IRB Determination

Att. 2 - IRB Determination.pdf

Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery

IRB Determination

OMB: 0920-1071

Document [pdf]
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Samuel, Lee (CDC/OID/NCEZID)
From:
Sent:
To:
Subject:
Attachments:

Chapman, Kristen (CDC/OSTLTS/OD)
Tuesday, May 02, 2017 11:31 AM
Samuel, Lee (CDC/OID/NCEZID); Youngblood, Laura (CDC/OID/NCEZID)
FW: Research Determination 29190: Mosquito Bite Prevention Kits (Puerto Rico) CORRECTED
Service Delivery Fast Track Template_MPK 2017.docx; MPK Feedback Postcard.pdf

Hi Lee and Laura,
The completed clearance form and a copy of the final instrument are attached. The instrument will be a postage-paid
comment card.
Please see research determination information below. Let me know if you need additional information regarding the
determination or the clearance request.
Thanks,
Kristen
From: Campbell, Scott (CDC/ONDIEH/NCBDDD)
Sent: Friday, April 28, 2017 1:01 PM
To: Chapman, Kristen (CDC/OSTLTS/OD) ; Visser, Susanna (CDC/OID/NCEZID) ; Stevens,
Melody (CDC/ONDIEH/NCBDDD) 
Cc: Johnson-James, Treana (CDC/ONDIEH/NCBDDD) ; Campbell, Scott (CDC/ONDIEH/NCBDDD)

Subject: RE: Research Determination 29190: Mosquito Bite Prevention Kits (Puerto Rico) -CORRECTED

NOTICE: The email that I issued earlier today had an incorrect project title within in the body of the
email. Please consider this email as the correct and complete determination—I apologize.
Dear Kristen, Sue, Melody:
The proposed project titled “Mosquito Bite Prevention Kits (Puerto Rico)” was reviewed by the
NCBDDD Human Subjects Contact and determined to be:
Non-Research: Public Health Practice—Program Evaluation
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.
If the scope of the project or CDC's role changes beyond that described, you must have the project
re-reviewed by the Human Subjects Contact in accordance with the federal regulations for the
protection of human subjects in research.

1

If you feel this determination requires revision, please email me immediately and a revised
determination will be considered.
This email is not an OMB-PRA determination.
Please save this email as documentation of the determination, and please email or call me with any
questions.
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, Science and Public Health Team
1825 Century Center, Room 2069
Mailstop E-87
Atlanta Georgia 30333

From: HSR HelpDesk (CDC)
Sent: Friday, April 28, 2017 11:25 AM
To: Campbell, Scott (CDC/ONDIEH/NCBDDD) 
Subject: HSR Protocol: Mosquito Bite Prevention Kits (Puerto Rico)

The HSR IRB Form (PDF) and associated documents you
requested are attached to this email.

Research Determination - 0.684
System Number

29190

Funding ID

OT13-1302 ((Cooperative Agreement))

Project Title

Mosquito Bite Prevention Kits (Puerto Rico)

Status

Approved By Center

Division

DBD

Lead Staff Member

Susanna Visser

Subtype

Initial

Project Type

Public Health Practice

Human Subjects

Unknown Type

Exempt Research

Unknown Type

Email HSR Help Desk

2


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