Non-Research Determination

12/18/2015

REQUEST FOR NCHHSTP PROJECT DETERMINATION & APPROVAL
NCHHSTP ADS/ADLS Office on behalf of CDC (New, Continuation, or Amendment)

This form should be used to request NCHHSTP/OD/ADS or ADLS office review and approval on behalf of
CDC of a new, continued, or amended project for those projects for which NCHHSTP staff/employees,
branches, divisions, and center/OD/ADS or ADLS office are responsible.
Any NCHHSTP activity that meets the definition of a project (see the following section) and represents
one of the four project categories must be approved by the respective NCHHSTP branch and division and
by the NCHHSTP/OD/ADS or ADLS office. Approval by the NCHHSTP ADS or ADLS office
([email protected]) of these projects indicates approval by CDC. This review and approval process
complies with obligations for adherence of projects to federal regulations, state laws, ethics guidelines,
CDC policies, and publication requirements.
For research that involves identifiable human subjects in which CDC/NCHHSTP is engaged, use CDC
Human Research Protection Office forms and submit them to CDC Human Research Protection Office
through the NCHHSTP ADS human subjects email box after approval at the branch and division levels.

RELEVANT INFORMATION
What is a project?
A project is defined as a time-limited activity that is funded for a specific period of time, an activity with
specified funds for a limited time, or as a limited time responsibility by specific CDC employees or staff,
including projects that might be ongoing or continuous for an extended period. A project has defined
objectives, tasks (e.g., essential public health services), dedicated resources, and is funded for a specified
time. NCHHSTP reviews and approves projects for the four project categories listed on this form. Every
project officer, project team and staff, NCHHSTP branch, and NCHHSTP division or office is responsible
for submitting this form for each project and for obtaining NCHHSTP OD/ADS or ADLS approval on behalf
of CDC before project initiation, continuation, or amendment. Such programs as surveillance are
approved and funded as specific projects for certain periods.

What is research?
The federal regulations and CDC/OD/ADS office define research as a systematic investigation, including
research development, testing and evaluation, designed to develop or contribute to generalizable
knowledge. Activities that meet this definition constitute research, regardless if these activities are
conducted or supported under a program that is not considered research for other purposes. For
example, demonstration and service programs sometimes include research activities.

What is a human subject?
A human subject is a living individual about whom an investigator (whether professional or student)
conducting research obtains
1. data through intervention or interaction with the individual or
2. identifiable private information.

What is an intervention?
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
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What is private information?
Private information includes information about behavior that occurs in a context in which an individual
can reasonably expect that no observation or recording is occurring and information that has been
provided for specific purposes by an individual and that the individual can reasonably expect will not be
made public (e.g., a medical record). Private information identifies individuals (i.e., the identity of the
person is or might be readily ascertained by the investigator or associated with the information) for the
information to constitute research involving human subjects.

What does being “engaged” mean?
An institution becomes “engaged" in human subjects research when its employees or agents intervene
or interact with living individuals for research purposes, or obtains individually identifiable private
information for research purposes. An institution is automatically considered to be engaged in human
subjects research whenever it receives funding or resources (e.g., a direct award) to support such
research. In such cases, the awardee institution has the ultimate responsibility for protecting human
subjects under the award.

What is surveillance?
CDC defines surveillance as “the ongoing, systematic collection, analysis, and interpretation of health
data essential to the planning, implementation, and evaluation of public health practice, closely
integrated with the timely dissemination of these data to those who need to know. The final link of the
surveillance chain is the application of these data to prevention and control. A surveillance system
includes a functional capacity for data collection, analysis, and dissemination linked to public health
programs.”

What is program evaluation?
Program evaluation is the systematic collection of information about the activities, characteristics, and
outcomes of programs to make judgments about the program, improve program effectiveness, or inform
or guide decisions about future program development. Program evaluation should not be confused with
treatment efficacy, which measures how well a treatment achieves its goals and that can be considered
research.

Sources (links)
 http://intranet.cdc.gov/od/oads/osi/hrpo/
 http://www.hhs.gov/ohrp/index.html

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Project Title: Z-CAN Contraceptive Access Pilot Project: Client Follow-up
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PROJECT REQUEST
Project Stage
Choose one by selecting a checkbox:
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New: Fill out entire form, even if a protocol is attached (approval is for work by CDC/NCHHSTP employees).
Continuation: For projects expected to continue beyond NCHHSTP approved date; include brief description
of changes and attach clean and marked copies of approved determination (approval is for continued work
by CDC/NCHHSTP employees).
Amendment: Include brief description of changes and attach relevant documentation and a copy of
approved project (approval is for continued work by CDC/NCHHSTP employees).

