Human Subjects 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 REQUEST
Project Stage
Choose one by selecting a checkbox:
New: Fill out entire form, even if a protocol is attached (approval is for work by CDC/NCHHSTP employees).
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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: Data Collection Through Web Based Surveys for Evaluating Act Against AIDS Social Marketing Campaign Phases Ta
NCHHSTP Project Number: PN - 0128 (IRB Online #6184)

Division: Division of HIV/AIDS Prevention (DHAP)

Project Location/Country(ies):
Multiple U.S. cities

Telephone: (404) 639-8297

CDC Project Officer or CDC Co-Leads:

Euna August

Project Dates:
Start 05/01/2018
End 04/30/2022
Laboratory Branch Submission:
If applicable, select the checkbox:

Project Categories
Select the corresponding checkbox to choose the category and subcategory.
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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.
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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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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 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: Data Collection Through Web Based Surveys for Evaluating Act Against AIDS Social Marketing Campaign Phases T

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:
Euna M. August, PhD, MPH, MCHES, Division of HIV/AIDS Prevention (DHAP), Prevention
Communications Branch (PCB)

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

Euna August, PhD, MCHES, (DHAP/PCB) will be working as the Technical Monitor on the
project. Dr. August will be responsible for overseeing each individual data collection and daily
management of the project.

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
DHAP/PCB: A range of staff from the the PCB may serve as project members on individual data
collection projects under this PD. These may include: Tiffiany Aholou, PhD, MSW, Elana Morris,
MPH, Dayna Alexander, DrPH, MSPH, MCHES, Jocelyn Taylor, MPH, Ann Ussery-Hall, MPH, CHES
RTI International: A range of staff from CDC's evaluation contractor may serve as project members
for individual data collection projects including: Jennifer Uhrig, PhD, Vanessa Boudewyns, PhD,
Jennie Harris, MPH, and Monica Scales, PhD

4. Institution(s) or other entity(ies) funding the project:
No other entities are funding the project.

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5. Project goals:

The goal is to evaluate the effectiveness of AAA campaign phases and messages aimed at
increasing HIV/AIDS awareness, increasing prevention behaviors, and improving HIV testing
rates among consumers. Evaluation findings will be used for ongoing improvement of the AAA
campaign.

6. Project objectives:
The main objectives are to examine receptivity to messages and perceived credibility among
populations exposed to AAA phases and messages; differences in attitudes, beliefs, and
knowledge about HIV among those who report exposure and do not report exposure to AAA
phases and messages; intentions related to HIV prevention; and behaviors among those who
report and do not report exposure to the various AAA messages.

7. Public health (program or research) needs to be addressed:
Information obtained through this project will be used to improve campaign messages by
informing CDC and its stakeholders about the potential effects of campaign messages among
the targeted sample, identifying how campaign messages should be modified. Information
gained will also be used to support the ongoing evaluation of the AAA campaign. The data from
the proposed evaluation may be used to assess the appropriateness of continued or expanded
funding and dissemination of the campaign.

8. Population(s) or groups to be included:
Adults aged 18 to 64 from cities across the United States will be included in this project. Based
on the target audience for the campaign phase or messages, we will oversample subpopulations
disproportionately affected by HIV, such as people living with HIV (PLWH), gay and bisexual
men (MSM), transgender people, Blacks/African Americans, Hispanics/Latinos, young adults
(aged 18 to 29 years), and people who inject drugs (PWID).
9. Project methods:
Evaluation data will be conducted via 30-minute closed-ended, online surveys with up to 2,148 individuals
annually. The recruitment method will vary depending on the nature of the campaign phase or messages being
evaluated (see item #10 for specific methods). Potential participants will be recruited through online survey panel
vendors, external partners (e.g., community-based organizations, membership organizations), and the Internet.
Individuals will be screened for eligibility using a standardized screening form. If eligible, individuals will be invited
to participate. Participants will self-administer the survey at home on their personal computer or devices.

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10. Selection, inclusion, or sampling of participants (persons or entities):
We will employ non-probability purposive sampling to recruit participants from cities across the United States. The
samples for the surveys will consist of participants selected from a combination of sources, including (1) online survey
vendors with proprietary panel lists, (2) external partners (e.g., community-based or membership organizations), and
(3) the Internet. Inclusion criteria will depend on the specific AAA phase being evaluated and the target population for
the messaging. The informed consent process and screener will be combined. Participants who consent will
complete the screener, and if eligible, they will be linked to the online survey.

