Developing cultural competence and overcoming ethical challenges in the informed consent process: an experience from Egypt.

Author:Abdel-Messih, Ibrahim Adib
 
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Introduction

Research activities are increasing in size, complexity, regulatory oversight, and cost, creating challenges and pressures on the research system. The ethical conduct of research related to health care in developing countries has been the subject of much recent discussion (Benatar & Singer, 2000; Lansang & Crawley, 2000; Bhutta, 2002; Caballero, 2002), particularly with the increase of research in these countries and the need to address their high burden of disease. Special challenges affect the conditions under which this research is conducted, such as sanitation, standards of care, and specific political, legal, and social contexts.

Wherever research is conducted, it must honor the autonomy and dignity of all persons, and fulfill the principles of respect for persons, beneficence, and justice--the three basic ethical tenets of the Belmont Report. Although these principles were developed in Western societies, they have been widely adopted and play a significant role in research ethics worldwide. Application of these principles to the conduct of research leads to consideration of informed consent, risk/benefit assessment, and the equitable selection of human subjects.

The principle of respect for persons is embodied in the informed consent process, through which subjects, to the degree they are capable, are given the opportunity to choose what shall or shall not happen to them. This principle is honored when the consent process is informed, understood, and voluntary.

When research is justified on the basis of a favorable risk/benefit assessment, the principle of beneficence is honored. Such an assessment addresses the probability and magnitude of possible harm and anticipated benefits. Possible harms, and their corresponding benefits, may be psychological, physical, legal, social, and economic.

The principle of justice is embodied in the equitable selection of subjects, and seeks to ensure that participants neither suffer undue burden nor benefit disproportionately from their role in research.

To apply these principles globally in a way that protects the rights and welfare of subjects, it is essential that researchers have sufficient knowledge of socioeconomic, political and cultural aspects of the local research context. An effective child assent process, for example, requires an understanding of how different cultures define relationships between parents and their children.

Questions that may be considered innocuous in the United States and Western Europe could be offensive elsewhere. Different cultures have different authority structures that influence how researchers address potential coercion.

In this paper, issues and challenges encountered in conducting research in Egypt will be presented to provide researchers and research administrators with insight in the design, implementation and management of research in different cultural settings.

The Egyptian Context

Egypt is a country of about 75 million people, with diverse cultural beliefs and practices. Egyptians are very religious, and religious principles are noticeable in their daily lives. The population consists primarily of Sunni Muslims (about 90%) and Coptic Christians (about 10%).

As an Islamic country bordering the Middle East, Egypt is an Arabic republic. At the same time, as a country of North Africa with a 5,000-year heritage, it is altogether unique. In every major Egyptian city there are traditions carried over from the time of the Pharaohs; other areas retain the tribal customs originated by the many invaders throughout the centuries.

Family ties are strong in Egypt. Egyptian society consists of a mixture of Middle Eastern family values, taken from different religious rules, whether Islamic or Christian. This mixture of values colours Egyptian decision-making in a way that may be difficult for many people in the west to understand. In Egypt, clan obligations unite extended families--grandparents, aunts, uncles, and cousins--in good times and bad. Clan elders arbitrate disagreements, even those between husbands and wives, and give opinions on topics ranging from farming techniques to religious obligations.

Issues and Challenges

Informed Consent Document Signatures

Populations with limited resources are particularly vulnerable, and the high-risk health conditions under which they live can affect both the researchers' and study subjects' assessment of the risk-benefit ratio...

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