Document Sample
					                                                                                                                           Form 17 CIRB 8/08
                                                                                                              Human Research Protection Office
                                                                                                                                     Box 8089
                                                                                                                                (314) 633-7400
                                                                                                                            Fax (314) 367-3041

                                                     (Cells will expand as needed)

                                                                                             HRPO #:
                                                                                             [ ] New             [ ] Revision/Amendment
                                                                                             [ ] Renewal         [ ] Progress Report
Principal Investigator
(Last, First, Credentials)
(must match the NCI title)
Cooperative Group Name

The PRMC approval stamp is necessary. All cancer research must be approved by the PRMC prior to HRPO submission.

NOTE: Signature of the Department Chairperson is not necessary for revision/amendments.

Signature of Department Chairperson                  Date            Signature of Principal Investigator                        Date
(When the Dept Chairperson is also the PI or an engaged              My signature affirms that a) this research conforms with
collaborator on the study, an alternate must sign as Dept.           WU Assurance of Compliance with HHS/FDA available in
Chairperson.)                                                        the HRPO office), and b) I have read and will comply with
                                                                     the Assurance of Commitment.

_____________________________________________                           My
Please Print Chairperson’s Name                                      Signature of Faculty Sponsor                               Date
My signature affirms that a) a scientific review of this             (Only needed if the PI is student or is not WU, BJH, or SLCH)
research has been conducted, b) confirms that the
researcher has adequate qualifications, resources and
budget to conduct the research c) represents my approval
of the research, and d) I have read and will comply with the
School/Departmental Assurance. List of Departments

                                                      For HRPO Use Only
 Committee #:                                   Date of Approval:                                          HRPO #:

                                      Date Reported to Full Board:
                                                                                                                             PI’s Last Name:

                                                                                                                                        Data Sheet
                                                                                                          Human Research Protection Office
                                                                                                                                 Box 8089
                                                                                                                           (314) 633-7400
                                                                                                                       Fax (314) 367-3041
                                                      INFORMATION SHEET
           (Attach one copy with each Form 1 and Form 7submission. Submit with Form 5 when changing the PI.
 Only fill out this form once and make copies to include with Form 1, Form 7, and Form 5. Cells will expand as needed)

  Principal Investigator*
  (Last, First, Credentials)
  PI’s Employer                        [ ] WU           [ ] BJH            [ ] SLCH
  (“x” appropriately)                  [ ] Other: (All non-WU staff must complete an “Unaffiliated Investigator Agreement.” Please contact the
                                                   HRPO office for more information.)
  Division / Department
  Department Billing #
  PI’s Address
  (For Non- WU Staff)
  PI’s Box #
  PI’s Phone #
  PI’s Fax #
  PI’s Email Address
  Faculty Sponsor*                     Name:                                              Email:
  (if PI is a student or a non-WU
  employee)                            Department:                                        Phone #:
  Administrative Person*
  (Receives copies of the paperwork)
                                       Is this person engaged in the research? [ ] Yes [ ] No
  Box #
  Email Address
  Phone #
  Fax #
  Study Coordinator*                   Name:                                                Phone #:
  (Can answer protocol questions)

* Washington University Employees: Use your complete name as on file with Human Resources (same name as
 on your paycheck).

      CIRB                                                                                                                                2
      Version date: 2/17/09
                                                                                                                                PI’s Last Name:

Study Team Member(s): Each study team member named has reviewed the protocol and has consented to his or her
inclusion. Note that this list should include regulatory coordinators, study coordinators, research nurses, as well as all
clinical or administrative staff and faculty members who meet the definition of engaged study team members, below. This
includes anyone listed on an FDA investigational drug form 1571 or 1572.

Each study team member named has reviewed the protocol and has consented to his or her inclusion.
List all study team members and collaborators, including any listed in study budget.

A. Engaged Study Team Members: An institution or individual becomes "engaged" in human subjects research when the
     institution’s employees or agents, or the individual, (i) intervene or interact with living individuals for research purposes; or (ii)
     obtain individually identifiable private information for research purposes [45 CFR 46.102(d),(f)].

     (Expand table as needed.)
                 Name                    Credentials       Department         Box         Phone
                                                                                                        (if other than WU (e.g. Vanderbilt, Duke, etc.))

B. Study Team Members who are not Engaged but listed on the Grant: The PI attests that all those listed below will not
     interact or intervene with living individuals for research purposes nor will they use or have access to any individually identifiable
     private information.

     (Expand table as needed.)
                 Name                    Credentials       Department         Box         Phone
                                                                                                        (if other than WU (e.g. Vanderbilt, Duke, etc.))

