IRB Determination

ATTACHMENT I

Form Version Date 08.22.07

NCIPC Determination of Applicability of Human Subiects Regulations,
Request to Classify Proiect as Not Involving Human Subjects or Research
Project Title: National Youth Violence Prevention Resource Center (NYVPRC) Pilot Evaluation

Science Officer(s)
Project Officer(s)-Marie

Division:
Telephone:
Ethics verification number:
Boyle

--

Division: PIDB
Telephone: 770-488-2040
Ethics verification number: 1461

Proposed Project Dates: Start: 07 11012008 Ending: 09 I3012010
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. Activitv is not research. Primary intent is public health practice: diseaselinjury control, surveillance,

improvement of programs or services. Objectives focused on a specific population.
A
. Epidemiclendernic diseaselinjury control activity; collected data directly relate to immetliate disease
control needs.
B
. Routine diseaselinjury surveillance activity; data used for disease control program or policy purposes
for a specific health conditioddisease in a specific population and setting. (Includes disease reporting)
-X-C. Program evaluation activity; data are used primarily for assessing, monitoring or improving a program
in a specific populatiodsetting.

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 collectiodanalysis of data about health facilities or other
organizations or units, which are not individual persons ....or...
B. Activity is research involving data andlor specimens from deceasedpersons ...or...
C
. Activity is research using unlinked anonymous h t a or specimens:
(1-4) of the following are
required:
1. No contact with human subjects is involved for the proposed activity...&.
_ 2. Data or specimens arelwere collected for another purpose...&,
-- 3. No extra datahpecimens arelwere collected for this purpose...&,
-4.
Identifying information either was not obtained or has been removed so that data cannot be
linked or re-linked with identifiable human subjects anywhere in the world. (Note: under certain
conditions, research may qualify as non-human subjects when identifiers are removed by local staff;
contact NCIPC ADS office for details.)
D . Public health practice activity; data are used for administrative or program development purposes (e.g.,
developing research agendus or strategic plans)

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

Form Version Date 08.22.07

-111. Activity is research involving human subiects but CDC - includin~emplovccs, visiting scientists, fellows.
and on-site contractors (but not off-site contractors or other collaborators) - will NOT obtain data bv
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 goalslairns, objectives, design,
setting and participants, methods, other data sources and plans for local IKB 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.
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: