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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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: Message Testing with Non-U.S.-Born Individuals Considered at High Risk for Tuberculosis
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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).
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: Message Testing with Non-U.S.-Born Individuals Considered at High Risk for Tuberculosis
NCHHSTP Project Number:

Division: Division of Tuberculosis Elimination (DTBE)

Project Location/Country(ies):
United States

Telephone: (404) 639-8332

CDC Project Officer or CDC Co-Leads:

Molly Dowling, MPH and Leeanna Allen, MPH

Project Dates:
Start 02/01/2019
End 09/14/2019
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).
■

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: Message Testing with Non-U.S.-Born Individuals Considered at High Risk for Tuberculosis
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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: Message Testing with Non-U.S.-Born Individuals Considered at High Risk for Tuberculosis
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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: Message Testing with Non-U.S.-Born Individuals Considered at High Risk for Tuberculosis

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:
Nickolas DeLuca, PhD, Chief of the Communications, Education, and Behavioral Studies
Branch, CDC DTBE

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

Molly Dowling, MPH, Project Officer, CDC DTBE Communications, Education, and Behavioral
Studies Branch; Oversees project activities and timeline

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
John Parmer, PhD, CDC DTBE Communications, Education, and Behavioral Studies Branch
Leeanna Allen, MPH, CDC DTBE Communications, Education, and Behavioral Studies Branch
Everly Macario, Sc.D., M.S., Ed.M., IQ Solutions, Inc.
Alejandra Brackett, MPH, IQ Solutions, Inc.
Rachael Picard, MPH, IQ Solutions, Inc.
Renee Clapsadle, MSB, IQ Solutions, Inc.
4. Institution(s) or other entity(ies) funding the project:
N/A; Project funded by CDC

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Project Title: Message Testing with Non-U.S.-Born Individuals Considered at High Risk for Tuberculosis
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5. Project goals:

CDC’s DTBE seeks to conduct message testing with individuals who were born in the top six
countries of origin that contribute to the U.S.’s current TB rates—a critical target audience group
that is considered at high risk for TB disease. The primary goal for this effort is to explore
participants’ reactions to messages related to testing for and treating latent tuberculosis infection
(LTBI).
6. Project objectives:
• To better understand the variances in knowledge, attitudes, beliefs, and misconceptions around LTBI across audience segments
and geographic locations, as well as the motivators and barriers to getting tested and treated.
• To gather insights into LTBI messages (facts, information, concepts) and terms (language, wording) that are clear, effective, and
motivating as well as the best received tone(s) for those messages.
• To garner information on audience-trusted health information sources, audience-seeking healthcare behavior (including where
they obtain healthcare services), audience-preferred communication channels, and audience-preferred information material formats
to ultimately develop and disseminate resources tailored to and aimed at educating populations at high risk for tuberculosis.

7. Public health (program or research) needs to be addressed:
For decades governmental and nongovernmental agencies, researchers, healthcare providers, and community workers have worked tirelessly to eradicate TB worldwide; however, despite
these efforts, the disease still exists nationally, as well as globally. Currently, one-fourth of the world’s population is infected with TB; and in 2017, 10 million people around the world became
sick from it. In the United States (U.S.), 9,105 TB cases were reported last year (2017) alone, with most cases identified among persons who were born in, and/or frequently travel to,
countries with high TB rates. More specifically, 70.1 percent of U.S. cases in 2017 were attributed to persons who were born abroad, but who have since immigrated to the states.
Key strategies for reaching elimination status include educating high-risk populations about LTBI and the progression to TB disease; encouraging LTBI testing; getting those who do test
positive for LTBI into treatment; and ensuring they adhere to their treatment.
In order to develop effective messaging that educates individuals at high risk for TB, CDC DTBE seeks to test draft message statements with representatives of each audience segment,
learn their preferences for seeking information, and gain a better understanding of the various knowledge, attitudes, beliefs, and misconceptions around LTBI across the different audience
segments and geographic locations.

