CDC Research Determination

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:

TBD/TBD

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

11/20/2018

Title of Project:

Evaluation of CDC's National Tobacco Education Campaign

Dates for project period:

Dates for funding (if applicable):

Beginning:

08/30/2019

Beginning:

Ending:

08/29/2022

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.
[]

New

[]

Revision

[]

Continuation, without revision(s)

[X]

Continuation, with revision(s)

Lead staff member:

Contact information:

Name:

Lauren Boyle-Estheimer

Division:

User ID:

YJW7

Telephone: 404-498-2283

Scientific Ethics number:

1.

Please indicate your role(s) in this project:

18583 Mailstop:

OSH

F-79

[]

Project officer

[]

Technical monitor

[X]

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:
Administration of surveys to an online panel to determine the impact of a national tobacco education campaign.

2.

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

3.

Research

[X]

Public health practice

Check one:

Check all that apply:

[X]

Human subjects involved

[]

Emergency Response

[]

Surveillance

[]

Human subjects not involved

[X]

Program evaluation

[]

Other (please explain)

If RESEARCH involving human subjects, has the project or research activities been reviewed by the CDC IRB for human
subjects protection?
a. [ X NO, New project, not yet reviewed

d. [ ]

YES, Reviewed and approved by CDC

]

b. [ ] NO, Existing project, not ready to submit

If YES, please list protocol number and

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

Form 684R_NR (revised January 2003)
ID:

33413

1

Tracking NO. TBD/TBD
Name

Role (project officer, investigator,
consultant, etc.)

Scientific ethics
number Prin

Diane Beistle

Project officer

8120

Jane Mitchko

Project officer

19631

Lauren Boyle-Estheimer

Principal Investigator

18583

Rebecca Murphy

Project officer

Robert Rodes

Project officer

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

[X]

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

[X]

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

[X]

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?
[X]

YES

[ ]

NO

If NO skip 6.3

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

YES

[X]

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

[X]

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

[X]

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:

[X]

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)

33413

[ ]

NO

2

Tracking NO. TBD/TBD
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

[X]
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.
To conduct an evaluation of a paid, national tobacco education campaign. These ads are designed to motivate adult smokers
to quit and nonsmokers to encourage family/friends who smoke to quit. The media buy will include placements of ads on
television, radio, out-of-home, print, and digital platforms, and will ensure a baseline level of population-wide exposure to
tobacco control measures. The evaluation will determine if the goals and objectives of the media campaign were achieved.
Any personal information collected will be done by the Contractor, kept with the Contractor, and will not be transferred to
CDC/OSH. Information collected by the Contractor will be delivered to CDC/OSH from the Contractor in aggregate form only.
While this is an evaluation of a campaign, certain aspects of the
evaluation activity involves collection of data from a panel that is designed to yield nationally representative data. No
personally identifiable or linkable information is however being collected, and the study poses no more than minimal risk.

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:

Approvals (signature and position title)
Lauren Boyle-Estheimer - Scientist

Date
01/14/2019

Research Determination / Remarks
[ X ] Public health practice
[ ]
Research not involving human subjects
[ ]
Research involving human subjects, no CDC investigators
[ X ] Research involving human subjects, CDC investigators, exempt
[ ]
Research involving human subjects, CDC investigators, not exempt
(check if applicable)
[ ]
Local IRB
[ X ] CDC Exemption
[ ]
CDC IRB

staff member completing this form

Form 684R_NR (revised January 2003)
ID:

33413

Comments:

3

Diane Beistle - LEAD HEALTH
COMMUNICATIONS SPEC.

01/15/2019

[ X ] Public health practice
[ ]
Research not involving human subjects
[ ]
Research involving human subjects, no CDC investigators
[ X ] Research involving human subjects, CDC investigators, exempt
[ ]
Research involving human subjects, CDC investigators, not exempt
(check if applicable)
[ ]
Local IRB
[ X ] CDC Exemption
[ ]
CDC IRB

Team Lead

Comments:

Israel Terungwa Agaku - Senior Service
Fellow

01/16/2019

[ X ] Public health practice
[ ]
Research not involving human subjects
[ ]
Research involving human subjects, no CDC investigators
[ X ] Research involving human subjects, CDC investigators, exempt
[ ]
Research involving human subjects, CDC investigators, not exempt
(check if applicable)
[ ]
Local IRB
[ X ] CDC Exemption
[ ]
CDC IRB

Division ADS

Comments:

Rachel Kaufmann - Assoc Director
Science

01/16/2019

[ X ] Public health practice
[ ]
Research not involving human subjects
[ ]
Research involving human subjects, no CDC investigators
[ X ] Research involving human subjects, CDC investigators, exempt
[ ]
Research involving human subjects, CDC investigators, not exempt
(check if applicable)
[ ]
Local IRB
[ X ] CDC Exemption
[ ]
CDC IRB

CUC ADS, Deputy ADS, or Human
Subjects Contact

Form 684R_NR (revised January 2003)
ID:

33413

Comments:

4