Darryl R. J. Macer, Ph.D. Eubios Ethics Institute 1992
Science and technology is used by everyone. In Japan, perhaps even more than in other countries, people may see science and technology as a panacea for improving the quality of life. Most people do not understand the details of science even though we all use the applications of it. Even scientists have become very narrow in their focus, so that they may not understand science outside of their area of research. More than 30% of young people enter higher education, and the amount of knowledge learnt in high schools is very high. This should mean that the public has a high level of awareness of science, which is consistent with the results of this survey (see chapter 3). However, a feature of Japanese society is that despite this knowledge, there is almost no involvement of the general public in issues connected with science policy. There is no case of significant policy change being initiated from the public, in contrast to the movements such as patient rights in North America or the environmental Green movement in Europe. The Green movement began from a coordinated network of ordinary people concerned about the environment, and it is growing in other industrialised countries. However in Japan, there is no single united forum from which the public puts forward its views on environmental protection. The environmental protest groups are small and generally scattered, as are other public protest movements. This inability to form a single forum may be due to the social customs of Japanese, and it is also to the advantage of those who currently have power in society to keep the public interest groups small and scattered. The Japanese societal system has been called structured paternalism, with the public having no direct influence on policy, and being "looked after" by others who make such decisions.
This is not to say that the scientists determine policy, rather a system of bureaucrats, industry leaders, and government has been developed to govern the country. People generally do not speak if they are not "experts", in marked contrast to Western democracies where people express their opinions on almost everything. In questions of science, scientists are in a position of advantage because of their knowledge of science, so they should realise better than others what technology is capable of, and what alternatives could be used. Although there is another problem in Japan, that such a high proportion of scientists are employees of industry, which may influence what they say about alternative technologies. It may be difficult for scientists to speak out against a company with whom they share lifelong loyalty. One feature of the Japanese system that is shared with other large countries is the power play between different government agencies which fund and guide research, together with industry.
Japan has the highest percentage of researchers per total of the population in the world, 0.7% (OECD 1991). In a 1985 public opinion survey in Japan (N=7439, PMO 1986a), people were asked what they thought about scientists and technical researchers, by choice between 5 options. 39% agreed that they do research to contribute to human happiness, 18% said that they are also thinking of the effect of technology on society, 14% said that they had much specialised knowledge but did not think about the effect on society, 5% said that they did not think about human happiness but only did science to seek knowledge, and 25% said they "don't know". It appears that the public has a reasonably good view of scientists, but this type of question is limited by its choice of options, we could think of some other motivations, like to perform research for economic reasons which must also be a common feeling among industrial company scientists. In a survey of the public in 1990 (N=2239, PMO 1990c), 32% said that scientists are only doing science to satisfy their own curiosity rather than because it was useful, whereas 49% said that they were not, i.e. they were also interested in use to humanity. 47% said that they would like to hear about science and technology from scientists, whereas 50% said that they were not interested in hearing from scientists. 57% said that the knowledge could be understood by most people if it was explained to them, whereas 32% said that it could not be; compared to 1987 when 49% said most people could understand and 39% said most people could not understand. There appears to be a trend for people to see science as more understandable. However, 58% said that they were worried that they could not keep up with technology development, whereas 36% said they did not; and 65% said that they were worried that science was becoming too specialised to understand while 25% said that it was not, and these values stayed similar between 1987 and 1990. 58% said that scientists had generally high social standing whereas 28% said they did not have especially high social standing.
As we have seen, biotechnology has many implications. Scientists often claim that scientific research is ethically neutral, and that technology is the applied activity which has ethical implications. What is ethically neutral is scientific knowledge, but the activity involved is like any other activity, it is not neutral. Any human activity is associated with a choice, whether to research one area or another, so scientific activity is not ethically neutral. Scientists like to claim that science is neutral to avoid pressure from government intervention (Proctor 1991). Scientists also like to claim academic freedom, and it is enshrined in the Japanese constitution (article 23), but this is not absolute. They do accept some limitations because of morality, such as worldwide ethical guidelines in human experiments, nationwide restrictions on animal experiments (though there is little discussion of this issue in Japan), and environmental restrictions. As we can see from history, the freedom of basic scientific research has brought society many benefits, and if society expects to benefit more, such freedom must be maintained, with the above mentioned restrictions. The applications of science, and biotechnology, are subject to more controls, particularly those on the safety to human health, environmental protection, and within the limits of common morality. The limits of common morality include things such as restrictions that have been placed in some countries to prevent commercial exchange of body organs, or reproductive services, and some of these can be argued from the fundamental principles of bioethics (see chapter 1), or from religious views shared between some of the major world religions.
The key point in such decisions on the applications of technology and the placement of these special restrictions, is that these decisions are multidisciplinary. The decisions involving the use of technology include a balancing of risk versus benefit among alternatives. The process of decision-making is learnt during life, though there is little education on how to make decisions during formal education in any country. All people make decisions, though not always good ones. Society should not entrust these multidisciplinary decisions to any special group, because the no single group is better at making them, especially in modern society where the specialists have become so specialised that they may not know much outside of their own area. Also the special group may have different views of the acceptable level of risk that should be tolerated, and of the goals for the future society. It is a responsibility of all people living in a democracy to participate in decision-making. In order to do this, we all need to be educated, through school and media.
The responses of the different sample populations to the questions in this survey, give us views of parts of the complete picture. There are clearly some questions in which there was surprising little difference in response detected, such as the questions on the use of medical genetics. There are also other questions where there are significant differences in response. In addition to the comparisons that have been made throughout this book between the responses to the general questions, some of the questions were directly associated with the relationship between scientists and the public.
