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.
| Original language | English |
|---|---|
| Article number | e92 |
| Journal | Journal of Clinical and Translational Science |
| Volume | 5 |
| Issue number | 1 |
| DOIs | |
| State | Published - 2021 |
Bibliographical note
Publisher Copyright:© The Association for Clinical and Translational Science 2021.
Funding
Acknowledgements. Research reported in this publication was supported by the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health under award numbers UL1TR003096, UL1TR00237, UL1TR001998, UL1TR001442, UL1TR002489, U24TR002260 and UL1TR000457. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors thank Julie Schwan and other members of the CLIC-CTSA team for programmatic assistance. Research reported in this publication was supported by the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health under award numbers UL1TR003096, UL1TR00237, UL1TR001998, UL1TR001442, UL1TR002489, U24TR002260 and UL1TR000457. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors thank Julie Schwan and other members of the CLIC-CTSA team for programmatic assistance. Disclosures. Dr. Patel reports grants from Merck, ContraFect, TenNor Therapeutics Limited and Shionogi. Dr. Patel is a consultant to Curetis, Specific Technologies, Next Gen Diagnostics, PathoQuest, Selux Diagnostics, 1928 Diagnostics, PhAST, and Qvella; monies are paid to Mayo Clinic. Dr. Patel is also a consultant to Netflix. In addition, Dr. Patel has a patent on Bordetella pertussis/parapertussis PCR issued, a patent on a device/method for sonication with royalties paid by Samsung to Mayo Clinic, and a patent on an anti-biofilm substance issued. Dr. Patel receives an editor’s stipend from IDSA, and honoraria from the NBME, Up-to-Date and the Infectious Diseases Board Review Course. Dr Elemento reports grants from Janssen, Johnson & Johnson, AstraZeneca, Eli Lilly, Volastra Therapeutics and Champions Oncology. Dr Elemento holds equity and provides scientific advice to Volastra Therapeutics, OneThree Biotech, Freenome and Owkin. Traditionally, approaches to support biospecimen repositories have been diverse in structure and approach. A common model for biorepositories has involved investigator-initiated, disease-oriented, prospective collections. Programs supported by the National Institutes of Health, including NCATS-sponsored Clinical and Translational Science Award (CTSA) hubs and NCI-designated Comprehensive Cancer Centers, have played a significant leadership role in promoting coordinated and organized biorepository management, including oversight and quality control/assurance. Often these resources rely on sophisticated tracking software, including OnCore biospecimen management (BSM), OpenSpecimen, Velos eSample or customized REDCap systems. The linkage to clinical data, manually abstracted from medical records, obtained directly from EHR, or augmented by patient surveys, is critical and adds tremendous value to the specimens. In some cases, annotated samples are digitally accessible or
| Funders | Funder number |
|---|---|
| Julie Schwan | |
| NCATS-sponsored | |
| NCI-designated Comprehensive Cancer Centers | |
| TenNor Therapeutics Limited and Shionogi | |
| National Institutes of Health (NIH) | UL1TR001442, UL1TR001998, UL1TR000457, UL1TR002489, U24TR002260, UL1TR00237, UL1TR003096 |
| Merck | |
| National Center for Advancing Translational Sciences (NCATS) |
Keywords
- Biorepository
- COVID-19
- CTSA
- SARS-CoV-2
- biobanking IRB
- informed consent
- regulatory
- sample
- specimen
ASJC Scopus subject areas
- General Medicine