What risks should be permissible in controlled human infection model studies?
Controlled human infection model (CHIM) studies involve the intentional exposure of healthy research volunteers to infectious agents. These studies contribute to knowledge about the cause or development of disease and to the advancement of vaccine research. But they also raise ethical questions about the kinds of risks that should be permissible and whether limits should be imposed on research risks in CHIM studies. Two possible risk thresholds have been considered for CHIM studies. The first suggests constraining ethically permissible risks according to a minimal risk threshold and the second endorses a higher risk threshold that excludes irreversible or fatal infections. I argue that neither of these thresholds is persuasive and situate questions about risk thresholds in CHIM studies within a broader debate about permissible risks in research. I argue that risks in CHIM studies should be constrained according to limits on research risks that do not offer corresponding benefits in all studies rather than developing a unique risk threshold for CHIM studies. I then propose five recommendations for the ethical assessment of risk in CHIM studies.
['Binik|Ariella|A|0000-0002-1557-9735']
D035843:Biomedical Research D003141:Communicable Diseases D032984:Ethics, Research D006805:Human Experimentation D006801:Humans D012107:Research Design D035842:Research Subjects D018570:Risk Assessment
risk controlled human infection model studies ethics risk threshold challenge studies clinical trials research ethics