Table 1.
Ethical considerations in the design of an influenza challenge model.
Selection of the appropriate strain and dose of influenza challenge stock to achieve mild to moderate influenza illness. |
Strict inclusion and exclusion criteria to ensure healthy volunteers with minimal comorbidities. |
Full review of the proposed study by a third-party ethics committee. |
Selection of appropriate clinical and microbiological endpoints to minimize risk to participants. |
Transparent informed consent and fair compensation for participants. |
Facilities and trained staff that can ensure close and careful monitoring of infected participants. |
Proof of decreased infectivity (e.g., undetectable virus by molecular testing) upon discharge to eliminate possibility of transmission to general public. |
Adequate clinical follow-up and evaluation for adverse events or sequelae of influenza infection. |