Relevant IRB policies/procedures:
To determine whether your research study will require you to obtain HIPAA authorization from study participants, you must first determine the type of Protected Health Information (PHI) you will be accessing/using.
A limited data set by definition, may include categories of PHI such as ZIP codes, geocodes, date of birth, data of admission/discharge/service, and other unique code.
If your research study will only access a "limited data set", you will not be required to obtain a HIPAA authorization from study participants. However, the covered entity from where you will be accessing the limited data set may require a HIPAA compliant Data Use Agreement. If you have questions about Data Use Agreements of Limited Data Set, please contact the FHCRC Office of the General Counsel at 206.667.1224.
A separate HIPAA Authorization Form(s) is required depending on the type of activity or where the activity will take place.
|Who is conducting the activity or Location of the activity||Complete and Submit this form|
|1. FHCRC Investigator|
2. FHCRC Clinical Research Division (CRD) Investigator
The Clinical Research Division (CRD) Faculty and Staff are to work with their assigned Protocol Review Coordinator (PRC) in the Protocol Office when developing and submitting HIPAA forms to the IRO.
|The FHCRC CRD General HIPAA Research Authorization Form. This form is generally used for transplant studies.|
|3. UW Consortium Investigator||UW HIPAA forms|
|4. Activity taking place at Seattle Children's||Seattle Children's HIPAA Form|
|FHCRC Investigator - requesting a complete Waiver of HIPAA Authorization||HIPAA Supplement and Waiver of Authorization Form|
|Accessing medical records solely for purposes of ascertaining potential subjects, partial waiver for recruitment purposes.||HIPAA Supplement Waiver of Authorization Form|
If a Covered Entity requires the use of their own HIPAA forms, these forms will be used in place of the FHCRC HIPAA forms. Please provide a cover memo which outlines the other entity's request to use their HIPAA forms and one (1) copy of each of the covered entity's forms to be included in the IRB file. These forms will not receive FHCRC IRB approval dates.
This method is not recommended, but can be used in some situation. Please contact the FHCRC Office of the General Counsel before using this method.
Revisions to a currently approved Separate PHI Authorization to a Research Consent