Ethics of human research in poor countries debated 

NEW YORK (IPS)-With most research on human subjects in developing countries undertaken by Western companies, concerns are growing that the ethical standards used in such trials may not be sufficiently rigorous or sensitive to local culture. 

After two years of consultations, an international working group of specialists in medicine, healthcare, anthropology, philosophy and public policy, led by the Britain-based Nuffield Council on Bioethics, has issued a new set of voluntary guidelines that it hopes will make such research more responsive to the needs of participants and host countries. 

"There are concerns that people in poorer countries will sometimes bear the risks of research while those in richer countries will receive the benefits," said Fred Binka, an associate professor of epidemiology at the University of Ghana and a member of the Nuffield team. 

"It is critically important that the local social, cultural, and economic context is taken into account when research is designed," Mr. Binka added. 

The Nuffield guidelines cover core issues like consent to participate in research, standards of care, need for research, and what happens to participants when research is concluded. 

For example, is it ethical to test a new drug in a country that would be unable to afford it should the drug prove effective? The question is not as straightforward as it may seem, the experts said, because sometimes, new treatments will quickly fall in price. 

In the Gambia, trials of a hepatitis B vaccine were conducted at a time when a course of the vaccine cost $60, a price far beyond the reach of poor countries. A few years later, the price was discounted to $1-$2 per dose, and it has since been widely administered in the Gambia and Taiwan. 

The experts concluded there is no simple answer to the problem of affordability, not only because the economics of treatment are subject to change but also because some diseases only occur in the developing world and it could be self-defeating to restrict research on the basis that the treatment cannot currently be afforded. 

If the Gambia trials were a positive example of research and development bringing benefits to developing countries, other incidents have been heavily criticized. 

In 1997, the World Health Organization, the Joint UN Program on HIV/AIDS, the U.S. Centers for Disease Control and Prevention, and others sponsored clinical trials in Africa and Thailand of a drug that blocked mother-to-child transmission of the HIV virus. The trials were designed to see if a short course of the drug, zidovudine, would be as effective as a longer course. Half the women were given placebos. 

Defenders of the trials pointed out that ethics committees in the countries had approved the research, and that no anti-retroviral treatments were available for pregnant women there anyway. 

But critics argued that trials involving placebos and a lesser course of treatment-the long course, as tested in the United States and France, effectively blocked the virus-would certainly be deemed unethical in wealthy countries. In a single study, women given placebos gave birth to 18 babies with HIV. 

"After much discussion, we concluded that wherever appropriate, participants should be offered the best standard of care available in the world for the disease being studied," said Kenneth Calman, chairman of the working group. 

However, he added: "This is not always appropriate or possible. For example, sometimes the medical facilities to provide such treatment just don't exist in developing countries. In these situations, we recommend that-at a minimum-participants should be offered the best treatment available from the public health system."

The Nuffield team, in a report entitled "The Ethics of Research Related to Healthcare in Developing Countries," builds on the principles of the 1964 Declaration of Helsinki. This document helped lay the foundation for government and private sector regulations for clinical trials around the world. 

The Nuffield report is to be sent to international organizations like the WHO, national agencies in both rich and poor countries, including research councils, research ethics committees, relevant academic departments, NGOs, pharmaceutical companies, research sponsors, and departments of health. 

"We will also be specifically liaising with various governments, research ethics committees and researchers in specific countries," said Nicola Perrin, a Nuffield spokesperson. "One member of the working party has been talking to the Indian Council of Medical Research and is hoping to work with them to run ethics training workshops for all researchers, based on the report's recommendations." 

In about one and a half years, the 14-member working group plans to reassemble to look at the impact of its guidelines and to follow-up in areas where there has been little change. 

It is unclear how receptive the pharmaceutical industry will be to a new set of guidelines. 

The U.S.-based PhRMa is one of the world's leading pharmaceutical trade associations. Its members spent more than $30 billion dollars on research last year and sponsored the vast majority of clinical trials worldwide. 

A PhRMa spokesperson said the association would likely review the Nuffield report but was satisfied with the guidelines currently in place and did not anticipate making any changes. 

Ultimately, the Nuffield working group urged developing countries to take more control over the research conducted within their borders, to ensure that it is appropriate and ethically sound. 

The report, in English, French and Spanish, can be viewed at the group's Web site, www.nuffieldbioethics.org. 

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