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Human Tissue Resource Center

Questions and Answers for Researchers < +->

  • What are Biospecimens?
    • Biospecimens are biological materials such as tissue and any body fluids that may be used for clinical testing, diagnosis and research. Biospecimens may be collected for research when a subject undergoes a biopsy, surgery, lab work or during any other testing which requires collection of a body fluid. A biospecimen may also be collected separately outside of any clinical testing. Research biospecimens are used for epidemiologic, translational, genomic and proteomic studies.
  • What is a Biospecimen Bank?
    • The Biospecimen Bank (BSB) at the University of Chicago Medical Center (UCMC) is a core facility where biospecimens are procured and stored for current or future research purposes. Services provided by the BSB include biospecimen procurement, processing, storage, distribution , and pathology verification. All activities within the Biospecimen Bank adhere to standard operating procedures providing quality control and maintain HIPAA regulations. The collection of biospecimens is performed in such a manner without compromising clinical testing or the diagnostic process.
  • What is the purpose of a Biospecimen Information System?
    • eSphere allows for documentation of collection protocols, tracks that informed consent has been secured by the PI, and manages all patient information relative to each protocol. eSphere manages all sample annotations, withdrawal information, and storage locations.
  • What services does the Biospecimen Bank provide?
    • The following services are available to all University of Chicago researchers and outside collaborators:
      • Support during protocol development
      • Patient consenting for pathology driven protocols.
      • Identification and tracking of surgical cases.
      • Biospecimen sampling and processing.
      • Biospecimen storage and release.
      • Processing of specimens during the analysis phase.
  • How are biospecimens collected?
  • How are samples stored and identified?    
  • Who provides the supplies for banking samples?
    • Supplies are included in the banking services, with the exception of special media specific to the study, which is provided by the researcher.
  • What are the costs of banking biospecimens for research?
  • What is Retrospective and Prospective Biospecimen Research?
    • 1. RETROSPECTIVE studies involve the collection and analysis of existing data, documents, records and pathologic specimens. “Existing” means before the research is proposed to the IRB. Biospecimens for research may be obtained from archival tissue collections from the Department of Pathology, and inventory tissue collections available from the Biospecimen Bank. Tissue samples in this category are known as “unlinked samples.” Protected Health Information is not associated with any unlinked sample.
      2. PROSPECTIVE studies involve the collection of future data, documents, records, and pathologic specimens. Prospective tissue collection studies may be either “unlinked” or “linked” studies.
  • What is the difference between “linked” and “unlinked” protocols?
    • LINKED protocols are protocols in which informed consent has been obtained for the collection of a biospecimen and abstraction of associated Protected Health Information (PHI). Linked cases contain subject identifiers and information that is related to a subject’s medical information/health care.
      UNLINKED protocols are protocols in which consent has not been obtained for the collection of a biospecimen and abstraction of PHI. No PHI is associated with the sample. Only a de-identified pathology report is received with each requested unlinked sample. that includes report date, year of birth, gender, and race.
  • Does all biomedical research need IRB approval? Do you need to consider IRB approval?
  • What is an “embargo period”?
    • Banked material/information will be held in the Department of Pathology and will not be released to a researcher for a minimum of 30 days . The purpose of the “embargo period” is so that if a diagnosis cannot be concluded on diagnostic material, the attending pathologist may request banked tissue to aid in reaching a final diagnosis.
      *The embargo period does not apply to non-diagnostic specimens collected for research purposes only.
      *Exceptions to the embargo period may be granted in special circumstances.
  • Can I obtain already collected inventory samples without PHI and clinical information?
    • Yes. The Department of Pathology Collection Protocol 12578A “Tissue Collection: Samples of Unlinked Tissue Excess” in which informed consent has not been obtained. No PHI is associated with samples collected under this protocol. A de-identified pathology report will accompany each sample.
  • Can I obtain inventory samples from the Biospecimen Bank along with clinical information?
    • Yes. The Department of Pathology Collection Protocol 11604B “SaLUTE: Samples of Linked Unused Tissue Excess” is a collection protocol in which informed consent has been obtained by the Pathology Research Nurse. A unique case number is assigned to each sample and only the BSB staff will be able to link the subject to the sample. .The research nurses in the Department of Pathology can abstract clinical data relevant to the researcher’s request at a nominal fee. The information provided to the researcher is in a de-identified anonymous format with all PHI removed in accordance with HIPAA standards.
  • Are all tissue samples received from the Biospecimen Bank pathology verified?
    • No, but pathologic verification of samples may be requested for a nominal fee.
  • After a biospecimen protocol receives IRB approval, what next?
    • After the IRB approval of a research investigation utilizing a biospecimen, the principal investigator and/ or appointed research staff member shall make an appointment with the BSB Research Nurse. Please email vstaszak@bsdad.uchicago.edu to schedule an appointment to outline the banking requirements of the protocol. Clarifications and/or concerns regarding specimen collection will be addressed during this meeting.
      Banking activities will not begin unless an initiation meeting has taken place.
  • What happens if a research study has expired?
    • Banking activities will cease if a protocol is expired or if an investigator fails to provide the Biospecimen Bank the necessary documents to show that the IRB protocol has been renewed
  • Do I need to notify the Biospecimen Bank if an amendment has been made to a protocol?
    • It is the responsibility of the investigator or research staff to notify the Biospecimen Bank of any amendment affecting sample collection. Please email vstaszak@bsd.uchicago.edu of any amendment affecting biospecimen collection.
  • How do I notifiy the Biospecimen Bank that informed consent has been obtained?
    • Once informed consent is obtained, the investigator, research nurse, or study coordinator will enter the subject’s consent into the Biospecimen Repository Information Management System “eSphere”. If a patient surgery date is the following day, entry should be made no later than 3pm. If patient entry is later than 3pm, notification via e mail is requested along with the entry into eSphere. The biospecimen banks e mail address is Tissue-bank@listhost.uchicago.edu. If patient entry occurs the day of surgery, page the Biospecimen Bank on call pager 188-7325 along with subject entry into eSphere.
      Under no circumstances will a biospecimen be collected for a consented collection protocol without prior subject consent.
  • What should I do if a subject withdraws from participation in a research study involving collection of a biospecimen?
    • The Biospecimen Bank must be notified immediately by email at Tissue-bank@listhost.uchicago.edu that a subject has withdrawn from participation in a research study requesting biospecimen collection. Followed by email notification, the Principal Investigator must forward to the Biospecimen Bank addressed to Victoria Staszak at MC 6101 a copy of the signed document of subject withdrawal and a copy of the original consent. Upon notification, any subject’s sample that remains in the Biospecimen Bank will be destroyed along with any related information in the Biospecimen Management Information System. The Principal Investigator will receive notification from the Biospecimen Bank that all sample(s) and information pertaining to all sample(s) have been destroyed.
  • Why is Biospecimen Committee review a requirement in some biomedical research?
    • The purpose of this review committee is to ensure equitable distribution of tissue to the broadest group of researchers.
  • How is the distribution of tissue prioritized?
    • Many factors play a role in the disbursement of tissue to investigators, such as scientific merit, number of samples requested, national studies, SPORE projects, peer-reviewed project, and funding.
  • Why is Clinical Trial Review Committee (CTRC) review a requirement in some biomedical research?
    • This committee is appointed by the Associate Director for Clinical Sciences with the approval of the University of Chicago Cancer Research Director (UCCRC). The CTRC is responsible for the evaluation of scientific merit and data and safety monitoring plans for all clinical research performed at the UCCRC. Studies cannot be activated without CTRC approval, which is required for IRB approval.