Download - KC IRB Implementation – Phase IV
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The Questionnaire
KC IRB Implementation – Phase IV
___________________________________________Human Research Protections Program
Office of Research ComplianceOffice of Vice President for Research
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Human Research Protections Program
Agenda
• Overview / Scope• Differences in KC IRB• Differences in the process• Differences in the website• Recap
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Human Research Protections Program
Agenda
• Overview / Scope• Differences in KC IRB• Differences in the process• Differences in the website• Recap
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Human Research Protections Program
Overview / Scope
• Questionnaires / Smart Form• Elimination of HSO Forms• Retention of HSO Forms• Considerations for Active Studies
• Revised HSO website• Researcher tool for determining level
of review• Revised policies / procedures / SOP
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Human Research Protections Program
Agenda
• Overview / Scope• Differences in KC IRB• Differences in the process• Differences in the website• Recap
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Human Research Protections Program
Differences in KC IRB
• Questionnaires / Smart Form• Elimination of HSO Forms• Retention of HSO Forms• Considerations for Active Studies
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Human Research Protections Program
Differences in KC IRB• Questionnaires / Smart Form
• Elimination of HSO Forms• SSS• HIPAA & Recruitment Checklist• Vulnerable Populations Request Forms• Request to Defer IRB Review• SSS• Amendment / Renewal forms
• Retention of HSO Forms• Considerations for Active Studies
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Human Research Protections Program
Differences in KC IRB• Questionnaires / Smart Form
• Elimination of HSO Forms• Retention of HSO Forms
• Drug & Biological Products Form / Medical Device Form
• Request form – In-vitro diagnostics• IU-PU-ND Deferral• Non-Human Subjects Research• Non-Research Student Projects• Noncompliance & Prompt Reports
• Considerations for Active Studies
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Human Research Protections Program
Differences in KC IRB• Questionnaires / Smart Form
• Elimination of HSO Forms• Retention of HSO Forms (con’t)
• Consent / Assent• Protocol• Recruitment materials• Etc.
• Considerations for Active Studies
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Human Research Protections Program
Differences in KC IRB• Questionnaires / Smart Form
• Elimination of HSO Forms• Retention of HSO Forms
• Considerations for Active Studies• Amendment and Renewal forms converted to
smart forms• Maintain existing forms (SSS, etc.) and replace
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Human Research Protections Program
Agenda
• Overview / Scope• Differences in KC IRB• Differences in the process• Differences in the website• Recap
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Human Research Protections Program
Differences in the process
• Submission• New studies• Amendments / Renewals
• Pre-review by HSO staff• Provisional Approvals / Tabling• Approvals
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Human Research Protections Program
Differences in the process• Submission
• New studies• Populate questionnaires instead of certain IU IRB forms• Remember to click the update button• Dynamically-populated questionnaire list
• Amendments / Renewals• Pre-review by HSO staff• Provisional Approvals / Tabling• Approvals
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Human Research Protections Program
Differences in the process• Submission
• New studies• Amendments / Renewals
• No amendment or renewal forms – converted to questionnaire• Continue to modify attachments (remember to replace)• Exceptions:
• Amending a new study which was created on/after 7/31• Amending an existing study to add:
• Vulnerable population• VA as a performance site
• Pre-review by HSO staff• Provisional Approvals / Tabling• Approvals
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Human Research Protections Program
Differences in the process• Submission
• New studies• Amendments / Renewals
• Pre-review by HSO staff• Open your Action List Notifications• Review the Subject Line• Includes link to take user directly to Protocol Actions tab• Review Comments / Review Attachments will contain revision
requests
• Provisional Approvals / Tabling• Approvals
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Human Research Protections Program
Differences in the process• Submission
• New studies• Amendments / Renewals
• Pre-review by HSO staff• Provisional Approvals / Tabling
• Notifications to study teams (no more email)• Action List Reminder from OneStart Workflow• Includes link to take user directly to Protocol Actions tab• Review Comments / Review Attachments will contain
provisions
• Submit to IRB once complete• Approvals
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Human Research Protections Program
Differences in the process• Exceptions (no differences):
• Noncompliance / prompt reports: no questionnaire; forms maintained
• Closeouts: no questionnaire or KC IRB process – still email closeout form to: [email protected]
• Non-Human Subjects Research, Non-Research Student Projects: no questionnaires; forms maintained
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Type of notification
Link to tab
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Human Research Protections Program
Differences in the process• Submission
• New studies• Amendments / Renewals
• Pre-review by HSO staff• Provisional Approvals / Tabling• Approvals
• Signatures• Ink versus electronic• New SOP – KC IRB• Deferrals will utilize approval letter versus signed request
form
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Human Research Protections Program
Agenda
• Overview / Scope• Differences in KC IRB• Differences in the process• Differences in the website• Recap
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Human Research Protections Program
Differences in the website
• Redesigned• New tool for determining level of review• KC IRB info embedded into site• Revised SOP document
• General updates to entire document• New SOP – KC IRB
• KC IRB Crosswalk document
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Protocol Decision Tree and E Learning Videos & Training Guides
• http://researchadmin.iu.edu/HumanSubjects/hs_pdt.html
• http://researchadmin.iu.edu/HumanSubjects/hs_elearning.html
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Human Research Protections Program
Agenda
• Overview / Scope• Differences in KC IRB• Differences in the process• Differences in the website• Recap
![Page 24: KC IRB Implementation – Phase IV](https://reader036.vdocuments.site/reader036/viewer/2022062304/56812e07550346895d936f11/html5/thumbnails/24.jpg)
Human Research Protections Program
Recap• Allot additional time for study preparation, especially
for New Studies• Questions investigators will answer are different;
not verbatim transfer from SSS / other documents• Review the new website & update your bookmarks• Review the updated SOP document• Review the updated Training Guides• Satisfy any pending / in-progress submissions• Don’t hesitate to call the HSO!
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Questions?
• Email:
[email protected] • Phone:
274.8289• Web:
www.researchadmin.iu.edu
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