Essays on Science and SocietyGLOBAL VOICES OF SCIENCE

<H4>Also see the archival list of the Essays on Science and Society.</H4> GLOBAL VOICES OF SCIENCE: It Takes a Village: Medical Research and Ethics in Mali

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Science  04 Feb 2005:
Vol. 307, Issue 5710, pp. 679-681
DOI: 10.1126/science.1109773
Ogobara K. Doumbo


Ogobara K. Doumbo, director of the Malaria Research and Training Center at the University of Bamako, knew he would become a doctor at the age of 10. Immersed initially in the traditional medicine of his grandfather, he earned his medical credential in his home country and then later earned a Ph.D. in tropical medicine and parasitology at the Universities of Marseille and Montpellier in France. With expertise also in tropical medicine and parasitology, and with extensive research connections throughout the world, Dr. Doumbo has been making a global impact on the study, treatment, and prevention of malaria. With both in-the-field and academic exposure to medical ethics issues, he also has been helping to develop research protocols that respect and honor the diverse populations that become involved in his medical research. In 2003, following a nomination by the president of Mali, Dr. Doumbo became a member of his country's National Committee on Ethics. He also has been knighted by France's Legion of Honor and Mali's National Order. His center was selected in 2003 as a Center of Excellence in Clinical Research by the Agence Universitaire de la Francophonie (AUF) and as a malaria vaccine site by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health in Bethesda, Maryland.


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The world is populated by rich and poor nations filled with a diversity of peoples and customs. For those scientists and physicians trying to have an impact on global health, conducting clinical trials and other types of medical research in these varied places, and among these different cultures, is central to the cause. It also is imperative that these efforts are undertaken in ethical ways that respect and honor those many individuals and communities that agree to participate in the investigations. To do that, researchers need to develop an understanding of the unique ways in which different cultural groups make decisions. Only then can the investigators feel assured that the human beings who consent to partake in their studies are fully informed about the possible risks and benefits of such participation.

Without knowing it at the time, I began to develop a sensibility to these issues as an 8-year-old child when I used to follow my grandfather while he practiced traditional medicine in the Dogon country in northeast Mali. I was impressed by his attitude toward his patients. He was very close to them, talked to them with respect and consideration, and showed compassion for their suffering. The patient and the caregiver in this care-providing system are so intimately connected that my grandfather considered the patients as part of his family, sharing the same food and shelter. Because of my grandfather's fame, and because he specialized in two diseases—pharyngitis and breast tumor/infection—some patients came to him from very remote areas.

The respect my grandfather showed while interacting with his patients marked my life. At the age of 10, I decided to become a medical doctor, and 7 years later I began my medical studies at the National School of Medicine and Pharmacy in Bamako, Mali. There, in my second year of medical studies, during rounds with the late Bernard Duflo of the Internal Medicine ward of the National hospital “Point G,” I witnessed a similar intensely ethical attitude in the patient-physician relationship. My grandfather and Dr. Duflo, a French physician, were from two completely different cultures, but they shared the same attitude in healing patients.

My “indoctrination” in the importance of ethics continued when I started my own medical research career in 1984. I was fortunate at that time to have been at the University of Marseille where I worked with parasitologist Philippe Ranque in the first Phase II trials in Mali of ivermectin, then a new drug for the treatment of onchocerciasis, or river blindness. Like my grandfather, Dr. Ranque's priority was to show his patients attention, care, and compassion. Dr. Ranque believed that protection of volunteers in medical trials was more important than achieving scientific goals.

Over time, my exposure to this sort of ethics-in-the field, as well as to more academic discussions of ethics, convinced me that scientists must consider ethical issues throughout the entire research process, from identifying a research question to analyzing and interpreting data.

In Mali, where most of the population cannot read and where the social structures demand that decision-making be done more communally than in the West, we have had to develop new procedures for obtaining informed consent from participants in our malaria research. The process doesn't always work, takes a long time, and requires more discussion and leg work than in the West, but it generates mutual understanding, medical care for the participants and often their entire communities, and valuable scientific results.*

Ethics in the Field: Informed Consent

At the Malaria Research and Training Center (MRTC) of the University of Bamako, Mali, we conduct different types of research, including laboratory-based studies, field research, and clinical trials. For us, ethical considerations constitute a dynamic process and are an integral part of the research enterprise. Here, I will focus on some study designs used at the MRTC and how we incorporate ethical considerations in our procedures for obtaining informed consent. I will also compare the strategies for getting documented and signed informed consent in developing countries, on the one hand, and in North America or Europe, on the other.

