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.
1 Introduction to Ethical innovation for global health: pandemic,
democracy and ethics in research. Part 1 Relevant constructions from a
middle-income country (MIC) and/or non-Western paradigms: Brazil, South
Africa, Taiwan, South Korea, and Japan.- 2 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.-
3 Equitable access to COVID-19 vaccines, vaccine research and Vaccine
Apartheid on the African continent: challenges and recommendations.- 4
Response to Covid-19 pandemic and Ethical Innovations in Taiwan.- 5 Between
truth and profit: Scientific misconduct case of human cloned embryonic stem
cell and revisiting cases during COVID-19 pandemic.- 6 Therapeutic
misconception as the basis for vaccine nationalism of Japan: a historical
reflection and perspectives for global public health.- Part 2 Historical
and international perspectives on the development of ethical principles in
research involving humans.- 7 The Declaration of Helsinki as a living
document: Revisiting its principles in a global pandemic.- 8 Hidden Medical
War Crimes and the Emergence of Bioethics in Japan.- 9 From Nuremberg to
Helsinki: Historicizing the Codification of Post-War Research Ethics.- 10
CIOMS research guidelines: Considering the needs of developing countries.- 11
Ethics of placebo-controlled trial: historical analysis including the
experience of COVID-19 pandemic.- 12 Post-trial access: historical analysis
considering the experience of COVID-19 pandemic.- 13 Our WMA Declaration of
Helsinki: opinions and pro-posals from patient and public for research
ethics.- Part 3 Alternative frameworks for innovation and drug development
strategies.- 14 Medicines development for global health: Learning from
COVID-19 vaccines R&D.- 15 Development of portfolios and pipelines of drugs
for the treatment, prevention and control of neglected tropicaldiseases.- 16
Patient and Public Involvement (PPI) and pharmaceutical development through
Open Innovation Processes ~ recent activities.
Chieko KuriharaNational Institutes for Quantum and Radiological Science and Technology Inage-ku ChibaJapan Dirceu Greco Federal University of Minas Gerais Belo Horizonte Brazil
Ames DhaiUniversity of the Witwatersrand School of Clinical Medicine Johannesburg South Africa
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