Specific Questions on Science and Technology
A series of specific statements was used (Q16), largely using those of Couchman & Fink-Jensen (1990) used in New Zealand. Q16a-g were the same in the questionnaires to all groups. The other questions (Q16h-j) were added to the questionnaires to the special groups. Q16j of the academics and teachers' survey was used as Q16h in the mailed public questionnaire. Q16a asks about the perceived benefit of science to Japanese life, which is common to many questionnaires internationally. It was discussed in chapter 3. Q16b and 16c look at the credibility of statements made from government and company spokespeople, as have also been examined in the USA (OTA 1987). Q16d asks about the hazards associated with science. Q16e asks about government support for science, a fairly common question internationally. Q16f looks at a specific application of GMOs, and was discussed in chapter 4. Q16g was novel, and considers the closed nature that decision-making in Japan is usually undertaken. Q16h and i look at the public awareness of science, and like 16j, were used in New Zealand, so can provide international comparisons.
Q16. To what extent do you agree or disagree with the following statements that other people have made?
1 strongly disagree 2 disagree 3 neither agree nor disagree 4 agree 5 agree strongly
a. Science makes an important contribution to the quality of life in Japan.
b. If a scientist working in a government department made a statement about the safety of a research project, I would believe it.
c. I would usually believe statements made by a company about the safety of a new product it had released.
d. The activities of scientists in Japan should be more closely regulated to protect public safety.
e. Science should receive more government support in Japan.
f. Genetically modified plants and animals will help Japanese agriculture become less dependent on chemical pesticides.
g. Decisions about Japanese science and technology policy should not be made hidden from the public.
h. Japanese scientists have mostly left it to others to communicate science to the public.
i. Public understanding and awareness of science is generally very poor.
j. Students should be informed about the social issues associated with science and technology so that they can participate in contemporary debates.
Q16b asked whether people would believe a statement made by a scientists working in a government department about product safety. The results are in Table 8-1. 35% of the public said that they would agree with such a statement, and 21% said that they would not, and 44% said that they would not be sure. Q16c asked about the credibility of company statements about product safety, and there was less trust of such statements, with 17% of the public saying that they would believe such statements and a greater proportion, 36% saying that they would not believe it, and half, 46% said that they would neither agree or disagree.
The public belief in product safety statements made by both companies and government scientists in Japan is lower than the public in New Zealand (Couchman & Fink-Jensen 1990). While both in New Zealand and Japan 35-36% of the public agreed with safety statements made by government scientists, and 20-21% disagreed with them (Figure 8-1). In Japan 17% agreed with company statements versus 26% in New Zealand, while in both countries 34-6% said that they would disagree with company statements. It appears that the public in both countries would question safety statements, especially those made by companies. In the USA, people were asked whether they would believe statements made about the risks of products by different groups (OTA 1987), and companies were less trusted than government agencies, with university scientists being the most trusted. Only 6% said that they would definitely believe a statement made by a company about its product, and 15% said they would not believe, with 37% inclined not to believe and 39% inclined to believe. The question was different, but it appears that the public in the USA may be more trusting of companies than the public in Japan and in New Zealand. This would be an interesting point to confirm, because often people observe that Japanese are less outspoken than Westerners, and draw the conclusion that they are less critical of authorities. These results, together with other experience, suggests that underneath they share at least as much distrust of authority as in the West, it is only that they do not openly express it.
Scientists were less committal about either statement, with 29% believing the government scientists and only 12% believing the company. However, company scientists were more trusting, with 36% agreeing with a government scientist, and 25% agreeing with a company scientist, whereas 22% of government scientists said they would agree with a safety statement made by a government scientist, and only 5% would agree with one made by a company scientist! A comparison of responses between company, government and industry scientist respondents to some questions is in Table 8-2. These comparisons show that the company scientists also expressed less concern about genetic manipulation (Q7b) and consuming foodstuffs made from GMOs (Q8b) than government and university scientists. We could conclude that the views of government and university scientists may be more representative of the public than those of company scientists. Among the ten different scientific specialities (Table 2-3), biologists expressed least concern in Q8b and biotechnologists least concern in Q7b.
Q16b: If a scientist working in a government department made a statement about the safety of a research project, I would believe it.
Q16c: I would usually believe statements made by a company about the safety of a new product it had released.
Abbreviations: comp=company govt=government univ=university scientist
(%') Q16: no=disagree (response 1,2) neither (3)
In a UK survey (Kenward 1989), the public were asked whether they had confidence in a list of institutions, in 1985 and in 1989. People generally had slightly less confidence in 1989 than they did in 1985, and about 20% said they had great confidence in the scientific community, compared to 18% for the legal system, 12% for major companies, 11% for the government, 13% for television and 5% for the Press (newspapers). However, 62% had confidence in medical institutions, by far the most trusted of the institutions that were in that survey. This type of question would also be interesting for international comparisons.
In a 1989 Chinese survey, of respondents in Beijing (Zhang 1991), "scientist" was listed as the most prestigious occupation, above physicians and engineers, almost double the prestige as a government official or journalist. As a choice of occupation, physician was rated above scientist. People were asked who is to blame for the social problems of science and technology, 70% said government decision-makers, 6% said scientists and 4% said engineers; and on the question on who can solve the social problems brought about by science and technology, 93% said scientists could, 57% said government decision-makers could and 41% said business decision-makers. A positive image of scientists may be universal, but it is clear from this survey that there is still considerable suspicion of what they say, in industrialised countries at least. This is especially true at the hint of business interests, and the involvement of many biologists with biotechnology companies does question their neutrality. This has led some USA; government review committees to exclude any scientists who have commercial interests including shares in biotechnology companies (Anderson 1992c).
