Category: IRB
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New IRB Protocol Templates Required for Upgraded System
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…
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IRB Update- New eIRB System
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…
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New eIRB System Coming Q1 2020
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…
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IRB Recruitment Spotlight
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…
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The Revised Common Rule is Almost Here!
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…
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Single IRB Review Reminder
If your NIH RFA will involve collaborating sites, and NIH requires the use of a single IRB (“sIRB”), we remind you to consult with the Emory IRB very early on in the grant-writing process, and to not submit your sIRB plan without our prior review. We also remind you that reliance on an independent IRB is…
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New Webinars Available in ELMS.
In the table below, you will find the Course Name and the Course Code of the recently added webinars. You may register for any of the following in ELMS.
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Common Rule Delay and Single IRB Requirement for Federally Supported Studies
On January 17, 2018, changes to the common rule that were scheduled to be effective on January 19, 2018, were delayed 6 months. The new effective and compliance date is July 19, 2018. This will allow time for the regulatory agencies to develop more guidance around the 2018 Common Rule, and they will also work…
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NIH ALERT: New NIH Submission Requirements Effective January 25, 2018
To all Investigators proposing human subjects research to the NIH, For NIH submissions with due dates on or after January 25, 2018, it is imperative to make an accurate determination of whether your study meets the NIH definition of a clinical trial. The NIH has broadly defined a “clinical trial” resulting in stringent requirements—some are…