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10.4Clinical Research and Ethics Committees

In parallel with the investigation by its federal government, the U.S. Congress enacted the National Research Act in 1974 for the purpose of protecting human subjects in medical research. This act obliged any researcher conducting a human experiment to submit a research protocol to the Institutional Review Board (IRB) and obtain approval prior to applying for a research grant (Fig. 10-1). The IRB evaluates the proposal in the light of the guidelines set by a federal level committee, and the evaluation particularly focuses on whether or not the informed consent obtained from the human subject is legitimate. Now that the 17 government agencies in the United States responsible for research funding have common guidelines to implement, the procedures are called the Common Rule. This rule stipulates that the IRB should invite outsiders, who are not only science specialists but also well versed in the areas such as law and ethics, as members of the committee to well balance the membership in terms of gender, race, and culture.

Fig. 10-1. Guidelines + Committee Structure

The birth of the IRB was made possible by America's commitment in bioethics, and for that matter, this is virtually the only exclusive regulation that exists in the United Sates. In the earliest years, researchers raised objections that this system would infringe the freedom of research. However, the revision of the Helsinki Declaration in 1975 added to its original text the new provision that editors of scientific journals should not accept research papers if they do not pass the IRB screening. Since then, the IRB has become widespread among researchers worldwide.
In Japan, in the beginning of the 1980s, in vitro fertilization received a great deal of public attention, and to deal with new challenges, medical departments at Japanese universities begun to set up their ethical committees within school. Since then, many ethical issues such as brain death and organ transplantation (see Column at the bottom) have appeared one after another, and the significance of ethical committees has grown over the years. However, Japanese ethical committees have no legal authority braced by regulations such as the National Research Act of the United States, and have no defined the criteria concerning the degree of its authority, the scope of the subject matter of examination, its personnel organization, and the openness of its council, etc.

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Brain Death and Organ Transplants

In 1997, the Organ Transplant Law was enacted in Japan. Organ transplantation based on the concept of brain death started that year. However, compared to other countries, the number of transplantations that actually took place is markedly small. One theory is that in Japan, the social cognition of brain death has not yet progressed. However, opinion polls in other countries show otherwise: about 60% consider brain death to be equal to a person's death, while 10–20% deny this, which is about the same worldwide, including Japan. The truth is that in other countries, society rarely raises objections about a physician group treating the patient in the most terminal stage judged to be "brain dead" as a person close to death. Thus, brain death and organ transplantation can be left to the discretion of physicians, and their authority and trust in medicine, and be considered as borderline medical treatments performed as a matter of routine, albeit involving a painful decision. In Japan, in contrast, its physician groups are not regarded as professional organizations with mandatory participation and cannot put these borderline medical treatments in their administrative power. As a result, the question of whether brain death should be considered equal to the death of a human being has been left much to public discretion.
In July 2009, the Japanese Diet adopted the amendment of the Organ Transplant Law. The revised law across the board sets brain death equal to the death of a human being. The new law has made it possible to remove organs from brain-dead people with the consent of their family in case the will of the concerned person is unknown. Also, the revision of the Organ Transplant Law has made organ transplantations from children aged 14 years or younger legally possible. However, nobody anticipates this revised law to ramp up organ transplantation in Japan.

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