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Pioneering study catalogs ethical issues of scientific research in developing world

11.09.2007
New advisory service to address ethics in global science program

The first comprehensive examination of the ethical, social and cultural (ESC) challenges faced by major science programs in developing countries has identified a complex assortment of issues with the potential to slow critical global health research if left unaddressed.

They range from problems such as government corruption to complex questions surrounding community and public engagement, cultural acceptability and gender.

The study, conducted by an international team of bioethics experts from the McLaughlin-Rotman Centre for Global Health in Toronto (MRC), was supported by the Grand Challenges in Global Health (GCGH) initiative, which is funded by the Bill & Melinda Gates Foundation, the Foundation for the National Institutes of Health, the Wellcome Trust, and the Canadian Institutes of Health Research. The investigators conducted interviews with academics, government officials, and NGO and private sector experts from developing countries. Their findings are published in the current edition of the prestigious journal PLoS Medicine.

“Concurrent with the rapid growth of scientific research in developing countries, there are more reports of projects that face challenges related to ethical, cultural and social concerns,” says Dr. Peter A. Singer, Senior Scientist at the MRC and a co-author of the report, Grand Challenges in Global Health: Ethical, Social and Cultural Issues Based on Key Informant Perspectives. “Our goal was to anticipate issues that could be faced by such programs and try to prevent them as this important work moves forward.”

Says co-author Jim Lavery, a Scientist at the Centre for Research on Inner City Health and Center for Global Health Research, The Keenan Research Centre in the Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto: “We have produced the first comprehensive description of ethical, social and cultural issues related to large scale health research programs in the developing world and should be of great interest to members of the science and development community.”

“Studying and understanding these issues will promote more effective project planning and ethical implementation, thereby increasing the chances of a successful outcome,” says MRC Senior Scientist Abdallah Daar, another leader of the study team. “It will also minimize the potential for adverse impacts on those who participate in research in developing countries.”

Developing country experts identify 13 areas of concern

Based on 70 interviews with academics, government officials, and NGO and private sector experts from developing regions, the study team pinpointed 13 ESC issues of concern for major science programs:

Community engagement

Developing world experts stressed the need for researchers to create opportunities to listen to and understand the concerns and interests of the communities in which they work. “For sustainability of any program, it has to be owned by the community,” says Prof. Dara Amar, of St. John’s Medical College, India.

Public engagement

The introduction of nutritionally enhanced foods and genetic strategies to control mosquitoes are cited as two examples of interventions where public input would be important. “You have to somehow get the information through the radio, newspapers and the TV,” says Florence Wambugu, head of Africa Harvest Biotech Foundation International. “But sometimes, to get to the grassroots, you have to get to the community through schools and churches. We have to get to the people.”

Cultural acceptability

Investigators identified several examples of technologies now in development that could face cultural barriers, including intravaginal and aerosolized vaccines, and nutritionally enhanced foods that look different from the traditional varieties. Developing world experts stress that awareness of cultural issues related to religion, history, gender, sexual practices and contraceptive use, and the existence of a “culture of science,” influence whether people who need a technology will use it. “Every technology is viewed first off in the context of how it might destroy the culture,” says Calestous Juma, Kenyan-born Director of the Program on Science, Technology and Innovation at Harvard University.

“Rather than shooting down the cultural beliefs,” says Dr. Gita Ramjee, Director of HIV Research with South Africa’s Medical Research Council, “try to integrate the new technology in an appropriate way that doesn’t impinge on their cultural beliefs.”

Gender

In many developing countries, according to the experts interviewed, culturally-ingrained discrimination limits women’s opportunities to make contributions in science and health and advocate for their needs. Several experts interviewed highlight the challenges facing researchers who work with vulnerable female populations, such as commercial sex workers, young girls and adolescents. They identified the need to help such populations resist abuse and exploitation through education, skills training and counseling.

Post-trial obligations/benefit-sharing

Experts said that a history of exploitation complicates the relationship between researcher and subject in developing countries. “Very little of the good results of all the research that has been done in sub-Saharan Africa ever gets back to the people who took part in the studies,” says Prof. Godfrey Tangwa, of Cameroon’s Yaounde University.

Ms. Ramjee of South Africa’s Medical Research Council, meanwhile, contends researchers should ensure subjects continue receiving treatment after a trial ends. “If you provide somebody with contraceptives, then you cannot just take that away when the trial is over. One needs to look at sustainability of an intervention that is provided. You cannot start something and take it away later.”

Collaboration

Developing world experts stressed the importance of North-South and South-South collaboration that strengthens scientific capacity in their countries, both to create sustainable science infrastructure and to ensure that resulting technologies are adopted. “International partnership is critical not only to help find solutions but [to] stimulate a culture in these emerging economies where in future they could increasingly make a contribution,” says M.K. Bhan, of India’s Department of Biotechnology.

