ࡱ> _ Jbjbj h1bh1bKbbRRRfff8zdfc!!!!&+,|,@ccccccc$hfiAc9R,*^&+,,Ac!!< zc///,R!R!c/,c//2Y0"^!Pr} gh-^{[.cc0c[ni-i\^iR^,,/,,,,,AcAc/,,,c,,,,i,,,,,,,,,bB :  IRB Modification Request Form Read the  HYPERLINK "/irb/submissions--post-approval-actions/post-approval-actions/" IRB Modification Request Policy before completing this form. PIs may not initiate any modifications prior to IRB approval unless necessary to eliminate apparent immediate hazards to subjects. All applications must be typed and have original (not typed) signatures. Email scanned, signed PDF or Word doc titled: LASTNAME.ModRequest.DATE to  HYPERLINK "mailto:irb@seattleu.edu" irb@seattleu.edu. Section 1: Investigator Information Principal Investigator (Last name, First)Project TitleIRB Protocol #Review Type (check one) FORMCHECKBOX  Expedited  FORMCHECKBOX  Full Board ReviewEmailDepartmentPhoneSchool or College 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 2: Modifications Overview 1. Check all that apply:  FORMCHECKBOX  Adding key personnel or research assistants FORMCHECKBOX  Removing key personnel or research assistants FORMCHECKBOX  Location changes FORMCHECKBOX  Adding funding source ( Include copy of the grant FORMCHECKBOX  Conflict of interest changes FORMCHECKBOX  Removing a funding source FORMCHECKBOX  Inclusion criteria changes FORMCHECKBOX  Increasing participants ( Number to add:  FORMCHECKBOX  Exclusion criteria changes FORMCHECKBOX  Decreasing participants ( Number to remove:  FORMCHECKBOX  Recruitment Advertisement  FORMCHECKBOX  Study procedures FORMCHECKBOX  Incentives FORMCHECKBOX  Informed consent/assent/parental permission form FORMCHECKBOX  Title change ( New title:  FORMCHECKBOX  Instruments: adding, removing, changing FORMCHECKBOX  Reopening enrollment FORMCHECKBOX  Other Specify:  Section 3: Personnel 1. If adding key personnel (involved in recruitment and/or data collection) list the following information for each person.Name / Title PhoneEmail Office address (if applicable)Qualifications/experience/training Specific role and duties in the protocol>> 2. If adding research assistants who will not be interacting with human subjects, provide the following information. ( Name ( Email ( Qualifications /training ( Specific role and duties in the protocol>> 3. If removing key personnel or research assistants, list their names and titles (if applicable) below and explain the reason for their removal. >> 4. If no other modifications are being requested, skip to Section 6 and attach CITI certificates for each new team member. (If individuals will NOT take CITI training, please explain below.)>> Section 4: Current Enrollment Status 1. If increasing, decreasing, or reopening enrollment, please indicate:Total number of subjects APPROVED for enrollmentTotal number of subjects ENROLLED in the studyApproved AGE RANGE of participants Section 5: Specific Modification Requests Briefly describe anticipated modification(s) and reasons for the request. (Attach any revised instruments, recruitment materials, updated consent form, etc., as separately labeled files, e.g.: LASTNAME.SurveyInstrument.DATE)>> 2. If the modification(s) may affect the risk to participants, explain and include what measures will be taken to minimize these additional risks.>> 3. If this modification(s) may affect the benefit to participants, explain how.>> 4. If this modification may affect current participants willingness to participate in the study (i.e., revised study procedures, change in incentives, etc.), explain below.>> 5. If currently enrolled participants will be informed about the modification changes, indicate how. FORMCHECKBOX Participants will complete a new informed consent/assent/permission form. ( Submit the new informed consent form as a separately labeled file, e.g.: LASTNAME.InformedConsent.DATE FORMCHECKBOX Participants will complete an addendum informed consent/assent/permission form. ( Submit the addendum form for review as a separate, clearly labeled file. Section 6: Investigator Statement of compliance By submitting this form, I certify all information is accurate and this project is being conducted according to federal regulations and ħԴ policies governing human subject research. I understand that I cannot initiate any changes in my protocol before I have received written IRB approval and/or complied with all contingencies made in connection with that approval. 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