11. Incentives to be provided to participants:
Participants will be offered a token of appreciation of $20-$40 cash or cash equivalent for taking part in a survey;
higher amounts will be offered for data collections involving specific audiences known to be difficult to reach (e.g.,
MSM, PLWH). By providing monetary incentives, we can improve coverage of specialized respondents, rare
groups, or minority populations, including MSM, transgender men and women, African Americans, and Hispanics.
Including these respondents is important to this study to improve the generalizability of findings and ensure that
the campaign materials reflect the information needs and perspectives of those at highest risk for HIV.

12. Plans for data collection and analysis:
The web-based surveys will be self-administered and accessible any time of day for a designated period. All data collection
materials are at an 8th grade reading level or below due to sample eligibility criteria and CDC requirements.
Each respondent can complete the survey only once. Data from completed surveys will then be compiled into an SPSS
(Statistical Package for the Social Sciences) dataset by the survey vendor and sent to the evaluation contractor for analysis,
with no information in identifiable form (IIF). Descriptive statistics (frequencies, means, and standard deviations) will be
calculated. Additionally, a variety of statistical analyses, including independent samples t-tests, chi-square tests, and one-way
analysis of variance, will be conducted to identify any statistically significant, group-level differences.

13. Confidentiality protections:
RTI, CDC's evaluation contractor, maintains restricted access to all data preparation areas (i.e., receipt and coding). All data files on multi-user systems will be under the control of a
database manager, with access limited to project staff on a “need-to-know” basis only. The online vendor panels take the following security measures to ensure separation between
participants’ identity and their survey data. First, the survey instrument does not contain PII. The only way a survey is identified is with a digital identification number. Second,
although the invitation method (i.e., e-mail, mail, or direct mail) will inherently have PII information included, this will not be combined with survey responses so the responses from
the survey cannot be linked to the PII. Third, screener data will be considered part of the survey data. The vendors will provide the results of the screener questions for all panelists,
regardless of whether they qualify for the study. However, they will not retain responses to screening questions for those who are deemed ineligible for any other purpose outside the
scope of this project. Fourth, the vendors will retain study records for the duration of the study. Upon final delivery of data files to RTI and completion of the project, the vendors will
destroy all study records, including data files, upon request. The vendors will not be able to supply or access this information for any reason, even at the request of RTI, once
destroyed. Finally, data coming directly from the survey engine are stored in a proprietary database. Although these data are not encrypted, once inside the firewall, they are stored
in a relational database protected by several layers of intrusion detection and access control. Data files delivered to RTI by the vendors will be sent via encrypted files. CDC will not
be provided with PII.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
Individuals may be uncomfortable answering questions related to sexual orientation or behavior, HIV
status, or substance use. However, participants are told that they can skip any question that makes
them feel uncomfortable. In addition, it is possible that someone else (e.g., family member, friend) could
view the survey on the participant’s computer with or without his/her knowledge, which could lead to
conflict or cause discomfort. The consent form suggests that participants take the survey in a private
location and reminds them to close their browser window when they are finished taking the survey.

15. Projected time frame for the project:
The projected time frame is 5/1/2018 to 4/30/2022, depending on the OMB approval process.

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16. Plans for publication and dissemination of the project findings:
Data collected will be analyzed and incorporated into written evaluation report(s). The findings
may also be published in peer-reviewed journal articles and/or presented at scientific
conferences.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
See attached documents:
Attachment 3: Potential Survey Items
Attachment 4: Sample Participant Consent Form
Attachment 5: Sample Email Invitation and Reminder for Non-Responders
Attachment 6: Sample Study Screener
Attachment 7: Identification of and Justification for Sensitive Questions

18. References (to indicate need and rationale for project):

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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

Jo E. Stryker S

Digitally signed by Jo E.
Stryker -S
Date: 2018.04.02 08:32:02
-04'00'

Branch Chief or Branch Science Officer

X

signed by Laura J.
Laura J. Fehrs Digitally
Fehrs -S
Date: 2018.04.16 12:46:48
-S
-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: Data Collection Through Web Based Surveys for Evaluating Act Against AIDS Social Marketing Campaign Phases T

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.
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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: Data Collection Through Web Based Surveys for Evaluating Act Against AIDS Social Marketing Campaign Phases Ta

X

Alcia A.
Williams -S6

Digitally signed by Alcia A.
Williams -S6
Date: 2018.04.17 12:47:41
-04'00'

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

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