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
(nchstphs@cdc.gov) 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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12/18/2015

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: Network Epidemiology of Syphilis Transmission
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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: Network Epidemiology of Syphilis Transmission
NCHHSTP Project Number: 7082

Division: DSTDP

Project Location/Country(ies):
Baltimore MD, Columbus OH, Chicago IL

Telephone: (404) 639-8659

Project Dates:
Start 05/02/2017
Robert Kirkcaldy (hgl8); Kyle Bernstein (kio8); Alex de Voux (yxj3)
End 03/31/2020

CDC Project Officer or CDC Co-Leads:

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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Project Title: Network Epidemiology of Syphilis Transmission
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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:*
John Hopkins School of Medicine
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Project Title: Network Epidemiology of Syphilis Transmission
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Supported institution/entity FWA Number:* 00005752
FWA expiration date:* 09/16/2020
Expiration date of IRB approval:* 01/22/2019
*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: Network Epidemiology of Syphilis Transmission
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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: Network Epidemiology of Syphilis Transmission

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:
Robert Kirkcaldy ESB/DSTDP/NCHHSTP
Kyle Bernstein ESB/DSTDP/NCHHSTP
Alex de Voux ESB/DSTDP/NCHHSTP

2. CDC Project Officer(s) and each person’s role and responsibilities and affiliations:
Kyle Bernstein, Robert Kirkcaldy:
Monitoring of grantee progress toward achieving study objectives
Ensuring that analyses and dissemination of study are conducted collaboratively by both CDC and participating study sites. Working with awardees to assure that study activities, at both the
awardee and CDC level, adhere to NCHHSTP data security and confidentiality guidelines.
Alex de Voux:
Co-ordination of development of methods and protocols for this study.
Facilitation of routine activity-related communications.
Provision of guidance and technical assistance (where requested or identified by CDC) essential to implementation of activities in compliance with these protocol.
Facilitating CDC clearance for manuscripts and presentations based on study findings.
Coordination of routine conference calls and annual collaboration meetings to review and plan program activities
Coordination of technical assistance facilitating secure electronic transmission of data

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
Yetunde Fakile, LRRB/DSTDP/NCHHSTP
Mayur Shukla, LRRB/DSTDP/NCHHSTP
Cheng Chen, LRRB/DSTDP/NCHHSTP
Ellen Kersh, LRRB/DSTDP/NCHHSTP
Ohio State University:
Abigail Norris-Turner
William Miller
Baltimore City Health Department:
Patrick Chaulk
Johns Hopkins School of Medicine:
Jacky Jennings
University of Illinois Chicago:
Richard Novak
Andrew Trotter
University of Chicago:
John Schneider

4. Institution(s) or other entity(ies) funding the project:
CDC/Division of STD Prevention

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Project Title: Network Epidemiology of Syphilis Transmission
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5. Project goals:

The goal of the NEST study is to address knowledge gaps in the transmission of syphilis among
men who have sex with men (MSM) in the United States by exploring the role of sexual and
social networks. In addition NEST will pilot the use of survey instruments to collect complex
longitudinal sexual network data among MSM at high risk for syphilis in the United States.

6. Project objectives:
The project objectives are to:
1) Understand how the structure and composition of networks of men who have sex with men (MSM) at increased risk of syphilis, that are
composed of sexual and social connections, change over time and contribute to the transmission of syphilis.
2) Estimate the incidence of new and repeat syphilitic infections among MSM at increased risk for syphilis.
3) Examine the individual social and sexual risk behaviors of MSM and how they change over time and contribute to the transmission of
syphilis.
4) Evaluate health care (and other service) access and usage patterns among MSM.
5) Explore longitudinal titer changes among MSM with incident, prevalent and repeat syphilis.

