To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.

Slides:



Advertisements
Similar presentations
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
Advertisements

1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
Introduction to Human Subjects Research at the University of Michigan – Dearborn. Debra Schneider IRB Administrator (313)
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
HRPP Policies & Forms Created/Revised for AAHRPP.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
Central IRBs: Ceding IRB Oversight
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
Continuing Review Presented by: Karen Jeans, PhD, CCRN, CIP Program Analyst, COACH.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
EXPEDITED PROTOCOL REVIEW AN IRB INFOSHORT APRIL 2013.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
THE INSTITUTIONAL REVIEW BOARD. WHAT IS AN IRB? An IRB is committee set up by an institution to review, approve, and regulate research conducted under.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
Reportable Events & Other IRB Updates February 2017
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the slide presentation, click on this button in the lower right hand corner of your screen. The presentation will start after the screen changes.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
Device Review Decision Tree Version Date: 4/28/15 This decision tree to be used for studies involving research on a device ( approved or unapproved)
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
Anca Miron, PhD IRB Chair, UW Oshkosh Kelly Schill, BS, CIP
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
Common Rule.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
Expedited Status Update January 14, 2019
Oct 16th, 2018 January 2019.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
Common rule update: continuing review
Changes to the Common Rule and Single IRB (sIRB)
Common Rule
Research with Human Subjects
Presentation transcript:

To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC

Continuing review Changes under the revised Common Rule (2018) Developed by: U-MIC University of Michigan IRB Collaborative

Continuing review changes Revised Common Rule scheduled to take effect January 19, 2018 continuing review no longer required for most studies that qualify for expedited review no more than minimal risk must meet federal criteria for an expedited review category studies that have completed subject intervention/interaction and in which activity is limited to final analysis of identifiable data and biospecimens accessing follow-up clinical data Developed by: U-MIC

Continuing review changes Existing studies U-M IRBs will evaluate need for continuing review at next amendment/scheduled continuing review for expedited studies that were approved prior to January 19, 2018 full-board studies in which subject intervention/interaction is complete Developed by: U-MIC

New studies Continuing review changes approved via expedited review on or after January 19, 2018 U-M IRB’s expedited reviewer will determine need for continuing review set "Continuing Review (CR) / No Continuing Review (No CR)" flag Most expedited studies will not require continuing review. When requiring continuing review of studies that meet regulatory No CR criteria, IRB should state reasons for requiring continuing review document reasons FDA-regulated or sponsor requires continuing review involves additional regulatory oversight, e.g., conflict of interest (COI) management research conducted internationally / at non-UM sites amendment or incident report reveals findings that require additional oversight investigator has had previous serious noncompliance or a pattern of non-serious noncompliance Developed by: U-MIC

Reminder e-mail Continuing review changes Even when continuing review is not required, study team must submit amendments for study changes report adverse events/ORIOs terminate study once it ends when personal identifiers are removed from data/biospecimens and all codes and keys are destroyed In absence of SCR process automated annual email reminder issued prior to anniversary approval date Developed by: U-MIC

Continuing review changes U-M IRBs may re-evaluate CR/No CR decision depending on type of changes proposed in amendment such as a protocol change that increases risk as outcome of review of adverse events/ORIOs Developed by: U-MIC

Continuing review changes under the revised Common Rule (2018) Developed by: U-MIC

Thank you. Brian Seabolt IRBMED Developed by: U-MIC

Feedback: Privacy Policy Feedback
Do Not Sell My Personal Information
About project: SlidePlayer Terms of Service

© 2025 SlidePlayer.com. Inc. All rights reserved.