Current policies related to the Duke Health IRB and Human Research Protection Program (HRPP) are located here. View the complete list of policies.The policies are below, and you can search for policies in the following categories:
Coded or Anonymized Private Information or Biospecimens
This policy applies to projects involving coded private information or human biological specimens (“coded specimens/data”). This policy applies only to the secondary use of data and/or specimens collected for purposes other than those of the currently proposed research application.
De-Identification of Protected Health Information
This policy discusses methods for de-identifying protected health information (PHI) as per the HIPAA Privacy Rule.
Research Databases, Specimen Repositories, and Contact Lists
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.