IRB 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:

To Be Determined

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

03/30/2018

Title of Project:

DP 18-1810 State Actions to Improve Oral Health Outcomes

Dates for project period:

Dates for funding (if applicable):

Beginning:

09/01/2018

Beginning:

09/01/2018

Ending:

08/31/2023

Ending:

08/31/2019

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:

Marcia Parker

Division:

User ID:

KUV7

Telephone: 770-488-6075

Scientific Ethics number:

1.

Please indicate your role(s) in this project:

Mailstop:

DOH

F-80

[X]

Project officer

[]

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)?
[]

3.

Research

[X]

Public health practice

Check one:

Check all that apply:

[]

Human subjects involved

[]

Emergency Response

[X]

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. [ ]

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:

32848

1

Tracking NO. To Be Determined
Name

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

Scientific ethics
number Prin

Marcia Parker
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:

32848

NO
[ ]

If NO skip to 7
NO

2

Tracking NO. To Be Determined
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.
The DP18-1810 State Actions to Improve Oral Health Outcomes program is a five-year cooperative agreement competitive
renewal to continue CDC investment in and support for state oral health programs. This program does not include research.
The purpose is to assist States to decrease dental caries, oral health disparities, and other co-morbid chronic diseases
associated with poor oral health outcomes. Recipients will accomplish these outcomes through implementing priority
strategies to support school sealant programs (including promoting adherence to infection prevention guidelines), supporting
and increasing community water fluoridation, conducting state oral health surveillance, and optionally integrating oral health
with other chronic disease programs (i.e., medical/dental integration). The proposed program replaces FOA 13-1307 [FY 2013FY 2017], and incorporates programmatic strategies from FOA 16-1609 [FY 2016-FY 2017] Models of Collaboration among
Chronic Diseases and Oral Health Programs, to support enhanced medical/dental integration and provide improved quality of
care. The public health impact from the successful implementation of priority strategies includes long-term outcomes of
decreases in dental caries, oral health disparities and other co-morbid chronic diseases.
CDC’s role is to provide programmatic, evaluation, epidemiologic, and technical assistance for recipients and their
stakeholders and partners through programmatic and one-on- one technical consultation, national training, workshops, Web
Conferences, SEALS, and Water Fluoridation Reporting System (WFRS) training, and other forms of guidance. CDC will also
facilitate technical assistance between national partners and recipients as needed.
Three electronic data systems address the collection of information to support states receiving 18-1810 funding. The Water
Fluoridation Reporting System (WFRS) is an online tool that helps states manage the quality of their water fluoridation
programs. WFRS information is also the basis for national surveillance reports that describe the percentage of the U.S.
population on community water systems who receive optimally fluoridated drinking water. Sealant Efficiency Assessment for
Locals and States (SEALS) is designed to capture, store, and analyze school sealant program data. Programs can use this
information to evaluate the effectiveness of individual school sealant programs by comparing the benefits (e.g., averted
treatment) with the associated costs (e.g., resources used, labor hours).These systems are tools useful to states in collecting
and reporting their performance measure information. States will also use CDMIS, a password protected web-based system
that allows funded state programs to submit their progress reports annually by entering information into the system, thereby
eliminating the need for additional written reports. Respondents provide progress report information through prompted data
entry points.

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:

32848

3

Approvals (signature and position title)
Lisa Petersen - Public Health Advisor

Date
03/30/2018

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
Marcia Parker - Team Leader

Comments:
03/30/2018

[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:
Reviewed and approved.

Lorena Espinoza - Dental Officer/Team
Lead

03/30/2018

[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:
DP 18-1810 has been released.

Shanna Cox - Associate Director for
Science

04/03/2018

[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:

32848

Comments:

4