Research Determination

Print Date: 3/14/23

Title:

Focus groups among adults with or caring for individuals with congenital heart defects (CHD), muscular dystrophy (MD), and spina
bifida (SB)

Project Id:

0900f3eb820e6f9b

Accession #:

NCBDDD-RDHOT-1/23/23-988e4

Project Contact:

Hollie A Clark

Organization:

NCBDDD/DBDID/BDMR/RDHOT

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

09/25/2023

Estimated Completion Date:

09/24/2026

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

Determinations
Determination

Justification

Completed

Entered By & Role

3/9/23

Campbell_Scott (sic3) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation
Quality Assurance / Improvement

PRA:
PRA Applies

3/9/23

Herron_Adrienne R. (xwj9) OMB / PRA

Description & Funding
Description
Priority:

Standard

Date Needed:

03/21/2023

Determination Start Date:

03/09/23

Description:

This surveillance project will conduct focus groups to obtain firsthand perspectives on the types of care adults (18 years and older)
with MD, SB, and CHD receive with a special focus on: medical care (including specialist care) and barriers and facilitators to
accessing, receiving, or reengaging in care; experiences around the transition from pediatric to adult care; experiences with clinics
that provide care according to specific care considerations; and the journey to diagnosis. Also, for MD and SB, perspectives will be
gathered from caregivers of children or adults with specific condition types. Each focus group will be virtual (i.e., conducted using
chat and recording-enabled videoconferencing software).

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:

No

IMS Activation Name:

Not selected

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

The purpose of this project is to conduct focus groups among adults living with or caring for individuals with congenital heart defects
(CHD), muscular dystrophy (MD), and spina bifida (SB) to obtain firsthand perspectives on the types of care individuals receive with
a special focus on: receipt of and access to medical care and barriers and facilitators to accessing, receiving, or reengaging care;
the journey to diagnosis; the transition period from pediatric to adult care (for persons diagnosed during childhood); and experiences
with clinics that provide care according to specific care considerations.

Objective:

The objective of this surveillance project is to obtain data that will enable federal, state, and local governments and organizations to
understand the perceived barriers to specialty care for adults with CHD, MD, and SB, allocate resources, establish programs
accordingly, address gaps in the literature, inform future surveillance, research, and data collection, and gather individual
perspectives that may be shared with clinicians and inform clinical care.

Does this project include interventions, services, or No
policy change work aimed at improving the health of
groups who have been excluded or marginalized and
/or decreasing disparities?:
Project does not incorporate elements of health
equity science:

Not Selected

Measuring Disparities:

Not Selected

Studying Social Determinants of Health (SDOH):

Yes

SDOH Economic Stability:

Not Selected

SDOH Education:

Not Selected

SDOH Health Care Access:

Yes

SDOH Neighborhood and Environment:

Not Selected

SDOH Social and Community Context:

Not Selected

SDOH Indices:

Not Selected

Other SDOH Topics:

Not Selected

Assessing Impact:

Not Selected

Methods to Improve Health Equity Research and
Practice:

Not Selected

Other:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Other - Adults with a congenital heart defect, muscular dystrophy, or spina bifida

Tags/Keywords:

Heart Defects, Congenital ; Muscular Dystrophies ; Spina Bifida Cystica ; Focus Groups ; Health Services Accessibility

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 ; CDC employees or agents will obtain or use anonymous or unlinked
data or biological specimens ; CDC employees will participate as co-authors in presentation(s) or publication(s) ; CDC is providing
funding

Method Categories:

Focus Group
CDC project staff will submit a task order to the Office of the Associate Director#s blanket purchase agreement (OADC BPA) and
via technical review panel, select a vendor to perform project activities. OADC BPA vendors include large and small businesses with
the capacity and capabilities to perform focus groups (see: https://intranet.cdc.gov/oadc/create-it/access-to-communication-servicesthrough-gsa-schedules.html). CDC will draft preliminary eligibility screeners and focus group discussion guides and work with the
contractor to finalize these items. The contractor will develop a work plan, recruitment plan, and data management plan for review
and final approval by CDC project staff. For CHD focus groups the contractor will recruit adults 19 years and older who participated
in the Congenital Heart Survey to Recognize Outcomes, Needs and well-beinG (CH STRONG). Between 2016 and 2019, CH
STRONG was administered to adults ages 19-38 with a confirmed CHD diagnosis, born in Arizona, Arkansas, and 5-county Metro-

Methods:

Atlanta, Georgia. CH STRONG assessed many factors, including access to care and healthcare utilization. Through survey
responses we will identify a subpopulation of respondents whose last cardiology encounter was ?3 years before survey completion,
who agreed to follow-up contact, and who provided a mailing and/or email address. The CDC will provide the contractor with the
residential address and/or email information for individuals who are eligible to be contacted for focus group participation. For MD
and SB focus groups, the contractor will implement the final recruitment plan developed for the project. The contractor will conduct
virtual focus groups for each condition and participant type (i.e., individual with the condition or a caregiver), for a total of 46 focus
groups. For CHD, 16 focus groups will be conducted with participants that have a CHD and have been out of cardiac care for three
or more years. For MD and SB, the contractor will perform 30 focus groups with adults 18 years or older, including 3 with individuals
with Duchenne or Becker muscular dystrophy (DBMD); 3 with adult caregivers (i.e., parent or other household member) of children
(younger than 18 years) with DBMD; 3 with individuals with facioscapulohumeral dystrophy (FSHD); 3 with individuals with myotonic
dystrophy (DM); 3 with individuals with limb girdle muscular dystrophy (LGMD); 3 with adult caregivers (i.e., parent or other
household member) of children with congenital or juvenile onset myotonic dystrophy (DM); 3 with adult caregivers (i.e., parent or
other household member) of children with congenital MD (CMD); 3 with participants with SB (excluding spina bifida occulta); 3 with
adult caregivers (i.e., parent or other household member) of children (younger than 18 years) with SB (excluding spina bifida
occulta); and 3 with adult caregivers (i.e., parent or other household member) of adults (18 years and older) with SB (excluding
spina bifida occulta).

