Attachment 7 Nonresearch Determination

Form Version Date 05.12.08

NCIPC Determination of Applicability of Human Subiects Regulatioi~s,
Request to Classify Proiect as Not Involving Human Subiects or Research
Project Title

The National Violent Death Reporting System

Science Officer(s)-Debra Karch , PhD

Division:
Telephone: 770-488-1307
Ethics verification number:-1 7473

Project Officer(s) Lerov Frazier, Jr., MSPH Division: DVP
Telephone: -770-488-13)Ethics verification number: 12220
Proposed Project Dates: Start: 1 1 - 9 1 20 10

Ending: -1/-8
1_
20 13

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

do involve human subjects but CDC not

X I.
-

Activity is not research. Primary intent is public health practice: diseaselinjury control, surveillance,
improvement of programs or services. Objectives focused on a specific population.
-A. Epidemiclendemic diseaselinjury control activity; collected data directly relate to i~ninediatedisease
control needs.
-X- B. Routine diseasetinjury surveillance activity; data used for disease control program or policy purposes
for a specific health conditionidisease 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 populationlsetting.

Justification: Please attach project goalslaims, objectives, design, setting and participants, methods, and data sources.

-11.
Activitv is research but does NOT involve identifiable human subiects. 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 andlor specimens fiom deceasedpersons.

Justitication: Please attach project goalslaims, objectives, design, setting and participants, methods, and data sources.

-111. Activity is research involvine human subjects but CDC - includin~employees. visiting scientists. fellows,
and on-site contractors (but not off-site contractors or other collaborators) - will NOT obtain data by
intervenin~or interacting with ~articipantsand will NOT have access to identifiable (including coded)
private data or biological specimens.

Form Version Date 05.12.08

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 goalslairns, 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 the Human Subjects
Contact (Natalie Gilles) for records keeping purposes.

Attach project description in enough detail to clarify "non-human subjects", "non-research or "not-engaged nature of
the product.
CornmentsIRationale:
Although CDC Human Subjects (IRB) review is not required in this instance, investigatorslproject 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 Si~natures: