Attachment 8

Form Version Date 08.22.07

NCIPC Determination of Applicability of Human Subiects Regulations,
Request to Classify Proiect as Not Involving; Human Subiects or Research
Project Title: Voluntary Product Satisfaction and Usability Assessment
N/A

Science Officer(s)

Division:
Telephone:
Ethics verification number:

Project Officer(s): Jennifer Middlebrooks Division: DVP Telephone: (770) 488-4223
Ethcs verification number:
824 1
Proposed Project Dates: Start: -1 0-11

7

I 2009-__ Ending: -10

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

/

17

/

201 2-

do involve human subjects but CDC not

-I. Activity is not research. Primary intent is public health practice: diseasehnjury control, surveillance,
improvement of programs or services. Objectives focused on a specific population.
__A. Epidernic/endernic diseaseiinjury 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 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 population/setting.

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

-11. Activity 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 data or specimens: All (1-4) of the following are
required:
1. No contact with human subjects is involved for the proposed activity...@.
2. Data or specimens are/were collected for another purpose...@,
3. No extra datalspecimens are/were 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 agendas or strategic plans)
--

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

Form Vers~onDate 08.22.07

-111. Activitv is research involving human subjects but CDC - including employees, visitinp scientists. fellows,
and on-site contractors (but not off-site contractors or other collaborators) - will NOT obtain data by
intervening or interact in^ with participants and will NOT have access to identifiable (including coded)
private data or biolo~icals~ecimens.

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/airns, objectives, design,
setting and participants, methods, other data sources and plans for local IRE3 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" natuie 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 Si~natures:

1

date