(UroToday.com) A series of talks were given on the regulations surrounding clinical and genomic data sharing in an attempt to establish a tissue biobank shepherded by the IBCN.
The first of these talks were given by Dr. Antonia Vlahou on the General Data Protection Regulation (GDPR) adhered to in the European Union. Dr. Vlahou introduced GDPR as policies first developed to protect consumers. She then clarified that GDPR was designed to project the data subject, or the identified natural person, as well as any personal data, which includes any information relating to an identified or identifiable natural person. This includes special categories data, such as those related to genetic, biometric, and health data that can be used to identify the subject, unless given explicit consent by the subject in question. In addition, GDPR also applies to pseudonymous or transformed data. Thus if any of the identifiers used during data transfer can be used by any of the study investigators to track the information back to the study subject, GDPR will be applied. Anonymization of the data thus follows very stringent standards, with specific and explicit consent preferred in the cases of use.
What this means is that personal or pseudonymous by default cannot be shared unless the project aims were included in the original consent form. However, exceptions may be applicable, including legitimation or exception. Dr. Vlahou further outlined the governance surrounding the international transfer of data, which can be allowed if consent were to be obtained. Alternatively, safeguards can be implemented regarding specific contractual clauses with administrative arrangements. She pointed out that exemptions can be made for projects leading to results important for the public interest.
In conclusion, Dr. Vlahou summarized that GDPR has raised impediments in research due to pseudonymized data considered to be personal, the need for explicit consent, and the requirement for increased safeguards for any exemptions. Exemptions are frequently decided by national law, which varies according to the EU state in question. At present, all data sharing requires in most part contractual and technological measures.
Presented by: Antonia Vlahou, BS, PhD, Biomedical Research Foundation, Academy of Athens, Greece
Written by: Roger Li, Urologic Oncologist, Moffitt Cancer Center, during the International Bladder Cancer Network Annual Meeting, September 28-October 1, 2022, Barcelona, Spain