News

Learning Opportunity

Developing a mobile app that has application in the health care or wellness sector, and wondering what regulations may apply? Join the Office of Compliance's upcoming presentation: Can I Make an App for That? How FDA, HIPAA and Contracting Affect Medical Mobile Device Apps. Click here for more information.

DEA Announcement Regarding Registration Renewals

DEA has announced that starting January 1, 2017, only one renewal notification will be sent to the registrant. Additionally, renewal applications must be received no later than the current license expiration date. If you allow your license to expire, a new application must be submitted. Late renewal applications will not be accepted by the DEA.

This notice affects both Researchers (renewal form 225a) and Practitioners (renewal form 224a). The notice, “Change in DEA Registration Application Renewal Notification Reminder”, can be viewed at: https://www.deadiversion.usdoj.gov/drugreg/index.html

Emory University Compliance Program Manual

The number of laws, regulations and policies that impact the multitude of activities carried out at Emory University is enormous, and keeping up with these requirements can be challenging.  Although the Office of Compliance and the Internal Audit Division are separate units with distinct operational charges, both units recognize that a strong compliance program demonstrates the commitment of the University and its employees not only to the laws that govern our activities, but also to the ethical principles at the core of the University as an institute of higher education, research, and health care.  Accordingly, the Office of Compliance and the Internal Audit Division have collaborated on creation of the Emory University Compliance Program Manual as a means of providing faculty and staff members with an overview of the University’s compliance program.  
 
This publication provides faculty and staff members with information about some of the major policies and regulatory requirements that govern employee activities and introduces employees to the strong ethical principles that form the basis for Emory’s mission and work.  We hope this publication will serve both as a useful overview for new employees, and a handy reference guide for current faculty and staff.   
 
The manual is available here

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Contact us at compliance@emory.edu or 404-727-2398.

Spotlight

Reporting Concerns Regarding Research Misconduct

Concerns regarding possible Research Misconduct can be reported to Emory’s Research Integrity Officer, Kris West at 404-727-2398 or via the Trust Line.  The Trust Line can accessed by calling 1-888-550-8850 or via the Trust Line Online reporting tool: http://www.mycompliancereport.com/EmoryTrustLineOnline.  For more information on Research Misconduct click here.  Additional information regarding the Trust Line is available here.

Authorship Issues:

Persons with questions regarding authorship issues are urged to consult with Emory Policy 7.30, Policy on Authorship Guidelines and Dispute Resolution and Emory’s Research Integrity Officer Kris West at 404-727-2398.

New International Assessment Questionnaire

Global Services and the Office of Compliance worked together to create an assessment tool to assist the Office of Compliance in identifying activities that require additional assessment under export control and related regulations, and to enable Global Services to provide assistance with the various administrative and business considerations (e.g., HR, travel) that international projects can involve.  More information available here.

Tutorial on Dangerous Drugs in Research

A tutorial on the use of "Dangerous Drugs" in research is available.

Information Resource for FDA Regulated Studies and  Sponsor-Investigator Studies

The Office of Compliance assists investigators, coordinators and the Emory research community by providing education and consultation regarding regulatory requirements, compliance obligations and best practices.  Specific information, forms and templates are available for Sponsor Investigators conducting Device Studies and Drug Studies.