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					STATE UNIVERSITY OF NEW YORK UPSTATE MEDICAL UNIVERSITY

                                                                                          FOR OFFICE USE ONLY
                                                                                          Original Approval Date:
                                                                                          Revised Approval Date:
STUDY #
                                                                                          Application Version 11/9/2010

PART A:           Application Form for IRB Review of Human Subject Research

Note: Incomplete or handwritten applications will be returned. Refer to IRB Guidelines & Policies available on the web at
http://www.upstate.edu/researchadmin/irb/pdf/guidelines_policies.doc

In order to “check” a “yes” or “no” box, double click on the box you want to check and choose “checked”

Title of Study:

Date of Submission:

5-Year Renewal Submission: Yes No
If Yes, a. Number of subjects enrolled since last Continuing Review Report:
        b. Total number of subjects enrolled since inception of study:

Principal Investigator Information:
(Note: PI must have an Upstate faculty appointment)

Name/Degree(s):                                                      Office Location (Bldg/room number):
Upstate Faculty Title:
Upstate Department:                                                  Phone:                 Pager:
Division:
                                                                     Email:
Upstate Medical University Employee? Yes        No
 If no, who is your employer?

CRA/Coordinator Information: (this individual is delegated to receive all correspondence from the IRB. If left blank, the PI will
receive all correspondence)

Name/Degree:                                Department:
Phone:            email:           Office Location (Bldg/room number):
Is this individual authorized by the PI to obtain consent/assent? Yes             No

*Mandatory Education Requirement:
 All faculty, staff and students, who participate in the conduct of research, involving human subjects, are required to complete the
 CITI (http://www.upstate.edu/researchadmin/irb/education.php). Approved studies will not be released until this requirement has
 been met.

Signature of Principal Investigator (PI)

Signature certifies that the information in this application is correct and that the research will be conducted in full
compliance with Upstate policies and federal regulations. The period of approval is determined by the IRB and
continuing review is required in order to maintain approval status. The PI must submit progress reports for this review.
Unanticipated problems and Adverse Events must be reported to the IRB per IRB policy, and changes in the study
must be approved by the IRB prior to implementation.

_______________________________                       ___________________
Signature of Principal Investigator                   Date

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                                                                                                                               Page 1
For Initial Submission or Change in PI ONLY:
Department Chair’s (or Dean’s, as appropriate) Signature (or Submit Signed Copy of Signed College Face Sheet)

      Signature certifies the proposal has been reviewed and is endorsed by the department, and is therefore
recommended for submission to the SUNY Upstate IRB for review.


____________________________________                 __________________________________                    __________
Printed Name of Department Chair (or Dean)           Signature of Department Chair (or Dean)               Date

Local Study Team: List all individuals who assist the PI in the conduct of the study. (For studies involving FDA regulated articles,
the listed investigators must include those members listed on the 1572 form).

Name (Last, First) / Degree       Upstate Status Information         Department & Office Location          Check if Authorized by PI
                                                                                                           to Obtain Consent/Assent
                                      Upstate Employee
                                      Upstate Student
                                                                                                                      Yes     No
                                      Voluntary Faculty Member
                                  If none: badge #:
                                      Upstate Employee
                                      Upstate Student
                                                                                                                      Yes     No
                                      Voluntary Faculty Member
                                  If none: badge #:
                                      Upstate Employee
                                      Upstate Student
                                                                                                                      Yes     No
                                      Voluntary Faculty Member
                                  If none: badge #:
                                      Upstate Employee
                                      Upstate Student
                                                                                                                      Yes     No
                                      Voluntary Faculty Member
                                  If none: badge #:
                                      Upstate Employee
                                      Upstate Student
                                                                                                                      Yes     No
                                      Voluntary Faculty Member
                                  If none: badge #:
                                      Upstate Employee
                                      Upstate Student
                                                                                                                      Yes     No
                                      Voluntary Faculty Member
                                  If none: badge #:
                                      Upstate Employee
                                      Upstate Student
                                                                                                                      Yes     No
                                      Voluntary Faculty Member
                                  If none: badge #:
                                      Upstate Employee
                                      Upstate Student
                                                                                                                      Yes     No
                                      Voluntary Faculty Member
                                  If none: badge #:
                                      Upstate Employee
                                      Upstate Student
                                                                                                                      Yes     No
                                      Voluntary Faculty Member
                                  If none: badge #:
                                      Upstate Employee
                                      Upstate Student
                                                                                                                      Yes     No
                                      Voluntary Faculty Member
                                  If none: badge #:

