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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. Visit our Contact Us page to see who to contact regarding new or on-going studies, or contact us at email@example.com.
Effective June 3, 2010 Emory University has updated its registration with both the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA).
If your sponsor requires an official letter with approval periods, please click here.
Research Match: The Emory IRB is pleased to provide administrative IRB support for Emory as a participating site for the ResearchMatch project (PI: Arlene Chapman, MD). For more information, please visit www.researchmatch.org. At the Emory IRB office, Rebecca Rousselle is available to answer ResearchMatch questions.
How are we doing? Are you a research participant? We want to know about your experiences with research at Emory. Please take a few moments to complete our Research Participant Survey.
Are you a Researcher or have otherwise worked with the IRB recently? 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 Maria Davila. We appreciate your feedback!
ORA Events Calendar
A comprehensive listing of up-coming and past events hosted by the Emory Office of Research Administration
What's New at the Emory IRB...
Consent & HIPAA Authorization Template Updates
- New language regarding known and unknown risks to the mother, fetus, and/or embryo in the case of preganancy while on study.
- Revision of Sensitive Study verbiage noting that reasonable steps will be taken to keep consent/HIPAA documents out of the subject's medical record.
The HIPAA Authorization template has also been updated. The revisions reflect changes to HIPAA that will require consent to disclose PHI for use in any substudies in addition to consent to disclose for the main study.
All of the new documents are linked here, and may also be found on the Forms & Tools page.
New Guidance Document on Using Dietary Supplements
The IRB, in conjunction with other Emory offices overseeing clinical research, is pleased to offer guidance to help investigators determine when the use of dietary supplements may require an IND. This joins an updated guidance document on determining when the use of a drug or device in a study may require an IND or IDE. Both documents are located on the Forms & Tools page, under Drugs & Devices section of the Other Researcher Tools tab.
Leadership Transition at the IRB
There will be a transition in leadership at the IRB office in April 2013. Sarah Putney has accepted a new position as Director of Administrative Compliance with the Emory Internal Audit Division, after serving as IRB Director since November 2007. In her new position, Sarah will be focusing on building Emory's compliance and ethics program in a variety of areas across campus to complement existing programs at Emory in healthcare and research. While we at the IRB are sad to see Sarah go, we are glad that we will continue to have opportunities to work with her.
Vice President for Research Administration David Wynes has appointed IRB Assistant Director Rebecca Rousselle as Interim IRB Director pending a search. After April 12, 2013, please direct IRB inquiries that previously would have been addressed to Sarah to the Emory IRB listserv or to Rebecca Rousselle. Thank you!
eIRB Inbox Issues following upgrade
We apologize for the inadvertent change to researchers' Inbox displays, after this latest change to eIRB. We are working hard on the problem and will let you know when it has been resolved.
In the meantime, please do the following in order to see what items need your immediate attention:
- Go the My Inbox tab.
- The last column should be titled Last State Change. That column lists the date of the most recent major action taken on the study (such as the IRB sending it back to you for changes, or you creating the study).
- Click that column title, and your Inbox will be sorted by that date. Click once more, if necessary, so that the most recent items are displayed first.
- Alternatively, if you want to see only studies that are in Pre-Submission state, use the Filter by line at the top of your Inbox. In the drop-down menu, choose State, and in the text box to the right, enter Pre-Submission.
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