Category: IRB
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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…
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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,…
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The Common Rule is Revised – but under temporary moratorium
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…
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Significant Emory HIPAA Policy Changes: Effective September 1, 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…
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Changes to Clinical Research Training
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…
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Eligibility Screening Questions May Require Informed Consent and/or HIPAA Authorization
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…
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Requests to rely on Central IRBs
Emory looks at several considerations when deciding if we can cede review to an external IRB. Currently we rely on one commercial IRB – Western IRB or WIRB – for industry-sponsored Phase IIb-IV drug/device studies. We will not rely on any other commercial IRBs. We often enter into study-specific reliance agreements when the relying institution’s…
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Updated Clinical Trials Consent Template
The Emory Biomedical, Grady, Children’s Healthcare of Atlanta, and Saint Joseph’s Hospital of Atlanta Consent/HIPAA templates have been updated. The new version date for all documents is 4-15-2016. Changes to the template include: A clarification to the guidance comments regarding medical records, Additional language for Cost Option 1 regarding what subjects may be liable for…
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Emory IRB Membership Drive
Do you wish the IRB could review clinical studies more quickly? Are you frustrated when your study cannot be placed on an earlier meeting? Do you wonder what on earth we do and why we ask for all of those changes? Are you interested in research ethics and how they are applied at Emory? If…
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Imminent Changes to Federal Regulations
The Notice of Proposed Rulemaking (NPRM) for revisions to the Common Rule has been released! The proposed changes to the regulations will have significant impact on the conduct and oversight of human subjects research, if passed. For example, completely deidentified biospecimens may become covered by the Common Rule, and their use in research will require…