Delays in implementing the lessons from empirical studies on bioethics to ethics committees in Asia


Notizie di Politeia 18 (2002), 25-39.
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>
Head, International Union of Biological Sciences (IUBS) Bioethics Program


 

Some methods of descriptive bioethics

            The perceptions that people have towards biotechnology are basic to the acceptance of new applications of biotechnology in agriculture and medicine.  Since the beginning of agriculture around 8-10,000 years ago, people have started to use living organisms to provide goods and services in a planned way.  Use of medicinal compounds is recorded by other Great Apes and seen across all human cultures suggesting it is even older. The importance of agriculture and medicine to human life is universal, which raises the questions, to what extent are the attitudes to the use of organisms to provide these goods, the relationships with the organisms and ecosystems that provide them, and attitudes to the consumption of the products, universal.  Is there something we could describe as a "global" perception, and in fact is there anything like a single perception of biotechnology in one culture?

Bioethics can be called the love of life (Macer, 1998). There are several ways to view bioethics:
1. Descriptive bioethics is the way people view life, their moral interactions and responsibilities with living organisms in their life.
2. Prescriptive bioethics is to tell others what is ethically good or bad, or what principles are most important in making such decisions.  It may also be to say something or someone has rights, and others have duties to them. 
3. Interactive bioethics is discussion and debate between people, groups within society, and communities about descriptive and prescriptive bioethics.

Descriptive bioethics is important to inform us of how people really think. This approach to bioethics was developed in Bioethics for the People by the People (Macer, 1994). It allows us to attempt to answer the questions above.  There are several possible strategies. Firstly we can look at the use of organisms and new products in different groups inside each society and between them, for example, do people eat beef or do they not?  Do they farm animals in open spaces or in factory farms?  We have to standardise for environmental and economic conditions, and also look at the religious traditions.  The religious traditions include guidance on ethical issues, answers to problems that are faced around the world.  In one sense looking at the end result of choices, the adoption of science and technology products, consumption, is the best description of acceptance of science and technology.  However, if we only look at the consumption statistics we may still not understand the reasons behind the choices, and whether, for example, there was really much free choice for the consumer given the prevailing norms of their home environment, medical system, and society.  The ideal model would say a consumer will determine what products are best, but this is arguably never seen in a world dominated by large commercial interests, trade groups and associations, and connections between producers, retailers and regulators.

            If people are very interested in science and technology they may purchase books and magazines on the subjects, or use them at libraries, or access relevant pages on the Internet.  These are all ways we could examine the interest, but do not show us how much, and what, is taken in. Another strategy that is used is to seek the guidance of traditional wisdom of a culture in determining what should be adopted.

Some governments attempt to stop human embryo research and human cloning, because it is against something called "human dignity", a concept that I agree is central to preserve, but no one really knows how to clearly define it in practice.  It seems that some practices that to me seem contrary to human dignity, like imbalance of rich and poor (a universal observation), are supported while others are not, perhaps because they are seen as unnatural. In fact not to develop biotechnology if it will help people is against human dignity, and beneficence (to love others or do good) is a basic principle of bioethics.

            The strategy that I think allows us to look at what individuals really accept, and the reasons they use, is survey research with them as individuals, sometimes supplemented by small group discussion forums.  Small group discussion forums do allow cross-stimulation of people's thinking and may arrive at a more balanced decision than if I am left alone in a room to think by myself.  However, I wonder if it really represents the way people make decisions in the real world, as not many people talk in such depth about an issue before chosing to try it, and then buy or use it.  This is a question for further research.

            Since 1991 I have been conducting opinion surveys in Japan and other Asian and Pacific countries, which I will discuss for the rest of this paper.  These surveys, with comparisons to other countries, allow trends to be examined, whether it be the adoption of new technologies such as gene therapy, genetic screening, and the arrival of foodstuffs from genetically modified organisms into supermarkets.  We can also ask whether the technology, and the associated debates, have altered opinions.

