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Specimen/Tissue Banks/Data Registries

Information and IRB application instructions for establishing repositories or registries to support future secondary research at UK.

HIPAA and Research Repositories

UK Research Registry Guidance [D130.0000]

UK Research Biospecimen Bank Guidance [D129.0000]

UK Information for IRB Application when Creating a New Biospecimen Bank [D166.0000]

Sample Repository/Registry/Bank Consent [F1.0170](.doc)

FDA’s "Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable" [T12.0000]

FDA Blood & Blood Products

OHRP Biological Material and Data

OHRP Guidance for Investigators and IRBs Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles [D74.0000]

IRB Application Guidelines and materials to submit for “Form EE” (Institutional Biosafety Committee (IBC)) [F1.2300]

IBC/IRB/ORI Coordination SOP [C6.0100]

Summary and Guidance Regarding the Genetic Information Nondiscrimination Act of 2008 (GINA) [D101.0000]

DHHS GINA: Information for Researchers and Health Care Professionals [D106.0000]

NIH Genomic Data Sharing (GDS) Policy

Guidance on the NIH Genome Data Sharing (GDS) Policy [D104.0000]

Secondary Research comprehensive webpage

IRB Framework for Biospecimen Storage, Sharing, and Study

Online Training

Go to online Biospecimen training

2025 ReSEED Session

Video [55 minutes]

View ReSEED session presentation

Contact us

405 Kinkead Hall
University of Kentucky
Lexington, KY 40506-0057

Phone: 859-257-9428

Email: rs_ORI@uky.edu