Category Archives: ORA

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, IRB, OSP | Tagged | 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 IRB | Tagged | Comments closed

Requests to rely on Central IRBs

July 29, 2016

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 […]

Also posted in IRB | Tagged | Comments closed

NSF Implementation of the Department of Labor’s new FLSA Final Overtime Rule

July 29, 2016

As we have announced previously, the Department of Labor has revised the Fair Labor Standards Act to update rules related to overtime pay. These new rules raise the threshold for requiring overtime pay to $47,476, effective December 1, 2016. These changes may have impact on staff working on federally-funded research grants, including postdoctoral researchers. NIH […]

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

GBP Requires License Renewal by June 30, 2016 for Animal Research Using Controlled Substances and Dangerous Drugs

June 8, 2016

2016 is the renewal year for all persons holding a Researcher Pharmacy registration from the Georgia Board of Pharmacy (GBP Researcher). GBP Researcher registrations expire on June 30 of even numbered years. You must maintain active status of your registration to lawfully possess Dangerous Drugs or Controlled Substances obtained using this registration. Renew prior to […]

Also posted in Announcements, IACUC, ORC | Comments closed

Program Updates from COI: External Investigators Engaged in Emory Sponsored Research

June 7, 2016

External investigators, who are engaged in Emory PHS -sponsored research and are following Emory’s COI policies, must complete the External Investigator Report of Financial Interests in Research Form at: Proposal submission; Annually if said investigator is engaged on the project that particular year; and Within 30 days of learning of a new financial interest related […]

Also posted in COI | Comments closed

Draft Version of the Proposal & Award Policies Procedures Guide (PAPPG) Available for Comments!

June 7, 2016

The National Science Foundation (NSF) has completed an updated draft of its Proposal and Award Policies and Procedures Guide (PAPPG) and posted it for review.  On May 16, 2016, NSF published a notice in the Federal Register announcing the availability of and giving access to a draft of the updated Proposal & Award Policies & […]

Also posted in NSF, OSP | Comments closed

Updated Clinical Trials Consent Template

June 7, 2016

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 […]

Also posted in IRB, OCR, OSP, OTT | Comments closed

Change to RAS Satisfaction Survey Process

June 7, 2016

RAS Central Operations launched faculty satisfaction surveys for pre and post award services provided by their home RAS unit in March of 2014. During the subsequent two years, surveys were distributed monthly and bi-annually for pre and post award activities, respectively. Despite numerous adjustments to the process we continue to experience multiple challenges including: low […]

Also posted in Announcements, RAS | Comments closed

2 CFR Part 200 – Uniform Guidance Online Training is LIVE!

June 7, 2016

The Office of Sponsored Programs is pleased to announce that the online training module for Uniform Guidance, 2 CFR (Code of Federal Regulations) Part 200, is available in Emory’s Learning Management System (ELMS).  The training is designed to explain at a fundamental level the Code of Federal Regulations as they apply to federal awards. The […]

Also posted in Announcements, Compliance, NIH, NSF, OSP | Comments closed