Do the ethical duties of donor, and administrators, depend on whether the database is public or private?


pp. 311-21 in Knoppers, B.M. ed., Populations and Genetics: Legal Socio-Ethical Perspectives (Kluwer Legal International 2003).
Author: Darryl R. J. Macer

Institute of Biological Sciences, University of Tsukuba,
Tsukuba Science City 305-8572, Japan
Fax: Int+81-298-53-6614
Email: Macer@sakura.cc.tsukuba.ac.jp
Director, Eubios Ethics Institute <http://eubios.info/index.html>



Our duty to contribute to advancement of knowledge
Confucius said that "to love a thing means wanting it to live" (1).1 The ethical principle of beneficence, which we could say means loving good, requires us to develop ways to help others in the world. One of these ways to help others is science and technology. Human beings have a right to exercise their mind and ingenuity to create alternative solutions to problems that they see to be important. As long as this creativity does not harm someone else, this right to think and then apply this thinking to innovations, is recognized on this planet as a fundamental human right. The human genome project itself is helping to find medicine, however some applications raise moral concerns. Although most of these were present in medical genetics before, modern medical genetics is going to touch everyone's life. What are the responsibilities of different sectors in society, such as patients, the general public, scientists, nurses, doctors, etc., to these challenges?
There is no person on the planet earth who does not benefit in some way from the advancement of technology by their forefathers, and most from the contributions of technology made through the global endeavor known as science. The pursuit of science has been a universally agreed goal, as explained in the UNESCO Charter. Despite the problems which technology has brought, there are inarguably benefits to all from the development of science, and knowledge. Considering the demands of solidarity to humankind (2)2, and to the heritage of life in general, we could argue that there is a duty upon all persons to contribute to the development of knowledge that will be used for the good of others.
Philosophers may debate the extent to which this duty is a moral obligation, however, if I, a member of society benefits from the actions of others, I also have a duty to contribute to the benefit of others. We could call this the biological ethical principle of altruistic goodwill, and it is a pre-human concept developed through evolution. It can be argued to be a forerunner to the underlying ethical principle of love (3).3 We have a moral duty to love others.
While all may agree that to love others and work for the good of all is desirable, there may still be some who disagree that the advancement of knowledge is a benefit for all. There are some who disagree that science contributes to improving the quality of life. There may be more who consider that the harms of scientific technology outweigh the benefits, and if someone held this view we should never impose an obligation to contribute to the advancement of all. As J.S. Mill wrote the only case where a person's liberty can be prevented is when they will harm others (4).4

Duties to contribute to genetic databases
We can also ask whether a citizen has some ethical duty to donate a sample to a database if that data will be used for the improvement of the health services to which they have enjoyed benefits from? This could apply to both private and public health care systems. The answer depends on whether genetic databases will do good, or more exactly, do more good than harm. There have been a range of questions asked for databases that involve large populations, such as the one in Iceland (5).5
The scientific logic of having databases for genetic mutations, and eventually for every gene we know, is clear. It speeds up the progress of research to organize, and the human mind is familiar to organizing data of many types. The genome project and genetic data has proven how genetic databases can aid research and diagnosis for not only medical genetics but other areas like public health. There have been concerns expressed however about ethical issues of genetic databases, including protection of privacy, and benefit sharing.
We could ask whether donors should be offered some discount in the fees for entry to the health system, or a priority in receiving services, as is seen in some countries for blood donors. Do these duties also apply to the family, and for how long? If a donor will receive returns from a database, then it may not mater to them whether it is private or public. However, if we assume that more knowledge is shared openly for scientists, and thus more science is benefited from databases that are freely accessible, there may be greater duty to contribute to open databases. It may not be of direct concern whether the database is public or private if the data will be openly available for all researchers, however, few private databases are openly available to all.
If a particular database will guarantee greater protection to everyone from the risks of the genetic knowledge being misused, either for the person who donates, their family line (which could also be considered as a donor), for everyone who shares a genetic mutation in the same point at one of the donor's 30,000 plus genes, or for the unrelated community in general, then the average person would want to donate their genetic sample to that database, rather than to a database which does not protect these so well. In some cases, if we believed that open data transfer would be detrimental, because the data could easily reach the hands of those who misuse science, we may decide to donate data to a less open database. This conclusion is the opposite of the previous paragraph, and depends on the way that the data is administered after collection.

