Bioethics and genetic diversity from the perspective of UNESCO and non-governmental organizations

Journal: pp. 265-274 in Knoppers, BM. et al., eds, Human DNA: Law and Policy. International and Comparative Perspectives (The Hague: Kluwer Law International 1997).
Author: Darryl R. J. Macer
1. Introduction

Today I have the pleasure to be in the Isle of Montreal, in Canada, in Quebec, in Hochelaga. During the two days before this session there were some events which stimulated me to think further about this subject. None of the lessons were totally new, the ethical analysis has always been challenging, rather it was further awakening.

Where are your roots? I come from Japan, Nihon. It is my home. I have another home, New Zealand, Aotearoa. I wonder how many generations back your roots go back in the place you call home? In the so-called new World maybe many of you are new to your home too?

Initially the non-governmental organization (NGO) in my title was HUGO, but the ways of heaven are not always clear. The minute I arrived from Japan I was invited to join a Press Conference the following morning. Coincidentally, a fact unknown to the conference organizers or me, this week Montreal hosted the Second Meeting of the Subsidiary Body on Scientific, Technical and technological Advice to the Convention on Biological Diversity. How timely - for a session on human genome diversity to also be occurring here. I joined that Press Conference of NGOs on the Human Genome Project, and was welcomed to share whatever views I had. I was on that day the only supporter of the HGDP. Fate has it, that in this conference, I must also represent the other side of my thinking.

Several days ago I received a draft of an open letter protesting against the HGDP, and I made my comments positive and negative in what I saw in the letter. Actually the most significant disagreement I had with the letter, that indigenous persons had always been excluded from conferences and discussion of the HGDP was modified, as I protested that we at UNESCO had included persons and invited comments on the drafting of a report. I did not sign it, but brought copies of it here today to make sure everyone could see the concerns. Given the absence of the authors to present this, I will do my best to try to build harmony between the views of the UN and all NGOs, however big or small, from RAFI to HUGO.

Harmony is considered, in my home, Asia, to be one of the basic principles of bioethics. As some of you know, I innocently, or optimistically, believe that much of ethics and culture is universal. The important word is not so much universal, but universally diverse. The need to support diversity is well recognized in international law, but not always in ethics or practice.

In my abstract, I said that the work in drafting the UNESCO report gave me the privilege to meet and contact sincere individuals on both sides of the debate. I would like to modify that, to say sincere friends. Friendship, I believe comes from what I consider to be the first principle of bioethics - love. Love includes all the traditional bioethics principles, autonomy, justice, do no harm, and try to do good. Friendship is a relationship, and relationships are another language of bioethics. For my analytic friends I should reassure them, that I do tend to spend most of my time working on ethical approaches to measure this diversity. However, I do tend to simply my language and vocabulary to words that may seem to familiar.

We need to think of the events of this week, and ask what makes people so upset? I understand the original reasons for not including a formal presentation from one group of people, so-called indigenous groups. This debate also occurred inside our UNESCO Bioethics Committee report. Diversity allows me to differ. There are a few thousand population groups in the world, only some members of these are active as indigenous people's groups. My earlier question to you could be reworded, "how many generations link you to your home?", it is related to the definition of who is indigenous? How many generations does it take? The question actually may not seem to be so important, however in ethics I think the concerns that someone has, and the respect for people, mean that we need to consider and answer all fears that people have. Minority groups can have real reason to be more afraid of abuses than those of a majority. The alleged abuses of genetics that they raise are relevant to us all, as they raise questions of how the knowledge will be used as well as how the research will be conducted.

Current population genetics research is under the oversight of different layers of control which vary widely around the world. This oversight ranges from the discretion of individual researchers, consent from the persons who provide the tissue samples, consent from the groups being studies, to several layers of ethical committee. International regulations on research involving human subjects are clear that informed consent is needed. Some funding agencies demand ethical review, such as NIH-funded research in the USA. Some universities in the world also demand ethical review, and the trend is to have more review. There have been some abuses under this current system of control, and a call is made for including other representatives in the oversight, especially members of communities. The spirit of friendship is one which should be added to that of professional ethical conduct in decisions about involvement in research.

Some of the ethical issues of population genetics research need to be further addressed include: Consent from individuals; Consent from population groups; How to obtain free and informed consent; Selection and participation; Use of the knowledge gained; Return of benefits to participants; Clash of world-views; Does the right not to know apply to communities?; Who speaks for a community?; Ownership of genes and derived knowledge; Public understanding and racism or eugenics; Stigmatization and genetic reductionism; International oversight of anthropologists & geneticists.