8. Population(s) or groups to be included:
Representatives from the top six countries of origin contributing to the U.S.’s TB rate: Mexico,
the Philippines, India, Vietnam, China, and Guatemala.

9. Project methods:
We will conduct 15 in-person focus groups with non-U.S.-born individuals considered at high risk for TB disease. We will conduct all focus groups in English. We will conduct all focus groups in five cities
representing different geographic regions in the U.S. Individuals participating in the focus groups will have immigrated from: Mexico, the Philippines, India, Vietnam, China, and Guatemala.
We will conduct between two and four focus groups in each of five metropolitan areas. We selected the cities based on 2017 TB case rate data, the latest population data, and locations which would provide a
geographically diverse sample. The metropolitan areas are: Chicago, Illinois; Houston, Texas; Miami, Florida; New York City, New York; and San Francisco, California. Each metropolitan area’s TB case rate
exceeds the national average of 2.8 cases per 100,000 population and represents metropolitan areas with some of the highest rates of TB within the U.S. Additionally, individuals born in the top countries of
origin for TB are well-represented among the populations of these cities.
Focus groups will be comprised of no more than nine participants each, and each discussion will last approximately 90 minutes.
We will test a total of 5 message themes/concepts/topic areas, with three to eight messages per theme, across the 15 focus groups. We will rotate themes and messages across focus groups (to test all
messages while not overburdening any one focus group).

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10. Selection, inclusion, or sampling of participants (persons or entities):
We will work with professional recruitment vendors, who are based in each proposed focus group geographic location, to recruit all focus group
participants. Participants must have been born in Mexico, the Philippines, India, Vietnam, China, or Guatemala.
For each focus group, we will aim to recruit a mix of men and women who have been in the U.S. for less than 10 years and those who have been in the
U.S. for more than 10 years, as well as a mix of participant demographic characteristics if/as possible. To further describe the participant sample, we will
also ask participants: their gender, age, education level, and total household income; where they typically get medical services; and their type of health
insurance (these questions are for descriptive purposes, not exclusion criteria). All participants must be at least 18 years of age and be able to speak and
read English clearly.

11. Incentives to be provided to participants:
We will provide a token of appreciation in the amount of $40 to each participant. Our team has recent
experience receiving approval from OMB on tokens of appreciation of this quantity for 90-minute in-person
focus groups. This quantity will allow the team to recruit the desired mix of participants within the limited time
frame we have to execute this project. A token of appreciation lower than this amount could introduce
recruitment challenges, including securing recruitment vendors and identifying participants willing to participate.

12. Plans for data collection and analysis:
We will hold the focus groups in facilities with one-way mirrors for in-person viewing. Live video-streaming capabilities will also be available for remote “real-time” viewing (as requested and as
possible). We will audio-record each focus group discussion. In addition, we will provide transcriptions of each focus group immediately following each discussion. The moderator and informed
consent form will inform participants of the live video-streaming and audio-recording features in advance of the discussion. The moderator will explain to participants that the live video-streaming will
be terminated at the end of each discussion and that there will be no archived video-recording for future viewing.
Following the conclusion of all focus groups, and receipt of all verbatim transcripts, we will analyze the data systematically using the qualitative analysis tool, Atlas.ti. All project team members will
arrive at consensus with respect to the findings, conclusions, and recommendations.
We will develop a comprehensive report that summarizes the findings and presents action-oriented recommendations. We will also develop a PowerPoint presentation to spotlight high-level
discussion findings.

