This Form Must Be Typewritten and Fully Completed

IRB APPLICATION

FOR

HIPAA WAIVER OF AUTHORIZATION

PROJECT NUMBER:
PROJECT TITLE:
INVESTIGATOR(S):

HIPAA Regulations allow IRBs to waive the use of an authorization form if all of the criteria requested are met.

1.  The use or disclosure of Protected Health Information (PHI)[1] involves no more than minimal risk to the privacy of individuals. Explain[2] how the risks are reasonable in relation to the benefits, if any, to the individuals, and the importance of the knowledge that may reasonably be expected to result from the research. Include a detailed list of the PHI to be collected and a list of the source(s) of PHI.

2.  HIPAA Regulations require reasonable efforts to limit PHI to the minimum necessary to accomplish the intended purpose of the use, disclosure or request. Please note that researchers are also accountable for any PHI released under a waiver. Explain why the PHI requested for this study is the minimum information required to meet the research objectives.

3.  Describe the plan to protect identifiers and indicate whether PHI will be stored and who will have access (researchers must list all entities that might have access to the study’s PHI, such as IRB, Resurrection Health Care (RHC) employees, RHC physicians, sponsors, FDA, data safety monitoring boards, and any others given authority by law).

4.  All identifiers collected during the study will be destroyed at the earliest opportunity consistent with the conduct of research. Indicate the timeline below.

PROJECT TITLE:

5.  Please respond to either 5A or 5B as appropriate.

A.  Please describe the procedure used to destroy all the data collected during the study (electronic, paper, audio, video, photographs, other) and the person responsible.

B.  OR, if the identifiers collected during the study will not be destroyed, please explain the reason they will not be destroyed and how they will be protected.

6.  Please explain the reason the research could not practicably be conducted without the waiver.

7.  Please explain the reason the research could not practicably be conducted without access to and use of the PHI.

The information supplied in this waiver application is accurate and all research staff[3] will comply with HIPAA Regulations and the waiver criteria.

I assure that the information I obtain as part of this research (including PHI) will not be reused or disclosed to any person or entity other that those listed on this form, except as required by law. If I want to reuse this information for other purposes or disclose the information to other individuals, I will seek IRB approval.

Principal Investigator: ______

Signature Date:

Printed Principal Investigator’s Name:

HIPAA Waiver Of Authorization Application

Page 2 of 2

Revised 6/5/2012

[1] PHI: Individually identifiable health information transmitted or maintained in any form (electronic, paper or oral communication) relating to the past, present or future physical or mental health or conditions of an individual.

[2] Additional sheets of paper may be attached as necessary to provide the requested information.

[3] Research staff is defined as ALL study personnel (including PI) who are involved in the research.