Research Determination

Etheredge, Alisha (CDC/DDNID/NCEH/DEHSP)
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Gieraltowski, Laura (CDC/DDID/NCEZID/DFWED)
Monday, April 20, 2020 1:05 PM
Gieraltowski, Laura (CDC/DDID/NCEZID/DFWED)
FW: Covid seroepi investigation protocol

From: Etheredge, Alisha (CDC/DDNID/NCEH/DEHSP)
Sent: Tuesday, March 24, 2020 8:38 AM
To: Biggs, Holly (CDC/DDID/NCIRD/DVD)
Cc: Tate, Jacqueline E. (CDC/DDID/NCIRD/DVD)
Subject: RE: Covid seroepi investigation protocol
Holly,
Thank you for submitting a research determination request for the project titled, “Investigation of SARS-CoV-2
Seroprevalence and Factors Associated with Seropositivity in a Community Setting”. The purpose of this project is to (1)
determine the extent of infection in communities as determined by overall SARS-CoV-2 seroprevalence; and (2)
determine factors associated with SARS-CoV-2 seropositivity among persons residing in areas with evidence of
community transmission. The extent of transmission in communities will be investigated to inform decisions about
prevention and control strategies and community mitigation interventions in the U.S. response to COVID-19. As this
activity involves the investigation of community transmission by a public health authority to provide timely situational
awareness and priority setting during the course of an event, it is consistent with non-research public health
surveillance. Once the volume of blood that will be collected is determined, I strongly encourage this information be
added to the consent and assent form.
This activity involves a CDC-led and conducted data collection from at least 210 households; therefore, the Paperwork
Reduction Act applies. A GenIC will be prepared and submitted under the Emergency Epidemic Investigations (EEI)
generic clearance (OMB Control No. 0920-1011, expiration date: 01/31/2023) before conducting this activity.
Thanks,
Alisha
Alisha A. Etheredge, MS, MPH
ADS, Human Subjects and PRA
2019 Novel Coronavirus Response
404-797-6726
[email protected]

From: Biggs, Holly (CDC/DDID/NCIRD/DVD)
Sent: Monday, March 23, 2020 4:40 PM
To: Etheredge, Alisha (CDC/DDNID/NCEH/DEHSP)
Cc: Tate, Jacqueline E. (CDC/DDID/NCIRD/DVD)
Subject: RE: Covid seroepi investigation protocol
Hi Alisha,
Thanks so much for your review and feedback. I have accepted all changes and attempted to address the comments in
the attached version. I included one marked up with responses to comments and another clean version.
Thank you,
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Holly
From: Etheredge, Alisha (CDC/DDNID/NCEH/DEHSP)
Sent: Monday, March 23, 2020 1:51 PM
To: Biggs, Holly (CDC/DDID/NCIRD/DVD)
Subject: RE: Covid seroepi investigation protocol
Holly, thanks for the call today. Attached are comments on the submitted protocol.
Thanks,
Alisha
From: Biggs, Holly (CDC/DDID/NCIRD/DVD)
Sent: Monday, March 23, 2020 9:53 AM
To: Etheredge, Alisha (CDC/DDNID/NCEH/DEHSP) ; Tate, Jacqueline E. (CDC/DDID/NCIRD/DVD)

Subject: RE: Covid seroepi investigation protocol
Hi Alisha,
Yes, would be happy to. I am free any time after 1pm.
Thanks,
Holly
From: Etheredge, Alisha (CDC/DDNID/NCEH/DEHSP)
Sent: Monday, March 23, 2020 7:48 AM
To: Tate, Jacqueline E. (CDC/DDID/NCIRD/DVD) ; Biggs, Holly (CDC/DDID/NCIRD/DVD)
Subject: RE: Covid seroepi investigation protocol
Hi Holly and Jackie,
Thank you for submitting a research determination request for the project titled, “Investigation of SARS-CoV-2
Seroprevalence and Factors Associated with Seropositivity in a Community Setting”. Would you happen to have some
time today to discuss this project?
Thanks,
Alisha
From: Tate, Jacqueline E. (CDC/DDID/NCIRD/DVD)
Sent: Friday, March 20, 2020 9:40 PM
To: Etheredge, Alisha (CDC/DDNID/NCEH/DEHSP) ; Biggs, Holly (CDC/DDID/NCIRD/DVD)