It is rather sad that people do not appear able to trust safety statements made by scientists, especially those statements made by companies. Moves should be made to increase confidence in safety statements. Some possibilities include letting independent groups, including the public, review results of safety tests, and to have public disclosure of test results. As discussed in chapter 6, a major concern about the consumption of foodstuffs produced from GMOs was the lack of information (Table 6-3). The public provision of data, including the publication in international scientific journals where the data must undergo independent scientific peer review, would increase public confidence. In the Nikkei (1983) survey of business people, they were asked whether information about biotechnology should be open. 29% said unconditionally open, 52% said it should be open if possible, while only 7% said that it was not necessary. The reasons for these opinions were asked via choice of several options 68% said it should be open because biotechnology deals with life, 12% said it should be open to get public interest, while 11% said to make the information open would make people worry unnecessarily. From the level of mistrust associated with science and technology and genetic engineering, it is clear that openly published and reviewed safety data would ease many people's concerns.
Of course, in the long term, it would increase public trust more if safety statements were reliable enough to be trusted! The survey result may, however, have a positive side, suggesting that people can think about product safety for themselves and not rely on opinions of others, especially those groups who may be unable to give an unbiased assessment.
Q16d asked whether the activities of scientists in Japan should be more closely regulated to protect public safety. The results are in Table 8-3. 51% of the public agreed with this statement, and 49% of teachers, 43% of University staff, whereas only 31% of the scientists and students agreed. 42% of the scientists, 28% of university students, 20% of the University staff,18% of the teachers and 17% of the public disagreed with this statement. This suggests that people do see some hazards from the activities of scientists and they think they should be regulated more closely. The scientists are against regulation of their activities, though still one third support it. The scientists in New Zealand were also against further regulation of their activity, with 42% opposed and 23% supporting more regulation, while the public expressed even greater support for regulation of scientist's activities, 67% agreeing with 11% opposed (Figure 8-1). This could be due to a more outspoken public in New Zealand than in Japan, rather than due to any particular local scientific accidents, but as seen in the responses to Q16b and Q16c, the Japanese public questioned safety statements that scientists made more than the New Zealand public. It may be due to the Japanese distrust of regulatory systems themselves, in addition to the scientists. This would also be interesting to investigate.
This statement did not refer to any particular branch of science, though people may have been thinking about biologists from the nature of the previous questions (Q7-15). In 1987 a public opinion survey in Japan found that 67% would support a ban on creating new forms of life, compared to 42% in the USA (Joyce 1988). Also, 42% said that they thought that the rules governing genetic engineering were too slack, 10% thought that they were too strict, and 27% thought that they were about right. In a 1989 survey of readers of the science magazine Newton (1989), half did not trust researchers of biotechnology when it comes to safety, and 77% were worried about the dangers of biotechnology. 87% thought that researchers would hide bad results from the public, whereas 3% said they did not think they would! Moreover, this sample was of a select group of science magazine readers, rather than the general public. In 1988 in the U.K., 41% of the public were not very, or not at all, confident with the safety controls over genetic engineering, while 40% were confident (RSGB 1988). In a large 1991 European survey covering all EC countries, with N=12800, 90% said that the government should control a range of specific applications of genetic engineering. However, when asked to choose from a list of who would be a reliable guide to "provide them all the truth about biotechnology", consumer groups were trusted by 27%, environmental groups by 32%, universities by 17%, while 7% trusted the government and only 1.3% trusted industry to do this (MacKenzie 1991). In this Japanese survey, a more specific question on biotechnology regulation was asked (Q20), which is discussed below.
Q16d: The activities of scientists in Japan should be more closely regulated to protect public safety.
Q16e: Science should receive more government support in Japan.
Q16g: Decisions about Japanese science and technology policy should not be hidden from the public. Public participation
The area of science that is being thought of clearly will affect people's attitudes. In a Japanese public survey in January 1990 (PMO 1990c), people were asked which research organ they saw as most appropriate to perform different areas of research, between industry, publicly-funded research, or universities (in general). Industry was seen as the place to do research into new material development (superconductors and ceramics), whereas in all other areas publicly funded research organs were seen as more appropriate, for the areas of biotechnology, alternative energy, substitutes for chlorofluorocarbon gases, and for health. Universities were favoured over industry for research into health, but otherwise industry was seen as somewhat more appropriate for research than Universities in general. However, in Japan certain publicly funded Universities are also noted for research excellence, and people may include these in their mind with other government funded research. It is also interesting that less than 1% of the people said that research was not needed in any of the areas, suggesting people do have a positive image of scientific research.
In a 1989 UK survey, the attitudes of the public to government funding of different areas of science and technology were compared (Kenward 1989). In some areas the people would like to see more money spent, such as for reducing pollution, scientific research, or health. On areas such as space exploration and weapons research, there was strong support for cuts in funding, people saying that the government spent too much. A general question about science funding was asked, whether people thought the government spent too much, too little, or about enough. The responses in Australia were also obtained (Anderson 1989). In the UK 51% said the government spend too little on science funding, in Australia, 61%; in the UK 10% said that they spend too much, in Australia, 9%, while 28% and 23% said that they spent the right amount in the UK and Australia, respectively. It would appear that there may be even stronger public support for science funding in Japan and New Zealand, though the questions were different.
Q16g was written to address a specific problem of Japan, that scientific decisions are usually made with little, or no, public consultation. 78% of the public agreed that decisions about Japanese science and technology policy should not be made hidden from the public (Table 8-3). Only 4% disagreed with this statement. Significantly, there was strong agreement with this statement by all groups, including scientists. This will be discussed in relation to biotechnology regulation.
