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International Ethical Guidelines for Health-related Research Involving
Humans, 2016
Vichai Chokevivat
Institute for the Development of Human Research Protections (IHRP), Health Systems Research Institute,
Building of Department of Medical Science, 8th Floor, Tiwanon Road., Amphoe Mueang, Nonthaburi ,
11000, Thailand
‡ Corresponding author: vichaichok@yahoo.com

Abstract
The Council for International Organizations of Medical Sciences and the World Health Organiza-
tion issued the first International Ethical Guidelines for Biomedical or Health-related Research Involving
Humans in 1982. After that three revisions were made in 1993, 2002 and 2016. The process for the latest
edition involved extensive and systematic reviews of relevant documents, in-depth studies on problems and
new knowledge, the use of methodology for ingeniously making conclusions and consensuses, and various
forms and forums for public hearings. A lot of opinions were obtained for drawing conclusions that covered
major issues and revising the writing patterns - maintaining the original formats for the main guideline text
and commentaries in various aspects, but changing the essence related to research in vulnerable persons. The
section related to such persons was not deleted as the deletion would result in a lack of knowledge and
information essential for further development of the methods and operations for their medical and health care,
while the protection and respect of their rights have to be dealt with correctly and appropriately. The new
guidelines contain additional sections on: the collection, storage and use of biological materials and related
data as well as data in health-related research: research in disasters and disease outbreaks; cluster randomized
trials; the use of data from the online environment and digital tools in health-related research; public
accountability for health-related research; conflicts of interest; and the importance of community. The process
for guideline development and revision is in line with section 77 of the Constitution of the Kingdom of
Thailand; so it should be a model for developing and revising rules, regulations and laws in the country.

Key words: research ethics, health-related research, CIOMS, biomedical research

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