None of the data held in PALGA's database is traceable to individuals. Personal data is pseudonymized at the laboratory stage. Following the transfer of data from the laboratory to PALGA's database, all personal data is pseudonymized a second time. ZorgTTP, a Trusted Third Party, performs this pseudonymization at the instigation of PALGA.
PALGA assessment framework
All requests submitted to PALGA are reviewed by the Scientific Council and the Privacy Committee. The Scientific Council issues a recommendation in accordance with Article 6.3 of the Scientific Council regulations:
6.3 The Scientific Council issues a recommendation on data requests, about their pathological, research-based, and epidemiological relevance. During the advisory process, account is taken of the extent to which the proposed study involves developing a hypothesis, investigating a hypothesis, or is intended to lead to confirmation of preliminary findings. Where necessary, a judgment is also made concerning the scope of the proposed scientific study, in terms of anonymous data processing on the one hand, and its processing of data that is traceable to individuals on the other.
PALGA’s Privacy Committee checks whether the data provision complies with existing legislation (Medical Treatment Contracts Act (WGBO) and the Personal Data Protection Act (WBP)) regarding the collection and provision of data (including medical data). PALGA’s Privacy Committee issues a recommendation in accordance with Article 7.1 of PALGA’s Privacy Committee regulations:
7.1 PALGA’s Privacy Committee advises the PALGA Foundation, either at the request of the Board or on its own initiative, for the protection of data subjects’ privacy, concerning provision by the Controller of personal data from PALGA's database to Recipients for purposes other than patient treatment.
Medical Research Ethical Committee
Neither PALGA’s Scientific Council nor its Privacy Committee are medical research ethical committees. PALGA takes the view that researchers themselves are responsible for having their studies reviewed by an ethical review committee at the institution where they are employed. This also applies to research that involves human tissue.
The Good Use Code states:
“It (human tissue) may only be used for health care studies that can be expected to benefit other patients at a later stage. This must be reviewed by a medical research ethical committee” and “It must be a good quality study, for which the use of human tissue is essential.”
In the case of cohort requests, data from PALGA’s database is provided based on identifying information concerning individuals/patients who are involved in a scientific study. Researchers will only be provided with data if they are in compliance with all the applicable rules and regulations. Any personal data provided in connection with cohort requests will be encrypted by ZorgTTP. This ensures that PALGA does not receive any data that is traceable to individuals. PALGA is therefore in compliance with the provisions of the Personal Data Protection Act (WBP).
If, during their treatment, patients object to the use of their data for scientific research, then this data is not added to PALGA's database. Data can also be removed retrospectively. See the patient leaflets for details.
In general, requests for links will be processed if the patient information and the informed consent state that links will be established with medical registries.