Ethical Innovation for Global Health : Pandemic, Democracy and Ethics in Research

This volume captures the recent changes and evolution in ethics in research involving humans and provides future directions to achieve alternative drug development strategies for equitable global health. It presents ethical considerations in current day clinical trials and new trends of ethics in research. It also describes the historical context, illustrates the process in alternative paradigms to achieve democracy after World War II, how the framework of ethics in research was established in different regions, and policies implemented to protect research participants from the exploitation of new drug development. The book is organized into three themed parts: relevant constructions from Brazil, South Africa, Taiwan, South Korea, and Japan; historical and international perspectives of principles of ethics in research; and alternative frameworks of clinical development and innovation. Ethical Innovation for Global Health: Pandemic, Democracy and Ethics in Research is an informative resource for academic researchers, the global pharmaceutical industry, regulators, civil society and other role players involved in global health. It is contributed to by leaders in global policy development in research ethics, and experts in drug development activities with its trajectory being global health. The COVID-19 pandemic, as a global disaster, necessitated not only socio-economic but also cultural transformation. While effective vaccines were developed under a successful new methodology, there remains inequity of distribution of these vaccines globally. The book re-engages with the notion of the primacy of distributing results of scientific innovation to those who most require the benefits. Contents About the Editors About the Contributors Introduction to Ethical Innovation for Global Health: Pandemic, Democracy, and Ethics in Research 1 Purpose of This Publication and Its Background 1.1 No One Is Safe Until Everyone Is Safe [16, 17] 1.2 COVID-19 Vaccines as a Global Public Good [21, 22] 2 Structure of This Volume 2.1 Part 1 Relevant Constructions from Global South and/or Asian Paradigms: Brazil, South Africa, Taiwan, South Korea, and Japan 2.2 Part 2 Historical and International Perspectives on the Development of Ethical Principles in Research Involving Humans 2.3 Part 3 Alternative Frameworks for Innovation and Drug Development Strategies 3 Historical Analysis on Pandemics and Ethics in Research (Table 1) 4 Expected Audience and how to Use this Book 5 Conclusion and Opening to the Following Chapters References Part I: Relevant Constructions from Global South and/or Asian Paradigms: Brazil, South Africa, Taiwan, South Korea, and Japan Democracy Restoration in Brazil, the Constitutional Guarantee of Health as a Right for All, Giving Rise to a Universal Health System (SUS) and of a National Research Ethics Commission 1 Health Emergencies in Brazil 2 Geopolitical Scenario 3 The Creation of Brazilian Unified Health System (SUS) 3.1 Combining Forces with a Common Goal 3.2 Participation of Civil Society 3.3 The Universities/Health Secretariats/Professionals/Academia 4 Scientific, Economic, Social, and Ethical Impacts of the AIDS Pandemic 4.1 In Science 4.2 Ethics, Research, and Access 4.2.1 The National Health Council (CNS) and the Role of the Brazilian Research Ethics Commission (CONEP) in Protecting Research Participants 5 Case Study: Confronting AIDS Vis-à-Vis Responding to the COVID-19 Pandemic in Brazil: An Antithetical Response 6 Challenges 7 Perspectives 8 Lessons Learned 8.1 The Impact of the Restoration of Democracy in Brazil 8.2 In Research 8.3 In Public Health 9 Conclusions References Equitable Access to COVID-19 Vaccines, Vaccine Research, and Vaccine