AIDS continues to be an epidemic killer in Africa. The antiviral drugs available today can extend the lives of people infected with HIV, but they are not a cure and they all have serious side effects. There is a great need for further research. New drugs and combinations of drugs are being tested around the world, including areas where the people are not familiar with Western traditions of medical research.
The use of placebos presents an ethical challenge even in the United States. If an established treatment is available for whatever disease is being researched, then it is ethically questionable to use placebos. The new treatment should be tested against the established treatment. When we see new drugs advertised in the United States, we tend to assume they're better than the older drugs. This is not necessarily true, since placebo testing is widely used for conditions that are not life-threatening.
When the disease is life-threatening, there are drugs that offer some benefit, and the research subjects have difficulty understanding what placebos are, then most of us would consider placebos unethical. But in some places, people with AIDS have no access to treatment other than joining a clinical trial. If the trial offers everyone a drug that is expected to benefit them, then the purpose of the trial becomes treatment rather than research for patients who have no other choice. Informed consent is supposed to be based on agreement with the research goals of the trial.
Informed consent is considered essential to ethical research in Western culture. In parts of Africa where large numbers of people are infected with HIV, it may be difficult to for researchers to provide adequate information. Some languages do not even have words for “research” or “science”, as distinct from medicine.
Signing a consent form is standard in Western culture. In some other cultures, signing papers is a tradition reserved for major events such as marriage. Another ethical challenge is illiteracy. When a test subject signs a form that he or she cannot read, it is difficult to know how much informed consent is being honored.
Autonomy is another challenge for research in non-Western cultures. African culture places more value on family and community based decision making, while Western researchers expect individuals to make their own decisions independently.
The reference article recommends the use of local counselors in medical research, as well as ongoing review of ethical issues.
Reference:
Mystakidou K et al, “Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries”, Journal of Social Aspects of HIV/AIDS 2009 September; 6(2): 46-57.
Linda Fugate is a scientist and writer in Austin, Texas. She has a Ph.D. in Physics and an M.S. in Macromolecular Science and Engineering. Her background includes academic and industrial research in materials science. She currently writes song lyrics and health articles.