Ethics of Clinical Trials in Human
SUKHIT PHAOSA V ASDI, M.D.*, SURASAK TANEEPANICHSKUL, M.D.*, YUEN TANNIRANDORN, M.D.*, AURCHART KARNJANAPITAK, M.D.*, CHUMSAK PRUKSAPONG, M.D.**, PINIT KULLA V ANIJA Y A, M.D.***,
Affiliation : * Member of Thai Medical Association. ** Deputy Secretary General, Medical Council of Thailand. ***President of the Royal College of Physicians of Thailand.
For the past 5 years the Ethical Committee was given the authority by the Medical Associa-
tion of Thailand to supervise all issues involving ethics. We have divided our work into 3 headings:-
1) The ethics of clinical trials in human.
2) The ethics in teaching.
3) The ethics of general practice with regard to the Universal Health Insurance Bill.
There are guidelines involving ethics in doing research in human by CIOMS, WMA and
WHO etc. All of these guidelines have similar principles which are to look after the volunteers closely,
with great care, not taking advantage, carefully observing any side effect or complication, keeping
private all the findings, respecting the human rights of patients and in being very fair etc. The researchers
also have to follow the progress of the research closely and report to the Research Committee regularly.
We can clearly see that using placebo or doing research in specific way or with bias is not appro
priate(1-4).
The general principles of ethics of doing clinical trials are to use common sense. However,
because of potential benefits (or not) involved it is necessary to have guidelines from various institu
tions as are well known(5).
So if the researchers do not have good ethics they will find it difficult to have their work
published because of the increasingly stricter ethical conditions laid down by various editors of leading
joumals(6).
The informed consent of a research project is a new step to be taken which can be difficult,
can be both good and bad. This is because it may look as if the researcher is trying to convince the
patient to join the trial or scaring the patient away. Still, we think explaining is beneficial, rather than
the opposite, to the patient, researcher, and to the supporting institutionm.(7)
There has been a few comments regarding the ethics of research committee in considering
the draft of a research because most people believe that members of the committee will try and
create benefit from the draft of the research project to themselves. This is so even though many ideas
have not been stolen or the benefits were placed wrongly. However, this will destroy the progress or
the foundation of creating good researchers(8).
Reporting the research results correctly is to be congratulated and is to be supported fully. But
sometime there is a problem of the law regarding the contract made with the sponsor. So the researcher
must know what the contract means as far as the law goes(9).
Lastly, we have presented the work of the ongoing research to serve society especially about
reproduction, eg. test tube baby, purchasing and selling sperm and ovum, examining and the use of
medicine in pregnant patients with AIDS including organ transplantation, and abortion. The main concern
is in not respecting the rights of patients, the standard of treatment which are still not being accepted,
and the doctors not respecting the laws of the country(10).
Keywords : Ethics, Human Research
