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Culture Clash:
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Gerald T. Keusch, M.D., director, Fogarty International Center, believes the future of science in developing countries requires investments in information and creating a culture of research ethics. |
As human subjects research increasingly crosses international borders, our nation's scientific community is facing a growing number of ethical questions about its obligations when conducting research in the developing world.
"There are many different issues that must be understood by people going into developing countries to do research, both about the societies and about ethical questions and dilemmas," says Richard Cash, M.D., M.P.H., a senior lecturer in the Department of Population and International Health at Harvard University. Researchers must not only be aware of international guidelines governing research but also be willing and able to look beyond their own cultural values, he stresses.
Various sets of international research ethics guidelines exist, all of which are statements of principles for investigators, but none of which have legal authority. The most widely consulted sets of guidelines include the Declaration of Helsinki, the Council for International Organizations of Medical Sciences Guidelines, and the Guidance on Good Clinical Practice. Existing guidelines also address specific research situations, such as epidemiological studies, biomedical studies, and pharmaceutical trials.
Researchers don't always follow international guidelines, and when they do, they don't always agree on how to implement rules in each study. "It seems easy for people to agree on principles at the most abstract level. But it's not always easy for them to agree on how these principles ought to be operationalized in any specific study," says James Lavery, Ph.D., a bioethicist at the Division of Advanced Studies and Policy Analysis at Fogarty International Center (FIC), an international component of the National Institutes of Health promoting scientific discovery abroad.
Many countries, including the United States, have specific guidelines on research ethics. U.S. regulations are legally binding and are supposed to be followed by American investigators no matter where they are doing research. But the regulations may not carry the same weight under other countries' legal systems. As Dr. Lavery explains, "Most of the problems U.S. investigators face when working internationally relate to how this country's regulations are supposed to apply overseas, especially when one runs into technical issues in the law. It is not always clear how U.S. regulations are supposed to apply in different jurisdictions."
Federally funded research is usually more scrutinized than privately funded research, unless a company intends on marketing a product tested in its research activities, requiring it to strictly abide by FDA regulations.
U.S. medical schools are heavily involved with international research in developing countries. Johns Hopkins University School of Medicine manages an international AIDS program in conjunction with the Fogarty International Center. The John Hopkins Fogarty AIDS International Training and Research Program has projects in Africa, Asia, Latin America, and Europe.
Harvard Medical School is another institution doing substantial research in developing countries. The school created a nonprofit corporation, Harvard Medical International (HMI), specifically to respond to the growing requests for its participation in international health care initiatives. HMI has been involved in more than 40 projects in 18 countries, supporting projects such as research program development, clinical and principal investigator training, and clinical programs development.
Developing Countries: Ethics under Different Scenarios
During the past half century, medical research has become increasingly cross-national and cross-cultural, and, responding to this reality, international organizations developed sets of rules guiding doctors and investigators in the complex world of human subjects research. Hoping to prevent future medical research abuses, the World Medical Association developed the Declaration of Helsinki in 1964. "It was a vehicle targeted specifically at doctors involved in research with their patients," according to Dr. Lavery.
The declaration requires that "in any biomedical research protocol, every patient-subject…should be assured that he or she will not be denied access to the best proven diagnostic, prophylactic, or therapeutic method that would otherwise be available." This stipulation touches on a controversial issue - whether everyone, regardless of economic status or national origin, should have access to the best possible medical care. Dr. Cash uses the example of an HIV-vaccine trial in a developing country to illustrate the ethical dilemmas researchers face in trying to implement this standard.
"If an HIV-vaccine trial was conducted in the United States and somebody became infected by the virus, he or she would be given whatever the best therapy there was available," he explains, even if that specific therapy costs thousands of dollars a year. But in developing countries, where health care budgets are much smaller and where the treatment available to all citizens is much more limited, it's harder to guarantee infected subjects the most effective and expensive treatment in the world, he says.
"What treatment should [human subjects in developing countries] get: the treatment one gets in the United States, for $50,000, or the treatment available to all citizens of that country, which [might be] a $1,000 treatment?" asks Dr. Cash.
