Program Book FERCAP

UNIVERSITAS GADJAH MADA The Forum for Ethical Review Committees SIDCER FAKULTAS KEDOKTERAN, in the Asian and Western Pacific Region KESEHATAN MASYARAKAT, DAN KEPERAWATAN Globalizing Ethics for Health Research 21st FERCAP Online International Annual Conference Ethical Lessons Learned During Epidemic Outbreaks hosted by Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada December 8-11, 2021 Program Book

Program Book 21st FERCAP Online International Annual Conference Ethical Lessons Learned During Epidemic Outbreaks December 8-11, 2021 Hosted by : Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada

CONTENTS Content ......................................................................................................................................... 1 Welcome Remarks: Dean of Faculty ........................................................................................... 2 Welcome Remarks: Rector Universitas Gadjah Mada ............................................................... 3 Welcome Remarks: Ministry of Health Indonesia ...................................................................... 4 Welcome Remarks: from the Organizing Committee .............................................................. 5 Conference Background .............................................................................................................. 6 Program Schedule & Conference Registration .......................................................................... 7 Pre Conference Schedule ............................................................................................................ 8 Conference Schedule ................................................................................................................... 9 Abstracts .......................................................................................................................................16 1

Welcome Remarks: Dean of Faculty Welcome to our Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada. It is truly an honor for our institution to host the virtual Forum for Ethical Review Committees in Asia and Western Pacific (FERCAP) 2021, that would be held on 8-11 December 2021. We sincerely thank our Indonesian Minister of Health, the SIDCER-FERCAP Foundation, and our international speaker from, Philippines, Malaysia, India, Nepal, Thailand, Sri Lanka, Korea, and USA, and Indonesia, to share all about ethical lessons learned during epidemic outbreaks. Ladies and Gentlemen. Different countries will be in different stages of readiness to provide an ethics review of epidemic-relevant research. Regardless of preparatory work that has been done so far, there are actions that ethics committees can and should undertake to prepare for rapid review of emergency research protocols, such as for Covid-19. The research ethics committee of Universitas Gadjah Mada is one of efforts to mitigate risk related to any possible irregularities that may occur in the process of conducting research. Therefore, the processes of research are expectedly carried out well, based on integrity and ethics and ensures the safety of all living things involved in. Hopefully, this 21st FERCAP 2021 program would be a forum to socialize the importance of ethical review in research and the role of a strong ethics commission in improving the quality of research. Second, will increase the knowledge of members of the research ethics committee and cooperation networks in the field of research ethics at home and abroad. After attending this course, all participants are expected to realize that it can increase public understanding on the importance of ethical review in research and the role of a strong ethics commission in improving the quality of research. Hopefully, this forum can establish a strong network of cooperation in the field of research ethics. Finally, we are pleased to invite all of you to join this 21st FERCAP 2021 with great enthusiasm to discuss all about various ethical issues in research in various scientific fields, including medicine and health, social, and humanities, with all of our experts. Please enjoy the 21st FERCAP 2021. Prof.dr. Ova Emilia, M.Med.Ed.,Sp.OG(K).,Ph.D 2

Welcome Remarks: Rector Universitas Gadjah Mada It has been almost two years since the COVID 19 epidemic hit all corners of the globe, and the pandemic has undoubtedly become an era-defining issue for the entire planet. Individual countries exchanged their experiences and best practices, resulting in a global public emergency that required coordinated global surveillance and monitoring systems. Even countries that had previously faced pandemics such as influenza could not cope with the COVID-19. As a result, the current pandemic has unambiguously proved that every country should have a strategy in place that can be implemented efficiently in future pandemics. It has implications in the public health sector and the global economy and political landscape. It has spread alarm and panics worldwide, with many countries unprepared to respond quickly, and sometimes ethically, to the disease outbreak. The 21st FERCAP 2021conference seeks to describe the ethical lessons learned from initiatives to address the COVID 19 pandemic, the ethical approaches used to implement scientific and innovative health interventions, the changes in ethics review practices, and the community engagement experiences that empowered the target populations. Therefore, it is a great honour and pleasure for Universitas Gadjah Mada to host the 21st FERCAP 2021. I would thus like to thank our partners for their kind support in organizing the conference. Special thanks to all the speakers who will share their insights and all participants who have committed their time to participate in the discussions. Last but not least, I would like to thank the organizers for their hard works in preparations and for dedicating their time in the coming days to ensure everything goes well. And on that note, I wish you all a fruitful conference! Prof. Ir. Panut Mulyono, M.Eng., D.Eng., IPU, ASEAN Eng. 3

Welcome Remarks: Ministry of Health Indonesia Assalamualaikum wr. wb., greetings to all of us, om swastiastu namo budhaya, salam kebajikan. Indonesia has an abundance of natural resources, vast land and sea areas, socio-cultural diversity, significant disparities, and a population of 260 million people. This is the primary capital to support national development goals by achieving the demographic bonus and Indonesia Gold in 2045. At the same time, we are also faced with health challenges, namely non-communicable diseases and infectious diseases, such as the COVID-19 pandemic that we are currently facing today. For almost two years, we have struggled with the COVID-19 pandemic, the management of COVID-19 has been established as an adaptive and dynamic strategy adapted to the development of epidemiology or transmission level or response capacity and level. The measures to manage the pandemic in Indonesia are classified into five main pillars: the detection pillar, the clinical management pillar for case management, the behavioral change pillar, the vaccination pillar, and the health system strengthening pillar, including maintaining the continuity of essential services. Research plays a vital role in outbreak response. One of the challenges in the health sector is the availability of pharmaceutical products, including vaccines and medical devices. As we understand, the COVID-19 is a newly emerging disease, no country has experienced dealing with it before, and the scientific development of COVID-19 is very dynamic. Various studies to understand this virus and the development of treatments and vaccinations need to be conducted continuously. Now, it is the time that the “smart” work, synergism and convergence of interdisciplinary and cross-sectoral of all components of the nation must be proven by working professionally and morally. I express my highest appreciation and honor for holding the 21st International Conference of the Forum for Ethical Review Committee in Asia the Western Pacific 2021. Hopefully, this event can enrich our knowledge to innovate in dealing with the COVID-19 and other new emerging diseases. Thank you, wassalamualaikum warahmatullohi wabarakatuh. Om santi santi om Ir. Budi Gunadi Sadikin, CHFC, CLU 4

Welcome Remark from the Organizing Committee Forum for Ethical Review Committees in the Asian & Western Pacific Region (FERCAP) 2021 Assalamu'alaikum wr. wb. The Covid-19 pandemic has become one of the major disasters experienced by all humanity worldwide. Apart from causing many deaths, Covid-19 has also caused paralysis in various sectors of life. The emergence of Covid-19 was caused by a new mutation of the Coronavirus, known as SARS-CoV2. As a newly mutated virus, science is not yet well acquainted with the nature of the virus: how it causes disease, how it lives and how it is transmitted. We have not yet understood how we can prevent and treat the disease caused by that virus. To answer all of those questions, various studies are needed to be be carried out immediately so that their results can be used to overcome the pandemic. Various efforts to prevent and to treat COVID-19, including the manufacturing or the testing of new vaccines and the manufacturing or the testing of various new drugs, needed to be carried out as soon as possible on a large scales. The speed of the manufacturing and the testing process is much faster than the time generally used for the development or the testing of vaccines or other drugs in situations before the Covid-19 pandemic. One of the biggest challenges in testing or developing new vaccines or drugs is ensuring that the process is done safely and according to procedures. Mild, moderate, or severe side effects may occur. This risk is, of course, even higher during the Covid-19 pandemic due to the hasty nature of its implementation. As a committee or a board responsible for protecting the rights, health and welfare of human research subjects, research ethics committee also bears the impact of the research frenzy in tackling this pandemic. The research ethics committee should work faster without compromising their vigilance in reviewing or assessing research protocols. The ethics committee needs to balance the urgent need to market or to use the new vaccines or drugs versus the possible risks for the research subjects. The Faculty of Medicine, Public Health, and Nursing (FK-KMK) UGM is hosting the 21st Forum for Ethical Review Committees in the Asian & Western Pacific Region (FERCAP) on 8-11 December 2021 virtually. Through this conference we hope that participants can learn and exchange experiences on the challenges and obstacles various research ethics committees throughout Asia and the Western Pacific faces and how to overcome them. Participants can also jointly formulate steps to optimize the future performance of the ethics committees, especially to anticipate the possibility of a similar disaster occurring. Thank you very much for your participation. We sincerely hope you have an enjoyable and fruitful conference Wassalamu'alaikum wr. wb. Prof. dr. Madarina Julia, Sp.A(K), MPH., Ph.D. 5

21st FERCAP ONLINE INTERNATIONAL ANNUAL CONFERENCE December 8-11, 2021 Hosted by the Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada Agenda Theme: Ethical Lessons and Best Practices Learned During the Pandemic Outbreak Conference Background It has been two years since the outbreak of the COVID-19 pandemic that affected all regions of the world. While not a single country was prepared to meet the challenges of the global pandemic, each country has adopted its own contingency measures to protect its population from the ravaging effects of the pandemic. There was a race among medical scientists to develop effective drugs and vaccines to contain the contagion and public health measures were adopted to prevent its spread. The pandemic also wreaked havoc on the global economy with hundreds of thousands of the population losing their jobs and inevitably causing an economic recession. It created a global public emergency that required coordinated global surveillance and monitoring systems as individual countries shared their experiences and best practices with each other. This FERCAP Annual International Conference will seek to describe the ethical lessons learned from the best practices derived from the health systems initiatives to address the COVID-19 pandemic, the ethical approaches used to implement scientific and innovative health interventions, the public health measures that were enforced, the changes in ethics review practices, and the community engagement experiences that empowered the target populations 6

Schedule Jakarta Time 7 December 2021 FERCAP Steering Committee Meeting Ÿ 14:00 - 16:00 Pre-Conference Training Ÿ Tuesday Ÿ Training on Addressing Ethical Issues in Social Science Research 8 December 2021 Ÿ Setting up a Social Science IRB Ÿ 1:00-5:00 pm Ÿ Wednesday Conference 9-10 December 2021 FERCAP Recognition Program and General Assembly Ÿ 08:30-17:00 Ÿ Thursday Ÿ 08:30-15:30 Ÿ Friday 11 December 2021 Ÿ Saturday Conference Registration: For Foreign Participants E-mail: [email protected] [email protected] 7

