Research Determination

Attachment 33 - Non-research determination.pdf

Emerging Infections Program

Research Determination

OMB: 0920-0978

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Samuel, Lee (CDC/DDID/NCEZID/OD)
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Samuel, Lee (CDC/DDID/NCEZID/OD)
Tuesday, January 29, 2019 10:38 AM
Samuel, Lee (CDC/DDID/NCEZID/OD)
Human subjects for EIP

From: Youngblood, Laura (CDC/DDID/NCEZID/OD) 
Sent: Tuesday, January 29, 2019 10:15 AM
To: Nti-Berko, Sonja Mali (CDC/DDID/NCEZID/DPEI) ; Samuel, Lee (CDC/DDID/NCEZID/OD)

Subject: RE: Privacy Impact Assessment for EIP - Follow-up
Dear Sonja,
I am writing to confirm that the core EIP surveillance projects – Active Bacterial Core Surveillance, FoodNet, flu, and
healthcare associated infections – are non-research.
As you know, many discrete projects are funded through EIP using the EIP surveillance platform – some of which are
research, and some of which are not. Every fall, I review the entire application for each state to identify all of the
projects that are proposed to be funded in that cycle, confirm that they have either a non-research determination, or
that they have IRB approval. Anything that is to be funded and that does not have a determination or IRB approval is
noted on the human subjects tracking form as requiring a restriction on the funding.
All of the major project areas include both research and non-research activities, but I can at least confirm that the
underlying surveillance programs for each project area – ABCs, FoodNet, flu, and HAIC are not research. Most predate
our current documentation processes by QUITE a long time, so we do not have formal determinations for them – but
they are long-standing and well-established surveillance systems that are widely recognized as being non-research, and I
personally review them on an annual basis as part of the funding renewal.
Thank you,
Laura
Laura Youngblood, MPH, CIP
Human Subjects Advisor | NCEZID | [email protected] | Office: (404) 639-6394 | Mobile: (404) 510-0093

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