Institutional Review Board
Human Research Protection Program
1 Park Avenue | 6th Floor | New York, NY 10016
http://irb.med.nyu.edu
Application for Exemption
When to Use this Form
Use the Exemption Checklist (below) to verify that your study qualifies for exempt status. If it does not, you
must submit an Application for New (Full Board or Expedited) Protocol Review.
The IRB will reject any form or application 30 or more days older than the current version on our website. The
IRB updates its forms regularly. Always use the IRB website to download to latest version of a submission
form.
Submission Instructions
Our website provides full instructions on submitting applications to the IRB: http://irb.med.nyu.edu/esubmission
Please contact the IRB office at 212 263-4110 with any questions.
Always Submit These
Submit These Only When
Applicable
Application for Exemption
CV/Resume for Principal Investigator and all Co-Investigators
Investigator Financial Disclosure Form for each staff member involved in the design
and/or conduct of this study
Questionnaires
Recruitment Materials
PRMC institutional approvals
any other information that is pertinent to the review of your project
Exemption Checklist
If you believe that your study constitutes one of the types of research which is exempt from review, please
indicate below the specific category(ies) under which your study should be considered exempt.
45 CFR 46.101(b)(1) Research conducted in established or commonly accepted educational settings, involving
normal educational practices such as (i) research on regular and special education instructional strategies, or (ii)
research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom
management methods. Research qualifies for exempt review under this category ONLY if:
The research does not involve prisoners
The research is not FDA regulated
45 CFR 46.101(b)(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behavior unless: (i) information
obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked
to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably
place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing,
employability, or reputation. Research qualifies for exempt review under this category ONLY if:
The research does not involve children
The research involves children but only educational testing or observation of public behavior *
The research does not involve prisoners
The research is not FDA regulated
* Note research under category 45 CFR 46.101(b)(2) MAY include children ONLY when the research involves educational tests and
research involving observation of public behavior when the investigators do not participate in the activities being observed.
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Application for Exemption
NYU School of Medicine IRB HRPP
45 CFR 46.101(b)(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public behavior that is not otherwise
exempt if: (i) The human subjects are elected or appointed public officials or candidates for public office; or (ii)
federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will
be maintained throughout the research and thereafter. Research qualifies for exempt review under this category
ONLY if:
The research does not involve prisoners
The research is not FDA regulated
45 CFR 46.101(b)(4) Research involving the collection or study of existing* data, documents, records, pathological
specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the
investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the
subjects. Research qualifies for exempt review under this category ONLY if:
The research does not involve prisoners
The research is not FDA regulated
*Existing means that the reviewed materials exist at the time the research is proposed to the IRB.
45 CFR 46.101(b)(5) Research and demonstration projects which are conducted by or subject to the approval of
department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit
or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes
in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for
benefits or services under those programs.
The research does not involve prisoners
The research is not FDA regulated
The research will be conducted pursuant to specific federal statutory authority
The research has no statutory requirements for IRB review.
The research does not involve significant physical invasions or intrusions upon the privacy interests of subjects.
The research has authorization or concurrence by the funding agency
45 CFR 46.101(b)(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods
without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level
and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found
to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food
Safety and Inspection Service of the U.S. Department of Agriculture. Research qualifies for exempt review under
this category ONLY if:
The research does not involve prisoners
Administrative Information
Study#
Date of this request
Study Title
Department
Division
Role*
Name
Email
Phone
Fax
Principal Investigator
Contact Person
Co-Investigator(s)
* PI and Contact Person are required; list all other study personnel as well, one line per person
All personnel listed above have
completed the CITI Tutorial
http://www.citiprogram.org
Yes
No
Disclosure of Financial Interest
This application must include a signed and dated Investigator Financial Disclosure Form for all study personnel
involved in the design and/or conduct of this study.