ADD LINES AS NEEDED

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                                                                                                                            Page 2
1.   SUMMARY DESCRIPTION OF STUDY (LIMIT TO ½ PAGE: Include: pertinent background, purpose, and a brief
     description of the study design. This MUST be written in language understandable to a layperson).



2.   HOW WILL THE NEW INFORMATION GAINED FROM THIS STUDY IMPACT THE TREATMENT FOR THIS
     DISEASE OR CONDITION?


3.   DRUGS/BIOLOGICS:             Yes       No (go to question #4)

         A. List the Names of ALL drug(s) to be used in the study:

         B. Phase of study: I      II     III    IV      N/A

         C. Will any drugs or biologics be used in this study, which are NOT FDA approved?             Yes       No
         If yes, complete the following for each applicable drug and submit (2) copies of the Investigational Drug Brochure (for each
         investigational drug):

             1. Name of drug:           IND#          Name of IND Holder:


         D. Will any marketed (FDA approved) drugs or biologics be used in this study, which involve a different formulation, dose,
            route of administration, or indication? Yes      No
                If yes, and this is NOT an NIH cooperative group study, provide the following:

                           1.   Name of drug:           IND#         Name of IND Holder:
                                Name of drug:           IND#         Name of IND Holder:
                                Name of drug:           IND#         Name of IND Holder:

                                                OR

                           2.   Complete and submit the IND application Exemption Checklist.

         E. Submit a copy the completed Pharmacy Worksheet.
               1. Date sent to pharmacy:

4.   DEVICES (such as instruments, implants, or in vitro reagents, etc.):         Yes       No (go to question #5)

         A. Name of all device(s) - please attach a description or picture of the device(s) to the application form:


         B. Does this study include the use of a FDA approved device, which is being used within its’ approved indication?
              Yes (go to question #4)        No

             If no, complete the following questions:

             1.   Is the device a significant risk device?     Yes       No

             2.   If a significant risk device, complete the following for each applicable device and submit (2) copies of the Report of
                  Prior Investigations (for each investigational device):
                  Name of device:           IDE#        Name of IDE Holder:

             3.   If not a significant risk device, substantiate this claim:
             4.   This investigational device holds the following FDA designation (check one):
                            a. Category A device *
                            b. Category B device
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                                                                                                                                Page 3
                  * There are specific billing restrictions associated with this designation, please contact Sue O'Brien (Fiscal Services) at
                  4-8086 for further information.


    5.   SPONSORSHIP/FUNDING:
         (NOTE: Grants and Contracts Must Be Administered Through The SUNY Upstate Sponsored Programs Office)

         a. This study is investigator (Upstate & non-Upstate) initiated ?     OR       sponsor initiated?

         b. Is this research project funded (this includes department funding)?
                  Yes → Go to section c

                 No → Is this study currently registered with clinicaltrials.gov?        Yes      No → provide explanation or date when
                     trial will be registered

         c. Please complete the appropriate box:

               CORPORATE SPONSORED STUDY:                                         NIH AND NON-CORPORATE SPONSORED STUDY:
                    (for-profit organizations)                                      (e.g. NIH, federal, state, not-for-profit organizations)

Sponsor Name:                                                                Sponsor Name:

Address:                                                                     Address:

Contact Name/Phone:                                                          Contact Name/Phone:

Protocol Version Number/Date:                                                Institution Receiving the Award:
                                                                             Award Number:
Is this study currently registered with clinicaltrials.gov?
     Yes       No If no, provide explanation or date when trial will be      Is this study currently registered with clinicaltrials.gov?
                    registered                                                    Yes       No If no, provide explanation or date when trial will be
                                                                                                 registered
Must submit 2 copies of the entire corporate protocol, model consent,
and Investigator’s Brochure(s) (if applicable).                              Must submit 2 copies of the entire grant application, including the
                                                                             face page plus 1 copy of the entire protocol, model consent, and
                                                                             Investigator’s Brochure(s) (if applicable).
     DESIGNATED NIH COOPERATIVE GROUP STUDY:                                        UPSTATE DEPARTMENT SPONSORED STUDY:
     (e.g. CALGB, COG, RTOG, CASG, GOG, NIAID, PACTG)
                                                                             Name of Department(s):
Name of Group:
                                                                             Is this study currently registered with clinicaltrials.gov?
Protocol Version Number/Date:                                                      Yes       No If no, provide explanation or date when trial will be
                                                                                                 registered
Is this study currently registered with clinicaltrials.gov?
    Yes        No If no, provide explanation or date when trial will be
                    registered
                                                                                                 Submit 2 copies of all materials.
Must submit 1 copy of the entire protocol, model consent, and
Investigator’s Brochure(s) (if applicable).


    6.   APPROXIMATE DURATION OF STUDY (total duration to complete all subjects):




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7.   MULTI-CENTER STUDY:                 Yes       No
     Note: For Upstate investigator initiated, multi-center studies, all remote investigators/sites require their own IRB approval
     (either local or private). The Upstate IRB will not serve as the IRB for remote investigators/locations unless an inter- institutional
     agreement is in place. It is the PI’s responsibility to ensure that each site has received IRB approval prior to their involvement
     in the study.

8.   PERFORMANCE SITE(S): (check all that apply)

              University Hospital (see Guidelines for Obtaining Research Support from University Hospital-UH Administrative Policy
                   R08 at: http://www.upstate.edu/intra/policy/uhpolicy.shtml)
              Crouse Hospital (must also be submitted/approved by Crouse Hospital IRB)
              VA Medical Center (must also be submitted/approved by the VA IRB)
              Clinical Research Unit (CRU)
              Institute for Human Performance (IHP)
              Syracuse University (must also be submitted/approved by the SU IRB)
              Other Upstate Medical University sites or sites under Upstate’s purview (Non-Upstate sites can be noted in Part B, Study
              Procedures section). Indicate Other Upstate Sites:

9.   RECRUITMENT OF STUDY SUBJECTS:

         a.    Subject Demographics:
               1. Approximate Number of Subjects to be enrolled locally:
               2. Number of Subjects to be enrolled nationally:
               3. Age range of subjects:

         b.    Describe the procedures to be followed for the recruitment and enrollment of study subjects; include how subjects will
               be identified, contacted (who will contact potential subjects) and enrolled.


         c.    Will potential subjects be identified from hospital or clinic records, logbooks, OR schedules or any UH database?
                 Yes No If yes, please explain.

         d.    Does the study sponsor offer “finder’s fees” for the referral of potential subjects and/or financial incentives or bonuses to
               anyone involved in the study for recruitment of subjects? Yes No
               If yes, please provide additional details.


         e.    Will you contact subjects with whom you do not have a relationship?        Yes        No
               If yes, please explain.

         f.    Which form of advertisement(s) will be used (attach to application)?

                   None                  Newspaper                   Web Site                    Brochure
                   Poster                Patient Letter              Physician Letter            Internet
                   Radio/TV              Other:

         g.    Are there enrollment restrictions based on race, gender or age?            Yes      No
               If “Yes”, specify the restriction and provide justification for the restriction(s).


         h.    Will participants be required to discontinue or modify any current medication, or
               be denied any standard of care for any condition, in order to be eligible for
               participation?    Yes       No If yes, please explain



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                                                                                                                                  Page 5
      i.     Will the study enroll vulnerable subjects?      Yes       No.
             Check all that apply:

                    Minors (<18)               Pregnant women           Fetuses                Prisoners
                Upstate employees/staff/students*    impaired decisional capacity           mentally compromised

             *(see administrative policy R08 Guidelines for Obtaining Research Support from University Hospital for additional
             UH requirements).

             1. List additional safeguards that have been included in the study to protect the rights and welfare of vulnerable
             subjects. For studies including minors, describe the plan for obtaining assent, if applicable. This section must be
             completed if any of the above boxes have been checked.


             2. If adult subjects with questionable capacity to provide consent will be involved in the research,
             explain the process for determining whether the potential subject has the capacity to provide informed
             consent AND how consent will be obtained if the potential subject is found to lack the capacity to provide
             consent.

      j.     For studies which involve children, will wards of the state or foster children be enrolled?  Yes       No
             If yes,
             1. Include a detailed summary of the plan to obtain permission of parents or guardians for wards of the
             state or foster children.

             2. Include what additional safeguards have been put in place to reduce the possibility of coercion or undue influence to
             participate.

10. BENEFITS AND RISKS

      A. Are there any potential benefits to the individual subject for participating in this study?       Yes           No
      If yes, describe:

      B. Check the types of risks to subjects for participating in this study (potential study related risks):

            None                        Physical                    Psychological               Legal
            Discomfort                  Social                      Privacy                     Other

      Briefly Summarize the potential study related risks to subjects (refer to the consent form for a complete listing)




11. ADDITIONAL COSTS ASSOCIATED WITH THE RESEARCH PROJECT:

           A. List all expenses (e.g., lab/radiology tests, clinic visits, medications, procedures, parking, etc.) not
              associated with usual clinical care, but necessary for the conduct of this research study:

           B. State who will be billed (sponsor, grant, subject and/or subject’s insurance carrier, etc) for each research
              related expense:


12. PAYMENT TO SUBJECTS:

           A. Will subjects be paid for participation?     Yes       No
              If yes, state the amount and schedule of payment (include details for subjects who withdraw early from the study):




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                                                                                                                                    Page 6
13. CONSENT PROCESS:

   A. Are you requesting a waiver of consent [per 45 CFR 46 116(d)]?              No (Go To SECTION B)
                                                                                  Yes (Complete SECTION A ONLY)
          1. Provide a rationale for the waiver of consent:


          2. Answer the following questions (1-4):
              a. Does the research present more than minimal risk to subjects?        Yes      No
              b. Will a waiver adversely affect the rights and welfare of the subjects?     Yes      No
              c. Can this research be practicably carried out without the waiver?       Yes     No
              d. Will subjects be provided with additional pertinent information after participation?   Yes          No

          3. Does this study involve the use of individually identifiable health information (coded or un-coded)?
                Yes       No

             1. If yes, can the study be conducted using a Limited Data Set of Health Information Yes           No
                    http://www.upstate.edu/researchadmin/document/limited_data_set_form.doc

                   a.   If yes, submit a completed Limited data Set Request Form
                   b.   If no, submit a completed Waiver of Authorization Form

             2. If no to question 3, submit a completed De-identification form
                     http://www.upstate.edu/researchadmin/document/de_identification_form.doc

      B. Are you requesting a waiver of documentation of consent* [per 45 CFR 46 117(c)]?          Yes      No (Go to section C)
              * please note: this means that you do plan to obtain consent from subjects but are requesting that the subjects not be
                 required to sign the informed consent form.
         If yes:
              1. Provide a rationale for the waiver of documentation of consent:
              2. Submit the written information to be provided to prospective subjects (this should contain all the required
                   elements of an informed consent form, except for the signature section).
              3. Submit the one most appropriate HIPAA form. [If the study does not involve the use of individually identifiable
                   health information, submit a completed De-identification form. If the study does involve the use of individually
                   identifiable health information, submit a Limited data Set Request Form (if applicable) or a Waiver of
                   Authorization Form.

      C. Will anyone other than the PI, CRA/coordinator or study team members (who are all listed on the application) obtain
         informed consent?     Yes       No     N/A      If yes, list names and positions:

      D. When will the consent interview be conducted in relation to the start of study procedures (including
         screening procedures)? How long will potential subjects have to consider study participation?
             (Note: consent must be obtained prior to any study related procedures including screening. It is
             usually not appropriate to seek consent at the time of a procedure, diagnosis or other stressful
             moment.)



14. MONITORING OF DATA AND SUBJECT SAFETY:

      A. Provide a detailed description of the overall plan to monitor subject safety during the study:

      B. Provide a detailed description of the overall plan to safeguard research data:

      C. Does this study have a formal Data/Safety Monitoring Board (DSMB, DMC) or similar safety committee?
           Yes*        No

          *DSMB reports should be reported to the IRB when received.

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       C. Have arrangements been made for the prompt transmission of pertinent safety information and DSMB reports to the IRB?
             Yes      No      N/A

       D. Will the sponsor, CRO, or other entity audit* the study?           Yes   No

            *audits which document serious non-compliance with a study protocol (including, but not limited to, enrolling
            subjects who do not meet eligibility criteria) must be promptly forwarded to the IRB

15. CONFIDENTIALITY OF DATA:

       A. Will any direct subject identifiers be used?           Yes        No
          (coded information is considered a direct identifier if the code is known to the investigators)

       B. Will any individual from another organization/agency (other than Upstate) have access to identifiable subject
          information?      Yes      No If yes, who:

       C.   Where will consent documents and research data be stored?
            (provide the building named and room number)

       D.   What steps been taken to protect confidentiality?


16. RESEARCH USING HUMAN BIOLOGICAL SAMPLES

       A. Does this study involve saving human biological samples for future research studies?
            Yes*       No *If YES, specific consent document language is required (see template for banking specimens).

       B. Does this study involve Genetic Testing?         Yes          No

                1. If yes, is the genetic variant inherited?     Yes*        No

            *the variant IS inherited, additional consent document language is required (see template for genetic research)

       C. Does this study involve transforming samples into immortalized cell lines?
            Yes (add language to consent form)          No

       D. Are subject-derived biological specimens (fresh human tissue or body fluids) being handled, transported, processed,
          packaged, or shipped by individuals who are not hospital employees (i.e., nurses, clinical pathology laboratory
          personnel)?
             Yes*     No        IBC Approval #

       E. Are subject-derived biological specimens (fresh human tissue or body fluids) being handled (processed, packaged, or
          shipped) in a research laboratory or other setting, other than a licensed Clinical Pathology Laboratory?
             Yes*        No      IBC Approval #

   *If YES to D or E, approval by the Institutional Bio-Safety Committee is required. Call the Biosafety Office at 464-4317
    for an IBC application and instructions or visit the IBC web site at http://www.upstate.edu/researchadmin/ibc/.


17. RESEARCH USING RADIATION

       A. Will normal subjects (i.e., healthy volunteers not being treated or evaluated for an existing or suspected
          medical condition) be exposed to ionizing radiation (e.g., X-rays, gamma rays, radionuclides) in any
          amount?
             Yes*       No

       B. Will patient/subjects (i.e., patients being treated or evaluated for an existing or suspected medical
          condition) be exposed to any type of ionizing radiation in diagnostic procedures, which is not considered
          standard care (not normally used in such treatment or evaluation)?          Yes*       No
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                                                                                                                           Page 8
             Note: this does not apply to therapeutic uses of radiation

             *If YES to A or B: Submit this completed application, consent document and summary of research
             protocol to the Radiation Safety Office (room 636 University Hospital) along with a cover letter which
             includes contact information. (Radiation Safety website: http://www.upstate.edu/researchadmin/rad.php)


18. FINANCIAL CONFLICT OF INTEREST:
    (This section should be reviewed with each study team member.)

    Does the principal investigator or any study team member involved in the study (or in aggregate with his/her spouse,
    dependents or members or his/her household):

    A. Have an equity interest in the entity that sponsors this research or the technology being evaluated that exceeds
     5% ownership interest or a current value of $10,000?       Yes       No

    B. Receive salary, royalty, licensing fees, or other payments from the entity that sponsors this research or the
     technology being evaluated that is expected to exceed $10,000 per year?       Yes       No

    C. Have a license agreement with the University or an external entity that would entitle sharing the current or
     future commercial proceeds of the technology being evaluated?      Yes       No

    If yes to any of the above, please submit detailed information to determine if additional considerations should
    be made.




                            PROCEED TO PART B: PROTOCOL SUMMARY




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                                                                                                                              Page 9
PART B: PROTOCOL SUMMARY

INSTRUCTIONS:
     Use the template provided below. This summary should not be more than 5 pages. Describe the study in a
     manner comprehensible to those outside of your specialty. Use a word processor, expanding each section as
     necessary.

I. STUDY TITLE:

II. BACKGROUND: (This section should be used to provide a rationale for the conduct of the study. Refer to existent or
preliminary studies as necessary. Include generic drug names: class of drug and mechanism of action for any investigational agent).


III. SPECIFIC OBJECTIVES:

IV. STUDY DESIGN: (brief description of study design; i.e., multi-center, prospective, randomized, placebo controlled study)


V. SUBJECT SELECTION: (Include inclusion/exclusion criteria)

VI. STATISTICAL METHODS, DATA ANALYSIS AND INTERPRETATION: (Include the factors considered in
determining an appropriate sample size)
VII. STUDY PROCEDURES: (Do not paste the entire procedures section from the protocol or consent form. Summarize study
procedures chronologically. Distinguish clearly between treatment-related (standard care) and study-related procedures the subject
will undergo).


      * Please Note: If the proposal includes genetic testing, some information about the genetic testing must be included, such as: the
      type of study planned; what genes are the investigators looking for, if known; why the genetic testing is being done (i.e., how it
      is relevant to the overall protocol); and where the work will be done.


VIII. SCHEMATIC DIAGRAM (a diagram of the study design must be included. This may be hand-drawn or
                                        excerpted from a larger protocol.)




                                  COMPLETE APPLICATION CHECKLIST:

PLEASE Attach the applicable items below, in the following order, to expedite the processing of this application:
1.   IRB Application Form (Parts A & B)
2.   Consent/Assent documents, if not requesting a waive of consent or waiver of documentation of consent.
3.   Pharmacy worksheet, for studies involving drugs
4.   An IND Exemption Checklist Form, if requesting an exemption from the IND requirements for Off label drugs use.
5.   A HIPAA Waiver of Authorization Form, if requesting a waiver of consent and authorization.
6.   De-Identification Form, if no individually identifiable health information will be collected or used for the study
7.   Limited Data Set Form, if appropriate.
8.   Individual Investigator Agreement Form, if applicable. This form is for voluntary faculty only, when research is being
     conducted off site. Please see IRB Policies and Guidelines.




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                                                                                                                             Page 10
Don’t forget to SUBMIT:

     (2) Copies of the complete IRB application, with items above attached (1-8, as applicable)
     (1) Copy of the Complete Grant Application, if applicable
     (1) Copy of the Protocol, if applicable
     (1) Copy of the Investigator’s Brochure fro each drug or Report of Prior Investigations for each device, if
         applicable
     (1) Copy of the Volunteer Recruitment Form, if website listing is desired
     (1) Copy of Any Additional Pertinent Material(s).




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