Form 684

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 approval.

Tracking Number:

XXXX-XXX/2014-C-003

(Use PGO number if cooperative agreement, grant, etc.)
Date submitted:

03/17/2014

Title of Project:

Young Women Breast Cancer Education and Awareness Campaign

Dates for project period:

Dates for funding (if applicable):

Beginning:

09/30/2014

Beginning:

Ending:

09/29/2016

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:

Name:

Temeika Fairley

Division:

User ID:

TFF9

Telephone: 770-488-4518

Scientific Ethics number:

1.

Please indicate your role(s) in this project:

8817 Mailstop:

DCPC

F76

[X]

Project officer

[X]

Technical monitor

[]

Principal
investigator

[]

Investigator

[]

Consultant

[]

Other (please explain)

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

[X]

YES

NO

If YES, list those activities which are research:

2.

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

Research

[X]

Public health practice

Check one:

Check all that apply:

[]

Human subjects involved

[]

Emergency Response

[]

Surveillance

[]

Human subjects not involved

[]

Program evaluation

[X]

Other (please explain)
The
proposed
work is part
of a new
congressio
nally
mandated
health
communica
tions
campaign.

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

Form 684R_NR (revised January 2003)
ID:

23924

d. [ ]

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

1

Tracking NO. XXXX-XXX/2014-C-003
c. [ ] NO, Submitted for approval

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,
consultant, etc.)

Scientific ethics
number Prin

Temeika Fairley

8817

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 6.3

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

YES

[ ]

NO

6.2.1

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;
[ ]

6.2.2

YES

NO

YES

[ ]

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

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

6.3.2

[ ]

YES

NO

[ ]

If NO skip to 6.4

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:

[ ]

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, financial status, or similarly compromising information).
[ ]

6.3

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

23924

[ ]

NO

2

Tracking NO. XXXX-XXX/2014-C-003
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

Is this material or information publicly available?
[ ]

6.4.2

[ ]
YES

NO
[ ]

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).

7.

[ ]

YES

(there are no identifying information and no unique identifiers or codes)YES

[ ]

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.
The CDC has been directed to develop and implement an education and awareness social media campaign focusing on topics
related breast cancer in young women. This campaign has multiple components that will address specific aspects of the
Education and Awareness Requires Learning Young Act (EARLY Act) legislation. This campaign will educate young women
and medical providers about breast health, breast cancer risk factors (including but not limited to BRCA gene mutation), and
survivorship among young women. The audiences for this campaign include women ages 15-44 (young women) at higher than
average risk for developing breast cancer such as Ashkenazi Jewish and African-American females; young women who are
breast cancer survivors; young women of all racial, ethnic, and cultural backgrounds; and medical providers.
The purpose of this project is to develop, implement, and launch this social media health communications campaign. The
overall activities include: 1) develop a communications and marketing plan; 2) purchase, place, and leverage media; 3)
develop campaign messages and communication products; 4) monitor, report, and evaluate campaign activities; 4) develop
and implement interactive/digital media strategies, materials, tools, and resources; 5) assist with media relations; 6) assist with
graphic design, photos, and layout of campaign materials; 7) assist with writing and editing; 8) provide translation and
adaptation services and support; 9) provide training, including presentations related to the campaign; and 10) provide data
rights and transfer of campaign materials at the end of the contract.
The CDC staff member will serve as the technical monitor and subject matter expert on this social media health
communications campaign.
This activity is public health practice because the purpose is to develop, implement, and launch this social media health
communications campaign. Through this contract, CDC seeks a contractor that would provide the specialized services for this
social media health communications campaign.

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:

23924

3

Approvals (signature and position title)
Temeika Fairley - EPIDEMIOLOGIST

Date
03/17/2014

Research Determination / Remarks
[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
staff member completing this form
Jameka Blackmon - Assoc Dir for
Program Devel

Comments:
03/19/2014

[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
Team Lead

Comments:

Cheryll Thomas - EPIDEMIOLOGIST

03/19/2014

[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
Division ADS

Comments:

Joan Redmond Leonard - PUBLIC
HEALTH ANALYST

3/26/2014

[ 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

CUC ADS, Deputy ADS, or Human
Subjects Contact

Form 684R_NR (revised January 2003)
ID:

23924

Comments:

4