7. Public health (program or research) needs to be addressed:
The United States is currently experiencing an ongoing syphilis epidemic. After reaching historically low rates in 2000 and 2001, the national rate of reported primary and secondary (P&S) syphilis has
increased nearly every year since then1. Reported primary and secondary syphilis cases and case rates increased by 67% between 2011 and 2015, and reported congenital syphilis cases and case rates
increased by 36% between 2011 and 2015. Gay, bisexual, and other men who have sex with men (MSM) are disproportionately impacted by syphilis. These sustained increases are especially concerning
given that reported cases of P&S syphilis continue to be characterized by a high rate of HIV co-infection, particularly among MSM. In 2015, in 31 states reporting both sex of sex partner and HIV status for at
least 70% of P&S syphilis cases, 49.8% of P&S syphilis cases among MSM with known HIV status were HIV-positive [1]. Syphilis can facilitate the transmission and acquisition of HIV infection [2–4]. In
addition, if left untreated, syphilis is associated with significant clinical complications, such as ocular syphilis and neurosyphilis. The recent resurgence of syphilis in the United States has been accompanied
by increased reports of visual impairment and blindness due to ocular syphilis [5–6].
Although the majority of incident syphilis cases in the United States occur among MSM, factors influencing transmission within this population, such as social and sexual network characteristics, sexual
behaviors, and health care utilization, are poorly understood. This study will attempt to address the knowledge gaps in the transmission dynamics and epidemiology of syphilis among MSM in the United
States. A better understanding of how these factors relate to the risk of syphilitic infection or re-infection will help inform prevention efforts for this key population. Understanding the complexities of the
epidemiology of syphilis among MSM beyond the individual level is critical to the development of effective interventions. This study will explore the potential role of sexual and social networks in MSM syphilis
epidemics and how these networks interact to transmit syphilis in a population, including repeated syphilitic infection in individuals.

8. Population(s) or groups to be included:
MSM who are 18 years or older and residing in the metropolitan statistical area (MSA) of
Chicago Illinois, Baltimore Maryland, or Columbus Ohio.

9. Project methods:
This will be a multi-site study enrolling a target sample of 720 MSM aged ≥ 18 years from three different geographic areas of the United States (~240 MSM per area). Assuming a 70–80% retention of
participants across the study period, study sites will aim to recruit a total of 240 MSM per site. The three geographic areas are: Chicago. Illinois; Baltimore, Maryland; and Columbus, Ohio. These men will
need to provide consent and meet specific inclusion criteria. The specific methods of contact and required consenting will be governed by each site’s IRB requirements.
Study participation will include up to nine in-person visits i.e., a baseline visit and follow-up visits every 3-months thereafter for a total period of 24 months. At the baseline visit, study staff will provide a
description of the study and administer a screener to assess eligibility. If the respondent is deemed eligible, written obtain will be obtained. All in-person visits will include completion of a survey (capturing
sexual behaviors, healthcare access and other variables), enumeration of the participant’s sexual network and clinical tests to determine infection with syphilis, HIV, chlamydia, and gonorrhea.
Routine clinical care, as per local clinical policies, will be followed for the collection of diagnostic specimens, clinical evaluation, treatment and any required clinical follow-up. The usual clinical management of
participants, and partners, will not be modified as a result of this study.
Five specimens (two serum samples, one rectal swab, one pharyngeal swab, and one urine specimen) will be collected as part of this protocol at each visit. A portion of the serum sample will be used for
standard of care testing for syphilis and HIV infection. A portion of the serum sample will be sent to the CDC for confirmatory testing and (if consent from the participant is obtained for specimen storage and
future use) biospecimen banking. The extragenital and urine specimen will be used for standard of care testing for N. gonorrhoeae and C. trachomatis.

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Project Title: Network Epidemiology of Syphilis Transmission
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10. Selection, inclusion, or sampling of participants (persons or entities):
Specific criteria of the target population at each of the participating site may differ depending on the local epidemiology. Sites may therefore have a more restrictive list of inclusion criteria. Inclusion criteria will serve as the minimum set of criteria. The criteria for participants to enroll in this
study are that they:
• have not previously participated in the syphilis research study, • are at least 18 years of age, • live in the participating MSA or Division, • identify as male AND assigned male sex at birth, • report having sex (oral or anal sex) with a man in the past 6 months, • had at least 1 sexual partner in
the past 6 months, • are able to provide contact and locator information for planned study visits,• are lucid at time of consent and interview (“lucid” is defined as the ability to understand a basic description of the study and to meaningfully respond to interview questions), • do not have any
medical conditions that would interfere with study participation and attendance at planned study visits.
Respondent Driven Sampling (RDS) will be the primary basis of recruitment. RDS is a chain-referral strategy in which a small number of men (“seeds”) are recruited into the study as participants and also serve as starting points for the chain-referral process. RDS has been found to be
effective for recruiting populations that are “hidden” or difficult to reach and that are connected by strong social networks and ties. RDS is comprised of four main activities: 1) formative research to identify potential networks and inform operating procedures for study implementation; 2)
recruiting, screening and interviewing of “seeds” or initial recruits; 3) screening and interviewing persons who present a valid coupon to project staff; and 4) training eligible participants to recruit others.
Study staff will recruit men into the study as the initial seeds. Seeds will complete all study activities as any other study participant. Each seed will then be asked to recruit a maximum of 6 individuals that they know and think meet the study eligibility criteria. Recruitment of other individuals
for the study is voluntary. Participants who are enrolled into the study after having been referred will complete all study activities and will be asked to recruit others. This recruitment process continues until the target sample size has been reached. There may be variation in the specific RDS
strategy employed at each site in order to reach the target population and the best methods for determining the criteria for selecting men as “seeds” and for identifying “seeds” will be determined locally by the sites.
The final sample of 240 MSM per site will be generated from approximately 20 seeds. Across the study, target enrollment is a total of 720 enrolled participants (three study sites contributing 240 men from each site).

