What if my new COVID-19 study involves collecting and/or analyzing biospecimens?

Last updated: 5.13.2020

COVID-19 BioBank Specimens

The UW Carbone Cancer Center (UWCCC) Translational Science BioCore (TSB) BioBank is now serving as the centralized collection, storage, and distribution resource for COVID-19 specimens. Please review the COVID-19 BioBank Resource memo released by the SMPH Associate Dean for Basic Research for more information.

Researchers who wish to use COVID-19 specimens must work with the BioBank in order to obtain available specimens. Because of the BioBank’s honest broker system, IRB review of research studies using BioBank specimens may not be required. This depends on the identifiability of the specimens and the research activities that will be conducted. If researchers plan to use identifiable specimens and/or are conducting FDA-regulated research with the specimens, IRB review is required. Researchers should work collaboratively with the BioBank and the IRB, as needed, to determine whether IRB review of their research study is required.

Note it is likely that not all researchers will be able to obtain these specimens, as they are of limited availability. An institutional application process for securing the use of UWCCC’s BioBank samples for UW researchers in the COVID-19 related research will be announced shortly. Do not contact clinicians directly for specimens, as they are not authorized to provide specimens directly to researchers.

Specimens obtained for research purposes:

A limited number of research studies may require collection of COVID-19 specimens that extends beyond what the UWCCC TSB BioBank can provide. In these cases, obtaining specimens from UW Health patients while they are in clinics or hospitals requires advance approval through the centralized process for assessing and reviewing COVID-19 research. In addition, these studies must use the Office of Clinical Trials (OCT) for study management, subject recruitment, consent, and blood draws, even those with PIs outside of SMPH. This allows OCT staff to coordinate the consenting and any sample collection to minimize impact on subjects and monitor total sample donation. IRB approval must also be in place before collecting the specimens, even if the specimens will ultimately be de-identified or anonymized.

Applying FDA regulations:

Using specimens to develop or test investigational assays or other laboratory tests for clinical diagnostic purposes may require applying FDA regulations to the research. For additional assistance in determining whether FDA regulations apply to the study, please contact the FDA Regulated Research Oversight Program.

Submission to the IRB:

If you have received institutional approval to conduct a new COVID-19 study using specimens and are unsure what type of IRB application is needed, please email IRBDirector@hsirbs.wisc.edu for assistance.

Keywords:coronavirus, specimens, samples, biological specimens   Doc ID:99768
Owner:Monica E.Group:Health Sciences IRBs
Created:2020-03-31 04:31 CSTUpdated:2020-05-13 12:34 CST
Sites:Health Sciences IRBs
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