Apartheid on the African Continent: Challenges and Recommendations 1 Introduction 2 The Current Context with Regard to Vaccine Development and Manufacture on the Continent 3 The African Union and Africa CDC Approach to Ensuring Access to COVID-19 Vaccines on the Continent [11] 4 COVID-19 Vaccines: A Global Public Good VS Vaccine Apartheid 5 Impediments to Access Including Corruption, Vaccine Hesitancy, and Poor Uptake of COVID-19 Vaccines 6 Corruption 7 Vaccine Hesitancy 8 Ethical Issues Associated with COVID-19 Vaccine Research in Africa 9 Conclusion References Response to COVID-19 Pandemic and Ethical Innovations in Taiwan 1 Introduction 2 Country with the Most Biobanks per Capita 3 Research Involving Indigenous People 4 Response to COVID-19 Epidemic 4.1 Severe Acute Respiratory Syndrome Outbreak in 2003 4.2 Constant Threat of China Invasion 4.3 A Large Population on a Small Island 4.4 History of Combating Infectious Diseases 5 Innovation for the Response to COVID-19 Pandemic 5.1 Strategy for Communicating Effectively 5.2 Strategy for Balancing Individual Rights with Public Health 5.3 Strategy for Prioritizing Resource Utilization 6 Conclusion References Between Truth and Profit: Scientific Misconduct Case of Human Cloned Embryonic Stem Cell and Revisiting Cases During COVID-19 Pandemic 1 Introduction 2 The Hwang WS Scandal: A Strange Case of Scientific Misconduct in Korea 2.1 Case Outline 2.2 Hwang WS First Public Lie in Science  2.3 The “Fabrication Case of Papers on Cloned Human Embryonic Stem Cells” and Its Timeline: 2005–2013 2.3.1 An Unfettered Race 2.3.2 Ryu’s Report and MBC PD Note’s Request for Verification 2.3.3 Hwang WS’s Resistance 2.3.4 The Revealed Truth and the Conclusion of SNU’s Investigation Committee 2.3.5 How Did a Scientific Study Fabrication Case End Up Standing Before the Court? 2.3.6 The Criminal Justice Process and Outcome 2.4 What Created the Scientific Research Manipulator 3 Democracy, Research Ethics, and Pandemic in Korea 3.1 A Legal System for Maintaining Research Ethics 3.1.1 The Bioethics and Safety Act 3.1.2 Hwang’s Intervention in the Legislative Process 3.1.3 Revision of the Bioethics Act After the “Hwang WS Scandal” 3.2 Has Research Ethics and Integrity in Korea Improved? 3.2.1 Research Ethics and Integrity Have Degraded Into a Tool for Eliminating Public Office Candidates 3.2.2 Re-Entry of Hwang WS and the Korean Society’s Reaction 3.2.3 The Park Geun-Hye Administration and Hwang’s Efforts to Recover 3.2.4 Recurrence Possibility of Scientific Fraud 4 Ethical Issues in Korea During the COVID-19 Pandemic 4.1 Ethical Issues Related with the COVID-19 Pandemic 4.2 CV-Building and Scientific Misconduct for University Admission 4.2.1 Research Ethics Violations by Daughters of Two Former Minister of Justice 5 Concluding Remarks References Therapeutic Misconception as the Basis for Vaccine Nationalism of Japan: A Historical Reflection and Perspectives for Global Public Health 1 Introduction 2 Democratic Constitution: Characteristics from the Perspective of Ethics in Research 3 Development of Framework of Ethics in Research Involving Humans 3.1 Development History 3.2 Application of Research Ethics Norms in Reality 4 Therapeutic Research During the COVID-19 Pandemic 4.1 Failure in the Development of a Japan-Originated Drug 4.2 “Special Approval” of a US-Originated Drug 4.3 Emergency Approval of a Japan-Originated Drug with “Social Value” 5 Vaccine Development in COVID-19 Pandemic 5.1 Panic Purchasing and Discard of Western-Origin Vaccines 5.2 Failure and Questions of Developing Japan-Originated Vaccines 6 Debates on Ethics of Resource Allocation 7 Discussion 7.1 Global Health Governance 7.2 Global Norm for Ethics in Research 7.3 Ethical Foundation of Health Governance and Ethics in Research 8 Conclusion