Research Using Coded Private Information or Biospecimens

Database, Repository, & Retrospective Research

Research that uses coded specimens or coded identifiable private information, including protected health information, can be determined to be research not involving a human subject, and therefore not subject to IRB review, if the requirements outlined in this policy are met. 

Research Databases, Specimen Repositories, and Contact Lists

Database, Repository, & Retrospective Research

The policy describes IRB requirements when investigators use databases and specimen repositories for research purposes.  Databases/specimen repositories require consent and HIPAA authorization by subjects for the storage and potential future research use of their data/specimens, or a waiver of consent and HIPAA authorization by the IRB.  Exemption from IRB review is not an option if the data/specimens retain an identifier or a link that would permit anyone to identify, directly or indirectly, the person whose data/specimens are stored.

De-Identification of Protected Health Information

Database, Repository, & Retrospective Research

This policy discusses methods for de-identifying protected health information (PHI) as per the HIPAA Privacy Rule.