Project Information:
Project Title: Z-CAN Contraceptive Access Pilot Project: Client Follow-up
NCHHSTP Project Number: Not assigned at this time

Division: DASH

Project Location/Country(ies):
Puerto Rico

Telephone: (404) 718-8145

CDC Project Officer or CDC Co-Leads:

Heather Clayton, PhD, MPH; Euna August, PhD, MPH, MCHES

Project Dates:
Start 08/22/2016
End 07/30/2017
Laboratory Branch Submission:
If applicable, select the checkbox:

Project Categories
Select the corresponding checkbox to choose the category and subcategory.
■

I. Activity is not human subject research. The primary intent of the project is public health practice or a disease
control activity.
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A. Epidemic or endemic disease control activity; collected data directly relate to disease control. If this
project is an Epi-AID; provide the Epi-AID number and documentation of the request for assistance,
per division policy. Epi-AID no.
B. Routine disease surveillance activity; data will be used for disease control program or policy
purposes.

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C. Program evaluation activity; data will be used primarily for that purpose.
D. Post-marketing surveillance of effectiveness or adverse effects of a new regimen, drug, vaccine, or
device.
E. Laboratory proficiency testing.
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II. Activity is not human subjects research. The primary intent is public health program activities.
A. Public health program activity (e.g., service delivery; health education programs; social marketing
campaigns; program monitoring; electronic database construction or support; development of patient
registries; needs assessments; and demonstration projects to assess organizational needs, management,
and human resource requirements for implementation).
B. Activity is purely administrative (e.g., purchase orders or contracts for services or equipment).
III. Activity is research but does NOT involve identifiable human subjects.
A. Activity is research involving collection or analysis of data about health facilities or other
organizations or units (i.e., not individual persons.)
B. Activity is research involving data or specimens from deceased persons.
C. Activity is research using unlinked or anonymous data or specimens: ALL (1–4) below are required:
1. No one has contact with human subjects in this project; and
2. Data or specimens are or were collected for another purpose; and
3. No extra data or specimens are or were collected for this project; and
4. Identifying information was (one of the following boxes must be checked)
a. not obtained;
b. removed before this submission, or before CDC receipt, so that data cannot be linked
or re-linked with identifiable human subjects; or
c. protected through an agreement (i.e., CDC investigators and the holder of the key
linking the data to identifiable human subjects enter into an agreement prohibiting
the release of the key to the investigators under any circumstances. A copy of the
agreement must be attached.)
IV. Activity is research involving human subjects, but CDC involvement does not constitute “engagement in
human subject research.” Select only one option by checking the box: A indicates the project has current
funding; B or C indicates no current funding is applicable.
A. This project is funded under a grant, cooperative agreement, or contract award mechanism. ALL of
the following 3 elements are required:
1. CDC staff will not intervene or interact with living individuals for research purposes.
2. CDC staff will not obtain individually identifiable private information.
3. Supported institution(s) must have a Federalwide Assurance (FWA), and the project must be
reviewed and approved by a registered IRB or an institutional office linked to the
supported institution’s FWA.*
Supported institution of primary investigator or co-Investigators/entity name:*

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Project Title: Z-CAN Contraceptive Access Pilot Project: Client Follow-up
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Supported institution/entity FWA Number:*
FWA expiration date:*
Expiration date of IRB approval:*
*Attach copy of IRB approval letter(s) supporting project review and approval.
B. CDC staff provide technical support that does not involve possession or analysis of data or interaction
with participants from whom data are being collected (no current CDC funding).
C. CDC staff are involved only in manuscript writing for a project that has closed. For the project, CDC
staff did not interact with participants and were not involved with data collection (no current CDC
funding).