2. The UNESCO International Bioethics Committee Report

Given the transnational nature of population genetics studies, the issues raised were the subject of a study by the UNESCO International Bioethics Committee. The report has been available on the Internet since completion in November 1995 (1). Key points of the UNESCO report were:

1. no endorsement of a particular population genetic project;

2. call for establishment of a separate ethical committee that is available to all population genetics researchers;

3. discussion of variety of ethical, ethnic and social issues.

There are many issues of population genetics research that were raised in general in the report that apply to the whole of genetics research. One of the issues is commercialization and use of the results of the collected DNA and cells. This controversial issue is discussed in the report, to the extent that it should be addressed by those involved in the collecting of samples and be part of the consent and cooperation agreements. The resolution of biotechnology patents and "genetic prospecting" was not a subject for the subcommittee to resolve, but we urged the clarification of this issue by a global body.

Financial returns are not the only form of benefits of research results which could be returned to subjects of research. The feedback of results to the communities concerned should also help to foster a greater sense of community identity in the face of aggressive cultural imperialism by industrial superpowers. But perhaps the most poignant problems of many populations involved in population genetics research is in the realm of public health. The provision of health and medical care, however, should be appropriate to the cultural and social context of the community and should be sustained. In this, the principles of primary health care as contained in the Alma-Ata Declaration (WHO/UNICEF) of 1978 should serve as a good set of guidelines to follow.

At the community level, the health data could be utilized for the improvement of local community health. Thus, benefits should also flow back to the groups and communities in the form of contributing to the formulation and implementation of local and national health care policies that would enable communities to better their positions. Commercial benefits could be expressed in other ways. While there could also be provision for a one-time gift of cells or blood with no conditions, as is found in some tissue donation forms for blood and body tissues, can one individual sign away commercial rewards to future research knowledge for the population to which they belong? It may be technically possible to conduct population genetics research among students of an international university, with them giving their cells to science, and whether they like it or not, they represent their population.

Genetic screening and genetic testing have been discussed in another report of the UNESCO International Bioethics Committee, and by numerous other persons and organizations over the last twenty years (2). Many of the issues in current genetic screening programs are relevant to population genetics research, but some significant issues are different, such as the notion of group consent (as discussed by H. Greely in the North American Protocol of the HGDP). Moreover, while at present we are focusing on research we should also foresee the applications and benefits flowing from the human genome project that could well apply to whole populations. Therefore the ethical considerations must be carefully treated, since whole groups of asymptomatic individuals are the targets rather than single individuals who come forward themselves.

The application of the ethical principle of informed consent and respect for integrity is a complex process at the level of populations. In order to ensure that that potential subjects understand the goals of research, the risks involved, the use to which research results could be put, and the rights of the groups and individuals under study, careful consideration is needed. The lines between genetic testing of individuals, genetic screening within one's own population, and population genetics research of other populations and groups, are not always clear. We do not ethically require group consent for most genetic testing, though society may draw the line at the freedom of choice to use genetic probes for non-therapeutic purposes (e.g. sex selection is banned in several countries, and would be banned under the European Convention on Bioethics). The fact that some recent population genetic studies may involve investigation of several hundred genes between single individual representatives of different populations makes the question of group consent extremely difficult.

There are various levels at which consent may need to be obtained for studies of population groups. High level governmental approval is in many countries mandatory for studies on specific populations of persons. Such official clearances need in every instance to be complimented by consent from the individuals and the local groups/communities selected for study - whether the consent is obtained directly or through formal/informal leadership, group representatives, or trusted intermediaries.

It is important to identify the most appropriate persons with whom to communicate, the persons from whom clearance should be obtained, and the appropriate content and media of communication. For example the media of communication via protests is not ideal, and both parties need to be in dialogue. Research will need to take account of the group's social organization, goals and aspirations, cultural values, and laws (both statutory and customary). If the research methods involve the use of saliva, skin, hair, or blood samples it is necessary to ensure that the collection of these body samples does not violate cultural norms and concepts relating to the human body and its functions (1).

The ways of approaching the communities must always take account of the particular social and cultural organization and laws. Sometimes the leader or the individual chief of a family or familial group is the person who gives consent for the other members of the community to participate in the inquiries and biological sampling. These persons may be difficult to identify. Of course the most difficult group consent question is who can give group consent for the genome project itself - a question that no one has been able to answer (3).