 

Survey methodologies used

            There are various methods used in surveys in Asia-Pacific countries, as elsewhere, such as face-to-face interviews (Couchman & Fink-Jensen, 1990), mail response (Macer, 1992, Macer, 1994; Ng et al., 2000) and telephone interviews (Macer et al. 1997).  The main methods I have used are written surveys as I have been trying to examine the in-depth responses that people have over bioethical dilemmas.  The problem of written responses that are completely anonymous so people feel free to answer what they realy want, is the low response rate.  Among the general public in national random surveys, in 1991 it was 26% in 1993 it was 25%, and in the year 2000 it was 13% in Japan.  Among scientists double that response was been obtained with no reminder. While the 1997 telephone survey I conducted obtained a 44% response rate (Macer et al. 1997), we also must question the interpretation of the results of any survey.  For example, almost no one I know says they answer telephone or door interviews, and until I started to conduct surveys myself I also would not feel any obligation to do so.  The mail surveys I have conducted among the public have been deliberately anonymous with no address or name known, no reminders sent, because of a desire to obtain in depth honest responses without privacy concerns, or exerting pressure for a fast reply.

            These surveys both fixed response questions, to choose options from set answers, and open questions.  Some comparisons to fixed response surveys conducted in the USA (Office of Technology Assessment, 1987), and Europe (Zechendorf, 1994; Gaskell et al. 2000) have been made. In New Zealand there was a study using both set and open questions in 1990 (Couchman & Fink-Jensen, 1990).  In the 1993 International Bioethics Survey that I conducted in ten countries with the aid of collaborators (Macer, 1994), questionnaires including 150 questions in total, with 35 open-ended questions, were developed to look at how people think about diseases, life, nature, and selected issues of science and technology, biotechnology, genetic engineering, genetic screening, and gene therapy. The open questions were designed not to be leading, unlike the use of questions with set responses that restrict the choices people may make.  The ideas in each comment were assigned to different categories, which were compared.

            The 1997 surveys in Japan and New Zealand were national random telephone number surveys, and responses were obtained from every region in New Zealand, and all 47 prefectures in Japan.  The average response rate in Japan was 44% (N=405) with the survey conducted from 28 December 1996 to 8 April 1997; and in New Zealand it was 25% (N=489) with sampling from February 1997 to 18 June 1997.  The margin of error at 95% confidence level for these sample sizes and responses rates for a 50% answer to a question is 4-5% in both countries (Macer et al. 1997). The questionnaire was the Eurobarometer 46.1 questionnaire, with minor modifications for local conditions from that used by Einsiedel in Canada (1997), as part of the international study on attitudes to biotechnology (BEPACG, 1997).  The results of this survey allow some comparisons to the 15 countries in Eurobarometer 46.1 (called EU here), and Canada (Einsiedal, 1997).  The EU sample included Belgium, Denmark, Germany, Greece, Italy, Spain, France, Ireland, Luxembourg, Netherlands, Poland, UK, Finland, Sweden, and Austria.

The 2000 survey on biotechnology and bioethics was carried out on national random samples of the public (N=297) and scientists (N=370) in November 2000-January 2000 throughout Japan. The public sample (P2000) was obtained by choosing 3000 random houses in representative areas across Japan, and dropping the survey in an anonymous cover envelope into the letterbox. The scientists sample (S2000) was obtained by sending the questionnaire to 1480 scientists, randomly selected from lists of Japanese researchers. Public and scientist surveys were sent with stamped return envelopes, and responses were obtained from 34 and 44 of the 47 prefectures of Japan, respectively.

 

Perceived benefits and risks of science, biotechnology and genetic engineering

            In all countries surveyed there is a positive view of science and technology.  It is perceived as increasing the quality of life by the majority in all countries.  In the International Bioethics Survey, when asked about specific developments of technology, including in vitro fertilization, computers, pesticides, nuclear power, biotechnology and genetic engineering, both benefits and risks were cited by many respondents.  These areas of science and technology include several controversial subjects. The results confirm people can perceive both benefit and risk, not simply taking up one position, for example, although Australians were more positive about biotechnology, they also had more worries, with 17% having a lot of worries, compared to 10% in NZ.  About a half did not say any benefit, and there was a variety of benefits given, with general hopes for humanity being the major reason.  Only a few saw it as unnatural, the major worry being human misuse (Macer, 1994).

            The attitudes to genetic engineering varied somewhat, even between close countries such as New Zealand and Australia, with 41% (NZ) and 62% (A) seeing it as worthwhile, and 39% (NZ) and 34% (A) having a lot of worries.  13-14% in NZ gave reasons that it was unnatural or playing God, compared to 9% in Australia, in both the benefit and risk question.  However, as we will see later, people were more positive about specific examples. The awareness of these words, and the techniques that they represent was reasonably high. 

