ࡱ> svr5 bjbjr2r2 4xXhXh  ppp*6****\#b$L$()))))))$,.p)p$:#"\#$$)  **)%%%$. 8*p*)%$)%%k(X(*]Ѱ%.())0*(,(/2%d(/((/p($$%$$$$$))%R$$$*$$$$(/$$$$$$$$$ X : Non-BU Institutional Review Board Submission Summary Form INSTRUCTIONS: Submit this completed form and required supporting documents, in a single email to  HYPERLINK "mailto:irb@bellarmine.edu" \h irb@bellarmine.edu. Submitting in multiple emails may delay the review process. Study MAY NOT be instituted until written approval from the BU IRB is received. Project Title: Principal Investigator:Department:Phone:Email: INVESTIGATOR INFORMATIONRole (PI, Co-PI, Collaborator, etc.)NameEmailDepartment/AffiliationStatus**Please indicate faculty, staff, student graduate (G) or undergraduate (UG), or other (please specify). You may insert additional rows for CoPIs as necessary.The following items must be SUBMITTED with the IRB proposal package for each investigator listed on this application: (1) Resume/curriculum vitae (2) CITI Human Subjects Training Certification ( HYPERLINK "https://about.citiprogram.org/" https://about.citiprogram.org/); expires after three years Sites where the study will be conducted: _____ Estimate the # of subjects to be studied: _____ Dates you plan to collect data: _____ In the box below, briefly describe the portion of your study that will involve live human subjects.  SHAPE \* MERGEFORMAT  RISK ANALYSIS: Consider the following: A Minimal Risk Study is one where the probability and magnitude of harm or discomfort is not greater than that ordinarily encountered in daily life or during performance of routine physical or psychological examinations or tests. Human subjects may be exposed to the following short-term and long-term risks by participation in the study: physical risks; psychological risks; financial risks or legal risks. In your opinion, does the study involve more than Minimal Risk? YES  FORMCHECKBOX  NO  FORMCHECKBOX  If yes, please explain: _____ COERCION AND AT-RISK STUDY POPULATIONS: As a faculty member, the Principal Investigator holds a special trust and may not exert undue influence when recruiting students and university employees as potential research subjects. Full Review by the IRB may or may not be required in this event. Other potential research subjects are considered at-risk, including minors, prisoners, or the cognitively impaired. These individuals may not be entered into studies without prior Full Review by the IRB. Is any potential subject in the proposed study either a student or employee under your supervision at ũ򵼺? YES  FORMCHECKBOX  NO  FORMCHECKBOX  Will any minors be involved in this study (less than 18 years of age)? YES  FORMCHECKBOX  NO  FORMCHECKBOX  Are any of the subjects in the proposed study cognitively impaired? YES  FORMCHECKBOX  NO  FORMCHECKBOX  (If YES to any question above, please explain in detail): _____ Will subjects be paid for their participation in this study? YES  FORMCHECKBOX  NO  FORMCHECKBOX  (If YES, explain the amount to be paid, how the amount will be pro-rated if the subject withdraws before study completion, and/or if there is any other type of compensation for participation, (e.g., coupons, raffles, etc.): _____ Do you intend to publish or present the results of this study? YES  FORMCHECKBOX  NO  FORMCHECKBOX  (If YES, please describe where/when you anticipate publishing or presenting this work): _____ SIGNATURES/REVIEW: Have the approval forms from the non-BU Institutional Review Board been submitted along with this form? YES  FORMCHECKBOX  NO  FORMCHECKBOX  Date of non-BU IRB approval: _____ Name non-BU IRB Institution: _____ Co-Investigator Signature & Date: ______________________________________________ (main person running the study at the non-BU site) PRINCIPAL INVESTIGATOR SIGNATUREBy providing my name in the box below, I certify that I have read, and I understand ũ򵼺s policies and procedures governing human subject research as described in Bellarmine IRB Handbook. I will fully comply with those policies and will not conduct any research activities without IRB approval. I further acknowledge my obligation to: (1) obtain written approval of deviations from the originally approved protocol BEFORE making those deviations; and (2) Immediately report all adverse events of the study to the Chairperson of the Institutional Review Board and the Research Sponsor, if applicable. This study will be conducted in a manner consistent with how it has been represented to the IRB and will follow any alterations in the procedures that may result from the IRB review process. Principal Investigator Signature & Todays DateCITI Training Completion Date DEPARTMENT CHAIR APPROVALDepartment Chairs, through appropriate procedures established within their respective departments, are responsible for reviewing research proposals/protocols for ethical considerations as well as scientific merit. By providing my name in the box below, I, as Chairperson of the PIs department, certify that I have reviewed this study protocol submitted to the IRB.  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