About Bio/Data Repositories
Bio/ Data repositories are an increasingly popular model for institutions with a high volume of biomedical research activities and sample collection. With proper consent, data and biological materials can be banked for prospective research. Tissue and blood samples that are routinely discarded after diagnostic and pathological testing can also be retained for study.
Institutions with electronic medical record systems can update de-identified data and may also link that to corresponding specimens in the repository .
The resources on this page provide information on the establishment of bio/ data repositories and associated ethical concerns.
Establishing a Bio/Data Repository
Issues to Consider HHS
How to Establish a Tissuebank NCI
Human Tissue/Specimen Banking Assessment & Recommendations PRIMR (PDF)
Biorepository & De-identification Open-source Software
Leading Biorepositories
dbGaP NIH GWAS Data Repository
HIV / AIDS Specimen Repository NIAID
Mayo Clinic
Harvard Biorepositories
Kaiser/ UCSF Research Program on Genes, Environment, and Health
University of Michigan Biorepository
NuGene Project Northwestern
BioVu Vanderbilt
Vanderbilt Biorepository Consortium
Veteran's Affairs GenISIS
Duke Institute for Genomic Sciences and Policy
Biorepository Ethics
Biospecimen Best Practices NCI
What Human Specimen Repositories Need to Tell Their IRBs: Points to Consider NCI (PDF)
Legal and Ethical Issues Related to Human Specimens and Associated Data NIH (PDF)
Model Informed Consent Documents NCI/NAPBC (PDF)
Consent Form Comparison Table
Informed Consent Templates for Genomic Research NIH
Coded Specimens Policy OHRP (PDF)
Biospecimen Research Database NCI
Biorepository Legal Concerns
California Law Governing Biospecimen Research NCI
Survey of State Laws Regulating Specimens Collection/Storage NCI
HIPAA FAQs on Biorepositories NIH
Research Repositories, Databases and the HIPAA Privacy Rule NIH
Genetic Information Nondiscrimination Act of 2008 (GINA)