Various groups of indigenous peoples have expressed their irritation with past population genetics research which they claim has been conducted without prior consultation and in a way where consent was obtained in terms inconsistent with their cultural norms. Practitioners of contemporary science do not always understand that the goals and aspirations of scientific projects may not always coincide with the goals and aspirations of particular cultures. It may not be ethically acceptable to some people to cooperate in the collection of samples for the purpose of storage and the establishment of "transformed cell lines", samples which would be basically identical to the individual of origin which are then made available for study to scientists around the world. Therefore many representatives of indigenous peoples have expressed strong concerns about the HGDP.

The planners of the HGDP got off to a bad start with misunderstandings and fears widely expressed among indigenous peoples. Because the HGDP was planning to collect blood samples some groups called the HGDP the "Vampire project" (4), while other groups were angry because they believed that they were possible target populations even though no community representatives had been contacted about the Project. The Mataatua Declaration on Cultural and Intellectual Property Rights of Indigenous Peoples of June 1993 (5) called for a halt to the HGDP until its impact has been discussed. Article 3.5. of the Declaration calls "for an immediate halt to the on-going 'Human Genome Diversity Project' (HUGO) until its moral, ethical, socio-economic, physical and political implications have been thoroughly discussed, understood and approved by indigenous peoples". The Declaration is actually not anti-science, and includes a call for involvement in scientific research, recommendation 2.11, "Ensure current scientific environmental research is strengthened by increasing the knowledge of indigenous communities and of customary environmental knowledge".

In fact the HGDP included all populations, not only indigenous populations. Since that time, the HGDP goals have shifted somewhat, but there has been a series of Declarations directed against this project (6). The HUGO HGDP Summary Document includes ethical guidelines which do address the question of participation, consent, and commercialization (7). Nevertheless, the controversy continues. In February, 1995, a forum of Indigenous Peoples in Asia (ARCW) issued a statement to the European Parliament in which they strongly opposed the HGDP and called for it to be stopped. The Beijing Declaration of Indigenous Women formulated at the United Nations Fourth World Conference on Women (30 August - 8 September 1995) demanded "that the Human Genetic Diversity Project be condemned and stopped" and that their "intellectual community rights" be recognized.

The open letter that was circulated against this conference included four demands or requests of scientists. The first was a moratorium on the HGDP and population genetics... Unfortunately it is beyond the control of any group to stop population geneticists who do not want to abide by ethics, although international pressure can help ensure that practice is not so distant from international norms of ethics and consent. The second was that researchers should investigate the samples that they have and show whether it was obtained with informed consent. This seems a worthy fact to reveal, and documenting this would provide some fresh data into the alleged abuses of the past. The third demand was that those samples that did not show evidence of being gathered with consent be destroyed. Already the accounts of many scientists suggest there are many samples in this category, especially those taken in past decades when consent was only vaguely recognized, if at all. Whether they should be destroyed is a question of analysis, but it is not without precedent, and one could at least place restrictions on the input of data into a global database should that be formed. The fourth request was against sharing of data from scientists with commercial or military researchers. The suspicions raised about past sharing of data make this another concern of research and documentation. The cases of data sharing need to be recorded and documented, and I suggest a database be established of what has been done in the past - it seems ethically more urgent that the database of cell lines.

DNA collected from population groups would present analogous problems relating to the adequate protection of privacy (8); but the meaning of privacy could vary across cultures. Furthermore, it is important to note that in population genetics research confidentiality issues have to be considered at the community level as well as at the individual level. The past examples would shed light on the likely future uses.

An issue which was dismissed by an editorial in Nature (9), is eugenics and racism. Although there is scientific evidence to suggest that there will be little population genetic diversity found that is unique to one particular group, there is also a logical possibility that there may be distinct genetic features that make one genetic group distinct from others. The fact is that, while eugenics (cf. Galton) was founded on racism, eugenics today does not have to be linked with racism (10). Those who continue to link their eugenics with racism will not be dissuaded by scientific evidence, since racism is an attitude of mind, or prejudice. People who tenaciously hold to such prejudices are usually not susceptible to the voice of pure reason and may even misappropriate scientific data to "prove" the truth of their own prejudices.

