Category Archives: IRB

IRB Recruitment Spotlight

December 21, 2018

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 eIRB, IRB, recruitment | Comments closed

The Revised Common Rule is Almost Here!

December 21, 2018

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 eIRB, FDA, human subjects, IRB, revised common rule | Comments closed

Single IRB Review Reminder

December 21, 2018

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 IRB, NIH, Policy, RFA, Single IRB, sIRB | Comments closed

New Webinars Available in ELMS.

April 6, 2018

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 Award, PCI, proposal, RPPR, Single IRB | Comments closed

Common Rule Delay and Single IRB Requirement for Federally Supported Studies

February 13, 2018

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 Common Rule, eIRB, grant applications, intramural research program, multi-site studies, NIH, Single IRB | Comments closed

NIH ALERT: New NIH Submission Requirements Effective January 25, 2018

January 2, 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 Clinical Trial, ClinicalTrials.gov, FORMS-E, GCP, IRB, NIH, NIH Program Officer, RAS, Single IRB | Comments closed

Important News About NIH-Funded Human Subjects Research

November 1, 2017

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 addendum, Common Rule, Confidentiality, consent, human subjects, ICF, research | Comments closed

Upcoming NCURA Webinars Hosted by OSP

June 1, 2017

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 cost sharing, data security, effort reporting, NCURA, revised common rule, Single IRB | Comments closed

Upcoming Human Research Community Event & Guidance on Data Sharing Certifications

May 1, 2017

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 forum, human research, NIH, research | Comments closed

The Common Rule is Revised – but under temporary moratorium

February 23, 2017

DHHS’s revised “Common Rule” governing human subjects research was finally published, and will become effective January 19, 2018 (except for the single-IRB requirement for cooperative research, which is two years later). However, there is a 60 day moratorium in effect at the moment. For summaries of the very significant changes (including removal of continuing review […]

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

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Recent Articles for Emory’s Research Administrator
New from NIH
- Reminder of Policy Changes January 8, 2019
  For your convenience, here is a roundup of recently announced changes impacting grant application submission for due dates on or after January 25, 2019. Continue reading →
  NIH Staff
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Category Archives: IRB

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Recent Articles for Emory’s Research Administrator

Emails from EHSO