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Ethical issues surrounding controlled human infection challenge studies in endemic low-and middle-income countries
Euzebiusz Jamrozik1,2, Michael J Selgelid1
1Monash Bioethics Centre, Monash University, Melbourne, Victoria, Australia.
Abstract:
Controlled human infection challenge studies (CHIs) involve intentionally exposing research participants to, and/or thereby infecting them with, micro-organisms. There have been increased calls for more CHIs to be conducted in low- and middle-income countries (LMICs) where many relevant diseases are endemic. This article is based on a research project that identified and analyzed ethical and regulatory issues related to endemic LMIC CHIs via (a) a review of relevant literature and (b) qualitative interviews involving 45 scientists and ethicists with relevant expertise. In this article we argue that though there is an especially strong case for conducting CHIs in endemic (LMIC) settings, certain ethical issues related to the design and conduct of such studies (in such settings) nonetheless warrant particularly careful attention. We focus on ethical implications of endemic LMIC CHIs regarding (a) potential direct benefits for participants, (b) risks to participants, (c) third-party risks, (d) informed consent, (e) payment of participants, and (f) community engagement. We conclude that there is a strong ethical rationale to conduct (well-designed) CHIs in endemic LMICs, that certain ethical issues warrant particularly careful consideration, and that ethical analyses of endemic LMIC CHIs can inform current debates in research ethics more broadly.
Insights
Controlled human infection challenge studies (CHIs) are increasingly needed in low- and middle-income countries (LMICs). Careful attention to ethical considerations, including participant risks and community engagement, is crucial for these endemic CHIs.
Area of Science:
- Medical Ethics
- Infectious Disease Research
- Global Health
Background:
- Controlled human infection challenge studies (CHIs) involve deliberate exposure of participants to pathogens.
- There is a growing demand for conducting CHIs in low- and middle-income countries (LMICs) where diseases are endemic.
- Ethical and regulatory considerations for CHIs in endemic LMIC settings require thorough examination.
Purpose of the Study:
- To identify and analyze ethical and regulatory issues specific to conducting CHIs in endemic LMIC settings.
- To evaluate the ethical implications of CHIs concerning participant benefits, risks, informed consent, compensation, and community engagement.
- To provide ethical guidance for the design and conduct of CHIs in LMICs.
Main Methods:
- Literature review of ethical and regulatory issues related to CHIs in LMICs.
- Qualitative interviews with 45 scientists and ethicists possessing relevant expertise.
- Analysis of ethical implications including direct benefits, participant risks, third-party risks, informed consent, participant payment, and community engagement.
Main Results:
- A strong ethical case exists for conducting CHIs in endemic LMIC settings.
- Specific ethical issues, including participant risks and community engagement, require heightened attention in LMIC CHIs.
- The study identified key ethical challenges and considerations for the responsible implementation of CHIs in these regions.
Conclusions:
- Well-designed CHIs in endemic LMICs are ethically justifiable and crucial for advancing global health.
- Ethical analyses of LMIC CHIs offer valuable insights into broader research ethics debates.
- Prioritizing careful ethical deliberation is essential for the successful and responsible execution of CHIs in LMICs.
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