Future Use of Data & Biospecimens
The IRB reviews and approves research that involves the collection, use, storage, and re-use of all biospecimens, human tissue, blood, or genetic material that are generated within, transferred to, or transferred from the University of Utah and its covered entity, as well as all associated data generated from the biospecimens.
- Future use of data and/or biospecimens is collecting and storing data/biospecimens for use in subsequent research.
- Retention of study-related data or biospecimens for further studies that may be directly related or not related to the purpose of a current study is considered future use.
- Future use of data and/or biospecimens is collecting and storing data/biospecimens for use in subsequent research.
- Retention of study-related data or biospecimens for further studies that may be directly related or not related to the purpose of a current study is considered future use.
This guidance will outline the IRB requirements for the collection, and storage of biospecimens for future research uses. This includes:
- Contributing data or biospecimens for future use
- Building data or biospecimen repositories for future use
- Use of collected data or biospecimens
Contributing Data or Biospecimens for Future Use
Information about collecting, retaining, or sending data/biospecimens to a repository, registry, or bank for future research use
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Building Data or Biospecimen Repositories for Future Use
Information about building data/biospecimen repositories, registries, or banks for future research use
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Transfer Agreements
Information to help you set up a Material/Data Transfer Agreement (MTA/DUA)
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Extramural Institutional Certifications
NIH Genomic Data Sharing (GDS), dbGaP, Data & Specimen Hub (DASH)
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Records Retention
Policies and guidance to help you properly store and archive your research records
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Use of Collected Data or Biospecimens
Information about the distribution and use of data or biospecimens from a repository, registry, or bank
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Terms Used in this Guidance
- Biospecimen, Human Tissue: Any human biological specimen or byproduct obtained from a living or deceased individual that is sufficient in type and quantity to permit an analysis of its physical or biochemical properties. This definition includes solid tissues, cells, cell cultures, molecules derived from tissues (DNA, RNA, proteins, etc.) and body fluids, and associated data and information.
- Sample: Lay language for “biospecimen”.
- Repository: Repository activities involve three components for future research purposes: (a) the collection of samples and data; (b) the storage and data management center; and (c) the re-disclosure of data and/or biospecimens. Repositories may also be called registries or banks. A repository may be with or without identifiers, and biospecimens may be with or without associated data.
Would You Like to Learn More About this Topic?
You can learn more about future use of data and biospecimens in our online class titled "Tissue Banking in Research", offered exclusively through the Office of Research Education (REd). In this class you will:
- Learn how federal regulations and University of Utah IRB policy affect how a research repository can be established and managed.
- Learn about acceptable models for a repository, including appropriate informed consent language for each model.
- Learn about how to construct a repository management plan.
- Learn how to complete the IRB’s Tissue Banking application page in ERICA.