Category Archives: IRB

Important IRB Updates

September 19, 2021

We have updated Data and Safety Monitoring guidance for Investigator-Initiated studies that are more than minimal risk. It is posted here under “DSMP, Site Monitoring, and DSMB Guidance,” under “Related Guidance.” Please note that some high-complexity studies do require external/independent monitoring, so please consult with the IRB, and/or Margaret Huber in the Office of Research […]

Posted in IRB | Tagged data and safety, DSMB, DSMP, grant, guidance, investigator, monitoring, NIH, proposal, Single IRB | Comments closed

IRB November Updates

November 19, 2020

Below are the following updates from IRB as of November 19, 2020: Attestation Forms must now be signed by human research participants visiting Emory campus. See the IRB’s Covid-19 page for the Attestation Form, required per Emory’s human research Visitor Policy. The form includes guidance on when and how to use. Please submit studies and […]

Posted in IRB | Tagged attestation form, Emory Visitor Policy, Emory Winter Recess, IRB, renewals, studies, updates | Comments closed

IRB Updates

August 29, 2020

We updated out COVID-19 guidance to include links to FDA guidance re: acceptable consent methods for participants in isolation. We also made various minor updates throughout. Important updated External IRB guidelines on what to submit to Emory IRB at time of continuing review and after major reportable events. Guidelines to avoid delay when submitting study […]

Posted in IRB | Tagged COVID-19, guidance, IRB, ramp-up | Comments closed

eIRB Upgrade News (as of 12/23/19)

December 23, 2019

An important message from the Emory IRB with Glad Tidings of a Shorter Strategic Slowdown for the eIRB Upgrade! We are very happy to announce that our upcoming strategic submission slowdown, to prepare for the eIRB upgrade, has been reduced from an anticipated three weeks to less than one week! Thank you to Emory LITS, […]

Posted in IRB | Tagged eIRB, submission slowdown, update, upgrade | Comments closed

OHRP Exceptions to Single IRB Review

December 3, 2019

On November 22, 2019, OHRP announced that federally-funded multisite studies with IRB approval before 1/20/20, do not need to move to single IRB review, per the revised Common Rule. OHRP made this announcement after receiving feedback from institutions pointing out that transitioning ongoing studies from local IRBs to a single IRB would result in unnecessary […]

Posted in IRB | Tagged Common Rule, exception, federally funded, IRB, multi-site study, OHRP, research, Single IRB | Comments closed

eIRB Upgrade News Update (as of 11/15/2019)

November 18, 2019

To view the most recent updates as of 12/23/19, please visit the latest article here. eIRB Upgrade Latest Information User Testing ended this week! Thanks to all who volunteered! **IMPORTANT** Upcoming Hiatus on Continuing Reviews** – see below Be Prepared: Strategic Slowdown in Submissions – see below New Protocol Templates Required for Upgraded System – see below **IMPORTANT** Upcoming Hiatus on Continuing […]

Posted in IRB | Tagged continuing reviews, eIRB, protocol templates, submissions, upgrade | Comments closed

eIRB Upgrade News

October 22, 2019

*Click on the image to access the pdf version with hyperlinks.

Posted in IRB | Tagged continuing reviews, eIRB, studies, submissions, upgrade | Comments closed

eIRB Update Project: Important Dates and Submission Restrictions

October 3, 2019

To migrate study data to the upgraded eIRB system, we need to have a strategic submission slowdown, to take place from January 7 to January 31. These dates are subject to change. We will keep you well-informed of any changes! Please read on to learn how the slowdown may affect your studies. New Studies: During […]

Posted in IRB | Tagged amendment, continuing review, eIRB, upgrade, WIRB | Comments closed

New IRB Protocol Templates Required for Upgraded System

October 3, 2019

The use of the new protocol templates is required for all new study submissions in the new system on the go-live date, but we encourage you to start using them now! You can review the new protocol templates on our website. For sponsor created protocols, we will also require a supplement to a sponsor protocol […]

Posted in IRB | Tagged eIRB, protocol template, upgrade | Comments closed

IRB Update- New eIRB System

July 30, 2019

Data/Study Migration is an important part of our System Upgrade project. This is where we move existing study information from the old to the new system. It is important that we can move away from our old system completely as quickly as possible. Data/Study migration is always a challenge, but our approach is designed to minimize […]

Posted in IRB | Tagged data migration, eIRB, IRB, study information | Comments closed

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Category Archives: IRB

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