            In the 1997 telephone surveys, and the 2000 mail survey in Japan, a question on the perceived impact of seven areas of science and technology began the questionnaire also (Table 1). Comparisons with the data from the European Union (EU) reveal that there is more optimism about solar energy, new materials and space exploration, in Japan and New Zealand (and Canada) but similar optimism towards computers and information technology, telecommunications to the EU.  However there is less optimism about biotechnology in Japan and New Zealand (Macer et al. 1997).

            The more negative attitudes to genetic engineering in New Zealand compared to Japan have been seen in the earlier surveys. In 1991 76% in Japan, and in 1990 57% in New Zealand, thought that genetic engineering would be a worthwhile area in their country, while 20% and 8%, respectively, were extremely worried about it.  In 1993 57% in Japan and 41% in New Zealand believed that genetic engineering was a worthwhile area for scientific research, while 15% and 49%, respectively, had a lot of worries about it. 

            There is a trend against genetic engineering over time, which was also observed in Europe (BEPCAG, 1997). This is particularly seen in the 2000 mail survey when compared to the 1997 survey, in Japan (Table 1). Genetic engineering was perceived to improve the quality of life more by scientists (S2000 72%), than by the public (P2000 59%, P97 54%).  The 1997 telephone survey results and the 2000 mail response survey results found the same proportion of optimism, however, there were more don't know responses and more who considered that genetic engineering (P2000 24%, P97 12%) or biotechnology (P2000 15%, P97 12%) would make life worse.  Biotechnology was perceived to be beneficial by more persons than genetic engineering, in all samples, and more persons thought genetic engineering would be harmful than they did for biotechnology.  The two developments, which were rated more highly as beneficial, were computers and information technology, and telecommunications.  Interestingly, however, the scientists viewed biotechnology more similar to telecommunications than did the public.

 

Table 1: Comparison of Attitudes towards Five Areas of Science and Technology in Japan

"Q.  Science and technology change the way we live. I am going to read out a list of areas in which new technologies are currently developing. For each of these areas, do you think it will improve our way of life in the next 20 years, it will have no effect, or it will make things worse?".

%

Computers and IT

Biotechnology

Genetic Engineering

Telecommunications

Space Exploration

 

P97

P2000

S2000

P97

P2000

S2000

P97

P2000

S2000

P97

P2000

S2000

P97

P2000

S2000

Will Improve

77.0

81.6

86.9

62.0

66.3

77

54.0

58.6

72.1

76.0

77.2

80.9

54.0

63.7

50

No Effect

4.0

3.8

1.1

4.0

4.5

3.6

7.0

2.4

3

13.0

10.5

8.7

17.0

19.3

23.9

Make Worse

9.0

8.5

4.6

12.0

15.1

7.7

12.0

23.6

12.6

5.0

7.8

3.8

6.0

5.8

5.8

Don't Know

10.0

6.1

7.4

22.0

14.1

11.8

27.0

15.4

12.3

6.1

4.4

6.6

23.0

11.2

20.3

No Answer

2.0

0

0.0

0.0

0

0.0

0.0

0

0.0

0.5

0.0

0.0

0.5

0.0

0.0

 

Images of biotechnology

            The next question was an open one to examine what images came to mind from the term "biotechnology". The comments were placed into up to two categories, and the comparisons for 1997 and 2000 (in Japan) are presented in Table 2. This illustrates the type of open question that can be used. There were more value statements made in response to this question, then to a later question on recollection of media stories, especially in New Zealand where several times more persons expressed a concern or hope of science than the public in Japan.  There may be people in society who are optimists and pessimists about genetics, but many expressed both, saying control was needed. 

Other open questions that were explored in earlier surveys among different countries include images of what is bioethics (Macer et al. 1996), and images of nature and life (Macer, 1994). A more general type of open question simply asks for the reasons that a person made the chose of agreeing or disagreeing to a specific question.

 

Table 2: Images of Biotechnology

Categorization of open responses in Japan (Public  1997 and  2000; Scientists 2000) and New Zealand (NZ97) to "Q.You've just indicated to what degree you think various new technologies will change the way we live. Now,  I would like to ask you what comes to mind when you think about modern biotechnology in a broad sense, that is, including genetic engineering."

 

%

P97

P2000

S2000

NZ97

Food

5

17

9

12

Medicine

11

13

17

18

Cloning and IVF

7

25

10

22

Gene tests

1

3

2

2

Gene therapy

3

11

12

0.2

Increase variety

20

11

15

2

Genes/genetic  engineering

11

16

21

6

GM animals

4

3

5

3

GM crops

9

16

8

5

Specific example

6

5

8

1

Industry

2

2

7

0.4

Tech./ scientific progress

6

9

21

19

Environment

3

3

2

4

Ethics

2

9

4

3

Benefits and Risks

3

9

6

3

Against nature

4

7

3

10

Other

2

6

5

1

Not stated

21

9

7

11

Don't know

11

1

1

1

 

 

Environmental release of GMOs

            There is strong support for the specific examples of environmental release of genetically modified organisms in all Asian countries in the 1993 International Bioethics Survey (Macer, 1994). These included better tasting tomatoes, meat that would be better for health, oil-degrading bacteria, disease resistant crops and cows that produce more milk, however there was less support for the example of genetic engineering for fun, a larger sports fish. The highest level of support was seen for bacteria to clean oil spills and disease resistant crops, with over half supporting tasty tomatoes or meat with less fat.

            In the 2000 survey in Japan (Ng et al., 2000), the level of support was highest for bacteria to clean oil spills, followed by disease resistant crops and tomato with better taste (Table 3).  The greatest resistance was for larger sport fish for all samples. There was no significant difference in opinion between the public and scientist samples except in the case of cows who produce more milk, which 60% of scientists supported compared to 42% of the public. Both samples showed majority support for the release of genetically modified plants in the form of tomatoes and disease resistant crops.  However, there was a decrease in the degree of support from the 1991 and 1993 surveys. Unlike the earlier surveys, the nature of concerns was investigated by asking "Why" after each application.  The comments reveal considerable concern expressed about foods produced using genetically modified organisms.  The concerns expressed by the largest proportions were that they were "unnatural", they would have unknown effects and were unnecessary (Macer and Ng, 2000).

            People can decide some uses that they disagree upon. There was less support for enhancing milk production in cows in the International Bioethics Survey, which may be because we ask whether we really need more milk.  This is consistent with the existing milk surplus in some countries. Europe decided not to allow use of bovine somatotropin (BST) based on safety concerns, public rejection and lack of a need. Australia, New Zealand and Norway also have not allowed it, though Canada began to allow the use of BST, later deciding in the year 2000 to ban its use. In the USA more than 10% of farmers used it in 1995, but they kept about one quarter of the 9.5 million dairy cows in the USA. Countries in Asia that have approved BST include Malaysia, Russia and South Korea.

 

Table 3: Attitudes towards products produced using GMOs in Japan from 1991 to 2000

Q8. If there was no direct risk to humans and only very remote risks to the environment, would you approve or disapprove of the environmental use of genetically engineered organisms designed to produce...?

 

%

P91

P93

P2000

S91

S2000

Tomatoes with better taste

 

Yes

-

69

58.2

-

59.0

No

-

20

31.8

-

32.5

DK

-

11

10

-

8.5

Healthier meat

 

Yes

-

57

51.6

-

56.5

No

-

26

33.0

-

33.5

DK

-

17

15.4

-

9.9

Larger sport fish

 

Yes

19

22

19.4

16.1

19.3

No

50

54

64

56.9

66.5

DK

31

24

16.5

27.0

14.2

Bacteria to clean up oils spills

 

Yes

75

71

65.4

83.1

65.9

No

7

13

20.7

6.7

23.9

DK

18

16

13.9

10.2

10.2

Disease Resistant Crops

 

Yes

75

66

54.5

85.7

60.7

No

6

17

28.7

5.0

26.1

DK

19

17

16.8

9.3

13.2

Cows which produce more milk

 

Yes

 

44

42.1

-

59.7

No

 

32

39.6

-

29.0

DK

 

24

18.3

-

11.4

 

 

 

Positive support for enhancement genetic engineering

              The 1993 survey (Macer, 1994) looked at the question of acceptance of enhancement genetics.  The sports fish is an example of genetic engineering for fun - and many people reject such genetic engineering. One of the most striking points of that question when compared across Asia is the high level of approval of this example in Thailand and India (Macer, 1994).  This trend was also seen in the Singapore and Hong Kong samples, and also reported in a student survey in China (Lo et al., 1994). 

