ࡱ> k ,qbjbj:: XubXubGQ22"""6668n6^x!!!!(++d:,4;^=^=^=^=^=^=^$ta*da^9"n,*^(+n,n,a^!!< ^...n,R!"!;^.n,;^..V"Y!{UP-jW,'^^0^Wd-BdXYYhd"+Zn,n,.n,n,n,n,n,a^a^.n,n,n,^n,n,n,n,dn,n,n,n,n,n,n,n,n,2B t:  IRB Unanticipated ProblemAdverse Event Report Form Read the  HYPERLINK "/irb/submissions--post-approval-actions/post-approval-actions/" Unanticipated ProblemAdverse Event Policy before completing this form. All applications must be typed and have original (not typed) signatures. Email scanned, signed PDF or Word doc titled: LASTNAME.Unanticipated.DATE to  HYPERLINK "mailto:irb@seattleu.edu" irb@seattleu.edu. Investigator Information Principal Investigator (Last name, First) FORMTEXT      Project TitleIRB Protocol # FORMTEXT      Email FORMTEXT      Department FORMTEXT      Phone FORMTEXT      School or College FORMTEXT       Co-Investigator (if applicable) FORMTEXT      Email FORMTEXT      Phone FORMTEXT       Faculty Advisor (if not the PI) FORMTEXT      Email FORMTEXT      Phone FORMTEXT       Funding Agency (if applicable) FORMTEXT       Section 1: Criteria  Does the event being reported meet the following criteria? 1. An unexpected (in nature, severity, or frequency) incident, experience, or outcome, given the procedures described in the IRB-approved research protocol and informed consent document; and given the characteristics of the research subject population. FORMCHECKBOX  YES FORMCHECKBOX  NO 2. An incident, experience, or outcome related or possibly related to participation in the research. (Possibly related means that a reasonable possibility exists that the incident, experience, or outcome may have been caused by research procedures.) FORMCHECKBOX  YES FORMCHECKBOX  NO 3. An incident, experience, or outcome suggesting that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than previously realized or anticipated. FORMCHECKBOX  YES FORMCHECKBOX  NO  ( If you answered YES to all three criteria, or a Serious Adverse Event has occurred, complete this form and return it to the IRB according to the timeline indicated in the Unexpected ProblemAdverse Event policy. Section 2: Urgency and Problem/Event Description Do you believe this event warrants immediate or urgent attention by the IRB and perhaps others? If yes, provide a detailed description of the unanticipated problem, adverse event, incident, experience, or outcome.>> Section 3: Consent and Participants 1. Is the risk of this unanticipated problem explained in the current consent form? FORMCHECKBOX  YES FORMCHECKBOX  NO 2. Should the consent form or any portion of this study be revised as a result? If Yes please describe modifications in Section 4. FORMCHECKBOX  YES FORMCHECKBOX  NO  3. Will currently enrolled participants be notified of this event? If yes, please describe method of notification.>> Section 4: Corrective Measures Describe any corrective actions that have been taken or are proposed in response to the unanticipated problem. If actions require changes to the protocol or consent form, fill out and attach the Modification Form with corresponding documents. >> Investigator Verification Statement By submitting this form, I certify all information is accurate and this project has been conducted in strict accordance with federal regulations and ħԴ policies governing human subject research. 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