References Part II: Historical and International Perspectives on the Development of Ethical Principles in Research Involving Humans The Declaration of Helsinki as a Living Document: Revisiting Its Principles in a Global Pandemic References Hidden Medical War Crimes and the Emergence of Bioethics in Japan 1 Introduction 2 Bioethical Deficit: Documentary Evidences at Suitland, Maryland, U.S. 3 Inhuman Experiments: Audio-Visionary Evidence at the Former Unit 731 Head-Quarter in Harbin, China 4 The Tragedy of Hibakusha: Genetic Evidence at Hiroshima and Nagasaki, Japan 5 Concluding Remarks References From Nuremberg to Helsinki: Historicizing the Codification of Post-War Research Ethics 1 Introduction 2 Controlling the Codification of Medical Ethics 3 The Road to Helsinki 4 Medical Ethics in the Time of War 5 A Special Code of Ethics 6 The Declaration of Helsinki 1964 6.1 Conclusion References CIOMS Research Guidelines: Considering the Needs of Developing Countries 1 Background 1.1 What Is CIOMS? 1.2 CIOMS Guidance on Research Ethics 1.3 CIOMS Activities in Medicines Development 1.4 CIOMS Activities in Medicines Safety 2 CIOMS International Ethical Guidelines for Health-Related Research Involving Humans 2.1 Background 2.2 Selected Key Aspects 2.2.1 Responsiveness to Communities’ Health Needs 2.2.2 Community Engagement 2.2.3 Vulnerable Populations 2.2.4 Data-Driven Research 3 CIOMS Working Group Report on Clinical Research in Resource-Limited Settings 3.1 Background and Overview 3.2 Selected Key Aspects 3.2.1 Ethical Considerations Vulnerability Protecting Research Participants Avoiding Exploitative Research Ethical Review and Capacity-Building Community Engagement 3.2.2 The COVID-19 Pandemic: Lessons Learned 3.3 Recommendations 4 CIOMS Working Group Report on Patient Involvement 4.1 Background 4.2 Selected Key Aspects 4.2.1 Ethical Considerations 4.2.2 Low- and Middle-Income Countries 4.2.3 Pandemic Considerations 5 Conclusion References Ethics of Placebo-Controlled Trials: Historical Analysis Including Experiences During the COVID-19 Pandemic 1 Introduction: Focus of the Issue 2 Foundations for Human Rights and Research Ethics Norms 2.1 International Instruments and Establishment of Research Ethics Principles 2.2 Ethical Principles for Controlled Trials 2.2.1 Declaration of Helsinki 2.2.2 CIOMS Guidelines 2.2.3 The Belmont Report 2.2.4 The International Conference on Harmonisation: Good Clinical Practice (ICH-GCP) 3 Process of the Pragmatic Modification of the Ethical Principles of Controlled Trials 3.1 Controversies in the HIV/AIDS Pandemic 3.2 The Twists and Turns of the Placebo Clause 3.3 Declining in Authority: FDA Abandoned the DoH 3.4 Declining in Authority: Latin America Rejected the DoH 3.5 Controversies Related to Research for Specific Illnesses 3.6 Three Contentious Issues in the Placebo Debate 4 Controversies in the Ebola Outbreak 5 Revisiting Placebo Clause in the COVID-19 Pandemic 5.1 Best Proven COVID-19 Vaccines 5.2 Misunderstanding of a WHO Ad Hoc Expert Group 6 Discussion 6.1 Standard of Care 6.2 Clinical Equipoise Versus Acceptable Risk Threshold 7 Conclusion References Post-Trial Access: Historical Analysis Considering the Experience of COVID-19 Pandemic 1 Introduction: Focus of the Issue 2 Post-Trial Access Debate in Response to the HIV/AIDS Pandemic 2.1 Downgrade in the DoH and Alternative Ideas 2.2 Strengthened Alternatives in CIOMS Guidelines 2.3 Exploring International Consensus 2.4 TRIPS Doha Declaration 3 Post-Trial Access Challenge During the COVID-19 Pandemic 3.1 COVAX to Overcome “Vaccine Nationalism” 3.2 The Proposal for a TRIPS Waiver to Patents 4 Discussion 4.1 Latin American Experience 4.2 Expanding Stakeholder Participation 4.3 Efforts for Post-Trial Access for Global Health 5 Conclusion References Our “WMA