11. Incentives to be provided to participants:
Participants will receive an incentive at each study visit in order to compensate for their time and
transportation-related expenses. The specific amount will range between $40 and $70 per study visit
depending on the study site location and reflect differences in the cost of living, median earning wage
and travel costs across the three study sites. Participants will also receive $20 for each new
participant they recruit into the study and $2 for each weekly smartphone survey they complete.

12. Plans for data collection and analysis:
There are three study grantees, two universities (Ohio State University and University of Illinois at Chicago) and one local health department (Baltimore City Health Department) in collaboration with a university (Johns Hopkins School of Medicine). The
recruitment of study participants as well as the data collection activities will be carried out at university-affiliated sites including local health departments, community LGBT organizations, local STD clinics and HIV/AIDS care facilities.
Before starting any data collection activities a short eligibility screener (Appendix 2) will be administered to prospective study participants and if determined to be eligible consent from the participant will be obtained. The screener will be administered by
local study staff and is estimated to take about 2 minutes to complete. Once consent (Appendix 3) is obtained data collection will begin and will include a baseline visit and follow-up visits every three months for a total follow-up period of 24 months. At each
visit participants will provide biological specimens (blood and urine) to facilitate testing for syphilis, gonorrhea, chlamydia, and HIV. In addition to providing biological specimens, participants will complete a standardized survey which will be delivered
electronically on a tablet or computer and will collect information on the participants’ sexual network, individual behaviors, healthcare access and demographics (Appendix 3). The survey consists of 13 questionnaire modules with a range of 5 to 15
questions per module. A small subset of sexual behavior questions will be delivered to the participant closer to real time using an open survey format and a weekly format (Attachment 5). The open survey format is a brief survey that participants can
respond to at any to record a sexual encounter or other event. The weekly format will be sent on Sunday nights with a reminder on Monday evening, to address sexual behavior in the last week. These brief surveys will also be delivered electronically to
participants and each survey is expected to take 2 minutes or less. Data collected on electronic devices will be stored on a secure web-accessible local server at each site which will only be accessible with a user name and password. Study site
investigators provided input (based on knowledge of relevant local communities) into development of the survey. Participant identifiable information will not be discernable from the data transmitted to the CDC.
Participant interview data will be maintained in electronic format by collaborating sites. Every third month, the local NEST site data manager will compile, clean, de-identify, recode, and transmit data to CDC through a secure access management system
(SAMS). At CDC, data will be downloaded from SAMS, stored, and maintained by a data manager in the Surveillance and Data Management Branch, Division of STD Prevention, of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.

13. Confidentiality protections:
Study staff will always conduct surveillance activities in ways that adhere to ethical principles and standards by respecting and protecting to the
maximum extent possible the privacy, confidentiality, and autonomy of participants.
All study staff will sign a confidentiality statement. Newly hired staff will sign a confidentiality statement before access to study data is authorized.
This statement will include language indicating that data will not be released to unauthorized individuals. The original statement will be held in the
employee’s personnel file and a copy given to the employee. Staff will sign the confidentiality statement on an established periodic basis e.g.,
annually.
Data sent to the CDC will not contain any personal identifiers such as name, social security number, date of birth, street address, or medical
record number.

