Building biorepositories in the midst of a pandemic

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.

Keywords: Biorepository; COVID-19; CTSA; SARS-CoV-2; biobanking IRB; informed consent; regulatory; sample; specimen.

Fig. 1.

Shifts in Biorepository Approaches before (pre-COVID-19) and in specific response to COVID-19. A. Comparison of the approaches in biorepository models (investigator-initiated, enterprise, hybrid). B. Observed shifts in participant consent and specimen acquisition. (Percentages reflect fraction of total survey respondents; weight of lines represents relative proportion of the shift).

Fig. 2.

Changes made to biospecimen acquisition and banking consenting procedures due to COVID-19. CTSA, Clinical and Translational Science Awards.

Fig. 3.

Major obstacles institutions encountered in enabling biorepository activities to support COVID-19 related research. “Other” category includes issues such as lack of funding, overwhelming demand, absence of biosafety level capacity, access to patients, and staffing challenges. CTSA, Clinical and Translational Science Award; IRB, Institutional Review Board.