VA Central IRB Forms - DOC by Sarahsinthekinchin

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									            REQUEST FOR IRB WAIVER OR ALTERATION OF PROTECTED
                 HEALTH INFORMATION* (PHI) AUTHORIZATION
This form must be included with the PI project approval form when requesting a waiver or
alteration of the PHI authorization requirement for the project as a whole or for a specific purpose,
such as for recruitment purposes only. NOTE: In order to ensure that the waiver is considered
and documented appropriately, please provide a reasonable amount of detail in your responses.

I. Project Identification
Title of Project

Principal Investigator

Date of Request


II. Type of Request
         Waiver of the PHI Authorization requirement is required for recruitment purposes only. PHI
         Authorization will be obtained from participants prior to their enrollment.

         Waiver of PHI Authorization requirement for entire project

         Alteration of all or some of the elements of the PHI Authorization requirement


III. Criteria to be Eligible to Submit a Waiver or Alteration Request
The Principal Investigator must check that the proposed research meets all of the following
criteria in order to be eligible to submit a waiver or alteration request.

           The use or disclosure of PHI involves no more than minimal risk to the privacy of individuals.

           There is an adequate plan to protect the identifiers from improper use and disclosure.

           There is an adequate plan to destroy the identifiers at the earliest opportunity consistent with
           the conduct of the research, unless there is a health or research justification for retaining the
           identifiers or such retention is otherwise required by law.
           The PHI will not be reused or disclosed to any other person or entity, except as required by
           law or for authorized oversight of the research project.
           The research cannot be practicably conducted without the alteration or waiver.

           The research cannot be practicably conducted without access to and use of the PHI.

           *If the study involves access to and/or use of information pertaining to drug abuse,
           alcohol abuse, HIV infection, sickle cell anemia: I have consulted with the SAVAHCS
           Privacy Officer and give assurances that (1) The purpose of the data is to conduct scientific
           research; and (2) no personnel involved in the study will identify, directly or indirectly, any
           individual patient or subject in any report of such research or otherwise disclose patient or
           subject identifiers in any manner.




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                                                                                              IRB Waiver Request
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III. Justification for Waiver or Alteration
The Principal Investigator must provide a response for each of the items listed below if applicable.


1. Will the research involve the access to or use of decedent’s PHI?          Yes         No

If “No,” skip down to Question 2.

    a. Does the research require the PHI of decedents only?

           Yes            No

If “No”, skip down to Question 2.

If “Yes”, the research does not require an IRB waiver of the PHI Authorization requirement and you do not
need to complete Questions 2-8. However, the SAVAHCS R&D Committee requires responses to the
following questions before deciding whether to permit access to and use of this information for research
purposes without written authorization.

    b. How do you plan to determine that the individuals are deceased? (You must be able to provide
    documentation of the death of the individuals to the SAVAHCS R&D Committee upon request,)



    c. Please describe why the use or disclosure of decedents’ PHI is necessary for research purposes.



2. Describe the PHI required as part of the research effort and list the source(s) accessed to obtain that
information.



3. Describe the plan to protect subjects’ identifiers from improper use or disclosure. Include information
on where and how the information will be stored and who will have access to the information .



4. Describe the plan to destroy the identifiers at the earliest opportunity, including a description of when
and how the information will be destroyed. If there is a health, research, or other justification for retaining
the identifiers, please provide such justification below.



5. Describe any other factors that ensure the use or disclosure of PHI will not have an adverse affect on
the privacy rights or welfare of the individuals.



6. Describe why the research would not be possible without the waiver or alteration (i.e., describe
reasons why it is not practicable to have patients sign an authorization form or to gain authorization in
another manner).



7. Describe why the research could not practicably be conducted without access to and use of the PHI.




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                                                                                               IRB Waiver Request
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8. If requesting an alteration, please indicate the alteration being requested.




IV. Investigator Certification
 By signature below, the Principal Investigator acknowledges the following:



1. The information listed in this waiver application is accurate and all research project staff will comply with
applicable laws and regulations, and the criteria set forth in this waiver or alteration request.

2. The Protected Health Information described above is the minimum necessary in order to conduct the
research.

3. Even though a waiver or alteration may be granted, I acknowledge that it is still my responsibility to
ensure that the rights and welfare of the participants are protected in accordance with VA and other federal
requirements.




      Signature                                                                             Date


*”Protected Health Information” means any individually-identifiable health information, including
demographic information, maintained in any form or medium, that is: (1) Created or received by a health
care provider, health plan or health care clearinghouse; (2) relates to the past, present, or future condition
of an individual and provision of or payment for health care; and (3) identifies the individual or a
reasonable basis exists to believe the information can be used to identify the individual.




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                                                                                               IRB Waiver Request
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