Research Institute
Human Investigation Committee
RESEARCH WAIVER OF AUTHORIZATION
Form required when searching records to identify potential research subjects, or conducting data collection study.
HIPAA Requirements to Review Patient Data without Patient Consent
The Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have made
provisions to the Health Insurance Portability and Accountability Act (HIPAA) that establishes the conditions under
which protected health information (PHI) may be used. This form is required to protect patient confidentiality rights
when there is a need to view patient information via charts, computer databases or other recorded information
sources when recruiting and locating potential subjects.
1. Please check one item below as it applies:
To accompany an HIC Initial Application
To accompany an Expedited review for Data collection Form
To accompany an HIC Exemption Status Request
2.
HIC #:
Protocol
Title :
(If applicable)
(be certain the project title and this title match)
3. I assure the Human Investigation Committee that the following apply to this research proposal:
 The PHI being used involves no more than minimal risk.
 The alteration or waiver will not adversely affect the privacy rights and welfare of the individuals.
 The research could not practicably be conducted without alteration or waiver; or without access to and
use of the PHI.
 The privacy risks to individuals whose PHI is to be used or disclosed are reasonable in relation to the
anticipated benefits to the individuals (if any), and the importance of the knowledge that may reasonably
be expect to result from the research.
 The PHI will not be reused or disclosed to any other person or entity, except as required by law.
4. Describe your plan to protect the identifier from improper use and disclosure.
a
b
How and where will data be stored?
Password protected computer
Encrypted flash drive
Secured/locked department office
Other:
NA Exempt study no identifiers
CHECK ALL THAT APPLY
Who will have access to the patient identifiers?
Key personnel listed on the study roster
Sponsor
Federal agencies
Other:
NA Exempt study no identifiers
Wavier of Authorization Form
1
CHECK ALL THAT APPLY
Revised 4/18/12
5. Describe your plan to destroy the identifier at the earliest opportunity. All lists generated with patient
identifiers, (e.g. name, medical record number) used to locate potential subjects, must be destroyed.
a
b
Describe plan to destroy list with patient identifiers:
Shredding of paper documents
Deletion of electronic data
NA Exempt study no identifiers
The list of identifiers will be destroyed:
Upon manuscript acceptance
Study completion
At the determination of the sponsor
At the time of consent
When deemed ineligible
Upon declining participation
NA Exempt study no identifiers
________________________________
Principal Investigator Name - Printed
CHECK ALL THAT APPLY
______________________________
Principal Investigator Signature
____________________________________________
HIC Chairperson Approval
Wavier of Authorization Form
CHECK ALL THAT APPLY
2
___________
Date
__________
Date
Revised 4/18/12