Evidence map›Paper›PMID 39931203›Full record

ReviewCurrent genomics2025

The Regulatory Landscape of Biobanks In Europe: From Accreditation to Intellectual Property.

Antonella Corradi, Giuseppina Bonizzi, Elham Sajjadi, Francesca Pavan, Marzia Fumagalli, Luigi Orlando Molendini, Massimo Monturano, Cristina Cassi, Camilla Rosella Musico, Luca Leoni and 6 more

Abstract readReview
In one paragraph

Review in Current genomics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Review
  3. Immunohistochemistry for PTEN testing in HR +/HER2- metastatic breast cancer.Virchows Archiv : an international journal of pathology · 2025
    Review
  4. Article
  5. A practical starting guide to tear fluid biobanking.Advances in ophthalmology practice and research
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Antonella CorradiGeneral Directorate for Libraries and Copyright, Italian Ministry of Culture, Rome, Italy.
Giuseppina BonizziBiobank for Translational and Digital Medicine, European Institute of Oncology IRCCS, Milan, Italy.
Elham SajjadiDivision of Pathology, European Institute of Oncology IRCCS, Milan, Italy.
Francesca PavanQuality, Accreditation and Clinical Risk Service, European Institute of Oncology IRCCS, Milan, Italy.
Marzia FumagalliTechnology Transfer Office, European Institute of Oncology IRCCS, Milan, Italy.
Luigi Orlando MolendiniValue Medicine, Clinical Risk and Privacy Area, European Institute of Oncology, IRCCS, Milan, Italy.
Massimo MonturanoValue Medicine, Clinical Risk and Privacy Area, European Institute of Oncology, IRCCS, Milan, Italy.
Cristina CassiBiobank for Translational and Digital Medicine, European Institute of Oncology IRCCS, Milan, Italy.
Camilla Rosella MusicoBiobank for Translational and Digital Medicine, European Institute of Oncology IRCCS, Milan, Italy.
Luca LeoniBiobank for Translational and Digital Medicine, European Institute of Oncology IRCCS, Milan, Italy.
Chiara FrascarelliDivision of Pathology, European Institute of Oncology IRCCS, Milan, Italy.
Oriana PalaDivision of Pathology, European Institute of Oncology IRCCS, Milan, Italy.
Elena Guerini RoccoDivision of Pathology, European Institute of Oncology IRCCS, Milan, Italy.
Adriana AlbiniScientific Directorate, European Institute of Oncology IRCCS, Milan, Italy.
Roberto OrecchiaScientific Directorate, European Institute of Oncology IRCCS, Milan, Italy.
Nicola FuscoBiobank for Translational and Digital Medicine, European Institute of Oncology IRCCS, Milan, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Biobanks are necessary resources for the storage and management of human biological materials, such as biofluids, tissues, cells, or nucleotides. They play a significant role in the development of new treatments and the advancement of basic and translational research, especially in the field of biomarkers discovery and validation. The regulatory landscape for biobanks, which is necessary to safeguard both privacy and scientific discoveries, exhibits significant heterogeneity across different countries and regions. This article outlines the standards that modern biobanks should fulfill in the European Union (EU), including general, structural, resource, process, and quality requirements. Special attention is given to the importance of transparency and donor consent following the General Data Protection Regulation (GDPR) and the ISO 20387:2018, the international standard specifies general requirements for biobanks. A dedicated section covers the preparation of donor information materials, emphasizing consent for research involvement and personal data processing. The delicate balance between donors' privacy rights and scientific research promotion is also discussed, with a focus on the patenting and economic use of biological material-derived inventions and data. Considering these factors, it would be warranted to refine legal frameworks and foster interdisciplinary collaboration to ethically and responsibly expand biobanking.

Indexed as

Biobanksbiological materialsbiomarkersclinical studiestranslational researchtransparency and consent

Identifiers

PMID39931203
PMCPMC11808582

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.