Revisiting the clinical trial history and regulatory mechanisms in Nepal in the context of COVID-19 pandemic.

Presence of Nepal in global clinical trials has been visibly negligible despite the history of conducting large scaled randomized controlled trial on Hepatitis E vaccine decades ago. Majority of the problem is attributed to the lack of collaborative work, financial and human resource constrains. COVID-19 pandemics seems to have triggered urgency among the authorities of Nepal leading to a substantial increase in the number of clinical trials in collaboration with national and international organizations/institutions. Immediately after detection of the first COVID-19 case on 13 January 2020, the Ethical Review Board (ERB) of NHRC received several research proposals, subsequently leading to the approval of the first clinical trial for COVID-19 on 01 July 2020 to investigate potential of traditional Ayurveda based medicine for COVID treatment. Soon, number of other clinical trial proposals received approval and implemented in the country, however budgetary allocation from the Government of Nepal (GON) was prioritized for COVID-19 outrage management and vaccination coverage only. Collaborations with various international institutions played a significant role in the successful implementation of large-scale clinical trials in the country and further laid the path for future. In this review paper we present the recent developments in clinical trials in Nepal, budgetary allocation from the government and the mechanisms in place for regulation of clinical research in the country along with challenges and way forward.

Assessment of Preparedness of Government of Nepal in COVID Designated Hospitals and Clinics for Pandemic Response.

BACKGROUND: Preparedness, readiness, and response status of any country is integral in identifying, managing, and preventing COVID-19 pandemic. The objective of this study is to assess the status of the Government of Nepal designated COVID hospitals and COVID clinics to respond against COVID-19. METHODS: A cross sectional study was conducted with the focal persons of COVID hospitals and COVID clinics using a semi-structured questionnaire from April 26, 2020 to May 27, 2020 via face to face interview with onsite observation and telephonic interview in few unreachable health facilities.  Results: Government of Nepal designated COVID hospitals and COVID clinics demonstrated efforts in establishing preparedness plans and committees such as COVID management core team (96.7% and 86%), provision of coordination with the government authority (both 100% ), preparedness response plan (93.3% and 84%), and infection prevention and control committee (63.3% and 65.6%) to respond to COVID-19 respectively. The participants reported differences in training provided to their health care workers with maximum COVID hospitals (80%) providing training on use of personal protective equipment and least (43.3%) on handling dead bodies. Only half of the COVID clinics (49.5%) had provision of triage systems. CONCLUSIONS: COVID hospitals and COVID clinics in Nepal demonstrated different status of COVID pandemic preparedness and readiness. In case of surge, Nepalese hospitals would struggle due to lack of trained workforce and infrastructure.  Interdisciplinary, multi-sectoral collaboration with various focused strategies, including in-service training to staff, is paramount to increase preparedness and readiness.  Keywords: COVID-19; Nepal; preparedness; readiness.

Ethical Characteristics of Research Proposals Related to COVID-19 Pandemic in Nepal: A Retrospective Review.

BACKGROUND: Public health emergency is vulnerable time where maintaining ethical principles is obligatory while doing research, on the other hand, it is the same time when breach in ethics is much likely whenever a researcher is unaware, unprepared or hastens to do research. The aim of this study was to assess ethical issues of the coronavirus disease 2019 (COVID-19) related research proposals submitted during the early stages of pandemic in Nepal. METHODS: Retrospective analysis of COVID-19 related research proposals and their informed consent document submitted to the ethical review board at Nepal Health Research Council was done for the study. The analysis was done as per the National Ethical Guidelines, Standard Operating Procedure for Health Research in Nepal and World Health Organization guidelines for infectious disease outbreak, 2016 under ethically relevant headings. Descriptive data were analyzed in SPSS v24. RESULTS: The major issues were observed in the informed consent documents where 55% were lacking principal investigator's contact information, 68% not having participant selection criteria, 70% without clear informed consent taking process, 57% without explanation of possible risks. Similarly, 68% of the interventional studies' consent form didn't mention possible adverse events and mitigation mechanisms. CONCLUSIONS: Most of the research proposals related to COVID-19 were devoid of major ethical elements which took longer time for receiving approval and eventually delayed the opportunity for evidence generation in critical time. More attention is needed to increase awareness and to develop capacity of researchers, reviewers, ethics committees and relevant stakeholders at the time of health emergencies.

Trend and Patterns of Research Proposals Submitted for Ethical Review in Nepal Health Research Council.

BACKGROUND: The characteristics of research proposals submitted to the Nepal Health Research Council reflect the trend of health-related researches being conducted in Nepal. The objective of the study was to analyze research proposals submitted for the ethical review in Nepal Health Research Council from 2017 to 2019. METHODS: A retrospective record review of research proposals received over three years from 2017 to 2019 were analyzed. A total of 2,305 research proposals was included in the study. The number of research studies per year, types of study design, priority area of research, and rejected proposal were the intended variables for the study. RESULTS: 91.45% (503), 92.19% (748), and 755 (80.1%) of received proposals were approved from Ethical Review Board in 2017, 2018 and 2019. The number of research proposals increased every year (550 in 2017, 812 in 2018, and 943 in 2019). Among the approved proposals non-communicable disease (n=150;15.90%) in 2019} was the topmost prioritized area in all three years followed by reproductive health [93 (9.86%) in 2019] and communicable disease [67 (7.10%) in 2019] respectively. Quantitative research was more than two-third in all the years. Among the approved proposals, more than half were for an academic purpose [610 (64.69%)]. The reason for the rejection of the proposal was the conduction of research before ethical approval [2 (0.36%) in 2017, 2 (0.25%) in 2018, and none in 2019]. CONCLUSIONS: There was a rising trend of research proposals for ethical clearance being submitted to the Nepal Health Research Council. Research related to non-communicable disease followed by reproductive health was the commonest one.

Historical Development of Health Research Ethics in Nepal.

Health research in Nepal initiated with a survey in malaria in 1952. The first regulatory body for health research was Nepal Medical Research Committee formed under Ministry of Health. Ethical Review Body is the first ethical review structure. Nepal Health Research Council is now an independent body to regulate health research in Nepal. Development of research ethics in Nepal is clearly evident with the development of ethical guidelines; functioning of Ethical Review Board; expansion of institutional review committees and initiation of online submission system. However, monitoring compliance with research ethics could be a challenge for the Nepal Health Research Council.