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

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.