Research Ethics Training Needs in Thailand and Vietnam

Background To describe the types of research being conducted and the availability of research ethics training and research ethics review in Thailand and Vietnam. Methods An English survey with four major domains, Research Area, Societal Conditions, Research Ethics, and Basic Information was translated into Thai and Vietnamese by native training partners from the NIH Fogarty Research Ethics Training Program. Setting/Participants The survey was administered in two modes - an online survey distributed via an email link in Thailand, and an onsite paper survey in Vietnam. Participants were Thai and Vietnamese trainees and investigators from prestigious universities. in of teachers, materials and delivery platform. Our the Medical Education (ACME) Fogarty Research Ethics Training Program, funded by the US Fogarty International Center, aimed to increase the capacity for research ethics training by applying the “train the trainer” model, using tele-education and in-person training sessions. 30 Prior studies have shown that “train the trainer” programs are very effective in building capacity in regions where there is a lack of local resources of experts of a field. 31,32. Our training program has trained more than 20 scholars in Vietnam, Thailand and Taiwan from 2014 to 2017; seven of the scholars have taken leadership positions in their Institutional Review Boards and ethics training programs. ethics

Conclusions We identified gaps in research ethics training in these two South East Asian countries undergoing rapid socioeconomic transition and identified future curricular focus opportunities.

Background
The quest to find cures and treatments for diseases has propelled the research enterprise globally; much of the progress was made possible due to animal and human experiments, and there is a need to train researchers to conduct research ethically. In the words of Claude Bernard-"The principle of medical and surgical mortality consists in never performing on man an experiment which might be harmful to him in any extent even though the result might be highly advantageous to science i.e. to health of others" 1  Thailand and Vietnam are two countries undergoing rapid economic transition, making them attractive locations for foreign investment and healthcare developments. 8,9,10. A report from The Association of Southeast Asian Nations (ASEAN) Economic Community (AEC) showed that Southeast (SE) Asian countries are competing for influence as medical hubs for billions of dollars of foreign direct investment (FDI). Between 2016 and 2017, the net FDI inflows increased from 2.81 bn to $8 bn for Thailand, and from $11.8 bn to 14.1bn for Vietnam, according to The World Bank Report Year 2018 11 this has been rapidly rising in recent years, according to ASEAN Investment Report Year 2018 and Bloomberg News. 12, 13. To maintain their reputations as auspicious potential healthcare partners, Thailand and Vietnam have aggressively invested in public and private healthcare infrastructure and workforce development, as seen in their increasing health expenditures as a total percentage of GDP from 1995 to 2014, where Thailand increased from 3.5% to 4.1% and Vietnam from 5.2% to 7.1%. 14,15,16. Pharmaceutical and medical device developments in major and provincial locations in the two countries validate market potential for burgeoning returns and positive impacts on health care accessibility and affordability. 17,18. If foreign partners align their expected outcomes with Thailand and Vietnam's social and economic goals and comply with government regulations, there are opportunities for mutual economic, healthcare, and quality of life advancements. 19. In Thailand, the National Research Council of Thailand was established in 1975. A 12-rule "Guidelines for Biomedical Research Involving Human Subjects" was distributed to research institutions throughout the country. 20 In addition, the Medical Council of Thailand, created by the Medical Profession Act, issued rules on "the observance of the medical ethics", acting as an additional oversight to medical ethics review at individual institutions in Thailand. 21  Today, ethics in research is a discipline of its own that requires rigorous training. The In research area, participants were asked to respond to several questions regarding their area of research. Participants could select multiple responses. For example, for the question: "What has been your main research area for the past five years?" There were seven large categories to choose from: non-communicable disease, genetics, infectious diseases, maternal and child health, non-clinical fields, nutrition and metabolism, public and environmental health, and other. Each of these categories had specific subcategories, City, and Hue University of Medicine and Pharmacy), it was determined that two modes of the survey administration were needed to fit societal survey practices. The online survey sent via email was created for Thailand based on the recommendation of our training partners, and an onsite paper survey was found to be the preferred mode for Vietnam.
In Thailand, at the recommendation of Mahidol University information technology department, an URL link to an online survey was emailed by co-investors at Mahidol University to faculty members (academia only, not including support staff) at Mahidol University, Burapha University (Chonburi Province) and Naresuan University (Phitsanulok Province), using an email list provided by those universities. The online survey was completed between October and December 2016.
In Vietnam, surveys were administered through convenience sampling in October 2016. Among the respondents, 23% were male and 75% were female from Thailand; 41% were male and 57% were females from Vietnam ( Table 1).. The proportion of respondents who had a PhD/Doctoral degree from Thailand was 47% compared to 10% from Vietnam. The majority of the respondents from both countries (>95%) work in their home country; 81% (Thailand) and 53% (Vietnam) of the respondents work in academic institutions.
Among those who conduct research, 81% in Thailand and 92% in Vietnam reported that their research involves human subjects (Table 2). Among these, 26% each from Thailand and Vietnam reported working on "clinical observations" (imaging, EKG, exams [physical exams and lab tests], study of nature of the disease); 29% from Thailand and 26% from Vietnam reported that their work involves "clinical interventions" (drugs, devices, biopsies, imaging with contrast).
In terms of [general] research ethics training received in these countries, 34% of the respondents in Thailand and 45% of the respondents in Vietnam had received formal education through their degree programs (i.e. medical doctor, nursing, social work, etc.).
In addition, 50% and 27% of respondents received ethics training on-the-job in Thailand and Vietnam respectively.
We examined the number of respondents who work on human subjects research and had prior training in ethics (not shown in tables). Among the respondents who reported conducting research involving human subjects from Thailand, 84% reported having ethics training; however, only 44% reported they had formal training, i.e. from their health professional degree programs. Among respondents from Vietnam who reported conducting human subjects' research, 66% reported having ethics training. Among those who received training, 72% reported they had formal training (from their health professional degree programs).
With regard to institutional review (see Table 3

