Appendix F Non Determination

Appendix F

Form Version Date 08.22.07

NCIPC Determination of Applicabilit~of Human Subiects Regulations,
Request to Classify Proiect as Not Involving Human Subiects or Research
Project Title: A Survey of Fire and Life Safety Education Activities Among Pennsylvania Fire
Departments
Science Officer(s): Shane Diekrnan

Division: DUIP Telephone: 770-488-4901
Ethics verification number: 13435

Project Officer(s) Shane Diekman

Division: DUIP Telephone: 770-488-4901
Ethics verification number: 13435

Proposed Project Dates: Start: 0910 112007 Ending: 0910 112009
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

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 immediate disease
control needs.
B . Routine diseaselinjury surveillance activity; data used for disease control program or policy purposes
for a specific health conditionldisease 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 populatiodsetting.

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

1 1 . 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 individualpersons ....or...
B . Activity is research involving data andlor specimens from deceasedpersons ...or...
C . Activity is research using unlinked anonymous data or specimens: 4 (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 datalspecimens arelwere collected for this purpose...&,
4
. Identifying information either was not obtained 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 Version Date 08.22.07

X 111. Activity is research involving human subiects but CDC - including employees, visitinp 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.
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 IRE3 review.
Once local IRE3 approval has been obtained please forward a copy (electronic preferred) to the Human Subjects
Contact (Natalie Gilles) for records keeping purposes.

The Division of Unintentional Injury Prevention contracted Johns Hopkins University to carry out
the survey. CDC will not be engaged in either obtaining the data or interacting with participants. In
addition, CDC will not have access to identifiable data.
Attached is a summary of the project.

Attach project description in enough detail to clarifL "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/projectofficers 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:

Project Title: A Survey of Fire and Life Safety Education Activities Among Pennsylvania
Fire Departments

Goals and Objectives: The United States Fire Administration (USFA) annually awards millions
of dollars to local fire departments for fire prevention activities. The USFA is collaborating with
the Centers for Disease Control (CDC) to determine whether these fire prevention programs are
effective. Johns Hopkins is working with the CDC on this initiative to determine the scope of fire
prevention activities and to describe elements of effective fire prevention programs. Setting and
participants: The state of Pennsylvania was selected for the current project because of its focus
on fire prevention and because it has the largest number of fire departments in the nation.
Contact information for the fire departments in Pennsylvania will be obtained through the 2007
National Directory of Fire Chiefs and EMS Administrators. Design and methods: A statewide
survey of Fire and Life Safety Education (FLSE) will be undertaken to determine the scope of
fire prevention activities in the state. The 35-item survey, which will be mailed to all 2,199 fire
departments in Pennsylvania, has three sections. Section I collects information about the fire
chief and general aspects related to fire prevention activities. Section I1 asks about the types,
number, focus, target population and partners of prevention activities offered by each fire
department. Section I11 collects information about the barriers and facilitators for fire prevention
activities. As a follow-up, a reminder postcard will be mailed to all non-responding fire
departments two months after the initial survey mailing. Four months after the initial mailing,
phone calls will be made to all non-responding fire chiefs to again solicit their participation.
Other data sources: To inform the larger goals of the study, several key informant interviews
will be conducted with fire department officials at the state and local level. IRB Review: This
study poses minimal risk to participants. All data collected will be confidential and stored in
locked filing cabinets. Participants will also be provided with a letter that explains the purpose of
the survey, the voluntary nature of the research, the procedures used for confidentiality, and
provides contact information for questions or concerns. Human subjects approval from the Johns
Hopkins School of Public Health IRB will be obtained before any participants are contacted.