     * Any individuals listed as authors on the project meet the criteria for collaborator per the WU Authorship Policy.
     If the research involves a non-WU collaborator, it is the responsibility of the WU PI to ensure that the collaborator has obtained IRB
     approval from his/her institution.

Is WU acting as the coordinating center for other, non-WU study sites? [ ] No [ ] Yes

a.   If yes, describe the method for management and communication of protocol information (e.g. unanticipated problems, serious
     adverse events, protocol modifications, interim findings).

b.   If yes, it is the responsibility of the WU PI to ensure that all collaborating sites have obtained IRB approval and that procedures are in
     place to ensure that protocol information is managed and disseminated to all participating sites. Complete Form B.

c.    If yes, list the PI/PDs for each site. Engaged collaborators from another University or organization may provide written proof of human
     subject education from another institution in lieu of completing the WU program.
                            Name                          Credentials                               Affiliation

       CIRB                                                                                                                                    3
       Version date: 2/17/09
                                                                                                                   PI’s Last Name:

      1. Does this research involve any of the following:
              a. Biologic (product derived from living organisms and manipulated for re-                            [ ] Yes [ ] No
                 introduction into human research participants, including tissue, cell
                 suspensions, blood banking, allergens and food supplements);
              b. Investigational drug or biologic (including radioactive drug);                                     [ ] Yes [ ] No
              c. An approved drug or biologic being used for an unapproved indication; or                           [ ] Yes [ ] No
              d. A medical device that is not approved by the FDA?                                                  [ ] Yes [ ] No
          If any of the above are answered yes, submit Form C.
          If you are using an investigational drug or biologic agent, or an approved drug or biologic being used
          for an unapproved indication, you must also submit Form 4.

      2. Does this research involve interviews or questionnaires?                                                   [ ] Yes [ ] No
          Provide names of interviews/questionnaires to be administered:

          Are the interviews/questionnaires considered to be standard screening tools?                              [ ] Yes [ ] No
          If yes, these do not need to be submitted to the HRPO.
          All non-standard screening tools must be enclosed with the submission.

          Please check the link interviews/questionnaires to determine whether you need to enclose a
          particular questionnaire with your submission (HRPO has reviewed and filed all standard
          questionnaires on this list - submission with your study is not necessary).

          A Certificate of Confidentiality is required for “U.S.-based” research involving illegal behavior,
          extraordinarily sensitive information, or genetic testing which could put participants at risk.
          Obtain a Certificate of Confidentiality

      3. Will this research uncover any incriminating data (i.e. drug testing, sensitive                            [ ] Yes [ ] No
         questionnaires, etc.)? If yes, a Certificate of Confidentiality may be necessary.
          [ ] Certificate enclosed with this submission              [ ] Certificate application is pending

      4. Is this research covered by a blanket Certificate of Confidentiality?                                      [ ] Yes [ ] No
          If yes, provide expiration date of Certificate:

      5. Check the box(es) below to indicate the performance site(s) for the research:

                               [ ] WU facility (e.g. CCIR)
                               [ ] BJH
                               [ ] SLCH (not including pediatric research unit)
                               [ ] Barnes-Jewish West County Hospital
                               [ ] Barnes-Jewish St. Peters
                               [ ] Metropolitan Psychiatric Center
                               [ ] Progress West
                               [ ] Rehabilitation Institute
                               [ ] Shriners Hospital.
                                      The HRPO serves as the IRB of record for the above sites.
                               [ ] Other. Complete Form B.

      6. Will the participant receive exposure to ionizing radiation from radiation therapy,                        [ ] Yes [ ] No
         diagnostic radiology imaging studies, standard nuclear medicine studies or other
         administration of radioactive drugs that would not occur except for the subject’s
         participation in research protocol? If yes, complete Form P.

      7. Does this research involve the administration of therapeutic radiation doses using                         [ ] Yes [ ] No
         sealed sources that would not be done if the subject were not participating in the research?
          Name of radionuclide:

       CIRB                                                                                                                   4
       Version date: 2/17/09
                                                                                                         PI’s Last Name:

        Simultaneously submit separate application to:      RSC, Box 8053
                                                            (call 362-2988 to obtain application form)
              DATE SUBMITTED:

   8. Does this research involve the deliberate transfer of DNA (or DNA or RNA derived from               [ ] Yes [ ] No
      recombinant DNA) into one or more human subjects as described in the NIH
      Guidelines for Research Involving Recombinant DNA Molecules, Section III-C

       Does this study utilize live, recombinant, and/or attenuated microorganisms for                    [ ] Yes [ ] No
       vaccination of one or more human participants?

