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 Differences in the website Recap Human Research Protections Program

Agenda Overview / Scope Differences in KC IRB Differences in the process Differences in the website Recap 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 Human Research Protections Program

Agenda Overview / Scope Differences in KC IRB Differences in the process Differences in the website Recap Human Research Protections Program

Differences in KC IRB Questionnaires / Smart Form Elimination of HSO Forms Retention of HSO Forms Considerations for Active Studies 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 Amendment / Renewal forms Retention of HSO Forms Considerations for Active Studies 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 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 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 Human Research Protections Program

Agenda Overview / Scope Differences in KC IRB Differences in the process Differences in the website Recap Human Research Protections Program

Differences in the process Submission New studies Amendments / Renewals Pre-review by HSO staff Provisional Approvals / Tabling Approvals 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 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 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 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 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: irb@iu.edu Non-Human Subjects Research, Non-Research Student Projects: no questionnaires; forms maintained Human Research Protections Program

Customize footer: View menu/Header and Footer September 22, 2018 Type of notification Link to tab Customize footer: View menu/Header and Footer September 22, 2018

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 Human Research Protections Program

Agenda Overview / Scope Differences in KC IRB Differences in the process Differences in the website Recap 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 Human Research Protections Program

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 Customize footer: View menu/Header and Footer September 22, 2018

Agenda Overview / Scope Differences in KC IRB Differences in the process Differences in the website Recap 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! Human Research Protections Program

Questions? Email: kcirb@iu.edu Phone: 274.8289 Web: www.researchadmin.iu.edu Customize footer: View menu/Header and Footer September 22, 2018