Non-research Determination

Print Date: 2/23/22

Title:

Sudden Death in the Young

Project Id:

0900f3eb81e89294

Accession #:

NCCDPHP-PIHT-2/9/22-89294

Project Contact:

Carri Cottengim

Organization:

NCCDPHP/DRH/MIHB/PIHT

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

04/30/2022

Estimated Completion Date:

09/30/2030

CDC/ATSDR HRPO/IRB Protocol #:
0920-1092

OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

2/17/22

Redmond Leonard_Joan (jrl3) CIO HSC

2/18/22

Still-LeMelle_Terri (cse6) OMB / PRA

45 CFR 46.102(l)(2)

ICRO:
PRA Applies

OMB Approval date: 4/9/19
OMB Expiration date: 4/30/22

2/22/22

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Determination Start Date:

02/09/22

Description:

The Sudden Death in the Young (SDY) Case Registry improves and standardizes case ascertainment so that funded jurisdictions
can better understand the incidence and risk factors for sudden death in youth. Information collection and reporting builds on
existing, state-based procedures for Child Death Review (CDR). Through their existing CDR programs, awardees compile data for
an estimated 739 cases per year, on a defined set of SDY questions and enter it into the existing SDY module that is part of the
existing National Fatality Review-Case Reporting System (NFR-CRS) run through the Michigan Public Health Institute#s (MPHI)
National Center for Fatality Review and Prevention (NCFRP) program. Data is abstracted by states/jurisdictions from primary data
sources, including medical examiner/coroner reports, death investigation reports, medical records, and child protective services
records. For approximately 370 of these cases per year, awardee jurisdictions also convene an advanced review team with relevant
clinical expertise, including state health personnel, pediatric cardiologists, pediatric neurologists or epileptologists, and forensic
pathologists. Awardees funded under DP18#1806 for SDY surveillance comprehensively review individual cases information from
multiple data sources, discuss the information, and use the information to classify cases according to a standardized algorithm that
differentiates causes of death. Additional information from these advanced case reviews is entered into the SDY module. This is
non-research public health surveillance to establish the incidence of SDY in funded jurisdictions. CDC will provide technical
assistance, receiving de-identified data for quality assurance activities and surveillance reports.

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 Sudden Death in the Young (SDY) Case Registry gathers information to learn more about young people who die suddenly and
unexpectedly. Babies, children and young adults up to age 20 are included in the SDY Case Registry.
The objectives of the SDY Case Registry are to gather and store information about sudden child deaths to help to 1)count the

Objective:

number and types of sudden deaths in babies, children and young adults up to age 20, 2)try to understand the causes for the
deaths, 3)see if some children are more at risk of dying than others, and 4)find ways to prevent these deaths. Data is shared with
CDC, which uses the data to provide technical assistance to improve completeness (including missing and unknown responses)
and timeliness of completed cases.

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:

Yes

SDOH Education:

Yes

SDOH Health Care Access:

Not Selected

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:

General US Population ; Children ; American Indian or Alaska Native ; Asian ; Black or African American ; Hispanic or Latino ;
Native Hawaiian or Other Pacific Islander ; White ; Female ; Male

Tags/Keywords:

Infant Mortality ; Child Mortality

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 provide substantial technical assistance or oversight

Method Categories:

Surveillance Support
Information collection and reporting builds on existing state-based procedures for Child Death Review (CDR). Through their existing
CDR programs, for an estimated 739 cases, awardees compile data on a defined set of SDY questions and enter them into the
existing SDY module that is part of the existing National Fatality Review-Case Reporting System (NFR-CRS) run through the

Michigan Public Health Institute#s (MPHI) National Center for Fatality Review and Prevention (NCFRP) program. For approximately
370 SDY cases, awardee jurisdictions will convene an advanced review team with relevant clinical expertise, including state health
personnel, pediatric cardiologists, pediatric neurologists or epileptologists, and forensic pathologists. The advanced review team will
comprehensively review information from multiple data sources, discuss the information and use the information to classify cases
according to a standardized algorithm that differentiates causes. All the additional information from these advanced case reviews
including the classification of the death is entered into the SDY module. Data is shared with CDC who uses the data to provide
technical assistance to improve completeness (including missing and unknown responses) and timeliness of completed cases.

Methods:

Collection of Info, Data or Biospecimen:

Data about the death is abstracted from primary data sources, including medical examiner/coroner reports, death investigation
reports, medical records, and child protective services records. It is then entered into the web-based SDY module.