Duties of database administrators
Genetic databases are being formed in all countries that conduct genetic research. Both public and private databases exist, and we can ask whether the ethical duties of administrators of these databases differ depending on the type. Some genetics research is conducted by local researchers, while other research by outsiders, such as foreign academic collaborators and multinational companies. This raises fundamental questions about whether the standards used for protection of the ethical, social and legal aspects in entry, storage, and retrieval of data from a database should be universal or local.
In the 1996 Statement On The Principled Conduct Of Genetics Research the HUGO Ethics Committee considered some concerns of genetic research. The four principles used can be repeated here as being relevant to the ethical responsibilities that researchers have in conducting genetics research and practice, namely:
- 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 administrators may wish to share the responsibility for ongoing ethical dilemmas with a group including donors of the material. At least an ethics committee should be required for not only the gathering of samples, but the ongoing issues on access to and use of samples. The HapMap project involves creating a community advisory board in each area, which will be available for ongoing consultation after the samples have been collected and used for research.

Ethical duties and culture
Bioethics considers the ethical issues raised in biology and medicine, and especially those raised by human activity in society and the environment using biotechnology. Bioethics is the process of reflection over ethical issues raised in our relationships with other living organisms; the consideration of the ethical issues in spheres including environmental ethics, health care ethics, social ethics, and in the use of technologies that affect life; and the love of life. These issues are found in all cultures, and a diversity of policy responses has been made in different countries at different times. If we consider that bioethics is love of life, then it is not surprising that the moral issues associated with genetics have been discussed in many cultures over time. It is into that heritage we can consider the above issues.
There are different ways to view bioethics and in discussions of bioethics we should be clear which approach we are addressing. These include:
Descriptive bioethics, which attempts to understand the way people view life, their ethical interactions and responsibilities with living organisms in their life.
Prescriptive bioethics or normative bioethics examines what is ethically good or bad, or what principles are most important in making such decisions. It may also be to inquire into when to say something or someone has rights, and others have duties to them.
In every society there are people who want to use new genetic techniques and those who do not. However, the policies on protection of genetic privacy and use of data from databases see differences between the groups of countries that actively encourage experimental use of data and those which emphasize privacy of participants. We can also ask how public perceptions are related to the policy imposed by governments upon scientists. When one person tells another what is ethically good or bad they are prescribing bioethics.
There are at least two essential approaches to bioethics, as outlined in the Eubios Declaration on Bioethics (2002) (6)6:
Interactive bioethics is discussion and debate between people, groups within society, and communities about descriptive and prescriptive bioethics.
Practical bioethics is action to make the world more bioethical, for example, health projects for medically deprived populations, and environmental activism.
Do the cultural differences mean different answers at practical and theoretical levels? The findings of numerous opinion surveys and interviews among persons in different cultures let us see how concepts such as autonomy, justice, beneficence and do no harm, are used in making decisions when faced with moral dilemmas. Some earlier surveys I have conducted suggest countries in Asia have greater enthusiasm for certain techniques, and different concerns about privacy of genetic data (7).7 However perhaps the inter-cultural differences are less than the diversity we see within a society.
Internationally the UNESCO "Universal Declaration on the Human Genome and Human Rights" (8),8 developed by the UNESCO International Bioethics Committee (IBC) (1993-1997), and unanimously approved by UNESCO in mid-November, 1997, provides the following useful general advice in some articles:
7. Genetic data associated with an identifiable person and stored or processed for the purposes of research or any other purpose must be held confidential in the conditions set by law.
10. No research or research applications concerning the human genome, in particular in the fields of biology, genetics and medicine, should prevail over respect for the human rights, fundamental freedoms and human dignity of individuals or, where applicable, of groups of people.
12.a) Benefits from advances in biology, genetics and medicine, concerning the human genome, shall be made available to all, with due regard for the dignity and human rights of each individual.
b) Freedom of research, which is necessary for the progress of knowledge, is part of freedom of thought. The applications of research, including applications in biology, genetics and medicine, concerning the human genome, shall seek to offer relief from suffering and improve the health of individuals and humankind as a whole.
13. The responsibilities inherent in the activities of researchers, including meticulousness, caution, intellectual honesty and integrity in carrying out their research as well as in the presentation and utilization of their findings, should be the subject of particular attention in the framework of research on the human genome, because of its ethical and social implications. Public and private science policy-makers also have particular responsibilities in this respect.
HUGO Ethics Committee has also released a series of statements, some of which provide advice to scientists involved in databases, and will release a Statement in 2003 specifically on genetic databases. The statements to date on the issue include: Statement on the Principled Conduct of Genetics Research (March 1996), Statement on DNA Sampling: Control and Access (March 1998), Statement on Benefit Sharing (April 2000). (9)9
In the Statement on DNA Sampling: Control and Access, we see the paragraph:
"The choices offered in the consent process should reflect the potential uses of the DNA sample and its information. It is important to indicate whether the sample and its information will: identify the person, code the identity, or anonymize the identity so that the person cannot be traced although some demographic and clinical data may be provided. Even if anonymization is appropriate in certain circumstances in research, caution should be exercised in any irreversible stripping of identifiers from the samples since it may preclude valuable uses of the samples and validation of results.",
"Security mechanisms must be put into place to ensure the respect of the choices made and of the desired level of confidentiality.",
"International standardization of the ethical requirements for the control and access of DNA samples and information is essential.",
"Routine samples, obtained during medical care and stored, may be used for research if: there is general notification of such a policy, the patient has not objected, and the sample to be used by the researcher has been coded or anonymized. Routine samples obtained during medical care and stored before such notification of such a policy may be used for research if the sample has been anonymized prior to use.
Research samples obtained with consent and stored may be used for other research if; there is general notification of such a policy, the participant has not yet objected, and the sample to be used by the researcher has been coded or anonymized. For the use of research samples obtained before notification of a policy, these samples may be used for other research if the sample has been coded or anonymized prior to use.
Special considerations should be made for access by immediate relatives. Where there is a high risk of having or transmitting a serious disorder and prevention or treatment is available, immediate relatives should have access to stored DNA for the purpose of learning their own status. These exceptional circumstances should be made generally known at both the institutional level and in the research relationship.
In the absence of need for access by immediate relatives, stored samples may be destroyed at the specific request of the person. Such destruction is not possible for samples already provided to other researchers or if already entered into a research protocol or used for diagnostic purposes. By their very nature, anonymized samples cannot be withdrawn or destroyed.
Unless authorized by law, there should be no disclosure to institutional third parties of participation in research, nor of research results identifying individuals or families. Like other medical information, there should be no disclosure of genetic information without appropriate consent. "
Regarding benefit sharing, the HUGO Statement on Benefit Sharing (April 2000) recommends:
"1) that all humanity share in, and have access to, the benefits of genetic research.
2) that benefits not be limited to those individuals who participated in such research.
3) that there be prior discussion with groups or communities on the issue of benefit-sharing.
4) that even in the absence of profits, immediate health benefits as determined by community needs could be provided.
5) that at a minimum, all research participants should receive information about general research outcomes and an indication of appreciation.
6) that profit-making entities dedicate a percentage (e.g., 1-3%) of their annual net profit to healthcare infrastructure and/or to humanitarian efforts."

