DEPARTMENTOFRESEARCH
LBH IRB Form #26: Waiver of Disclosure of PHI Page 1of 2
Version 3, 01-05-17
Institutional Review Board
Waiver of Disclosure for Use of Protected Health Information (PHI) in a Research Study
Please complete and submit this form to the IRB office with a summary of your research proposal at least 2 weeks in advance of the date the research is to begin. You may not initiate the research until you receive a signed IRB approval of the waiver request. Please remove and replace italicized text prior to completion.
Title:
Principal LBH Investigator:
Sub-Investigators:
Outside Sponsor or Funding Source (if any):
Purpose for Which Waiver is Requested: (i.e. screening by study nurse, or records reviewby PI)
Date of Application:
Research Summary: Please complete the requested information below or on an attached separate sheet
Type and Design of Study:
# Of Subjects to be enrolled or # of Records to be Reviewed:
# Of Sites:
List the Objectives or Endpoints:
All Methods or Procedures to be used:
List all Data to be collected in the Study:
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Please document ALL of the following:
- The proposed uses and disclosures of information involve no more thanminimal risk to the individual’s privacy, based on the following:
An adequate plan to protect the individualfrom improper use and disclosureof PHImethods will be used to safeguard the PHI from unauthorized access or improper use ordisclosure (Examples of responses: Files kept under lock/key or in a restricted area, limited access to investigators/study personnel; personnel trained in Privacy practices.)
(Insert Name) “I certify that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of PHI would be permitted”
( cite the applicable provision, if any).
2. Theresearchcould not practicably be conducted without the waiver(Insert an explanation of why it is not practicable to obtain individual authorization or to use de-identified information or a limited data set for this research.)
3.Theresearchcould not practicably be conducted without access to and use of the PHI.
(Insert an explanation of why access to PHI is necessary for this research..)
4. Insert Name“I acknowledge that it is my duty under MarylandState law not to re-disclosepatient-identifying PHI that is obtained for research without individual consent, and that such PHI will be used only for purposes of research and will be subject to all other applicable requirements of the IRB.”
By signing the package I attest that all the information included in this document is accurate.
LBH IRB Form #26: Waiver of Disclosure of PHI Page 1of 2
Version 3, 01-05-17