Ethics in Biomedical Research: Practical Considerations

Arri Eisen and Roberta M. Berry (2002) emphasize the need and the importance of introducing courses on ethics not only to undergraduate or graduate students but to biological researchers at all levels. They point out that modern biotechnological research is heavily funded by taxpayers' money, is often directed toward lucrative industrial applications, and ventures into relatively unknown and unforeseen areas of human reproduction or other cellular biology that has the potential to directly impact ethical behavior. As a teacher in microbiology of medical and graduate students and a biomedical researcher trying to develop anticancer agents from microbial sources with potential clinical applications, I am all too familiar with ethical considerations related to engaging students in future money-making ventures, the use of large numbers of animals for introducing tumors and later testing our products on tumor regression (in the process causing a good deal of pain, suffering, and ultimate death to such animals), as well as the wisdom of conducting research based not on what's good for humanity but on what's fundable. I would like to invite readers to consider the following dilemmas that confront biomedical researchers on the question of ethics in research.

What will be the norms of ethics given the fact that most research institutions have a multiethnic, multicultural mix of researchers? Students and postdoctoral fellows from certain countries have learned that it is neither ethical nor legal to subject certain prisoners to capital punishment —something that is ethically and legally accepted in the United States. Researchers from certain countries might be used to the fact that it's perfectly ethical to cut off the hands of thieves, or to subject people to flogging or even death by stoning for particular crimes—punishments that most in the United States do not accept as ethical. The concept of ethics is regional, as are the laws in individual countries. Given the international scope of scientific research, it's not going to be easy to say which research is ethical and which is not.

Who decides what kind of research is ethical? It is well known that in Western developed countries, we conduct medical research based on the needs of our own people, particularly the needs of those who can pay for it. We do not conduct research, or do so minimally, for diseases rampant in poor tropical countries in Africa or Asia. Is it ethical to use our intellect and resources only for the benefit of ourselves and particularly for those of us who can pay for it?

As we know very well, the direction of biomedical research is unpredictable. There is great political controversy about whether therapeutic cloning of human embryos for generating pluripotent embryonic stem cells should be permitted in the United States, even though such technology might provide major relief to patients suffering from degenerative tissues or requiring organ transplantation. A major advantage of embryonic stem cell technology is that patients can provide their own nucleus for somatic cell nuclear transfer, thus minimizing rejection of the stem cells or the transplanted organ. A limiting factor might be the unavailability of the millions of eggs needed for the production of embryos from which stem cells can be extracted and used to benefit the millions of patients suffering from diabetes, Alzheimer's, Parkinson's and other diseases. Since human eggs, as opposed to kidneys or even blood, are disposable, an international market for getting such eggs from poor women in Third World countries will likely develop. Is it ethical to help develop international trading in disposable human tissues? Conversely, should poor women be deprived of the right to earn a livelihood by selling disposable parts of their bodies? Why should healthy politicians, religious people, and their supporters deny what sick and dying people might need for treatment?

Finally, there is the question of patenting life-forms, including human genes, cells, and organs. European patents have a public interest...