COVID-19 Guidance
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