Non-Research Determination

From: Campbell, Scott (CDC/ONDIEH/NCBDDD)
Sent: Wednesday, December 07, 2016 10:51 AM
To: Bitsko, Rebecca (CDC/ONDIEH/NCBDDD) <dvk2@cdc.gov>
Cc: Campbell, Scott (CDC/ONDIEH/NCBDDD) <sic3@cdc.gov>; Fox, Michael H. (CDC/ONDIEH/NCBDDD) <imv9@cdc.gov>; Bertolli, Jeanne (CDC/ONDIEH/NCBDDD) <jub7@cdc.gov>
Subject: Research Determination 26781: Assessment of Developmental Outcomes in Infants Born with Congenital Zika Infection: An Amendment to Follow-up the Assessment of the association of Zika virus infection and microcephaly

Dear Becky:

The proposed project titled “Assessment of Developmental Outcomes in Infants Born with Congenital Zika Infection: An Amendment to Follow-up the Assessment of the association of Zika virus infection and microcephaly” was reviewed by the NCBDDD Human Subjects Contact and determined to be:

PUBLIC HEALTH PRACTICE: surveillance

The scope of all activities should be limited to public health practice and must not involve research. Since the project is not considered to be research, no further action is required by CDC for human subjects protections in accordance with federal regulation for the protection of human subjects in research. 

RE-REVIEW REQUIRED: The activities of this award should be monitored closely by the CDC project officer to ensure the activities do not involve research.  The CDC project officer should request re-review of the activities periodically by the NCBDDD Human Subjects Contact to ensure the scope of the activities are still considered Public Health Practice.

Please save this email as documentation of the original research determination.

Signed,

Scott

 

Scott Campbell, BSN, MSPH

Health Scientist

Centers for Disease Control and Prevention

National Center for Birth Defects and Developmental Disabilities, Office of the Director

404-498-4026 (office)

404-498-3072 (fax)

sic3@cdc.gov

From: HSR HelpDesk (CDC)
Sent: Wednesday, December 07, 2016 10:41 AM
To: Campbell, Scott (CDC/ONDIEH/NCBDDD) <sic3@cdc.gov>
Subject: HSR Protocol: Assessment of Developmental Outcomes in Infants Born with Congenital Zika Infect

	The HSR IRB Form (PDF) and associated documents you requested are attached to this email.
Research Determination - 0.684
System Number	26781
Funding ID	200-2010-37203/N/A/017 ((Contract))
Project Title	Assessment of Developmental Outcomes in Infants Born with Congenital Zika Infection: An Amendment to Follow-up the Assessment of the association of Zika virus infection and microcephaly
Status	Approved By Center
Division	DHDD
Lead Staff Member	Rebecca Bitsko
Subtype	Initial
Project Type	Public Health Practice
Human Subjects	Unknown Type
Exempt Research	Unknown Type

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