Emory IRB Guidance: Resuming In-Person Research Activities

Whether your study was temporarily on hold, or is newly starting up, the below guidance outlines the safety measures required for different kinds of in-person study activities, and if and when IRB modifications are required to resume these activities.

Emory IRB COVID-19 Ramp-Up Guidance

 Addressed in the above Guidance:

• What PPE and other safety measures are needed to resume non-essential in-person research activities?
• How can I request an exception to the guidelines?

Emory Visitor Policy and Required Attestation Form

**NEW in November 2020**

• The latest Emory Visitor Policy requires human participants to sign this Attestation Form when visiting Emory Campus - including Emory Healthcare spaces
• Not required if the research visit is combined with a clinical care visit (same day/same facility)
• Required on the first visit only
• Investigators must keep the forms in their records

Emory IRB Guidance: Managing Research during Covid Pandemic

In this unusual circumstance of a pandemic illness, it may be necessary to urgently modify research study procedures. New protocols may also need prioritized IRB review.

Emory IRB Guidance for Managing Research during Covid-19

Addressed in the above Guidance:

• When and how must the Emory IRB be notified of changes to approved research?
• When may prior Emory IRB approval not be needed?
• How quickly can the IRB review new COVID-19 protocols?
• Will Emory IRB’s review capacity be impacted due to Emory’s closures?
• What are my Informed Consent options (electronic and other)?
• What if we experience a decrease in the workforce?
• What if I need to request an expanded access use for patient treatment?
• Links to additional resources
• Example of a Screening Log

   

NEW 8/23/2020: FDA issues Emergency Use Authorization for Convalescent Plasma

Important: You must provide the FDA-provided "fact sheets" to patients/care givers and medical providers.

Other Relevant Emory IRB Guidance

• Emory Electronic Informed Consent Guidance
• Current LITS approved apps and software for PHI or IIHI sharing (review the guidance as some apps only allow sharing between Emory personnel)
• When is a LITS security review needed? Guidance to help you determine if you need a LITS security review when using a software or app for research.
• Instructions for email encryption at Emory

Other Guidance and Resources

• Emory Office of Research Administration COVID-19 Guidance Page
• Emory University COVID-19 Guidance Page
• 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