Category Archives: IRB

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 […]

Posted in IRB | Tagged , , , | Comments closed

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 […]

Posted in IRB | Tagged , , | Comments closed

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 […]

Posted in IRB | Tagged , , , , | Comments closed

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 […]

Posted in IRB | Tagged , , , , , | Comments closed

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.

Also posted in Announcements, NCURA, NIH, NSF, OSP | Tagged , , , , | Comments closed

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 […]

Also posted in NIH, OHRP | Tagged , , , , , , | Comments closed

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 […]

Also posted in Announcements, NIH, RAS | Tagged , , , , , , , , | Comments closed

Important News About NIH-Funded Human Subjects Research

NIH Policy for NIH-Funded Human Subjects Research Effective October 1, 2017, all new and ongoing NIH-funded research meeting certain criteria is deemed to be issued a Certificate of Confidentiality (CoC) via a new NIH policy. This policy results from a directive in the 21st Century Cures Act. For more information about the change in policy, please see this notice. Previously, researchers […]

Also posted in Announcements, NIH | Tagged , , , , , , | Comments closed

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 […]

Also posted in Announcements, NCURA, ORA, OSP | Tagged , , , , , | Comments closed

Upcoming Human Research Community Event & Guidance on Data Sharing Certifications

Emory Co-Sponsoring a Human Research Community Forum – Augusta GA, July 18-19, 2017: Convenient human subjects research education! Emory joins Augusta University and DHHS’ Office for Human Research Protection, to host a Research Community Forum called “Navigating a River of Change: Bringing Research Up to Par.” The event takes place in Augusta, GA, July 18-19, […]

Also posted in Announcements, HHS, OHRP | Tagged , , , | Comments closed