen, Syria, United Arab Emirates (UAE), Jordan, Palestine, Lebanon, Kuwait, Oman, Qatar and Bahrain and the indirect data included in the codes of ethics.

Ten documents from 8 countries (UAE, Qatar, Bahrain, Kuwait, SA, Jordan, Egypt and Lebanon) were eligible for review.  Of which, 5 were guidelines, 3 national laws and 2 medical codes. Countries were classified into 2 main groups; the first group had guidelines and was divided into 2 sub groups; sub group 1 consisted of the countries that had national research ethics guidelines (SA, Qatar, Bahrain, UAE, Kuwait and Jordan) while sub-group 2 was composed of the countries that had general documents with few paragraphs about research ethics (Lebanon and Egypt). The second main group constituted of countries with no guidelines regulating research but referred to international ones (such as; Declaration of Helsinki and CIOMS) as in Syria and Iraq, or had none as in Oman, Palestine and Yemen. The first local GCP structured document appeared through the Saudi Food and Drug Authority in 2005. GCP structure was also maintained in UAE and Kuwait guidelines while Bahraini, Jordanian and Qatari documents did not follow the GCP layout. The guidelines with most ethical protections were present in the Qatari documents (19 protections) while the Jordanian and Lebanese guidelines had 3 and 2 protections respectively. Obtaining Informed consent was the only common protection listed in all documents, 9 stated the obligation of review by ethics committee and 7 acknowledged the determining of benefit/risk ratio and the protection of confidentiality. In addition, only 5 discussed inducement to participate in research. Moreover, 5 guidelines required limiting the risks when dealing with disabled populations, while only 4 discussed acquiring their consent. Regarding research conducted on children, only 4 guidelines mentioned the need for special protections. As for women and pregnant women they were only mentioned once.

This review showed considerable efforts to regulate human subject research in the MEA countries; however there is vast variability among the guidelines between countries.  Moreover, if compared to international guidelines, the MEA guidelines are inadequate in content and structure, which could jeopardize the credibility of clinical research conducted in the region. International guidelines and the respect of Islamic law were the 2 main external resources used. MEA countries were at different levels of research ethics guidelines development, which can be attributed to the vast differences in levels of financial support given to the health care and research between GCC and non-GCC countries.

In my opinion, research ethics guidelines are still a major concern in MEA countries as only 43% of the recruited countries in this review had national guidelines but with some major deficiencies in human subject protection for example;  the protection of vulnerable populations. As little research has examined research ethics guidelines adopted in MEA countries, this review merits a noticeable credit while data reliability could have been better achieved if  authors utilizing other sources for obtaining information on the guidelines for example, contacting Ministries of health officials in the MEA countries.

References:

Alahmad, G., Al-Jumah, M., & Dierickx, K. (2012). Review of national research ethics regulations and guidelines in Middle Eastern Arab countries. BMC medical ethics, 13(1), 34