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The Questionnaire KC IRB Implementation – Phase IV _____________________________________ ______ Human Research Protections Program Office of Research Compliance Office of Vice President for Research

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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 - PowerPoint PPT Presentation

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Page 1: KC IRB Implementation – Phase IV

The Questionnaire

KC IRB Implementation – Phase IV

___________________________________________Human Research Protections Program

Office of Research ComplianceOffice of Vice President for Research

Page 2: KC IRB Implementation – Phase IV

Human Research Protections Program

Agenda

• Overview / Scope• Differences in KC IRB• Differences in the process• Differences in the website• Recap

Page 3: KC IRB Implementation – Phase IV

Human Research Protections Program

Agenda

• Overview / Scope• Differences in KC IRB• Differences in the process• Differences in the website• Recap

Page 4: KC IRB Implementation – Phase IV

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

Page 5: KC IRB Implementation – Phase IV

Human Research Protections Program

Agenda

• Overview / Scope• Differences in KC IRB• Differences in the process• Differences in the website• Recap

Page 6: KC IRB Implementation – Phase IV

Human Research Protections Program

Differences in KC IRB

• Questionnaires / Smart Form• Elimination of HSO Forms• Retention of HSO Forms• Considerations for Active Studies

Page 7: KC IRB Implementation – Phase IV

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

Page 8: KC IRB Implementation – Phase IV

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

Page 9: KC IRB Implementation – Phase IV

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

Page 10: KC IRB Implementation – Phase IV

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

Page 11: KC IRB Implementation – Phase IV

Human Research Protections Program

Agenda

• Overview / Scope• Differences in KC IRB• Differences in the process• Differences in the website• Recap

Page 12: KC IRB Implementation – Phase IV

Human Research Protections Program

Differences in the process

• Submission• New studies• Amendments / Renewals

• Pre-review by HSO staff• Provisional Approvals / Tabling• Approvals

Page 13: KC IRB Implementation – Phase IV

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

Page 14: KC IRB Implementation – Phase IV

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

Page 15: KC IRB Implementation – Phase IV

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

Page 16: KC IRB Implementation – Phase IV

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

Page 17: KC IRB Implementation – Phase IV

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

mailto:[email protected]
Page 18: KC IRB Implementation – Phase IV

April 19, 2023Customize footer: View menu/Header and Footer

Type of notification

Link to tab

Page 19: KC IRB Implementation – Phase IV

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

Page 20: KC IRB Implementation – Phase IV

Human Research Protections Program

Agenda

• Overview / Scope• Differences in KC IRB• Differences in the process• Differences in the website• Recap

Page 21: KC IRB Implementation – Phase IV

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

Page 22: KC IRB Implementation – Phase IV

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

April 19, 2023Customize footer: View menu/Header and Footer

http://researchadmin.iu.edu/HumanSubjects/hs_pdt.html
http://researchadmin.iu.edu/HumanSubjects/hs_pdt.html
http://researchadmin.iu.edu/HumanSubjects/hs_elearning.html
http://researchadmin.iu.edu/HumanSubjects/hs_elearning.html
Page 23: KC IRB Implementation – Phase IV

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

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!

Page 25: KC IRB Implementation – Phase IV

Questions?

• Email:

[email protected] • Phone:

274.8289• Web:

www.researchadmin.iu.edu

April 19, 2023Customize footer: View menu/Header and Footer

mailto:[email protected]
http://www.researchadmin.iu.edu/

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