One of the fundamental points of opposition of indigenous groups towards genetic studies of human history is that the results may contradict indigenous people's views of oral and traditional history, and the meaning of genes and genealogy. For example, Maori people have two words to describe the human gene, one meaning "life spirit of mortals (Iratangata)and the other genealogy (Whakapapa), which connects Maori with themselves and others (6). The gene and genome are not the property of individuals but rather are part of the heritage of families, communities, tribes and entire indigenous nations. In this regard the UNESCO position on the human genome being part of the common human heritage is more compatible with the views of indigenous persons, than the view supporting patents on genes.

The UNESCO report did not endorse any particular population genetic project, but this is not a critique of the HGDP. It was rather our personal view that the role given to us by UNESCO could better be served, as could science, by the establishment of a separate ethical committee that is available to all population genetics researchers. Rather than being exclusively linked with one particular project and focusing attention solely on it, we want a wider selection of scientists to feel able to seek an international ethical committee, and we invited scientists to contact us (11). Several have, but the progress towards such a committee is currently in limbo.

In the UNESCO Declaration on the protection of the Human Genome and Human Rights there is a paragraph in the preamble also discussing diversity, "Bearing in mind also the United Nations Convention on Biological Diversity of 2 June 1992 and emphasizing in that connection that the recognition of the biological diversity of humanity should not give rise to any interpretation of a social or political nature which could call into question the fundamental principle of equal dignity inherent in all members of the human family, ". The role of the UN organizations is to be consistent to work for the dignity of humankind.

3. HUGO Code of Ethics

The Human Genome Organization (HUGO) Ethics Committee has endorsed a Code of Ethics for genetic sampling, based on a report prepared by BM. Knoppers, M. Hirtle, S. Lormeau, which is later in the book. It stresses similar issues to those raised by the UNESCO subcommittee. It starts from the same principles: Recognition that the human genome is part of the common heritage of humanity; Adherence to international norms of human rights; Respect for the values, traditions, culture, and integrity of participants; and acceptance and upholding of human dignity and freedom.

The HUGO - ELSI Committee Code of Ethics was endorsed by HUGO in March 1996. It recommends principles for genetics research based on: scientific competence, understandable communication (two way), consultation with participants, free and informed consent, respect the choices of those involved, confidentiality, international collaboration, avoid conflict of interest, undue inducement through compensation, and continual review of the research.

There are other non-governmental studies of population genetics underway, and especially of the HGDP. These include a study still being made by the US National Academy of Sciences, and work of the UNDP on indigenous populations.

4. Conclusions

International research projects raise the issue of how universal bioethics are, and whether different standards can be applied to different population groups and peoples. Results of an International Bioethics Survey conducted in more than a dozen countries since 1993 suggest the same diversity of opinions on issues raised by genetics is found inside each society (12).

There are two ways to think of the term "bioethics" (13), one is as descriptive bioethics - the way people view life and their moral interactions and responsibilities with living organisms in life. The other is prescriptive bioethics - to tell others what is good or bad, what principles are most important; or to say something/someone has rights and therefore others have duties to them. Both these concepts have much older roots, which we can trace in religions and cultural patterns that may share some universal ideals. If this descriptive bioethics study is correct, then the work of prescriptive bioethics in providing universal guidelines can proceed with more confidence.

While all admit the function of the United Nations system is to protect the Universal Human Rights of all persons, another function of international organizations may be to foster studies into how to best protect the interests of different groups, which can best be done after finding out what their interests are. We need to ask whether, if in the same way that our genetic diversity suggests the word "race" is inappropriate, our ethical and cultural diversity also does? The data suggests the answer is yes although our prejudices may deny this.

It is ethically and scientifically desirable to have regulatory oversight of research involving sampling of human populations, meaning a certain degree of scientific and ethical review prior to acceptance of a research protocol, once accepted, ongoing monitoring and surveillance usually are not assured. Can there be sanctions? Disciplinary measures including for example, suspension, withdrawal of privilege and fines, constitute the usual avenue of professional measures. In addition, where research subjects have been harmed, civil and criminal sanctions are also possible. Funding bodies may withdraw funds and sometimes even retroactively. If researchers are to become more accountable and actual practices more transparent, other forms of sanctions or at least of publicity, should be envisaged. Stricter, standardized reporting requirements, on a regular basis and publication of such reports are one such avenue. The UNESCO committee considered the latter to be a basic ethical obligation that should be universally applied.

If researchers are to be subject to greater scrutiny, the same holds true for the media whose duty of honest, scientific reporting and preservation of privacy needs to be underscored. Whole populations, communities and the researchers themselves have often been wrongly depicted and wrongly represented with the resulting unjust labeling and discrimination. Such practices only serve to undermine public confidence and participation in research.

