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:

DP15-1513

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

12/11/2017

Title of Project:

Zika Reproductive Health and Emergency Response Call-Back Survey, 2018

Dates for project period:

Dates for funding (if applicable):

Beginning:

01/30/2018

Beginning:

Ending:

03/29/2020

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.
[]

New

[X]

Revision

[]

Continuation, without revision(s)

[]

Continuation, with revision(s)

Lead staff member:

Contact information:

Name:

Karen Pazol

Division:

User ID:

IJB2

Telephone: 770-488-6305

Scientific Ethics number:

1.

Please indicate your role(s) in this project:

17083 Mailstop:

DRH

F74

[]

Project officer

[]

Technical monitor

[X]

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

[X]

Emergency Response

[X]

Surveillance

[]

Human subjects not involved

[]

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:

30658

1

Tracking NO. DP15-1513
Name

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

Karen Pazol

Principal Investigator

Scientific ethics
number Prin
17083

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:

30658

NO
[ ]

If NO skip to 7
NO

2

Tracking NO. DP15-1513
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.
During the 2015 Zika virus outbreak it was determined that infection in pregnancy is a cause of microcephaly and other birth
defects. Because of these outcomes, as a part of preconception counseling, CDC developed recommendations that
healthcare providers screen women of reproductive age (WRA) for possible exposure to Zika and discuss travel plans, which
may expose WRA to additional infectious diseases that affect pregnancy.
While the unique needs of WRA were recognized during the Zika outbreak, more recently in 2017 the importance of identifying
the needs of WRA became apparent during public health response efforts to hurricanes in the Gulf Cost and Caribbean, given
that natural disasters have been associated with adverse pregnancy outcomes and a wide range of needs specific to women
and children.
To assess the preparedness of US jurisdictions for meeting the needs of WRA, this survey will address the following
objectives: 1) Are WRA being screened for potential travel related exposures and are they knowledgeable about
recommendations for pregnancy timing in regards to Zika exposure? 2) Are WRA prepared for natural disasters and other
types of public health emergencies? and 3) Do WRA show variation in their level of knowledge and preparedness based on
their current plans for achieving or avoiding pregnancy and responsibility for children?
This survey will contain questions used in 2017 for a similar assessment of WRA in Puerto Rico, with the exception that some
questions related to Zika have been replaced with more general emergency preparedness questions. The survey conducted
in 2017 was determined to be surveillance/emergency response (HSR #26964). As with the 2017 survey, the currently
proposed survey will use methods from CDC’s Behavioral Risk Factor Surveillance System (BRFSS) to conduct a phone
survey. WRA participating in the 2018 BRFSS (Protocol #2988) who agree during their initial interview will be contacted again
for this survey.
CDC staff involved in the survey will work with jurisdictional partners on the following: survey and sampling design,
questionnaire development, monitoring the progress of the assessment, data analysis, and report writing and dissemination.
The role of the jurisdictional partners will primarily be to carry out the interviews and keep CDC updated on progress.
Preparation of data files for analysis will be carried out by the BRFSS staff at CDC/Atlanta; no personally identifying
information or data keys will be included in the files received by CDC.
The findings from this survey will be used to guide emergency responses preparedness. The information collected in each
jurisdiction will not be not generalizable to other settings or situations and will be used for preparedness planning and public
health response.

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:

30658

3

Tracking NO. DP15-1513
Approvals (signature and position title)

Date
12/11/2017

Karen Pazol - Deputy ADS

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

Comments:
12/11/2017

Karen Pazol - Deputy ADS

[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:
12/11/2017

Karen Pazol - Deputy ADS

[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:
12/12/2017

Joan Redmond Leonard - PUBLIC
HEALTH ANALYST

[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

Comments:

List of Grantees
Grantee #

Grantee Name

6015

Alabama Department Of Public Health

6018

Arizona Department Of Health Services

Form 684R_NR (revised January 2003)
ID:

30658

4

6031

District Of Columbia Department Of Health

6033

Florida Department Of Health

6036

Georgia Department of Public Health

6037

Guam Department Of Public Health And Social Services

6026

Louisiana Dept of Health & Hosptials,Office Of Public Health

6039

Maryland Department Of Health And Mental Hygiene

6053

Mississippi State Department Of Health

6057

Puerto Rico Department of Health

6050

State of New Mexico Department of Health

6055

Texas Department Of State Health Services

6062

Virgin Islands Department Of Health

Form 684R_NR (revised January 2003)
ID:

30658

5