Laws on Medicine
Lecture No.3 (in Classroom 22, on Wednesday, October 15, 2008, at 15:00-16:40)
１） Ethics committee: What is jurists’ role in there?
２） In clinical research, how is a drug trial different from anautonomous clinical test?
３）Why is informed consent necessary in clinical research? Whatis the function of an ethics committee?
Faculty of Law, University of Tokyonhiguchi@j.u-tokyo.ac.jp Norio Higuchi and Yasuji Kodama

1Three Examples
1 “At 4:30 p.m. on a certain Friday, there was an incoming callto you being a legal advisor to a 300-bed hospital. The call wasfrom Dr. Smith looking for your advice. This doctor examineda 37-year-old patient named Johns who was in the terminal
stage of lung cancer that was already metastasizing to thebones. The status quo was that the remnant of his life was one
month at best, and that the treatment was wholly focused on
chemotherapy to delay disease progression and on an easingof throbbing pain. Besides, Johns had a pacemaker implanted.
Well, Johns said to the doctor to please discontinue
chemotherapy and bring the pacemaker to an end. The same
request was made repeatedly, and it was the doctor’s judgmentthat the patient expressed his consistent intent under the clear
consciousness. Accordingly, the doctor made a consultation asto what he should do.”23rd Social Page of Morning News of Asahi Shimbun Dated 10/8/08,
Reporter Shinoda in NHK News Program of 10/7/08“No problem from an ethical standpoint” as to removing respirator from the patient of an
intractable disease: Opinion of a hospital ethics committee in Chiba
The ethics-issue exploratory committee of Kameda General Hospital (director NobusukeKameda) located in Kamogawa-city, Chiba-pref. established an opinion that “there is noethical problem” regarding a patient of amyotrophic lateral sclerosis (ALS) who makes arequest to remove an artificial respirator when the patient becomes disabled to communicate
with those around him. Removing a respirator from progressed cases of ALS might have adecisive impact on life. According to a self-help patient group, it is rare that a medical
institution’s ethics committee expresses an opinion on such a request of a case of ALS.
But the ethics committee does not make a definite statement as to how to respond to therequest as “there is a possibility of criminal prosecution against any personnel who hasremoved respiratory apparatus.”
This patient is a male (68) from the same prefecture, who was diagnosed with an
intractable disease ALS in 1991, and the following year got into respiratory difficulties
requiring tracheotomy and wearing a respiratory apparatus. While bedridden, hecommunicates with his family by writing sentences with PC by the use of his right cheek thatcan move a few millimeters.
According to the family, this man considers that he “lives a human life only while there arecommunications with the family, friends, and medical staff,” and wishes to “have a respiratorremoved” when he becomes incapable to do that.
NHK news reported: “Discussion and research are necessary,” and “no law approves theremoval of respiratory apparatus ,” and Prof. Itakura’s opinion of “ a possibility of theequivalent of murder by contract .”3

Three Examples
2Doctor A is a neurosurgeon in the department of neurosurgery of a certain
university hospital. In his clinical experience, he came up with the following idea:
Drug B, already approved as a new medicine and covered by health insurance, waslikely to have a good effect on some critical cases of cerebral infarction. To verify
this was quite meaningful, and the doctor considered to implement a clinical test.
To do that, he was told, it was important to obtain informed consent and anapproval of the ethics committee. But he could not understand what these meant.
So he asked an attorney of his acquaintance , but who responded that he knew littleof such matters. An instruction on a fundamental thought is requested as to how thesubject ought to be considered.

3 Doctor R is a family physician in a small provincial town. There came an approachfrom a contract research organization (CRO) for the doctor to participate in clinicaltesting for new nonsteroidal anti-inflammatory drugs (NSAID) against
osteoarthropathy. She was to receive money in proportion to the number of patients
she would register for clinical researches. The CRO guaranteed that it had obtained
all approval for this testing, as well as the one by the ethics committee. Having noexperience of participating in a drug trial, Dr. R felt good about it particularly for aspecial compensation to be provided for. Thus she accepted to take part in it
without any further inquiry about scientific and ethical aspects of this testing.

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Course of Actions on Three Issues
Problem No.1: Case book of U.S.
In this example, the attorney advises the doctor topresent the problem to the ethics committee. Dr.
Smith is considered to be lucky in that he is in acircumstance where the ethics committee and thelegal advisor are willing to spend time standing faceto face with this kind of ethical issue. The bookconcludes that even if the discussion arrived at thesame conclusion as Dr. Smith reached by himself,
this sort of process per se makes a meaningful
difference from an ethical point of view (make amoral difference).
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Course of Actions on Three Examples
Course of actions on the 2nd question for an examination
Two approaches:1)Meaning of an autonomous clinical test; to explain about themeanings of informed consent and an ethics committee
2)What kind of advice would the attorney being requested for aconsultation give to Dr. A?
→Function/role of a legal advice
Apt to be excessively inhibitory (threatening)→“Not rocking the boat”

6Distinction Between Autonomous
Clinical Test and Drug Trial
Why are there distinctions?
Should distinctions continue to be there?
What sort of distinctions are there?

7Role of Informed Consent in Clinical Test(Research)
What is informed consent?
Why is it necessary?
What should be explained?
In the light of the four principles of bioethics…

8Ethics Committee
Who are its members?
What sort of role is the committee expected to play?
Ethical review on a clinical test
Ethical review on a clinical research
In the light of the four principles of bioethics…
What role can the jurist fulfill?

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Course of Action on 3rd Example◎On the one side, an encouragement of private
practitioners’ participation in a clinical research◎On the other, “concerns expressed in the manual ofWorld Medical Association”
Why? What are they concerned about?

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