The Emory IRB received the following message from The Office for Human Research Protections (OHRP) regarding IORG-IRB registration for the FDA and OHRP:

The update/renewal for your institutional review board (IRB) organization (IORG) registration, submitted electronically, has been processed. IORG0000267 represents the overall registration, with each IRB receiving a distinct identification number under the IORG. The following IRB(s) are registered with the Office for Human Research Protections (OHRP):

IRB00000453 Emory U IRB #1 - Behavioral IRB (SHB Cmte) (Expires 9/14/2012)

IRB00000569 Emory U IRB #2 - Biomedical IRB (Cmte A) (Expires 9/14/2012)

IRB00000570 Emory U IRB #3 - Biomedical IRB (Cmte B) (Expires 9/14/2012)

Note:  Emory's Federalwide Assurance (FWA) expiration is 3/7/2011.

This registration is listed on the OHRP website at http://ohrp.cit.nih.gov/search/search.aspx. Funding agencies use this website to verify that an institutional review board (IRB) has an active registration.

If your sponsor requires an official letter, please click here.

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If you need a new eIRB account, you may experience a delay of one or more days.  The PeopleSoft conversion has affected the data feeds used to create new eIRB accounts.  IT personnel are working on the problem and hope to resolve it quickly.  We apologize for the inconvenience and appreciate your patience.

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How are we doing?  Please take a few moments to complete the Emory IRB Satisfaction Survey and let us know. We will use your responses to improve our service to the Emory research community. If you have any questions, please email Sarah Marie Huban (sarahmarie.huban@emory.edu). We appreciate your feedback!

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Quick Links:

• Emory International Website
• CITI Training Programs
  
• Forms and Tools
• IRB Membership Letter
• Meeting Schedule
• U.S. Food and Drug Administration (FDA)
• Office for Human Research Protections (OHRP)
• Noncompliance and Unanticipated Problems Guidance (ver. 8-31-09)

E-IRB WILL BE DOWN every Saturday from 8 PM 'til Sunday at noon starting October 31st. We expect to need these weekend downtimes through the month of November to complete key maintenance. Further, e-IRB WILL BE DOWN WEDNESDAY NOV. 25 from 8:00 PM UNTIL NOON on SATURDAY NOV. 28. Updates to this schedule will be posted here.

We sincerely regret the inconvenience to our eIRB community the outages are causing. Please be assured that these short-term sacrifices are necessary to set the stage with uncluttered new hardware to support enhancements and faster speeds in the long term.

Please let us know if you have any questions at irb@emory.edu. Thank you for your continuing patience and cooperation.

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The Emory IRB is pleased to provide administrative IRB support for Emory as a participating site in the newly launched ResearchMatch project (PI: Arlene Chapman, MD).  For more information, please visit www.researchmatch.org.  At the Emory IRB office, Stephanie deRijke and Carol Corkran are contacts for ResearchMatch questions. 

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Part 11 Compliance

Sponsors often inquire whether the Emory IRB is compliant with the FDA's regulations on electronic signatures at 21 CFR 11 (known as "Part 11 Compliance").  The Emory IRB's electronic system of record is Part 11 compliant, according to the vendor, Click Commerce:  "Click Commerce’s eResearch Portal product meets or exceeds the requirements in 21 CFR Part 11 for “closed” systems by providing manageable name/password administration, strong passwords with rotation options and electronic signature components that are only executable by, and designed to be used only by, specified individuals for specific approval actions."

For more information:

Click Commerce Statement on Part 11

FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures -- Scope and Application (August 2003)

21 CFR 11 Regulations

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New to Emory?  If you are a new investigator at Emory, we encourage you to make an appointment with the IRB to take stock of your studies and prepare a plan for a smooth transfer of your research projects.  For sociobehavioral studies, contact Donna Dent.  For biomedical studies, contact Madeline Peyton.

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A Spanish translated HIPAA authorization form is now available on our forms and tools page.