REQUEST FOR WAIVER OF AUTHORIZATION TO USE
PROTECTED HEALTH INFORMATION
A. Principal Investigator (PI)
Name: _________________________________________
Phone number(s): ________________________________
________________________________
E-mail address: __________________________________
FAX number(s): _________________________________
_________________________________
B. Protocol Title:
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
C. Source of Protected Health Information (PHI)
PHI = Health Information + identifiers
1.
Marquette University Sources
School of Dentistry
College of Health Sciences
College of Nursing
Dental Hygiene
Speech Pathology and Audiology
Counseling and Educational Psychology
Clinical Psychology
Student Health Service
Intercollegiate Athletics
Other (describe) ________________________________________
2.
Non-Marquette University Sources
Hospital medical records (in and/or outpatient)
Health professional/Clinic records
Health professional/Office records
Laboratory, pathology, and/or radiology results
Biological samples
Interviews/questionnaires
Mental health records
Billing records
Data previously collected for research purposes
Decedent information
Other (describe) ________________________________________
D. Waiver Criteria
How does your research meet the following criteria ?
1.
There is minimal risk to the privacy of the participant (subject) because
a. Safeguards will be in place to protect identifiers from improper use or
disclosure (check all that apply)
The information will not be disclosed unless it is stripped of all
identifiers
Identifiers will be stored separately with a key to re-identify the
data
Data will be coded prior to any disclosure
P.I. and research staff will sign a confidentiality agreement
Other (describe) ________________________________________
b. Identifiers will be destroyed upon completion of
data collection
data analysis
specimen/sample processing
other (describe)
OR
c. Identifiers will be retained indefinitely because
this is a longitudinal study
of legal requirements
other (explain)
AND
d. The information will not be disclosed to any other person or entity except
as required by law
for any research for which disclosure or use is permitted by
HIPAA
2.
The research cannot practicably be conducted without access to PHI. (Explain
the reasons).
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
3.
The research cannot practicably be conducted without a waiver of authorization.
(Explain the reasons).
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
I certify that the information provided in this request is complete and accurate.
_____________________________________
Name of Principal Investigator
_____________________________________
Signature of Principal Investigator
____________________
Date