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Application for Exemption
NYU School of Medicine IRB HRPP
Each staff person must submit a Financial Disclosure Form for each protocol, even if no financial interest
exists. In other words, this application must be accompanied by financial disclosure forms for every research
study personnel involved in the design and/or conduct of this study.

Investigator Financial Disclosure Form can be found at: http://cmu.med.nyu.edu/forms
In addition to the protocol-specific forms outlined above, all research staff must also submit the Annual
Disclosure Form. This annual institutional submission is a separate electronic form submitted to the Conflicts
Management Unit.

Annual Disclosure Form can be found at http://cmu.med.nyu.edu/forms
For more specific information on NYU Langone Medical Center’s policy on disclosures for researchers see:
http://cmu.med.nyu.edu
If disclosure forms are not received for all personnel on this study the submission cannot be processed.
Submit When Applicable
this submission requires completed Investigator Financial Disclosure Forms from all
personnel involved in the design and/or conduct of this study
the Research Conflict of Interest Committee has made a determination regarding a
disclosure; attached is a copy of that determination
Study Location(s)
Indicate the site(s) to be used in this study.
Single center
Multi-center;
I am the P.I. of multi-center trial
Other; specify:
Study Site(s)
Bellevue Hospital Center (BHC)*
NYU Child Study Center
Charles B Wang
NYU College of Dentistry
Co-op Care
NYU College of Nursing
Coler-Goldwater Specialty Hospital and
NYU Graduate School of Arts and
Nursing Center
Sciences
Coney Island Hospital
NYU HJD
Faculty Group Practice (FGP)
NYU School of Medicine
Faculty Practice Offices (FPO)
NYU Steinhardt School of Education
CTSI/ACTG
NYU Wagner School of Public Services
CTSI/Bellevue*
NYUMC (Tisch Hospital)
CTSI/HJD
Nathan Kline Institute (NKI)
CTSI/NYUMC
Radiology – 660 1st Avenue
CTSI/Skirball 8z
Rivergate Building
Gouverneur Hospital
Rusk Institute
Hassenfeld Children’s Center
Smilow
Kings County Medical Center
VA Medical Center
Lincoln Medical & Mental Health Center
Woodhull Medical & Mental Health
Metropolitan Hospital
Center
NYU Cancer Center
Other; specify:
* Studies conducted (in part or whole) at Bellevue Hospital must also apply online using the REASON system at:
http://reason.nychhc.org/ Questions? Call Bellevue at 212.562.4176
Study is a
Indicate the building(s) and
room number(s) where the
study will take place
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Application for Exemption
NYU School of Medicine IRB HRPP
Describe Your Study
Study Description
Use this section to provide details
regarding your project. At minimum,
you must include the methods to be
used for this research and a detailed
description of the data, records or
samples that will be studied in the
course of this project, with an
emphasis on what will happen to the
subjects.
You may submit an attachment
when describing your study; write
ATTACHED in the DESCRIPTION
box.
Proposed length (time period) of the
study
Sponsor
Risk
Subjects
Estimate the number of subjects that
will be included in the study
Data Use
Data you generate will be used for
(check all that apply)
Category 4 Exempt; you are
studying existing samples
existing means the samples, data
specimens have already collected at
the time this project is proposed to
the IRB
Vulnerable Populations
Check off any/all of the populations
listed at right if they might be
subjects in your study
Consent
Is consent being obtained from
subjects?
State number of years, months, or weeks:
Justify that the proposed period of time is sufficient to conduct and complete this
study:
NIH
Investigator-initiated (Departmental)
Industry (specify):
Foundation (specify):
Other (specify):
Minimal; describe why this category is appropriate:
Greater than minimal; STOP – not eligible for exemption
Oral Presentation
Publication
Other; explain:
Yes
No
Children
Pregnant Women/Fetuses/Neonates
Cognitively Impaired
Senior Citizens
Handicapped
Institutionalized Persons
Prisoners
Non-English Speaking
Students
Employees
Yes; describe consent/documentation process:
No; justify:
PHI/Authorization
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. Complete this section in
order to obtain a waiver of authorization to use/disclose PHI.
