Instructions:
Please complete the application below.
Upon completion of this application, you will have the option to PDF this form. In addition, a copy of the PDF will be emailed to the contact information listed in the survey.
Please upload this PDF to your study submission in Research Navigator under the "consent" section in order to initiate review of the application.
Questions should be directed to irb-info@nyulangone.org.
In order to access or use an individual's Protected Health Information (PHI) in the conduct of research without the express authorization of the individual, you must request a waiver of authorization.
In order to conduct research without the express written consent of a human subject, you must request a waiver of informed consent.
You may also request an alteration in consent or authorization. In other words: you will be obtaining written consent but may require certain elements of the consent be altered and you will need to request an alteration in consent and authorization.
You may request a waiver of documentation of consent. There are required elements that must be met, but a waiver of documentation of consent means that you will obtain consent, but you do not use an informed consent document.
Administrative Information
Principal Investigator's name
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Institution
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Department
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Phone number
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E-mail address
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Study Number (begins with "s" or "i")
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Study title
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Types of Waiver Request
(Check all that apply)
In order to use or disclose an individual's Protected Health Information (PHI) in the conduct of research without the expressed authorization of the individual, the investigator must request for a waiver of authorization OR an alteration of authorization. IRB may approve a full waiver of the requirements for written HIPAA Authorization to use or disclose PHI OR an alteration of the requirements.
In order to conduct research without the expressed consent of an individual, the investigator must request for a waiver of consent OR an alteration of consent. IRB may waive the requirements to obtain consent OR approve a consent process which does not include, or which alters, one or more of the elements of consent.
IRB may waive the requirement for the investigator to obtain a signed consent under some circumstances. The investigator still needs to obtain consent following the same requirements as written consent but the subject would not have to sign a consent. This process is often referred to as verbal consent. For this process, the investigator must request for a waiver of documentation of consent.
All research conducted under the waiver(s) below meets the definition of minimal risk. Research that does not meet this definition requires subjects' signed authorization and consent.
(Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.)
* must provide value
Section 1: Identifiable Private Information
SECTION 1.1
(Check all identifiers that will be collected, used, or disclosed in your study)
Name (including initials)
Street address
County or precinct
Any of the following: city, state, zip code (or equivalent geocode)
All elements of dates (except year) for dates directly related to an individual (e.g., date of birth / death, dates of admission / discharge, etc.)
For those 90 or older: Any element of date (including year) indicative of age, or recording actual age (i.e., rather than recording age as '90 or older')
Telephone numbers
Fax numbers
Email addresses
Social security numbers
Medical record numbers
Health plan beneficiary numbers
Account numbers
Certificate / license numbers
Vehicle identifiers and serial numbers including license plate numbers
Device identifiers and serial numbers
Web Universal Resource Locators (URLs)
Internet Protocol (IP) addresses
Biometric identifiers including finger and voice prints
Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code (a rare disease can be considered a unique ID)
No identifiable private information will be collected, used, or disclosed in this study
SECTION 2: Request for WAIVER OF AUTHORIZATION or ALTERATION OF AUTHORIZATION
SECTION 2.1
(Check all sources of the PHI for your study)
If other, explain in this section
Confirm who will have access to the PHI checked in section 1.1 above
If other, explain in this section
Describe the risks to privacy involved in this study and explain why the study involves no more than minimal risk to privacy
If other, explain in this section
Describe investigator's plan to protect the PHI from improper use or disclosure and for destroying PHI at the earliest time
If other, explain in this section
Explain why it is not possible to seek subjects' authorization for use or disclosure of the PHI
If other, explain in this section
Explain why it is not possible to conduct this study without use or disclosure of the PHI
If other, explain in this section
SECTION 3: Request for WAIVER OF CONSENT or ALTERATION OF CONSENT
Describe the possible risks of harm to subjects in this study and explain why the study involves no more than minimal risk to subjects
If other, please explain in this section
Explain why the research cannot practicably be carried out without waiver or alteration
If other, explain in this section
If the research involves the use of identifiable private information and / or identifiable biospecimens, explain why the research cannot practicably be carried out without using this identifiable private information and / or identifiable biospecimens
If other, explain in this section
Explain why the waiver or alteration will not adversely affect the rights and welfare of the subjects
If other, explain in this section
If appropriate, explain how subjects will be provided additional pertinent information after participation. If not appropriate, explain why not.
If it is not appropriate, explain in this section
SECTION 3.2
(for alteration of consent only)
Briefly describe the consent process for the study and describe which elements you are omitting and / or altering.
SECTION 4: Request for WAIVER OF DOCUMENTATION OF CONSENT
Briefly describe the consent process for your study
SECTION 4.2
(Complete Subsection 1, 2, or 3)
SUBSECTION 1
(studies in which the only record linking the subject to the research would be the consent form)
The only record linking subjects to the research would be the consent form because:
If other, please explain in this section
The principal risk be potential harm resulting from a breach of confidentiality because:
(Note: to proceed with a waiver under this subsection, each subject or legally authorized representative must be asked whether they want documentation linking them to this study. You must include this in the description of the consent process in Section 4.1 above and in your protocol)
If other, explain in this section
SUBSECTION 2
(studies involving no procedures for which written consent is normally required outside of research)
The study involves no more than minimal risk to subjects because:
If other, explain in this section
This study involves no procedures for which written consent is normally required outside the research context. The study involves only involves:
If other, explain in this section
SUBSECTION 3
(studies involving members of a distinct cultural group or community)
The study involves no more than minimal risk to subjects because:
If other, explain in this section
The subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects, and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
If "Yes", explain in this section
Will subjects or legally authorized representatives be provided with a written statement regarding your study?
If other, explain in this section
Principal Investigator's Signature
Sign date
* must provide value
PI Signature
I assure the NYU Langone Health IRB that the PHI which I have detailed in this waiver application will not be reused or disclosed to any person or entity other than those listed above, except as required by law, for authorized oversight of this research study, or as specifically approved for use in another study by the NYU Langone Health IRB.
I also assure the NYU Langone Health IRB that the information that I provide in this application is accurate and complete, and that the PHI that I request is the minimum amount of identifiable health information necessary for my research project.
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Check this box in order to finish the application
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Submit
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