UID:
almahu_9949881074902882
Format:
1 online resource (1122 pages)
Edition:
1st ed.
ISBN:
9783031484087
Note:
Intro -- Foreword -- Preface -- Learning Tracks: Fields of Study and Practice -- Acknowledgments -- Contents -- Editors and Contributors -- About the Editors -- Contributors -- Abbreviations -- I: Pandemic Preparedness and Research Response: A Necessary New Field -- 1 Introduction -- 2 Clinical Research on Infectious Diseases: An Overview -- 1 Introduction -- 2 Evolution of Clinical Trial Methodology -- 2.1 The Inclusion of a Placebo Group in Clinical Trial Design -- 2.2 Concurrent Versus Historical Control Groups -- 2.3 Randomization Versus Alternation in Enrollment -- 2.4 Formal Ethical and Regulatory Frameworks -- 3 Critical Ground Rules for Research Studies During Epidemics -- 3.1 Jurisdictional Levels and Collaborations -- 3.2 Community Engagement -- 3.3 Identifying and Clarifying the Elements of Engagement -- 3.4 Broad-Based Scientific Participation -- 3.5 Communication and Messengers -- 3.6 Special Considerations in Conflict Zones and Failed States -- 4 Lessons Learned from Emergency Clinical Research -- 4.1 The Genesis of the Ebola Epidemic in West Africa: The Consequences of Early Errors in Response -- 4.2 Launching Clinical Trials of Therapeutics and Vaccines -- 4.3 Is it Ethical to Conduct Controlled Clinical Trials During a Public Health Emergency? -- 4.4 Contentious Study Design Issues -- 4.5 The Relevance of Adaptive Clinical Trial Designs and Prepositioned Research and Patient Networks -- 4.6 Achieving Trust and Support of the Affected Community -- 4.7 Speeding the Clinical Research Process and Regulatory Approval Without Compromising Safety -- 4.8 Recommendations to Improve Clinical Research and Trials During Public Health Emergencies -- 4.9 The Emergence of SARS-CoV-2 and the COVID-19 Pandemic -- 5 Conclusions -- References -- 3 Guiding Principles for Emergency Research Response -- 1 Introduction -- 2 Principles.
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2.1 Principle 1: Research Should Be an Integral Part of Preparedness and Emergency Response -- 2.2 Principle 2: Research Response Should Align with the Goals of the Health Emergency -- 2.3 Principle 3: Research Response Should Be Implemented Quickly and Efficiently Based on Outbreak Preparedness Plans -- 2.4 Principle 4: The Scientific and Ethical Norms for Human Subject Research Do Not Change During a Health Emergency -- 2.5 Principle 5: Research Response Should Be Led by the Government of the Country Experiencing the Health Emergency -- 2.6 Principle 6: Good Participatory Practice Applies to Research in Health Emergencies -- 3 Other Applicable Principles and Considerations -- References -- II: Norms for Emergency Research Response -- 4 Ethics of Pandemic Research -- 1 Introduction -- 2 Do Pandemics Necessitate or Justify Deviations from Ethical and Scientific Standards for Research? -- 3 Do Pandemics Raise Novel Ethical Issues for Research? -- 4 Setting Research Priorities During a Pandemic -- 5 Research Versus Response or Research as Response? -- 6 Research Governance, Coordination, and Oversight During Pandemics -- 7 Conclusion -- References -- 4.1 In Practice: Vaccine Efficacy and Safety Testing-An Ethical Case for Individual Randomization -- 1 Introduction -- 2 Supporting Considerations -- 3 Conclusion -- References -- 4.2 In Practice: Research Ethics Committee Review in Public Health Emergencies -- 1 Introduction -- 2 Historical Notes -- 3 Research Intervention in a Public Health Emergency -- 4 Seeking and Retaining Stakeholder Commitment -- 5 Future Directions -- References -- 5 Health Emergency Research amid Global Inequities: Some Considerations for Researchers -- 1 Introduction -- 2 Research Participants and Communities -- 2.1 Research Participant Rights and Benefits -- 2.2 Building Mutual Respect with Communities.
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2.2.1 Respect Community Beliefs and Cultural Practices -- Include all Relevant Stakeholders -- 2.2.2 Avoid Exploitation and the Perception of Exploitation -- 2.3 Post-trial Access to Trial Products, Procedures, or Devices -- 3 Partnerships -- 3.1 Minimizing North-South Inequality in Research Partnerships -- 3.2 Fair Treatment and Support for Front-Line Workers -- 3.3 Equity in Publication -- 3.4 Work with Non-government Organizations (NGOs) Already on the Ground or with Relevant Experience -- 4 Nation-States and Global Response -- 4.1 When Governments Put Their Own Interests First -- 4.2 Protecting Nations at Risk -- 4.3 International Economic Interventions Can Undermine Preparedness -- 4.4 National Sovereignty vs. Possible Global Impact -- 5 Questions and Conclusion -- 5.1 Can We Achieve Sustainable Preparedness and Response? -- 5.2 Conclusion -- References -- 6 Meeting Regulatory Criteria and Seeking Licensure: Medicines Development Before and During Public Health Emergencies -- 1 Introduction -- 2 Development and Licensure of Medicinal Products in Brief -- 3 Medical Countermeasure Development During a Public Health Emergency -- 4 Lessons Learned and Regulatory Strategies to Prepare for Future Emergencies -- 4.1 Chemistry, Manufacturing, and Controls and Reliance on Available Data on Platform Technologies -- 4.2 Preclinical Studies -- 4.3 Clinical Studies -- 4.4 Post-approval Monitoring -- 5 Regulatory Communications and Stakeholder Exchange -- 5.1 Additional Considerations on Chemistry, Manufacturing, and Controls -- 6 Concluding Remarks -- References -- 7 Research, Sample, and Data Sharing During Outbreaks, Pandemics, and Beyond -- 1 Introduction -- 2 The Impact of Pandemic Diseases on Health Data Sharing -- 3 The Utility of Viral Sequences -- 4 Sharing Data -- 4.1 Mechanisms for Sharing Data -- 4.2 Rapidity vs. Equity? -- 4.3 Legal Frameworks.
