Legal Helpdesk Service & Legal Knowledge Base
The Legal Helpdesk is a service offering BBMRI.at partners a room to address their questions on legal and regulatory matters related to biobanking and the use of biological samples and data for research purposes. In the BBMRI.at Legal Knowledge Base these questions & answers are presented.
Biobanking and using biological samples and data for research must be legally and ethically secure
Before and during biobanking and using biological (e.g. human, animal/veterinary, or microbiome) samples and data for research, a variety of legal question may arise.
Considering, analyzing, and tackling these legal issues is crucial. It ensures compliance with legal and ethical standards which is fundamental for protecting the rights of donors (e.g. research study participants, patients), maintaining public trust, and facilitating the advancement of scientific research and personalized medicine.
BBMRI.at has, therefore, a dedicated work package on legal issues (WP2) where legal experts from University of Vienna offer a BBMRI.at Legal Helpdesk Service. They answer submitted questions on specific legal topics and present legal content in the open-access BBMRI.at Legal Knowledge Base.
In addition, BBMRI.at monitors the legal and regulatory developments at national and EU-level, and provides input to current legal discussions. In particular, within a dynamic regulatory environment on data-driven legislative frameworks, the Legal Helpdesk helps BBMRI.at partners to establish their position in further legal frameworks. BBMRI.at partners are early informed about upcoming legal developments and can contribute to shaping them where possible.
Our Service: The Legal Helpdesk & Legal Knowledge Base
Navigating these legal complexities can be challenging, which is why BBMRI.at is committed to providing comprehensive support for BBMRI.at partners through the dedicated Legal Helpdesk and the respective Legal Knowledge Base.
The BBMRI.at Legal Helpdesk is managed by legal experts from BBMRI.at partner University of Vienna. It is designed to assist biobankers, researchers, legal and ethical departments at BBMRI.at partners etc. in addressing (their) legal and regulatory issues under national Austrian and European law, especially in the areas of data protection, data security, intellectual property rights and biodatabase law.
BBMRI.at partners are welcome to send their questions to the dedicated email address (as share among the members).
The Legal Knowledge Base – Questions & Answers (Q&A)
The legal Knowledge Base is an Q&A section on the BBMRI.at website. BBMRI.at provides knowledge on legal and regulatory issues under national Austrian and European law dedicated to biobanking and the research use of biosamples and biodata. Special focus is on the areas of data protection, data security, intellectual property rights. The Q&A presented herein originate from the framework of the BBMRI.at Legal Helpdesk Service and are made publicly available to the biobanking and the scientific community.
Do you want to know about
– the legal framework applicable to biobanking in the European Union?
– the legal provisions applicable to genetic testing in Austria?
– the legal basis for the automatic further use of research samples?
– the legal requirements for setting up a biobank?
or other legal issues?
Then read the answers in the legal Q&A section BELOW.
More legal Q&A will be provided periodically – so check out the BBMRI.at website regularly.
The Legal Helpdesk Service and the Legal Knowledge Base are part of the BBMRI.at work programme (BBMRI.at #3 2023-2028) WP2 Legal and Regulatory Challenges and Opportunities (work package lead: Univ.- Prof. Dr. Nicolaus Forgó).
Further guidance of ethical, legal and societal (ELSI) topics is given in the ELSI Knowledge Base of BBMRI-ERIC.
Disclaimer: these Q&A aim to provide a summary of the main legal issues related to the questions put by interested stakeholders at BBMRI.at and to direct them to the relevant legal provisions that are applicable. It does not, however, preclude from reading the official sources of legislation relating to the subject matters of this document as well as those quoted by the authors and does not constitute legal advice.