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Project Title: Z-CAN Contraceptive Access Pilot Project: Client Follow-up
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Project Description
Participating project staff must complete all 18 elements of this section.
This is a required description from CDC employees or staff for review and approval of a project plan or
proposal (or for changes) for projects conducted by CDC or in which CDC is involved. All 18 elements
are required to standardize the review and approval process across NCHHSTP, document that all 18
elements have been addressed, expedite review and approval by the NCHHSTP ADS or ADLS office, and
minimize CDC/OD/ADS office audit requests for additional information. A protocol may be attached to
this form, but it does not eliminate the requirement to complete all 18 elements.
PROJECT TITLE: Z-CAN Contraceptive Access Pilot Project: Client Follow-up

Instructions: Use the following boxes to complete the 18 items. Each box will expand as you type, and you are not
limited in the length of your answers. Formatting features and symbols also may be used.
1. CDC Principal Investigator(s) or Project Directors and branch/division/office affiliations:
Heather Clayton, PhD, MPH (co-lead): NCHHSTP/DASH (working in EOC Zika Response)
Euna August, PhD, MPH, MCHES (co-lead): NCHHSTP/DHAP (working in EOC Zika
Response)

2. CDC Project Officer(s) and each person’s role and responsibilities and affiliations:

T'Ronda Flagg - Public Health Advisor; NCCDPHP (working in EOC Zika Response)

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
CDC Personnel:
Denise Jamieson, MD, MPH, CAPT - USPHS - NCCDPHP/DRH/MIHB
Margaret (Peggy) Honein, PhD, MPH - NCBDDD/BD/OD
Eva Lathrop, MD, MPH - CDC Pregnancy and Birth Defects Team
Lisa Romero, DrPH, MPH - NCCDPHP/DRH/OD
Erin Berry-Bibee, MD, MPH - NCCDPHP/DRH/OD
Kate Curtis, PhD, MPH - NCCDPHP/DRH
Collaborating investigators and institutions:
Turquise Sidibe and Reema Bhakta - Project officers at CDC Foundation.
Nabal Bracero, MD - Medical Director and President, PROGyn (implementing partner of Z-CAN program)

4. Institution(s) or other entity(ies) funding the project:
CDC Foundation

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Project Title: Z-CAN Contraceptive Access Pilot Project: Client Follow-up
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5. Project goals:

The goal of the Z-CAN client follow-up survey is to determine if the Z-CAN program has been
implemented as intended.

6. Project objectives:
1. To determine what brought the client to the Z-CAN provider for contraceptive services; 2.
contraceptive method preference and influence of Z-CAN provider counseling on method
preference; 3. client experience with Z-CAN service providers; and 4. client satisfaction with
services received.

7. Public health (program or research) needs to be addressed:
The Zika Contraception Access Network (Z-CAN) was established by CDC Foundation to address an urgent need to improve
contraception access in Puerto Rico during the Zika outbreak, to give women who want to delay or avoid pregnancy effective
means to do so, and to avoid the devastating impact of Zika infection in pregnancy. The proposed client survey is intended to
address an important question –whether or not women who have participated in a Z-CAN contraception counseling visit felt that
they were able to freely choose a method of contraception, and that the method they received through Z-CAN was the method
chosen. The client follow-up survey conducted within 1-2 weeks of the client’s initial Z-CAN program visit will assure that Z-CAN
clients received contraception counseling in a manner that was free from coercion.

8. Population(s) or groups to be included:
The target population for Z-CAN is women of reproductive age (15 to 44 years) in Puerto Rico.
Women who have participated in Z-CAN are eligible to participate in the client follow-up survey.

9. Project methods:
The follow-up survey will include 3200 women who consent to follow-up contact, who have been recruited consecutively
from among women who visit any Z-CAN provider in Puerto Rico. These women will be invited to participate in an
anonymous web-based survey application (platform is not yet selected – likely will be high level survey monkey with HIPAA
level protections) through their preferred means of contact, email or text, 1-2 weeks following their visit with the Z-CAN
provider. CDC staff will rapidly analyze the data using a statistical plaform such as SAS. Analyses will include frequencies,
cross-tabs, and multivariable modeling. Findings will be communicated with Z-CAN providers to improve service provision.

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10. Selection, inclusion, or sampling of participants (persons or entities):
ENROLLMENT
During the initial Z-CAN visit, the Z-CAN client will receive a notification of follow-up contact that describes the follow-up contact planned for monitoring and evaluation of the Z-CAN program (Appendix A). This letter
explains the purpose of the follow-up activities, and provides information on how clients can opt out of participation in follow-up activities.
SELECTION PROCESS
All Z-CAN clients (age 15 to 44 years) who are interested in participating in follow-up activities will be eligible to participate. 3,200 women will be invited to participate in the follow-up survey. Women will be selected
consecutively, so as to assure adequate capture of data during the peak mosquito season (August 2016 to November 2016) – a time that may heavily influence women’s intentions to delay or prevent pregnancy in the
context of the ongoing Zika outbreak in Puerto Rico. Furthermore, this time period is early in the implementation of the Z-CAN program, and from a monitoring perspective, it is important to identify problems with the
implementation of the Z-CAN program as early as possible, so that any necessary changes can be undertaken to improve service delivery while the program is still in the implementation phase.