Should genetic databases in different countries have different regulations?
Genetic databases are being formed in all countries that conduct genetic research. There are already a number of genetic databases in Asia, and we can expect exponential growth. Some of these databases are made based on comparing ethnic groups. Some of this research is conducted by local researchers, while other research by outsiders, such as foreign academic collaborators and multinational companies.
The findings of numerous opinion surveys and interviews among persons in different cultures let us see how concepts such as autonomy, justice, beneficence and do no harm, are used in making decisions when faced with moral dilemmas. Some earlier surveys I have conducted suggest countries in Asia have greater enthusiasm for certain techniques, and different concerns about privacy of genetic data. While in all countries there is a positive view of science and technology, and it is perceived as increasing the quality of life by the majority in all countries, when people are asked about the benefits and risks of specific developments of technology, both benefits and risks are cited by many respondents (10-11). 10,11 People do not have a simplistic view of science and technology, and can often perceive both benefits and risks (12).12 Various moral arguments are given. This is despite the range of media programs and films produced on these topics, which have influenced people's thoughts. When specific details of an application are given there is generally greater acceptance, suggesting people have some discretion. This balancing of good and harm is one indicator of the bioethical maturity of a society.
The practice of medicine also raises cultural issues, which are not always apparent in opinion surveys. Rather than the single patient, a family decision is made in disease prognosis and treatment decisions. The issue of familial shame and risk arise, which may mean the right not to know may be treated more as a family than merely an individual. A fundamental issue is that there are differences in the extent of truth telling in medicine between countries of the world in different times. Informed consent is being introduced in Asia, and can be expected to be the way for the 21st century in the information age.
The level of knowledge about genetics is also important. Asia lags behind North America in the inclusion of genetics in medical school and training varies widely. Even medical practitioners may be poorly informed about genetics, so they may not provide adequate counseling about genetics questions. There may not be well coordinated or central data-collecting for checks on accuracy
There are several arguments for local standards. Cultural norms differ between societies, which may include the concept of the family structure, who one would like to share genetic data with, and privacy ideas (13).13 Local regulations may enable better community involvement and participation in provision of samples in countries where the export of genetic data is sensitive for national sovereignty. Such concerns have been expressed in legal regulations in India and China, and in social acceptance in Japan. Of course in some cases there may be greater trust in international regulatory authorities than in national authorities, as found for biotechnology in general (14).14
Local regulations may mean better involvement of the local medical staff and researchers with the persons giving the samples, and in the consideration of ethical issues, because the researchers were directly involved in making the regulations. There is legal diversity in different countries. There could be more immediate response to local issues, such as media events, changes in social stigma and discrimination that communities may face.
There is still debate over the extent of anonymization of data and the duty to feedback medically useful knowledge to donors of material. There could be abuses in certain communities if local regulations where the only means of protecting data. International regulations would provide more protection in some cases, especially for countries which do not have their own regulatory system. There may also need to be an international system as genetic databases are increasingly accessed from researchers in many countries. This is true of private and public databases. Some multinational companies also attempt to streamline their research by gathering all the genetic samples in one location, which raises questions over the export of genetic samples from donor countries.
The Haplotype Map Project (HapMap) is an international collaborative project collecting blood samples from people from various parts of the world. It will collect samples from around 100 people from each of about 10 major racial, ethnic, or geographic groups. It will not collect names or health information, and researchers will only know what group each sample came from. The project raises ethical issues in the way that the samples are collected, the way the samples are sent to a central repository and then stored as cell lines for access by researchers around the world. While elaborate procedures have been considered to protect the participants who donate samples, there are concerns that the samples may be used to label broad ethnic groups in the future. In future studies, researchers may find that certain genetic variations show up more often in people from one group than in people from other groups, and that these variations are more common in people with a certain disease. When these findings become public, some people could think less of a particular group, or more of another group. This type of project requires international oversight, which is being made through NIH coordination. There will be no benefit to the donors, except the future promise of medical research results.

