Stored Biospecimens

Requesting Biospecimens

The HCHS/SOL is supportive of ancillary studies (AS) and strives for a balance between providing biospecimen volumes sufficient to test the AS hypotheses and preserving HCHS/SOL biospecimens (PDF) for future studies. Requests for biospecimens from the "Restricted Use Biorepository Reserve" (urine, RNA, citrated plasma specimens) require scientific review by the Lab Committee.

The approved biospecimen aliquot volumes are as follows:

  • Serum, EDTA plasma, citrate plasma: 250 µL
  • DNA/RNA: 0.5 µg
  • Urine: 0.5 mL

These are maximum volumes, unless there is a compelling scientific justification for larger volumes/amounts. Investigators are encouraged to request only the volumes required to conduct the planned testing. A request for an increase in biospecimen volume or in the number of aliquots of >10% of the approved amounts requires full review of a revised AS proposal.

Please note that biospecimen use associated with approved AS proposals is considered provisional. The AS Committee reserves the right to require constraints on how biospecimens are identified, selected, and handled when the project moves forward.

Steps for requesting biospecimens BEFORE funding is obtained:

  1. Determine the biospecimen type, visit, number and volume of aliquots required for the AS. Include this information on the AS Proposal Form.
  2. Request a Biorepository Impact Statement for stored biospecimens from the Central Laboratory. This request should be sent to the Central Laboratory PI (Stefani Thomas; stefanit@umn.edu) and the Central Laboratory Project Manager (Sharon Minnerath; minne002@umn.edu). Please allow at least 5 business days for this request to be filled.
  3. Submit the completed Biorepository Impact Statement along with the AS Full or Amendment Proposal Form to HCHSAncillary@unc.edu.
  4. Request a budget for the Central Laboratory activities such as retrieval from the biorepository, aliquoting, and shipping BEFORE submitting budgets to sponsors.
  5. Request a budget for the Coordinating Center activities such as preparing sample lists, executing DMDA, receiving assay results, and integrating these with HCHS/SOL database BEFORE submitting budgets to sponsors.

The University of Minnesota requires that all Central Laboratory work have a contract; a purchase order alone is not accepted. Per university policy, the contract associated with the use of the biospecimens must be finalized before the Central Laboratory can begin its work. External Sales Agreements (ESA) are typically used for projects that involve only supplying biospecimens. A subcontract from sponsored funds is also acceptable and is preferred when the project includes laboratory testing at the Central Laboratory. The ESA or sponsored project subcontract is between the AS PI’s institution and the University of Minnesota. Contact the Central Laboratory Project Manager (Sharon Minnerath; minne002@umn.edu) for guidance.

Steps for requesting biospecimens AFTER funding is obtained:

  1. Notify the CC and Central Laboratory.
  2. Establish a Data and Materials Distribution Agreement (DMDA) between the University of North Carolina, Chapel Hill (CC institution) and the institution or commercial party where the laboratory testing will be conducted. If the testing is not conducted by the Central Laboratory, a fully executed DMDA must be signed with the CC before the Central Laboratory is allowed to ship the biospecimens.
  3. AS and CC work together to determine the sample list.
  4. CC sends sample list to the Central Laboratory.
  5. Central Laboratory begins their work after the contract is finalized.
  6. If applicable, Central Laboratory ships biospecimens to the laboratory performing the testing.

Timeline

  • ESA or sponsored project funding subcontract development: ≥ 2 months
  • DMDA: ≥ 2 months
  • Sample list creation: 2-6 weeks
  • Biorepository retrieval: Small pulls (<1,000 samples) can be completed in 2 months. For large pulls (≥1,000 samples), please contact the Central Laboratory for an estimate. Note that estimates cannot be made until the Central Laboratory has received the sample list.
  • Testing: Assay- and queue-dependent; contact the Central Laboratory for an estimate.
  • Aliquoting: The Central Laboratory can complete ~ 300 aliquots per day. Contact the Central Laboratory for an estimate on the queue.

Steps for sending assay results to CC:

  • If testing is conducted by Central Laboratory:
    • Results are sent directly to CC who then shares the data with AS PI
  • If Central Laboratory only provides samples to AS and does NOT conduct testing:
    • Central Laboratory provides samples to AS with participant IDs removed (leaving only Lab IDs and HCHS/SOL investigator use IDs)
    • AS PI is responsible for sending assay results to CC

If you have questions about the process or website, please feel free to send an email to HCHSAdministration@unc.edu