Pre Conference Pre Conference Training Agenda (International) 8 December 2021 13.00-17.00 Opening Remarks Yayi Suryo Prabandari Session Chair: Nur Atik Addressing Ethical Issues in Social Science Research: Setting Up a Social Science Institutional Review Board Prof. Cristina E. Torres, Ph.D. - FERCAP Group Discussion Tea Break Plenary (presentation of group/groups) Closing Session 8

Conference Conference Agenda Day 1: 9 December 2021 08:30-9:30 Opening Ceremony Jakarta time Session Chair: Yodi Mahendradata Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada Introduction of Country Kenji Hirayama Delegation FERCAP Chair Welcome Address Ova Emilia Dean, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada Panut Mulyono Rector, Universitas Gadjah Mada KEYNOTE Address Budi Gunadi Sadikin Indonesian Minister of Health Session 1 Towards an Ethical Environment during the COVID Pandemic 9:30-12:00 Session Chair: Nandini Kumar Forum of Ethics Review Committees in India Vajira Dissanayake Forum of Ethics Review Committees in Sri Lanka Comparing Efficacy of Mario Antonio Jiz, II COVID-19 Vaccines across Vaccine Expert Panel Asia Department of Science and Technology Philippines Implementing Drug and Togi Junice Hutadjulu Vaccine Registration during a Indonesian FDA (BPOM) Pandemic Update Mego Pinandito Role of Ethics in Research National Research and Innovation Agency and innovation during the (BRIN), Indonesia Covid-19 Pandemic Facilitators and Challenges to N.K. Arora COVID-19 Vaccine Development in Asia The INCLEN Trust International Chair of the Committee on Vaccines, New Delhi, India 9

Session 1 Scientific and Ethical Issues Jacinto Blas Mantaring, III 09:30-12:00 in COVID-19 Vaccine Chair, Single Joint Research Ethics Board, Clinical Trials Department of Health, Philippines Vaccine Acceptance in Dita Ramadonna Indonesia UNICEF, Indonesia 12:00-13:00 Lunch Break and Poster Viewing Session 2 Parallel Sessions 13:00-15:00 Vulnerability Issues in Addressing Challenges Ethics Review Practices in COVID Research in Ethics Education Indonesia during the Breakout Rm. 1 COVID Pandemic Breakout Rm. 2 Breakout Rm. 3 Parallel Session 2A Parallel Session 2B Parallel Session 2C Panel Discussion Session Chair: Session Chair: Session Chair: Anton Rahardjo - Eti Nurwening Madarina Julia - Faculty Sholikah - Faculty of of Medicine, Public Health FIRREC Chair Medicine, Public Health and Nursing, Universitas and Nursing, Gadjah Mada Universitas Gadjah Mada Defining Vulnerability Pedagogical Changes Ethics Review of COVID in Health Research during the COVID Clinical Studies Rizky Harnawan et al Disruption National Institues of Ernawan D.K. et al Health Research and Julia Patrick Engkasan et al Development, Indonesia University of Malaya Recruitment of Military Mindful Learning Ethical Issues at Full Personnel for COVID System in Medical Board Trials Teguh Haryo Sasongko Education Ariastuti, NLP et al et al, Perdana University, Dien Mardhiyah et al Udayana University Malaysia Universitas Airlangga Indonesia 10

Session 2 Decision Making for Addressing Ethical Gaps Role of the REC in the 13:00-15:00 Children's in COVID Research Pandemic and Beyond Proposals Participation in Nur Atik, Padjadjaran Research Namita Ghimere et al University Nepal Research Council Lui Sze Chiang et al University of Malaya Death Rituals during Clinical Self Efficacy Fast Track Review of the COVID Pandemic Among Nursing COVID Protocols Students Puri Swastika Gusti Eti Nurwening Sholikhah et Krisna Dewi et al Theresia et al. Universitas al, Faculty of Medicine, Public Universitas Gadjah Pelita Harapan Mada, Indonesia Health and Nursing, Universitas Gadjah Mada Session 2 Conducting a Research Reviewing COVID Vaccine 13:00-15:00 Ethics Practicum Clinical Trials during a Pandemic Rumana Safi et al Rizka Humardewayanti University of Malaya Asdic et al Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada Ethics Review of Therapeutic Research Yunita Widyastuti et al Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada Ethics Review of Online Research Yayi Suryo Prabandan et al Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada 15:00-16:00 Cultural Presentation 16:00-17:00 Poster Viewing 11

Day 2: 10 December 2021 08:30- Ethical Dilemmas in Parallel Sessions Asian Multi-country Survey 10:00 COVID Vaccine of REC Review of Covid Session 3 Multi-Stakeholder Protocols Perspectives of Risk Breakout Rm. 1 Breakout Rm. 2 Breakout Rm. 3 Parallel Session 3A Parallel Session 3B Parallel Session 3C Session Chair: Session Chair: Session Chair: Rita Sita Sitorus - Juntra Karbwang - Faculty of Medicine - Mohammad Hakimi - SIDCER Coordinator University of Indonesia Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Indonesia COVID Vaccination of Animal Testing from an Paresh Koli, India Pregnant Women Ethical Lens Liza Amir, Indonesia Ma. Stephanie Fay Ch'ng Wang Ping et al Cagayan et al, Skipping Animal Testing Asyraf Syahmi Mohd Noor, University of the Malaysia Philippines Teong Win Zee et al University of Malaya Prakash Ghimire, Nepal COVID Vaccine Inequity Skipping Animal Testing Edlyn Jimenez, Philippines Teong Win Zee et al Anoop Manakkadan et University of Malaya Chandanie Wanigatungge, al, Government Sri Lanka Nurse Anxiety Level in Medical College, India COVID Isolation Room Kwanchanok Yimtae, Thailand Su Jok as Tri Widarti Complementary RSUP Dr. Soeradji Tseday Tilahon, Africa Medicine Therapy Tirtonegoro Klaten, for COVID-19 Indonesia Intansari Nurjannah, Universitas Gadjah Mada, Indonesia 12

08:30-10:00 Risk Factors Affecting Exploring Cancer Session 3 Health Workers Exposed Patient Perception of to COVID Participation in Clinical Trials Dyna Verawan Ch'ng Wan Ping et al., Dr. Soeradji Tirtonegoro National Cancer Hospital Klaten Institute, Malaysia Indonesia KAP of Risk/ Benefit Assessment of REC Members Padmaja Marathe et al Seth GS Medical College, India 10:00-10:30 Break 10:30-12:00 Parallel Sessions Session 4 Addressing Informed Challenges to Ethics Ethics and Regulatory Consent Concerns Review during a Perspectives Pandemic Parallel Session 4A Parallel Session 4C Parallel Session 4B Session Chair: Magdarina Agtini - Session Chair: Session Chair: Eti Nurwening MRIN Madarina Julia - Sholikah - Faculty of Faculty of Medicine, Medicine, Public Health Public Health and and Nursing, Universitas Nursing, Universitas Gadjah Mada, Indonesia Gadjah Mada Consent Declines and Ethics Review in a Korean Accreditation Withdrawals in RCTs Resource Limited of Bioethics Committees NJ Gogtay, King Edward Setting Memorial Hospital, India Suraweera C. Yeong Hee Cho, Wanigatungge C, Sri National Institute for Lanka Medical Bioethical Policy, Korea Association Obtaining Consent in Pre-Pandemic vs. Motives and Obstacles Telehealth Services Pandemic Outcomes in Giving Biological Alvin Marcelo, St. Luke of Ethics Review Medical Center, Materials Philippines Shetty YC et al, Seth Muhammad Hasan GS Medical College, Bashari et al., India Universitas Padjadjaran, Indonesia 13

10:30-12:00 Use of Multimedia Implementing an IRB Biobank Regulations Session 4 Informed Assent Online System and Guidelines in among Pediatric LMICs 12:00-13:00 Patcharaporn Sudchada 13:00-15:00 Patients et al, Naresuan Kuen Yei Chin et al., Session 5 University of Malaya Piya Rujkijyanont et al University, Thailand 15:00-15:15 Phramongkutklao Hospital, Thailand Evaluating Questions Monitoring COVID Incorporating during the Consent Vaccine Clinical Trials Clinical Psychology into Health Services Process Pio Justin Asuncion et al, Tina Solomons, Godbole CJ et al Kotelawala Defence Seth GS Medical College Department of University, Sri Lanka Health, Philippines India Lunch Break and Poster Viewing Lessons Learned during a Pandemic and Beyond Session Chair: Vicente Belizario, Jr. FERCAP Vice Chair Prakash Ghimire FERCAP Local Coordinator, Nepal Ethical and Legal Issues during a Andreas Reis Pandemic Outbreak Co-Lead, WHO Global Health Ethics & Governance Unit Ethical Issues in COVID Genetic Kenji Hirayama Research FERCAP Chair Public Health Ethics during a Cristina E. Torres Pandemic FERCAP Coordinator Regulatory Oversightof Experimental Rose Bernabe Therapies during a Pandemic University of Oslo, Norway Benchmarking Best Practices in Carl Coleman Research Ethics to Enhance Public Professor of Law Trust Seton Hall Law School, USA Closing Remarks Kenji Hirayama 14

FERCAP General Assembly and Recognition Program 11 December 2021 09:30-12:00 Welcome Remarks Kenji Hirayama FERCAP Chair FERCAP Partners in Indonesia Indonesian National Ethics Committee Pratiwi Pudjilestari Sudarmono Chair, National Ethics Committee Forum of Indonesian Recognized Anton Rahardjo Research Ethics Committees (FIRREC) FIRREC Chair FERCAP Reports Annual Report Cristina Torres Annual Financial Report FERCAP Coordinator Recognition Ceremony Closing Remarks Kesara Na Banchang Master of Ceremony FERCAP Treasurer Juntra Laothavorn SIDCER Coordinator Kenji Hirayama FERCAP Chair Arthur Navarro FERCAP Program Manager 15



