Evidence map›Paper›PMID 41425236›Full record

ArticleHRB open research2025

Documenting participant Consent in archival records: Aligning yesterday's practices with today's processes.

Nimitha Kuriakose, Heidi Annuk, Saoirse Duggan, Oliver Carroll, Michael Kerin, Nicola Miller

Abstract read
In one paragraph

Article in HRB open research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

6 authors.

Nimitha KuriakoseDiscipline of Surgery, Lambe Institute for Translational Research, University of Galway, Galway, County Galway, Ireland.ORCID https://orcid.org/0009-0009-7792-378X
Heidi AnnukDiscipline of Surgery, Lambe Institute for Translational Research, University of Galway, Galway, County Galway, Ireland.ORCID https://orcid.org/0009-0002-8827-9298
Saoirse DugganUniversity of Galway, Galway, County Galway, Ireland.ORCID https://orcid.org/0009-0005-4062-2773
Oliver CarrollDiscipline of Surgery, Lambe Institute for Translational Research, University of Galway, Galway, County Galway, Ireland.
Michael KerinDiscipline of Surgery, Lambe Institute for Translational Research, University of Galway, Galway, County Galway, Ireland.
Nicola MillerDiscipline of Surgery, Lambe Institute for Translational Research, University of Galway, Galway, County Galway, Ireland.ORCID https://orcid.org/0000-0002-5416-7047

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Cancer Biobank collects, processes, stores and distributes biological specimens and associated data from consenting participants, under a joint data controllership agreement between the University of Galway and HSE West and North West. Working towards improved transparency and in line with the requirements of ISO 20387 Biobanking accreditation, the Cancer Biobank has supported clinical trials and translational research for over 20 years. The process of consent acquisition has evolved since the earliest samples (and data) were collected for research in 1998. With the introduction of GDPR (General Data Protection Regulation) in 2018, a consent declaration was sought from the Health Research Consent Declaration Committee (HRCDC) in 2019 to continue to store personal data on participants recruited to the Cancer Biobank when versions 1 and 2 of the consent documentation were in use (April 1998 - October 2008). This work outlines the process of clarifying which versions of consent forms were used to recruit participants from 1998-2025. The task of verifying consent documentation for 8,925 participants recruited to the Cancer Biobank between 1998 and 2025 required detailed manual checking, recording, and scanning of all paper and electronic consent forms. Among these participants, 65% had signed Cancer Biobank consent forms, 14% had other types of study-specific consent forms and 21% had no proof of consent on file. Consent auditing is essential in biobanking to safeguard participant data, to maintain regulatory compliance and ethical research standards and to sustain public confidence in the use of irreplaceable biological resources. Applying modern compliance standards to archival biobank records has involved navigating incomplete and incompatible consent records, evolving ethical norms, upgrading privacy protections, managing operational challenges and securing appropriate regulatory approval, namely a consent waiver. This complex environment requires adaptive governance strategies balancing legal, ethical and scientific priorities for responsible public interest biobanking.

Indexed as

Biobank networkBiospecimen accessData annotation and managementEthical governanceInformed consentQuality controlQuality dataResearch reproducibility

Identifiers

PMID41425236
PMCPMC12712454

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.