Conclusions for developing database regulation
The purpose of regulation is to avoid doing harm, loving life. Loving good also demands us to do good, so genetic data that might lead to curing disease is a good. There is a stronger tradition of community spirit and cooperation towards the good of the total society in Asia so one could expect more emphasis on these aspects in regulations in Asia.
At present however, the trend for many countries, like Japan, to copy what happens in the USA or Europe. We should be very careful when making generalizations about issues like private and public databases in terms of openness of data. The most important distinction is that a good database will only contribute to the good of donors and society, and we hope that this is attained by minimization of any potential risks to donors and communities.
Every person has a lifelong responsibility to develop his or her own bioethical maturity and values. We could define bioethical maturity as the ability to balance the benefits and risks of ethical choices, considering the parties involved and the consequences. At the societal level, public policy and law need to be developed, which requires a social mechanism for balancing conflicting ethical principles. Whatever form of research involving genetic samples is allowed, steps should be taken to ensure that such research be carried out within the framework of a regulatory system that would give due weight to ethical considerations, and set up appropriate guidelines.
Do we share the same ideas about how to apply privacy arguments? People in the world are increasingly being given the same media coverage of technology, and education also has many similarities. Therefore it is not surprising that the data also generally finds most of the total diversity in all samples is found in any one country or group. We still do not know how to protect the interests of all persons, but the simplest procedure is to continue to require informed consent for donation of genetic samples to databases. While the goals of database creators may be to use them for the good of all, adequate protection of persons and data should be made, in a way that can contribute to knowledge in the spirit of altruistic holism with the global community.

Notes
1. Macer DRJ, Bioethics is Love of Life: An Alternative Textbook. Christchurch: Eubios Ethics Institute; 1998.
2. Chadwick R, Berg K. Solidarity and equity: New ethical frameworks for genetic databases. Nature Reviews, Genetics 2001;2:318-21.
3. Macer DRJ, Bioethics is Love of Life.
4. Mill JS, On Liberty. Reprinted, Garden City, NY.: Doubleday; 1961.
5. Chadwick R. The Icelandic database - do modern times need modern sagas? British Medical Journal 1999;319:441-4.
6. Eubios Declaration on Bioethics, March 2002. Available at: http://eubios.info/eeidec.htm
7. Macer DRJ, Bioethics for the People by the People. Christchurch: Eubios Ethics Institute; 1992.
8. UNESCO, Universal Declaration on the Human Genome and Human Rights. 1997 Available at: http://eubios.info/unesco.html

9. HUGO statements are available on-line from either or
10. Ng MC, Takeda C, Watanabe T, Macer D. Attitudes of the Public and Scientists to Biotechnology in Japan at the start of 2000. Eubios Journal of Asian and International Bioethics 2000;10:106-13
11. Macer DRJ, Attitudes to Genetic Engineering: Japanese and International Comparisons. Christchurch: Eubios Ethics Institute; 1992.
12. Macer DRJ, Ng CM. Changing attitudes to biotechnology in Japan. Nature Biotechnology 2000;18: 945-7.
13. Maekawa F, Macer DRJ. Japanese concept of familial privacy and genetic information. Eubios Journal of Asian and International Bioethics1999; 9: 66-69.
14. Macer D, Bezar H, Harman N, Kamada H, Macer N. Attitudes to Biotechnology in Japan and New Zealand in 1997, with International Comparisons. Eubios Journal of Asian and International Bioethics 1997; 7:137-151.

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