COVID-19

All of Emory's Covid-19-related guidance can be found at Emory Forward

• The Emory IRB expects that all researchers comply with the Emory guidance when conducting research on campus.
• When interacting with research participants off-campus, researchers must follow current CDC guidelines. For international sites, follow the local public health guidelines
• Emory Forward has links to policies for visitors, travel, mask-wearing, vaccine requirements, and more.

Can my Covid-19 study be fast-tracked?

Emory has a "Rapid Response Trial" process for Covid-19 or other research of public health importance:

• Guidance on how Emory expedites high priority studies of experimental therapeutics
• Rapid Response Team Service Request Form and Submission Instructions (PDF)

Conducting Research Safely in the Covid-19-endemic Era

• Emory Electronic Informed Consent Guidance (PDF)
  • For minimizing in-person contact when not necessary
• Current OIT approved apps and software for PHI or IIHI sharing (broken link)
  • Review the guidance as some apps only allow sharing between Emory personnel
• When is a OIT security review needed? (PDF)
  • Guidance to help you determine if you need a OIT security review when using a software or app for research.
• Instructions for email encryption at Emory

FDA-related Guidance

• Updated FDA Covid Guidance
• FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
  • Contains excellent Q&A on all aspects of trials
• FDA Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency
• FDA Guidance on the Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers
• FDA News Release on Convalescent Plasma - Emergency Use Authorization, including required Fact Sheets for patients and providers
• FDA Guidance on Post-marketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic

Previous guidelines that are no longer applicable:

• An Attestation Form is no longer required from research participants

• Teams are no longer required to complete a screening process beyond what is required by the research site. See Emory Healthcare, Grady, Atlanta VA guidelines as applicable, or those of your research venue.