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:

TO BE DETERMINED

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

02/18/2016

Title of Project:

Monitoring Changes in Attitudes and Practices among Family Planning Provider and Clinics – Phase III

Dates for project period:

Dates for funding (if applicable):

Beginning:

08/01/2016

Beginning:

Ending:

07/31/2018

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:

Lauren Zapata

Division:

User ID:

DVQ8

Telephone: 770-488-6358

Scientific Ethics number:

1.

Please indicate your role(s) in this project:

410 Mailstop:

DRH

F74

[X]

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:

25946

1

Tracking NO. TO BE DETERMINED
Name

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

Scientific ethics
number Prin

Lauren Zapata

410

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:

25946

NO
[ ]

If NO skip to 7
NO

2

Tracking NO. TO BE DETERMINED
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.
The US Medical Eligibility Criteria for Contraceptive Use (US MEC) was published by CDC in 2010. The US Selected Practice
Recommendations for Contraceptive Use (US SPR) was published by CDC in 2013. Providing Quality Family Planning Services
(QFP) was published by CDC and the Office of Population Affairs (OPA) in 2014. These national guidance documents include
evidence-based or evidence-informed recommendations to improve family planning services. To monitor diffusion and perceived
utility of the guidance, as well as changes in provider attitudes and practices and clinic practices over time, we initiated a multiphase assessment. Phase I was initiated in December 2009 (collected baseline information related to US MEC) and Phase II was
initiated in June 2013 (collected follow-up information related to US MEC and baseline information related to US SPR and QFP).
Phase I and Phase II were approved as public health practice. This summary describes Phase III. The purpose of Phase III is to 1)
understand the current use of contraceptive guidance in practice and valued sources of contraceptive information, including
awareness and use of the US MEC/SPR and QFP; 2) describe current provider attitudes and practices and clinic practices related
to content included in the US MEC/SPR and QFP and assess changes from baseline; and 3) identify targeted training needs in use
of guidance and family planning service delivery (e.g., provider tools, continuing education modules). The Phase III evaluation will
consist of surveys mailed to sampled providers (provider survey) and clinics (provider survey and administrator survey). Surveys
will contain a unique identification number; only the contractor will have access to a list matching providers/clinics with unique
identification numbers. CDC and OPA will receive de-identified data. We seek to sample 2,000 office-based physicians specializing
in obstetrics/gynecology, family medicine, and adolescent medicine; and 2,000 Title X and 2,000 non-Title X clinics. The surveys
will include content related to recommendations included in the US MEC/SPR and QFP (e.g., attitudes about the safety of
intrauterine devices for postpartum women; required exams and tests prior to contraception initiation). Phase III is nonresearch/public health practice (as was Phase I and II) given its primary intent to monitor changes over time and provide data
needed to improve family planning-related public health practice. Information will be used to inform activities supporting
dissemination and uptake of the guidance, including evaluation of its use and effectiveness over time, tailoring of dissemination
activities, and development and targeting of provider tools to those in greatest need. CDC will collaboratively work with OPA on
survey development, data collection procedures, data analysis, manuscript preparation, dissemination activities, and development
of provider tools.

8.

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

Primary Site

Site Name

Site Location

Centers for Disease
Control and
Prevention/DRH

Atlanta, GA

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:

25946

3

Approvals (signature and position title)
Lauren Zapata - SENIOR RESEARCH
SCIENTIST

Date
02/19/2016

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
Suzanne Folger - EPIDEMIOLOGIST

Comments:
02/19/2016

[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:
Approved for WHFB

Shanna Cox - Associate Director for
Science

03/07/2016

[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

03/08/2016

[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:

25946

Comments:

4