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:

TBD/TBD/TBD

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

01/29/2015

Title of Project:

CDC Worksite Health Scorecard Evidence Review and Update

Dates for project period:

Dates for funding (if applicable):

Beginning:

09/30/2015

Beginning:

Ending:

03/31/2018

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:

Name:

Jason Lang

Division:

User ID:

BZL0

Telephone: 770-488-5597

Scientific Ethics number:

1.

Please indicate your role(s) in this project:

5935 Mailstop:

DPH

F78

[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

[]

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:

24902

1

Tracking NO. TBD/TBD/TBD
Name

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

Scientific ethics
number Prin

Jason Lang

5935

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:

24902

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.
One of the strengths of the CDC Worksite Health Scorecard is that the strategy and intervention questions posed in it are
based on evidence and are validated. This requires a regular review and update to ensure that the science-base for the
effectiveness and health impact of the strategies contained in the Scorecard are current and valid. The Scorecard has also
demonstrated some initial success as a useful assessment and planning tool by employers and organizations that work to
support employer-based health promotion and protection programs. This has generated interest in examining potential areas
or topics to be added to the Scorecard. The purpose of this project is to do a complete review and update as necessary to the
CDC Worksite Health Scorecard topic areas, individual questions, evidence-base, and weighted scores as well as developing
new Scorecard modules using the same methodology as previous versions. This project will build on the existing Scorecard
methods and content and ensure that the Scorecard can continue to be viewed as a credible instrument of practical use to
employers and practitioners who are developing or enhancing workplace health promotion and protection programs.
The project is designated public health practice. This is an existing evidence based tool under going reviewed. The
organizational level data that will be reviewed through literature and epxert input will be used to determine the effectiveness
and health impact of the interventions that are available to employers to implement at worksites. The knowledge generated will
probably not be generalizable in all workplace settings. No individual employee data will be collected for this project.
This is a contract where CDC NCCDPHP staff will participate mostly as the contracting officers representative (COR). The
methods proposed will be those of the contract in accordance to the tasks specified in the requirement. CDC will provide
oversight and surveillance of the contractor's progress. CDC will have regular communications with the contractor to provide
input and technical guidance but will not be involved in overall operations, data collection or analysis. CDC will receive monthly
and annual progress reports.

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)

Date

Jason Lang - TEAM LEAD-WORKSITE
HLTH PROGRAMS

01/29/2015

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

Form 684R_NR (revised January 2003)
ID:

24902

Comments:

3

01/30/2015

-

[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,
Mehran

Kurt Greenlund - EPIDEMIOLOGIST

02/03/2015

[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:

Shanna Cox - Associate Director for
Science

02/09/2015

[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:

24902

Comments:

4