Tag: 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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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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ORA Office Overview
The Office for Research Administration encompasses many individual offices, each of which retain expertise in different areas of the research process. Your first point of contact will usually be your local RAS representative. They will help you determine which of the other touchpoints are necessary to submit a grant application, conduct a clinical trial, or…
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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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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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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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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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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…