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:

200-2015-87977

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

09/13/2017

Title of Project:

National Tobacco Education Campaign

Dates for project period:

Dates for funding (if applicable):

Beginning:

09/29/2015

Beginning:

Ending:

09/28/2017

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:

Please indicate your role(s) in this project:

Name:

Michelle O'Hegarty

Division:

User ID:

IZR0

Telephone: 770-488-5582

Scientific Ethics number:

OSH

16113 Mailstop:

[]

Project officer

[]

Technical monitor

[]

Principal
investigator

[]

Investigator

[]

Consultant

[X]

Other (please explain)

Project Lead for formative
activities

1.

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

[]

Human subjects not involved

[]

[]

Emergency Response

[]

Surveillance

Program evaluation

[X]

Other (please explain)
Public
Health
Campaign
Developme
nt

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

d. [ ]

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

If YES, please list protocol number and

c. [ ] NO, Submitted for approval

Form 684R_NR (revised January 2003)
ID:

29568

YES, Reviewed and approved by CDC
expiration date

e. [ ]

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

f. [ ]

N/A (Not Applicable)

1

Tracking NO. 200-2015-87977
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.)

Michelle O'Hegarty

Scientific ethics
number Prin
16113

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

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)

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

[ ]

NO

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

Form 684R_NR (revised January 2003)
ID:

29568

[ ]

NO

If NO skip to 7

2

Tracking NO. 200-2015-87977
6.4.1

Is this material or information publicly available?
[ ]

6.4.2

YES

[ ]

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.
Important NOTE/CONTEXT: OSH has developed rough cut advertisements for the 2018 National Tobacco Education
campaign. Rough cut advertisements are near-final versions of advertisements with unedited photos, placeholder, and
voiceovers.
A. Purpose: Rough cut testing is a formative activity that evaluates participants’ reactions to near final versions of
advertisements to ensure they are clear, credible, believable, and persuasive. Rough cut testing is crucial to ensuing that the
ads inform the target audience of the health consequences caused by smoking cigarettes and motivates them to take action
(e.g., quit smoking cigarettes or talk to a loved one about the dangers of smoking cigarettes). The rough cut ads were
developed by Arnold Worldwide and The Plowshare Group in collaboration with CDC which are designed to encourage
smokers to quit. There are seven rough cut ads that will be tested among adult cigarette smokers and adult nonsmokers. The
rough cut ads feature former smokers from the Tips® campaign and focus on the following: Brian (lung cancer); two
executions featuring Christine (oral cancer); Sharon (throat cancer); a nicotine replacement therapy ad featuring
Tiffany/Sharon (two versions will be tested with the call to action being the sole difference); and one ad (Brian, Christine, or
Sharon) that features a participant voiceover for the call to action as opposed to the announcer voiceover featured in previous
Tips® ads. Quantitative methods will be used to collect information with adult cigarette smokers and adult nonsmokers 18-54
years old to gather feedback on the ads. Information learned from the online quantitative test has immediate benefit for the
program. The results from testing will be used to refine and finalize the ads for the 2018 campaign.
B. Project status section: Public Health Practice. This activity is designed to inform the 2018 National Tobacco Education
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:

Approvals (signature and position title)
Lindsey McCarter - HEALTH
COMMUNICATION SPECIALIST

Date
09/13/2017

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

Form 684R_NR (revised January 2003)
ID:

29568

Comments:

3

Diane Beistle - LEAD HEALTH
COMMUNICATIONS SPEC.

09/13/2017

[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:
approved

Israel Terungwa Agaku - Senior Service
Fellow

09/13/2017

[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

09/13/2017

[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:

29568

Comments:

4