“Wabu” is a term that traditional healers in Mali use when referring to a condition marked by fever, seizures, delusions, or coma, the hallmarks of severe malaria. Traditional thought assigned the cause of wabu to a bird taking the spirit of a child at the moment that the bird and the child cry out simultaneously.


In recent years, we conducted an observational study of the natural history of malaria in the field as part of the Mali-Tulane Tropical Medicine Research Center (TMRC) project, funded by the National Institute of Allergy and Infectious Diseases (NIAID). The grant included three projects all located at Bancoumana, a large rural village in Mali with 12,000 inhabitants.

In Project 1 we studied a cohort of about 3500 children under 9 years of age, all of whom had been exposed to malaria. We recorded data on the natural history of malaria with the aim of identifying risk factors for infection or disease.

Because our studies were being done in the field and in a variety of social structures that respond differently to medical researchers coming into their lives, we needed to develop a dynamic approach to obtaining informed consent and to maintaining it over time. Usually, this was a stepwise process. First, we needed to get permission from the community to proceed. This began as a discussion with the group of village elders. Next, we convened focused group discussions with the heads of extended families. Then we held similar discussions with mothers whose children might become part of the malaria study. Finally, we obtained consent of the individual families involved in our cohort. 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. In developing this approach, I always had my grandfather and other ethics mentors in mind.

The villagers in the study received a tangible benefit too. Because we needed to examine the children many times during the course of the study, it meant that the villagers benefited from repeated contacts with the study physicians who lived in the village. Previous malaria studies in Africa commonly used a design typical of developing countries in which the interaction between study subjects and investigators is more limited and usually confined to clinical settings.

The second TMRC project was also unique in the strategy of getting informed consent. We wanted to test gametocyte infectivity in the community by directly exposing members already carrying the gametocytes to Anopheles gambiae mosquitoes—the most effective vector of the malaria parasite, Plasmodium falciparum, in Mali—collected in that village. Our aim was to determine the factors that influence how efficiently the mosquitoes would pick up the gametocytes from the infected villagers to initiate the sporogonic cycle during which the infective form of the malaria parasite proliferates inside the insects. Such direct exposure to these mosquitoes—even ones that were themselves not yet carrying the parasite and grown under controlled conditions—generates many ethical concerns. How could we prove to ourselves and to the community that the lab-reared Anopheles really were safe? How should we select the volunteers? How should we approach the community and document the process of community permission and individual consent (versus assent)? How should we explain the malaria life cycle to a population where 70 to 80% of its members are illiterate?

Champion Infector

The Anopheles gambiae mosquito is the most effective vector of malaria in Mali.


The first time we presented our protocol to the Institutional Review Board (IRB) of the Faculty of Medicine, Pharmacy and Odontostomatology, which oversees informed consent procedures, and to the village community, the design was rejected. The IRB deemed that it was not acceptable to expose humans to Anopheles even if the insects were reared in a well-qualified laboratory. We had to spend days and nights explaining the protocol to the villagers and to the Malian IRB members. Part of the process involved bringing representatives from two villages to visit our center at Bamako so that they could see how the exposure procedure would unfold. They spent 2 days with us and questioned us about all aspects of the experiment. In the end, the protocol was accepted, providing testimony to the ways in which responsible, open, and patient explanation of well-designed studies sometimes can alleviate participants' fears and misgivings.

The third NIAID-funded project—in collaboration with colleagues at the U.S. Centers for Disease Control in Atlanta, GA, and the National Malaria Control Program of Mali—was designed as a supplement to the original TMRC project. It was particularly ethically charged because it involved a vulnerable population of pregnant women. We wanted to conduct this study to generate data important for developing public health policies to help protect pregnant women from contracting malaria in ways that minimize risks to the fetus.

We designed a community-based open label trial to compare three prophylactic drug regimens in pregnant women. Given the special importance of pregnant women in African culture, we knew that we needed to be extremely careful about ethical considerations. Although these drugs were recommended by the National Malaria Control Program and the World Health Organization, their use in pregnant women needed rigorous ethical scrutiny.