Describe the risks to privacy
involved in this study and explain
why the study involves no more than
minimal risk to privacy
Indicate your study’s source(s) of
health information
physician/clinic records
interviews/questionnaires
mental health records
lab, pathology and/or radiology
results
biological samples obtained from the
subjects
billing records
hospital/medical records (in- and
out-patient)
data previously collected for research
purposes
other; specify:
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Application for Exemption
PHI USAGE: Check off every type of
PHI being temporarily used in your
study
Research which involves the use of
“de-identified” PHI is exempt from
HIPAA requirements. To qualify for
exemption, the following identifiers
must be stripped or not accessible
before you begin your research. For
most Exempt studies this is not
possible. Therefore you may need to
use the PHI for a period of time but
will not permanently record it. In
these circumstance, the IRB may
grant a waiver of authorization.
For retrospective chart reviews
looking at the chart is considered
examining PHI (therefore using)
identifiers for research purposes.
NYU School of Medicine IRB HRPP
Names (individual, employer, relatives, etc.)
Address (street, city, county, precinct, zip code – initial 3 digits if geographic unit contains
less than 20,000 people, or any other geographical codes)
Telephone and Fax numbers
Social Security numbers
Dates (except for years) including Birth date, Admission date, Discharge date, Date of
death
Ages >89 and all elements of dates indicative of such age (except that such age and
elements may be aggregated into a category “Age >90”)
E-mail addresses
Health Plan Beneficiary numbers
Account numbers
Certificate/license numbers
Vehicle Identifiers and Serial numbers (e.g., VINs, License Plate numbers)
Device Identifiers and Serial Numbers
Web Universal Resource Locators (URLs)
Internet Protocol (IP) address numbers
Biometric Identifiers (e.g. finger or voice prints)
Full face photographic images) and any comparable images
Any other unique identifying number, characteristic, or code
If any PHI USAGE box is checked,
list every research staff member or
other staff member who will have
access to this data
If any PHI USAGE box is checked,
describe investigator’s plan to
protect PHI from improper use or
disclosure
If any PHI USAGE box is checked,
describe investigator’s plan to
destroy PHI as soon as possible
Explain why it is not possible to seek
subjects’ authorization for use or
disclosure of the PHI
Explain why it is not possible to
conduct this research without use or
disclosure of the PHI
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Application for Exemption
NYU School of Medicine IRB HRPP
PI’s Signature
Date
Print Name
Signature
I certify that the Protected Health Information (PHI) that will be received or reviewed by research
personnel for the study referenced above will not record any of the 18 identifiers listed above. I also
certify that I do not have knowledge that any of the remaining information could be used, alone or in
combination with other information, to identify an individual who is the subject of the information.
I will conduct the study identified above in the manner described in the above Description. If I decide
to make any changes in the procedure, or if a participant is injured, or if any problems occur which
involve risk or the possibility of risk to participants or others, I will immediately report such
occurrences or contemplated changes to the IRB.
Department Chair’s Signature
Date
Print Name
Signature
I CERTIFY THAT THIS INVESTIGATOR IS A MEMBER OF MY DEPARTMENT IN GOOD
STANDING, THE DEPARTMENT OR NEW YORK UNIVERSITY SCHOOL OF MEDICINE HAS THE
RESOURCES NECESSARY TO CARRY OUT THIS RESEARCH, AND THE INVESTIGATOR IS
QUALIFIED TO BE THE PRINCIPAL INVESTIGATOR ON THE PROJECT.
Service Chief’s Signature
Required for studies being conducted at BHC
Date
Print Name
Signature
Subject’s Department Chair’s Signature
If subjects covered under this research protocol are under the administrative responsibility of a different
department of departments, approval is required.
Date
Department
Print Name
Signature
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