Defining Vulnerability in Health Research Ethics for COVID-19 Studies Harnawan Rizky1,2*, Phang Kean Chang2, Ng Chirk Jenn2 1. Faculty of Medicine, University of Malaya (UM), Kuala Lumpur, Malaysia 2. Forum of Indonesian Recognized Research Ethics Committees (FIRREC) Introduction: As an abstract concept, vulnerability in health research is widely used to define participants who require special protections and has increasingly become more debatable in scientific literature. To improve the process of Research Ethics Committee review and enhance researchers’ apprehension in identifying and determining vulnerability, definitions and concepts of vulnerability available in various published manuscript and guidelines should synthesized and consolidated systematically. Therefore, a practical account in defining domains of vulnerability may produce a simpler and more relevant approach to understanding of vulnerability, especially for COVID-19 patients recruited as study participants. Methodology: This study uses a scoping review approach, guided by the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) reporting guideline, to identify existing definitions of vulnerability in health research ethics. Kipnis’ taxonomy of vulnerability consisting of 6 concepts was used as conceptual framework. PubMed database was searched using two main concepts to expand the search for appropriate keywords. The first one is ‘vulnerable populations’, which resulted in several keywords: “vulnerable”, “disadvantaged”, “sensitive”, “underserved, and “vulnerability”. The second concept was ‘research ethics’, the selected words were “Research Ethics Committee”, “research ethics”, “IRB”, and “Institutional Review Board”. Results: The search yielded 3,484 records, screened through 235 title/abstract and eventually fortythree articles were reviewed individually to extract the necessary information. Forty-eight definitions of vulnerability were identified and synthesized to simplified the wording. Kipnis (2001) taxonomical categories of vulnerability was used to synthesize the results. Simplified domains were built after completing the synthesizing of the entire record. The definitions were put into specific domains that share semantic commonalities: incapacity to consent; lack of protection; prone to harm or exploitation; lack of basic human rights; and limited access to resources. These categorical domains will be useful for researchers and ethics committee member when developing or reviewing health research protocols involving vulnerable subjects especially for COVID-19 patients. By implementing the five domains in this study, it should be easier to define vulnerability, and hopefully development of appropriate strategies to protect research these COVID-19 participants. Conclusion: A practical account in defining domains of vulnerability may produce a simpler and more relevant approach to understanding of vulnerability. Based on the extensive narrative evaluation of the literature, the researcher is able to determine the wide range of definitions of

vulnerability. Domains are created from the synthesized text that came from the narrative evaluation. There is a potential for researchers and research ethics committees to use these domains as a starting point for better protection of study participants and conducting quality ethics reviews on vulnerability. This study can also be applied for future works to provide understanding of vulnerability in health research ethics review beyond COVID-19 studies. These simplified and mainstreamed domains can be a starting point for better quality ethics reviews. However, more research is needed to evaluate the suitability of using these domains in analyzing vulnerability in health research.

Addressing the 3R Principles in ‘COVID-19 Vaccine’ Non-Human Primate (NHP) Trials Harnawan Rizky1,2*, Sharifah Zamiah binti Syed Abdul Kadir3, Mohammed Abdullah Mahdi Alshawsh3 1. Faculty of Medicine, University of Malaya (UM), Kuala Lumpur, Malaysia 2. Forum of Indonesian Recognized Research Ethics Committees (FIRREC) 3. Department of Pharmacology, Faculty of Medicine, University of Malaya (UM), Kuala Lumpur, Malaysia Introduction: Animals can play an essential role in both basic research and testing in the search for vaccines and treatments for COVID-19 pandemic we are currently living in. Animal tests normally constitute a critical step in vaccine and drug development to determine safety and efficacy at preventing the disease in question. During worldwide pandemic, research needs to be done fast as solutions become urgent to avoid human deaths. This overview focuses on the basic ethics principle for animal research, especially in the use of Non-Human Primate in COVID-19 vaccine development. Methodology: A literature search on Non-Human Primate experiments in COVID-19 vaccine development with its ethical implications was conducted from April to June 2021. PubMed database was searched using keywords such as COVID-19 vaccine, Non-Human Primate (NHP) experiments, ethical issues or concerns. Results: Reports arise about a “shortage” of monkeys for use in the research. The word “shortage” framed monkeys as if they were mere laboratory equipment, things like test tubes and centrifuges. It ignores the ethical point that monkeys are entities with moral concern. It fails to emphasizes that monkeys are needed for vaccine research because of their genetic and biological similarity to humans. There is a call for ethicist to think more deeply and critically about the scientific use of NHP in COVID-19 vaccine development. Researchers need to re-address the basic ethics principles for animal research, the 3Rs, Replacement, Reduction, and Refinement. To have a shortage of primates for COVID-19 vaccine research, means they are massively being used. It raises concern about the “Reduction” principle. Another concern is the “Refinement” principle, how are these animals actually being treated, does the 5 freedom principles applies in the NHP’s COVID-19 research. And about the “Replacement” principle, what is actually the more suitable animal for this research Conclusion: We should implement the 3Rs principle to address this issue. One way is by creating a global database of all studies using NHP for COVID-19 vaccine development, this will represent the “Replacement” principle. Researchers around the globe should have access to all preliminary data to continuously develop a better vaccine without having to use more animals or at least reduce its usage to a very minimum, as required in the “Reduction” principle. Last but not least, all NHP experiment should also consider the 5Fs, as well as the “Refinement” principle.

Recruitment of military personnel for COVID19 trials - Autonomy or Duty? Teguh Haryo Sasongko1*, Kusmarjanto2, Hans Van Rostenberghe3, Zabidi-Hussin ZAMH4 1Royal College of Surgeons in Ireland (RCSI) School of Medicine and Center for Research Excellence, Perdana University, Kuala Lumpur, Malaysia. Email: [email protected]; 2Faculty of Theology, Sanata Dharma University and Center for Bioethics and Medical Humanities School of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia; 3Human Research Ethics Committee, Universiti Sains Malaysia Health Campus, Kubang Kerian, Malaysia, 4School of Medicine and Center for Bioethics and Humanities, International Medical University, Kuala Lumpur, Malaysia Recruitment of military personnel for the COVID19 trial has raised significant ethical concerns, mainly on ensuring autonomy through voluntariness to participate. To some extent, countries have scrambled to recruit COVID19 trial participants from among their military personnel. While such recruitment may provide a quick practical solution to new therapies or vaccines trials during an emergency like a pandemic, there remained significant doubt whether participation can be genuinely voluntary. We wish to highlight the following potential ethical dilemma: military personnel have voluntarily taken on the duty to protect the country in times of armed threats and other crises. Could it be considered the duty of military personnel to participate in a vaccine or therapeutic trials to help the country out of a severe problem like the recent pandemic that has caused many deaths, a paralysis of the economy and extreme stress on the health care system? Suppose that would be an acceptable position of ethical committees. In that case, counter- arguments could include that the products tested will be commercialized, that the duty of the military may not involve taking the country out of a health care crisis and when it comes to medical experiments, the autonomy of the individual needs to be respected to avoid dangerous precedents that could lead to more complex ethical dilemmas.

DECISION-MAKING FOR CHILDREN’S PARTICIPATION IN RESEARCH: PERSPECTIVES OF MALAYSIAN CHILDREN AND THEIR PARENTS Lui Sze Chiang1,2*, Azanna Ahmad Kamar1, Nishakanthi Gopalan1, Asiah Kassim2 1. Faculty of Medicine, University of Malaya (UM), Kuala Lumpur, Malaysia 2. Clinical Research Centre (CRC), Hospital Tunku Azizah, Kuala Lumpur, Malaysia Background: Research involving children is challenging as researchers need to respect both parents' and children’s perspectives, whilst ensuring children’s independence in the expression of their views. While there has been a drastic increase in research involving children in Southeast Asia, the literature on decision-making for research participation among children in this region remains limited. Objective: The purpose of this research is to explore the perspective of Malaysian children and their parents in decision-making for children to participate in research. Associated factors which had possibly influenced research participation were also explored. Methodology: We approached children under 18 years old and their parents, who visited the outpatient clinics (either as patients or visitors) in two tertiary hospitals in Klang Valley, Kuala Lumpur, Malaysia, between April and May 2021. We employed a qualitative method, using semistructured in-depth interviews, and explored the perspectives of children for participation in research revolving around these four domains: (1) Involvement of children in decision- making, (2) Frequently asked information by the parents and children, (3) The minimum age requirement to provide child assent, and (4) The order of person-approach for recruitment of children in research. The interviews were voice-recorded, transcribed and analyzed manually, combining deductive and inductive approaches. Results: We interviewed a total of eight parents and ten children and identified four themes: (1) Decision-maker, (2) Consent and assent processes, (3) Decision age, and (4) Person-approach sequence. A majority of the participants agreed that although parental consent is compulsory, the children should have shared decision-making in research participation. Both parents and children themselves provided a decisional age of between 17 and 24 years old for independent consent without necessitating parental consent. The parents in our study had largely identified themselves as the main decision-maker. However, we identified that both parents and children had expressed a need for a different approach in child recruitment by obtaining the child’s assent before parental consent, which may improve children's satisfaction in research participation. The main influencing factors in research participation were the nature of the research, potential harms, benefits, and previous results. However, parents would also consider other factors such as the child’s interest, time commitment, related costs, and data confidentiality; while the children themselves had focused on their interests and their parents’ views on their research participation. Conclusion: Although parents play a critical role in deciding the children's participation in research, shared decision-making between parents and children is necessary. Malaysian children want their opinions to be included in the decision-making process. This study supports the need to review the existing children's research guidelines and incorporate the assent process to better engage both children and parents in decision-making. Keywords: perspective, decision-making, children, assent, research

Dying with Dignity and Death Rituals During The Covid-19 Pandemic Puri Swastika Gusti Krisna Dewi1,2,3* Imanuel Eko Anggun Sugiyono4 1Fakultas Kedokteran, Keperawatan, Kesehatan Masyarakat Universitas Gadjah Mada 2Center of Bioethics Medical Humanities 3Sekolah Tinggi Ilmu Ekonomi Bisma Lepisi 4Sekolah Tinggi Filsafat Driyarkara Throughout the situation of the covid-19 pandemic, more severe health protocols have been implemented. These protocols have limited the total number of people permitted to participate in an activity. The impact on mourning and funeral rituals in the pandemic time involve restricting total attendees. Families have been restricted to attend the bereavement and funerals in that the implementation of religious rituals around the dying and bereavement process may not proceed as usual. This condition creates problems for most religious families as many Indonesians still uphold strong religious beliefs in their lives. Traditional practices are important and significant components in the Indonesian society crucial to uphold thus, ritual restrictions enforced following the death of covid-19 patients have caused significant problems. We have used qualitative research methods in obtaining data. In this study, we used a phenomenological approach that investigated health care workers' unique experiences. The depth interview model was used for data collection. The health care workers shared their experiences of service provision to the patients and families. We collected the data, analyzed, and grouped them according to identified themes. Due to the heightened sensitivity of the pandemic, it was found that families benefited from health care workers patiently explaining the new and standardized procedure. They were permitted to play the religious music and devotional instruments during the patients hospitalization however the patients were not allowed to have their primary caregivers at their bedsides in the time of suffering, and even dying. The health care workers also ensured pictures or videos of the patient were shared with the bereaved families during the process of body cleansing, purifying, and wrapping. The tension between families’ desires to accompany the dying, keep the religious and beliefs ritual faithfully, and obey the health protocols should be balanced and solved. In the health services and facilities, the health care workers should take care and pay attention to the spiritual and religious desires and needs of patients and families. The health protocols related to the dying and death rituals need to be adaptively implemented. If the dying protocol, death service, and rituals are neglected during the times of the pandemic, it will continue to cause problems and bad feelings to the Indonesian patients and families. Keywords: dying, death ritual, covid-19 pandemic, religious services, end-of-life.

