Reserach determination

Reset Form

NCIPC Determination of Applicability of Human Subjects Regulations,
Request to Classify Project as Not Involving Human Subjects or Research
Project/FOA Title: ________________________________________________________________________________
Improving the understanding of traumatic brain injury through policy
_______________________________________________________________________________________________
and program evaluation research
Science Officer(s): _________________________________
Division: ____________
Telephone: _______________
Michael Lionbarger
DUIP
770-488-0592
Ethics Verification Number: ______________________
12303
Project Officer(s): _________________________________
Lisa Garbarino

Division: ____________
Telephone: _______________
DUIP
770-488-1496

11484
Ethics Verification Number: ______________________

09/01/2014 Ending: ___________
08/31/2016
Proposed Project Dates: Starting: ___________
Award Title: _____________________________________________________________________________________
Improving the understanding of traumatic brain injury through policy & program eval. research.
Award Institution: ________________________________________________________________________________
CSR, Inc.
Funding Mechanism #__________________
• FOA#: __________________
• Cooperative Agreement #: __________________
• Grant #: __________________
• Contract#: __________________
200-2013-F57134
Funding Sponsor: _________________________________________________________________________________
Number of Participants in Study: __________
Intramural or

Extramural

Categories of data collection that do not constitute human subjects research OR do involve human subjects but CDC not
engaged are listed below. Please check appropriate category:

I. Activity is not research. Primary intent is public health practice: disease/injury control, surveillance,
improvement of programs or services. Objectives focused on a specific population.
A. Epidemic/endemic disease/injury control activity; collected data directly relate to immediate disease
control needs.
B. Routine disease/injury surveillance activity; data used for disease control program or policy purposes
for a specific health condition/disease in a specific population and setting. (Includes disease reporting)
C. Program evaluation activity; data are used primarily for assessing, monitoring or improving a program
in a specific population/setting.

Justification: Please attach project goals/aims, objectives, design, setting and participants, methods, and data sources.

-1-

Next Page
CDC 0.1485 (E), February 2011, CDC Adobe Acrobat 10.1, S508 Electronic Version, October 2013

Previous Page

-ORII. Activity is research but does NOT involve identifiable human subjects. Primary intent is to develop or
contribute to generalizable knowledge.
A. Activity is research involving collection/analysis of data about health facilities or other
organizations or units, which are not individual persons.... or...
B. Activity is research involving data and/or specimens from deceased persons.

Justification: Please attach project goals/aims, objectives, design, setting and participants, methods, and data sources.
-ORIII. Activity is research involving human subjects but CDC – including employees, visiting scientists, fellows,
and on-site contractors (but not off-site contractors or other collaborators) - will NOT obtain data by
intervening or interacting with participants and will NOT have access to identifiable (including coded)
private data or biological specimens.
Justification: Please provide a summary of CDC’s role and explain that CDC will not be “engaged” in either obtaining
data by intervening or interacting with participants or have access to identifiable data. Staff can have access to
data that have been stripped of the codes that link information to individuals and still be considered to not be
“engaged” in human subjects research. Also, please attach a summary of project goals/aims, objectives, design,
setting and participants, methods, other data sources and plans for local IRB review.
Once local IRB approval has been obtained please forward a copy (electronic preferred) to Jahlani Akil - the
Human Subjects Contact - for records keeping purposes.

Attach project description in enough detail to clarify “non-human subjects”, “non-research” or “not-engaged” nature of
the product.
Comments/Rationale:
Although CDC Human Subjects (IRB) review is not required in this instance, investigators/project officers are expected
to adhere to ethical principles and standards by respecting and protecting to the maximum extent possible the privacy,
confidentiality and autonomy of participants. All applicable State and Federal privacy laws must be followed.
Additional Comments:

Required Signatures:

Tamara
Haegerich -S
03/20/2015
_______________________________________________________________________________________
Digitally signed by Tamara Haegerich -S
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC,
ou=People, 0.9.2342.19200300.100.1.1=1000312349,
cn=Tamara Haegerich -S
Date: 2015.03.20 13:46:02 -04'00'

Division Official (e.g., Director or ADS)

Date

Digitally signed by Karen C. Angel -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People, cn=Karen C. Angel -S,
0.9.2342.19200300.100.1.1=1000551064
Date: 2015.03.20 15:17:00 -04'00'
03/20/2015
________________________________________________________________________________________

Karen C. Angel -S

National Center Human Subjects Contact

Date
-2-

Email Form

Save Form

CDC 0.1485 (E), February 2011, CDC Adobe Acrobat 10.1, S508 Electronic Version, October 2013

Next Page

Previous Page

_____________________________________________________________________
Office Use Only
Funding Amount:

Email Form

Print Form

-3-

CDC 0.1485 (E), February 2011, CDC Adobe Acrobat 10.1, S508 Electronic Version, October 2013

Save Form