In a 1985 public opinion survey in Japan (N=7439, PMO 1986a), people were asked how far people should know about the context and research of life science. 14% said that people should know the context (present research situation and the aims of researchers) and the influence to society, in detail, 38% said that it was OK if the public knows this in general, 5% said that they need to know the context in general, 16% said that they need to know the influence to society in general, while only 10% said that it doesn't matter if people don't know, and 17% said "don't know". In another question people were asked what life science research should be like and whether it was good to use in society. The responses were measured via choice of one option from a list of 6 possible options. 43% said that researchers need the nation's understanding before they use technology, 22% said that even for research public understanding is required, 10% said that researchers were free to use technology, 4% said do research but don't apply it, 1% said research should be banned, and 21% said they "don't know".
Q20 is similar to a question used in a 1991 European public opinion poll, and is a topical issue because the Japanese Agency for the Environment was considering legislation to control genetic engineering.
Note that the total %'s are somewhat more than 100%
because several respondents listed two answers for Q20.
|Industry & Government||62.2||59.1||46.7||54.5||52.3||54.0|
Comments included in the "Others", expressed as a % of the total number answering Q20. (Abbreviations include; G, government; I, industry; R, researcher; env., environmental).Scientists Environment
|Add env./consumer gps||0.4||0.5||0||0.3||0||0.2|
|Case-by-case, don't need||1.2||0.5||0.4||0.3||0.4||0.6|
It is desirable that international standards are developed, and several respondents actually said in their response to Q20 that they thought international standards should be used because they could not trust Japanese regulatory procedures. The level of public confidence would increase if the procedures used followed international trends, and this would also be supported by the majority of scientists. Although the first Japanese recombinant DNA regulations were a copy of the USA NIH regulations, because they took several years to be translated and approved by all the authorities and committees in Japan, the regulations were approved only shortly before the NIH changed their regulations. Recently, the USA guidelines (PCC 1991), and European guidelines (EP 1990), have been in a great state of flux, generally becoming less strict and less bureaucratic because of the results of many experiments which have shown there is little possibility of harm. There is also concern about the negative impact of bureaucracy which causes delays for regulatory approval which may make the country less competitive in the international biotechnology market. The exception is Germany, which has introduced a very bureaucratic system requiring much paperwork even for the lowest risk level experiments (GT 1990, Kahn 1992).
Environmental Release of GMOs
In December 1991 the Agency for the Environment special committee in Japan released a report on the regulation of the release of GMOs (EA 1991), fortunately after the questionnaires had been returned from the public so that the publicity did not interfere with the results of this survey. In that report, a decision was made not to introduce a specific law to regulate the release of GMOs, though the opinions were divided on this issue. The deliberations were based on international trends which have moved to product based regulation. This means that the product is considered in assessing the environmental or food safety, rather than the method used to produce the product. The idea is that we should not impose especially strict regulations on a new variety of plant if it was bred using genetic engineering, while we have no such regulations against varieties made in other ways, because other breeding methods may be just as likely to produce a variety with bad ecological effects.
In a February 1991 survey conducted by the Agency for the Environment (N=1363, EA 1992), but only released publicly in March 1992, several questions on regulation of biotechnology were asked. As discussed in chapter 4, the questions were somewhat leading and were answered after reading several pages of "introductory material", but they do give us some more information on Japanese attitudes to this topic. One question was "If you make the regulation about biotechnology very strict some people say that the development and use of biotechnology will be hindered. Chose the statement that matches your opinion most closely". 49% chose "although biotechnology makes life prosperous, we should give priority to the environment, so we should make the regulations very strict", 29% chose "although biotechnology makes life richer, we also need to keep the environment safe, so we should try to make regulations that do not hinder the development of biotechnology", 19% chose "we need to keep both sides, so we should rely on the good morals of researchers and companies to control biotechnology", 0.6% chose "because biotechnology makes life rich we do not need to worry about the environment", 2.4% said "don't know" and 0.1% said something else. It is encouraging that the public appears to value the environment highly, but the question they used suggests that the environment will only be protected by imposing strict regulations, which is not necessarily so. Most of their respondents appear to have followed the set responses and it is a contrast to the responses to Q20 where 12% cited other methods to regulate biotechnology, but in the Agency for the Environment survey only 0.1% (1 person?) listed their own reason. As discussed in section 4.6, the results of this survey (Q19) and the Agency for the Environment survey found that the majority of people support the environmental release of GMOs, and some type of guideline is required to ensure environmental safety, and to have public confidence.
The last question in the Environment Agency survey was "From now on, in order for biotechnology to be smoothly accepted, what is necessary? (You can chose every answer)". 54% said "in order to use biotechnology in various fields we should more positively emphasise the need to consider safety", 56% said "because the public don't know about the safety of biotechnology, researchers and industry need to explain so that people understand", 36% said "when using biotechnology, in order to maintain safety the government needs to have stronger control", 59% said "the government or city needs to make an effort to give people information", 1.6% said "don't know", and 2.6% said something else. In Q20 of this survey, the majority chose a combination of industry and government to regulate biotechnology, with some calls for wider involvement. In light of the strong call for public openness (Q16g), and the results from the Agency for the Environment survey, it is clear that the decision-making involved in regulation of biotechnology needs to be open to the public if it is to satisfy the public demand for open information.
There are different regulations and guidelines applying to recombinant DNA experiments under each government agency (JBA 1991). A committee is the only method to regulate such decisions. Whether the committee is statutory or not, the question is over who is on the committee, and how many committees there are. In a large country like Japan, there are sufficient academic resources to have separate committees for each government ministry, though none can be said to have much experience because there has only been one GMO to be released in the environment (a TMV-resistant tomato), and several approvals for growth of transgenic plants in glasshouses. There have been over 250 applications for large scale fermentation of recombinant DNA containing microorganisms and growth of tissue culture cells in Japan, but they are usually only required by these committees to meet good industrial large scale practice (GILSP) rather than special regulations (Furuya 1990). In the absence of any accidents there has been little concern with such fermentations, though the wastes should be sterilised. There is less safety concern if experiments do not require environmental release of a living organism, or don't involve work with pathogenic organisms, however, they should all be initially screened by an independent committee separate from the researchers involved.