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

15. Projected time frame for the project:
5/2/2017-3/31/2020

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Project Title: Network Epidemiology of Syphilis Transmission
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16. Plans for publication and dissemination of the project findings:
Findings from this study are likely to result in national and local products and publications. CDC is responsible for disseminating national reports, usually via the Morbidity and Mortality Weekly Report (MMWR) and
other peer-reviewed journals. CDC will also present at national conferences and meetings. Local study sites are responsible for disseminating local results to health department officials and the public by presenting
results at conferences, preparing reports for community planning groups, or publishing results in peer-reviewed journals.
CDC will have the principal responsibility for analyzing and disseminating multi-site data. The CDC analyses will focus primarily on questions related to the primary and secondary objectives of this study described in
section 5. Multi-site reports, presentations, and publications will include at least one named author (up to 2 named authors) from each site submitting data and at least one CDC author, and in some cases may include
additional named authors from CDC. These authors will be included as individual contributing authors. Furthermore, contributors from study sites and CDC who are not included as named authors will be acknowledged
as part of the study working group “NEST Working Group” which will be included as an author. Published reports should include mention of names of collaborators who make up the NEST working group either as a
footnote or as an acknowledgement.
Local study sites will retain full rights to analysis, research, and publication of their locally collected data. Any use of study data should be discussed with the study site principal collaborators and CDC. CDC encourages
sites to inform CDC and other study site principal investigators of site-specific analyses of data in order to promote and stimulate use of data. Study sites are encouraged to establish Community Advisory Boards
(CABs) or similar organizations to transmit study findings to the target community and any stakeholders within the community. It is encouraged but not necessary to include a CDC staff as a co-author on any
publications reporting findings from a site-specific analysis. All presentations, abstracts, or manuscripts with a CDC co-author listed will need to undergo CDC clearance prior to submission or presentation.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
Appendix 1. Study protocol
Appendix 2. Eligibility screener
Appendix 3. Generic consent form
Appendix 4. Data elements
Appendix 5. IRB approval letter

18. References (to indicate need and rationale for project):
1. Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2015. Atlanta: U.S. Department of Health and Human Services; 2015.
Available at https://www.cdc.gov/std/stats15/std-surveillance-2015-print.pdf
2. Jarzebowski W, Caumes E, Dupin N, et al. Effect of early syphilis infection on plasma viral load and CD4 cell count in human immunodeficiency virus-infected men:
results from FHDH-ANRS CO4 cohort. Archives of Internal Medicine 2012; 172: 1237–1243.
3. Buchacz K, Patel P, Taylor M, et al. Syphilis increases HIV viral load and decreases CD4 cell counts in HIV-infected patients with new syphilis infections. AIDS 2004;
18: 2075–2079.
4. Fleming DT, Wasserheit JN. From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual
transmission of HIV infection. Sexually Transmitted Infections 1999; 75: 3–17.
5. Woolston S, Cohen SE, Fanfair RN, et al. Notes from the field: A cluster of ocular syphilis cases — Seattle, Washington, and San Francisco, California, 2014–2015.
Morbidity and Mortality Weekly Report (MMWR) 2015; 64(40): 1150–1151. Available at https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6440a6.htm
6. Centers for Disease Control and Prevention. Clinical advisory: Ocular syphilis in the United States. Updated March 34, 2016. Available at:
https://www.cdc.gov/std/syphilis/clinicaladvisoryos2015.htm
7. Higgins D.L., O’Reilly, K., Tashima, N., Crain, C., Beeker, C., Goldbaum, G., Elifson, C.S., Galavotti C., and Guenther-Grey, C. Using formative research to lay the
foundation for community level HIV prevention efforts: an example from the AIDS Community Demonstratio Projects. Public Health Rep, 1996. 111 Suppl 1:28–35.
8. Ulin, P., Robinson, E., and Tolley, E. Qualitative methods in public health research. A Field Guide for Applied Research. 2005, San Francisco, CA: Jossey-Bass.

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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

Kyle T.
Bernstein -S

Digitally signed by Kyle T.
Bernstein -S
Date: 2018.01.31 12:53:20
-05'00'

Branch Chief or Branch Science Officer

X

Jami Leichliter
-S

Digitally signed by Jami
Leichliter -S
Date: 2018.02.02 14:18:28
-07'00'

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: Network Epidemiology of Syphilis Transmission
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NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL
Project Title: Network Epidemiology of Syphilis Transmission

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: Network Epidemiology of Syphilis Transmission

X

Alcia A.
Williams -S6

Digitally signed by Alcia A.
Williams -S6
Date: 2018.02.12 14:56:38
-05'00'

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

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