What is informed consent?
It is an ethical and legal principle which applies to the doctor–patient relationship, and which grants patients the right to be properly informed about their situation. Doctors must give patients adequate information about their condition and the various treatment options available so that the patient can reach a decision. This principle also applies to research, and all researchers must have the informed consent of participants before including them in studies.

How can the same principle apply to two such different aspects of medicine as treatment decisions and whether or not to participate in research?
Although these situations are very dissimilar, it is really only the specific circumstances which differ. The fact that the underlying principles are the same means that the concept of informed consent applies in both cases.

Does the informed consent have to be signed, or can it be given orally?
Informed consent can be given either orally or in writing, although the weight attached to each depends on cultural factors. In the United States, both forms are required. However, more important than the issue of whether or not a form has been signed is the need to ensure that the patient has understood the explanations given by the doctor, who must outline the risks associated with each option and ensure that the patient understands these.

What criteria are used to decide whether a person is competent to take decisions?
Competency is a legal and psychiatric term which refers to a patient’s capacity to understand and to make make decisions. Sometimes patients suffer from intermittent dementia, and this may make it very difficult for doctors to accurately assess the patient’s level of competency. Normally, minors are excluded from decision-making, although the principle of assent is sometimes applied to children aged eight and over. Children from this age onwards are believed to be able to distinguish between good and bad, and this means that they are sometimes able to participate in the process even if they do not actually make the final decision.

What should doctors do when faced with parents who are unable to agree on a decision about the treatment of their child?
Doctors suggest; they never make decisions unilaterally. Some years ago in the United States there was a case of a terminally ill child whose parents were separated. The child lived with his mother, and the father had apparently had nothing to do with him over the preceding years. When the child was admitted to hospital in a terminal state, the father asked that everything possible be done to keep him alive. The situation was irreversible and, given that the treatment would be very painful, the mother did not want her son to suffer any further. In this situation, the hospital’s ethics committee decided to take the mother’s side.

What happens if a patient opts for an ill-advised medical treatment?
Patients are usually intelligent enough to choose what is best for them. When a friend of mine was diagnosed with cancer, her doctor suggested three alternatives, of which, in his opinion, the best was to attend the hospital three times a week for treatment. My friend reached the conclusion that this would worsen her quality of life and decided to undergo surgery. A few years later she is in perfect health. The one-to-one relationship she had with her doctor played a key role in enabling her to choose her treatment.

The case of Terry Schiavo, a woman who had spent 15 years in a vegetative state, is a good example of a patient unable to decide for herself. Faced with a dispute between the patient’s parents and her husband, the law supported the husband’s decision to disconnect the life support machine. What is your opinion of this case?
I believe that this was the right decision. In cases such as this, two issues need to be taken into account: whether the patient is competent to take a decision (in this case, the patient was not competent) and whether there is any hope of improvement in the future (her condition was irreversible). However, the case then became politicised and became a national issue. In my opinion, someone should have explained Terry’s medical condition to her parents and helped them to understand that there was no hope of improvement. Nobody helped them to overcome this problem. We should also remember how expensive it is to keep somebody in a persistent vegetative state, particularly when we bear in mind that in the United States there are millions of people without access to the health system.

Do you believe that this decision should have been taken in a medical context: that is, by an ethics committee?
Lots of interests became involved. The government, the opposition and various lobbies politicised the issue when they should have stayed out of it. In light of what happened, I would have supported the decision being taken not by the courts but by an ethics committee made up of professionals from a range of disciplines – medicine, philosophy etc. – to ensure a variety of perspectives.

You have worked in both the United States and Asia. What differences do you see between patients in these countries?
We are talking about radically different societies. In Anglo-American culture, bioethics is based on individual values and there can be a conflict of interests between the good of the individual and the collective good, although this tension is sometimes positive. In Asia and particularly in Japan, this duality does not exist because what really matters is the group, usually in the form of the family. People are incredibly loyal to the group, and respect its decisions because they believe that these will be for the benefit of all. This principle of group loyalty is very deeply rooted in Japanese society, not only in the sphere of medical care but also in the world of business.