Project determination

AttJ_STARS_Determination.pdf

Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery

Project determination

OMB: 0923-0047

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Project Determination
EFFECTIVE RISK COMMUNICATION FOR WATER-RELATED EMERGENCIES
AND DISEASE OUTBREAKS
Project ID:

0900f3eb81c2d7a0

Accession #:

-NCEH-10/1/20 -fae24

Project Contact:

Brake_Heather (hhb9)

Organization:

OS/OS/OSI

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

11/01/20

Estimated Completion Date:

10/01/21

CDC/ATSDR HRPO/IRB Protocol#:
OMB Control#:

Description
Priority
Standard

Date Needed
11/24/20

Determination Start Date
11/10/20

Description
This study is a series of 9 individual focus groups taking place across three cities. The focus groups will be discussing participant's experience with water-related
emergencies and their preference for receiving public health information before, during, and after the incident.

IMS/CIO/Epi-Aid/Chemical Exposure Submission
Yes

IMS Activation Name
2019 Novel Coronavirus Response

CIO Emergency Response Name
Not selected

Epi-Aid Name
Not selected

Assessment of Chemical Exposure Name
Not selected

Goals/Purpose
The intent of this activity is to identify needs and develop best communication practices to individuals during water emergencies.

Objective
1. Identify and understand the experiences and communication needs of the general public who have received communications regarding water emergencies.
Identify best methods/platforms for receiving these communications during public health emergencies such as flooding, hurricanes, and disease outbreaks. 2.
Discuss determinants of health behaviors during water-related emergencies among adults who experienced them. 3. Discuss sources, tone, format, and placement
of health communication materials during water-related emergencies. 4. Discuss ways to prepare the public for water-related emergencies. 5. Discuss
communication strategies and materials for post-emergency recovery.

Activities or Tasks
New Collection of Information, Data, or Biospecimens

Target Population to be Included/Represented
General US Population

Tags/Keywords
Water Pollutants: Drinking Water: Floods

CDC's Role
Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design and data collection as a condition
of any funding provided

Method Categories
Focus Group

Methods
1. The contractor will recruit a sample of U.S. adults who have experienced a diverse range of water emergencies to participate in nine virtual focus groups of at
least 10 individuals per group. Recruitment will occur in the following three communities: Wilmington, NC, Salem, OR, and Newark, NJ. There will be three focus
groups in each city for a total of nine. The contractor will use screening and recruitment materials developed by CDC and follow CDC’s guidance. 2. Recruitment
will occur as follows: The contractor will post an advertisement in the local newspaper one week prior to the focus group study taking place. Participants can
register to participate via website. Targeted social media will be used in each of the cities to recruit participants. When clicking on the tweet, participant will be

directed to a web page to find more information about the focus group and to sign up to be contacted for the phone screening survey. Name, phone number and
email address will be collected for each individual. If the individual is eligible to participate, they will receive a confirmation email about their eligibility and the date
and time of the focus group. An email will be sent out to each participant 3-days prior to the focus group and on the day of to remind participants of the event and
provide the address for the focus group.

3. As participants arrive, the trained contractor will direct them to sign the consent form and provide additional

instructions for participating. The contractor will explain to participants that the focus group is expected to take 90 minutes and that they will receive a gift card as
a token of appreciation upon completion.

4. The contractor shall conduct the focus groups to examine determinants of determinants of health behaviors during

water emergencies among U.S. adults who have experienced a diverse range of water emergencies, as well as test existing health materials (provided by CDC)
used during these emergencies. Each focus group will last 90 minutes. Three focus groups will be conducted in each of the following three communities:
Wilmington, NC, Salem, OR, and Newark, NJ. 5. The contractor will use a trained moderator to conduct the focus groups who uses best practices for focus group
moderation such as using probes, encouraging participation, minimizing moderator bias, and managing group dynamics. The moderator will use a semi-structured
focus group guide developed by CDC to guide the focus group discussion. Focus groups will be conducted in an environment conducive to discussion. This includes
conducting the focus groups in an environment that is comfortable, quiet, nonthreatening, and free of distractions; and situating focus groups such that
participants and the focus group moderator are seated around a circular or rectangular table. 6. The independent contractor will obtain informed consent from
focus group participants based on protocols, and using materials, developed by CDC.

Collection of Info, Data, or Bio specimens
The independent contractor will audio record the focus groups using at least two digital audio recording devices at opposite parts of the room to ensure that all
participants are heard.

