Table 3 Conditions that make foregoing informed consent procedures (more) acceptable

Effectiveness

Surveillance data is really put to use for public health purpose

Necessity

Informed consent procedures reduce data validity by introducing bias

Less intrusive alternatives for collecting information not available

Implementation of informed consent procedures not feasible

Least infringement

Opt-out option is provided instead

Taking data against the will of the patient is preceded by attempt of convincing to give voluntarily (last resort)

Minimum amount of (preferably anonymized) data necessary for surveillance purpose is collected

All relevant information about surveillance system is supplied to people affected

Data are maintained securely to minimize further risks

Proportionality

Benefit to be realized/harm averted through surveillance activity considerable in probability and magnitude

Minimal Risks involved in data collection

Implementation of informed consent procedures would demand excessive resources

No particularly sensitive information (e.g. mental or sexual health) is collected

Potential public health benefits outweigh considerations of privacy protection

Implementing informed consent would set harmful standards for other surveillance programs

Public justification/engagement

The community/the public/those affected were engaged in decision.

Vulnerability^a

Data is collected to protect the health of children (who need special protection)

No data from children is collected (because their privacy rights need special protection)

Legitimacy^a

Only legitimate entities trusted by the public collect surveillance data

Harm principles/unreasonable exercise requirement^a

Surveillance activity supposed to prevent harm to other individuals, not (only) same people being surveilled