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KC IRB Implementation – Phase IV. The Questionnaire. ___________________________________________ Human Research Protections Program Office of Research Compliance Office of Vice President for Research. Agenda. Overview / Scope Differences in KC IRB Differences in the process

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kc irb implementation phase iv

KC IRB Implementation – Phase IV

The Questionnaire

___________________________________________

Human Research Protections Program

Office of Research Compliance

Office of Vice President for Research

agenda
Agenda
  • Overview / Scope
  • Differences in KC IRB
  • Differences in the process
  • Differences in the website
  • Recap
agenda1
Agenda
  • Overview / Scope
  • Differences in KC IRB
  • Differences in the process
  • Differences in the website
  • Recap
overview scope
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
agenda2
Agenda
  • Overview / Scope
  • Differences in KC IRB
  • Differences in the process
  • Differences in the website
  • Recap
differences in kc irb
Differences in KC IRB
  • Questionnaires / Smart Form
    • Elimination of HSO Forms
    • Retention of HSO Forms
    • Considerations for Active Studies
differences in kc irb1
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
differences in kc irb2
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
differences in kc irb3
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
differences in kc irb4
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
agenda3
Agenda
  • Overview / Scope
  • Differences in KC IRB
  • Differences in the process
  • Differences in the website
  • Recap
differences in the process
Differences in the process
  • Submission
    • New studies
    • Amendments / Renewals
  • Pre-review by HSO staff
  • Provisional Approvals / Tabling
  • Approvals
differences in the process1
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
differences in the process2
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
differences in the process3
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
differences in the process4
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
differences in the process5
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: irb@iu.edu
    • Non-Human Subjects Research, Non-Research Student Projects: no questionnaires; forms maintained
slide18

Type of notification

Link to tab

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differences in the process6
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
agenda4
Agenda
  • Overview / Scope
  • Differences in KC IRB
  • Differences in the process
  • Differences in the website
  • Recap
differences in the website
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
protocol decision tree and e learning videos training guides
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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agenda5
Agenda
  • Overview / Scope
  • Differences in KC IRB
  • Differences in the process
  • Differences in the website
  • Recap
recap
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!
questions
Questions?
  • Email:
    • kcirb@iu.edu
  • Phone:
    • 274.8289
  • Web:
    • www.researchadmin.iu.edu

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