Medical Research: Exploring the Principles of Regulation and Support : Professor Tetsu Isobe

Title：Medical Research: Exploring the Principles of Regulation and Support
Professor Tetsu Isobe, Law School, Keio University
【Description】
I research in the field of administrative law and medical law.

Medical law is a research field where we address advanced medical technologies such as organ transplantation, prenatal diagnosis and assisted reproduction technology.
Also, medical law is an interdisciplinary research area where we have to consider issues from various legal points such as constitutional law, administrative law, criminal law and civil law.

The traditional themes in medical law include the healthcare system, the status and duty of healthcare professionals, and the physician-patient relationship; however, the issue of medical research regulations has recently come to be subject of debate.
In clinical practice, the highly-professional discretion and judgment of medical staff such as physicians and nurses are generally respected. This is because we believe that they are professionals who place the patient's best interest such as their life and health as the highest priority.

In contrast, healthy subjects and patients are used as a means, a "tool" for scientific knowledge in medical research to develop new medicines and treatments.

Therefore, sufficient ethical considerations for human subjects are necessary such as through a review by a Research Ethics Committee.

Such ethical rules about the protection of human subjects have been established through inappropriate medical research and experimental therapy experiences including Nazi human experimentation and many adverse drug incidents that have occurred in our country.
Ensuring data reliability, prevention of research misconduct, and management of conflicts of interest are also important issues of medical research.
Nevertheless, laws regulating medical research in Japan exist only in few fields, such as clinical trials, clone technology, and regenerative medicine.

Many other issues are subject to ethical guidelines established by the administrative bodies. This is a remarkable system.

Following the Diovan incident in 2014, Japan enacted Law on Clinical Research, and a portion of clinical research, such as research that receives corporate funding, will be regulated from this year.

I consider that, in Japan, when problems occur, distinct individual measures have been adopted and the consistency and conformity of the entire system has been neglected.
There are opinions that laws to comprehensively regulate all sorts of medical research should be established with reference to France and others.

Now we shouldn't think that all our problems will be fixed by recklessly importing the system from another country that is significantly different in social trends; however, It is common that people, things, and information surrounding medical research cross borders; therefore, the system solely based on Japanese law theory without foresight into the present circumstances only will cause a decline in the international status of Japan.

In terms of internationality, I am interested in Catholic bioethics.

When I speak with my Vatican Academy Member colleagues, I learn about the various efforts based on the circumstances of each country,

and I'm also aware that they have an extremely strong interest in the Japanese research environment, which has produced results like induced pluripotent stem cell.
It is no exaggeration to state that the global development of medical research will serve as the foundation for the 21st century.

I believe that specialists across many differing fields inside and outside of Japan must share their knowledge and corporate on establishing legal theories not only to regulate medical research, but also to assist and promote it.

http://k-ris.keio.ac.jp/Profiles/200/0019950/prof_e.html

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