Development of Human Resources who Support Ethical Decision Making
Center of Life Science and Society (CLSS)
Center for Biomedical Ethics and Law (CBEL)
INABA Kazuhito
1. Introduction
There are 2 fields in bioethics: those on birth and death. "Tailor-made" Medicine (individually customized treatment), which is drawing public attention nowadays, is the medical study and treatment using gene therapy and it includes many bioethical problems such as personal data protection, discrimination, intelligence management, and other legal and ethical questions. Our center, Center of Life Science and Society (CLSS), is offering the service of consultation to official and semi-official organizations concerning these issues.
Within jurisprudence, there are two kinds of law, civil and criminal, and ways to determine them (litigation, etc.).
Researchers have a peer review system to maintain proper procedures of research in the medical fields. But its limititation has appeared, and ethics committees began to be take precedence over the peer review system. It is said that ethics committee should be open and independent, and should have proper members,
CLSS and CBEL accept both working students and university students, and train them to be scholars or consultants. The education curriculum for scholars and consultants are the same. It consists of lectures, exercises and practices. In the lectures, a knowledge-based aspect is taught, such as history of bio/medical ethics, theories, recent trends and so on; and we have small group discussions with plenty of case studies. These discussions are an opportunity for every attendee to think logically and to explain their own position to others.
In the seminars, we have exercises for ethics committees and ethical consulting. In the former, mock ethics committees are held as training. In these exercises, we have communication training with the intent of enabling specialists to successfully communicate with lay people. I sometimes help students to discuss important matters in proper proportions.
In the latter, students discuss in groups the problems happening everyday in the medical field. I consider that both exercises are training fields for students to reach conclusions through discussions containing various values and ways of thinking that may be in opposition.
In the practices, students are obligated to go to hospitals and research institutions to observe the actual field of gene research and clinical trials and to consider practices that enable attendees to debate current issues in medical practice and research.
On Thursdays, we have fourteen three-hour lectures and small group discussion classes, three Saturday afternoon classes including mock ethics review committee and ethical consultation exercises, and three-days of training.
We have 2 kinds of staff with different backgrounds: health care practitioners (such as medical doctors, nurses, psychotherapists) and social science (such as ethics, philosophy, and law). We have 291 students. 62are medical doctors, 38 are nurses, 52 are other co-medicals, 40 are from pharmaceutical companies, 95 have other backgrounds.
2. Basis of Law
Legal rights and duties are interrelated. Lacking either means failing to complete one's responsibility. From a moral viewpoint, right and duty are not always connected.
In the Civil Code, the subject of rights are a natural person and a juristic person, and the object is a thing. A natural person has the capacity of all rights. An article says rights begin at birth. What's about an unborn baby? There are specific articles on an unborn baby, though, no article on an embryo and a fertilized egg. This is called a defect of law or blank of law. in regards to right's capacity, an ability to take a legally valid action is called legal capacity. It is a problem to use a person's genetic information when at the end there is no declaration of intention or an acceptable representative.
To commit a crime, the constituent elements of illegality and criminal intent must exist. When there is any justification on legal terms or intent, a crime is not committed. Whether an organ transplant is a crime or not, such as taking the liver of a healthy person, depends on the justification of its legality.
Malpractice is a problem in the Civil Code. To show proof, the plaintiff and defendant dispute their evidence on negligence, damage and causation, and a judge passes judgment on them. Damage is defined as harm to patients, and negligence causes damage. This relationship is called causation.
Lawyers embrace the doctrine of judicial precedent set in past cases. A judgement is conclusive; and those that have been declared as binding such as by the Supreme Court are called a precedent. The famous Yokohama district court judgment in the Tokai University euthanasia case, is of little value for attorneys.
3. Bio/Medical Ethics, Law and Guideline
In the past bio/medical ethics had three main issues such as transplant, reproduction and genetic cure. In recent years, we have ES cells, a new issue, which overlaps the three issues above.
The Helsinki Declaration, which is an ethical norm concerning medical research on humans, is a basic norm to regulate clinical research. I think a person who will be a member of an ethics committee should necessarily read it completely at least once. It is really fundamental.
In the Japanese history of IRB, we had the Scientific Technology Conference Bioethics Committee in the Ministry of Education, Culture, Sports, Science and Technology. There were three committee meetings at that time; clone committee meeting, human embryo study committee meeting, and human genome study committee meeting and each made clone prohibition into law and made specific embryo guidelines, the ES cells guideline and human genome guideline. On clone and human embryo research, these were compiled as "Basic Consideration on Human Embryo Treatment" at Council for Science and Technology Policy specialized in bioethics investigation on July 2004. As the Total Science Technology Conference belongs to the Cabinet, it's in a higher position than those belonging to the Ministry of Education, Culture, Sports, Science and Technology the Ministry of Economy, Trade and Industry and the Ministry of Health, Labor and Welfare. Clinical study ethics guideline and other guidelines have some overlap.
We have five guidelines: the guideline on human genome, ES, genes, epidemiological research, and clinical research. In ERB activities, it is important to determine which guideline is to be applied to the problem.
What is the difference between guidelines and law? The high risk potentionial of organ transplant has made it into law. Cloning has risks for insurance discrimination, employment, living and so on; I think a law is needed for cloning, but one does not exist yet. In Japan arguments on bioethics policies has not yet been thorough enough.
4. Law in Terminal Care
Person's capacity is stipulated in the Civil Code.
In argument on terminal care, there is a system called "Advanced Directive". A directive contains the Living Will and Durable Power of Attorney. A Living Will is to define treatment or precise care to doctors (ex. no useless prolongation treatment). It is similar to yuigon in Japan; however, yuigon is only about property and it works validly only after death. Durable power of attorney is a system to ask specific person to decide matters in some specific situation. It's usually called durable power of representation. In the U.S. this system has developed because Japan and the U.S. have different civil code system. In Japanese Civil Code, the legal or voluntary representative has no power of consent in medical treatment.
