Workshop “Ethics of Research in Humans”
the National Research Office in
collaboration with the Faculty of Humanities and Social Sciences . Surat Thani Rajabhat University
Forum for Ethical Review Committee in Thailand (FERCIT)
August 4, 2021 is an online training via electronic media.
1. Principle and Rationale
It is recognized that the advancement of various fields of science Medical science, in particular, is based on research and partly depends on human research. Conducting research involving people must place the well-being of subjects as a priority before interests in science, humanities and social sciences. purpose in conducting research involving people to understand the cause Pathogenesis of disease, study of prevalence, incidence, development of prevention, diagnosis, treatment process. improving the quality of medical care health promotion Improving the quality of life of patients In addition to doing research in the social sciences and humanities related to people Although there were no interventions that could cause harm to the volunteers. But research studies using questionnaires, interviews or surveys can also pose a risk. or the impact on the volunteer economically, socially, mentally, may cause stigma on the volunteer. The potential risks to the research subject are always the responsibility of the researcher. Researchers must protect life, health, privacy. and the dignity of the volunteers
In the development of new drugs that have undergone pharmacological and toxicological studies in laboratory animals until data shows efficacy and safety at pre-clinical levels, need to be studied in humans This is an important step to prove and confirm its efficacy and safety in humans before being considered for registration as a new drug. The period of time for research and development of new drugs is about 3-15 years, making new drugs have a patent protection when they are released to the market for a short time. Drug R&D companies based in the US and Europe developed countries Therefore, there is a tendency to conduct clinical trials outside the country of drug developers. because there are many volunteers and patients The study will be completed faster and cost less than the study conducted in the drug developer’s country. At present, there are many clinical research studies in Thailand. and will increase rapidly in the future because Thailand has factors and infrastructure that facilitate clinical research studies. If the quality of clinical trials is developed in line with international standards of Good Clinical Practice (GCP), which places great emphasis on the protection of the rights, dignity, safety and well-being of volunteers and patients who participate in clinical research This will give Thailand an opportunity to be a center of excellence in clinical research studies. At present, although there is no law applicable to conducting research in humans. But there are rules such as the regulations of the Medical Council on ethical treatment of the medical profession. mentions to medical practitioners who conduct research studies and human trials Must be approved by the Board Only relevant research ethics and academic journals, especially medical journals There are requirements to receive published research papers.
Incidentally, the Office of the National Research Council which is an organization with a mission to support Promote research in all fields in Thailand in accordance with the national development strategy. Quality research must consist of researchers who adhere to internationally standardized guidelines and research ethics. of the Office of the National Research Council Research in all fields of humanities, social sciences and health sciences Research ethics must be followed by people who are internationally recognized. The rights, dignity and well-being of the volunteers participating in the research are protected. in order to obtain reliable research results. internationally recognized
from the above reasons Faculty of Humanities and Social Sciences Surat Thani Rajabhat University Recognizing the importance of human research studies or related to people to create new knowledge to solve problems or to develop work in various fields including the arrangement teaching Faculty of Humanities and Social Sciences Surat Thani Rajabhat University has formulated a specific development plan in this area. to have a system regulations to be in accordance with international standards Faculty of Humanities and Social Sciences Surat Thani Rajabhat University and the Forum for Ethical Review Committee in Thailand (FERCIT) deem it appropriate to organize training sessions to strengthen committees to consider research ethics. as well as researchers know the principles of research ethics according to international principles This will encourage human-related research studies to follow good research principles. taking into account the rights, safety, and well-being of the volunteers Consistent with the Declaration of Helsinki by using FERCAP’s internationally standardized training courses. Faculty of Humanities and Social Sciences Surat Thani Rajabhat University in collaboration with Forum for Ethical Review Committee in Thailand (FERCIT)
2. Objectives for trainees
2.1 Understand the principles and criteria for ethical research involving human subjects Assessing the risks and benefits that trial subjects will receive in the process of obtaining participant consent on various research ethical considerations. good research practice How to operate the Ethics Committee standard
2.2 Able to develop research study quality in accordance with international standards on research ethics