Pak: Our first session is on the Ethics of Medical Research. Thank you Dr. Zhai, are there any questions?
Macer: I wanted to ask you about autonomy. Autonomy comes from the Greek word for self-rule. It was first used for city states. You were saying that the Chinese concept for autonomy was very different. I was wondering which parts of autonomy do Chinese people don't show? For example, individual autonomy-how is the Chinese concept different from that of the United States.
Zhai: One difference is that in Western nations autonomy is absolute individual decision-making. But in China, decision-making involves family, friends and significant others. Thus, physicians and researchers would like to get everyone's opinion and not just the individual's.
Macer: Yes. I think that in many Western cultures, the family is involved as well. Zhai: Yes, but sometimes regulations insist on absolute individual autonomy. Even if we insist that individual decisions should be made. Actually, this does not reflect the truth.
Pak: Before comments, please let us know you name and position.
Leavitt: I am from Ben Gurion University in Israel. I have a comment. Asian bioethicists assume that the West (Europe and North America) has autonomy and informed consent. In medical clinical trials in the West I think that this is an illusion; they pretend to have it but they don't. I want to make three points to make it clear what I'm saying. In every clinical trial contract, which I have seen, researchers have a right to publish data about drugs only if they get permission from drug companies. In some contracts, doctors are only allowed to publish data that benefit drug companies. This means that if a doctor discovers that the drug being tested is damaging to the patient, he can't tell the patient without permission of the drug company. In which case, patients don't have a right to withdraw at anytime they want because the patient does not know what is going one. The patient is not informed. This is one problem. Another problem is placebo. Patients are put in a situation wherein they have to make a choice between not being treated at all or taking a chance that they may be treated; that is, taking a risk that they may get sugar rather than medicine. This is coercion. This is not free voluntary informed consent. My third example is that sick people are not as mentally capable as people who are well. There have been many researchers conducted comparing patients inside and outside the hospital. I don't mean regular psychiatric patients but regular sick people whose intellectual ability to solve problems is not as good. They are sick; they are frightened; they don't feel well. Then they are made to get an informed consent to a clinical trial of a drug; it's not informed consent. I am suggesting that autonomy in the West is an illusion. And I don't think that Asian bioethicists should think that the West has something better---they don't.
Azariah: I'm from India. I would like to know whether you have many different dialects in Chinese language. In that case, how do you get informed consent?
Zhai: Yes, that's a very good question. Usually, we use Mandarin. The researchers use Mandarin. And almost everyone can understand Mandarin. And when we had to go to remote places that have very distinct languages, we had to find local persons who helped us negotiate and communicate with patients.
Rei: I'm from Taipei. If the subject disagrees with the family, in your research how does the doctor respond? My second question is whether in some cases the head of the village needs to give their permission about what criteria they consider whether to give their consent or not?
Zhai: In cases where there is conflict between patients and family members, usually researchers and physicians try to make them resolve it and come up with mutual agreements. But if they can't, we have to give up . That's the usual situation. As for your second question, we need to get the permission of the head of the village before we can do anything. We get the permission first. Then we can interview the subjects.
Shinagawa: You said that Western ethics is based on human rights. And Chinese ethics is based on duty. Do you think that young people still find duty-based ethics important?
Zhai: Some people say that Chinese culture has changed. But I think this aspect is still relevant. And I can see this in the attitudes of my students; especially when they have to deal with issues of majority and minority.
Pak: Thank you. Are there any questions for Dr. Niu?
Gupta: I am from India. You mentioned a very interesting case where some women were given forms that they couldn't understand. I think this is particularly also very relevant in other countries. How can you make laws that will make legalese more understandable to people who aren't so highly educated? Su: I'm from PUMC in China. You mentioned that in Taiwan, compensation of human subjects takes into consideration future harm. How do you go about this? How long into the future do you consider?
Leavitt: I just have two brief questions. The first is that you said that no major ethical principles serves for compensating injured human subjects. Wouldn't you be able to do this using the principle of justice? My second question is that you mentioned that there are 129 teaching hospitals in Taiwan. How many medical schools are there that are served by these teaching hospitals?
De Castro: I'm Leo de Castro from the University of the Philippines. You mentioned that uncertainty or scientific uncertainty being a cause of harm or injury. Can you please clarify this point further.
Niu: The uncertainty of the cause makes it difficult to decide negligence and decide compensation. As for Su Baoqi's question about how to deal with injuries that occurred in the past, we have to prove that there is a causal linkage. This means if we can prove that the research contributed to the injury, it is easy. But the most difficult part is how to prove this. Because sometimes the injury may not have been caused by the research alone, but other researches may have contributed to this result. That's why out of 80,000 cases were proven to have direct causality. The problem is that the patient does not possess adequate knowledge as to what exactly contributed to the injury. We know something went wrong but we cannot prove it. As for the Dr. Gupta's comment on informed consent forms, I think that this is an issue in most countries not just Taiwan. I do not think anywhere deals with it properly. In theory, we would like to improve it by making patients know what is going to happen; but , in practice, most medical doctors don't have time, and if they don't explain because it will take too long. So they don't explain clearly to make things easier to deal with. I think that this is not something the law deals with. We do have forms but I think it is very difficult to include all the points on a simple informed consent form. As for Dr. Leavitt's question, there are 13 medical schools served by these. This is the official information. Justice is used in different ways. Could justice be the final weapon. It is ok to use justice if we can clearly see the negligence, but for uncertainty I think there are different arguments about it. It is not always clear after investigation. The link between compensation and justice has not been fully explored. I agree that we could argue from the point of justice or social justice but there are still many points that need to be clarified.
Pak: Thank you to Dr. Niu. Are there any questions for Dr. Kim?
Leavitt: You mentioned non-medical members of IRBs, can you please give some examples? What kind of non-medical people serve on IRBs. My second question is that you said that IRBs review payments to the participants. Do you think that they should review payments to doctors?
Bagheri: I'm from Iraq and Japan. Does the IRB approve such compensations?
Kim: First of all, in Korea it is common to have members of religious organizations on IRBs such as pastors, nuns or Buddhist monks. And there are also lawyers on some IRBs. As for the second question, I think that's a big issue globally. We need to seek for more concrete answers on that issue. As for Dr. Bagheri's question, there has to be a classification of the type of compensation first. There are forms for this particular purpose that one has to fill out. But in reality, although researchers must have compensation policies as mandated by law; in academic research, they don't event submit the protocol to IRBs. So we don't know.
Wang: I am from the Chinese Academy of Social Sciences. But now I'm teaching at a medical university in Korea. I heard of an interesting story on the relationship of IRBs with the hospital. One doctor told me of an interesting case. A Japanese person wanted a kidney but the donor was a hospital employee. There were questions about whether the case was ethical, and the person was fired from the IRB. Should the director of the hospital strictly follow the IRB's decision?
Kim: We have two separate ethics committees in the hospital. I think you are referring to the case of hospital ethics committee that is in charge of reviewing medical practices. But we also have IRBs who are in charge of reviewing research protocols. Your case is the later case.
Pak: The next speaker is Dr. Nurten Aksoy. Are there any questions?
Macer: In Turkey, do medical lawyers accept medical ethicists very well? How do they work together in the committees?
Nurten Aksoy: Yes, in central committees they work together well. But in local committees they do not have lawyers.
Zawawi: I am from Malaysia. I have two questions. First, with regards to the composition of the committee, who ultimately decides who ought to be on the board or who should be committee members? My second question is does religion play a role in making decisions in the research ethics committee?
Nurten Aksoy: A regulation of the Turkish higher education authority decides who can become members of the committee. As for your second question, no, we don't have religious people in these committees.
Pak: Thank you. Next is a paper by Mrs. Suda and Dr. Macer. Are there any questions? Gupta: Can you please explain what snowball sampling means?
Suda: Usually, a few persons will first be contacted. After explaining the project and getting their consent to participate in the project, they will be asked to pass the information to about ten of their acquaintances of different occupations and so on. This will include members of different occupation, and also will include some members of research institutes.
Pak: I express my gratitude and I very much appreciate the contribution of all of you for the successful progress of this morning's session.