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App New Exempt 2011 07 06

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					                                                                                               Institutional Review Board
                                                                                                             Veteran’s Administration Hospital
                                                                 Physical Address: 423 East 23rd Street | 10th Floor, West Wing | NY, NY 10010
                                                                  Mailing Address: 550 1st Avenue | #VET 10th Floor, West Wing | NY, 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
You must obtain an R# for any new study you wish to submit to the IRB. Get your new study’s R# by
contacting the Office of Clinical Trials. For full information, consult: http://oct.med.nyu.edu/
The documents you need to send the IRB are outlined below. Incomplete or inaccurate submissions will delay
review. The IRB website includes a guidance page on submitting this application: http://irb.med.nyu.edu/forms-
guidance/guidance-submission.
Note that we require your forms to be submitted electronically via email—consult our eSubmission Guidelines
for full details.
Please contact the IRB office at 212 263-4110 with any questions. IRB website: http://irb.med.nyu.edu/
         Always Submit These          Application for Exemption
                  Documents           CV/Resume for Principal Investigator and all Co-Investigators
                                      Investigator Financial Disclosure Form: for all staff involved in the design and/or
                                      conduct of this study
 Submit Only Where Applicable         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




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                                        Application for Exemption    NYU School of Medicine IRB

 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.

  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
                           R#                                              Date of this request
                   Study Title
                  Department                                                          Division
       Role*               Name                                                    Email                   Phone             Fax
  Principal Investigator
        Contact Person



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                                           Application for Exemption    NYU School of Medicine IRB

        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
                                          Yes
      completed the CITI Tutorial
       http://www.citiprogram.org         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.
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.
                      Study is a        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:


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                                           Application for Exemption   NYU School of Medicine IRB

* 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
    Indicate the building(s) and
     room number(s) where the
           study will take place


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       State number of years, months, or weeks:
                                study      Justify that the proposed period of time is sufficient to conduct and complete this
                                              study:
                              Sponsor                                                       NIH
                                              Investigator-initiated (Departmental)
                                                                                            Industry (specify):
                                              Foundation (specify):
                                                                                            Other (specify):
                                   Risk       Minimal; describe why this category is appropriate:
                                              Greater than minimal; STOP – not eligible for exemption
                                Subjects
Estimate the number of subjects that
          will be included in the study
                               Data Use      Oral Presentation
  Data you generate will be used for         Publication
                  (check all that apply)      Other; explain:
         Category 4 Exempt; you are
            studying existing samples
   existing means the samples, data           Yes
specimens have already collected at           No
  the time this project is proposed to
                                 the IRB
               Vulnerable Populations         Children                                         Institutionalized Persons
 Check off any/all of the populations         Pregnant Women/Fetuses/Neonates                  Prisoners
        listed at right if they might be      Cognitively Impaired                             Non-English Speaking
                 subjects in your study       Senior Citizens                                  Students
                                              Handicapped                                      Employees
                            Consent
                                              Yes; describe consent/documentation process:
      Is consent being obtained from
                           subjects?          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


                                   Document1 | email irb-info@nyumc.org | phone 212.263.4110 | page 4 of 6
                                           Application for Exemption    NYU School of Medicine IRB

   Indicate your study’s source(s) of         physician/clinic records
                                                                                                 billing records
                   health information         interviews/questionnaires
                                                                                                 hospital/medical records (in- and
                                              mental health records
                                                                                                 out-patient)
                                              lab, pathology and/or radiology
                                                                                                 data previously collected for research
                                              results
                                                                                                 purposes
                                              biological samples obtained from the
                                                                                                 other; specify:
                                              subjects
PHI USAGE: Check off every type of           Names (individual, employer, relatives, etc.)
  PHI being temporarily used in your         Address (street, city, county, precinct, zip code – initial 3 digits if geographic unit contains
                                 study        less than 20,000 people, or any other geographical codes)
 Research which involves the use of          Telephone and Fax numbers
   “de-identified” PHI is exempt from        Social Security numbers
  HIPAA requirements. To qualify for
                                             Dates (except for years) including Birth date, Admission date, Discharge date, Date of
  exemption, the following identifiers
                                              death
   must be stripped or not accessible
                                              Ages >89 and all elements of dates indicative of such age (except that such age and
 before you begin your research. For
       most Exempt studies this is not        elements may be aggregated into a category “Age >90”)
possible. Therefore you may need to          E-mail addresses
  use the PHI for a period of time but       Health Plan Beneficiary numbers
      will not permanently record it. In     Account numbers
    these circumstance, the IRB may          Certificate/license numbers
       grant a waiver of authorization.      Vehicle Identifiers and Serial numbers (e.g., VINs, License Plate numbers)
       For retrospective chart reviews       Device Identifiers and Serial Numbers
    looking at the chart is considered       Web Universal Resource Locators (URLs)
      examining PHI (therefore using)        Internet Protocol (IP) address numbers
    identifiers for research purposes.       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




                                   Document1 | email irb-info@nyumc.org | phone 212.263.4110 | page 5 of 6
                                      Application for Exemption    NYU School of Medicine IRB

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




                               Document1 | email irb-info@nyumc.org | phone 212.263.4110 | page 6 of 6

				
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