For some, the answer is that everyone should be given the most effective treatment, regardless of cost. Yet many developing countries are wrestling with issues of poverty, basic health care, and sanitation, and are unable to provide every sick person with cutting-edge or even effective treatments.
The Helsinki Declaration's requirement that every patient be given the best possible treatment "that would otherwise be available" worries proponents of egalitarian access to care because of its implication that if no treatment is available, as is the case in many developing areas, then doing nothing for a control group would satisfy the declaration's principle.
Double-blind medical trials, in which half the subjects receive a placebo instead of the medication being tested, raise similar concerns. Commonplace in the United States, these trials take on new significance in developing societies in which the question arises of whether it is fair to deny treatment to people who would not have access to the medication otherwise. Additionally, the concept of a placebo might not be understandable or even acceptable in some cultures.
Informed consent is another potentially thorny area for investigators. The notion, more familiar to Americans, might not translate to other cultures, Dr. Cash says. "We are a society that believes the individual must be the only one making a decision affecting him or her," he explains. "But there are societies where the rights of the group are also considered very important. These are societies where the individuals who are part of a family unit don't act very autonomously. They are part of a collective, and that collective participates in these decisions."
Some women from other cultures might have problems getting permission from their spouses to participate in clinical trials, for example.
These issues have been the focus of growing media attention, especially in the wake of controversy surrounding AZT (zidovudine) trials in Africa, where researchers treated HIV-positive pregnant women with the drug to examine its ability to prevent the virus's transmission to unborn children. Hundreds of HIV-positive infants were born to the subjects who were given a placebo during the study. The trials were extensively covered in the lay press and medical journals alike, including a 1997 editorial in the New England Journal of Medicine criticizing the researchers and arguing that the use of a placebo in the above case was unethical.
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World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects "…In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society. "…Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. "…Research Investigators should be aware of the ethical, legal and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration." |
Implementing International Guidelines
When the AZT trials captured the media's attention, research ethics problems had already been on the radar screen of scientists from the developing world for decades, according to Marilia Coutinho, Ph.D., a Brazilian political scientist and biotechnology expert.
"From time to time, this subject has been brought to light," says Dr. Coutinho. "However, between being 'brought to light' and 'something being legally done,' there is a great distance."
Dr. Coutinho stresses that enforcing ethical guidelines in established democracies is very different from applying them in emerging democracies or non-democratic countries. "We have very young democracies in Latin America. We have even younger democracies in other parts of the developing world. And we have no democracy in all the rest," she explains. "This means that [in the non-democratic countries], no matter how long the scientific community is concerned with those matters, nothing will be done."
Dr. Lavery also worries that individual countries' political structures might affect the implementation of international research guidelines. "One of my particular interests is how the different socioeconomic and political circumstances in various countries relate to their ability to do ethical research or to apply ethical standards," he says. Applying international standards will be extremely difficult in countries with weak political, economic, and social structures, such as Afghanistan and Angola, he warns.
"There also are some countries that we typically think of as 'developing,' such as India and Brazil, which are emerging as strong research countries. But we still know very little about how the social, economic, and political conditions in these countries affect the application of international ethical standards. These are issues we are starting to examine in more detail," Dr. Lavery says.
Developing countries have a harder time keeping up with technological and scientific advances, which can lead to missed opportunities to advance local health issues, says FIC Director Gerald T. Keusch, M.D. The FIC announced a new research program last December that aims to reduce the disparities in health status between developed and developing countries through the use of genetic sciences. "We have been very concerned that this revolution in biology will only target the major diseases of the developed world, where products and approaches can be developed and sold and where populations will be able to afford them," he says.
"We're concerned that the genetic sciences in the developing world will not be supported and promoted, and that populations might end up exploited," he says, "unless research is conducted in the context of a strong ethical framework."
"The future of science in developing countries requires investments in information technology, the creation of a culture of research ethics, and investments in modern science," says Dr. Keusch. "International researchers must give priority to ethical, legal, and social issues, along with the technical and scientific aspects of their work."
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