Human Subjects Protection Across the Globe

pp. 140-150 in Human Subjects Research. (National Health Research Institutes, Taiwan, 2001).

Darryl R. J. Macer

Institute of Biological Sciences, University of Tsukuba, Japan

Whose Perspective?

When we consider what is a global perspective on human subjects protection is we first have to ask whose perspective are we considering? We could consider taking global views inside one particular community, for example, involving the patient, family, local community values, researchers, doctors, etc. If we are considering research that involves genetics, then because genetics is of familial importance we can envisage conflicts between different members of a family. This means that although one person may volunteer to be involved in the human research project, the results of that research when it disclosed to that family member may have implications for the health of other family members. There is a growing recognition of the duty to inform not only the subjects of the research about the health implications of their sample analysis, but also a recognition that there may be duties to inform other members of the family about the avoidable conditions which the tests undertaken as part of the research project have revealed.

If the research involves a pregnant woman, imagine a situation where there is a conflict between a fetus and the mother. For example, if there is an indication that the fetus should undertake surgery in order to be able to survive when it is born, then it if the mother does not wish to undergo a this type of therapeutic intervention, then there will be a conflict between the fetus and the mother might occur later. As we could note Iin almost all countries around the globe, we find that no physician in the globe we would never undertake the treatmentto treat of the fetus without the free and informed consent of the mother. Another example of different perspectives within a family involves the cases when a family may require for one child a bone marrow donor, and in order to obtain a suitable donor they may select an embryo, using preimplantation diagnosis, or the fetus, using prenatal diagnosis and selective abortion, so that the new child is also the correct immune type to be a good donor for the preexisting child in the family.

Perhaps more frequently and more commonly across a broad range of research fields and therapeutic situations is the conflict between the patients and the medical professional in societies which are still moving from a paternalistic system towards a system of informed consent, and which may not have yet reached a paradigm of informed choice for medical treatment., there is often a serious conflict between with the physician and the patient. This conflict between patient and medical professional could also come up, for example, whenWe can also imagine with the interests and goals of different research scientists differ from each other from their patients or when associated with different medical professionals and each may have their own particular goals for this research. Aa particular hospital, or even a country, begins tomay wish to be involved in particularly new and exciting research for a variety of reasons. The reasons could one or several including. Perhaps the general level of academic recognition of a hospital in a country where recognition is related to the number of clinical protocols for research, and/or very innovative research in new therapies., so they may be striving to achieve such. Certain countries as a whole may also attempt to become one of the top countries known fora member of the first class of countries in terms of new therapeutic innovations. In any of these cases, the interest of the patient may begin to differ from the real interest of the investigator.

If we attempt to take a global perspective from the point of view of the global community, we must start with the premise that not all members of the global community have the same paradigm forof what is the best option is. There are diverse views of what is healing and what is health is. Although these also differ within a community, we can find within certain communities that have not yet joined the global culture of the 21st century that there may beare paradigm of disease, life, and death that we may not have considered. It may very well not be the goal of living, that to live as long as one can with the best quality of life that one can. is the first goal. Therefore, when international research protocols are being designed, we must take into account of the possibility that the assumptions that one can make in a small community is that everyone wants to get better may not be, if they have a disease is not a valid under certain circumstances. An individual person in onewithin a community might think that it is his or her God-given right to receive to receive the best medicine possible is their God given right, while another person in another community, considering the cost and the effort, etc., may think it is selfish to try to get better.however another person may think that it is a selfish motivation to try to get better.

Who Can We Trust?

Opinion surveys have shown that when asked to choose who they would trust, a majority of persons trust the United Nations organizations, for example the World Health Organization, rather than their own governments and their own national regulatory authorities. For example, in surveys conducted in Japan and New Zealand in the late 1990's we see over 60 percent of those questioned the persons saidsay they would trust the United Nations for information about the safety of biotechnology, whereas only a around 10 percent would trust their own government authorities.1,2 Scientific organizations are trusted it a little bit more than governments, because scientists are perceived to be experts independent of the government. Independent ethics committees are also trusted more than government authorities, and this may be particularly relevant to the discussion of today's international symposium. Because an Institutional Review Board is a form of an Ethics Committee, it is essential that it is well trusted across the community. Ethics committees are relatively new invention, so it is interesting that they have already they have reached a good reputation in countries that have established ethics committees that are independent of authorities. This is especially true when those authorities, meaning the industries, physicians, or governments, which are perceived by the people to have a conflicts of interest., for example industry, physicians, or governments. It is a very important principle for a successful institutional review board that they arewill be seen to be independent, and that they can be trusted to say yes or no to a research protocol without being manipulated by those who have particular interests in conducting the research protocol. The people conducting the protocol could possibly have a which may conflict with the best interests of the persons, patients, or local community involved. involved, for example the patients, and of the local community.

