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What risks should be permissible in controlled human infection model studies?

Ariella Binik¹

¹Department of Philosophy, McMaster University, Ontario, Canada.

|March 3, 2020

Summary

This summary is machine-generated.

Controlled human infection model (CHIM) studies pose ethical dilemmas. This research argues against unique risk thresholds for CHIM studies, proposing broader ethical guidelines for human research instead.

Keywords:

challenge studies clinical trials controlled human infection model studies ethics research ethics risk risk threshold

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Area of Science:

Medical ethics
Infectious disease research
Clinical trials

Background:

Controlled human infection model (CHIM) studies intentionally expose volunteers to pathogens for research.
These studies are vital for understanding disease and developing vaccines.
CHIM studies raise significant ethical questions regarding acceptable risk levels for participants.

Purpose of the Study:

To critically evaluate existing risk thresholds for CHIM studies.
To situate CHIM risk assessment within the broader context of research ethics.
To propose a framework for the ethical evaluation of risks in CHIM studies.

Main Methods:

Philosophical analysis of ethical principles in human research.
Review and critique of proposed risk thresholds for CHIM studies.
Development of recommendations for ethical risk assessment in CHIM.

Main Results:

Existing proposed risk thresholds (minimal risk and higher thresholds excluding severe outcomes) for CHIM studies are found to be unpersuasive.
The study argues for applying general research risk limitations, rather than unique CHIM-specific thresholds.
Five recommendations for ethically assessing risk in CHIM studies are presented.

Conclusions:

A unique risk threshold for CHIM studies is not ethically justified.
Ethical oversight of CHIM studies should align with broader principles governing research risks.
Implementing robust ethical assessment frameworks is crucial for responsible CHIM research.