IRB - Viral Shedding Study

Samuel, Lee (CDC/OID/NCEZID)
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Patterson, Jocelyn (CDC/OID/NCHHSTP)
Wednesday, March 16, 2016 11:25 AM
Youngblood, Laura (CDC/OID/NCEZID)
Paz-Bailey, Gabriela (CDC/OID/NCHHSTP); Sharp, Tyler M. (CDC/OID/NCEZID);
Roberson, Lashonda (CDC/OD/OADS); Samuel, Lee (CDC/OID/NCEZID);
NCEZIDHumanStudies (CDC)
RE: 6848 -- final revisions to address documentation of parental permission

Thank you for incorporating these changes. I approve protocol #6848.
From: Youngblood, Laura (CDC/OID/NCEZID)
Sent: Wednesday, March 16, 2016 10:51 AM
To: Patterson, Jocelyn (CDC/OID/NCHHSTP)
Cc: Paz-Bailey, Gabriela (CDC/OID/NCHHSTP) ; Sharp, Tyler M. (CDC/OID/NCEZID) ;
Roberson, Lashonda (CDC/OD/OADS) ; Samuel, Lee (CDC/OID/NCEZID) ;
NCEZIDHumanStudies (CDC)
Subject: 6848 -- final revisions to address documentation of parental permission
Importance: High
Thank you for your flexibility, Jocelyn!
The following revisions have been made:
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Title page and footer: version and date have been updated
Page 22 (Informed consent process): “For all non-emancipated minors 14 and 16 to 20 years old who wish

•

to participate and are not accompanied by their parents, we will request a waiver of documentation
for parental permission…”
Page 22 (Request for waiver of documentation): “…we are requesting to have the parental permission
documentation waived for non-emancipated minors age 16 (legal driving age) to 20 who are not
accompanied by a parent.”

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Page 29, 34 (symptomatic and asymptomatic consent documents): “If parental permission is sought verbally by
telephone, please confirm the following: Participant is a non-emancipated minor age 14 16-20…”

You’ll probably see that these revisions are attributed to me in the tracking; please note that all revisions were discussed
with Dr. Paz-Bailey via telephone, and she authorized me to make these revisions on her behalf. I think we got all of the
references to waiving parental permission, but please let me know if any were missed.
Many thanks,
Laura

Laura Youngblood, MPH, CIP
Human Subjects Advisor | NCEZID | [email protected] | Office: (404) 639-6394 | Mobile: (404) 510-0093

From: Patterson, Jocelyn (CDC/OID/NCHHSTP)
Sent: Wednesday, March 16, 2016 10:09 AM
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To: Youngblood, Laura (CDC/OID/NCEZID)
Cc: Paz-Bailey, Gabriela (CDC/OID/NCHHSTP) ; Sharp, Tyler M. (CDC/OID/NCEZID) ;
Roberson, Lashonda (CDC/OD/OADS)
Subject: RE: 6848 -- interpretation of expedited review category 2
Yes, that would be great. Once I receive those changes I will approve the protocol.
From: Youngblood, Laura (CDC/OID/NCEZID)
Sent: Wednesday, March 16, 2016 10:08 AM
To: Patterson, Jocelyn (CDC/OID/NCHHSTP)
Cc: Paz-Bailey, Gabriela (CDC/OID/NCHHSTP) ; Sharp, Tyler M. (CDC/OID/NCEZID) ;
Roberson, Lashonda (CDC/OD/OADS)
Subject: RE: 6848 -- interpretation of expedited review category 2
Hi Jocelyn,
Thanks for calling me on Monday! I have talked with the investigators, and they have confirmed that for SEDSS, seeking
parental permission via telephone really only comes into play for those who are old enough to drive – and for the most
part, a parent has always been available to give permission, since SEDSS recruitment occurs while the patient is acutely
ill.
The investigators are agreeable to limiting verbal parental permission procedures to only those age 16 and older, as you
and I discussed on Monday.
Do you want the investigators to go ahead and revise the protocol accordingly and send back to you (with track changes,
and copying LaShonda)?
I’m here until 4:30 today, so feel free to call, if needed.
Thanks,
Laura

Laura Youngblood, MPH, CIP
Human Subjects Advisor | NCEZID | [email protected] | Office: (404) 639-6394 | Mobile: (404) 510-0093

From: Patterson, Jocelyn (CDC/OID/NCHHSTP)
Sent: Monday, March 14, 2016 2:34 PM
To: Youngblood, Laura (CDC/OID/NCEZID)
Subject: RE: 6848 -- interpretation of expedited review category 2

Hi Laura - I've completed my initial review of the responses. Overall, everything looks good. I still have some
concerns about number 10. I need to do a little more research into the regulations to make sure I understand. I
will follow up with you tomorrow.

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