IRP Repository for COVID-19 Samples

Purpose

Provide all Intramural Investigators with COVID-19 approved protocols the opportunity to store samples in a stable biorepository.

Introduction

DCEG/NCI is committed to stand up, maintain and administer a biorepository for COVID-19 approved protocols within the Intramural Research Program. Once an investigator within the NIH IRP has approval to begin to collect human biospecimens, DCEG will house, store and distribute the biospecimens according to the Principal Investigator’s written instructions. Biospecimens will be stored in the state-of-the-art facility at the Frederick National Lab under the Leidos contract. The DCEG staff, who regularly oversee the biorespository of more than 11.2 million human biospecimens, will work with each PI to develop a processing and storage plan, perform the appropriate steps for the biobanking and ensure timely distribution of sets of aliquots (not single samples).

Basic Principles of the COVID-19 IRP Biobank

• Full biorepository support for all COVID-19 related IRP protocols that are IRB approved and have at least one IRP PI, who oversees the scientific purpose and execution of the protocol specific aims.
• Each study will be under the provenance of the PI and who will have the authority to delegate others to approve movement of biospecimens.
• The COVID-19 IRP Repository will house human biospecimens but not viral isolates for propagation or study (consult the nascent NIAID biorepository).
• The Repository will provide state-of-the art tracking of samples and aliquots in a safe, secure and stable manner, according the needs of the sample, through the existing Biospecimen Inventory (BSI) system.
• Special aliquoting or manipulation can be arranged through Leidos as part of an agreement (not done at the actual biorepository but done at a Leidos lab). Cost will be considered and discussed on an individual basis.
• The biorepository can adapt lab-specific protocols that differ from the posted standard SOPs. Nomenclature must follow existing DCEG guidelines and a key is always generated for linkage by the PI, when necessary.
• Each sample received will be assigned a BSI/Leidos biorepository tracking number, which will be shared with the PI and their coordinators. The PI will be responsible for linking tracking numbers to the separately collected and archived clinical/phenotype data.
• Personal Identifying Information (PII) will not be stored by the Biorepository; a BSI number will be assigned to each sample according to the current IT system in place.
• Timely provision of samples upon request and written approval of the PI of the study will occur through coordination with DCEG staff.
• There will be regular review of status of specimens in study.
• An oversight committee will be convened to ensure the timely use of resources and address challenges as they arise. The oversight committee will be advisory. The primary responsibility for oversight and use of stored specimens will reside with the Study PI.

Additional Value Added Components

• Guidance will be provided for the use of the DCEG contract data base for managing covariates/phenotypes/clinical information but DCEG will not assume responsibility for the covariates/phenotypes/clinical information.
• In development is a dashboard available within NIH IRP (and not outward facing) that will list the studies and sample types of all COVID-19 IRP IRB approved studies. This will be available to IRP PIs to search for possible collaborations. It will include protocol title and hot-link to protocol.

Additional Comments

• The Biobank will not serve as an omnibus protocol for receiving samples collected. All stored samples must be collected under an IRB-approved protocol with specific scientific aims.
• Receipt of payment or funds from extramural PIs is not permitted. All samples must come through collaboration with NIH intramural PIs and under the auspice of an IRB-approved IRP-led protocol. The Frederick contract prohibits direct receipt of grants – so if extramural materials arrive, the associated costs must be covered by the IC directly under the purview of the IC approved IRB protocol.
• The advisory committee will consider steps necessary to assume provenance of studies if the PI retires or departs from NIH.