Expected Use of Findings/Results and their impact:

CDC shares findings with awardees and works with them by providing technical assistance to improve data over time. Data
analyses beyond quality improvement analyses conducted by CDC are determined by the awardees. Awardees use their data to
develop targeted prevention strategies to reduce the number of infant and childhood deaths. The data will be made available via
request only, and researchers can request data for analyses. These data inform our understanding of the epidemiology of SDY,
including the incidence, and risk factors. These data elements are used to establish incidence of SDY, inform prevention strategies
and develop best practices for multi-state surveillance of SDY.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

Budget Amount

CDC Cooperative Agreement

SUID and SDY Case Registry

DP18-1806

2018

5

2200000.00

HSC Review

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office
Estimated number of study participants

No

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

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

No Selection

Other method

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

Carri
Cottengim

01/14/2023

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

CITI Good Clinical Practice
Exp. Date

Staff Role

Project
Officer

Email

Phone

Organization

770-4884290

PERINATAL INFANT
HEALTH TEAM

Data
DMP
Proposed Data Collection Start Date:

9/30/18

Proposed Data Collection End Date:

9/30/23

Proposed Public Access Level:

Restricted

Restricted Details:
Data Use Type:

Research Data Center

Data Use Type URL:

www.keepingkidsalive.org

Data Use Contact:

[email protected]

Public Access Justification:

A public use data set is not generated because the data is governed by data use agreements between NCFRP and individual states
and these agreements allow only for data sharing to researchers who apply to use the data.

How Access Will Be Provided for Data:

Data can be requested using the following link https://www.ncfrp.org/resources/data-dissemination/ Researchers must be affiliated
with eligible Receiving Institutions (i.e., an institution of higher education, research organization, non-profit agency or government
agency that either employs or contracts with the Investigator). The Institution must be registered with the U.S. Office for Human
Research Protections. Any release of data will be subject to a signed Contract for Access to and Use of Data (Contract for Data)
between NCFRP and an authorized representative of the Receiving Institution. An Application for De-identified Dataset must identify
a principal investigator (PI). The PI serves as the primary point of contact for all communications involving the Contract for Data.
The PI must sign the Contract for Data, by which the PI assumes responsibility for compliance with all terms of the Contract for Data
by employees of the Receiving Institution, including the day-to-day security of the electronic data and all printed output derived from
the files. Each additional researcher who will have access to the NCFRP dataset must be identified on the Application for Data and
must sign a Confidentiality Agreement. The applicants may not release or permit others to release the dataset in whole or in part to
any persons other than those identified in the Application for Data. No data file that includes HIPAA-defined personally identifiable
elements is available to researchers. The complete Case Report tool contains more than 300 questions (approximately 2,600 data
elements) about an individual fatality. (The Case Report form can be viewed and downloaded at www.ncfrp.org.) Although states
often enter HIPPA-defined personally identifiable data elements (child#s name, address, date of birth, date of death, date of
incident, and incident county) into the NFR-CRS, all personally identifiable data elements will be removed from any dataset made
available to researchers. The data elements that will be removed from the dataset are listed in the Application for Access to Deidentified Dataset and in the DUA between NCFRP and the state. Due to the potentially large size of the data set and the labor
involved in assuring that identifiers are not inadvertently put into the narrative section. The #Narrative# field contained in Section O
of the Case Report form will only be released to researchers under special circumstances (i.e. smaller data sets).
All data submitted via the Internet using the NFR-CRS are stored on a server located within the MPHI Data Center. Data are stored
on this server indefinitely unless a state terminates the data use agreement. Per the Data Use Agreement, if a state terminates its
agreement, at their request, MPHI will remove all of the case data from its server. However, state data stored on back up tapes

cannot be removed, but it will never be reported or disseminated by MPHI. MPHI will maintain all data in accordance with Executive
Order 13556 -- Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies
and schedules and HHS/CDC policies and shall not dispose of any records unless authorized by HHS/CDC. De-identified data sets
submitted to CDC are also stored indefinitely. They are housed on CDC servers and managed by the CDC data steward. Currently
there are no anticipated storage concerns for this data. These data are considered official public records and are preserved
according to The Federal Records Act of 1950 (amended to 44 U.S.C. Chapter 31). Retention of such records will follow the
Scientific and Research Project Retention Schedule available at: http://intranet.cdc.gov/ocoo/docs/sbiu/records-management/bbscientific-research.docx.

Plans for Archival and Long Term Preservation:

Spatiality

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

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date