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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 (Nuffield Council on Bioethics, 2003). Complex documents and legalistic language make it increasingly difficult for prospective subjects to decide about their participation. Truly independent consent may be limited by cultural context and distorted when populations of limited economic means are offered incentives to participate.
The requirement to document consent through a signature or thumbprint may be difficult for investigators working with culturally diverse populations or with individuals who are socially marginalized or involved in illegal activities. In some areas of the world, both individuals and communities have suffered politically, socially, or economically because they signed "legal" forms that resulted in sanctions against them. Signing a document in some communities is always associated with a major life event, and asking research participants to sign a consent form can imply lack of trust.
Readability and Literacy
Comprehension of information during consent discussions is often influenced by misunderstandings about research. There are often negative connotations associated with the words "investigation" and "study," and a suspicion of "experimenting" or "practicing on my child." In many African languages, there is no word for research or science; the word used is generally the same as the word for medicine. The concepts of randomization and placebos used in clinical trials can be especially hard to explain, particularly when international researchers are working with communities and individuals who may be illiterate.
Influence of Medical Tradition on Consent
In many developing countries, medical doctors enjoy a high status and regard as a particularly knowledgeable group. Patients expect health professionals to make decisions for them and are reluctant to choose when given options about their treatment, as they do not question the medical competence in decision-making about their own care. This attitude is routinely applied to health care research, and can result in reduced participant autonomy. Individuals have limited familiarity with the notion of research and research design and find it unacceptable for doctors to express uncertainty regarding the best option available. This places the principal investigator/ clinician at great risk of conflict of interest. In Egypt, it is important to take this medical tradition into consideration.
Influence of Social Structure on Consent
A critical element of conducting research is the process of obtaining informed consent. Sometimes, in non-U.S. communities, people other than the individual taking part in the research may be required to give permission before the potential subject can be asked to participate. These individuals may include a spouse, a head of household, or a group leader. The investigator must design a consent process that honors local custom. However, another individual's permission should not substitute for a subject's voluntary informed consent, unless that consent process has been waived by an Institutional Review Board (IRB) or equivalent local review committee. Unique cultural, religious, and socio-economic factors in Egypt pose many challenges for researchers obtaining informed consent.
Post-Study Communication
Another particularly difficult challenge for researchers in developing countries is what happens when the research is concluded. The Declaration of Helsinki (Principle 30) states, "At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic, and therapeutic methods identified by the study." However, in practice, results are neither communicated to nor discussed with the public. Progress to rectify this issue is desperately needed to ensure concise, accurate IRB study completion standards. In fact, IRBs cannot usually follow up the successive phases of the research and ensure that the succeeding study was properly managed.
Overcoming the Challenges
Understanding and Sensitivity
Research managers, administrators, and investigators involved in international research should have some understanding of, and be sensitive to, the social, economic, and political milieu that affects the context in which their research is taking place. This cultural competence would enable them to establish recruitment procedures consistent with cultural, political, and social practices, while developing sensitivity to the individuality of different cultural groups. Lessons learned from genuinely collaborative efforts in multi-center research could be applied in this context.
Disclosure of information should be sensitive to the local context during the informed consent process, and conducted in the local language, employing culturally appropriate idioms and analogies understandable to prospective participants. This obviously entails a need for collaborative partnership between investigators conducting research and local communities.
Novel Consenting Strategies and Maintaining Voluntary Participation
An experience from Mall (Doumbo & Ogobara, 2005) clearly illustrates the importance of cultural competence. A dynamic approach to obtaining informed consent and to maintaining it over time was developed through a stepwise process. First, permission from the community was sought by a discussion with the group of village elders, who determined that a particular study could proceed. Then focus group discussions were convened with the heads of extended families. Similar discussions were initiated with mothers whose children might become part of the study. Finally, consent of the individual families involved in the research study was obtained. "The consent process was open and better suited to the needs of the population than were more conventional approaches. It generated more confidence by the villagers in the research project and a better understanding for us of the village culture and behavior." the author reported in page 2, second column.
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