Non-research determination

Attachment 8
From: Campbell, Scott (CDC/DDNID/NCBDDD/OD)
Sent: Friday, November 16, 2018 11:16 AM
To: Reyes, Nimia (CDC/DDNID/NCBDDD/DBD)
Cc: Campbell, Scott (CDC/DDNID/NCBDDD/OD) ; Johnson-James, Treana
(CDC/DDNID/NCBDDD/OD) ; Abe, Karon (CDC/DDNID/NCBDDD/DBD)
Subject: Research Determination 33377: A Survey of Venous Thromboembolism Prevention Practices in
U.S. hospitals

Dear Nimia:
The proposed project titled “A Survey of Venous Thromboembolism
Prevention Practices in U.S. hospitals” was reviewed by the NCBDDD
Human Subjects Contact and determined to be:
Non-Research: 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.
If the scope of the project or CDC's role changes beyond that described, you
must have the project re-reviewed by the NCBDDD Human Subjects Contact
in accordance with the federal regulations for the protection of human subjects
in research. If you feel this determination requires revision, please email me
immediately and a revised determination will be considered.
This is not an OMB-PRA determination. Please see Treana JohnsonJames (who is CC’ed on this email) to obtain an OMB-PRA
determination. I believe that this survey of institutions will require some
type of OMB-PRA clearance.
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, November 16, 2018 11:10 AM
To: Campbell, Scott (CDC/DDNID/NCBDDD/OD)
Subject: HSR Protocol: A Survey of Venous Thromboembolism Prevention Practices in U.S. hospitals
The HSR IRB Form (PDF) and associated documents you requested are attached
to this email.

Research Determination - 0.684
System Number

33377

Funding ID

xxx/xxx ((Contract))

Project Title

A Survey of Venous Thromboembolism Prevention Practices in U.S. hospitals

Status

Approved By Center

Division

DBD

Lead Staff Member Nimia Reyes
Subtype

Initial

Project Type

Public Health Practice

Human Subjects

Unknown Type

Exempt Research Unknown Type
Email HSR Help Desk