How the Covid-19 Disruption Forced a Pedagogical Evolution: The Case of Masters of Health Research Ethics (MOHRE) Julia Patrick Engkasan1*, Nishakanthi Gopalan2, Esther Gnanamalar Sarojini A. Daniel3,and Tivyashinee2 Department of Rehabilitation Medicine, Medical Humanities and Ethics Unit (MedHEU)2, and Medical Education and Research Development Unit (MERDU)3 Faculty of Medicine This paper is about how the Covid-19 pandemic brought about an abrupt change in the Spectrum of Teaching-Learning (T-L) in Higher Education. This change and the adaptations which came about will be described specific to the Masters of health Research Ethics (MOHRE) programme. MOHRE is a 1-year postgraduate programme offered in the Faculty of Medicine, Universiti Malaya (UM) developed in collaboration with the Berman Institute of Johns Hopkins University, USA. The first batch of students enrolled in September 2019 and was in semester two when Malaysia went into its first full lockdown in March 2020. Scrambling for continuity, face-to face T-L shifted to online platforms almost overnight. How did MOHRE adapt and cope? The focus of this paper will be the Pedagogical Evolution that took place and will be described in four stages. First, two main online platforms which were called into play with great speed. These were Microsoft Teams and the university’s Learning Management System (LMS) which is called SPeCTRUM. Nevertheless, instructors and students were given the liberty to use other platforms such as Zoom and Google Meet for out-of-class meetings and discussions. Second, plans were made for the T-L process. The official MOHRE documents for T-L were reviewed to include synchronous and asynchronous online class sessions which will demand some form of pedagogical change. The Student-Learning Time (SLT) were also relooked at to suit online T-L. Third, the instructors were gathered quickly to discuss the pedagogical changes necessary for the change. Assessment was a big challenge which needed careful planning for execution. Students were also instructed as to what pedagogical and assessment changes that will be made. The disruption like no other has generated a wide range of T-L experiences for all instructors and students of the MOHRE programme. In the span on 2 years, MOHRE underwent a full spectrum change in teaching and learning experiences; from fully face-to-face to complete online with some hybrid mode in between. Thus, the final and fourth stage was the overall evaluation stage where the outcomes of this forced pedagogical evolution were scrutinised for each cohort which were used to enhance to the sessions for the following cohorts. The COVID-19 pandemic provided us with the opportunity to experience the digital transformation and future education towards advancing the academic and intellectual excellence aligned with UM’s transformation plan.

THE MINDFUL LEARNING SYSTEM IN MEDICAL EDUCATION IN THE COVID-19 PANDEMIC ERA Dien Mardhiyah, Hendy Hendarto, Ali Imaduddin Futuwwah, Fitriah Dwi Susilowati Faculty of Economics and Business – Faculty of Medicine, Universitas Airlangga, Surabaya The COVID-19 pandemic has caused changes in various areas of life, including higher education. This study explores student assessments and expectations regarding mindful learning systems, which are ethically appropriate, in medical education during the COVID-19 pandemic era. This study uses a qualitative research design by conducting focus group discussions with the main informants, namely students. Eleven medical students from Universitas Airlangga participated as informants in this study. The data analysis technique used in this research is content analysis using computer assisted qualitative data analysis (CAQDA) called NVivo-12. The results of this study found 6 factors for the formation of wise learning (mindful). The six factors are summarized in 2 major categories, namely the category of academic and non-academic aspects. The academic aspect consists of 4 dimensions, namely the dimensions of the lecturer, the teaching-learning process, the curriculum and share responsibility. Meanwhile, non-academic aspects consist of 2 dimensions, namely the dimensions of infrastructure and communication with the faculty. Keywords: mindful learning system, medical education, marketing ethics, COVID-19, marketing ethics, quality of education

Ethical Characteristics of Research Proposals Related of COVID-19 Pandemic in Nepal: A Retrospective Review Namita Ghimire,1 Pawan Kumar Hamal,1 Asmita Panthee,1 Anju Vaidya,1 Mira Khadka,1 Namra Kumar Mahato,1 Mukesh Kumar Karn,1 Shashi Verma,1 Meghnath Dhimal,1 Prakash Ghimire,1 Pradip Gyanwali1 Affiliation: 1 Nepal Health Research Council, Ramshah path, Kathmandu, Nepal. 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. So, this study aimed to assess ethical issues of the coronavirus disease 2019 (COVID-19) related research proposals submitted during early phase of pandemic in Nepal. Methods: Retrospective analysis of COVID-19 related proposal submitted to the ethical review board at Nepal Health Research Council was done. The analysis was done as per the National Ethical Guidelines, Standard Operating Procedure for Health Research in Nepal and WHO guidelines for infectious disease outbreak, 2016. Descriptive data were analyzed in SPSSv24. 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 process, 57% without explanation of possible risks. Conclusions: Most of the proposals related to COVID-19 were devoid of major ethical elements which eventually prolonged the approval time and delayed the opportunity for evidence generation during pandemic. More attention is needed to increase awareness and develop capacity of researchers, reviewers, ethics committees and stakeholders during health emergencies. Keywords: COVID-19; ethics pandemic; proposals

Clinical Self-Efficacy among Undergraduate Nursing Students in Caring for Tuberculosis Patients in Indonesia Theresia1, Hsiu-Mei Huang2, Chieh-Yu Liu2, Tzu-Ying Lee2, 1 National Taipei University of Nursing and Health Science, Master of Nursing Science graduate students no 365 Mingde Road, Beitou District, Taipei, Taiwan Faculty of Nursing; Universitas Pelita Harapan, no 20 Jendral Sudirman Road, Bencongan, Kelapa Dua, Tangerang, Banten, Indonesia 2 National Taipei University of Nursing and Health Sciences (NTUNHS), no 365 Mingde Road, Beitou District, Taipei, Taiwan Corresponding author: Email address: [email protected] (Theresia), [email protected] (Hsiu Mei Huang), [email protected] (Chieh-Yu Liu), [email protected] (Tzu-Ying Lee) ABSTRACT Background: Tuberculosis (TB) exposure is greater for nurses and nursing students than other health care professionals because they spend more time and have higher intensity contact with patients. In Indonesia, a country with high TB incidence, there is a need to assess undergraduate nursing students’ self-efficacy during their clinical practicums. This study aimed to explore factors associated with nursing students’ clinical self-efficacy for caring for TB patients. Methods: This cross-sectional study used an internet survey based on the United States National TB Curriculum Consortium (NTCC) in September and November 2020. The questions focused on TB knowledge, beliefs about the value of TB instruction, and self-efficacy in caring for TB patients. This study used the Indonesian version of the original NTCC survey. Data were analyzed using descriptive statistics, t-test, ANOVA, Pearson’s correlation coefficient, and hierarchical regression. Results: The higher their year of study, the more knowledge about TB students possessed (r = .290, p < .001). However, students perceived TB instruction as less valuable as they neared graduation (r = -.233, p < .001) and with more frequent practice in the TB unit (r = -.162, p < .001). However, students who spent more time learning about TB outside of class perceived the TB instruction in the nursing curriculum more positively (r = 0.181, p < .004). Univariate analysis showed a significant difference between nursing students’ belief in the value of TB education and their clinical self-efficacy in caring for TB patients (F = 5.711, p < .001). Hierarchical regression results showed that experience caring for TB patients and number of TB patients cared for predicted clinical self-efficacy. Conclusions: Clinical self-efficacy had no significant relationship with the demographic characteristic of the nursing students. Students who believed TB education was valuable also had greater clinical self-efficacy. Keywords: clinical self-efficacy, nursing students, tuberculosis

Conducting a Research Ethics Practicum During a Pandemic: Challenges, Opportunities and Lessons Learned Rumana Saifi, PhD1; Jeremy Sugarman2, MD; Joseph Ali2, JD; Adeeba Kamarulzaman 1 1. CERiA: Centre of Excellence for Research in AIDS, Faculty of Medicine, University of Malaya, Kualalumpur 2. Johns Hopkins Berman Institute of Bioethics, Baltimore, USA Corresponding author: Rumana Saifi, PhD [email protected];[email protected] The Practicum in Health Research Ethics is a key component of the Master of Health Research Ethics (MOHRE) programme at University of Malaya (UM), Kuala Lumpur, a collaborative effort of the Johns Hopkins Berman Institute of Bioethics and the University of Malaya. Complementing text and classroom-based courses, the practicum is designed to integrate the practical aspects of ethical issues in real-life settings, including but not limited to research settings. In general, there are three practicum tracks: (1) Institutional Review Board (IRB); (2) Research and (3) Organizational. Students select a track and an individually-tailored practicum plan is designed for them. All the tracks intend to provide a broad but reasonably detailed exposure to a range of ethical issues that might emerge in the setting where students are doing their practicum. The traditional educational model at UM as well as other learning institutions were challenged with the advent of the COVID-19 pandemic. The Ministry of Education in Malaysia launched digitally-driven ‘remote learning’ in April 2020. Although virtual learning became the default in 2020, the transition from an in-person to online practicum was perplexing as this course was predicated on hands-on experiences with the intense engagement of practicum hosts. This paper discusses the challenges, opportunities and lessons learned from an online practicum course that was developed and implemented; and it identifies some strategies that could be incorporated in the current practicum course format. In 2020-21 eight students completed their Master program in health research ethics with all of them putting their learning into practice via customized online practicum plan. Students were attached with TREAT Asia, UNHCR, Malaysian AIDS Council (MAC), University of Malaya Medical Centre IRB, UM Dentistry IRB and research projects to achieve their practicum interest and goals. A MOHRE student received practical exposure from TREAT Asia in different aspects of ethics considerations related to large database research. Students who were fascinated with ethics around key population groups chose to work with UNHCR and Malaysian AIDS Council (MAC). UNHCR and MAC offered the platform to assess ethical challenges to work with various key populations from refugees to injection drug users to men who have sex with men to transgender to female sex workers. As a part of their practicum activity, students prepared research ethics awareness talks catering the needs of undergraduate medical students and community workers. Optimal solutions to conducting the practicum on a digital platform include: identifying possible barriers prior to the start of virtual practicum; ensuring meaningful communication

among the practicum coordinator, students and host organization; communicating with students beyond online practicum sessions; facilitating both group and one-on-one discussion with students; and exercising flexibility during the practicum process. The online practicum in research ethics proved to be largely beneficial and advantageous for students working with sensitive ethics issues and with students working with external collaborators. Additionally, it increased the opportunity for students to access hidden population groups. Lessons from online practicum experience during the times of pandemic will help rethink and revisit the original in- person design of the practicum.

