ࡱ> z|y G`bjbjޥ 1rǴǴ1%AC"("(r(r(r((((8(R)L({C)\++++-/ 0RBTBTBTBTBTBTB$AEGdxBr(^5-@-^5^5xB"("(++5C:::^5R"(8+r(+RB:^5RB::?XZ(A+U\75VA(>BKC0{C~A(WH6WHPAWHr(AM1k2:733M1M1M1xBxB`9M1M1M1{C^5^5^5^5WHM1M1M1M1M1M1M1M1M1 &:  ӶƵ State University Institutional Review Board (IRB) ӶƵ State University Project Update and Closure Form Application for:  FORMCHECKBOX Continuing Review  FORMCHECKBOX  Project Closure If your research approval expires before the application for Project Update and Closure is processed, you must resubmit your entire protocol for the review and approval process. Adverse events must be reported to the IRB at  HYPERLINK "mailto:msu.irb@murraystate.edu" msu.irb@murraystate.edu immediately following any such occurrence. The principal investigator should complete this application. If the investigator is a student, the students faculty sponsor must approve the application. All research that has been approved by the IRB must be reviewed annually regardless of whether the research was classified as Level 1 or Level 2 or Level 3 until closed by the IRB Coordinator. This form must be submitted for IRB review before the end date of the approval period as stated in the most recent approval letter. Failure to complete the Project Update or Closure form in the stated time frame will result in the closure of the study due to noncompliance and the ӶƵ IRB will no longer accept any responsibility for the research. You must submit this signed form as a pdf document along with a pdf copy of the consent document actually used in this study to  HYPERLINK "mailto:msu.irb@murraystate.edu" msu.irb@murraystate.edu. Principal Investigator(s):  FORMTEXT        FORMCHECKBOX  Undergraduate Student  FORMCHECKBOX  Graduate Student  FORMCHECKBOX  Faculty  FORMCHECKBOX  Other Faculty Sponsor (if P.I is a student):  FORMTEXT       Project Title:  FORMTEXT       Current IRB Protocol Number:  FORMTEXT       Identify Current Status of Research:  FORMCHECKBOX  Ongoing  FORMCHECKBOX  Completed  FORMCHECKBOX  Discontinued Identify the Previous Level of Review of the Research:  FORMCHECKBOX  Level 1  FORMCHECKBOX  Level 2/Expedited  FORMCHECKBOX  Level 3/Full Has data collection been completed?  FORMCHECKBOX  Yes  FORMCHECKBOX  No If yes: a) Total number of subjects:  FORMTEXT       b) If project was Level 2/Expedited or Level 3/Full: What was the minimum number of subjects needed as identified in the original protocol application?  FORMTEXT       c) If the total number of subjects (a) is less than the minimum number needed (c), please explain why the protocol is being closed with fewer than the minimum number of needed subjects.  FORMTEXT       d) Is data totally anonymous with no identifiers attached and no method of determining the identity of the participants?  FORMCHECKBOX  Yes  FORMCHECKBOX  No If yes, you may request that the protocol be closed to further IRB review (see section 7 below). If no: Number of subjects accrued to-date:  FORMTEXT       Number of subjects planned for next twelve months:  FORMTEXT       Has data analysis been completed?  FORMCHECKBOX  Yes  FORMCHECKBOX  No If no: Has data analysis begun?  FORMCHECKBOX  Yes  FORMCHECKBOX  No If no, will analysis begin in the next twelve months?  FORMCHECKBOX  Yes  FORMCHECKBOX  No Provide a short status report on the progress of the research to date or, if the project is complete, provide a brief summary of the results/findings.  FORMTEXT       Attach one copy of the consent form, signed by a research participant, or one copy of the cover letter used in this research. Is the consent form or cover letter identical to the one approved by the IRB?  FORMCHECKBOX  Yes  FORMCHECKBOX  No If no, please provide an explanation of the changes.  FORMTEXT       List any reportable adverse events that have occurred since the previous approval. A detailed report should have been submitted to the IRB promptly following any such occurrence.  FORMTEXT       Provide answers to items 4, 5, and 6 only if your research is ongoing and you are requesting continuing review: Provide a summary of any recent literature, findings, or other relevant information about risks associated with the research.  FORMTEXT       Is the research protocol currently in use identical to that previously approved by the IRB?  FORMCHECKBOX  Yes  FORMCHECKBOX  No If no, attach a new application form. Describe any changes or proposed changes in the study design. If research includes a revised questionnaire or interview, the new questionnaire must be included. Changes to the research design or to the informed consent document(s) must receive IRB approval prior to implementation.  FORMTEXT       Request for Closure of a Continuing Protocol that uses Anonymous Data Only: If your data collection is completed AND your data is non-identifiable/anonymous, you may request that the protocol be closed to further review by the IRB. However, closure of the study means that no additional data may be collected. Should you find that you need to continue data collection, a new protocol will have to be submitted for IRB review and approval before such data collection can begin. SIGNATURES: I confirm the accuracy of this application, and I accept responsibility for the conduct of this activity, the supervision of participants, and maintenance of informed consent documentation as required by the IRB. I confirm that all data collected in this study is anonymous and cannot be identified in any way. I understand that should there be a need to collect additional data, I will have to submit a new protocol to the IRB for review and approval before such data collection can begin. A.___________________________________________________ _______________________ Principal Investigator Date B. Statement of Approval by Faculty Mentor (required for all students): I confirm the accuracy of this application, and I accept responsibility for the conduct of this activity, the supervision of participants, and maintenance of informed consent documentation as required by the IRB. I confirm that all data collected in this study is anonymous and cannot be identified in any way. 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