Can Global Bioethics Committees Function?

I wish to give several examples of international or global bioethics committees, and for different situations we may use different models.

Council of Europe Bioethics Convention and the Council of Europe Steering Committee on Bioethics

The Council of Europe includes nearly 50 members from countries across Europe, and has been able to reach a consensus on the Convention on Human Rights and Biomedicine that has been ratified by member countries. The Convention has been signed by twenty-nine Member States of the Council of Europe (Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Moldova, Netherlands, Norway, Poland, Portugal, Romania, San Marino, Slovakia, Slovenia, Spain, Sweden, Switzerland, the former Yugoslav Republic of Macedonia, and Turkey). Eight of these countries (Denmark, Georgia, Greece, Romania, San Marino, Slovakia, Slovenia, and Spain) haves already ratified the Convention. In these eight countries, the Convention has also already comecame into effect, even though there are still controversial issues including. Although the issues are often a matter of hot dispute, for example, human embryo research or , and how to get the consent is obtain from of persons who may not understand what is involved, be able to express the idea themselves for example, mentally handicapped persons, or children.

UNESCO International Bioethics Committee

UNESCO, is an international agency of the United Nations with including around 180 members, and in 1993 UNESCO established the International Bioethics Committee in 1993. For the first five years the committee focused on developing the Declaration on the Human Genome and Human Rights, which that was adopted unanimously adopted by all member countries of UNESCO in 1997. This Declaration represents a global bioethics consensus onof the way that research in human genetics should be conducted.

InFrom the 1998 a new committee was formed towhich is now focusing on implementingation of the Declaration, and continueing to developing some statements and reports on particular issues in bioethics. The first Committee, which had 50 members from a wide range of countries and which performed its role from 1993 to 1997. The members were appointed to act as individuals, not representative of their governments. included 50 members from a wide range of countries, appointed in their individual capacity and not connected with their governments. As one of the members, I enjoyed the reflection across culture and discipline, and we all learnt a lot. The second committee hasincludes 38 members, has a limit of one member per country., and is more linked to with the particular countries. Also in 1998, UNESCO established another committee, theIn addition that there is also an Inter-governmental Bioethics Committee of the UNESCO established in 1998, which is to officially represent their official government views. However, it is not clear if this is really a success in practical terms because it hasis only just been established and results are unclear. Nevertheless, these committees this represents the globalization of the concept of Bioethics.

Human Genome Organization (HUGO) Ethics Committee

The HUGO Ethics Committee,is is a small cCommittee comprised of 12 members from different countries who represent the human genomics community, and have made a series of position statements. These statements include a SStatement on the principled conduct of genetics research, a SStatement on DNA sampling: Control and Aaccess, a Statement on cloning, a Statement on benefit sharing, and a Statement on gene therapy research. In this series of short statements, the Ethics Committee deliberated on what could be justified ethically as a good research protocol, and made their suggestions to the Council of the Human Genome Organization, who has always endorsed the statements, although with some dialogue over a fewthe minor details. of these statements. The Human Genome Organization is ain international scientific organization with members from a around the world and it can be said to represent the voice of the genetics community for science. Because it is free of governmental constraints and does not have to conform to governmental policy, some of their our recommendations can be quite innovative. because they do not have to conform to governmental policy as it stands today.

International Union of Biological Sciences (IUBS) Bioethics Committee

The International Union of Biological Sciences is an umbrella organization representing scientists from around the world, and all the professional biological associations of different countries. Because of the common involvement of biological scientists in research which involves ethical issues, thisa bioethics committee washas been established to which is working on a more global approach to bioethics. One of these projects is to develop a bioethics dictionary which is accessible to all, and includes contributions from all cultures and disciplines.

Lay Persons in Ethics Committees

One of the features of an Ethics Committee that canwill make it more trustworthy its membership.people trust the committee is the membership of that committee. Among different countries there is quite a different range of members of committee memberss, not only in terms of their gender ratio, and ages structure, but also in terms of who is considered a the inclusion of what are called lay persons. Often these lay persons areThese people are not academics; they are, and not specialists in a particular discipline. Rather they, they are rather peoplesomeone from the community who areis willing to think independently about the clinical research protocol. In the New Zealand the majority of the Ethics Committee members and itsthe chair person of an Ethics Committee must be lay persons. However, in Japan it is very rare to find any member of the committee who is not associated with athe medical school or , and whose chair is not the Dean of athe medical school.