Characteristics of clinical trials studies related to Covid -19 submitted to the Research Ethics Committee, Faculty of Medicine, Universitas Udayana Ernawati, DK1*; Ariastuti, NLP1; Saputra, K1; Darwin, AE1; Sumadi, IWJ1; Yanti, NPED1; Triningrat, AAMP1; Rahayu ML1; Sutadarma IWG1; Suega, K1; Widiana, IGR1 1Research Ethics Committee, Faculty of Medicine, Universitas Udayana A Research Ethics Committee is an independent body within an institution either in the hospital or education settings. One of the role is to assess the quality of research protocol to ensure the five ethical aspects is taken into consideration by health researcher involving human. During the Covid-19 pandemic, many researchers initiated Covid-19 related research. Research on clinical trials were massively conducted around the globe to examine potential remedies to treat Covid-19. This report aimed to evaluate clinical trial protocols submitted to the Research Ethics Committee, Universitas Udayana. Protocols submitted since the start of pandemic to the mid of October 2021 were scrutinized and characterised based on the issues raised by the reviewers. Eight of the 2140 protocols identified from 1 March 2020 to 15 October 2021 were on clinical trials protocols. Of the protocols, four were primary investigator’s initiated, one was national research and the other three were international research. All of the reviewers decided to have the protocol discussed in Full board meetings. Most reviewers commented on the safety and quality of investigational products understanding the products were new entities to treat Covid-19. The reviewers also had concerns on compliance on clinical trial conducted in Indonesia based regulation applied in Indonesia i.e. the National Agency of Drug and Food Control of Indonesia. One protocol was retracted for administrative errors, two protocols were withdrawn by the primary investigator, three protocols are currently under reviewed, and only two of the protocols granted ethical clearance after more than 30 days from initial submission. It is indicated that studies related to Covid-19 reviewed in our Research Ethics Committee required fast track to ensure relevancy of the study to the current pandemic status. Protocols in clinical trials submitted to the Research Ethics Committee at Universitas Udayana received sufficient number of studies based on its capacity. Keywords: clinical trials, protocols, Covid-19; ethics

Common ethical issues discussed during Full Board Meetings in 2021 at the Research Ethics Committee, Faculty of Medicine, Universitas Udayana Ariastuti, NLP1*; Ernawati, DK1; Saputra, K1; Darwin, AE1; Sumadi, IWJ1; Yanti, NPED1; Triningrat, AAMP1; Rahayu ML1; Sutadarma IWG1; Suega, K1; Widiana, IGR1 1Research Ethics Committee, Faculty of Medicine, Universitas Udayana A full board meeting is one of meetings conducted at an Ethical Research Committee. The meeting aims to discuss issues raised by reviewers on ethics aspect in a protocol. At the Research Ethics Committee, Faculty of Medicine, Universitas Udayana has a full board meeting every fortnightly. This report aimed to describe ethics issues raised by the protocols reviewers based on methodology, ethics and informed consent form (ICF) issues. Methodology issue included study design, sample size, and site of research; ethics issue involved vulnerability, risk and benefits, confidentiality, withdrawal criteria and compensation; ICF issue covered complete information, language comprehensiveness and voluntariness of subject participations. Minutes of the full board meetings since March to August 2021 were selected for a review. There were 11 full board meetings were delivered during the time frame and 59 protocols were discussed in the meetings. All of the studies were clinical trials in which 55 protocols were primary investigator initiated and 4 protocols were sponsored. This study found that 24 protocols had methods issues such as sample selection, sample size, study design, randomisation and withdrawal procedures; 15 protocols had concerns of safety and efficacy of the investigational products, 13 protocols had no GCP certificate from the primary investigator, and the primary investigator did not provide any memorandum of understanding for sponsored protocols. The reviewers also identified 3 clinical trials protocols were initiated by undergraduate students and 1 protocol by medical residential student. In relation to ICF issues, 5 protocols required revision to ensure the language understood by participants. Findings of this report indicated that the three ethics aspects had been identified by the reviewers. This shows that our ethical committee has a strong capacity to ensure the quality of research protocols reviewed. This study also suggested that the primary investigator may have lack of understandings of what to expect when they conducted clinical trials particularly those involving sponsors. This may mean that the committee need to provide more exposure on ethics in conducting research both for internal audiences across the university and externally outside the university. Keywords: full board meetings, methodology, ethics issues, informed consent.

The Role of Research Ethics Committee in the Pandemic and beyond: The experiences from Research Ethics Committee, Padjadjaran University Nur Atik1,2*, Muhammad Hasan Bashari1,2 and Meita Dhamayanti2,3 1Department of Biomedical Sciences, Faculty of Medicine, Padjadjaran University, Bandung, Jawa Barat, Indonesia 2Research Ethics Committee, Padjadjaran University, Bandung, Jawa Barat, Indonesia 3Department of Child Health, Faculty of Medicine, Padjadjaran University, Bandung, Jawa Barat, Indonesia The outbreak of Coronavirus disease 2019 (COVID-19) that begin at the end of 2019 in Wuhan, China, due to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has raised global concern. It has been declared as a pandemic by World Health Organisation (WHO) since March 2020. Though this was not the first pandemic status in the world, the challenges are still become an extensive concern to be faced, including for the ethics research committee. This pandemic has raised numerous clinical and ethical challenges globally. Many research to find a new therapy, both as a definite therapy or adjuvants, were raised during the pandemic. The new vaccine development to overcome the COVID-19 also has its ethical concern. Each Ethical committee (EC) has its unique system, though principally, the function is the same. The primary responsibility of the EC is to protect potential participants in the research, but it must also take into account potential risks and benefits for the community in which the research will be carried out. The pandemic condition forced the EC should fast adapt to the condition. Some should be transformed to conform with the current situation, such as the submission process with the online system, full-board (FB) using virtual meeting platform, and shorten the duration of the review process without reducing the quality. The presentation will focus on the EC functions’ to ensure the subjects’ safety and welfare according to our experience during the pandemic. There were some adaptations that we performed to address the challenge. It includes the online system submission, increasing the frequency of FB meetings, improving scientific knowledge regarding the Covid-19 until collaborating or discussing with other experts from other EC. Additionally, we will discuss a future challenge after the pandemic, such as the ethical concern for FB by virtual meeting platforms. In summary, the EC has a crucial role in ensuring the safety of subjects in this pandemic situation. The adaptation is strictly needed to reach the principal objective of the EC. Keywords: COVID-19 Pandemic, Research Ethics Committee, Role of Ethics Committees, SARS-CoV-2.

Fast Tract Ethics Review for Study Related to COVID-19 during Pandemic in Medical and Health Research Ethics Committee of Faculty of Medicine Public Health and Nursing Universitas Gadjah Mada - Sardjito General Hospital Eti Nurwening Sholikhah1,7*, Madarina Julia1,2, Yunita Widyastuti1,3, Arief Budiyanto1,4, Shinta Prawitasari1,5, Rizka Humardewayanti Asie1,6, Niken Trisnowati1,4, Widyawati1,8, Yayi Suryo Prabandari1,9, Tri Wibawa1,10 1)Medical and Health Research Ethics Committee, 2)Department of Pediatric, 3) Department of Anesthesiology and Intensive Therapy, 4)Department of Dermatology and Venereology, 5)Department of Obstetrics and Gynecology, 6)Department of Internal Medicine, Faculty of Medicine Public Health and Nursing Universitas Gadjah Mada – Sardjito General Hospital 7)Department of Pharmacology and Therapy, 8)Department of Pediatric and Maternity Nursing, 9)Department of Health Behavior, Social Medicine and Environmental Health, 10)Department of Microbiology, Faculty of Medicine Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia The ethics committee is responsible to safeguard the rights, safety, and well-being of all trial subjects. The ethics committee responsible for reviewing all protocols involving humans as subjects before the research is started. The COVID-19 pandemic has changed the protocol review process. Although the ethics committee implements an online system that makes it easier for all steps of the review process during the pandemic, several steps need to be modified. The pandemic has encouraged researchers to conduct research related to COVID-19, so that many research protocols related to COVID-19 have submitted to the ethics committee. These protocols must be reviewed immediately, especially the research protocol related to policy making for the community. So that, the review process needs to be accelerated. Some of the modifications have made by the ethics committee. The secretariat staffs are always responsive to every incoming protocol, checking whether the protocol is related to COVID-19 research. When the submitted research protocol is related to COVID-19, the secretariat staff sends a notification to the secretary to appoint a reviewer as soon as possible. The reviewer will receive a notification immediately from the online system that there is a protocol that must be reviewed. In addition, the secretariat staff will send a special notification that there is a research protocol related to COVID-19 that must be reviewed immediately. Reviewers are expected to complete their review immediately, without degrading the quality of the review. After the review is completed, the secretariat staff proceeds to the next process immediately. The protocol with full board review criteria will be discussed at the nearest full board meeting schedule. It has not to wait until the panel full board meeting on duty.

Essentials Issues Discussed in COVID-19 Vaccine Trial Protocols Review Rizka Humardewayanti Asdie1,6, Eti Nurwening Sholikhah1,7*, Madarina Julia1,2, Yunita Widyastuti1,3, Arief Budiyanto1,4, ShintaPrawitasari1,5, Niken Trisnowati1,4, Widyawati1,8, Yayi Suryo Prabandari1,9, Tri Wibawa1,10 1)Medical and Health Research Ethics Committee, 2)Department of Pediatric, 3) Department of Anesthesiology andIntensive Therapy, 4)Department of Dermatology and Venereology, 5)Department of Obstetrics and Gynecology, 6)Department of Internal Medicine, Faculty of Medicine Public Health and Nursing Universitas Gadjah Mada – Sardjito General Hospital 7)Department of Pharmacology and Therapy, 8)Department of Pediatric and Maternity Nursing 9)Department of Health Behavior, Social Medicine and Environmental Health, 10)Department of Microbiology, Faculty of MedicinePublic Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia Background. Vaccines are crucial to protecting people from the highly contagious SARS-CoV-2 virus. While a lack of understanding of the pathogenesis and the predictive role of vaccines in the clinical pathway of persons being infected by SARS-CoV-2 and the finding that antibody-dependent enhancement (ADE) may contribute to the exaggeration of SARS-CoV-2 disease has not yet been established, many clinical trials of vaccine to seek the most effective protective for COVID-19 infection. Global efforts to accelerate the availability of the COVID-19 vaccines had pushed scientists to streamline the rigorous procedural and regulatory standard in developing the vaccine. This streamlining posed consequential effects defying the traditional ethics of vaccine research and development, particularly for the rearing principle of beneficence and non-maleficence. This paper will explore the ethical issues arising from clinical trials for COVID-19 vaccine. How the ethical committee must ensure the safety of both patients and health workers, determine whether ongoing trials should proceed or be modified, be suspended, or be discontinued altogether will be reviewed. Methods. We conducted an internal audit of vaccine trial protocol minutes from MHREC Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada to identify the ethical issues during the COVID-19 pandemic. Results. Most concern about dose vaccine, effect of kinds of vaccine, risk of the vaccine, vaccine acceptor, long term effect follow up of the vaccine, the availability of adequate health systems and facilities to warrant appropriate treatment and care for the trial subjects and their families and/or communities in the event of serious adverse associated with clinical outcomes including assurance. Conclusion. All important issue was raised and discussed during full board review. Key word. Concern issues, COVID-1 vaccine trial

ETHICAL ISSUES IN THERAPEUTIC STUDY DURING COVID-19 PANDEMIC Yunita Widyastuti, MD, PhD; Madarina Julia, MD, PhD, Arief Budiyanto, MD, PhD; Tri Wibawa, MD, Ph.D; Eti Nurwening Sholikhah, MD, PhD; Shinta Prawitasari, MD, PhD; Rizka Humardewayanti Asie, MD; Widyawati, PhD; Yayi Suryo Prabandari, PhD, Niken Trisnowati, MD, PhD Medical and Health Research Ethics Committee Faculty of Medicine, Public Health and Nursing UGM – RSUP Dr Sardjito The COVID-19 pandemic made the clinical research community face some challenges that led to the global impairment of operations and conduct of trials. While the effective novel therapy has not yet been established, many clinical trials were conducted to seek the most effective treatment for COVID-19 infection. On the other hand, the disease posed many ethical issues both in its management and itself. This paper will explore the ethical issues arising from clinical trials for COVID-19 therapy. How the ethical committee must ensure the safety of both patients and health workers, determine whether ongoing trials should proceed or be modified, be suspended, or be discontinued altogether will be reviewed. We conducted an internal audit of clinical trial protocol minutes from Medical and Health Research Ethics Committee Faculty of Medicine, Public Health and Nursing UGM – RSUP Dr Sardjito to identify the ethical issues during the COVID-19 pandemic. Most problems arose from clinical trials using off-label drugs, novel experimental drugs, herbal and complementary therapy, stem cell study, and plasma convalescence treatment. Modifications were noted from the informed consent process, the regulation of control negative placebo, and long-term effect follow-up of the drugs.

Ethical Issues on the Online Public Health and Health Social Science Research related to COVID 19 Yayi Suryo Prabandari1,2*, Madarina Julia1,3, Yunita Widyastuti1,4, Arief Budiyanto1,5, Shinta Prawitasari1,6, Rizka Humardewayanti Asie1,7, Eti Wening Sholikhah1,8*, Niken Trisnowati1,5, Widyawati1,9, Tri Wibawa1,10 1)Medical and Health Research Ethics Committee, 2)Department of Health Behavior, Social Medicine and Environmental Health, 3)Department of Pediatric, 4) Department of Anesthesiology and Intensive Therapy, 5)Department of Dermatology and Venereology, 6)Department of Obstetrics and Gynecology, 7)Department of Internal Medicine, Faculty of Medicine Public Health and Nursing Universitas Gadjah Mada – Sardjito General Hospital 8)Department of Pharmacology and Therapy, 9)Department of Pediatric and Maternity Nursing, 10)Department of Microbiology, Faculty of Medicine Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia Internet based research has increased during pandemic COVID 19, although online surveys have started more than a decade along with the advance of information technology. When the survey is carried out online, there are some considerations on the research ethics. Study on KAP (knowledge, attitude, practice) and perception on certain topics related to COVID 19 among different groups of participants have been submitted to MHREC FM PHN UGM (Medical Health Research Ethics Committee of Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada). In this paper, we examined the ethical issues in the online KAP and perception of public health and health social science studies related to COVID 19. We first carried out literature review on the internet-based research to find some ethical issues on that kind of studies for examining the ethical issue themes. We then conducted a simple thematic analysis on the minutes and review of online public health and health social science research related to COVID 19 protocols that have been submitted to the MHREC FM PHN UGM. The ethical issues related to the internet-based research were about confidentiality, the procedure of informed consent and assent, how to recruit the participants and sampling methods, and the anonymity. All of those themes were found to be discussed and reviewed in the minutes and report. Additional issues that we found were the inclusion and exclusion criteria, the language of the informed consent and the compensation for participants. The recommendation for the researcher was to add some information and revision on the part that arose ethical issues.

Informed, Included and involved: a developing world perspective on the ethics of COVID-19 vaccination in pregnant women [email protected] Maria Stephanie Fay S. Cagayan,1,2 Lumberto Mendoza,3,4 John Noel M. Viana5,6 1 Department of Pharmacology and Toxicology, University of the Philippines Manila, Manila, Philippines 2Perinatal Association of the Philippines Research Committee, Quezon City, Philippines 3Department of Philosophy, University of the Philippines Diliman, Quezon City, Philippines 4National Kidney Transplant Institute Research Ethics Committee, Quezon City, Philippines 5Australian National Centre for the Public Awareness of Science (CPAS), ANU College of Science, The Australian National University, Canberra, Australian Capital Territory, Australia 6Responsible Innovation Future Science Platform, Commonwealth Scientific and Industrial Research Organisation (CSIRO), Brisbane, Queensland, Australia Abstract COVID-19 still persists as a global health issue, with pregnant women being one of the most vulnerable groups during the pandemic. COVID-19 vaccination in the United States at the outset included extremely vulnerable pregnant women but uptake has been reported to be lower in pregnant women (11.1%) compared with nonpregnant females aged 18–49 years (24.9%) (CDC, unpublished data, 2021). Due to limited availability, COVID-19 vaccination in the Philippines only began in March 2021. Pregnant women were generally excluded, except for healthcare workers given their higher exposure risk. However, the incursion of the Delta variant in the Philippines in June 2021, and the associated increase in mortality of symptomatic COVID-positive pregnant women (UP-PGH, unpublished data, 2021), led to the Philippine Department of Health and the Philippine Obstetrical and Gynecological Society releasing guidelines for the vaccination of pregnant and lactating mothers. Early data from numerous international drug safety registries do not show significant harm to both the mother and baby. Pre-clinical data from Developmental and Reproductive Toxicity (DART) for the Pfizer- BioNtech, Moderna, and Janssen (Johnson & Johnson) COVID-19 vaccines also did not raise significant safety concerns in pregnancy. Since most of the fetus’s organ systems are rapidly developing during the first trimester, COVID-19 vaccines are recommended to be given during the second trimester and onwards. This presentation explores ethical and societal issues in the vaccination of pregnant women in the Philippines, using insights from the medical and ethics literature, author’s personal experience in vaccinating women in underserved and socio- economically disadvantaged Philippine municipalities, and accounts of Filipino cultural values. We highlight the importance of proper and sensitive communication of the vaccine’s risks and benefits to pregnant women, ensuring that they are adequately informed and not coerced when providing consent to be vaccinated. Healthcare workers should employ socio-

economic and culturally-sensitive forms of communication that address concerns and combat misinformation, both in clinical and community settings. With the continued underrepresentation of pregnant women in COVID-19 clinical trials, we also forward the need to re-examine their exclusion and to develop procedures to encourage greater involvement while minimising possible harms to the woman and the unborn child. Although COVID-19 presents unique challenges in making public health decisions concerning pregnant women, in light of limited evidence, it also provides new opportunities to better engage, include, and involve pregnant women in health and medical research that can profoundly influence their and their child’s health and well-being.

Vaccine inequity- Biggest hurdle in fight against corona pandemic Anoop Manakkadan1#, Sreejith P.S1, and Chandramohanan Nair K.R2 1 Multidisciplinary Research Unit, Government Medical College Thiruvananthapuram, Kerala, India. 2 Retired Dept. of Anatomy, Government Medical College Thiruvananthapuram, Kerala, India. # Presenting Author. Email: [email protected] A world without COVID-19 will not be possible until everyone has equal access to vaccines. The global failure to share vaccines equitably is taking its toll on some of the world’s poorest and most vulnerable people. It also allows even more deadly variants to emerge and spread across the globe. The present study aims to highlight the ethics behind the inequitable vaccine distribution across the globe with data collected from relevant online sources. According to the Global Dashboard for Vaccine Equity (established by UNDP, WHO and Oxford University) as of Oct. 20, 62.79 per cent of people in high-income countries have been vaccinated with at least one dose, compared to 4.51 per cent in low-income countries. The vaccination rate (at least one dose) in high-income countries like the US and UK are around 65.2 and 70.92 percentage respectively, while those of poorest countries remain at just 0.09 and 1.15 percent in Democratic Republic of the Congo and Venezuela respectively. Also to achieve the target of vaccinating 70% of their population, the high-income countries will have to just increase their health care spending by 0.8%, while that for low-income countries would be around 56.6%, which would further increase their economic burden. Though nations have agreed to channel the vaccines through COVAX platform, only 4% of the global production has been released through it. Also, out of the 1 billion doses promised by the high-income countries, less than 15% of those doses have been materialized. Even after placing an order of 220 million doses by the African union for single dose vaccine, the company supplied just 9 million and exported the rest to Europe instead. To make matters worse, over 15 million doses have been discarded in US alone since March 2021 even while many low-income countries are yet to vaccinate even their healthcare workers. We believe prominent international bodies should come forward with more precise planning in terms of vaccine sharing among world countries. Scaling-up vaccine manufacturing, reducing its cost and delivery charges, initiatives to eliminate export restrictions and trade barriers among world nations; and providing timely financial support to low-income countries are urgently required to make the vaccine more accessible. A better vaccine management strategy with the active participation of all the nations is urgently required to overcome the present crisis. Because access to COVID-19 vaccines alone offers the best hope for slowing the Corona virus pandemic, saving lives and securing a global economic recovery.

Complementary alternative therapy: Su Jok to reduce symptoms in the respiratory tract in COVID-19’s patient: A case series Intansari Nurjannah1*, Zakiah Novianti2, Agus Suharto2, Muhammad Yasir Sudarmo2, Ki Hariyadi3 1Department of Mental Health and Community Nursing, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Indonesia 2General Hospital dr. Soeradji Tirtonegoro Klaten, Central of Java, Indonesia 3 Faculty of Science and Technology, State Islamic University of Sunan Kalijaga, Yogyakarta, Indonesia Research purposes. The purpose of the study was to determine the effect of complementary alternative therapy: Su Jok to reduce symptoms in the respiratory tract of COVID-19 patients. Research methods. A total of 4 male COVID-19 patients were included in this study. The inclusion criteria were: oxygen saturation less than 96% and at least one symptoms of shortness of breath, cough, pain in throat, anosmia, excess in sputum production, feeling pressure in chest, and gustatory sensation problem, with score ≥ 2 (1 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 4 = severe symptoms, 5 = very severe symptoms). The respondents were given Su Jok therapy protocol using massage, putting colour and seed. The intervention took about 3 minutes and after that, oxygen saturation and the symptoms were measured on 5th, 15th and 30th minutes. Results. In all patients, the oxygen saturation increased above 96% in the 5th minutes of measurement. Shortness of breath was experienced in all patients and the symptoms score decrease in all patients. The symptoms reduce from severe to mild at 5th minutes in one patient, another patient reduce the symptom reduce from severe to moderate at 5th minutes. Two other patient experienced moderate symptom and the symptoms gone (score 1) in patient at 30th minutes and in one patient symptom reduce on mild on 30th minutes of measurement. There were 3 people who had a cough and one person experienced a decrease in symptoms from moderate to mild started from the 5th minute and lasted until the 30th minute. Another patient had experienced a decrease in a cough symptoms from moderate to mild on 15 minutes but increased again to moderate symptoms at 30 minutes. One patient had a cough symptoms completely disappeared (none) from moderate at 15 minutes and persisted until 30 minutes. Anosmia occurred in two patients with very severe symptom (score 5) and these symptoms disappeared completely (score 1) at 15th minutes. Meanwhile, in other patients anosmia reduce from moderate to mild at 5th minutes and stay in mild symptom at the 30th minutes of measurement. There is only one patient experienced gustatory sensation problem with scale very severe symptom (score 5) and the symptom gone (none = score 1) at 15th minutes of measurement. Conclusion. Sujok therapy able to increase oxygen saturation and to reduce symptoms of shortness of breath, cough, anosmia and gustatory sensation problem in a short period of time, no more than 15 minutes after therapy. Keyword. Complementary alternative, Su Jok, Breathing, COVID-19

Risk Factors Affecting Health Workers Exposed to COVID-19 at Dr Soeradji Tirtonegoro Hospital Klaten Dyna Verawati1 1Applied Health Information Management, Cases of health workers exposed to COVID-19 are increasing. Health workers have risk factors for contracting COVID-19 which results in an increase in transmission cases and makes the COVID-19 virus infect more severely. It is necessary to know the factors that affect health workers exposed to COVID-19 at Dr Soeradji Tirtonegoro Hospital Klaten as the basis for making service security policies and efforts to break the chain of spread of COVID-19. This study aims to determine the factors that influence health workers exposed to COVID-19 in the Klaten RSST. The research design is quantitative analysis, cross sectional method, data analysis using Multiple Logistic Regression Test. The research was conducted at the Klaten RSST in July 2021 with a sample of 100 respondents. The results of the age significance value were 0.593; gender 0.817; comorbid 0.011; increased immunity 0.449; working area zone 0.001; application of health protocol 0.999 and transmission 0.003. There was no significant effect of age, gender, immunity, and health protocols on health workers exposed to COVID-19 at the Klaten RSST. There is a significant effect of comorbidity, work area zone and transmission on health workers exposed to COVID-19 in the Klaten RSST. Health workers who have comorbidities have a risk of being exposed to COVID-19 by 10,271 times compared to those who do not. Health workers who work in high-risk zones have a 6,596 times risk of being exposed to COVID-19 compared to those who work in non-high-risk zones. Health workers who are exposed to transmission have a 5,204 times risk of exposure to COVID-19 compared to those who do not. Keywords: Health workers; COVID-19; Expose

Could Covid-19 spell the end of animal testing? -Through the lens of ethics Ch’ng Wan Ping1,2*, Sharifah Zamiah Binti Syed Abdul Kadir3, Mohammed Abdullah Mahdi Alshawsh3 1 Department of Oncology and Radiotherapy, National Cancer Institute, Putrajaya Malaysia 2 Faculty of Medicine, University of Malaya (UM), Kuala Lumpur Malaysia 3 Department of Pharmacology, Faculty of Medicine, University of Malaya (UM), Kuala Lumpur Malaysia BACKGROUND: According to NIH, >90% of the animal experimentations fail to lead to treatment for humans. It is always a debate between science and ethics about the necessity of animal research where science community always thought that animal research is the means of preclinical safety and efficacy testing before starting human trials which forms the foundation in building the fundamental knowledge that feeds into new treatments and medical innovations while critics always argue that the practice is unnecessary and ineffective. In the emergence of the Covid-19 pandemic, FDA has authorized for emergency use of covid vaccine of certain companies. The rapid speed at which the vaccine gained FDA approval was achieved because the standard FDA drug development process via a series of animal testing was bypassed before moving on to human clinical trials. People for the Ethical Treatment of Animals (PETA)has then started to echo their previous statement calling on FDA to modernize its stale and inefficient drug development process by shifting from relying on animal tests to prioritizing human relevant, non- animal testing strategies. So, does Covid-19 actually spell the end of animal testing? RESEARCH QUESTIONS: In the era of post covid-19 pandemics in future: 1. Can animal testing be truly replaceable? 2. What are the promising alternatives to animal testing that is available and how far is the utilisation? 3. How do we balance between the usefulness of animal in research with animal welfare through the 3Rs, should we have to use animal for the research? METHODOLOGY: A literature search on the preclinical animal studies from June 2020 - June 2021 and the concerning ethical issues was performed.PubMed and Google Scholar databases were searched using key words like animal model/testing, alternatives to animal testing, covid 19 vaccine. FINDINGS: 1. Animal tests are never skipped in developing Covid 19 vaccine. Scientists still believe that animals are key for evaluating the protective efficacy and safety of any new treatments before it is used in humans. In fact, animals play important role in 2. Non-existence of an optimal alternative yet.Alternatives e.g.,3D tissue model, Lung on chip had been used in COVID-19 vaccine development. Nonetheless, their uses are

limited because they fail to replicate close to the complexity of the viral pathogenesis in humans. Also, there is a lack of knowledge of and expertise in the technology 3. Important to address the ethical issues in animal research with the application of 3Rs ethical principles, i.e, Replacement, Reduction and Refinement.Understanding how the 3Rs can be applied is the key. CONCLUSION Current Covid 19 crisis does not spell the end of animal testing. Instead, it highlights the necessity of animal testing. Until the discovery of a superior substitute, it will remain as indispensable part of the battle not only against COVID-19 but other potential deadly diseases. Instead of curtailing animal research, we should all work together to make animal research as efficient and effective such that rapid response to new emerging health threats can be achieved while maintaining an ethical research ecosystem with optimal animal care.

Can We Skip Animal Testing on the Development of COVID-19 Vaccine? Teong Win Zee1,2, Sharifah Zamiah Syed Abdul Kadir1, Mohammed Abdullah Alshawsh1 1 Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia 2 Clinical Research Centre, Queen Elizabeth Hospital, Sabah, Malaysia The COVID-19 pandemic has affected the globe for more than a year and a half. The devastating economic and humanitarian impact spurred the rush to develop vaccines. Vaccine development is a multi-stage process and usually a decade-long endeavour, but the first authorised COVID-19 vaccine took less than 12 months to produce. This study aims to understand the stages to develop a vaccine, the changes in this process brought upon by the COVID-19 pandemic, and analyses whether we are ready to skip or minimize animal testing for future vaccine development A literature review was conducted in April 2021 to June 2021 to achieve this aim. The disease and subsequently the vaccine candidates have to be studied in vitro and in vivo before the vaccine can be given to humans in clinical trials. As a result of the pandemic, timeline for the development of a vaccine has shortened significantly. The COVID-19 pandemic highlighted major limitations of animal testing such as the lack of a suitable animal model that can mimic the pathophysiology of the disease. Several animal models were used to study different aspects of COVID-19 infection as no single model can ideally mimic the pattern of infection as humans. While studying the disease in humans is still the best option, it is not always feasible. As such, animal models that are biologically similar and susceptible to the same disease become a good alternative. Some alternative in vitro testing successfully employed in the development of the COVID-19 vaccine includes 3D cells, organoids, organs-on-chips, ex vivo organs, and in silico modelling. While these alternatives have reduced the number of animals used in vaccine development, currently available methods still cannot emulate complex human biological processes. Skipping animal testing and proceeding straight to human studies from in vitro studies may compromise the scientific validity and, most importantly, the safety of end consumers. Tragedies due to abandoning animal testing were happened, such as the thalidomide tragedy in the 1960s. As such, animal testing is still very much needed in the biomedical field including vaccine development. The 3Rs concept (Replacement, Reduction, and Refinement) has guided the usage of laboratory animals to ensure their wellbeing and minimise their suffering. The contribution of animals in the development of COVID-19 vaccines is immeasurable. Awareness of the ethical and humane treatment of laboratory animals is on the rise, and alternatives are being developed with the ultimate aim of replacing animal use in research altogether. Until we find an ethical way to conduct medical research without harming human subjects, animal use is still necessary. Keywords: stages of vaccine development; COVID-19 vaccine; in vitro testing for COVID- 19 vaccine; preclinical investigation; animal research

