IUPUI Institutional Biosafety Committee - Get as DOC by X8ee493

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									                                  INDIANA UNIVERSITY INSTITUTIONAL REVIEW BOARD (IRB)
                                                  CONTINUING REVIEW
                                                   DATA ANALYSIS ONLY
Reviewing IRB (please choose one):                                                                   IRB STUDY NUMBER:
Biomedical:        IRB-02     IRB-03         IRB-04       IRB-05
Behavioral:        IRB-01     IUB IRB

Please type only in the gray boxes. To mark a box as checked, double-click the box, select “checked”, and click “OK”. Please see
the Continuing Review/Closeout Form Instructions for more information.
                                            SECTION I: INVESTIGATOR INFORMATION
Principal Investigator:
Name (Last, First, Middle Initial):
Department:                              Phone:               E-Mail:

Additional Study Contact:
Name:                                    Phone:               E-Mail:

Project Title:
Sponsor/Funding Agency:                  Sponsor Number.

                                                  SECTION II: CURRENT STUDY STATUS
    ONGOING – CLOSED TO ENROLLMENT; DATA ANALYSIS ONLY
    Participants have completed all research-related intervention or interaction and long-term follow-up has been completed. The
    remaining research activities are limited only to data analysis that may require access to records and/or specimens.

No changes have been to the IRB-approved documents since the last review. All information provided to the IRB at last continuing
review is still relevant and correct and no information has changed.
        Yes. No additional information is necessary. Please submit only this form for review.
         No. Please complete the Continuing Review – Closed to Enrollment form and submit all relevant continuing review
         documents.


                                      SECTION VIII: INVESTIGATOR STATEMENT OF COMPLIANCE
By submitting this form, the Principal Investigator assures that all information provided is accurate. He/she assures that procedures
performed under this project will be conducted in strict accordance with federal regulations and Indiana University policies and
procedures that govern research involving human subjects. He/she acknowledges that he/she has the resources required to conduct
research in a way that will protect the rights and welfare of participants, and that he/she will employ sound study design which
minimizes risks to subjects. He/she agrees to submit any change to the project (e.g. change in principal investigator, research
methodology, subject recruitment procedures, etc.) to the Board in the form of an amendment for IRB approval prior to
implementation.
                                                      SECTION IX: IRB APPROVAL
                                                 For IU Human Subjects Office Use Only

Type of review:                Full Board
                               Expedited: Category:

STATUS OF STUDY: ONGOING, Closed to Enrollment

This continuing review has been reviewed and approved as meeting the criteria for IRB approval as outlined in 45 CFR 46.111(a) by
the Indiana University IRB. Based on the criteria for determining the frequency of continuing review and the level of risk, this study
will expire on:___________________. If the study is not re-approved prior to that date all research activities must cease on that date,
including enrollment of new subjects, intervention/interaction with current participants, and analysis of identified data.


Authorized IRB Signature:                                                                    IRB Approval Date:

Printed Name of IRB Member:




      For IU Human Subjects Office use only.

 Recorded in the Minutes of:




                                                                     2                                                IRB Form v02/01/2012

								
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