International Ethical Guideling Health-related Forwork Involving Humans 2016

Abstract

The Council for International Organizations of Medical Sciences and the World Health Organization 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.