This open access book provides an extensive review of ethical and regulatory issues related to human infection challenge studies, with a particular focus on the expansion of this type of research into endemic settings and/or low- and middle-income countries (LMICs). Human challenge studies (HCS) involve the intentional infection of research participants, and this type of research is rapidly increasing in frequency worldwide. HCS are widely considered to be an especially promising approach to vaccine development, including for pathogens endemic to LMICs. However, challenge studies are sometimes controversial and raise complex ethical issues, some of which are especially salient in endemic and/or LMIC settings. Informed by qualitative interviews with experts in infectious diseases and bioethics, this book highlights areas of ethical consensus and controversy concerning this kind of research. As the first volume to focus on ethical issues associated with human challenge studies, it sets the agenda for further work in this important area of global health research; contributes to current debates in research ethics; and aims to inform regulatory policy and research practice. Insofar as it focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided here is directly relevant to HCS involving pandemic diseases including COVID19.

This open access book was solicited and funded by the Wellcome Trust Provides comprehensive coverage of research ethics and regulatory issues related to human challenge studies The first book on the ethics of human challenge studies, which many consider controversial Informed by interviews with experts in infectious diseases and bioethics Includes a detailed history of human challenge studies in low- and middle-income countries and case studies of recent research programs in these settings

Autorentext

Doctor Euzebiusz Jamrozik is a practising physician and bioethicist at Monash University's Monash Bioethics Centre. He completed an MA Bioethics at Monash after prior studies in medicine and philosophy. He has multidisciplinary interests including infectious diseases and public health ethics. Recent publications include work on ethical implications of vector-borne diseases such as malaria (Malaria 2015) and Zika virus infection (Journal of Medical Ethics 2018) as well as vaccination ethics (Journal of Medical Ethics 2016). He has worked on human challenge studies, vector-borne diseases, drug resistance, and public health surveillance within the Monash World Health Organization (WHO) Collaborating Centre for bioethics, and he was a research fellow on a Wellcome Trust-funded project on ethical and regulatory issues related to human challenge studies in endemic settings. Professor Michael Selgelid is Director of the Monash Bioethics Centre; Director of the World Health Organization (WHO) Collaborating Centre for Bioethics therein, and Adjunct Professor in the School of Public Health and Preventative Medicine at Monash University. He is a member of the Scientific Committee of the Brocher Foundation in Geneva/Switzerland, and he serves as a member of the General Ethical Issues Sub-committee of the Alfred Hospital Ethics Committee (in Melbourne). Michael was previously a member of the Board of Directors of the International Association of Bioethics and the Ethics Review Board of Médecins Sans Frontières; and he was Chair of the Global Network of WHO Collaborating Centres for Bioethics from 2016 to 2018. Michael edits a book series in Public Health Ethics Analysis for Springer and is Co-Editor of Monash Bioethics Review.

Klappentext

This open access book provides an extensive review of ethical and regulatory issues related to human infection challenge studies, with a particular focus on the expansion of this type of research into endemic settings and/or low- and middle-income countries (LMICs). Human challenge studies (HCS) involve the intentional infection of research participants, and this type of research is rapidly increasing in frequency worldwide. HCS are widely considered to be an especially promising approach to vaccine development, including for pathogens endemic to LMICs. However, challenge studies are sometimes controversial and raise complex ethical issues, some of which are especially salient in endemic and/or LMIC settings. Informed by qualitative interviews with experts in infectious diseases and bioethics, this book highlights areas of ethical consensus and controversy concerning this kind of research. As the first volume to focus on ethical issues associated with human challenge studies, it sets the agenda for further work in this important area of global health research; contributes to current debates in research ethics; and aims to inform regulatory policy and research practice. Insofar as it focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided here is directly relevant to HCS involving pandemic diseases including COVID19.

Inhalt

1. Introduction.- 2. Methods.- 3. History of human challenge studies.- 4. ethical issues.- 5. Community engagement, ethics review, and regulation.- 6. Case studies.- 7. Conclusions.- Acknowledgements.