Discussing data protection and ethical issues in biomedical research

January 28 is the European Data Protection Day. To mark the day, on 27 January 2023, a seminar “Data Protection and Ethics in Biomedical Research” was held at Scholarly Communication and Information Centre of Vilnius University. The event featured presentations by the representatives of the Faculty of Medicine of Vilnius University, the State Data Protection Inspectorate, Vilnius Regional Biomedical Research Ethics Committee, Vilnius University Hospital Santaros Klinikos and the Office. During the seminar, the problems of legal regulation of the informed consent were presented, the requirements for the protection of personal data in clinical trials were discussed, the ethical aspects of conducting research were highlighted, the procedures and issues related to the authorisation of a biomedical trial were presented, and the experience of Vilnius University Hospital Santaros Klinikos in the field of scientific research and data protection was shared.

Dr Julija Umbrasaitė, the Senior Specialist (Senior Analyst) of the Office, familiarised the participants with the European guidelines and recommendations in the field of research integrity, national documents regulating academic ethics, the participants of the academic ethics in research and higher education and presented the areas of activity of the Office.

      Photo from the archive of B. Liekė

Possible ways to improve the legal framework for data protection were discussed during the seminar. During an interactive discussion, participants asked questions relevant to them. They asked whether the consent of both parents to biomedical research on children is required, whether ethical approval of a research on human biological samples where no personal data is collected is required, whether a physician can use a patient’s existing contact details to invite him/her to take part in a biomedical research, what are the responsibilities of the sponsor of the research and the health care institution where the research will take place (who is the data controller, who is the data processor), etc.

More than 100 participants (biomedical researchers, medical personnel, lecturers, students and administrative staff) attended this seminar.