Building biorepositories in the midst of a pandemic.

Jennifer A Croker,Marietta Barton-Baxter,Olivier Elemento,Shannon Wallet,Gary S Firestein,Robert P Kimberly,Robin Patel,Kenneth S Campbell

doi:10.1017/cts.2021.6

Abstract

Biospecimen repositories play a vital role in enabling investigation of biologic mechanisms, identification of disease-related biomarkers, advances in diagnostic assays, recognition of microbial evolution, and characterization of new therapeutic targets for intervention. They rely on the complex integration of scientific need, regulatory oversight, quality control in collection, processing and tracking, and linkage to robust phenotype information. The COVID-19 pandemic amplified many of these considerations and illuminated new challenges, all while academic health centers were trying to adapt to unprecedented clinical demands and heightened research constraints not witnessed in over 100 years. The outbreak demanded rapid understanding of SARS-CoV-2 to develop diagnostics and therapeutics, prompting the immediate need for access to high quality, well-characterized COVID-19-associated biospecimens. We surveyed 60 Clinical and Translational Science Award (CTSA) hubs to better understand the strategies and barriers encountered in biobanking before and in response to the COVID-19 pandemic. Feedback revealed a major shift in biorepository model, specimen-acquisition and consent process from a combination of investigator-initiated and institutional protocols to an enterprise-serving strategy. CTSA hubs were well equipped to leverage established capacities and expertise to quickly respond to the scientific needs of this crisis through support of institutional approaches in biorepository management.

Highlights

Since January 2020, the world has witnessed the grave societal impact of the newly emerged SARS-CoV-2 virus on morbidity and mortality, not to mention serious effects of the infection on national and global economies
Such access is essential for well-powered investigations of biologic mechanisms, validation of disease-associated biomarkers, development, validation and verification of diagnostics assays, recognition of microbial evolution and identification of targets for intervention that lead to development of new therapeutics [1]
Important considerations for development of a biorepository include the consenting process, frequency and timing of collections, specimen-types and volumes involved, quality assurance for sample processing, appropriate facilities to protect against biohazards that may be present in the specimens, linkage to clinical phenotypic information and rigorous management tactics for tracking storage, retrieval and distribution

Summary

Introduction

Since January 2020, the world has witnessed the grave societal impact of the newly emerged SARS-CoV-2 virus on morbidity and mortality, not to mention serious effects of the infection on national and global economies. Pre-COVID-19 pandemic biorepositories faced numerous challenges, ranging from limited consent, high costs of banking and sample annotation, alignment between collected specimens and investigator needs, unequal sample utilization, and processes for prioritization and governance.

Results

Conclusion