Population genetics is not simply a multiplication of the individual ethical and legal issues already raised by genetic research. There are different concerns and traditions in each group under study, and even among individuals within any group. The degree of information, consultation and cooperation must reflect such differences in participants. Likewise, the role and responsibilities of the researchers and of the local and national authorities, as well as the societal implications, will differ. For the future we need consultation with populations; individual and group consent mechanisms; ongoing ethical review; inclusion of representatives of populations in decision-making; communication, education, benefits, and feedback strategies at the population level; confidential data and sample banking; continual scientific review and monitoring; and appropriate sanctions. We also need to start gathering systematically the examples of use and abuse of DNA and cell sampling, to give us the necessary knowledge to better predict the future. Above all we need to have anthropologists and scientists who seek ethical sampling.

6. References

1. Chee, H.L., El-Hamamsi, L., Fleming, J., Fujiki, N., Keyeux, G., Knoppers, B.M. and Macer, D., "Bioethics and human population genetics research", Report of the UNESCO International Bioethics Committee Third Session, 1995, from the subcommittee on bioethics and population genetics <">..

2. Recent reviews include: Chadwick, R. et al., Ethical implications of human genome analysis for clinical practice in medical genetics with special reference to genetic counseling (Centre for Applied Ethics: Cardiff, 1993); McCarrick, P.M. "Genetic testing and genetic screening", Kennedy Institute of Ethics Journal 3: 333-54 (1993); Murray, T.H., "Genetics and Just Health Care: A Genome Task Force Report", Kennedy Institute of Ethics Journal 3: 327-31 (1993); Nuffield Council on Bioethics,Genetic Screening: Ethical Issues (Nuffield Council: London, 1993); Nielson, L. & Nespor, S., Genetic Tests, Screening and Use of Genetic Data by Public Authorities in Criminal Justice, Social Security and Alein and Foreigners Acts, (The Danish Center for Human Rights, 1994).

3. Macer, D., "Whose Genome Project?", Bioethics 5: 183-211 (1991).

4. Lock, M., "Interrogating the human diversity genome project", Social Science & Medicine 39: 603-6 (1994).

5. Mataatua Declaration on Cultural and Intellectual Property Rights of Indigenous Peoples of June 1993 [From the First International Conference on the Cultural and Intellectual Property Rights of Indigenous Peoples, 12-18 June, 1993, Whakatane, Aotearoa (New Zealand).

6. Mead, A. "Genealogy, sacredness, and the commodities market", Cultural Survival Quarterly (Summer 1996), 46-53. Declarations against the HGDP include: Karioca Declaration (June, 1992, Brazil); Mataatua Declaration (June, 1983, Aotearoa New Zealand); UN-Working Group on Indigenous Populations, 10th Session (July, 1993, Geneva); Maori Congress (1993, Aotearoa New Zealand); National Congress of American Indians (3 December, 1993, Resolution NV-93-118); Maori Congress Indigenous Peoples Roundtable (June 1994); Guaymi General Congress (1994, Panama); Geneva IPR Workshop (August, 1994); Latin & South American Consultation on Indigenous Peoples Knowledge, Santa Cruz de la Sierra, Bolivia (September, 1994); Asian Consultation on the Protection and Conservation of Indigenous Peoples Knowledge, Sabbah, malaysia (February 1995), Pan American Health Organisation Resolution (15 April, 1995); Pacific Consultation on the Protection and Conservation of Indigenous Peoples Knowledge, Suva Statement (May, 1995).

7. HGD Committee of HUGO, The Human Genome Diversity (HGD) Project. Summary Document, 1994.

8. Annas, G.J., "Privacy rules for DNA databanks. Protecting coded 'future diaries'", JAMA 270: 2346-50 . (1993); see also JAMA 267: 2158 (1992).

9. Nature 377: 372-3(1995).

10. Macer, D.R.J., Shaping Genes: Ethics, Law and Science of Using Genetic Technology in Medicine and Agriculture (Eubios Ethics Institute, 1990) <">.

11.Macer, D. Fleming, J. Keyeux, G. & Knoppers, B.M. "Unesco and population genetics", Nature 379: 11 (1996).

12.Macer, D.R.J. Bioethics for the People by the People (Eubios Ethics Institute, 1994) <">.

13. Macer, D., "Bioethics: Descriptive or Prescriptive?", Eubios Journal of Asian and International Bioethics 5: 144-6 (1995).

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