Research Determination 1815 Pt B - IRB approval not required

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:

07/20/2018

Title of Project:

CDC-RFA-DP18-1817: Innovative State and Local Public Health Strategies to Prevent and Manage
Diabetes and Heart Disease and Stroke

Dates for project period:
Beginning:
Ending:

Dates for funding (if applicable):

09/30/2018

Beginning:

09/29/2023

Ending:

09/30/2018
09/29/2019

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:

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 funding
package

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

Public health practice
Check all that apply:

[]

Human subjects involved

[]

Human subjects not involved

[X]

[]

3.

[X]

Check one:

Emergency Response

[]

Surveillance

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:

33167

1

Tracking NO. To Be Determined
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
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:

33167

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.
This is a new non-research cooperative agreement program being jointly funded by the Division of Diabetes Translation (DDT)
and the Division for Heart Disease and Stroke Prevention (DHDSP). The purpose of this NOFO is to design, test, and evaluate
novel approaches to address a set of evidence-based strategies aimed at reducing risks, complications, and barriers to
prevention and control of diabetes and CVD among high-burden populations.
Work will occur in state and local/city/county health departments with a population of 900,000 or more where significant reach
may be achieved. Consortia of smaller local/city/county health departments may submit one application that, together,
includes a population of 900,000 or more. High burden populations are those that data indicate are affected disproportionately
by high blood pressure, high cholesterol, diabetes, or prediabetes due to socioeconomic or related factors. Category A
includes diabetes management and type 2 diabetes prevention strategies. Category B includes CVD prevention and
management strategies. Applicants may apply for Category A, Category B, or both. In both categories, applicants will select
from a menu of strategies, and should focus in areas where they have capacity to achieve greatest reach and impact.
CDC will work in partnership with recipients to ensure success by:
•Supporting recipients in implementing cooperative agreement requirements and meeting program outcomes; Providing
technical assistance (TA) to revise annual work plans; Assisting recipients in advancing program activities to achieve project
outcomes; Providing scientific subject matter expertise and resources in support of the selected strategies; Collaborating with
recipients to develop and implement rigorous evaluation plans that align with CDC evaluation activities; Providing TA on
recipients' evaluation and performance measurement plans; Providing TA to define and operationalize performance measures;
Using webinars and other social media for recipients and CDC to communicate and share tools and resources; Establishing
learning communities to facilitate information-sharing among recipients; Providing professional development/training
opportunities to share the latest science, best practices, success stories, and program models; Participating in relevant
meetings, committees, etc., related to the cooperative agreement requirements to achieve outcomes; Coordinating
communication and program linkages with other CDC programs and Federal agencies; Providing surveillance TA and statespecific data collected by CDC; Providing TA to other CDC programs and Federal agencies on how to interface with recipients;
Translating/disseminating lessons learned through publications, meetings, and other means on promising and best practices
to expand the evidence base; and Hosting 2 meetings/trainings during the project period. Recipients for this program will be
determined by objective review in early August 2018.

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)
Jeannette May - Public Health Advisor

Date
07/20/2018

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

Form 684R_NR (revised January 2003)
ID:

33167

3

staff member completing this form
Patricia Schumacher - SENIOR TEAM
LEAD

Comments:
07/23/2018

[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:
Approved.

Elizabeth Luman - EPIDEMIOLOGIST

07/23/2018

[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:
approve

Joan Redmond Leonard - PUBLIC
HEALTH ANALYST

08/07/2018

[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:

33167

Comments:

4