The current committee members are mainly scientists, from government and private universities, with some industry scientists. None of them involve any public involvement, and the discussions are closed to the public. The view is that because they are guidelines there is no need for public involvement. There is no room for public objections to be expressed, because the applications for research permission are discussed in public only when a decision is made, accepting or rejecting the proposal. This is not unique to biotechnology decisions, but a feature of Japanese committees in general. This is in contrast to the situation in New Zealand, where even when there was only guidelines, the guidelines asked for public notification of the main features of the release in daily newspapers, so that the public could submit their opinion (Macer et al. 1991). In Britain (HMG 1990, HSE 1991) and the USA public notification is required by law for application to release of a GMO, so that the public can submit their opinions. An easy and obvious way to increase Japanese public confidence in the procedures would be to allow public submissions, and to release details of the discussion behind the decisions.
There has been significant money spent on public promotion of biotechnology in Japan, yet there are still many who see problems in the regulation of science, and risks from genetic manipulation. The promotion includes meetings on biotechnology, funded by the Science and Technology Agency (STA), and advertising effort through the media, emphasizing the benefits to Japanese people from technology. They have tended to concentrate on biotechnology in general, and biodetergents are used in almost every household, while biocosmetics have also been widely used, also increasing the familiarity of the public. The Ministry of International Trade and Industry (MITI) works through the Japan Bioindustry Association (JBA) to gain public acceptance. However, they should still note the level of public uneasiness, as seen in Q5 and Q7. In light of the responses to Q16g, such decision-making should be made open to the public. It would seem an obvious step to improve public confidence in the procedure to allow public submissions, and to make the decision making more open. One can only be cynical of decision-making processes that are kept closed to the public, in the same way that we can be cynical of decisions made on the safety of products when the results of tests are not published (see also chapter 6 and section 8-2). To protect commercial secrecy, industry can ask for the protection of the commercially sensitive information in a proposal, which is allowed in all countries.
Among the ideas expressed in the comments of people to "other" methods of regulation in Q20, most saw a role for a third party group in such decisions, such as other academics, and the public, that could be seen as independent. Ideally, there should be some non-scientists or public members on committees, but at least there should be room for public submission of opinions, and disclosure of discussions. However, there is no strong call for a special law to regulate biotechnology in the results from Q20, rather people see a role for the government and industry in regulation, with limited expressed support for the researchers being involved. They clearly rejected leaving such decisions to industry alone.
Some examples of the comments are below (unmarked comments are from the public, T=teachers, A=academics):
"The government, industry scientists and some wise public who are fairly selected should control the study"
"Make an ethical committee in universities and research organsiations"
"Government, administrators, scientists, research institute and the public"
"Industry, government, scientists and the general public should decide"
"Third party including specialists and ordinary people"
"2 plus individual researcher or specialist and ordinary people and philosophers"
"You need a third party organisation because the government and industry do not have ethical thinking, they always seek for their own benefit. Also the government's "ethical committee" is always on the side of power so we can't trust"
"Government decides regulation and needs citizen's consensus"
"Should ask people's opinion more widely"
"Have communication between consumers and producers"
"All humans should think about it, such as government, industry, universities, research institutes and the public"
"Government, industry and scientist and citizens should cooperate to decided the basis of regulations and how to do it"
"If industry or government decides they go for benefit, so it is better for independent researchers and ordinary people who have no connection with benefit, to decide" T
"As a country we should decided standards and the way of experiments, don't let academics or industry which have other motives decide" T
"Researchers, religious people and companies should be involved in a group, have a wide range of people" T
"Government, private and environmental protection organisations" A
"Society, the nation, industry and researchers" A
"Listen to the opinion of a wide range of people" A
"Practices should be decided by the reflection of the assessment by public groups" A
"Open debate by scholars from diverse fields" A
"We must strictly regulate that the safety data is directed to the public" A
"Should establish committees at each laboratory and university, and consider religious and philosophical advice"
"I don't think it is decided by the common sense of only one country"
"I don't understand who should decide, but whoever decides should stop academics and industry going to quickly"
"We should think worldwide"
"Should be regulated by an international group" T
"Experts of each country and each field may decide it at an international agency" A
"A committee of representatives of government, industry and knowledgeable people should decide"
"Independent people from every field should join the project to decide"
"Rather than the government, a third sector should be given the right to decide. As members, social and natural scientists should be included"
"Check by an independent and open research institute"
"Government, industry and researchers, everything"
"Group of researchers should decide, if they can't decide they should open their eyes to more public opinion and society"
"Conscience of scientists"
"I think the people who know this research and its safety well should decide fairly how to use it"
"I'm afraid that industry or individual researchers may think only of their own benefit"
"People who are affected most and industry and government, and they publish their results"
"Depends on the situation. If researcher's have a heart to aim for world peace I want them to do it for peace on earth"
"Government should decide under the direction of researchers who have no connection with industry"
"Joint decisions by government, industry, researchers and intellectuals in public"
"Before you make regulation, publish the research context and purpose. It is more important for individuals to have opinion and think about it"
"Government standards and citizen's opinion"
"Short-sighted judgement for political reasons should be avoided"
"Independent organisation" A
"Specialists should decide the standard by confirming the safety" A
"Specialised committee of researchers decides considering the opinions of Japanese and foreign intellectuals" A
"Establish a neutral organisation to widely collect the nation's opinion before making decisions" A
"I don't have a good idea because I can't trust government or industry" A
"Industry, government and academics" A
"A wider range of people should participate in making the decisions. It is not good that the system for making decisions only consists of people of one generation" A
"Researchers outside of industry and government should be added"
"Even if the government decides I don't know whether it is correct or not"
It would make sense to have a single independent multidisciplinary committee with room for public involvement, to overview all decisions. The problem is that the government ministries have been involved in a power play in biotechnology throughout the 1980's (Brock 1989), and this will continue, no ministry would like to give up power. Some people strongly expressed the opinion that the committee should be independent of the researchers. It may also be useful for the committee to be independent of any one government agency. Researchers face enough burden having to pass through the bureaucracy for one approval process, so may not support the idea of an extra committee. One process that might win the support of both the public and researchers might be to replace the existing committees with a single combined committee, that would apply standard procedures independently for all applications to release GMOs. There has only been one field release of a GMO in Japan so far, so it is unlikely to be swamped with too many applications. A single committee is responsible in most European countries which have regulations about release of GMOs, and they process many more applications than have been submitted in Japan. There are already some commercially available GMOs approved for general release in some countries, and this will arise soon in Japan. Establishing a single committee would prepare for the increasing number of applications for release that are coming as products are approved for commercial use overseas. The import of new varieties is generally controlled by the Ministry of Agriculture, Forestry and Fisheries (MAFF), and they have experience in handling such applications, therefore they are the obvious base for a central committee. But it would be politically important for other agencies to have input also, such as the Agency for the Environment, the Ministry of Education, Science and Culture, STA and MITI, which are involved with much of the Japanese research developing new varieties using genetic engineering. There is also broad support for industry and independent academics being directly involved in such decision-making.
There is an attitude prevailing in many circles that if something is not stated in the law, then it does not need to be done. However, since the beginning of genetic engineering in 1974, scientists have taken a lead in establishing voluntary guidelines on their work. There was a voluntary moratorium on genetic engineering research until certain safety experiments were performed. This phase of genetic engineering was contained in laboratories. This created a positive atmosphere between scientists and the public. In 1984 the first transgenic plant was tested in the environment, in Canada. The controversy over the field release of GMOs really began in the mid-1980's when a proposal to release a genetically modified bacteria to reduce frost damage to strawberry plants was made in the USA (see OTA (1988b), HMG (1989), NAS (1989), Macer (1990) for general background). Court cases were held and it was only by 1988 that a reasonably acceptable procedure for the release of GMOs in the USA had begun to work and large numbers of field trials began. In Europe there is also controversy, but standard law has been enacted in EC countries (EP 1990), though it will only be enacted in 1992 or later in many (Shackley & Hodgson 1991).
In these countries public involvement is legally laid out, though the details of scientific assessment procedures are still being developed. In New Zealand there has been little controversy, and the procedures are still becoming statutory (Macer et al. 1991). This may be because public involvement has been allowed, in the form of submissions, despite the agreement with the statement (Q16d) that the activities of scientists should be regulated more. In Japan, there has been local opposition to two contained facilities for genetic engineering (see chapter 4), but there is little controversy because there has only been one release of a GMO. Major controversy may have been avoided, but at the expense of not conducting field trials so that the development of the use of genetic engineering to breed new varieties has been delayed. We can see three basic approaches in these examples, regulate by law, regulate by cooperation, or avoid controversy by not having experiments to regulate! The most desirable is cooperation and a good relationship between researchers, the public and the regulatory committees. In some countries there is interplay between researchers and the committee during development of a GMO, which is useful to aid the researcher. Because Japan has been slow in this area of agricultural development of GMOs and field testing, at least it can gain from international scientific and regulatory experience.
Scientists know that they need to be careful because an adverse event would create public objection to further cases. One legal point that should be clarified is the question of who should take financial responsibility for damage caused by any accidents, no matter how small the chance. This is not very difficult to do before an event, but it can end up in extended court battles if it is not done. If it is a commercial product, it is obvious that company should compensate all parties, plus pay some environmental penalty. In Britain, Lloyds offers insurance for such accidents. Compulsory insurance should be obtained by parties as part of the conditions of a release. This sort of regulation should not be limited to GMOs but should apply to any newly introduced variety of organism.
Food and Drug Safety
The regulation of drug and food safety is simpler, it is handled by the Ministry of Health and Welfare. They released procedures for drug approval for products made from recombinant DNA in 1986, as discussed in chapter 6. They issued guidelines in March 1992 (MHW 1992). These guidelines were discussed in chapter 6, it is still to be seen how any of the international guidelines work. Only novel components that involve genetic engineering will be required to submit to extensive safety tests, which is reasonable. Publication of all safety test results may allay some concerns that the public may have.
Another area that should be regulated in its initial clinical trials is human somatic gene therapy trials. There are some differences internationally in the number of regulatory steps that must be passed. The USA has had most experience, with at least 16 approved trials and other rejected applications for gene transfer and gene therapy trials. They have recently reduced the number of committees required for approval to avoid duplication of effort (Gershon 1992). Although approval must be obtained from the Recombinant Advisory Committee (RAC), ultimate approval rests with the FDA, especially as commercial therapies are being developed and some have been approved to begin clinical trials (Bluestone 1992). They have a set of "Points to consider in human somatic cell therapy and gene therapy" (FDA 1991). In the UK a committee was established in February 1992, after publication of a Government report recommending the trials of gene therapy (Clothier 1992). Australia and Canada and some European countries have also issued reports on gene therapy, and have established committees. Any regulatory system should involve the participation of medical and scientific experts, and should be conducted in an open manner, presumably in the Ministry of Health and Welfare in Japan. The public consensus for trials exists, as shown in the survey results (section 7.3.).
Q16h and Q16i were addressed to the special groups, and were related. The results are in Table 8-5. 30% of the scientists, 28% of the teachers, and 26% of Tsukuba University staff thought that scientists had largely left it to others to communicate science to the public, which is much lower than the proportion of these groups that thought so in New Zealand, 69% and 60% of the scientists and teachers, respectively (Figure 8-3). Moreover, 47% of the teachers and 40% of the scientists in Japan thought that the public understanding of science is generally very poor, while 86% of New Zealand biology teachers thought so. 39% of the Tsukuba University staff agreed with this statement. About one fifth of the Japanese respondents disagreed with this statement, implying that they think that the Japanese public understanding of science is not very bad.
Internationally, Japan is regarded as one of the top countries in education (Newsweek 1991). New Zealand also has a high education level. However, many teachers in both countries think that public understanding of science is poor. Obviously in both countries, moves do need to be made to increase public understanding in the groups that have left educational facilities. There are also always possible improvements that can be made to school education, and there has been criticism of the rigid exam-learning processes required in the Japanese educational system. Such a system is not the best to educate people about decision-making, or thinking. Though the reason for the maintenance of such a system may be that these goals may not be desirable to all.
Q16j (Q16h in the public questionnaires) asked whether students should be informed about the social issues associated with science and technology so that they can take part in contemporary debates. The results are summarised in Table 8-6. 85% of Tsukuba University staff, 88% of the public, 89% of scientists, and 93% of high school biology teachers agreed with this statement. This is a clear mandate for inclusion of these issues in the curriculum, and this question was further addressed in the questionnaires to the teachers and scientists (some of whom are University teachers), in Q21. 95% of New Zealand high school biology teachers agreed with this statement, and 86% thought that the school biology curriculum should include discussion of the values associated with science and technology in New Zealand (Couchman & Fink-Jensen 1990).
A question that had been used for New Zealand high school teachers was asked of teachers, scientists and University staff, to examine the question of teaching of the issues associated with genetic engineering (Q21) more specifically.
For scientists and University staff:
Q21a. Have you ever taught about genetic engineering at high school?
1 Yes, undergraduate students 2 Yes, postgraduate students 3 No
Q21a. Have you ever taught about genetic engineering at high school? Circle all that apply.
1 Yes, third year students 2 Yes, second year students
3 Yes, first year students 4 No
Q21b. Have you ever discussed in class the social, ethical and/or environmental issues associated with genetic engineering? Circle all that apply.
1 Yes, social issues 2 Yes, ethical issues 3 Yes, environmental issues 4 No
Q21c. Do you think that more room should be made in the curriculum for discussion of these issues associated with genetic engineering? Circle all that apply.
1 Yes, social issues 2 Yes, ethical issues 3 Yes, environmental issues 4 No
Q16h: Japanese scientists have mostly left it to others to communicate science to the public. Scientists
Q16i: Public understanding and awareness of science is generally poor.
Among the University of Tsukuba staff that responded to this question, only 15% (16 individuals) said that they had taught about the social, ethical or environment issues associated with genetic engineering to postgraduate students, and 11% (12 individuals) to undergraduate students. However, there were only 22 individuals with a speciality in biological sciences. Therefore we should look at this group to look at the teaching of genetic engineering. Of these 22 individuals, 18 had taught about genetic engineering to undergraduates and 7 to postgraduates. Of the 18 that had taught about genetic engineering to undergraduates, 5 said they had talked about social issues, 6 said they had talked about ethical issues, and 8 said they had talked about environmental issues. Similar proportions had taught about these issues to postgraduates, but the numbers of these samples are not sufficient to draw general conclusions. The responses of the samples that had taught about genetic engineering to Q21c were the same as the whole University staff, and academic sample. Approximately half of these respondents had talked either about ethical or environmental issues, less about social issues.
There was strong general support, however, for the inclusion of these issues in the curriculum, with 61-77% of all academic respondents to Q21 agreeing to their inclusion in the curriculum. The responses for the scientists sample were similar, though a greater proportion of those who answered the question had taught about these issues (63 had taught about genetic engineering to postgraduates and 72 to undergraduates), all of these aspects had been discussed and there was similar support for their inclusion in the curriculum to the high school teachers. There was actually stronger support for Q21c from the company employees among the respondents who had taught about genetic engineering, with 8/9 agreeing with the inclusion of discussion of the environmental issues, and 7/8 agreeing with the inclusion of discussion about the ethical issues.
Another survey in Japan looking specifically at the current teaching of these issues was conducted in July 1991. A 52% mail response rate was obtained from faculty members of Universities (N=416, Honda et al. 1991). The response rate was similar to the response rate obtained from this survey, but the sex ratio was 95% male. They looked at the inclusion of discussion of various topics in undergraduate courses. 47% had covered genetic engineering applied to non-humans and 24% had discussed human genetics, compared to 30% who said they had covered IVF, 12% who had discussed contraception, 9% who had discussed abortion and 11% who had discussed surrogate mothers. Among what they called issues of bioethics, 47% had discussed the " destruction of the environment and organisms", 37% had discussed "genetic engineering", 18% "human reproductive biology", 13% "human bio-engineering" and 23% "human health and disease".
There should be research into how these issues might be taught, whether it is through their inclusion in science courses, and/or specialised courses in bioethics. Specialised courses in bioethics are only available at a few Universities in Japan, such as Waseda University, but they have focused on medical issues. A course including nonmedical subjects is taught in the College of Biological Sciences, of the University of Tsukuba, in addition to some teaching of bioethics in a general introductory biology course. There is a course on the philosophy of science and bioethics taught in the biology course of Tokyo Institute of Technology, but there may be none at other Universities in Japan yet. Scientists should also be encouraged to supplement the teaching of such specialised courses with inclusion of some discussion of these issues in science courses, in view of the results of this survey.
