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.
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
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
- 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.