UNESCO has undertake to draft a Declaration on Bioethics. "Since the 1970s, the field of bioethics has grown considerably. While it is true that bioethics today includes medical ethics issues, its originality lies in the fact that it goes much further than the various professional codes of ethics concerned. It entails reflection on societal changes and even on global balances brought about by scientific and technological developments. To the already difficult question posed by life sciences – How far can we go? – other queries must be added concerning the relationship between ethics, science and freedom."
The Director General has just published a report on progress to date in drafting the Declaration.
This blog has focused on Knowledge for Developmet. I support the expansion of scientific research for and in developing nations, and the building of capacity to do research and to utilize scientific and technological knowledge for development. There is reason for concern that in efforts to assure that research meets the highest ethical standards, there will be damage done to the scientific program. The issue with assuring the ethical conduct of research is always balancing the need to protect against the unethical against the need to conduct the research.
I am concerned that appropriate ethical safeguards be institutionalized in developing nations. This is important because it is right. But it is also important because there is nothing more dangerous to our efforts to strengthen research than to have unethical research practices discovered.
The State Department has the difficult job of representing the U.S. with its many divergent interests. The job is especially difficult when dealing with a complex subject such as bioethics. Certainly State should represent the scientific community, and the importance of doing research in developing nations. It should also represent the development community that wants to see capacity built in developing nations that will be used to combat poverty. It represents the environmental and public health communities that are worried about the threats to the biosphere created by unregulated research. State represents U.S. industry that wants its IPR protected, and it represents the animal welfare activists. Thus the State Department is faced with a double balancing act, seeking appropriate balance in the Declaration and appropriate balance in the factions it represents.
The draft Declaration
I am certainly not an expert on these matters. However, the draft Declaration looks problematical to me. Here are some personal comments.
What are the distinction made by philosophers between "human beings" and "human persons"? See, for example: Personhood Bibliography. One aspect of the distinction is that some would say that the rights of "human persons" do not apply to embryos and fetuses, while the rights of "human beings" do. Thus one aspect of the question is whether the Declaration applies to stem cell research, or indeed to research on human contraception.
A major problem with international medical research occurs when the needed conditions for the research occur in a country in which the population is unlikely to benefit from the research. Is the Declaration adequate to militate against such problems? Thus a lot of pharmaceutical testing is best done in places where the incidence and/or prevalence of the disease is high -- frequently poor countries. But often the populations in which the research is done will be too poor to buy the resulting drugs. How do you deal with the problem of peoples who will not benefit from the research bearing its risks?
I think of Carleton Gajdusek, who did his Nobel prize winning research on a brain disease, Kuru, studying a tribe of cannibals in New Guinea; that tribe will almost surely not benefit from the work, while the ultimate eventual beneficiaries of the work were likely to be Alzheimer's patients and potential victims of mad-cow disease in rich countries! Certainly there is an argument that research risks should be borne by the people who are likely to benefit from the research, but there is also an argument that research that may benefit millions should be done where it can done most easily and effectively. How does a Declaration deal with such complex issues?
Does the Declaration apply to human tissue? Laws in different countries differ on the legal requirements. I think some issues in this area are bioethical. Does a surgical patient have to provide informed consent before tissues removed during surgery are used in research? Who owns a tissue culture made using cells from a human subject? What rights does the subject have over the tissue culture.
There is a dispute about the ethical standards for treatment of DNA in efforts like the Human Genome project. The Declaration is not specific on the topic.
Another example: I think of bioethics in the context of science to include the ethical treatment of animals involved in the research. In the U.S. there are regulations on the housing of laboratory animals, on their treatment during the research (e.g. the use of anesthesia). There are in the U.S. different rules for the treatment of:
- livestock involved in veterinary research,The ethical treatment of animals is not addressed at all in the draft Declaration! A large number of Americans would not be satisfied with a Bioethics Declaration that did not deal with the ethical treatment of animals!
- laboratory animals, and
- wild animals involved in research done in the field.
Article 10 – Informed Consent: Questions of informed consent get very tricky in practice. In some African societies, one has to get the consent of village or tribal leaders (as "concerned persons") to the treatment of a human subject. In some countries, only fathers and not mothers are allowed to give consent for treatment of minors.
Article 23 – Transnational Practices: The declaration says, probably naively, "When research is carried out in one country and funded partially or wholly by sources from one or more other countries, such research should be subjected to ethical review in all of the countries involved." I agree. But, what do you do in practice when the reviews disagree? In many countries in which the U.S. might wish to fund research, there are not adequate institutional mechanisms to assure informed consent -- do we impose ours on societies in which they may not be ethically complete?
Article 2 – Scope: Adding social science to the mix adds questions to the mix. The Association of Internet Researchers, for example, has spent years working out a code of ethics for the field. I am not sure that most people would see that as bioethics, but it is typical of the ethical concerns that one faces when gathering social science data from human subjects.
Here their be landmines! Remember that the U.S. policy on State Department approval for international research was created when Project Camelot blew up. Research funded by the U.S. Government on "internal war potentials" in Chile and other countries was considered highly unethical by some parties in those countries!
I am not sure what is involved in Article 15. "Responsibility towards the Biosphere". This seems to open the entire issue of containment of recombinant organisms. Do we want a UNESCO declaration to do so? If so, should it not be more specific and complete?
How about the containment of human pathogens? Is this covered? If so, is the Declaration sufficiently specific? How about animal pathogens? Crop pathogens? How about invasive species? Radiation? Hazardous chemicals? These are all topics that have been extensively regulated, and which require major institutional investments in developing nations. Are the covered, and if so, should there be more specificity?
What about environmental impact statements? U.S. regulations exempt small agricultural experiments? Is this allowed under the Declaration? What does it mean when the US subscribes to a (non-binding) UNESCO Declaration that seems to contradict some aspect of US practice?
I was responsible for research on civil engineering work during my time with USAID – underground dams, water catchment technologies, etc. We did some careful environmental reviews of these projects, but one would not usually think of that as "bioethics". Does such research fall under the terms of the Declaration?
What about Article 14 – "Sharing of Benefits a) Benefits resulting from scientific research and its applications shall be shared with society as a whole and within the international community, in particular with developing countries."
What does this mean in terms of intellectual property rights? Does the Declaration affect the sale of off-patent drugs for AIDS in Africa?
Is the U.S. National Commmision on UNESCO or State's Bureau of International Organization Affairs competent to deal with these issues?
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