       If you responded yes to either of the questions above, this research must be approved by the
       Institutional Biological and Chemical Safety Committee (IBC) prior to HRPO submission.
       Submit application to:  Office of Biological and Chemical Safety, Environmental Health and
                               Safety Office, Box 8229
                               (call 747-0309 or 362-6816 for additional information)
       For guidelines and forms, see
       HRPO review is pending documentation of approval from the Office of Biological and
       Chemical Safety and, if applicable, the NIH Recombinant DNA Advisory Committee (RAC).


   9. Does this research involve administration of an FDA-approved drug that is non-                      [ ] Yes [ ] No
      formulary (i.e., is not normally carried in the pharmacy), or for which use is restricted
      to patients?

       To check if you are using a non-formulary either call 454-8399 or go to
       from a WU server. Login: bjcform, Password: bjclex.

       If yes, obtain prior approval from the Pharmacy and Therapeutics Committee at:

             [ ] Barnes-Jewish Hospital

       For antibiotics at BJH, obtain prior approval from the Antibiotic Utilization Review
       Subcommittee at 362-5372.

                 DATE APPROVED:

       For all other medications at BJH or for questions, including formulary status, contact the
       BJH Drug Information Center at 454-8399.


       [ ] St. Louis Children’s Hospital

       For more information contact the Pharmacy Clinical Manager, Melissa Heigham at 454-

                 DATE APPROVED:

10. Does this study involve the use of human embryonic stem cells for research purposes?                  [ ] Yes [ ] No
   If yes, submit your study to the Embryonic Stem Cell Oversight Committee (ESCRO) prior to HRPO
   review. Complete ESCRO form at

11. Approximate the number of WUMC subjects to be accrued.
   [45 CFR 46.116(b)(6)]
    CIRB                                                                                                            5
    Version date: 2/17/09
                                                                                                         PI’s Last Name:
    (Initial accrual estimates should be realistic. Estimates should include loss due to
    screening or attrition but should not be exaggerated.

12. Does this study involve the use of a placebo? If yes, submit Form S.                                  [ ] Yes [ ] No

13. Will this research take place at Barnes-Jewish West County Hospital (BJWCH)?                          [ ] Yes [ ] No
    If yes, please provide a letter of support from BJWCH. For information, please contact Mary
    Mantese, 314-996-8567.
14. Does the PI* or any individual* involved in the design, conduct, or reporting of the                  [ ] Yes [ ] No
    research have, or anticipate having, any income from or financial interest in: the sponsor
    of the protocol, the supporting organization, or the company that owns/licenses the
    technology being studied?
    If yes, submit Form T and apply to the Disclosure Review Committee.
    A “Conflict of interest exists if an employee’s position or authority may be used to influence or
    make decisions that lead to any form of financial or personal gain for that employee or for his or
    her family which *includes spouse or dependent children.

     CIRB                                                                                                           6
     Version date: 2/17/09
                                                                                                         PI’s Last Name:
B. REVISION/AMENDMENTS ONLY: If you are proposing any revisions to the PI/PD, protocol, questionnaires, and/or the
   consent form see Submission Instructions for Changing the PI/PD, Protocol, Questionnaire, and Consent Form.

      Complete this table or attach a previously prepared itemized summary.

          Proposed changes

    2. Number of participants currently enrolled in the study at this location:

    3. Does the change, in your opinion represent increased risks to participants?                                      [ ] Yes [ ] No

    4. If yes, describe the plan to inform participants currently enrolled.          [ ] N/A

    5. Does this revision or amendment affect the consent document?                                                     [ ] Yes [ ] No

        If yes, briefly describe changes. (Include the revised consent form with changes highlighted in yellow.) If using
        computer generated highlights, please submit both a highlighted copy and a clean copy for stamping)


       1. Accrual Progress

             Prior HRPO Approval is required if additional participants are needed to obtain valid data.
              Total number of participants currently approved by HRPO
              Participants accrued since initial HRPO approval**

             **The number accrued cannot exceed the total number being accrued for the entire study. However,
               HRPO recognizes that the total number accrued at WU may exceed the number stated on the initial

       2. Breakdown of WU Subject Accrual

              Gender          Number Accrued                            Ethnic/Racial              Number Accrued
              Female                                                 African American
              Male                                                   Asian
              Adult                                                  Hispanic/Latino
              Minor                                                  Native American
                                                                     Pacific Islander
              Prisoner                                               Other

              Please provide an explanation if there is a significant disparity in the gender or racial/ethnic numbers of
              participants accrued:

   Instructions: Cumulative annual reports for all unanticipated problems occurring since the initiation of the study should be submitted to
   the HRPO at the time of renewal.

