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

06/19/2018

Title of Project:

Million Hearts Hospital or Health System designation program

Dates for project period:

Dates for funding (if applicable):

Beginning:

06/03/2019

Beginning:

Ending:

12/31/2021

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:

Jessica Barnett

Division:

User ID:

NMA4

Telephone: 404-498-1705

Scientific Ethics number:

Mailstop:

DHDSP

F-73

[]

Project officer

[]

Technical monitor

[]

Principal
investigator

[]

Investigator

[]

Consultant

[X]

Other (please explain)

Project Coordinator

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

[]

Emergency Response

[]

Surveillance

[]

Human subjects not involved

[]

Program evaluation

[X]

Other (please explain)
Project to
recognize
practices
using
Million
Hearts
strategies
to improve
cardiovasc
ular
outcomes.

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

Form 684R_NR (revised January 2003)
ID:

33123

d. [ ]

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

1

Tracking NO. No Funding
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

Name

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

Scientific ethics
number Prin

Jessica Barnett
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

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

Form 684R_NR (revised January 2003)
ID:

[ ]

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)

33123

[ ]

NO

2

Tracking NO. No Funding
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?
[ ]

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.
Million Hearts is a national initiative to prevent 1 million heart attacks and strokes by 2022.
The purpose of the Million Hearts Hospital or Health System Designation program is to recognize institutions working to
systematically improve the cardiovascular health of the population and communities they serve through a focus on Keeping
People Health, Optimizing Care, Improving Outcomes for Priority Populations, and Innovating for Health.
Hospitals and health systems will self-nominate through an online portal by doing one of the following:
a.)Commit to implement policies that promote cardiovascular health
b.)Provide documentation of current policies that they are implementing in order to promote cardiovascular health
c.) Provide documentation of current policies that they are implementing in order to promote cardiovascular health and provide
data that shows positive health outcomes as a result of those policies being implemented
Nominations will be scored using predetermined criteria and a scoring rubric and reviewed by an expert panel of judges.
Recognized designees will participate in the development of a success story product to be shared broadly with the public
health and clinical audiences.
CDC staff members have developed the application criteria, data collection instruments, and selection criteria. CDC staff will
consult on data storage and confidentiality, any data analyses conducted, and record review protocols.
The status for this project is public health practice. The objective is to identify and recognize hospitals and health systems that
work to improve cardiovascular health in a narrative or documentary format. No individual patient level data will be collected,
only practice level summary data. No generalizable knowledge will emerge from this project. A manuscript is not planned at
this time. Selected hospitals and health systems will be recognized through web-based platforms.

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:

33123

3

Approvals (signature and position title)
Jessica Barnett - Assistant/Program
Analyst

Date
06/22/2018

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
Judith Hannan - Million Hearts Advisor

Comments:
06/29/2018

[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:
looks good

Mary George - SENIOR MEDICAL
OFFICER

06/29/2018

[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:
in question 2, "practices" likely should be "hospitals", but this doesn't
change the overall document.

Joan Redmond Leonard - PUBLIC
HEALTH ANALYST

07/01/2018

[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:

33123

Comments:

4