Ethical Issues in Medical Research and Guideline for Practice
Article Sidebar
Main Article Content
Abstract
Research leads to academic progress in various aspects. It is an important tool for creating new knowledge and developments in management, teaching, manufacturing, and services. Medical science also benefits greatly from academic researches. Research in medical service involves human, either regular people,patients, elderlies, and children, who are vulnerable in our society. Therefore, researchers should uphold core values of research ethics, respect of person, as wellas beneficence and justice for every research subject, and practice accordingly. Ethical issues in medical research are commonly found in research among vulnerable groups, research analyzing patients’ histories, research in emergency situations, child’s consent, consent in research conducted by medical practitioners, and the exemption of consent. The supervision of research regulatory institutions and the responsibility of the researchers are crucial elements to make the research and its result credible and widely accepted.
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
References
National Research Council of Thailand. Research ethics involving human subjects. [Internet]. [cited 2019 December 20]. Available from: https://www.nrms.go.th/FileUpload/AttatchFile/News/256204301206016213675.pdf (in Thai).
Wikipedia. Nuremberg code. [Internet]. [cited 2020 April 22]. Available from: https://en.wikipedia.org/wiki/Nuremberg_Code.
Kefauver-Harris Amendments Revolutionized Drug. Development Consumer Health Information. [Internet]. [cited 2020 April 22]. Available from: www.fda.gov/consumer.
World Medical Association. WMA Declaration of Helsinki -ethical principles for medical research involving human subjects. [Internet]. [cited 2020 April 22]. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects.
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013;310(20):2191-4.
Chokevivat V, Posayanont T, Translator. The Belmont Report. Nontaburi: Institute for the Development of Human Research Protections; 2008. (in Thai).
Ahmad W, Moeen Al-Sayed. Human subjects in clinical trials: ethical considerations and concerns. J Transl Sci 2018;4(6):1-5.
Department of Health and Human Services. E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1); International Council for Harmonization; Guidance for Industry; Availability. Federal Register 2018;83(412): Notices.
The Medical Council Regulations on Medical Ethics Preservation, B.E. 2549 (2006). [Internet]. [cited 2019 December 20]. Available from: http://www.tmc.or.th (in Thai).
Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) International Ethical Guidelines for Biomedical Research Involving Human Subjects. CIOMS Geneva 2002. [Internet]. [cited 2020 March 20]. Available from: https://cioms.ch/wp-content/uploads/2016
National Health Commission Office. National Health Act, B.E. 2550. [Internet]. [cited 2019 December 29]. Available from: http://pcmc.swu.ac.th/EC/document/form/dw_form4/17.pdf (in Thai).
Tanyasittisuntorn, P. Document for the lecture on “Good clinical research practice in accordance with ICH-GCP”. February 21-22, 2020. Somdech Phrapinklao Hospital, Naval Medical Department, Bangkok. Samutprakan; 2Twin Printing; 2020. (in Thai).
World Health Organization. Research ethics committee: basic concept for capacity building. [Internet]. [cited 2020 March 20]. Available from: https://www.who.int/ethics/Ethics_basic_concepts_ENG.pdf
Central Research Ethics Committee. Memorandum of understanding on research ethics review in multicenter study. [Internet]. [cited 2020 April 22]. Available from: https://crecthai-research.org/about.php
Lertakyamanee J. Human research ethics and Siriraj’s research ethics committee involving human subjects. Siriraj Medical Bulletin: Ethics in Medical Science and Research. 2009;2(1):2-6. (in Thai).
Hope T, McMillan J. Challenge studies of human volunteers: ethical issues. Journal of Medical Ethics 2004;30(1):110-6.