Human Subjects 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/TBD

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

02/22/2019

Title of Project:

National Survey of Community-Based Policy and Environmental Supports For Healthy Eating And
Active Living 2.0

Dates for project period:

Dates for funding (if applicable):

Beginning:

01/01/2021

Beginning:

Ending:

06/30/2021

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:

Deborah Galuska

Division:

User ID:

DBG6

Telephone: 770-488-6017

Scientific Ethics number:

6100 Mailstop:

DNPAO

F77

[]

Project officer

[]

Technical monitor

[]

Principal
investigator

[]

Investigator

[]

Consultant

[X]

Other (please explain)

COR

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:
This is a project designed to provide collect data on the prevalence of policy supports for PA and nutrition in local governments.
Although its primary purpose is surveillance, data will be based on a representative sample and analyses related to the project may
include questions designed to contribute to generalizable knowledge.

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:

[]

Human subjects involved

[]

Emergency Response

[X]

Surveillance

[X]

Human subjects not involved

[]

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. [ ]

NO, New project, not yet reviewed

d. [ ]

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

YES, Reviewed and approved by CDC
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:

33648

1

Tracking NO. TBD/TBD/TBD
Name

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

Scientific ethics
number Prin

Deborah Galuska

6100

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

6.4.1

Is this material or information publicly available?
[ ]

[ ]
YES

Form 684R_NR (revised January 2003)
ID:

33648

NO
[ ]

If NO skip to 7
NO

2

Tracking NO. TBD/TBD/TBD
6.4.2

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.
7a. This project is the second survey of a nationally representative sample of municipalities in the US to determine the
prevalence of policy supports for physical activity and nutrition. Information is about policies in the municipality. City managers
are surveyed about these policies. The primary purpose of this data is to compare estimates to prior 2014 estimates as part of
a potential surveillance system. However, results from the survey could be used to address additional research questions
related to the municipal level predictors of the policies. A contractor will administer the survey electronically to target
respondents and CDC will review and approve all study design plans as the COR.
7b. This project is non-human subjects research. Although data is obtained via self report of a city manager, this data is about
written policies in the municipality which would presumably be able to be obtained publically. Information municipalities
including target respondents is also publically available via the Census of Governments. The data will not contain personal
information on the city manager.

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:
$0.00
The project is non-human subjects research thus no amount of the award will be restricted pending IRB approval.

Approvals (signature and position title)
Latetia Moore Freeman - Deputy Associate
Director for Sc

Date
02/22/2019

Research Determination / Remarks
[ X ] Public health practice
[ X ] 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
Latetia Moore Freeman - Deputy
Associate Director for Sc

Comments:
02/22/2019

[ X ] Public health practice
[ X ] 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

Form 684R_NR (revised January 2003)
ID:

33648

3

Team Lead

Comments:

Latetia Moore Freeman - Deputy
Associate Director for Sc

02/22/2019

[ X ] Public health practice
[ X ] 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

02/28/2019

[ X ] Public health practice
[ X ] 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:

33648

Comments:

4