About terminal care, some members of the house of Representative and the House of Councilors have suggested the preparation of a draft of death with dignity.
If a patient asks his or her medical doctor to turn off a life-support in terminal care, the doctor has to consider murder, bodily injury resulting in death, abandonment against protecting duty, aiding and abetting a suicide, and murder with agreement, from the viewpoint of criminal law.
There are clear differences between essence of Law and that of ethics concerning death. The law's purpose is to prevent deviations and ethics' purpose is to live better. Therefore the essence of law is similar to the SOL idea and that of ethics is similar to QOL idea .
5. Variation of ERB; Clinical Ethics
There are three kinds of Ethical Review Boards (ERB): Research Ethics Committee, Clinical Ethics Trial Committee, and Clinical Ethics Committee. The former two are included in IRB, and the last is included in Hospital Ethics Committee (HEC).
The competency for ethical consultation and that for research ethics judgment are different. Both need the basic knowledge of laws relevant to ethics and medical treatment. In consultation, a consultant has to talk to patients, their families, and people of other jobs. Many nurses get interested in the field. On the other hand, in research ethics judgment, a judge has to understand a study's significance. People with a medical or academic background tend to be interested in it. Some say that the purpose of ethics consultation is to assist better decision making in medical treatment.
We allow four hours for the ethics consultation exercise in our course.
6. Personal Data Protection
The law protecting personal information requires that organizations should specify the purpose of gathering and using data, and should let the test subject know in advance if he or she could know his or her personal data, and shouldn't use the data for other purposes (responsibility of enterprises treating five thousand cases and more). The principal can demand disclosure of the information. And in case of academic study needs, the information can be used for other purposes.
Today gene data is coming into question. Big enterprises have begun to form a gene data bank. A criminal investigation database has begun to be used, which has the problem that it includes the data of not-guilty people who were arrested but were not guilty.
In gene screening, we have to discuss social discrimination, right to know, and the right not to know.
The Act for Protection of Computer Processed Personal Data Held by Administrative Organs in Japan is not a specialized act in medical care. We have two kinds of issue in the Personal Data Protection within health care; personal data protection in clinic practice and in epidemiological study. There are guidelines for the former, Personal Data Protection. We have a guiding principle for human genome research besides legal grounds because the personal data protection act doesn't apply to medical study (article fifty paragraph one number three). The restricting situation is quite troublesome in that we have only principles and no law for medical treatments that include a lot of genetic information.
Q & A
1. Career path of the graduates
Q: What are the backgrounds of the graduates of the course and in which fields are they working after they finish the course?
A: Many have doctor or nursing backgrounds, Almost half of the students have health care background including co-medical. Also we have people from pharmaceutical companies. In the summer concentrating course, around a quarter were university teachers.
After they graduate, some began to work as ethics committee members or committees' secretaries. But most went back to their former jobs. We have only eighty grads through two seasons. I heard they have some exchanges with people from the division of health care policies of Tokyo University.
2. EBM Ethics
Q: Today we have emerging technology in which the influence to human body and environment is not clear. How and what kind of processes are taken to make ethical judgments with new medical treatment without evidence?
A: We have medical treatments of which evidences are not established.. Sometimes even medical examination guidelines are decided without evidence. I mentioned about EBM ethics because I wanted to say that we should check if evidence exists. Analytical work is needed to determine if evidence exists or not and if the evidence is strong or weak?
About judgment without evidence, we'd better distinguish the field of political decision making from the clinical field. In the clinical field, we would inform patients of risk and support their decision making. In the political decision making, we should gather basic materials of other countries' policies on these issues. Otherwise a decision may be made by power politics.
3. Regeneration Medicine, Cloning, Embryonic Stem Cell
Q: You described the emergence of regeneration medicine, and ES cell as "Birth of problems across the fields". Do you think we should establish guidelines for the new technology, integrating various guidelines in existence?
A: No, I don't. Because ES cells are quite influential in society, it's not enough to pile up the existing guidelines like a patchwork. Debate over each guideline is needed. As with ES cells it's essential to grasp the latest in medical study. (I'm wondering if anybody is sure ES can be used in regeneration medical treatment.) We ought to think thoroughly about restrictions with an accurate understanding of the latest situation and possibilities. There might be an unrealizable story included.
Q: How do you make ethical decision on the newest technology?
A: For the regeneration case in Kansai Medical School, it took about year to make the decision because they could not tell if the regeneration treatment had effects. The methods for decision making on the newest technology has not been established.
4. Present Situation of CBEL in Tokyo University
Q: Do more participants from the local district than from metropolitan area join in summer intensive course? Competitive rate is eighty attendees against two hundred and ninety applicants? What are the criterion to choose attendees?
A: Many are from neighboring areas in ordinary courses, as the classes are on Thursday night. So we are planning to take more people from local district in summer. At the first seminar, the competitive rate was five to ten. We try to make the proportion of the variation of students background that same as that of an actual ethics committee.. We want to choose students who can apply what they learn in CBEL soon after they graduate. Also, we try to choose people who applied for the course several times.
5. Which universities or which programs are the models of CBEL?
Q: You said that you let your staff attend programs abroad. Are there any programs in foreign countries that are models for Tokyo University CBEL?
A: The Kennedy Ethics Institute and Australia are the ones. In the Kennedy, ethics education syllabuses are gathered from around the world. There we collected thirty and chose the core ones and made a priority to form the core curriculum.
Q: Can I see the Kennedy ones on the web?
A: I think you can.
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