KC IRB Implementation – Phase IV

The Questionnaire

___________________________________________Human Research Protections Program

Office of Research ComplianceOffice of Vice President for Research

Human Research Protections Program

Agenda

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

Agenda

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

Agenda

Differences in KC IRB

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

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

• 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

• Elimination of HSO Forms• Retention of HSO Forms (con’t)

• Consent / Assent• Protocol• Recruitment materials• Etc.

• Considerations for Active Studies

• 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

Agenda

Differences in the process

• Submission• New studies• Amendments / Renewals

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

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

• 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• 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

• 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 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

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

Type of notification

Link to tab

• Signatures• Ink versus electronic• New SOP – KC IRB• Deferrals will utilize approval letter versus signed request

Agenda

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

• http://researchadmin.iu.edu/HumanSubjects/hs_pdt.html

• http://researchadmin.iu.edu/HumanSubjects/hs_elearning.html

Agenda

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?

• Email:

kcirb@iu.edu • Phone:

274.8289• Web:

www.researchadmin.iu.edu

KC IRB Implementation – Phase IV

Documents

IRB Workshop: Creating an IRB Submission · 2017. 2. 16. · IRB Workshop: Creating an IRB Submission Kim Fowler, CIP Interim Director Mysti Scheuer, IRB Analyst II. ... (1) data

HIPAA, Researchers and the IRB Alan Homans, IRB Chair and Nancy Stalnaker, IRB Administrator

15. 10% of the energy is passed on 9, 000 kc 90 kc 900 kc 9 kc

IRB# 123456789

IRB Proposals

IRB 140 - RobWelding 140/IRB 140T 5 kg 810 mm Orange IRB 140F/IRB 140TF 5 kg 810 mm Foundry Plus Orange Protection IRB 140CR/IRB 140TCR 5 kg 810 mm Clean Room, White

IRB Blueppgrinting Workshop 1 · 30/10/2013 · Questionnaire KC does not provide a summary list of questions that need to be completed with hyperlinks to the

IRB Competition Gear and Equipment Regulations...IRB COMPETITION GEAR AND EQUIPMENT REGULATIONS Inflatable rescue boat (IRB) competition is intended to bring together IRB operators

IRB Member Education The IRB Review Process & Membership Responsibilities

Preparing IRB Submissions for Human Subjects Research · Preparing IRB Submissions for Human Subjects Research Tips for Preparing IRB Protocols IRB Educational Session-Psychological

IRB Inspections

Kuali Coeus Research Management (KCRM) User Guide: Create a … · 2016-03-03 · Kuali Coeus Research Management - User Guide – Update an IRB Protocol. KC 5.2.1 9 . c. Create the

Institutional Review Board (IRB) Policies and …...Approved IRB Committee C, December 10, 2019 I. INTRODUCTION AND IRB OVERVIEW _____ 1 A. IRB RESPONSIBILITIESB. IRBC. APPEAL OF IRB

Social-Behavioral Research IRB Procedures and Operations Kenyon College IRB

IRB 7.2 IRB Member Training

R KC-A60J KC-A50Jsupport.sharp.net.au/downloads/opmanuals/KC-A50_60J_om.pdf · KC-A60J KC-A50J AIR PURIFIER with Humidifying Function OPERATION MANUAL * The number in this technology

Kuali Coeus Implementation: IRB Progress Report · Administrative Correction. ... – Reviewer data ... Institutional Review Board. HRPP. Human Research Protection Program. KC

WQ 127 - S tyx R iv er, ho alw nd P kC B s · ! !! !! !! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !

new Catalog TPLT 2019 new - Thaipollutech · Gun Standard Unit Robot Turn Table IRB 52 IRB 5510 IRB 5400 IRB 5500 ABB IRB 52 6 7 1561 1225 250 Floor, inverted, wall, tilted ABB IRB

Exempt Research Mary Banks BS, BSN IRB Director CRC IRB and BUMC IRB