Tag: Single IRB
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Important IRB Updates
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…
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OHRP Exceptions to Single IRB Review
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…
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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…
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Upcoming NCURA Webinars Hosted by OSP
EFFORT REPORTING Thursday, June 1: 2:00-3:30 pm EDT — Room 5C Registration opens April 26 Featuring: Lisa Mosley, Arizona State University; Jeremy Forsberg, The University of Texas at Arlington; David Ngo, The New School; Jayne Goby, University of Illinois at Urbana-Champaign; Linda Gregory, University of Illinois DATA SECURITY Thursday, June 15: 2:00-3:30 pm…
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Requests to rely on Central IRBs
Emory looks at several considerations when deciding if we can cede review to an external IRB. Currently we rely on one commercial IRB – Western IRB or WIRB – for industry-sponsored Phase IIb-IV drug/device studies. We will not rely on any other commercial IRBs. We often enter into study-specific reliance agreements when the relying institution’s…