            In a separate question on gene therapy conducted in the Interational Bioethics Survey, support for specific applications of gene therapy was significantly less for "improving physical characters", "improving intelligence" or "making people more ethical" than for curing diseases like cancer or diabetes, except in India and Thailand (Macer et al. 1995), but there was little difference between inheritable or non-inheritable gene therapy.  A significant preference for therapeutic over cosmetic  applications of gene therapy was also seen in the USA (OTA, 1987). In India and Thailand more than 50% of the 900+ total respondents in each country supported enhancement of physical characters, intelligence, or making people more ethical.  It could suggest several things: that poor living standards and infectious disease make people more pragmatic about "improvement", or that people in those countries have not thought about the implications (even though they were relatively highly educated samples).  It is interesting if this is a general trend in developing countries, as it could have significant implications for international policy (Macer et al., 1995). 

 

Trust is highest in the United Nations

            When given a range of bodies, international organizations like the UN and WHO were considered the best placed bodies to regulate modern biotechnology by 62% in both countries (Macer et al. 1997). In the 2000 survey in Japan this proportion increased to 69% by the public, and 72% of scientists agreed. In Europe 34% chose them from the six bodies given (BEPCAG, 1997).  As information sources, in NZ schools, universities or research institutes were trusted by most people and also the most trusted by 54%, as found in Canada (71% said they could trust them).  In Japan consumer organizations were most trusted, but environmental organizations were a close second, whereas they were significantly less trusted in New Zealand.  In Canada and Europe environmental organizations were trusted more than consumer organizations, as in Japan.  In Japan industry came ahead of public authorities, the reverse of the other countries except for Denmark. However, still it is negligible in most countries.  In the 2000 survey in United States, the trust in the FDA dropped to a level that is more similar in trust in national regulatory authorites in other parts of the world, and this may have been a factor in the decrease in approval of biotechnology applications in the USA (Priest, 2000; Einseidal, 2000).

Surveys also find that 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 already they have reached a good reputation in countries that have established ethics committees that are independent of authorities, which are perceived to have conflicts of interest, for example industry, physicians, or governments. It is a very important principle for a successful institutional review board that they will 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 which may conflict with the best interests of the persons involved, for example the patients, and of the local community.

 

Whose perspective to consider in an ethics committee?

When we consider human subjects protection 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. As we could note in almost all countries in the globe we would never undertake to treat 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 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. We can also imagine with the interests of different research scientists associated with different medical professionals and each may have their own particular goals for this research. A particular hospital, or even a country, may wish to be involved in particularly new and exciting research for a variety of reasons. Perhaps the general level of academic recognition of a hospital in a country 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 a member of the first class of countries in terms of new therapeutic innovations.

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 of what is the best option. There are diverse views of what is healing and what is health. 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 are paradigm of disease, life, and death that we may not consider, 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 account of the possibility that the assumptions that one can make in a small community is that everyone wants to get better, if they have a disease is not a valid. An individual person within a community might think that to receive the best medicine possible is their God given right, however another person may think that it is a selfish motivation to try to get better.

 

Can Global Bioethics committees function?

There is a growing trend to see ethics committees in Asia, but they range widely between countries. There is also trust shown in international bodies, often more than local university ethics committees that suffer from having few external members. I wish to give several examples of international or global bioethics committees, and for different situations we may use different models.

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

The Council of Europe includes nearly 50 member countries across Europe, and has been able to reach a consensus 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) has already ratified the Convention. In these eight countries the Convention also came into effect. Although  the issues are often a matter of hot dispute, for example, human embryo research, and how to get the consent of persons who may not be able to express the idea themselves  for example mentally handicapped persons, or children.  While other countries were invited to join the Council of Europe Convention, there is no signs that a country in Asia will join their Convention.

 

B. UNESCO International Bioethics Committee

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

From the 1998 a new committee was formed which is now focusing on implementation of the Declaration, and continuing to develop some statements and reports on particular issues in bioethics. The first Committee from 1993 to 1997 included 50 members from a wide range of countries, appointed in their individual capacity and not connected with their governments.  As one member I enjoyed the reflection across culture and discipline, and we all learnt a lot. The second committee includes 38 members, has a limit of one member per country, and is more linked to with the particular countries. In addition that there is also an Inter-governmental Bioethics Committee of the UNESCO established in 1998, which is to represent official government views. However it is not clear if this is really a success in practical terms because it is only just been established and results are unclear. Nevertheless this represents the globalization of the concept of Bioethics. Given the high trust seen in the UN, the UNESCO IBC has been important for guiding some countries national regulations, for example, Japan and India. WHO has also significant influence in Asia.

