Category Archives: IRB

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

Significant Emory HIPAA Policy Changes: Effective September 1, 2016

August 29, 2016

As previously announced, significant Emory HIPAA policy changes were to be effective pending changes to the HIPAA sections of our electronic IRB submission system. The testing is concluded, and the effective date of the updated HIPAA policy will be September 1, 2016. All studies created on or after this date will fall under the updated […]

Also posted in Announcements, Audit, ORA, OSP | Tagged HIPPA | Comments closed

Changes to Clinical Research Training

July 29, 2016

You may have received a letter from Dr. Jeffrey Lennox, summarizing changes to the required training for researchers working on clinical trials. That training is now partially conducted via CITI, the same site that provides our IRB-required ethics training. However, until further notice, the IRB will still require your proof of completion to be uploaded […]

Also posted in Compliance, OCR | Tagged Fringe, OCR | Comments closed

Eligibility Screening Questions May Require Informed Consent and/or HIPAA Authorization

July 29, 2016

Whether done over the phone, online, or in person, collecting identifiable private information for study screening purposes requires informed consent (and HIPAA authorization, if applicable). This consent/authorization can be much shorter than for the form for the study itself and the IRB can waive the requirement for a signature, if needed. The IRB has a […]

Also posted in ORA | Tagged Screening | Comments closed

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Recent Articles for Emory’s Research Administrator
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- Working Together to Protect the Integrity of NIH-funded Research November 15, 2018
  When research findings are made up from thin air, misrepresented in some way, or blatantly and without credit copied from others, we risk eroding the public’s trust, damaging institutional reputation, harming careers, incurring skepticism, misleading future research, and, arguably most importantly, hurting patients. NIH takes research misconduct seriously. We are being proactive. Continue reading →
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Category Archives: IRB

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Recent Articles for Emory’s Research Administrator

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