11. Incentives to be provided to participants:

Participants will receive an incentive valued at $10 through an electronic gift card (electronic gift
card code can be sent to the same contact provided by the survey participant for the survey
invitation). The type of gift card has not yet been determined locally (e.g. fuel card, phone
minutes top up card, etc). Our program implementing partners (in Puerto Rico) will determine a
locally appropriate (and acceptable) type of gift card.
12. Plans for data collection and analysis:
Data will be collected from the client that focuses on the following: (1) what brought the client to the Z-CAN provider for contraceptive services; 2. contraceptive method preference
and influence of Z-CAN provider counseling on method preference; 3.client experience with Z-CAN service providers; and 4. client satisfaction with services received.
DATA ANALYSIS
A Z-CAN staff member with access to both the Z-CAN program and Z-CAN follow-up questionnaire data will link the Z-CAN client’s data by the unique Z-CAN identifier – the Z-CAN
client ID number. For example, data from the Z-CAN client initial encounter form (see attachment) and the client follow-up survey will be linked using the Z-CAN unique ID number,
which is assigned to the client during her initial Z-CAN visit. Data from the Z-CAN client follow-up survey will be analyzed with a statistical software package such as SAS with
SUDAAN (for weighted data if necessary) or STATA. Analyses of the quality of the client-centered contraceptive counseling, as well as comparison of contraceptive methods used
before and directly after the initial Z-CAN visit will be conducted using appropriate analytic tests (e.g., chi-square tests, multivariable logistic regression).

13. Confidentiality protections:
There are several protections in place for human subjects in this project:
• All Z-CAN staff who work with potential identifiers will receive training in ethics and protection of human subjects – through an online course such as CITI.
• No identifying information will be collected on the follow-up questionnaire.
• No identifying information will be collected on any other Z-CAN client forms or questionnaires.
• The client notification document with the client’s signature remains with the client’s medical chart at the Z-CAN program office. This document will not be transferred to the Z-CAN program office.
• Only the client’s Z-CAN ID number, first name, email address and/or phone number will be transmitted to the Z-CAN program office. Data is transmitted securely – through a fax to a fax machine in a locked office, or through a secure FTP site. Only Z-CAN program staff who have been
certified in human subjects training, and who are authorized to work with the client contact information database will have access to client contact information for the purposes described in this protocol.
• Z-CAN clients will receive an electronic link to the online follow-up survey through an email invitation or through a text message on their smart phone (whichever the Z-CAN client prefers). This link will be described generically as a “satisfaction survey.” The Z-CAN program will not be
mentioned by name in the invitation link. This description is vague enough to prevent someone who may have access to the invitation (who is not the target participant), from immediately knowing the purpose of the survey, and also consistent enough with the language regarding the
survey used in the notification of follow-up contact for the Z-CAN participate to connect the request with Z-CAN. This is an added layer of protection for the Z-CAN client. No additional identifiers will be collected on the questionnaire form, nor any other Z-CAN program data collection
instruments.
• All electronic files will have restricted access. The client contact information database will be password protected. Back-up files of data will be password protected and securely stored.
• Access to all electronic data and contact information files will be restricted to Z-CAN program staff who will receive training in ethics and protection of human subjects (personnel TBD – hiring processes underway shortly).
• The web-based survey does not contain identifiers. All data from the questionnaire will be stored with only the Z-CAN client ID. The Z-CAN ID is need to link follow-up questionnaire data to the Z-CAN client’s intake data (e.g. initial encounter form).
• Data collected through the survey and other Z-CAN program documents (e.g. initial intake form) do not contain identifiers. While the data is not sensitive, it will be handled securely. Datasets will be developed in Puerto Rico at the Z-CAN program offices, and transferred securely to CDC
through use of secure file transfer protocol, or password protected email attachments.
• CDC will not include information in reports that may identify Z-CAN clients. Information that could potentially be used to indirectly identify an individual will be suppressed; for example, aggregated data will not be stratified into subcategories that might allow for identification of individuals.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
None to discuss.

