All research conducted at the Faculty of Tropical Medicine (FTM), Mahidol University, must comply with the relevant ethical standards, according to the Mahidol University Announcement (8 January 2021) entitled “Research Compliance Practices for Ethical Standards in Pre- and Post-award Funding”). The following regulations relate to research projects;
Human research is conducted in various fields, including medicine/science of well-being, sociology and behavioral sciences, philosophy, economy, politics, and military fields. Mahidol University has endorsed the Policy on Human Research Protection B.E. 2559 (2016). Institutional Review Boards (IRB) or Ethical Review Committees (EC) are responsible for the review of human research protocols and projects for ethics compliance and approval. There are many related issues, such as the use of stem cells For FTM, please refer to the FTM-EC webpage for more information.
Animal research is defined as any scientific study involving the use of animals. Animals for scientific purposes are defined as vertebrate animals, excluding human beings, Animals may include marine animals, invertebrates, cells that are not yet reproductive cells but can develop and increase in number to become an embryo and part of an organ. This research also extends to biological products from animals (blood, secretions, autopsy products, etc.). Thailand has endorsed the Animals for Scientific Purposes Act, B.E. 2558 (2015) . Mahidol University also has a Policy on Animal Research Subjects B.E. 2560 (2017).
The Institutional Animal Care and Use Committee (IACUC) regulates animal research for ethical approval. Please visit the FTM-IACUC webpage for more detail.
Biosafety and biosecurity issues are crucial to research and must comply with the Pathogens and Animal Toxins Act, B.E. 2558 (2015) “Pathogen” means microorganisms (bacteria, fungi, viruses and parasites), biological substances and other germs, as prescribed in the Notifications issued under section 6 (3). “Animal toxin” means a toxin from animals that causes a condition that interferes with the normal bodily function of humans, livestock, and beasts of burden. “Biological substance” means a culture or any part of it made or modified from animal toxins, microorganisms or proteinaceous infectious particles (Prion). In addition, there are issues around genetic resources, as stated in the Nagoya Protocol. The Institutional Biosafety Committee (IBC) is responsible for granting biosafety approval. For more information about FTM-IBC, please visit the webpage
Plant research is partially regulated by the Department of Agriculture (DOA) under section 53 of the Plant Varieties Protection Act B.E. 2542 (1999) Forms are available for research involving plants, and for declaration of the purpose.
Research involving forest conservation or protected areas must be approved by the Department of National Parks, Wildlife and Plant Conservation (DNP). This is required to comply with the National Parks Act, B.E. 2562 (2019) and the Wildlife Conservation and Protection Act B.E. 2562 (2019)
Forms pertaining to research involving forest conservation/ protected areas are available at https://op.mahidol.ac.th/ra/orra_download/
Material Transfer Agreements (MTA) are provided to enable the shipment or transfer of specimens. Details of MTA forms and guidelines for submission can be found at https://sp.mahidol.ac.th/th/MTA-DSA/index.html#
Data Sharing Agreements (DSA) must be signed by the organizations between whom the information will be shared. Please visit Mahidol University Center of Ethical Reinforcement for Research (MU-CERR) for more details.
Moreover, the topic about research integrity is another crucial aspect. FTM has been upholding the international guidelines, pertaining to research integrity including Singapore Statement and APEC Guiding Principles for Research Integrity. This is to ensure that research performed in the FTM system is conducted safely, ethically, and legally.