IRB Email Blast

This page is updated each time a new newsletter is shared by the Emory IRB. Bookmark this webpage to see topics from the latest Emory IRB email blast!

Email blasts are sent to registered users of the Emory eIRB system. If you would like to receive these emails or would like information about a previous email blast, please contact the IRB email inbox.

August 2025

Insight Go Live is August 29^th – What We Need From You for a Smooth Transition

• Study is permanently closed to enrollment
• All research activities are complete including data analysis. (Do not leave studies open to allow for secondary data analysis in the future unless it’s a repository, as those require new IRB submissions.)
• See the closeout instructions at the bottom of our eIRB page level help.

• New trial with competitive enrollment
• New trial with strict sponsor requirement for start up (e.g. NCI)
• Modification with impact on subject safety or welfare
• Also: Any submissions awaiting study team response for more than 60 days will be withdrawn before go-live, and need to be resubmitted in Insight.

(3) RNI’s: Follow the modification timeline unless you risk following outside the 10 business day window.

(4)Does your study start with “IRB000…”?  If yes, please help fill in the gaps. These studies migrated from our old system. If they haven’t been brought up to date, please submit a Mod to add missing information (e.g. full Lay Summary, missing drug/device info, any required smartform fields, update study team members...).

(5)Renew Early to avoid lapses!

• If your study expires before September 30, submit your Continuing Review by July 30 to avoid a lapse.

• Insight automatically confirms CITI certification. If your training is not linked to your Emory ID, there may be issues. Go here to “Log In Through My Institution” at least once before go-live.

(7) XIRB (external IRB) studies

• XIRB studies cannot migrate to Insight until they are fully “Active” in eIRB – including external IRB approval for
  our site.
• So, you would have to submit your XIRB to us study in time to get our local sign-off, and to get external IRB
  approval, by August 25.
• Given the late date, most studies will likely need to wait until Insight goes live before submitting for local review
  and sign-off.

You can keep informed about the Insight project across all of Research Administration on the Insight SharePoint page.

Insight Transition: What Comes After Go-Live?

• Please take the required training in Brainier before using Insight. It will make your experience much better.
  • Your assigned trainings will show up automatically in the "Assigned" tab under My Learning
  • Your access may be revoked after a certain grace period, until you complete the training.
• Insight's “Humans” module relies more on forms questions, and less on attachments. Some types of
  submissions will no longer even need a protocol attachment. The forms questions should help the IRB get exactly the information we need, with less back and forth.
  • For existing studies migrating into Insight: We are transferring as much data as we can, but
    you‘ll need to complete many new form questions when you submit your first Amendment. We will
    provide guidance.
  • Even if you don’t need to do an Amendment any time soon, please submit one at your earliest convenience to get the new questions filled in.
• PI's will need to sign off on all submissions, including Amendments, Continuing Reviews, and resubmissions. There is not (yet) a "PI Proxy" option in Insight, but they may include that in a future release.
• You may see different Funding information in migrated studies, since we will get data directly from Compass.
• Also, you will not see past Amendments, Continuing Reviews, or RNI's in Insight, at least initially. eIRB will still be available for a few months, after which there will be an archive for any records that are not placed into the Insight study record.
• The External IRB workflow is now called "Cede Review" and will be a bit different than in eIRB. Be sure to review our training and guidance as it becomes available.
• IRB Submission Numbers will not be created until studies are submitted to the IRB (not right when the
  submission is created). Other Emory stakeholders are aware of this, and all are preparing workarounds.
• There will be a support ticketing system along with a place to provide feedback on the new system - so don't hesitate to use it!

Seeking Clinicians to Join Emory IRB: Shape Ethical Research

Join Emory IRB: Shape Ethical Research

It is our mission to

• Safeguard and promote the dignity and well-being of participants in research by assuring their rights, safety and welfare are protected, and
• Provide timely and high-quality review and monitoring of human subjects research.

What does being an IRB member involve?

• Attend one Zoom committee meeting each month, between 4:00 – 6:00 p.m.
• Complete 1-5 reviews of new studies, amendments, and/or continuing reviews, which have been pre-screened by expert IRB staff
• Apply your medical expertise
• Ensure that the studies meet the IRB Approval Criteria under the Federal Regulations (OHRP, FDA, DOJ, etc)
• Overall time monthly commitment: 4-6 hours

These are our greatest needs currently, but we welcome all:

Would you like more information?

• IRB Assistant Director, Carol Corkran, MPH, CIP: ccorkra@emory.edu  or 404-712-8545
• https://irb.emory.edu/member/index.html