Role of civil society organizations(CSOs)

With their established networks and rural outreach efforts, CSOs can play a critical role in health research and interventions. However, according to one expert, partnerships can only succeed when the missions of the partner organizations align. She cited the example of HIV work conducted by religious groups, some of which “put such a negative view (on preventative measures) … they do more harm than good.”

Affordability

At present, many new technologies will need to be donated or heavily subsidized to reach those in need, many of them living on less than a dollar a day. Affordability, experts say, should be seen as a question of equity.

Accessibility

Adequate facilities and equipment staffed by competent healthcare workers are key to ensuring access. Developing world interviewees cite frutration, especially in rural areas, with poor roads and transport and power cuts – even a lack of potable water to administer pills.

Regulations

Experts said that weak or nonexistent intellectual property laws discourage researchers in the developing world from taking risks that lead to innovation. Regulatory structures “must strike a balance between ensuring consumer safety and facilitating product development and distribution,” the authors say. “The absence of functioning regulatory regimes in the developing world diminishes both consumer trust and regional collaboration.”

“If we want to join . . . the development ladder, we have to agree that the intellectual property is something that we have to respect,” says Prof. Yonguth Yuthavong, of Thailand’s National Science and Technology Development Agency.

Intellectual property regulations, however, should acknowledge humanitarian needs, experts said. With AIDS drugs, for example, price must not keep treatment out of the hands of those who need it most. “It’s a question of humanity,” says Prof. Yuthavong.

Collection, management and storage of tissue samples

Group discussion sessions revealed that guidance on the use of human tissues in research is still poorly developed, particularly for international collaborative research projects. Developing world experts noted that the lack of guidelines, or overly strict regulations, can hamper research.

Corruption and poor governance

Some developing world experts said that with the power to approve new technologies resting solely with governments and little transparency in those approval processes, political considerations often trump public health care. Those from the NGO sector say collaboration with the public sector breaks down when government officials demand bribes, and that poor governance starves public health initiatives of resources.

Unintended consequences

Investigators working in developing countries must anticipate and work to mitigate unintended outcomes of their research (for example, an unintentional increase in unsafe sexual practices during trials of HIV prevention tools). Developing world experts saw many potential areas of concern, including the effects of genetically modified organisms on biodiversity, disruption of local economies and drug resistance. Commenting on GM foods, one interviewee says: “I want to be sure that people are safe in eating these crops and that they’re not exposed to future disease problems. In curing one issue, we don’t want to create a public health disaster. And we must take whatever safeguards we can to prevent cross-pollination and pollution of a gene pool.”

Focus on Role of Community Engagement and Civil Society Organizations

The McLaughlin-Rotman Centre team has supplemented its ESC investigation with two separate reports, also published in the current issue of PLoS Medicine, focusing on engaging communities and civil society organizations (CSOs) in biomedical research in developing countries.

Paulina Tindana, from the Navrongo Research Centre, Ghana, a bioethicist with the GCGH ESC Program, and lead author of GCGH: Community Engagement in Research in Developing Countries, says that successful completion of the research and adoption of the resulting technologies depends on successful engagement with the intended beneficiaries.

“Recent research in developing countries, such as the closed trials in Cameroon and Cambodia of tenofovir as pre-exposure prophylaxis against HIV infection, has shown that even in studies where ethical issues have been addressed, challenges related to community engagement can still undermine research,” the report says.

In GCGH: Engaging Civil Society Organizations in Biomedical Research in Developing Countries, lead author Dr. Anant Bhan, a physician from Pune, India and bioethicist with the GCGH ESC program, notes that the trials in Cameroon and Cambodia were terminated primarily as a result of concerns from CSOs, underscoring the importance of engaging with these groups and being sensitive to their needs and concerns.

“Over the next two years, we will conduct a global case study on community engagement to identify a set of ‘good practices’ for developing world settings,” adds Dr. Lavery.

First ever ESC Advisory Service

The MRC studies will help inform the work of an ESC Advisory Service, established within the GCGH to address ethical, social and cultural issues identified at the beginning of projects as well as challenges that surface as projects progress. The Advisory Service assigns a co-leader and lead bioethicist to every GCGH project.

“This is the first time ethical, social, and cultural counsel has been engaged on a large scale to provide advice in a systematic way on these issues in a developing world context,” says study co-author Dr. Jerome Singh of Centre for the AIDS Program of Research (CAPRISA) in Durban, South Africa, and a co-leader of the GCGH ESC advisory service.

Terry Collins | EurekAlert!
Further information:
http://www.geneticsethics.net
http://www.gcgh.org

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