THE RELATIONSHIP OF GENERAL SELF EFFICACY TO NURSE'S ANXIETY LEVEL IN THE COVID-19 ISOLATION ROOM Tri Windarti 1*),Dewi Susilowati 2*), Ari Wibawa 3*) The psychological condition of nurses in dealing with the covid-19 pandemic can be disrupted because they face life-threatening situations caused by the effects of infection from covid-19, very intensive work, the large number of patients so that psychological problems arise with different levels. Psychological disorders can be caused by fatigue, anxiety and depression during the task of fighting covid-19. Anxiety can be influenced by general self-efficacy, stress overload and social support. Based on a preliminary study in the Covid 19 isolation room, RSUP dr. Soeradji Tirtonegoro Klaten in April 2021, which was carried out on 5 nurses, all of them experienced moderate anxiety, and from interviews with 5 nurses who caused work anxiety, they were fear of contracting disease, anxiety about dealing with covid-19 patients who were in critical and terminal conditions. The design of this research is an analytical survey research with a cross sectional approach. The respondents of this study were 22 respondents. The sampling technique was purposive sampling in accordance with the inclusion criteria. The data collection instrument used a questionnaire on the characteristics of the respondents, the HADS anxiety level questionnaire and the General Self-Efficacy Scale (KGSC) questionnaire. Bivariate data analysis with Chi Square. The results of the study obtained a p value of 0.03 <0.05, thus, there was a significant (significant) relationship between General Self Efficacy on the anxiety of nurses in the Covid 19 isolation room RSUP dr. Soeradji Tirtonegoro Klaten. The results of this study are expected as a reference for determining policies in terms of services related to the management of psychosocial problems, especially nurses' anxiety in hospitals and also the results of this study are expected, especially nurses with severe anxiety levels, rotational mutations can be carried out according to their area of competence or interest. Keywords: General Self Efficacy, Anxiety, Nurse, Covid 19 Isolation Room

EXPLORING THE PERCEPTIONS OF PATIENTS WITH METASTATIC CANCER DISEASE IN THEIR PARTICIPATION IN CLINICAL TRIALS - A QUALITATIVE PILOT STUDY IN MALAYSIA Dr Ch’ng Wan Ping1*, Dr Chong Lee Ai2, Ms. Krisna Velli A/P Balakrisnan3 1Department of Oncology and Radiotherapy, National Cancer Institute, Putrajaya Malaysia 2Department of Paediatric Palliative Care, University Malaya, Kuala Lumpur Malaysia 3 Clinical Investigation Centre, University Malaya, Kuala Lumpur Malaysia BACKGROUND Informed consent is the cornerstone of ethics in clinical research. With the emerging novel cancer treatments, the informed consent forms in oncology trials have grown increasingly lengthy and complex. The perceived voluntary participation in a clinical trial without adequate comprehension of the informed consent and the subtler clouding of the distinction between treatment and research which constitutes therapeutic misconception (TM) impose serious threats to voluntariness in research participation especially amongst patients with cancer who are seen as vulnerable from various aspects. It adversely compromises autonomous decision-making and violates the ethical principle of respect for persons and the dignity of the research participants. OBJECTIVES This study aims to: 1. Explore the perceived voluntariness in metastatic cancer patients enrolling in therapeutic clinical trials. Factors affecting patients’ decisions in participation are explored as well. 2. Evaluate if trial participants have TM and put forward recommendations to researchers on the possible ways to mitigate TM. STUDY METHODOLOGY Recruitment was performed in two government oncology centres in Klang Valley Malaysia. Metastatic cancer patients currently participating in clinical trials were recruited. Data collection was performed through in-depth semi-structured interviews. A total of eight respondents from the two cancer centres were recruited. The audio recordings of the interviews were transcribed and analyzed using thematic analysis. RESULTS & DISCUSSION This study revealed that almost all the participants were perceived to participate in the clinical trial voluntarily. Additionally, factors namely the relationships with clinician/ investigator, the relationship with family/friends, monetary benefit, altruism, the influence of social media are identified to be influencing the decision-making dynamics for trial participation. The participant-clinician/investigator relationship carries the most significant weightage in aiding participants’ decision-making in participation and this is believed to be due to their strong trust and respect in doctors. The influence of social media is also interestingly found to be a factor aiding decision-making in participation. Potentially, the lengthy ICF can be replaced by the incorporation of media sources to become a powerful tool in helping participants to understand clinical research better including their rights with their

participation. Nonetheless, the use of social media should be allowed with due diligence, given that social media can spread misinformation faster than ever before due to its unrestricted access. A few respondents said to have manifest TM. This result indeed reflects its prevalence within the community which is not to be ignored. CONCLUSIONS The investigator of a clinical trial who is also the treating clinician must be cognizant of the dependent clinician-patient relationship. The trust built should be carefully protected from any exploitation. Effective communication during the informed consent process can be potentially enhanced by the diligent use of electronic media resources. The presence of TM not only vitiates meaningful informed consent but is also ethically problematic as it poses concern about the misplaced trust and exploitation of such trust. Efforts should be made by the researchers to help trial participants to achieve a better understanding of the informed consent and thereby their interests are protected.

Knowledge, Attitude and Practices regarding Assessment of Risks and Benefits of Proposed Clinical Research Studies by Ethics Committee members: A Questionnaire- Based Study Dr Padmaja Marathe*, Dr Sandhya Kamat*,Dr. Harshad Kesari*, Dr. Sonali Karekar*, Dr Kruttika Chitnis* Mr. Manoj Prabhu**, Dr Murugananthan K**, Dr. Parth Gokhale**,Ms Swapna Jadhav** * Department of Pharmacology and Therapeutics, Seth GS Medical College andKEM Hospital, Mumbai, India **Indian Council for Clinical Research, Mumbai, India Background and Objective: The Belmont’s principle of beneficence and nonmaleficence needs to be scrupulously followed by Ethics Committees while assessing risks and benefits of a research proposal. There have been no previous studies assessing the knowledge, attitude and practices of Ethics committee members regarding risk-benefit evaluation of research study protocols. Hence, the present st\\ y was conceptualized. The objective of the study was to assess the knowledge, attitude and practices regarding risk- benefit assessment of clinical research studies by ethics committee (EC) members. Methods: This study is registered in the clinical trials registry of India (CTRI/2020/10/028515). It is a cross-sectional, observational, questionnaire-based study conducted among EC members from institutes across India after obtaining institutional ethics committee permission and taking written/ implied consent from the participants. The EC members currently serving on registered ECs for a minimum period of one year and reviewing regulatory clinical trials, interventional studies, biomedical and health research studies were approached. The questionnaire consisted of four domains: respondent details and consent, knowledge, attitude and practices. It was validated for content validity and face validity. The responses recorded were analysed using descriptive statistics. Results (The results have been presented partly as the data analysis is ongoing at present). The knowledge, attitude and practices (KAP) questionnaire was validated by 10 experts. The relevance was assessed by the experts on the scale of 1 (not relevant) to 4 (very relevant). The content relevance (I-CVI/Ave) was 0.96. Essentiality was assessed on the scale of 1 (not essential) to 3 (essential). The average CVR for each domain as follows: Knowledge- 0.67, Attitude- 0.8 and Practices- 0.8. The questionnaire was administered manually by hand as well as in the form of a google drive link. We received complete responses from 115 participants. The type of ECs included: Government institutes-44, Private institutes-57 Independent Institutes’ ECs- 17. The respondents were member secretary-31, basic medical scientists-30, chairperson-22, clinicians- 27 and non-medical members i.e. lawyer (7), layperson (7) and social scientist (8). Some respondents worked in more than one EC and played two roles (for e.g. member secretary and clinician / basic medical scientist). Out of 115 EC members, 84 had more than 3 years of

experience of serving on ECs. Regarding the question on whether they received training to do risk-benefit assessment (RBA), majority of them said that they received training initially as a part of GCP training and learnt on the job. More than 50% of those members who reviewed both regulatory and non-regulatory type of studies, responded that they differentiate between regulatory studies and non-regulatory studies while dong RBA. When asked about the right time to do RBA of research studies, 90 percent of them responded that right time is to do RBA initially as well as at the time of continuing review/ SAE review and that they do so in their respective ECs. However, 15 responded that they carry out RBA only at initial review. To the question whether there is any objective method followed for risk-benefit assessment (RBA) by your EC, 20 EC members replied that there is no such practice whereas the rest of the EC members said they send comments and do RBA by filling in the review assessment form. Interestingly, there were 40 EC members who mentioned that they had a separate RBA checklist prepared by their ECs. Regarding who should carry out RBA, the responses were varied. Most of them had ticked all EC members. A few had marked only member secretary/ basic medical scientist/clinician/lawyer. EC members (60%) stated that they follow ICMR guidelines and New Drugs and Clinical Trials Rules to do RBA, others stated ICH-GCP/ local EC-SOPs/ USFDA/ FERCI conferences and 40% said that they were not aware of any guidance document for RBA. Only 13 EC members responded that the review and discussion related to RBA is not done separately for each study and 7 stated that the minutes of the EC meeting do not capture RBA discussion for each study. Conclusion: The KAP survey findings indicate that the EC members in India are aware of the importance of RBA and need to do RBA for each research study. There is no formal separate training received by the EC member to carry out RBA. However, overall practices across the ECs regarding RBA were not found to be uniform. There is scope of capacity building by introducing novel RBA tool to train ECs.