15. Projected time frame for the project:
Data collection must begin as soon as possible. The anticipated time frame is August 22, 2016
to June 30, 2017.

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16. Plans for publication and dissemination of the project findings:
Project findings will presented through presentations (e.g., conferences, stakeholder meetings),
reports, and publications (peer-reviewed).

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
Protocol
Follow-up questionnaire
Notification document
Z-CAN Master List Template
Z-CAN initial encounter form

18. References (to indicate need and rationale for project):
Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. NEJM; 2016 Mar 3;
374(9):843-52.
Dehlendorf C, Henderson JT, Vittinghoff E, Grumbach K, Levy K, Schmittdiel J, et al. Association of the quality
of interpersonal care during family planning counseling with contraceptive use. Am J Obstet Gynecol. 2016;
Briggs, L. Discourses of forced sterilization in Puerto Rico. Differences. 1998; 10(2):30-66.
Briggs, L. Contraceptive programs: the risk of coercion. Women’s Health Journal. 1994; 52-53.

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Project Title: Z-CAN Contraceptive Access Pilot Project: Client Follow-up
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PROJECT APPROVAL
Choose one of the following options (Division or Center/OD Project)

DIVISION PROJECT

NCHHSTP BRANCH AND DIVISION ADS REVIEW AND APPROVAL (Sign electronically by clicking next to the X
and following the prompts)

X

Jeanne M.
Bertolli -S

Digitally signed by Jeanne M. Bertolli -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1000660578,
cn=Jeanne M. Bertolli -S
Date: 2016.08.19 08:24:34 -04'00'

Branch Chief or Branch Science Officer

X

Stephen
Banspach -S

Digitally signed by Stephen Banspach -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1001274135,
cn=Stephen Banspach -S
Date: 2016.08.21 12:19:42 -04'00'

Division ADS, Acting ADS, or Deputy ADS

CENTER/OD PROJECT

NCHHSTP OD OFFICE REVIEWS AND APPROVALS (Sign electronically by clicking next to the X and following
the prompts)

X

X

Office Associate Director or Designee

NCHHSTP ADS or Designee

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Project Title: Z-CAN Contraceptive Access Pilot Project: Client Follow-up
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NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL
Project Title: Z-CAN Contraceptive Access Pilot Project: Client Follow-up

Date received in NCHHSTP ADS or ADLS office: 08/22/2016
Date received by NCHHSTP Deputy ADS or ADLS:
Select the checkbox for each applicable comment for Nos. 1–5 or select the checkbox for No. 6 if all of the comments apply.
Additional applicable comments may be added to No. 7. If additional information is required before approval can be
granted, select No. 8.

1. This project is approved by NCHHSTP/CDC and CDC (per CDC policies and federal regulations) for CDC staff
participation.
2. Participating partners and sites must obtain project review and approval, according to their institutional
policies and procedures and according to local, national, and international regulations and laws, including
45 CFR 46 regulations and state laws. CDC project officers must maintain a current copy of local sites’
approvals in project records.
3. CDC investigators and project officers need to adhere to the highest ethics standards of conduct and to
respect and protect the privacy, confidentiality, autonomy, data, welfare, and rights of participants and
integrity of the project. All applicable country, state, and federal laws and regulations must be followed.
4. Informed consent or script is needed as required by laws and regulations. Information conveyed in an
informed consent or script process needs to address all applicable required elements of informed consent.
Consent of employees in related projects about their institutions needs to include a statement that their
voluntary participation or withdrawal would not affect their employment status or opportunities.
5. OMB Paperwork Reduction Act determination by the NCHHSTP OMB/PRA Coordinator might be needed for
this project.
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6. All previous comments apply.
7. Other applicable comments: Type your comment in the box. The space will expand as you type.

8. More information is required before approval is granted: Explain what additional information is requested by
typing in the box. The space will expand as you type.

Date Information was requested:
Date Information was received:

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Approval must be granted by the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Associate
Director for Science (ADS), Acting ADS, or Deputy ADS, or for laboratory-associated projects, by the Associate
Director for Laboratory Science (ADLS) or Acting ADLS.

Project Title: Z-CAN Contraceptive Access Pilot Project: Client Follow-up

X

Janella
Dodson

Digitally signed by Janella Dodson
DN: cn=Janella Dodson,
o=NCHHSTP, ou=OADS,
[email protected], c=US
Date: 2016.08.22 22:42:45 -04'00'

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

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