FERCAP Program Book

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