IRB 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:

200-2017-93524

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

11/28/2017

Title of Project:

Evaluation of Zika Care Connect

Dates for project period:

Dates for funding (if applicable):

Beginning:

04/14/2017

Beginning:

Ending:

12/31/2018

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:

Caitlin Green

Division:

User ID:

LKJ8

Telephone: 404-498-1462

Scientific Ethics number:

1.

Please indicate your role(s) in this project:

Mailstop:

DCDD

E86

[]

Project officer

[X]

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:

30647

1

Tracking NO. 200-2017-93524
Name

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

Scientific ethics
number Prin

Caitlin Green
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:

30647

NO
[ ]

If NO skip to 7
NO

2

Tracking NO. 200-2017-93524
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.
CDC, in collaboration with the March of Dimes, has established a specialty provider network, known as Zika Care Connect, in 20
high-risk jurisdictions in the United States. ZCC aims to improve access to specialty healthcare services for the management of
Zika virus infection during pregnancy and associated outcomes in infants. The program targets the most important and removable
barriers to care, as identified by maternal and pediatric care experts. ZCC focuses on women infected with Zika during pregnancy,
as well as infants born to mothers with laboratory evidence of Zika. Central to the ZCC program is a healthcare professional
network, accessible through the ZCC website and HelpLine, which helps connect pregnant women and families to specialists who
can provide care. The purpose of this project is to evaluate the implementation and outcomes of a public health program, Zika Care
Connect (ZCC).
This evaluation aims to answer the following questions regarding the ZCC program:
1) Did Zika Care Connect achieve its program objectives?
2) How can Zika Care Connect be improved?
3) How did ZCC contribute to improving access to Zika-related clinical services?
To answer these questions two surveys will be conducted; one with ZCC website users and the other with healthcare professionals
enrolled in the ZCC Network. In addition, program metrics (e.g. website and HelpLine usage, ZCC Network enrollment) will be
analyzed. This evaluation will aid in understanding the program components that were most beneficial for patients and healthcare
professionals, identifying any gaps in program components, and assessing the impact of the program to increase access to
specialty healthcare services for the management of Zika virus in twenty jurisdictions. Furthermore, the findings will aid in
determining whether this public health approach is appropriate for replication or adaptation in other jurisdictions that may be
similarly affected by the Zika virus or for other emerging diseases requiring specialty healthcare services in the future.
Surveys will be completed by website users and healthcare professionals. All survey data will be anonymous; no PII will be
collected. It is anticipated that approximately 600 individuals will visit the website during the study period. We anticipate a 10
percent response rate yielding a sample size of 60 persons. The healthcare professional network is estimated to consist of
approximately 1200 members. All members will be invited to participate in the survey and it is anticipated approximately 25% will
complete the survey yielding a sample size of 300 participants.
CDC staff includes: Caitlin Green, technical monitor; Laura Viens, consultant on preventive medicine; Nicole Fehrenbach, project
officer; and Matthew Williams, project officer.

8.

Please list the primary project site and all collaborating site(s).

Primary Site

Site Name

Site Location

Zika Care Connect

https://www.zikacareconnect.org

Assurance Number
(FWA, MPA or SPA)
if applicable

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:

30647

3

Approvals (signature and position title)
Caitlin Green - Epidemiologist

Date
11/28/2017

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
Shelia Fehrenbach - Deputy Division
Director

Comments:
12/04/2017

[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:

Jon Baio - BEHAVIORAL SCIENTIST

12/12/2017

[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:

Scott Campbell - Health Scientist

12/12/2017

[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
CUB ADS, Deputy ADS, or Human
Subjects Contact

Form 684R_NR (revised January 2003)
ID:

30647

Comments:

4