 

C. Human Genome Organization (HUGO) Ethics Committee

This is a small Committee of 12 members from different countries who represent the human genomics community, and have made a series of position statements. These statements include a Statement on the principled conduct of genetics research, Statement on DNA sampling: Control and access, Statement on cloning, 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 with some dialogue over the minor details of these statements. The Human Genome Organization is in international scientific organization with members from a around and it can be said to represent the voice of the genetics community for science. Because it is free of governmental constraints some of the our recommendations can be innovative because they do not have to conform to governmental policy as it stands today.  HUGO will hold its annual meeting for 2002 in China, and the recommendations of HUGO have had some influence in Asia.

 

D. 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, a bioethics committee has been established 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 will make people trust the committee is the membership of that committee. Among different countries there is quite a different range of members of committees, not only in terms of their gender ratio, and age structure, but also the inclusion of what are called lay persons. These people are not academics, and not specialists in a particular discipline, they are rather someone from the community who is willing to think independently about the clinical research protocol. In the New Zealand the majority and the 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 the medical school, and whose chair is not the Dean of the medical school. However in most Asian countries it is difficult to see lay members at all in medical ethics committees, and this is one gap in the implementation of bioethics principles to ethics committees.

In the guidelines of Taiwan one person on the Ethics Committee should not belong to the hospital. This represents some progress from Japan for example, and a number of other countries, however it is still a long way from a truly independent Ethics Committee (Macer, 1999). We need to have the bioethics for the people by the people (Macer, 1994), and understand that all members of the community can make educated and good decisions over difficult questions of 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 is not good science, and it would seem very difficult to really obtain informed consent from the general member of the public if you couldn't explain it to the members of an Ethics Committee first.

 

Education for a bioethically mature society

Some of the conclusions of the surveys include that education is not a predictor of attitude. Japanese scientists are also divided into three cultures on acceptance of biotechnology, especially of GM food (i.e. Yes, No, Don't know).  The trends are for increased concern over genetic engineering and gene therapy in Japan between 1991 and 2000 among both public and scientists. The most significant result of the surveys between countries is that a culture is not defined by nationality, race, gender, education or religion (Macer, 1994; 1998).  Rather we can see cultres of those who accept new technology easily, those who do not accept new technology easily, those who do not care, and those who think a lot.  The later two may often say they do not know in response to survey questions.

Secondly, there was  more acceptance of specific applications, and if we want to develop a bioethically mature society, one which can balance benefits and risks of science applications, this is the better measure of acceptance of science. I would call a mature society a society that 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 the empowerment is a natural extension of the recognition of human rights and human dignity, and loving our neighbor as ourselves (Macer, 1998).

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 measure. One step for immediate action I could suggest is a disclosure of information about the activities of institutional review boards, and the process, on the Internet. Not only through public meetings, and through secondhand reporting by the media, but also it is important for the Committee to provide information directly to society. Internet is one of the modern ways that 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 achieving excellent science and excellent clinical practice, they include respecting all persons human values and rights.

 

Conclusions

Human subjects protection committees are 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 (Tsuchiya, 2000; Nie, 2001). Some lessons for ethics committees from the surveys are:

      The purpose of regulation is to avoid doing harm, loving life. At the same time, loving good also demands us to do good, and people express support for both ideals.

      We need to educate people how to exercise informed choices in medical therapy, restricting choice only if this will harm others or society in general. 

      Members of ethics committees need to consider whether they can limit choices that people make for themselves or their family?

      They also need to limit access to dangerous medical interventions because sick people may grasp at everything because of the common image to prolong live by all means, reinforced by the media.

      Education is necessary and cooperation between all sectors of society to understand medicine and genetics. Ethics committees can play a role.

      An ethics committee should build consensus between persons, but empirical studies show that there is no predictor of a persons' views based on a group they can be categorized into. Every group is pluralistic when resolving moral dilemmas.

 

Acknowledgments

            I wish to thank the many persons involved in the many surveys as listed in the references. Please note the references by Macer are available on-line on the Eubios Ethics Institute Internet site <http://eubios.info/index.html>.

 

References

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