Category: IRB
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Effective October 1: IRB Protocol and Consent Template Updates
The IRB has released new protocol and consent templates for biomedical research, available on the IRB website. Additional templates will be updated in the near future. Biomedical Protocol updates include: Clarity around information needed Attestation checkboxes Removal of the checklist DSMP questionnaire now embedded within the protocol Updated DSMP charts Biomedical Consent updates include: More…
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2023 ORA Dragon Service Awards
On April 24, 2023, the Office of Research Administration (ORA) held the fourth ORA Dragon Service Awards. This is part of an ongoing commitment to recognize and celebrate the contributions and achievements of ORA’s staff and members of the Faculty/Research community who demonstrate outstanding partnership with ORA. The winners of this year’s awards were nominated…
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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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IRB November Updates
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…
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IRB Updates
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…
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eIRB Upgrade News (as of 12/23/19)
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,…
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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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eIRB Upgrade News Update (as of 11/15/2019)
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…
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eIRB Update Project: Important Dates and Submission Restrictions
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…