App F

REQUEST FOR DETERMINATION OF RESEARCH STATUS
To be completed by the staff member with lead responsibility for the project and approved by branch chief (if applicable) and Division ADS.
A separate PGO funding memo is required if project is research and involves human subjects regardless of the CDC staff role.
Instructions:

(1) Use this form to declare: (a) the research status of any project, (b) role or roles of CDC staff
(2) A short summary should be attached offering specific details about the project and the role of staff.
(3) Be sure to complete all applicable items, obtain appropriate signatures and submit this form for appr oval.

Tracking Number:

200-2007-20014/2008-C-011

(Use PGO number if cooperative agreement, grant, etc.)
06/10/2008

Date submitted:

Cancer Prevention and Control Strategic Campaign and Communication Initiatives

Title of Project:

Dates for project period:

Dates for funding (if applicable):

Beginning:

09/01/2008

Beginning:

Ending:

03/08/2014

Ending:

Project is (choose one):

NOTE: Revision, as used below, refers to any substantive change made to the project including scope of project, funding restrictions,
personnel, role of CDC staff member, determination of research status, etc.
[X]

New

[ ]

Revision

[ ]

Continuation, without revision(s)

[ ]

Continuation, with revision(s)

Lead staff member:

Contact information:

CYNTHIA GELB

Division:

DCPC

[ ]

Project officer

[X]

Technical monitor

User ID:

CMG7

Telephone:
Mailstop:

770-488-4708
K64

[ ]

Principal investigator
Consultant

[ ]

Investigator
Other (please explain)

4187

Scientific Ethics number:

1.

Please indicate your role(s) in this project:

Name:

[ ]

[ ]

Are any or all of the activities within this project DESIGNED to contribute to generalizable knowledge (i.e., research)?
[ ]

YES

[X]

NO

If YES, list those activities which are research:

2.

Is this CDC project research or public health practice (check all that apply)?
[ ]

Research

Check one:
[ ] Human subjects involved
[ ] Human subjects not involved

Form 684R_NR (revised January 2003)
ID: 14568

[X]

Public health practice

Check all that apply:
[ ]
Emergency Response
[ ]
Program evaluation

[ ]

Surveillance

[X]

Other (please explain)

The purpose of this
project is to identify
gynecologic and other
cancer related public
health
information/messages
for a national
awareness campaign
and communication
initiatives.

1

200-2007-20014/2008-C-011

Tracking NO.
3.

If RESEARCH involving human subjects, has the project or research activities been reviewed by the CDC IRB for human subjects
protection?
a.

[ ]

NO, New project, not yet reviewed

b.

[ ]

NO, Existing project, not ready to submit

d.

c.

[ ]

NO, Submitted for approval

[ ]

YES, Reviewed and approved by CDC
If YES, please list protocol number

and

expiration date
e.

[ ]

NO, RESEARCH, no CDC investigators (CDC IRB not required)

f.

[ ]

N/A (Not Applicable)

If RESEARCH, list any other CDC staff involved in this project, please include the name, role, and scientific ethics number
Name

Role (project officer, investigator,

Scientific ethics number Prin

consultant, etc.)

IF YOU THINK THE RESEARCH PROJECT MIGHT QUALIFY AS EXEMPT RESEARCH (as identified in 45CFR46.101), PLEASE
ANSWER questions 4-6, OTHERWISE SKIP TO question 7.
4.

5.

Does the proposed research involve prisoners?
[ ]

YES

[ ]

NO

If YES, this research cannot be exempted and must be reviewed by an IRB (skip to question 7).

Does the proposed research involve fetuses, pregnant women, or human in vitro fertilization as targets (such that Subpart B would
apply)?
[ ]

YES

[ ]

NO

If YES, this research cannot be exempted and must be reviewed by an IRB (skip to question 7).

Educational Research
6.1

Is this research conducted in established or commonly accepted educational settings, AND does the research involve
normal educational practices (e.g., research on regular and special education strategies or research on the effectiveness of,
or comparison among instrucational techniques, curricula or classroom management methods)?
YES

[ ]

NO

[ ]

Research Involving Surveys, Interview Procedures (including Focus groups), Observation of Public Behavior, or Educational Tests
6.2

Will this research use educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview
procedures or observation of public behavior?
[ ] YES

NO

[ ]

If NO skip to 6.3

Will children (<18 years of age) be research subjects?
[ ]

YES

[ ]

NO

6.2.1

If YES, this research cannot be exempted and must be reviewed by an IRB (skip to item 7)

Is the information obtained recorded in such a manner that human subjects can be identified directly or indirectly
through identifiers (such as a code) linked to the subjects;
[ ] YES

6.2.2

[ ]

NO

Will any disclosure of the human subjects' responses outside of the research setting have the potential to place the
subjects at risk of criminal or civil liability, or be damaging to the subjects' financial standing, employability or
reputation? (Examples here may include: the collection of sensitive data regarding the subjects' (or relatives' or
associates') possible substance abuse, sexuality, criminal history or intent, medical or psychological condition,
[ ] YES

6.3

[ ]

NO

Will this research use educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview
procedures, or observation of public behavior but the research is not exempt under paragraph 6.2 of this section:
[ ] YES

6.3.1

[ ]

If NO skip to 6.4

Will this research involve human subjects that are elected or appointed public officials or candidates for public office?
[ ] YES

6.3.2

NO

[ ]

NO

Does federal statute(s) require(s) without exception that confidentiality of the personally identifiable information
will be maintained throughout the research and thereafter? (Note: CDC can use this exemption criterion only in
the case where a 308(d) Assurance of Confidentiality has been obtained to cover the research).
[ ] YES

Form 684R_NR (revised January 2003)
ID: 14568

[ ]

NO

2

Tracking NO.

