If the records that you intend to use in your research contain identifying information in them, then you will need to obtain informed consent. Identifying information does not refer only to name, but to any other information that would allow you or another to identify participants within the record.

If you receive the records from the record owner (site) de-identified, then informed consent is not necessary. If the site cannot provide the records to you de-identified, contact the IRB Office and speak with your mentor on other possible ways to de-identify the records (for example, if you have physical access to the records, you may photocopy them with the identifying information blocked out).

There is additional information that must be contained within the informed consent form if you are using identifiable HIPAA records due to the laws around HIPAA. If you intend to use identifiable records protected by HIPAA, contact the IRB for more information.