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5 A Roadmap to Improve Data Sharing -- 6 Conclusion -- References -- III: Preparedness for Emergency Research Response -- 8 Building Biomedical Research Capacity in Low- and Middle-Income Countries: Why It Matters and Some of the Barriers to Success -- 1 Introduction -- 2 Local or National Research Agendas Enable Research Capacity to Respond to Local Needs -- 3 Investing in Local Research Infrastructure Before Crises -- 3.1 Education and Training -- 3.2 Institutional Infrastructure -- 3.3 Operational Needs -- 3.4 Community Engagement -- 4 Research, Public Health, and Healthcare Capacity as Synergistic Forces for EID Response -- 5 COVID-19 and Lessons for Research Capacity Strengthening -- 6 Systemic Challenges to LMIC Research Capacity Strengthening -- 7 Conclusion -- References -- 9 Laboratory Needs for Research Response -- 1 Introduction -- 2 Who, What, Where, When, and Why -- 3 Field Laboratories -- 3.1 Where? Site Location -- 3.2 Assay and Equipment Selection -- 3.3 Regulatory and Legal Concerns -- 3.3.1 Regulatory Management Tools for Emergencies -- 3.3.2 Expedited Evaluation and Approval Processes -- 3.3.3 Diagnostic Preparedness -- 3.4 Specimen Collection, Transport, and Storage -- 3.5 Obstacles to Proper Sample Packaging and Transport -- 4 Implementing Effective Laboratory Biosafety and Biosecurity -- 5 Documentation, Data Quality, and Data Management -- 6 Case Study -- 7 Summary and Conclusion -- References -- 10 Understanding How and Where Pathogens Emerge: Preparedness and Response for Zoonotic Diseases -- 1 Introduction -- 2 Why Is Pre-outbreak Information Important? -- 2.1 Impact of Uncontrolled Emerging Zoonoses -- 2.2 Increasing Rates of Emergence and Potential Future Threats -- 2.3 Availability of Targeted Interventions to Prevent, Detect, and Respond to Emerging Zoonoses.
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2.4 Time, Focus, and Resources Are Limited Once Outbreaks Start -- 3 Pre-outbreak Information: What We Already Know About How and Where Pathogens Emerge -- 3.1 The Risk Landscape Is Not Uniform: Specific Conditions Create Spillover Hot Spots -- 3.2 Specific Conditions and Human Behaviors at Hot Spots Affecting Spillover, Amplification, and Geographical Spread -- 3.3 Certain Animals Tend to Be Associated with Zoonotic Pathogens and Spillover Events -- 3.4 Some Zoonotic Pathogens Are More Capable of Spillover -- 3.5 Spillover of Zoonotic Pathogens Can Change Over Time -- 3.6 Interventions to Reduce Spillover Risk -- 4 What We Still Need to Know -- 4.1 Characterization of Risk at the Animal-Human-Environment Interface -- 4.2 Developing and Assessing Safety and Efficacy of Interventions to Reduce Spillover, Amplification, and Geographical Spread -- 5 Pre-outbreak Information: Best Practices and Recommendations -- 5.1 Strengthening Country Capacities Improves Detection and Response for Zoonotic Pathogens -- 5.2 Systematic Collection of Pre-outbreak Information -- 5.3 Surveillance and Research Networks Improve Information Sharing, Preparedness, and Response -- 5.4 Targeted Risk Reduction Interventions Work -- 5.5 Coordination with Other Infectious Disease Programs and Across Sectors to Improve Prevention, Detection, and Response -- 5.6 Linking Action Plans to Resource Mapping -- 6 Recommendations -- 6.1 Strengthen and Prioritize Collection of Pre-outbreak Information -- 6.1.1 Country Activities, Taking into Consideration the Best Practices and Gaps Previously Mentioned -- 6.1.2 Regional and Global Activities, Taking into Consideration the Best Practices and Gaps Previously Mentioned -- 6.2 Strengthen In-County Data Systems and Their Linkages with International Databases.
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6.2.1 Country Activities, Taking into Consideration the Best Practices and Gaps Previously Mentioned.
Additional Edition:
Print version: Higgs, Elizabeth S. Principles and Practice of Emergency Research Response Cham : Springer International Publishing AG,c2024 ISBN 9783031484070
Language:
English
Keywords:
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