Should my site submit for a HIPAA Waiver?
Each participant must sign a HIPAA authorization form, and the site must keep a copy on-file, as NARCRMS will collect limited PII (year and quarter of birth as well as zip code) from each patient. A template HIPAA authorization form has been incorporated in the NARCRMS Sample Informed Consent form and sites may modify the form as required by their IRB. NARCRMS also recommends that sites apply for a partial HIPAA waiver, as this waiver allows the site investigator or site staff to review patient records in order to identify potential subjects for recruitment into NARCRMS.
Updated – 5/9/2017