What is the HIPAA Waiver Authorization form for and when does it need to be submitted?
For “preparatory research” (screening of patients, not requiring a consent form) or use of a database to prepare papers presenting clinical descriptions, HIPAA mandated privacy rights will require researchers to submit a HIPAA Waiver Authorization to the IRB for permission to access PHI for “preparatory research” as defined above. Once the IRB grants a waiver, informed consent is not needed. However, you must submit an Excel datasheet containing a list of patients studied and what information was accessed to the Medical Records Department (Information Management). This will permit the Medical Records Department to provide a list of who has accessed PHI for non-treatment purposes when requested by a patient or patient representative. However, please note that chart review studies require IRB review and should be submitted to the IRB as an initial submission.
Related Questions
- By establishing new waiver criteria and authorization requirements, hasn t the HIPAA Privacy Rule, in effect, modified the Common Rule?
- The sample consent form supplied by my clinical trial sponsor includes HIPAA language. Do I still need to use the HIPAA authorization form?
- I have submitted the test waiver form. What is the next step?