Discussion
Our needs assessment survey fielded in Thailand and Vietnam has allowed us to gain an insight of the current landscape in research ethics training and research ethics review in these two SE Asian countries. By identifying the training gaps at the major training centers of these two countries, we can begin to identify opportunities to address research ethics needs in these two countries. Furthermore, it provides a unique opportunity to expand research ethics-training programs in SE Asia that are tailored to each country's needs and unique cultural context.
According Accreditation of Human Research Protection Programs 2018 report, 94% of institutions have their own IRB, only 6% do not have their own IRB. Most research institutions, universities, and health-care facilities have at least one IRB, and the majority has more than one 25 , in addition, there are a number of independent or commercial IRBs. 26 Our finding that 97% of Thai survey respondents reported having established ethical guidelines for research is reassuring and higher than previous estimates of 88% 20 however, we found that 6% reported not having an institutional review board in their institutions, a potential problem for research ethics reviews. Similarly, in Vietnam, even though 89% reported having established ethical guidelines in their institutions, 18% reported they do not have an institutional IRB (5% did not respond to this question). This  Availability of data and materials The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing Interests
The authors declare that they have no competing interests.    The study described current research ethics training landscape in Thailand and Vietnam.
The survey was designed with considerable input from our local training partners in Thailand and Vietnam and the translation was done by native Thai and Vietnamese research scholars taking into consideration the language, social and cultural differences between the east and the west.
Survey questions were specifically designed to probe the unmet needs in research ethics training from the survey participants.
Because the online email survey in Thailand and a paper survey using convenience sample in Vietnam were conducted from leading universities, our findings may under-estimate the current gaps in research ethics training across the overall landscape.
Two different survey modes were used based on local conditions, which may limit our ability to directly compare the results between Thailand and Vietnam.