Understand Translational Research Tools


A biorepository or biobank is fundamentally a library that stores and manages biosamples, also known as biospecimens, for use in research. Your group can lead the effort to establish a biorepository for your disease(s).

  • A biorepository can accelerate the development of new therapies by providing researchers with biosamples to:
    • Improve understanding of the underlying disease process.
    • Examine gene expression at different ages, disease stages, or tissue types.
    • Predict toxicity of potential treatment in tissue samples.
    • Identify and clarify biomarkers.
    • Aid in the selection of preclinical cellular and/or animal models.
  • Biosamples may include:
    • Tissue
    • Blood
    • Saliva
    • Plasma
    • Purified DNA
    • Urine
  • Donors to the biorepository may include:
    • Patients.
    • Siblings who do not have the disease.
    • Parents or other close relatives, depending on disease family pattern.
  • Timing of the collection of samples will depend on the disease, samples being collected, and end goal of biorepository. 
    • During patient lifetime:
      • During surgical procedures or tests.
      • At the time a patient joins biobank. 
      • Specific times throughout the course of disease.
    • At time of patient’s death:
      • Although possibly a very sensitive topic while a patient, especially when the patient is a child living with a currently fatal disease, you may wish to educate patients (if old enough) or parents about providing samples to the biobank before the end stage of disease so arrangements can be made ahead of time. 
  • Donor (patient) information, such as data about their medical condition and demographic characteristics, is usually collected along with samples.
  • Informed consent processes should be in place for donors.
  • Current best practices should be used to collect, maintain, and share the highest quality biosamples.
  • Long term financial burden of maintaining biorepository should be considered prior to beginning the process.
  • Researchers applying for use of specimens from biorepository should have Institutional Review Board (IRB ) approval for their research study.
  • Prior to developing a biorepository, make sure one does not already exist for your disease(s).
  • Check with the NIH Institute or Center (IC) most closely aligned with your disease to determine whether there are any grant opportunities or programs to start a biorepository.
  • Learn more about biorepositories using the following resource:
    • The National Cancer Institute (NCI) Best Practices for Biospecimen Resources (2016) outlines the state of biosample research practices and principles that can be used by laboratories to develop research procedures. Organizations can use this document to evaluate and better understand biosample resource practices. 


Assay Guidance Manual National Center for Advancing Translational Sciences (NCATS) (link)
CDER Biomarker Qualification Program U. S. Food and Drug Administration (FDA) (link)
Cell and Animal Models
Animal Model Qualification Program U. S. Food and Drug Administration (FDA) (link)
NCI Best Practices for Biospecimen Resources National Cancer Institute (NCI) (link)