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The World Health Organization started the Expanded Program on Immunization in 1974, including 6 antigens with up to 8 vaccine doses for childhood vaccination. The number of antigens has now increased to 11 antigens in 21 vaccines. The expansion of vaccination programs to include more antigens and doses has led to concerns about the burden of multiple injections on infants and children, as well as factors such as fear of adverse reactions, pain, and overall acceptability of vaccines. To address these challenges, there's a call for research to focus on developing combined vaccines that can be administered through more acceptable routes, such as oral, nasal, or needleless administration. This approach could potentially reduce the number of injections required and increase the willingness of individuals to receive vaccines. We highlight the importance of ongoing research and innovation in vaccine development and delivery methods to ensure that vaccination programs remain effective, efficient, and acceptable to the communities they serve, particularly in resource-limited settings.

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With the rapid advancement of health delivery, there has been a renewed interest in conducting research among healthcare professionals in Nepal. However, concern is there regarding availability of funds and mechanisms of awarding. The purpose of this scoping review is to map the available evidence regarding the evolution and current status of health research funding in Nepal and to highlight gaps and areas for future research. We searched three databases for empirical papers and several gray literature. Our search, conducted between March and April 2024 yielded 76 documents of which 30 that met the selection criteria were included in the scoping review. Almost all studies identified lack of funding as a deterrent to research. We found a paucity of research focusing on the role of researchers in funding decision-making. Our findings revealed that there are 12 national and four international organizations providing funds for research. University Grant Commission is the largest funder from Nepal whereas the Research Council of Norway is the biggest international funder. There were certain barriers and facilitators for obtaining funds identified by this scoping review. Further efforts are needed to increase the amount and availability of funds in Nepal to enable high-quality research.

Introduction: The universal health research ethical principles must be adhered to ensure a balance between science and safeguarding participants' rights, safety and dignity. A cross-sectional study was conducted to assess the knowledge, attitude, and practice of research ethics among researchers in Nepal. Methods: The study was carried out among 449 researchers who submitted proposals for ethical review and approval from the Ethical Review Board of the Nepal Health Research Council between January 2017 to August 2021. Simple random sampling was done ensuring a proportional representation of researchers from all areas of health research. A structured questionnaire was administered online for data collection. Results: The participants aged between 23-80 years old consented to complete the survey questionnaire. The median age of the respondents was 35 (23-80) years. Among all the respondents, 52 (11.58%) were unaware about the National Ethical Guideline for Health Research. Similarly, 110 (24.50%) respondents strongly agreed that the ethical review process impairs research and makes it harder for researchers to conduct research; 372 (82.85%) respondents had pursued research activity only after obtaining ethical approval. Conclusions: Half of the respondents had knowledge on different aspects of research ethics.

Background COVID-19 is a highly challenging infectious disease. Research ethics committees (RECs) have challenges reviewing research on this new pandemic disease under a tight timeline and public pressure. This study aimed to assess RECs’ responses and review during the outbreak in seven Asian countries where the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) networks are active. Methods The online survey was conducted in seven Asian countries from April to August 2021. Two sets of online questionnaires were developed, one set for the chairs/secretaries and another set for the REC members. The REC profiles obtained from the REC members are descriptive in nature. Data from the chairs/secretaries were compared between the RECs with external quality assessment (SIDCER-Recognized RECs, SR-RECs) and non-external quality assessment (Non-SIDCER-Recognized RECs, NSR-RECs) and analyzed using a Chi-squared test. Results A total of 688 REC members and 197 REC chairs/secretaries participated in the survey. Most RECs have standard operating procedures (SOPs), and have experience in reviewing all types of protocols, but 18.1% had no experience reviewing COVID-19 protocols. Most REC members need specific training on reviewing COVID-19 protocols (93%). In response to the outbreak, RECs used online reviews, increased meeting frequency and single/central REC. All SR-RECs had a member composition as required by the World Health Organisation ethics guidelines, while some NSR-RECs lacked non-affiliated and/or layperson members. SR-RECs reviewed more COVID-related product development protocols and indicated challenges in reviewing risk/benefit and vulnerability (0.010), informed consent form (0.002), and privacy and confidentiality (P = 0.020) than NSR-RECs. Conclusions Surveyed RECs had a general knowledge of REC operation and played a significant role in reviewing COVID-19-related product development protocols. Having active networks of RECs across regions to share updated information and resources could be one of the strategies to promote readiness for future public health emergencies.

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.

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.

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.

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. Keywords: Ethical approval; ethical review board; research proposals; record review

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.

Background: The Government of Nepal promulgated health as a human right via Interim constitution and implemented Free Health Service Program in 2008 as a commitment to universalize basic health care services. So, the aim of this study was to understand reported access to medicine and health care services received by outpatients in public primary facilities. Methods: The study followed cross sectional study design. Two hundred and thirty-four For data 234 out patients were interviewed on the day of the field visit in March and October 2014 across 28 primary health facilities of seven purposively selected districts representing three ecological belts and five development regions of the country. Results: Our study revealed that the average number of medicines prescribed per patient was 2.65 per case in primary public health facilities, of which 91.2% were dispensed. Around 86.6% dispensed medicines were appropriately labeled and 84% of outpatients had proper knowledge of dosage and timing of medicine use. Around 55.6% of outpatients purchased some or all prescribed medicines from nearby private facilities which were not available in public facilities. Around 40% of them travelled more than half an hour to reach the facility. Conclusions: The gap in medicines prescribed and dispensed, Out of Pocket expenditure coupled with opportunity cost of travelling, appear as hurdles in access to basic health care services. So increasing free medicines list in public primary facilities with all round the year availability might answer major part of the problem. Keywords: Free health care; out of pocket payment; primary facilities.

Background COVID-19 is a highly challenging infectious disease. Research ethics committees (RECs) have challenges reviewing research on this new pandemic disease under a tight timeline and public pressure. This study aimed to assess RECs’ responses and review during the outbreak in seven Asian countries where the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) networks are active. Methods The online survey was conducted in seven Asian countries from April to August 2021. Two sets of online questionnaires were developed, one set for the chairs/secretaries and another set for the REC members. The REC profiles obtained from the REC members are descriptive in nature. Data from the chairs/secretaries were compared between the RECs with external quality assessment (SIDCER-Recognized RECs, SR-RECs) and non-external quality assessment (Non-SIDCER-Recognized RECs, NSR-RECs) and analyzed using a Chi-squared test. Results A total of 688 REC members and 197 REC chairs/secretaries participated in the survey. Most RECs have standard operating procedures (SOPs), and have experience in reviewing all types of protocols, but 18.1% had no experience reviewing COVID-19 protocols. Most REC members need specific training on reviewing COVID-19 protocols (93%). In response to the outbreak, RECs used online reviews, increased meeting frequency and single/central REC. All SR-RECs had a member composition as required by the World Health Organisation ethics guidelines, while some NSR-RECs lacked non-affiliated and/or layperson members. SR-RECs reviewed more COVID-related product development protocols and indicated challenges in reviewing risk/benefit and vulnerability (0.010), informed consent form (0.002), and privacy and confidentiality (P = 0.020) than NSR-RECs. Conclusions Surveyed RECs had a general knowledge of REC operation and played a significant role in reviewing COVID-19-related product development protocols. Having active networks of RECs across regions to share updated information and resources could be one of the strategies to promote readiness for future public health emergencies.