Collection of Info, Data or Biospecimen:

For this project, a contractor will collect qualitative data via 46 virtual focus groups consisting of 5-8 participants each. Focus group
recordings will be transcribed, coded, and synthesized. The de-identified data will be submitted to the CDC along with final CHD,
MD, and SB summary reports void of personal identifiers (e.g., void of name, date of birth, county of residence, or other identifying
information).

Expected Use of Findings/Results and their impact:

Findings will be presented at internal CDC meetings, to partners, and at national conferences and submitted for publications in peerreviewed journals. Findings may improve understanding of individual's perspectives of healthcare access and utilization, barriers to
specialty care, transition of care, and the needs and experiences of individuals with CHD, MD, or SB.

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 this project covered by an Assurance of
Confidentiality?

No

Does this activity meet the criteria for a Certificate
of Confidentiality (CoC)?

No

Is there a formal written agreement prohibiting the
release of identifiers?

No

Funding

Funding
Type

Funding Title

Funding
#

CDC
Contract

Multiple Award Blanket Purchase Agreement (BPA) for Health Marketing Support Services for the CDCs Office of the
Associate Director for Communication (OADC)

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

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research

Original
Budget Yr

# Years
Award

Budget
Amount

2020

5

100000000.00

Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations

Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp. Date

CITI Biomedical
Exp. Date

Catharine
Riley

12/22
/2024

Hollie Clark

02/10
/2025

03/27/2023

Jennigije
Reefhuis

04/06
/2025

10/05/2024

Shannon
Moss

10/15
/2024

10/19/2024

Sherry
Farr-mus

11/28
/2025

CITI Social &
Behavioral Exp. Date

Staff Role

Email

Phone

Organization

Co-Investigator

xan2@cdc.
gov

4044983330

RARE DISORDERS AND HEALTH
OUTCOMES TEAM

Contract Officer
Representative

hdc3@cdc.
gov

4046393983

RARE DISORDERS AND HEALTH
OUTCOMES TEAM

Co-Investigator

nzr5@cdc.
gov

4044983917

EPIDEMIOLOGY TEAM

10/19/2024

Co-Investigator

sez7@cdc.
gov

4046391314

EPIDEMIOLOGY TEAM

12/30/2024

Co-Investigator

bwa0@cdc.
gov

4044983877

LIFESPAN SURVEILLANCE &
RESEARCH TEAM

03/13/2026

CITI Good Clinical
Practice Exp. Date

Data
DMP
Proposed Data Collection Start Date:

9/25/23

Proposed Data Collection End Date:

9/24/26

Proposed Public Access Level:

Restricted

Restricted Details:
Data Use Type:

Data Sharing Agreement

Data Use Type URL:
Data Use Contact:

Public Access Justification:

MD, SB, and CHD are rare diseases for which the constellation of clinical characteristics and diagnoses can be very unique and
potentially identifiable. These data will be restricted to ensure that they will not be used in any way except for statistical reporting
and analysis; will not be shared with anyone without approval from project collaborators; will not be used to learn the identity of any
person or establishment; and that reasonable measures will be used to protect all individual-level data from eye observation, theft,
or accidental loss or misplacement. Access will be granted if a researcher's proposal is
approved by the project publication committee, is sponsored by a principal investigator, and after a Confidentiality and Data Use
Acknowledgement form has been signed and returned to CDC project staff.

How Access Will Be Provided for Data:

The contractor selected to collect data for this project will be identified based on offers submitted by OADC BPA vendors (see
https://intranet.cdc.gov/oadc/create-it/access-to-communication-services-through-gsa-schedules.html). OADC BPA vendors are
required to have current Federal Wide Assurance and adhere to any OMB, IRB, and Privacy Act requirements. From the OADC
BPA, p. 13: "The Contractor shall be responsible for properly protecting all information used, gathered, or developed as a result of
work under a resulting BPA. In addition, the Contractor shall protect all Government data, files, equipment, etc. by treating the
information as sensitive. Sensitive but unclassified information, data, and/or equipment will only be disclosed to authorized
personnel as described in the Task Order. The Contractor shall ensure that appropriate administrative, technical, and physical
safeguards are established to ensure the security and confidentiality of this information, data, and/or equipment is properly
protected. When no longer required, this information, data, and/or equipment shall be returned to Government control; destroyed; or
held until otherwise directed by the Contracting Officer. Items returned to the Government shall be hand carried or mailed to the
Contracting Officer#s Representative. The Contractor shall destroy unneeded items by burning, shredding or any other method that
precludes the reconstruction of the material." CDC will receive de-identified data from the focus groups, along with summary
documents of findings. These data and documents will be kept on password protected systems only accessible by the contract
organization and CDC project staff.

Plans for Archival and Long Term Preservation:

Spatiality

Spatiality (Geographic Locations) yet to be added .....

Dataset
Dataset
Title

Dataset
Description

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Dataset yet to be added...

Supporting Info
Current

Current

CDC Staff
Member and
Role

Clark_Hollie A.
(hdc3)
Project Contact

Date Added

Description

Supporting Info Type

Supporting Info

02/06/2023

OADC BPA RFQ template
/Performance Work Statement for
"Focus groups among adults with
or caring for individuals with
congenital heart defects, muscular
dystrophies, and spina bifida"

Statement of Work

MD SB CHD FGs_OADC BPA RFQ_02032023.docx