IRB HIPAA Waiver of Authorization

This form is required when a Waynesburg University protocol involves access to identifiable Protected Health Information (PHI) and must be completed in addition to IRB or QI determination.

My IRB project necessitates identified members of my study team access the following elements of protected health information (PHI) for the reasons outlined here.

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The Quality Improvement study entitled
Email
Project Leader Project Leader First Last
List ALL sub-leaders
Statistician Statistician First Last
List doctoral/masters committee members
List others with access to this PHI
Note: Others may include key members of the capstone project team that have not been previously named. Examples include, but are not limited to, others who will have access to subjects, either during consenting or during collection of data; others who will have access to identified [raw] data; anyone else who reasonably might have access to any PHI he/she would not reasonably have accessed as part of his/her regular job duties.
Elements of Protected Health Information (PHI) to be accessed (check all that apply):

Elements of Protected Health Information (PHI) to be accessed (check all that apply): Names Telephone numbers Email addresses Social Security numbers Medical records numbers Fax numbers Health plan beneficiary numbers Account numbers Certificate/license numbers Vehicle ID & serial numbers, license plate numbers Device identifiers & serial numbers Web URL's IP addresses Biometric ID's, including finger and voice prints Full face photographic images & comparable images All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older All geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, & their equivalent geocodes, except for the initial 3 digits of a zip code if, according to the current publicly available data from the Census Bureau Any other unique identifying number, characteristic, or code, except as permitted in section immediately above
Per Federal Regulations:

TO BE ELIGIBLE FOR CONSIDERATION OF WAIVER OF AUTHORIZATION, THE USE OR DISCLOSURE OF PROTECTED HEALTH INFORMATION CANNOT INVOLVE MORE THAN A MINIMAL RISK TO THE PRIVACY OF INDIVIDUALS. IN ADDITION, THE FOLLOWING CRITERIA MUST BE SATISFIED FOR THE IRB TO APPROVE A WAIVER OF AUTHORIZATION UNDER THE PRIVACY RULE.
Describe why this project cannot be completed without accessing PHI or gaining consent of subject to whom PHI belongs (patient).
Describe your plan to protect the identifiers from improper use and disclosure.
Describe your plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research. Be sure to address both paper and electronic data storage, security, and destruction. If there is a health or research justification for
retaining the identifiers or such retention is otherwise required by law, please describe fully.
PI Assurance

PI Assurance As project leader, I hereby assure that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project.
Describe alternatives/limitations to project design if access of PHI is not granted.
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IRB HIPAA Waiver of Authorization

IRB HIPAA Waiver of Authorization

Per Federal Regulations: