YALE UNIVERSITY SCHOOL OF MEDICINE by HC12110723176

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									                              YALE UNIVERSITY
                    HUMAN INVESTIGATION COMMITTEE
    Request to Reapprove a Biomedical Research Study Involving Human Subjects
                               100 FR5R (2012-3)

If you have questions about completing this form, contact the HRPP office, 203-785-4688, or
YSMHIC@yale.edu.

HIC Protocol Number:
Title of Research Project:

Principal Investigator:                                Yale Academic Appointment:

Campus Address:

Campus Phone:              Fax:                     Pager:            E-mail:
Protocol Correspondent Name & Address:

Campus Phone:              Fax:           E-mail:
Yale Cancer Center CTO Protocol Correspondent Name & Address (If applicable):

Campus Phone:                    Fax:               E-mail:
Faculty Advisor: (required if PI is a student, resident, fellow or other trainee)

Yale Academic Appointment:
Email:
Campus Phone:
Current Research Team Members and Their Affiliation:
                       Name                                     Affiliation:           NetID
                                                                Yale/Other Institution
                                                                (Identify)

Role:

Role:

Role:

Role:

Role:

Role:

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    Role:

    Role:



    As the Principal Investigator of this research project, I certify the following:
     That the information provided in this application is complete and accurate.
     That I assume full responsibility for the protection of human subjects and the proper conduct of the
        research.
     That subject safety is of paramount concern, and every effort is made to protect subjects’ rights and
        welfare.
     That the research is performed according to ethical principles and in compliance with all federal, state
        and local laws, as well as Yale University policies regarding the protection of human subjects.
     That all members of the research team are kept apprised of the research goals and progress of the study.
     That I will obtain continuing approval from the HIC for this research study and obtain approval for any
        subsequent revisions prior to initiating any revision of the project.
     That I will report to the HIC any unanticipated problems involving risk to participants (including serious
        unanticipated adverse events at least possibly related to the protocol) in accordance with HIC policies.
     I will identify a qualified successor should I cease my role as principal investigator and will facilitate a
        smooth transfer of investigator responsibilities.

    ____________________________________
    Signature of PI                                            Date
    _________________________                   __________________
    Signature of Faculty Sponsor (if necessary) Print name of Sponsor                          Date

Investigator Interests:
    Does the principal investigator, or do any research personnel who are responsible for the design,
    conduct or reporting of this project or any of their family members (spouse or dependent child)
    have an incentive or interest, financial or otherwise, that may affect the protection of the human
    subjects involved in this project, the scientific objectivity of the research or its integrity? Note: The
    Principal Investigator (Project Director), upon consideration of the individual’s role and degree of
    independence in carrying out the work, will determine who is responsible for the design, conduct,
    or reporting of the research.
    See Disclosures and Management of Personal Interests in Human Research
    http://www.yale.edu/hrpp/policies/index.html#COI
       Yes           No

    Do you or does anyone on the research team who is determined by you to be responsible for the
    design, conduct or reporting of this research have any patent (sole right to make, use or sell an
    invention) or copyright (exclusive rights to an original work) interests related to this research
    protocol?
       Yes           No

    If yes to either question above, list names of the investigator or responsible person:


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        The Yale University Principal Investigator, all Yale University co-investigators, and all Yale
        University individuals who are responsible for the design, conduct or reporting of research must
        have a current financial disclosure form on file with the University’s Conflict of Interest Office.
        Yale New Haven Hospital personnel who are listed as con-investigators on a protocol with a Yale
        University Principal Investigator must also have a current financial disclosure form on file with the
        University’s Conflict of Interest Office. If this has not been done, the individual(s) should follow
        this link to the COI Office Website to complete the form: http://www.yale.edu/coi/

        NOTE: The requirement for maintaining a current disclosure form on file with the University’s
        Conflict of Interest Office extends primarily to Yale University and Yale-New Haven Hospital
        personnel. Whether or not they are required to maintain a disclosure form with the
        University’s Conflict of Interest Office, all investigators and individuals deemed otherwise
        responsible by the PI who are listed on the protocol are required to disclose to the PI any
        interests that are specific to this protocol.


        1. Is this study designed to specifically recruit any of the following (Choose all that apply):

          Children                                                     Healthy Controls
          Decisionally impaired                                        Non-English Speaking
          Economically Disadvantaged                                   Employees
          Females of childbearing potential                            Pregnant women
          Fetal material, placenta, or dead fetus                      Prisoners
                                                                       Students

         2. Funding Source: Indicate ALL of the CURRENT and ACTIVE funding source(s) for this study.
Check all boxes that apply.
         Has the funding source changed since this HIC application was last renewed? Yes      No

        PI              Title of Grant        Name of Funding           Funding                Funding Mechanism
                                              Source
                                                                            Federal              Grant-M#
                                                                            State                Grant #
                                                                            Non Profit         Award Expiration:
                                                                            Industry             Contract#
                                                                            Other For Profit
                                                                                                 Contract Pending
                                                                            Other
                                                                                                    Investigator/Department
                                                                                               Initiated
                                                                                                   Sponsor Initiated
                                                                                                   Other, Specify:

                                                                            Federal              Grant-M#
                                                                            State                Grant #
                                                                            Non Profit         Award Expiration:
                                                                            Industry             Contract#
                                                                            Other For Profit
                                                                                                 Contract Pending
                                                                            Other
                                                          3
                                                                                              Investigator/Department
                                                                                         Initiated
                                                                                             Sponsor Initiated
                                                                                             Other, Specify:

                                                                      Federal              Grant-M#
                                                                      State                Grant #
                                                                      Non Profit         Award Expiration:
                                                                      Industry             Contract#
                                                                      Other For Profit
                                                                                           Contract Pending
                                                                      Other
                                                                                              Investigator/Department
                                                                                         Initiated
                                                                                             Sponsor Initiated
                                                                                             Other, Specify:



3. Location[s] of the study: Please identify the hospital, in-patient or outpatient facility, school or
       other agency that will serve as the location of the research. Choose all that apply:

   APT Foundation, Inc.                                    Keck Laboratories
   Cancer Data Repository/Tumor Registry                   Magnetic Resonance Research Center
   Church Street Research Unit (CSRU)                   (MR-TAC)
   Clinical Neuroscience Research Unit (CNRU)              Yale Cancer Center/Smilow
   Connecticut Mental Health Center                        Yale Cancer Center/Clinical Trials Office
   Department of Veterans Affairs, West Haven*           (CTO)

   Haskins Laboratories                                    Yale-New Haven Hospital
   Hospital Research Unit (HRU)                            Yale University PET Center
   John B. Pierce Laboratory, Inc.                         Yale-New Haven Hospital-Saint Raphael
                                                        Campus

   International Research Site (Specify location(s)):

   Other locations, Specify:

*Note: Studies that include the West Haven VA must have the approval of the WHVA IRB
(VA-HSS)


4. Protocol History

   a. When was this HIC application first approved?

   b. When was approval for this HIC application last renewed?

   c. Is the study in data analysis ONLY? Yes           No


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Note: If the study is in data analysis only and all of the data being analyzed is de-identified, submit
a Request to Close form, and not a renewal application.


5. Lapse in IRB approval

Has IRB approval of the study lapsed (expired) since the last annual renewal?
  Yes      No

 If yes, explain why IRB approval was not achieved in time to ensure continuous approval of the
protocol.



       If yes, during this lapse period have any subjects been
                 Recruited Yes       No      Number of subjects: ___
                Enrolled Yes       No       Number of subjects: ___
                Seen for study interventions (e.g, administering drugs, performing surgery,
                counseling) Yes        No       Number of subjects: ___
                Seen for research interaction, (e.g., collecting urine or blood, conducting an MRI,
                conducting interviews, asking for informed consent to use medical records)
                Yes       No       Number of subjects: ___
       Seen for follow-up or treatment Yes           No       Number of subjects: ___During this lapse
       period has there been any
                Collection of data Yes       No
                Data analysis Yes       No
                Sharing of Data Yes        No
                Other (Describe):



       What corrective actions are planned to prevent this type of deviation from occurring in the
       future?
       .


It is a violation of federal regulation and University policy to continue to conduct research
activities once IRB approval for a study has lapsed unless permission is granted by the Yale
IRB to continue research interventions. Such permission will be granted by the IRB when
discontinuing the research interventions may jeopardize the health or welfare of a
participant.

Contact the Yale HRPP office immediately if permission is required to continue research
interventions on a study participant.

Under no circumstances can federal funds be expended on research and research-related
activities during a lapse period. If this study is federally funded, you must immediately

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contact your Grant and Contract Administration (GCA) and Grants and Contract Financial
Administration (GCFA) representatives for more information.

   6. What is the purpose of this research project?

   7. Medical Record Reviews: for studies that are exclusively retrospective medical record
   reviews:
          1. How many records have been reviewed since the last approval/reapproval?__
          2. How many records have been reviewed since the beginning of the study? ___
          3. Are records still being reviewed? Yes         No
          4. Has the use and/or distribution of protected health information been consistent with
          the use and distribution noted in the current HIPAA Research Authorization form that
          was reviewed and acknowledged by the HIC and/or the HIPAA Waiver that was
          approved by the HIC? Yes          No      If no, attach two copies of an appropriately
          revised Research Authorization Form and the Medical Record Review form and explain
          why the use and/or distribution differs from the original plan.

   8. Repositories: For studies that involve or include a repository for biological specimens and/or
                      data:
          a. How many specimens and/or individual data sets have been collected since the
              beginning of the study? _____
          b. How many specimens and/or individual data sets have been collected since the last
              re-approval? _____
          c. Are specimens and/or individual data sets still being collected? Yes        No


9. Progress of the study to date: Please explain the study progress since the last full approval
                      (initial or annual).


10. Publications/ Dissemination: Please list any publications (published or in press) derived from
this study in the past year as well as any informal dissemination of results that have been conducted
in the past year or are planned in the coming year, beyond the published peer-reviewed scientific
literature process. (e.g., newsletters, presentations at professional meetings, universities, or in
community settings)

11. Enrollment: What is the targeted enrollment (HIC approved number needed to complete the
research) for this protocol? _____

       a. From the beginning of the study to date:
             i. How many subjects have consented to participate? _____
             ii. How many subjects completed the study, including all research interventions and
                     follow up? ____
             iii. How many subjects dropped out or were lost to follow-up? ______

       b. Since the last HIC annual renewal
              i. How many subjects consented to participate _________

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               ii. Number found to be ineligible ____
               iii. Number who became active study participants ___
               iv. Number who were excluded because of non-compliance ___
               v. Number who withdrew ___
                       State reasons for withdrawal, if known:
               vi. Number who were lost to follow up ____
               vii. Number who completed all interventions and follow-up ___

       c. Subject Enrollment: Has subject enrollment progressed as planned? Yes            No
       If no, please explain why and whether this will impact the ability to complete this study.

               i.     Is the accrual to date sufficient to meet targeted enrollment? Yes      No

               ii.    Will the targeted enrollment be possible to achieve within the stated
                      study duration? Yes      No

               iii.   Is a change to the number of subjects to be enrolled requested?
                      Yes       No
                      If yes, attach amendment request form with rationale.


12. Study Status: Please characterize the status of the study by checking each item that is
applicable and answering the questions below:

           a. Are subjects still being enrolled? Yes    No        If No what is the date enrollment
           stopped? (MM/DD/YY)

           b. For currently enrolled subjects:

               i. How many remain on study intervention? _____

               ii. Are all subjects in long term follow-up ONLY?

               Yes      No     If yes, what does it consist of?


13. Study Extension: Is an extension to the expected duration of the study requested?
       Yes    No       If yes, attach amendment request form with rationale.


14. Serious Adverse Events: Please account for only those events that are possibly, probably, or
definitely related to the study.
            a. In the past year, how many serious and unanticipated adverse events have occurred
                at Yale? _____
            b. If the Yale Principal Investigator is the study chair for a multi-center study, how
                many serious and unanticipated adverse events have occurred at all participating
                sites? _____


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           c. Were each of these events reported to the HIC and other organizations as
              appropriate? Yes       No
           d. Are there any updates to previously reported adverse events that should be reported
              to the HIC? Yes         No

15. Unanticipated Problems: Examples of unanticipated problems include, breach, or the potential
for breach, of confidentiality due to loss of laptop, CD or study files.

           a. In the past year, how many unanticipated problems have occurred at Yale? _____

          b. If the Yale Principal Investigator is the study chair for a multi-center study, how
       many unanticipated problems have occurred at all participating sites? _____

16. Frequency/Magnitude: Is the frequency and/or magnitude of expected side effects different
from what was anticipated? Yes     No     If yes, please explain:


17. Complaints: Have there been any complaints from subjects relating to the study?
      Yes     No      If yes, describe the complaint(s) and resolution.


18. Protocol Deviations/Noncompliance: In the past year, were there any instances of protocol
deviations/noncompliance that occurred at Yale? Yes       No
           a. In the past year, how many protocol deviations/noncompliance problems have
           occurred at Yale? _____
           List all deviations below
           Date                 Brief Description           Date Reported to HIC (If applicable)




           b. Were each of these events reported to the HIC per University policy and other
              organizations as appropriate? Yes       No     N.A
           c. Are there any updates to previously reported protocol deviations/noncompliance that
           should be reported to the HIC? Yes         No       If yes, please summarize.



19. Study Monitoring/Audits: Was this study audited during this last year? Yes        No      If yes,
                    by whom?
                          FDA:
                          External Sponsor:
                          Cooperative Group:
                          HRPP Compliance
                          Other: (Specify)
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   Include the most recent progress report submitted to this protocol’s sponsor, if any.
   Attach a copy of the monitoring or auditing report(s) that identifies a major protocol deviation
   or violation or other issue concerning the rights and/or safety and welfare of research subjects
   (Do not include reports generated by the HRPP Compliance Section).


   If this study operates under an IND and the Principal Investigator serves as the sponsor-
   investigator, submit a copy of the most recent annual IND report submitted to the FDA. The
   IND annual report may suffice as the summary provided that the annual report summarizes the
   research plan, assesses risk to subjects, and addresses the progress of the study to date.



20. Data and Safety Monitoring: Is this study monitored by a Data and Safety Monitoring Board
(DSMB) or a Data and Safety Monitoring Committee (DSMC)? (Do Not Include Site Monitoring
Visits by Sponsors or their CROs.) Yes    No
Were there any summary reports or recommendations issued by the DSMB or DSMC in the past
year? Yes        No
 If yes, attach.

21. Amendment History: Have any protocol amendments been approved in the past year?

       Yes     No       If yes, state dates and purpose of amendment (e.g., August 201X, dose
       modification; September 201X, new investigator added).



22 Risk/Benefit Ratio: Since the last HIC review has anything occurred or is there any new
information which may affect the risk/benefit ratio, either from the literature or from the Principal
Investigator’s findings? Yes    No      If yes, please explain:

23. Other Relevant Information: Please specify
       * any reports from related studies done at Yale or elsewhere,
       * any multi-center trial reports which might have implications, either positive or negative,
       for your research.
       * If applicable, any significant marketing developments, such as approval of marketing in
       any country or withdrawal or suspension from marketing in any country.

       Attach copies of relevant publications or trial reports.

24. Confidentiality/Privacy: Have the methods and procedures used to safeguard the
confidentiality and privacy of subjects and their data as outlined in the approved protocol been
adhered to? Yes        No      If no, please explain the mechanisms that will be implemented to
ensure the proper use and continued protection of these data:



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25. Certificate of Confidentiality: Does this study have Certificate of Confidentiality?
    Yes     No      If yes, what is the expiration date of the Certificate? (MM/DD/YY)




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