Research with Biological Materials & Data

Studies that involve the establishment of databases and/or biorepositories are subject to IRB review. Likewise, studies that plan to use data or samples previously collected for research or clinical purposes may also be subject to IRB review. The information on this page will assist investigators in determining whether their project requires IRB review, identify issues to consider during protocol development and clarify IRB review requirements specific to research proposing to use, store and/or maintain data or biological materials for research purposes.

Additional Resources

The resources below provide additional guidance on research with biological materials and data.

1. The NIH FAQ page answers a variety of common questions.

2. OHRP Guidance on Biological Materials and Data

3. NCCN Points to Consider on the Best Practices for Biorepositories, Registries and Databases.

4. OHRP Issues to Consider in the Research Use of Stored Data or Tissues