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Such believes are myths as stated in Item 16 of the Declaration of Helsinki 2013 çIn medical practice and in medical
research, most interventions involve risks and burdens.é
Thailand has had some experience with toxicities of herbal medicines, for example, in the case of ùMa Klueaû or the
fruit of ebony tree from the plant with scientific name Diospyros mollis. Traditionally, the fruit of ùMa Klueaû has long been
used as an anthelmintic that can effectively expel different types of intestinal worms. But later on when it was widely used
in a nationwide campaign to eradicate intestinal worms in children, some cases of blindness, a rare adverse effect, were
detected. Another example is ùKhi Lekû or the leaves of Siamese cassia from the plant Senna siamea used as sleeping pill
was later found to be toxic to the liver. Therefore, it is necessary to conduct studies to prove and confirm the safety, and
of course, efficacy of herbal medicines, and in the end, researches involving human subjects must be conducted as stated
in the Declaration of Helsinki Item 5 that çMedical progress is based on research that ultimately must include studies
involving human subjectsé.
Ethical consideration on research involving human subjects
In the field of indigenous and traditional medicine
Even though indigenous medicine and traditional medicine have basic theories, diagnostic and therapeutic
methods that are different in various aspects from those of modern medicine, whenever TM/IM researches involving
human subjects will be conducted, ethical considerations for research in human, similarly used in modern medicine
research, must also be followed.
First of all is the three basic ethical principles, initially stated in the Belmont Report on 18 April 1979 as çEthical
Principles and Guidelines for the Protection of Human Subjects of Researché, namely:
1. Respect for persons
2. Beneficence
3. Justice.
These three basic ethical principles must be applied and strictly adhered to as follows:
The First Principle çRESPECT FOR PERSONSé demands that subjects enter into research voluntarily and with
adequate information. Hence, informed consent from each human subject is required. Informed consent must comprise of
all three components, namely 1) study information which has to be adequate, clear, simple, without duress, deceit, or
undue inducement, and 2) human subjects must enter the study on the basis of voluntariness with full understanding of
the project.
The Second Principle çBENEFICENCEé - requires that there should be systematic assessment of risks and benefits
and beneficent actions are expressed as 1) do no harm and 2) maximize possible benefits and minimize possible harm.
The Third Principle çJUSTICEé - is that there should be fair procedures in the selection of research subjects.
Second of all, in addition to the three basic ethical principles in the Belmont Report, researchers must follow
international guidelines on research ethics, particularly:
1) Declaration of Helsinki
2) International Ethical Guidelines for Biomedical Research Involving Human Subjects prepared by the Council
for International Organization of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO)
3) For clinical trials of herbal products çOperational guidance: Information needed to support clinical trials of
herbal productsé of WHO TDR (WHO Special Programme for Research and Training in Tropical Diseases) should also be
followed.
Special considerations
As mentioned previously that indigenous medicine and traditional medicine have different basic theories and
practices from those of modern medicine, it is essential to have special considerations so that it can be applicable to
clinical research in these fields of medicine. Researchers should follow çWHO General Guidelines for Methodologies on