Subject: RE: Covid seroepi investigation protocol
How about this one?
Jackie

From: Etheredge, Alisha (CDC/DDNID/NCEH/DEHSP)
Sent: Friday, March 20, 2020 9:37 PM
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To: Biggs, Holly (CDC/DDID/NCIRD/DVD)
Cc: Tate, Jacqueline E. (CDC/DDID/NCIRD/DVD)
Subject: RE: Covid seroepi investigation protocol
That one’s not working either. I tried saving it and then opening but still get the same message about “unreadable
content” and a file error.
From: Biggs, Holly (CDC/DDID/NCIRD/DVD)
Sent: Friday, March 20, 2020 9:29 PM
To: Etheredge, Alisha (CDC/DDNID/NCEH/DEHSP)
Cc: Tate, Jacqueline E. (CDC/DDID/NCIRD/DVD)
Subject: Re: Covid seroepi investigation protocol
Hi Alisha,
I hope this one will open.
Thanks,
Holly
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From: Etheredge, Alisha (CDC/DDNID/NCEH/DEHSP)
Sent: Friday, March 20, 2020 9:12 PM
To: Biggs, Holly (CDC/DDID/NCIRD/DVD)
Cc: Tate, Jacqueline E. (CDC/DDID/NCIRD/DVD)
Subject: RE: Covid seroepi investigation protocol
Hi Holly,
Sure, happy to help! I’m not able to open the file you attached, though. Would you mind resending?
From: Biggs, Holly (CDC/DDID/NCIRD/DVD)
Sent: Friday, March 20, 2020 9:05 PM
To: Etheredge, Alisha (CDC/DDNID/NCEH/DEHSP)
Cc: Tate, Jacqueline E. (CDC/DDID/NCIRD/DVD)
Subject: Re: Covid seroepi investigation protocol
Hi Alisha,
We have developed a COVID-19 seroepi protocol that we would like to submit for HSR and PRA determination
(attached). Can you help with the current process to submit this?
Thank you,
Holly
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From: Etheredge, Alisha (CDC/DDNID/NCEH/DEHSP)
Sent: Friday, March 20, 2020 6:58 PM
To: Vagi, Sara J. (CDC/DDPHSIS/CPR/DEO); Biggs, Holly (CDC/DDID/NCIRD/DVD)
Cc: Tate, Jacqueline E. (CDC/DDID/NCIRD/DVD)
Subject: RE: Covid seroepi investigation protocol
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Hi Sara,
Yes! I’m still handling HSR and PRA determinations for the response. Holly, feel free to reach out!
Thanks,
Alisha
From: Vagi, Sara J. (CDC/DDPHSIS/CPR/DEO)
Sent: Friday, March 20, 2020 5:37 PM
To: Biggs, Holly (CDC/DDID/NCIRD/DVD) ; Etheredge, Alisha (CDC/DDNID/NCEH/DEHSP)

Cc: Tate, Jacqueline E. (CDC/DDID/NCIRD/DVD)
Subject: RE: Covid seroepi investigation protocol

Last I heard, these should go to Alisha Etheredge. I’ve been in the field and lost touch with what’s happening back at the
ranch.
Alisha are you still handling determinations?

Sara
Office Phone: 404-639-0879 | Mobile Phone: 404-772-9348

From: Biggs, Holly (CDC/DDID/NCIRD/DVD)
Sent: Friday, March 20, 2020 2:35 PM
To: Vagi, Sara J. (CDC/DDPHSIS/CPR/DEO)
Cc: Tate, Jacqueline E. (CDC/DDID/NCIRD/DVD)
Subject: Covid seroepi investigation protocol
Hi Sara,
We (Epi Studies and Surveillance Platforms Team/Epi TF) have developed a protocol for a community
seroepidemiological investigation that we would like to submit for HSR and PRA determination. Are you still the right
person to reach out to for human subjects review?
Thank you,
Holly
Holly Biggs, MD, MPH
Medical Epidemiologist
Respiratory Viruses Branch
Division of Viral Diseases
National Center for Immunization and Respiratory Diseases
U.S. Centers for Disease Control and Prevention
Office: 404-639-3989
Email:[email protected]

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