In the guidelines and survey as presented in this symposium we found that one person on the Ethics Committee should not belong to the hospital. While tThis represents some progress in comparison to Ethics Committees offrom Japan. for example, and in comparison to a number of other countries, however it is still a long way from a truly independent Ethics Committee.3 We need to have the bioethics for the people by the people,4 and understand that all members of the community can make educated and good decisions over difficult questions regardingof human subject research. Some scientists may claim that the scientific details are too complex for an ordinary person to understand, however I would always argue that unless the science can be made simple so that an ordinary person can understand it, it is not good science. It would, and it would seem very difficult to really obtain true informed consent from the general member of the public if science could not first explain its work the you couldn't explain it to the members of an Ethics Committee first.

Education for a Bioethically Mature Society

I would call a mature society a society which can balance the benefits and risks of different choices, one which can debate these choices in public, and one which can accept that different members may make different choices, and these choices will be tolerated within general limits of medical law. In order to ensure an informed and bioethically mature society, we need to have public education and patient education. We need to empower persons to move from beyond paternalism through informed consent, to informed choice. There is a role for every medical professional in this transfer of decision making power, because such anthe empowerment is a natural extension of the recognition of human rights and human dignity, and loving our neighbor as ourselves.5

One way to accomplish this education it is to target all of society through school education, and community health centers. Patients groups and families to support these persons also need to be closely involved, as do associations of aged persons who are often seen in hospitals. There are many approaches and methods that can be used and it is important to attempt many types of measures. One step for immediate action I could suggest is a disclosure of information about the activities of institutional review boards, and how they the proceedss, on the Internet. It is not enough to provide information Not only through public meetings, and through secondhand reporting by the media. It is, but also it is important for the cCommittee to provide information directly to society, and the . Internet is one of the modern ways that the ill have been people who are sick have been empowered by.

An important aspect of this is professional responsibility. There are international norms of good practice by scientific researchers, and medical practitioners. These international norms must be followed by the professionals in research, and also by clinicians in the clinic. These professional norms do not only consist of requiringachieving excellent scientific ce and excellent clinical practice, they also include respecting all persons' human values and rights.

I would also like to conclude by to suggesting that the time has come for a Bioethics Association a bioethics center to be established in Taiwan, and a devoted bioethics center to develop scholars to deal with the subject here. The center would also have an important role in educating people onon of all sides of this debate, and ensuring thatso that there can be a global perspective be maintained withininside the the community, between different disciplines and different sides. The survey of the functioning of human subjects protection committees in Taiwan as presented in this symposium is a good example of how a government should review the mechanism of institutional review boards. In this way, so that different interpretations can be used to educate all about different perspectives that can be reached. It is also a method of quality control that is essential for developing trust in an area of medicine that has so often been abused in the past.6,7

Notes and Citations

  1. Chen Ng, M.A., Takeda, C., Watanabe, T. & Macer, D. 2000. " Attitudes of the Public and Scientists to Biotechnology in Japan at the start of 2000", Eubios Journal of Asian and International Bioethics 106.4: 106-13.
  2. Macer, Darryl; H. Bezar, N.Harman, H. Kamada, N. Macer 1997. "Attitudes to Biotechnology in Japan and New Zealand in 1997, with International Comparisons", Eubios Journal of Asian and International Bioethics 7: 137-151.
  3. Macer, D. 1999. "Bioethics in and from Asia", Journal of Medical Ethics 25: 293-295.
  4. Macer, Darryl R.J. 1994. Bioethics for the People by the People. Christchurch NZ: Eubios Ethics Institute.
  5. Macer, Darryl R.J. 1998. Bioethics is Love of Life. Christchurch NZ: Eubios Ethics Institute.
  6. Tsuchiya, Takashi. 2000. "Why Japanese doctors performed human experiments in China 1933-1945", Eubios Journal of Asian and International Bioethics 6: 179-80.
  7. Nie, Jing-Bao. 2001. "Challenges of Japanese Doctor's human experimentation in China for East Asian and Chinese bioethics", Eubios Journal of Asian and International Bioethics 11: 3-

Further up-dated references on bioethics in Japan can be found at the Eubios Ethics Institute world-wide web site <>.

To Papers list
To Eubios Ethics Institute book list
To Eubios Ethics Institute home page

Please send comments to Email < >.