13. Confidentiality protections:
All participants will provide written and signed informed consent to participate in the focus groups prior to their participation.
During the discussions, we will maintain participant privacy by using first names only (no last names). The moderator will never see information
connecting individual participants’ full names with their demographic characteristics or other personally identifiable information. Only one
non-CDC project team member (from IQ Solutions, the contractor) will keep, in a password-protected computer and excel spreadsheet, the list
containing participants’ full names connected with their personal characteristics. No personally identifiable information will be disclosed in the
project results or reporting. Further, information regarding a person’s health status or immigration status will not be collected.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
Almost all, if not all, of the questions asked will not be of a sensitive nature. There will be no requests for participants' Social Security Numbers. Demographic questions (i.e., gender, country
of birth, age, number of years in the U.S., level of education, race/ethnicity, income level, health insurance type, source of medical care)--collected only during the participant recruitment
process to confirm participant eligibility, assure a diverse mix of participants per focus group, and describe the focus group participant sample--could be considered sensitive, but not highly
sensitive. The informed consent protocol will apprise participants of the topics to be covered in the focus groups. This project includes a number of procedures and methodological
characteristics that will minimize potential negative reactions to potentially sensitive questions, including the following:
•
Participants will be informed that they need not answer any question that makes them feel uncomfortable or that they simply do not wish to answer.
•
Should participants have any questions or concerns about the project or their rights as a participant, participants will be provided with the telephone number of the project manager.
We will combine all focus group information collected in the aggregate when we report results in a summary report.
Raw data from this data collection effort will never become part of a system of records containing permanent identifiers that can be used for retrieval.
All data collection activities will be conducted in full compliance with CDC regulations to maintain the privacy of data obtained from participants.

15. Projected time frame for the project:
February 1, 2019 through September 14, 2019.

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16. Plans for publication and dissemination of the project findings:
DTBE may wish to publish findings from this project in relevant journals, such as the Journal of
Health Communication, American Journal of Public Health, Journal of Communication in
Healthcare, Preventive Medicine Reports, and Health Promotion Practice. DTBE may also wish
to submit conference abstracts for consideration at relevant meetings, including the National
Conference on Health Communication, Marketing, and Media and the American Public Health
Association Annual Meeting.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
A: Methodological Plan
B: Recruitment Screener
C: Moderator's Guide
D: Themes and Messages
E: Informed Consent Form
F: Educational PowerPoint

18. References (to indicate need and rationale for project):
Centers for Disease Control and Prevention. (2018). Data and statistics. Atlanta, GA: CDC. Retrieved October 26,
2018, from https://www.cdc.gov/tb/statistics/default.htm
Centers for Disease Control and Prevention. (2018). Reported tuberculosis in the United States. Atlanta, GA: CDC.
Retrieved October 26, 2018, from https://www.cdc.gov/tb/statistics/reports/2017/table1.htm
Centers for Disease Control and Prevention. (2018). Trends in Tuberculosis, 2017. Atlanta, GA: CDC. Retrieved
October 26, 2018, from https://www.cdc.gov/tb/publications/factsheets/statistics/tbtrends.htm
Centers for Disease Control and Prevention. (2018). Trends in Tuberculosis, 2017. Atlanta, GA: CDC. Retrieved
October 26, 2018, from https://www.cdc.gov/tb/publications/factsheets/statistics/tbtrends.htm
Centers for Disease Control and Prevention. (2018). Tuberculosis in the United States (Slide 13). Atlanta, GA: CDC.
Retrieved October 30, 2018, from https://www.cdc.gov/tb/publications/factsheets/statistics/tbtrends.htm

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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

Nick M.
Deluca -S

Digitally signed by Nick M.
Deluca -S
Date: 2018.12.12 10:19:44
-05'00'

Branch Chief or Branch Science Officer

X

Carla Winston
-S

Digitally signed by Carla
Winston -S
Date: 2018.12.13 15:56:54
-05'00'

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: Message Testing with Non-U.S.-Born Individuals Considered at High Risk for Tuberculosis
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NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL
Project Title: Message Testing with Non-U.S.-Born Individuals Considered at High Risk for Tuberculosis

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: Message Testing with Non-U.S.-Born Individuals Considered at High Risk for Tuberculosis

X

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

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