200-2007-20014/2008-C-011

Existing Data Which Is Publicly Available or Unidentifiable
6.4

Does this research involve only the collection or study of existing* data, documents, records, pathological or diagnostic
specimens? (* 'existing' means existing before the study begins)?
[ ] YES

6.4.1

[ ]

NO

Is this material or information publicly available?
[ ] YES

6.4.2

If NO skip to 7

[ ]

NO

Is this material or information recorded in such a manner by the investigator that the subjects cannot be identified
directly or indirectly through identifiers linked to the subjects?
(Note: If a link is created by an investigator even temporarily, for research purposes, this criterion is not met. If a
temporary link is created by clinical staff who already have access to the data, this criterion is met).
YES
[ ]
(there are no identifying information and no unique identifiers or codes)
[ ]

7.

NO

(there are identifiers (including codes))

Please prepare and attach a short summary paragraph (<1 page);
if this is new:
a.

Be sure to include the purpose of the project, specific details about the project and the role of the CDC staff member(s) in the
project. In explaining one's role as a consultant be particularly careful to identify involvement in things like: study design
decisions, oversight of protocol development, participation in review of data collection procedures, and particpation in data
analysis and/or manuscript preparation, as well as whether there will be access to identifiable or personal data.

b.

Explain your project status selection (research--non-exempt, exempt, no CDC investigator or not involving human subjects;
public health practice). If you selected research not involving human subjects be sure to indicate if the data includes any
personal information (e.g., name, SSN), linkable study identification numbers or codes, or geographical information.
Cancer Prevention and Control Strategic Campaign and Communication Initiatives
The proposed formative activities are non-research because their intent is to help identify optimal cancer-related public health information
and messages for a national awareness campaign and other strategic communication initiatives.
We feel that the project activities are non-research as per the: Guidelines for Defining Public health Research and Public Health
Non-Research, http://www.cdc.gov/od/science/regs/hrpp/researchDefinition.htm, which states that the "major difference between
research and non-research lies in the primary intent of the activity." "The primary intent of non-research in public health is to prevent or
control disease or injury and improve health, or to improve a public health program or service. Knowledge may be gained in any public
health endeavor designed to prevent disease or injury or improve a program or service. In some cases, that knowledge may be
generalizable, but the primary intention of the endeavor is to benefit clients participating in a public health program or a population by
controlling a health problem in the population from which the information is gathered."
The purpose of the proposed formative activities is to develop and test materials and messages for consumers and health care providers
with a representative sampling of the intended audiences. This will help ascertain that messages are clear and compelling to the target
audience(s), and appropriate for the proposed media. We anticipate that concept testing of materials may be combined with focus groups
to assess knowledge, behavior and attitudes related to gynecologic and other cancers. Focus group testing with consumers will take
place in 3-4 cities in the U.S., with at least 3 English groups and 1-2 Spanish groups in each city, and health care provider groups will take
place in 3-4 cities or via the internet or telephone.
Up to 9 participants will be included in each focus group and will be drawn from the target audiences using standard market research
techniques, and will represent geographic and demographic diversity to assure appropriate audience representation. As a result of these
activities, DCPC will raise awareness about gynecologic and other cancers to reduce mortality.
A contractor, under CDC Technical Monitor supervision, will develop a recruitment plan, moderator guide and other testing tools, and will
conduct focus groups. All testing shall be under the direction and approval of the Technical Monitor.

8. Please list the primary project site and all collaborating site(s).

Explanation of project components:

9.

If project involves research that is funded extramurally, list amount of award that should be restricted pending IRB approval and
describe which project components will be affected, if known:

Form 684R_NR (revised January 2003)
ID: 14568

3

Tracking NO.

200-2007-20014/2008-C-011

Approvals (signature and position title)

CYNTHIA GELB - HEALTH
COMMUNICATION SPECIALIST

Date
06/10/2008

Research Determination / Remarks

[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt

[ ]

Research involving human subjects, CDC investigators, not exempt

[X ]
[ ]
[ ]

(check if applicable)
[ ]
Local IRB
CDC Exemption
CDC IRB
Comments:
[ ]
[ ]

staff member completing this form

Please review this as soon as possible.

NAHEED LAKHANI - ORISE FELLOW

06/10/2008

[X]
[ ]
[ ]
[ ]
[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB
Comments:

Team Lead

NAHEED LAKHANI - ORISE FELLOW

06/10/2008

[X]
[ ]
[ ]
[ ]
[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB
Comments:

Division ADS

JOAN REDMOND-LEONARD PUBLIC HEALTH ANALYST

06/20/2008

[X]
[ ]
[ ]
[ ]
[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB
ADS, Deputy ADS, or Human Subjects
Contact

Comments:

List of Grantees
Grantee #

Grantee Name

Form 684R_NR (revised January 2003)
ID: 14568

4