Step 3: Ethics and Data Protection

    Confidential data is any personal information relating to an individual that would make it possible to identify the person either directly or indirectly by reference to an identification number or by reference to one or more factors specific to her/his physical, physiological, mental, economic, cultural or social identity.

    Data presented in statistical form, which are of such a type that the persons concerned can no longer be reasonably identified, are no longer considered to be confidential data, as all efforts have been made to ensure anonymity.

    Confidentiality in the use of personal data in medical research is governed both by the ethical guidelines of the medical profession and by data protection legislation in each country. The principles of confidentiality must apply not only within the surveillance system but also to any data released by it, whether as public information or to individual researchers. As a safeguard, all surveillance system staff should be required to sign a confidentiality agreement when first appointed, in addition to the confidentiality forms they have signed if they are hospital staff.

    Preservation of confidentiality is not only an obligation but is also essential for maintaining the trust of those who provide the surveillance system with information.

    Surveillance system staff must adhere to the following:

    • Permission to access medical records must be sought from the ethics committee of each individual hospital
    • An information leaflet describing the surveillance system should be made available in a suitable place within each participating hospital (See the Supplementary materials section for an example)
    • The surveillance system must cause no disadvantage, harm or distress to any person
    • Appropriate safeguards must be in place to preserve the confidentiality of the information in the custody of the surveillance system
    • Reports of the surveillance system must not contain information which could disclose any person’s identity.

    Tip! Following establishment, it is important to have constant monitoring of the registration system. This involves effective communication between the coordinating committee and the work-team / steering committee and the surveillance management team.