IRB Approval

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:

CIMS Contract TBD/TBD

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

02/08/2017

Title of Project:

Customer Service Center for Training and Technical Assistance to Support Organizations in Scaling
and Sustaining the National Diabetes Prevention Program

Dates for project period:
Beginning:
Ending:

Dates for funding (if applicable):

09/30/2017

Beginning:

09/30/2017

09/29/2020

Ending:

09/29/2018

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:

Jeannette May

Division:

User ID:

JXM5

Telephone: 770-488-5016

Scientific Ethics number:

10297 Mailstop:

DDT

F75

[]

Project officer

[]

Technical monitor

[]

Principal
investigator

[]

Investigator

[]

Consultant

[X]

Other (please explain)

Assisting with Contract
Processing

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)
Customer
service
center to
provide
technical
assistance
and training

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
c. [ ] NO, Submitted for approval

Form 684R_NR (revised January 2003)
ID:

26917

d. [ ]

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

1

Tracking NO. CIMS Contract TBD/TBD
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.)

Jeannette May

Scientific ethics
number Prin
10297

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
Form 684R_NR (revised January 2003)
ID:

26917

2

Tracking NO. CIMS Contract TBD/TBD
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.
Objectives:
The objectives of this contract are to strengthen CDC’s capacity to provide information technology that is culturally appropriate
to support training and information on prediabetes and the National DPP to further type 2 diabetes prevention efforts across
the U.S. The overall objective is to develop a scalable and centralized location for diabetes support, closely linked to CDC, to
include:
•a repository and distribution system for tools/materials and virtual and in-person trainings;
•the development and maintenance of an information technology platform for educational materials, electronic mailing lists,
third-party social media sites (such as Twitter and Facebook), and a ”National DPP Ask” Help Desk (hereafter referred to as
“Help Desk”) to connect stakeholders to technical assistance coordinators and subject matter experts;
•the development and maintenance of an information technology platform to systematically track and analyze delivery of
technical assistance, training, and materials to support the growth of the National DPP;
•a repository and distribution system of information to educate and inform stakeholders about prediabetes and the National
DPP.
Scope of Work:
The development of a Customer Service Center (CSC) was identified as a priority for the National DPP. As outlined, the CSC
will serve four main functions:
1)Provide a centralized location for easy access to DPRP resource materials (videos, toolkits, webinar archives, etc.) to
support CDC-recognized organizations, organizations considering applying for CDC recognition, and other partners;
2)Provide an information platform to supplement current CDC efforts in training, technical assistance, and consultation to link
organizations to subject matter expertise (SME) and consultation necessary to assist CDC partners and stakeholders in
scaling and sustaining the National DPP, particularly in the areas of coverage and program implementation;
3)Provide an automated platform to triage and respond to questions submitted to the National DPP Help Desk mailbox
([email protected]) to enhance the National DPP’s current method for receiving and responding to questions from partners;
and
4)Provide a centralized location for easy access to information about prediabetes and the National DPP.

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:

26917

3

Approvals (signature and position title)
Jeannette May - Public Health Advisor

Date
02/10/2017

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
Patricia Schumacher - SENIOR TEAM
LEAD

Comments:
02/10/2017

[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:

Elizabeth Luman - EPIDEMIOLOGIST

02/21/2017

[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:
approve

Joan Redmond Leonard - PUBLIC
HEALTH ANALYST

02/21/2017

[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:

26917

Comments:

4