Category Archives: IRB

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

New eIRB System Coming Q1 2020

July 1, 2019

IRB is actively working with our system vendor, Huron, on updating our current electronic system. Currently, we are actively working on updating templates, guidance and other documents that you will need when we launch the new eIRB system, scheduled for Q1 2020. The development process is intensive – so please bear with our staff as […]

Posted in IRB | Tagged data migration, eIRB, system upgrade, webinar | Comments closed

IRB Recruitment Spotlight

December 21, 2018

Remember, “cold calling” is generally prohibited as a recruitment strategy, even if the IRB approves your review of the Clinical Data Warehouse (e.g.) to find potential subjects. Initial contact must come from a treating provider, unless the patient has authorized contact via Emory Healthcare’s “front door authorization” (see flag in the medical record). Requests for […]

Posted in IRB | Tagged eIRB, IRB, recruitment | Comments closed

The Revised Common Rule is Almost Here!

December 21, 2018

Effective January 21, 2019, human subjects research is subject to revised regulations. *Please note that FDA has not yet harmonized, so parts of the new Rule cannot be applied to FDA-regulated research.* Details are available in our recent webinars here: http://irb.emory.edu/Training/webinars.html. What will you see in eIRB? If you submit, or edit a new submission, after […]

Posted in IRB | Tagged eIRB, FDA, human subjects, IRB, revised common rule | Comments closed

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  The public health emergency due to COVID-19 is causing difficulties in many aspects of our lives. My colleagues and I here at NIH are well aware of the challenges being felt in the research community as institutions are closing, people are being asked to practice social distancing, and resources and attention are justifiably focused on […]
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Category Archives: IRB

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Recent Articles for Emory’s Research Administrator

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