Ethics Dumping: Case Studies from North-South Research Collaborations (SpringerBriefs in Research and Innovation Governance)

This book is published under a CC BY 4.0 license. This book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of __un__ethical conduct are essential for research ethics training. Foreword 7 Acknowledgements 9 Reference 10 Contents 11 About the Editors 13 1 Ethics Dumping: Introduction 14 Abstract 14 Introduction 14 Background to Ethics Dumping 15 The Cases 16 Vulnerable Populations 17 Clinical Trials 18 Benefit Sharing 18 Animal Research 19 New and Emerging Technologies 19 Ethical Governance and Processes 19 References 20 2 Social Science Research in a Humanitarian Emergency Context 22 Abstract 22 Area of Risk of Exploitation 22 Background 23 Specific Case and Analysis 23 Lessons Learned 25 Recommendations 26 Reference 26 3 International Genomics Research Involving the San People 28 Abstract 28 Area of Risk of Exploitation 29 Specific Case and Analysis 29 Terminology 30 Published Conclusions Far Removed from Genomic Research 31 Individual Versus Collective Consent 31 Lack of Respect for or Reference to Indigenous Research Protocols 32 Failure of Research Ethics Committees/Institutional Review Boards 32 Breaches of Privacy in the Findings 33 Lessons Learned 33 Recommendations 34 References 34 4 Sex Workers Involved in HIV/AIDS Research 36 Abstract 36 My Experience Visiting Majengo 36 About Majengo 37 The Majengo Clinic 38 Majengo Research 39 Majengo Research Participants 40 Research Literacy Among the Sex Workers 40 Ethical Concerns and Benefits 41 Conclusion and Looking Forward 43 References 43 5 Cervical Cancer Screening in India 45 Abstract 45 Area of Risk of Exploitation 46 Context 46 Background on Cervical Cancer Screening in India 47 Study Design 48 Three Cluster Randomized Controlled Trials of VIA with “No Screening” Controls in India 49 The Mumbai Trial 50 Osmanabad Trial 52 Dindigul Trial 53 Analysis 54 Ethical Implications of Research in Communities Without Universal Access to Health Care 55 Regulatory Weaknesses 56 Recommendations 57 References 57 6 Ebola Vaccine Trials 61 Abstract 61 Area of Risk of Exploitation 62 Specific Case 62 Case Analysis 63 The Informed Consent Process 65 Conclusion 69 Supplement to the Ebola Vaccine Trial Case – The Importance of Trust 70 References 71 7 Hepatitis B Study with Gender Inequities 73 Abstract 73 Area of Risk of Exploitation 73 Case Description 73 Analysis 74 Outcome of the Application for Ethics Approval 77 Lessons Learned and Recommendations 77 Acknowledgements 77 References 77 8 Healthy Volunteers in Clinical Studies 79 Abstract 79 Area of Risk of Exploitation 79 The Problem 80 The Way Forward 81 References 81 9 An International Collaborative Genetic Research Project Conducted in China 83 Abstract 83 Area of Risk of Exploitation 84 Background 84 Specific Case and Analysis 86 Lessons Learned 88 Recommendations 90 References 91 10 The Use of Non-human Primates in Research 93 Abstract 93 Area of Risk of Exploitation 93 Animal Research Worldwide 94 Specific Case and Analysis 97 Recommendations 99 Conclusion 100 References 100 11 Human Food Trial of a Transgenic Fruit 103 Abstract 103 Areas of Risk of Exploitation 104 Risks of Participating in the Food Trial 104 Risks of Undermining Local Food Systems 105 A Proposed Human Food Trial 105 Risks Related to Unknown Human Health Impacts 106 Impacts on Local Food and Cultural Systems 106 Threats to Banana Agrobiodiversity 107 Lessons Learned 108 Recommendations 108 References 109 12 ICT and Mobile Data for Health Research 111 Abstract 111 Area of Risk of Exploitation 112 Context-Based and Fully Informed Consent Should Be Obtained 113 Only Necessary Data Should Be Collected 113 Any Tracking Should Be Proportionate and the Correct Person Should Be Tracked 113 Research Participants Should Know Exactly Which Data Is Collected and Who Will or Could Have Access to It 114 Incentives to Take Part in Research Should Be Proportionate and not Result in Exploitation 114 Specific Case and Analysis 115 Recommendations 116 References 116 13 Safety and Security Risks of CRISPR/Cas9 119 Abstract 119 Area of Risk of Exploitation 120 Analysis 120 Recommendations 123 Technical Level 123 Containment Level 123 Governance and Oversight level 123 International Standardization 124 References 124 14 Seeking Retrospective Approval for a Study in Resource-Constrained Liberia 126 Abstract 126 Area of Risk of Exploitation 127 Background 127 Details of the Case 128 Reasons for IRB Decision and Conclusion 129 References 129 15 Legal and Ethical Issues of Justice: Global and Local Perspectives on Compensation for Serious Adverse Events in Clinical Trials 131 Abstract 131 Areas of Risk of Exploitation 132 Background 132 The Case 133 Procedure for Compensation Claim in China 134 The Source of Disagreement 134 Update 136 Lessons Learned & Recommendations 136 Acknowledgements 137 References 137 Other Resources 139 Index 141 Front Matter ....Pages i-xiii Ethics Dumping: Introduction (Doris Schroeder, Julie Cook, François Hirsch, Solveig Fenet, Vasantha Muthuswamy)....Pages 1-8 Social Science Research in a Humanitarian Emergency Context (Gwenaëlle Luc, Chiara Altare)....Pages 9-14 International Genomics Research Involving the San People (Roger Chennells, Andries Steenkamp)....Pages 15-22 Sex Workers Involved in HIV/AIDS Research (Anthony Tukai)....Pages 23-31 Cervical Cancer Screening in India (Sandhya Srinivasan, Veena Johari, Amar Jesani)....Pages 33-48 Ebola Vaccine Trials (Godfrey B. Tangwa, Katharine Browne, Doris Schroeder)....Pages 49-60 Hepatitis B Study with Gender Inequities (Olga Kubar)....Pages 61-66 Healthy Volunteers in Clinical Studies (Klaus Michael Leisinger, Karin Monika Schmitt, François Bompart)....Pages 67-70 An International Collaborative Genetic Research Project Conducted in China (Yandong Zhao, Wenxia Zhang)....Pages 71-80 The Use of Non-human Primates in Research (Kate Chatfield, David Morton)....Pages 81-90 Human Food Trial of a Transgenic Fruit (Jaci van Niekerk, Rachel Wynberg)....Pages 91-98 ICT and Mobile Data for Health Research (David Coles, Jane Wathuta, Pamela Andanda)....Pages 99-106 Safety and Security Risks of CRISPR/Cas9 (Johannes Rath)....Pages 107-113 Seeking Retrospective Approval for a Study in Resource-Constrained Liberia (Jemee K. Tegli)....Pages 115-119 Legal and Ethical Issues of Justice: Global and Local Perspectives on Compensation for Serious Adverse Events in Clinical Trials (Yali Cong)....Pages 121-128 Back Matter ....Pages 129-134 This book is published under a CC BY 4.0 license. This book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of un ethical conduct are essential for research ethics training.