The independent contractor will use a non-participatory observer to take field notes during the virtual focus group. The observer should be

in the videoconference and may take notes as an observed with their video camera on, but audio muted. Field notes should include key quotes or expressions,
facial or body language, and attribution of comments when multiple people are talking at once. The independent contractor will share with CDC the field notes from
the focus groups using a password protected, encrypted, FTP site supplied by CDC. The independent contractor will transcribe the focus group discussion audio
recordings verbatim, which captures both the words spoken by the participants and the facilitator. The independent contractor will identify the speaker with
appropriate titles (P1, P2, I, etc.), label transcripts with interviewer identifier, speaker identifier, participant’s emotions in brackets, and features of natural speech
and expression (um, oh). All transcripts should be anonymized to eliminate identifiers (e.g., real names of participants, institutions/locations that may identify an
individual). The independent contractor will share with CDC the transcripts from the focus groups using a password protected, encrypted, FTP site supplied by CDC.

Expected Use of Findings/Results and their impact
The results of the focus group discussions will provide suggestions to standardize and ensure consistent delivery of risk communications messages, improve
implementation of public health recommendations for mitigating risks, and help communities address environmental issues in the most impactful manner. In
addition, the data will be used to show site differences in delivery of activities, respondent knowledge, perceptions, and community interactions. With input and
oversight from a CDC health communications specialist, the independent contractor will develop a final creative concept, taking into account the feedback during
the focus group discussions on messages, tone, pictures, font, colors, and organization of content. Upon approval from CDC, the final creative concept will be used
to develop health promotion materials. These materials might include, but are not limited to: Print materials (e.g., brochure, reminder/tip sheet, fact sheets),
videos and audio podcasts that can be posted on CDC and partner websites, public services announcements, digital media tailored content (e.g., apps, shareable
images, quizzes or engagement resources), posters, banners, social media infographics.

Could Individuals potentially be identified based on Information Collected?

Yes

Will PII be captured (including coded data)?
Yes

Does CDC have access to the Identifiers (including coded data)?
Yes

Is an assurance of confidentiality in place or planned?
No

Is a certificate of confidentiality in place or planned?
No

Is there a formal written agreement prohibiting the release of identifiers?
No

Funding
Funding Type

Funding Title

Funding #

Original Fiscal
Year

# of Years of
Award

CDC Contract

Testing Effective Risk and Crisis Communication

2019-36009-02

2019

2

Messages for Water Emergencies $350,000

HSC Review
HSC Attributes
Program Evaluation
Yes

Quality Assurance / Improvement
Yes

Regulation and Policy
Do you anticipate this project will be submitted to the IRB office:
No

Institutions
Institution

FWA #

FWA Exp.
Date

IRB Title

IRB Exp. Date

Funding #

Staff
Staff Member

SIQT Exp.
Date

Heather Brake

11/13/2022

Citi
Biomedical
Exp. Date

Citi Social
and
Behavioral
Exp. Date

Citi Good
Clinical Exp.
Date

Staff Role

Email

Phone #

Organization/
Institution

Co-Investigator

hhb9@cdc.

404-639-

NATIONAL

gov

3323

CENTER FOR
ENVIRONMENTAL
HEALTH

DMP
Proposed Data Collection Start Date

11/02/20

Proposed Data Collection End Date

06/30/21

Proposed Public Access Level

Public

Public Access justification

Once identifiers are removed, we will be able to publish the information collected about the public's
learning styles and preferences for risk communications materials on water-related emergencies.

How Access Will Be Provided for Data

Data will not be shared in a raw form, but rather as an aggregate through peer reviewed
publications.

Plans for archival and long-term preservation of

Screening forms, digital audio-recordings of focus group discussions, transcriptions, and any other

the data

electronic documents containing sensitive data will be stored only on password-protected computers
located in locked offices. Physical documents, such as screeners, and informed consent documents
will be stored securely in locked cabinets or offices.

Spatiality (Geographic Location)
Country
United States

State/Province

County/Region

Determinations
Determination

Justification

Completed

Entered By & Role

HSC:

Not Research / Other

10/09/20

Abel_Jason A. (jza5) CIO HSC

11/10/20

Abel_Jason A. (jza5) CIO OMB / PRA

11/10/20

Zirger_Jeffrey (wtj5) ICRO Reviewer

Does NOT Require HRPO
Review

45 CFR 46.102(l)

Program Evaluation
Quality Assurance / Improvement
PRA:
PRA Applies
ICRO:
Returned with No Decision


File Typeapplication/pdf
AuthorAbel, Jason (CDC/DDNID/NCEH/OD)
File Modified2020-11-10
File Created2020-11-10

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