   1. Summary Reports of Unanticipated Problems (Unanticipated problems involving risks to participants or others
      include events that are serious, unanticipated, and reasonably related to the research – this includes, but is not limited
      to, serious adverse events (SAEs). For guidance on unanticipated problems, see OHRP guidance document at, or request a copy from the HRPO staff.)
         CIRB                                                                                                                          7
         Version date: 2/17/09
                                                                                                          PI’s Last Name:

           A. Type of reports submitted (check all that apply):
                   [] No Unanticipated Problems have been reported for this study.
                   [] WU cumulative report from the electronic Notification System and/or Form 6.
                   [] Sponsor’s summary/progress or data monitoring report that includes a summary of unanticipated
                      problems. Required of all studies with a data monitoring committee.
                   [] Recent monitor’s report that includes information about unanticipated problems.
                   [] Other cumulative report that includes a summary of unanticipated problems.
                   [] No report submitted. Please explain. If data monitoring committee has not met, explain how safety is
                      being monitored.

1. Summary of Adverse Events: Adverse events are events that are anticipated and do not increase risks to
   participants. Please provide a summary of all adverse events that occurred since the last HRPO review:

    []     Not applicable (No adverse events were reported during the last approval period.)
    []     Adverse events are consistent with the severity and frequency experienced in comparable non-research
           participant population.
    []     Other (explain below)

2. Have there been any complaints about the research since the last review? Reportable complaints are those that
   indicate previously unforeseen risks or those that cannot be resolved by research staff.
   [] No
   [] Yes (Provide a summary below)

3. Have any protocol exceptions or errors (also known as protocol deviations) occurred during the last approval
   period, including all protocol exceptions pre-approved by the study sponsor? Reportable protocol errors or exceptions
   are those that result in actual or potential harm to a participant, alter the potential for study benefit, or have the
   potential to occur again. (Note: Please do not submit new errors or exceptions with this renewal.
   [] No
   [] Yes (Provide a summary below and report all protocol exceptions or errors electronically)

4. What is the cumulative effect regarding risks to participants due the events submitted?
   [] No increase in risks to participants. No changes needed to the protocol.
   [] Increased risk for participants. No changes have been made to the protocol or consent. Explain.

    [] Increase in risks that have been mitigated by changes to the protocol and/or consent. Describe changes below:

5. Coordinating Center Reports:
   a. Is this a multi-center trial? [] No. [] Yes.
   b. If yes, has the coordinating center issued a multi-center report? [] No. [] Yes. Please attach a copy of the report.

Please include the CIRB-approved consent form, not the Cooperative Group’s model consent form.

Add the following WU elements to the CIRB-approved consent form:

[ ] Standard WU consent form header (i.e. WU logo, PI, name, protocol title) (CIRB header should remain above the WU
[ ] The HRPO standard death risk statement
[ ] WU contact information paragraph
[ ] The cooperative group injury statement should be replaced with the WU language regarding research-related injury
[ ] HRPO signature lines should be inserted
[ ] The HIPAA authorization (including the Siteman statement) should be an addendum to the main consent form with
    HRPO signature lines listed again

         CIRB                                                                                                        8
         Version date: 2/17/09
                                                                                                         PI’s Last Name:

Checklist for submission:
Submit two (2) complete copies for review.
[ ] HRPO Form 17
[ ] HRPO Form 4 and Investigator’s Brochure (if investigational drug is used)
[ ] HRPO HIPAA compliance application
[ ] CIRB application form (download from CIRB website:
[ ] CIRB approved protocol (download from CIRB website:
[ ] CIRB approved consent form with WUMC standard language included

Please note the following CIRB review procedures:

    -     All events following the initial review such as renewals, revision/amendments, data monitoring progress reports
          should be submitted to the PRMC and the HRPO with the CIRB application form for the event and the applicable
          revised CIRB approved documents (i.e. protocol, investigator’s brochure, revised CIRB approved consent form
          including WU standard statements).

    -     Only SAEs that occur at WU must be reported to HRPO on Form 6. It is not necessary to submit non-WU SAEs
          to the HRPO on a Form 6.

For HRPO use only:
[ ] PRMC approval confirmed
[ ] CIRB review documents printed from CIRB website
[ ] CIRB consent form contains required WU language
[ ] Facilitated review by Executive Director or Executive Chair of the HRPO
[ ] Review results reported to Committee
[ ] Notified CIRB of protocol acceptance (if new submission only)

        CIRB                                                                                                        9
        Version date: 2/17/09

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