Unconsenting hosts.

Women of child-bearing age, like these three walking to market in the Dogon region of Mali, are particularly vulnerable to malaria.


Central to the project, of course, was to obtain the community's permission to conduct the study. A key early step was to discuss the benefit of learning more about these drugs with the women's local council. Then we met with the mothers-in-law of each pregnant woman. After all of these discussions, we met with the individual pregnant woman. Toward the end of the process, the women requested that we meet with their husbands and fathers-in-law as well. (It is a widespread custom in African cultures that a pregnant woman belongs to the family-in-law, which is responsible for her care.) The overall goal of this project was to determine risk factors for contracting malaria, and we were able to offer the community the benefit of yearly feedback of all the results about the likely infectivity of their local mosquito population, before the next transmission season.

Consenting Partners

These three experiences show how different the informed consent process needs to be in different places in the world. For one thing, the issue of who “signs off” on consent must be carefully considered. Informed consent in Europe and in North America usually involves written documents, which the prospective volunteer must read and sign in order to participate in a study. The emphasis is on the autonomy of individuals.

In some developing countries, however, individual and community consent are part of the same process. We cannot separate them in our countries, and this reality should be understood by sponsors and funding agencies and northern research institutions. We need to think about the protection, safety, risks, and benefits of individuals and of the community at large. We have learned in particular that the initial focus and discussion should be with the leaders of the community, rather than individuals. By approaching individuals first, one is likely to introduce social conflict in the village, and this could be unethical.

Another challenge is the need to document the consent process using a signed document. At the beginning of our TMRC projects, the villagers we approached were opposed to signing any document, because they strongly believed that “they gave their words” and that that should be sufficient. It took very careful explanation and patience to overcome this resistance. Informed consent must be based on a thorough understanding of the society in which the study is to take place. For outsiders, the role of local guides, local investigators, and socio-anthropologists is critical.

Documents and legal language also pose difficulties. One of them is that in developed countries, the heavy use of legal language and documents makes it increasingly difficult and murky for participants to discern the risks and benefits of participating in studies. The goal of these legal documents seems to have more to do with protecting the investigators and sponsors than the volunteers. What's more, legal language is hard enough for a highly educated person to understand. In Mali, less than 20% of adults are literate, so written documents can easily discourage rural populations from participating in studies. Also, for rural communities, paper often means trouble with the government.

From both ethical and biological standpoints, the particular case of pregnant women needs special attention. In Malian traditional communities there is a very good but discreet representation of women in decisions concerning the village's affairs. Foreign researchers may overlook this important involvement of women and thereby lose the confidence of the community. Similar decision-making subtleties go with enrolling children in medical trials.

In the developed countries, children normally are excluded from medical trials of new medicines, but in Africa we have to test products on children because the target populations for malaria and many infectious diseases are children and pregnant women. It can be especially challenging to convince the community that it ultimately is in its best interest to allow children to participate in trials that could have widespread medical benefits in the future.

One way to earn the confidence of the community is to provide medical care for the community while the study is being conducted. In rural regions of developing countries where medical care is limited or nonexistent, the research team often has to set up its own clinic. Providing standard care for both study participants and others in the community during a research project where the team is the sole source of medical care can be a form of community compensation. Almost all studies in developing countries should guarantee care for volunteers who experience serious adverse events during the study and after it has been completed. Care must be taken to ensure that the provision of these services, and the establishment of a clinic, do not induce the community to participate in the study when in fact it might not be in the community's interest to do so. This ethical dilemma is not yet solved and remains a big concern.

The challenge of obtaining informed consent for medical research from communities in developing countries can be daunting, especially from rural and mostly illiterate populations in rural regions. Even so, our 15 years of international research experience in dealing with these complex issues of informed consent in Mali shows that these difficulties can be overcome in a way that benefits medical science and public health.

  • *O. Doumbo, Multilateral Initiative on Malaria (MIM), Durban, South Africa, March 1999.

  • †Y. T. Touré et al., Am. J. Trop. Med. Hyg. 59, 481 (1998).

  • ‡K. Kayentao et al., J. Infect. Dis. 191, 109 (2005).

  • I thank all the populations that participated in the studies, the MRTC/DEAP teams and partners, and my collaborators who read and corrected the manuscript: M. A. Thera, A. A. Djimdé, and D. A. Diallo.

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