Life Sciences Horizons Brochure 2025 - Flipbook - Page 45
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2025 Horizons Life Sciences and Health Care
How to collect tissue samples during clinical trials for further research
Collection of tissue samples in clinical trials is
increasing, particularly in the context of the
development of advanced therapy medicinal
products. At the end of the clinical trial, what are
sponsors allowed to do with the remaining tissue
samples? Potentially, tissue samples can be used as
materials for further research. To do so, additional
requirements under local laws will need to be met,
which differ across jurisdictions, making reuse of
samples more complex in multijurisdictional trials.
Requirements in France and the UK can be used as
common standards to devise a global approach in
Europe, which can then be fine-tuned depending on
specific local requirements.
Donor consent: Obtaining informed consent from donors is
crucial. Participants should be made aware that their samples
may be used for future research. Best practice is to secure clear
and enduring consent at the time of collection, even if the
specifics of future research are unknown, and to consider
implementing a two-part consent process where participants
can agree to both current study participation and future
sample usage, or offer tiered consent allowing participants to
specify certain types of future research they are comfortable
with. If future research may involve DNA analysis, then donor
consent should cover this specifically as well.
Ethics approval: Any proposed use of tissue samples in future
research must receive approval from an REC, ensuring that all
ethical guidelines are followed.
Storage of samples: The tissue samples will need to be
transferred to a facility that has an establishment license from
local authorities (e.g., the UK Human Tissue Authority (HTA)
and the French Ministry of Research) following the completion
of the clinical trial.
Participant information: Clear patient information sheets
will need to be prepared that outline how samples will be used,
including potential sensitive areas of research, and they must
ensure participants understand what they are consenting to.
Confidentiality and data protection: Donor identities
must be protected in compliance with data protection laws,
particularly when analyzing DNA or other identifiable
biological materials.
Governance procedures: Robust governance frameworks
will need to be put in place to manage consent preferences
effectively and comply with donor wishes regarding sample
usage over time.
Export authorizations: If tissue samples collected for future
research will be exported to research sites located in different
countries, specific authorizations may be required from local
authorities (e.g., the Ministry of Research in France). In the UK,
an export license is not required from the HTA.
Note that the EU SoHO Regulation (EU) 2024/1938) (SoHO
Regulation), due to enter into force in 2027, will harmonize blood
and tissue regulations across the EU and extend the requirements
for tissue and blood sample-collections during clinical trials to
all substances of human origin (other than organs). The UK
government is considering whether similar changes are necessary
in Great Britain.
Mikael Salmela
Partner
Paris
Jane Summerfield
Partner
London
Joséphine Pour
Senior Associate
Paris
Alexandra Wood
Associate
London
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