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:

10/27/2016

Title of Project:

Formative assessment regarding contraception use in the U.S. Virgin Islands (USVI) in the context of
Zika

Dates for project period:

Dates for funding (if applicable):

Beginning:

11/01/2016

Beginning:

Ending:

02/01/2017

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:

Anna Brittain

Division:

User ID:

AVG8

Telephone: 770-488-5515

Scientific Ethics number:

1.

Please indicate your role(s) in this project:

Mailstop:

DRH

F74

[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

[X]

Emergency Response

[]

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:

26739

1

Tracking NO. No Funding
Name

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

Scientific ethics
number Prin

Anna Brittain
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:

26739

NO
[ ]

If NO skip to 7
NO

2

Tracking NO. No Funding
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.
Increasing access to contraception among women who choose to delay pregnancy in USVI is a primary strategy to reduce Zikarelated adverse outcomes. There are an estimated 21,000 USVI women of reproductive age (WRA), approximately 12,000 of whom
are at risk of unintended pregnancy. There is an urgent need for effective messaging about contraception and contraceptive
access. DESIGN: CDC staff will conduct 6 focus groups with USVI women and men(18-44 years) to assess knowledge, attitudes,
and beliefs regarding contraception use and access within the USVI. CDC staff will also assess preferred communication channels
for receiving messages. Each group will be a maximum size of 12. We propose to conduct 5 focus groups with WRA that are
stratified by age(i.e., 18-24 years vs. 25-44 years). We will conduct 1 focus group with men (not stratified by age) because of the
important role they play in decisions about contraceptive use. DATA COLLECTION: Trained CDC project team members will
conduct focus groups in-person using semi-structured focus group guide developed by the project team. Before the focus group,
each participant will receive an informed consent form, including the purpose, as well as benefits and risks of participation. The
guide and the consent form will be reviewed by partners in the USVI to ensure that they are culturally appropriate. Each focus
group is expected to last from 90 to 120 minutes. A note taker will be present to observe the focus groups and capture salient
points discussed, as well non-verbal cues within the group. In addition, the focus groups will be audio-recorded. DATA ANALYSIS:
CDC team members will analyze the data manually and/or using a qualitative software package. A thematic analysis approach will
be used to determine common themes related to the categories addressed in the discussion guides. Codes will be developed
based on themes and applied to the text, and the data will be synthesized. All information collected will be held in confidence to
the extent allowed by law. All individuals involved in data collection will receive ethics training as well as training concerning
procedures and practices to ensure privacy of data. No personal identifying information will be collected during the focus groups or
maintained in any data files. No data will be collected other than what is collected during the focus groups. All audio-recordings will
be destroyed after notes have been verified. CDC will summarize the information for use in developing messaging specific to
contraception as part of emergency response. If a description of focus group findings is published, data will be reported in
aggregate and will not include information that may be used identify respondents directly or indirectly.
This activity is public health practice as the data will identify, characterize, and solve an immediate health problem and the
knowledge gained will directly benefit only those communities of focus group participants.

8.

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

Primary Site

Site Name

Site Location

Community based
organization,, e.g.
Women's Coalition of St.
Croix

St. Croix

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:

26739

3

Approvals (signature and position title)
Anna Brittain - HEALTH
COMMUNICATIONS SPECIALIST

Date
10/27/2016

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
Lee Warner - RESEARCH SCIENCE
OFFICER

Comments:
Thank you for your review! -Anna
10/27/2016

[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:
hi shanna, per discussion yesterday here is the RD form for the USVI
for Zika for the EOC. thanks in advance for your help

Shanna Cox - Associate Director for
Science

10/29/2016

[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:

Joan Redmond Leonard - PUBLIC
HEALTH ANALYST

10/31/2016

[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:

26739

Comments:

4