Att 37 Project 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: Program Monitoring of the National Network of Sexually Transmitted Disease Clinical Prevention Training Centers (N
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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: Program Monitoring of the National Network of Sexually Transmitted Disease Clinical Prevention Training Centers (NN
NCHHSTP Project Number: To be determined

Division: DSTDP

Project Location/Country(ies):
U.S.A.

Telephone: (404) 718-8525

CDC Project Officer or CDC Co-Leads:

Jami Risley, Ph.D.

Project Dates:
Start 10/30/2016
End 10/30/2019
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.
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.
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).
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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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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: Program Monitoring of the National Network of Sexually Transmitted Disease Clinical Prevention Training Centers (N
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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: Program Monitoring of the National Network of Sexually Transmitted Disease Clinical Prevention Training Centers (N

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:
Jami Fraze Risley, Ph.D., PDQIB/DSTDP/NCHHSTP/CDC

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

Jami Fraze Risley, Ph.D., PDQIB/DSTDP/NCHHSTP/CDC: Project Officer who will oversee the
evaluation from CDC.

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
n/a

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

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5. Project goals:
This monitoring project will help us learn:
1. how many primary care health professionals (who care for at-risk populations for STDs) receive NNPTC training and technical
assistance activities.
2. how many primary care health professionals (who care for at-risk populations for STDs) report increased knowledge about the
CDC’s STD Treatment Guidelines and put them into practice.
3. If and how health professionals attending training and technical assistance activities think that NNPTC services can be improved.

6. Project objectives:
This monitoring project will examine primary care health professionals' satisfaction with NNPTC services and
changes in knowledge, skills, and practice patterns as a result of NNPTC training and technical assistance.
Specifically, this information will be used to:
• Assess the quality of services delivered by the NNPTC;
• Assess changes in primary health care professionals' knowledge and skills, of NNPTC service delivery; and
• Identify and address programmatic areas of improvement.

7. Public health (program or research) needs to be addressed:

National Network of STD Prevention Training Centers (NNPTC)

8. Population(s) or groups to be included:
Health care providers (e.g., physicians, nurse practioners, physicians assistants, and nurses)
who provide treatment for STDs in patients and who attend training or receive technical
assistance delivered by the NNPTC.

9. Project methods:
Data will be collected primarily online or in-person at training and technical assistance events
using surveys with closed- and open-ended questions.

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10. Selection, inclusion, or sampling of participants (persons or entities):

Health professionals wanting to attend NNPTC training will complete the NNPTC Abbreviated
Health Professional Application for Training (NNPTC HPAT).

11. Incentives to be provided to participants:

CDC will not provide incentives to participants.

12. Plans for data collection and analysis:
The NNPTC HPAT is administered online through an NNPTC Learning Management System. After NNPTC training or technical
assistance has been delivered, the Learning Management System automatically sends each registrant an invitation to complete
an on-line Post-Course Evaluation Instrument corresponding to the type of course attended or type of technical assistance
received. The invitation contains a link to the appropriate web-based Post-Course Instrument. Approximately 90 days after the
training or technical assistance the NNPTC’s Learning Management System sends an invitation with a link to an online Long
Term Evaluation Instrument corresponding to the course or technical assistance attended.

13. Confidentiality protections:
The NNPTC Abbreviated HPAT is the only instrument that collects categories of information in identifiable format from individual respondents
such as: name, work mailing address, work phone numbers, work email address, and work organization. These identifiable NNPTC HPAT data
elements are needed to send information about the training or technical assistance for which they have registered, send electronic invitations to
complete evaluation instruments, and identify county of workplace and type of employment setting. Analysis of evaluation measures is done by
the NNPTC’s National Evaluation Center. The NNPTC Abbreviated HPAT data transmitted to CDC will include no identifying information. A
unique identifier will be generated for all data collection instruments to enable linking data from multiple data collection tools. The unique
identifier consists of the first two letters of the first name, first two letters of the last name, month of birth, and day of birth.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
The CDC NCHHSTP PRA Coordinator reviewed this submission and determined that the
Privacy Act does not apply to this activity.

15. Projected time frame for the project:
10/31/2016-10/31/2019.

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16. Plans for publication and dissemination of the project findings:
Information from this evaluation will be shared in annual reports with CDC, in relevant public
health conference presentations and practitioner-based journal articles.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
In order to sufficiently monitor this program, there are 7 Post-Course Evaluation Instruments that correspond to the content and length of
training session and 7 corresponding Long-Term Evaluation Instruments. The Evaluation Instruments correspond to the type of content and
length of the training session.
Attachments 5 & 7: Intensive Complete Post-Course and Long-Term Evaluations
Attachments 9 & 11: Intensive Didactic Post Course and Long-Term Evaluations
Attachments 13 & 15: Practicum Post-Course and Long-Term Evaluations
Attachments 17 & 19: Wet Mount Post-Courser and Long-Term Evaluations
Attachments 21 & 23: STD Treatment Guidelines Complete Post-Course and Long-Term Evaluations
Attachments 25 & 27: STD Treatment Guidelines Short Post-Courser and Long-Term Evaluations
Attachments 29 & 31: Basic Post-Course and Long-Term Evaluations

18. References (to indicate need and rationale for project):
DSTDP has funded NNPTC services for STD training efforts for over 30 years. However, there
has not been an overall monitoring system to evaluate the NNPTC’s services in the aggregate.
Moreover, there has not been a monitoring process in place to determine the degree to which
NNPTC clients were satisfied with NNPTC services nor an assessment of whether NNPTC
services resulted in health care professionals' knowledge about current STD screening,
diagnosis, and treatment methods.

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Project Title: Program Monitoring of the National Network of Sexually Transmitted Disease Clinical Prevention Training Centers (N
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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

Deborah W.
Gould -S

Digitally signed by Deborah W. Gould -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1000220686,
cn=Deborah W. Gould -S
Date: 2016.09.29 17:05:48 -04'00'

Branch Chief or Branch Science Officer

X

Frederick
Bloom -S

Digitally signed by Frederick Bloom -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1000343387,
cn=Frederick Bloom -S
Date: 2016.09.29 16:38:22 -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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NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL

Project Title: Program Monitoring of the National Network of Sexually Transmitted Disease Clinical Prevention Training Centers (N

Date received in NCHHSTP ADS or ADLS office:
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.
■

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: Program Monitoring of the National Network of Sexually Transmitted Disease Clinical Prevention Training Centers (N

X

Janella
Dodson -S

Digitally signed by Janella Dodson -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People, cn=Janella Dodson -S,
0.9.2342.19200300.100.1.1=1000626972
Date: 2016.10.04 13:28:33 -04'00'

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

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