There should also be moves made to increase adult education. This could come through teaching these issues in lectures through the media University of the Air, but this has limited coverage of Japan. Major television networks, such as NHK, also need to be actively involved. There are some written publications, but the quality is very varied. The mass media is obviously the major medium through which the general public will obtain information on these issues.
|Number who responded to Q21a&b||218||330||127||270|
Q21a & b; The number of survey respondents who answered yes to the following questions:
a. Have you ever taught about genetic engineering? To...
|1st year high school students||71||-||-||-|
|2nd year high school students||106||-||-||-|
|3rd year high school students||91||-||-||-|
|To undergraduate students||-||73||16||71|
|To postgraduate students||-||63||12||61|
b. Have you ever taught about these issues associated with genetic engineering?
|Yes, social issues (N)||91 (41%)||70||13||65|
|Yes, ethical issues (N)||110 (51%)||76||20||69|
|Yes, environmental issues (N)||126 (58%)||88||20||86|
Q21c: Should these issues be included in the curriculum?
|Number who responded||217||363||131||295|
|Yes, social issues (%)||49.8||62.1||66.1||61.4|
|Yes, ethical issues (%)||53.0||63.2||68.2||61.8|
|Yes, environmental issues (%)||70.4||73.6||77.1||74.2|
Q16j: Students should be informed about the social issues associated with science and technology so that they can participate in contemporary debates.
To look at how the media communication of science was made, several questions (Q1-4) were asked, and these were discussed in chapter 3. A question (Q15) was used which was similar to that of Couchman & Fink-Jensen (1990) in New Zealand in the questionnaires to the University staff, scientists and high school teachers, to look at the perceived standard of media coverage.
"There is a great gap between newspapers. Only interesting topics are reported, they don't report conclusive articles, or negative articles, or else they only report negatively from the beginning" T
"I think that TV newscasters are the worst. They make the mass of people feel anxiety" A
"It's not the matter whether they broadcast or not, but they have no idea of the context of science and technology, and how it is understood and the social influence" A
The responses to the question "How do you rate
media coverage of science and technology in Japan?" (%'s).
An indirect method to look at this question was by asking people what they thought influenced their thinking. Towards the end of the questionnaire people were also asked what are the sources of their feelings about these issues (Q18 special groups, Q15 public), as another measure of the influences on the opinions expressed in the survey.
Q18. What things are the source of your feelings about these issues?
(MARK ALL THAT APPLY)
1 What your friends or family have said
2 What you have heard on the television
3 What you read in the newspaper
4 Your religious belief
5 Other (Write down)
The meaning of this question in Japanese was somewhat ambiguous, so that when its position in the questionnaire was in a different place (after Q14 instead of after Q17), some people gave specific answers depending on the question placement. Q14 concerned using gene therapy on children, and a few people wrote that they would do anything to help their children, or that they suffered from a genetic disease so that they would try any treatment. When the question was after Q17, concerning patenting, a few people gave answers relating to the patent law. Nevertheless, the question is still valuable for some insight into the way people think that they reach decisions, as was discussed in chapter 7.
Scientists tended to use the newspaper more than other media, 29% listing newspapers, while only 19% listed the television, 3% friends, 3% religion, but 73% listed other sources, including books and personal ideas. 45% of teachers listed the newspaper, while 33% listed television, 2% listed friends, none listed religion, with 55% citing other sources as being important in coming to their conclusions on these questions. The mass media is a source of information for specialists as well as the general public, as has been shown in studies of medical papers cited by scientists (Phillips et al. 1991). Academics cannot read all the literature, and the media amplifies some research. The most important discoveries are usually reported in the media, and the way they are reported is important for all groups, public, teachers and academics.
In Japan, the information gathering habits of people have been examined before. In the Nikkei (1983) survey of business people, people were asked about their reading habits, with regard to newspaper articles about biotechnology. 18% said they read them carefully, 66% said they read it if they see an article, the rest said they might look at the titles or else would not notice it. Only 23% said the articles were easy to read. They were asked where they got their information about biotechnology, 86% said from newspapers, 55% said from television, 37% said from industry newspapers, 22% said from ordinary magazines. In a 1985 survey of the public in Japan (N=7439, PMO 1986a), people were asked what were the major sources of their information about life science, via agreement with a series of options. 79% said television and 69% said newspapers, whereas the other options were all minor sources; 7% said they got information through periodical magazines, 4% via science magazines and 4% from friends, with only 1% listing books, while 7% said they don't get information. In another survey in January 1990 (N=2239, PMO 1990c), people were asked what were their information sources for science and technology in general. 90% said television, newspapers, radio and magazines, 24% said conversation with friends and family, 11% said specialised magazines or books, and 7% said via museums or science exhibitions, while 8% said that they don't get information. In the 1991 Agency for the Environment survey (EA 1992) people were asked where they heard about biotechnology from. 91% said from the mass media, 15% said that they had read a book, 13% said that they had visited a facility doing biotechnology, 7% said other sources, and 1% didn't answer. The media is obviously important in informing people, and this was also seen in section 3.1., when looking at public interest in science. It also presents a more understandable message than do most scientists and scientific books, so it will remain the major source until scientists can communicate themselves.
This is also true of other countries, for example in the Netherlands in 1991, 75% of the public said they had heard of genetic engineering and 75% of these said they learnt about genetic engineering from the media (Hamstra 1991). The media has a major responsibility to educate the public, and to publicly report on the subject. The different groups concerned with public interest in biotechnology must use the media to convey their messages. We hope that the public is becoming discerning of what they read. The results of opinion surveys in the USA (OTA 1987) and in Britain (Kenward 1989) have suggested that the public has low confidence in the media as a source of information, but it is the most widely available source.
The total is more than 100% because respondents could
list several influences.
|Q14 or Q17
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