Declaration of Helsinki”: Opinions and Proposals from Patient and Public for Research Ethics 1 Introduction 1.1 Background 1.2 Methodological Aspects (Fig. 1) 2 International Norms and Health Systems Related to the DoH 2.1 International Norms 2.1.1 World Health Organization Constitution (WHO) (Adopted in 1946) [11] 2.1.2 United Nations Declaration of Human Rights (1948) [13] and the United Nations International Covenants on Human Rights (1966) [14, 15] 2.1.3 Act on the Protection of Personal Information 2.1.4 Sustainable Development Goals (SDGs) (2015) [21] 2.2 Other Related Documents of the WMA and the Core Principles of the DoH 2.3 Medical Research and Public Insurance 3 Scope of the DoH 3.1 Scope of the Protection 3.2 Scope of Obliged Persons 4 Visions for Future Generations 4.1 Environmental and Social Impact 4.2 Responsibility After the Completion of Research 5 Multidisciplinary Collaboration and Patient and Public Involvement in Research 5.1 Multidisciplinary Collaboration 5.2 Involvement, Collaboration, and Leadership of Patient and Public 5.3 Physician’s Responsibilities and Limitations in Risk Management 6 Research Ethics Committee 6.1 Diversity of Membership of the Research Ethics Committee 6.2 Support System of the Committee 7 Informed Consent 7.1 Right to Self-Determination and Shared Decision-Making 7.2 Research Involving an Individual Incapable of Giving Consent, and Having No Relative 7.3 Declaration of Taipei (DoT) and Alternative Expressions of Consent 7.3.1 Broad Informed Consent 7.3.2 Dynamic Consent 7.3.3 Social Contract and Consensus in Society 8 Discussion: Disagreements and Limitations 9 Conclusion References Part III: Alternative Frameworks for Innovation and Drug Development Strategies Medicines Development for Global Health: Learning from COVID-19 Vaccines R&D 1 Background 2 Build Future Preparedness 2.1 Challenges and Opportunities for Innovation 2.2 Operation Warp Speed 2.3 Next Generation COVID-19 Vaccines 2.4 Information and Technology Sharing 3 Global Research Priorities in the Public Interest 4 The COVID-19 Technology Access Pool 5 Conclusion References Development of Portfolios and Pipelines of Drugs for the Treatment, Prevention and Control of Neglected Tropical Diseases 1 Introduction 2 The NTD Movement: Establishment and Recent Trends 3 Landscape of Players and Roles 3.1 Product Development Partnerships (PDPs) as a Catalyst 3.2 PDP Portfolios and Clinical Targets 3.3 New Models for Partnership and R&D 3.4 PDP Pharma Biotech Partnership and Impact 3.5 Rules, Guidelines, Understandings and Structures for Partnerships 4 Outstanding Issues and the Future 4.1 Sustaining the Expertise 4.2 Connect Development to Implementation 5 Conclusion References Patient and Public Involvement (PPI) and Pharmaceutical Development Through Open Innovation Processes: Recent Activities 1 Introduction: Pharmaceutical Medicines Development and Patient and Public Involvement 2 History of Patient Engagement in the United States, Europe and International Initiatives 2.1 Government Actions in the US 2.2 European Initiatives with Patient–Public Involvement 2.3 International Initiatives 2.4 Successful Examples 3 Patient and Public Involvement During the COVID-19 Pandemic 3.1 Resident Survey Summary 4 Changes in the Clinical Trial Environment During the COVID-19 Pandemic 5 Patient Engagement from a Global Overview; Working Toward Localization 6 Need to Establish PPI Activity in Japan 7 Good Examples of Adapted PPI Activity 7.1 Construction of the Educational Course 7.2 Testimonials from Course Participants 7.2.1 Noriko Iwaya, Intractable Disease Society Support Familia Yamaguchi 7.2.2 Keiko Inoue, A Board Member of the Association for Medical Malpractice Victims 8 Conclusion: Patient Involvement as Social Co-Creation References