IRB determination

Attachment 5_Suicide Epi-Aid_ IRB Determination.docx

Rapid Response Suicide Investigation Data Collection

IRB determination

OMB: 0920-1243

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Project Determination


Investigation of an increase in suicide in Ohio, 2022



Project ID:

0900f3eb81fdf996

Accession #:

NCIPC-ST-9/21/22-df996

Project Contact:

Asha Ivey

Organization:

NCIPC

Status:

Pending Clearance

Intended Use:

Project Determination

Estimated Start Date:

10/31/22

Estimated Completion Date:

11/11/22

CDC/ATSDR HRPO/IRB Protocol#:


OMB Control#:






Description

Priority

Urgent

Date Needed

09/23/22

Priority Justification

Processing for Epi-Aid investigation

Determination Start Date

09/27/22

Description

The Ohio Suicide Prevention Foundation and the Ohio Department of Mental Health and Addiction Services contacted the Ohio Department of Health (ODH) in April of 2022, regarding possible increases in suicide deaths in several Ohio counties for the first quarter of 2022. ODH conducted preliminary data analysis of mortality data and syndromic surveillance data, and found that compared to quarter 1 of 2021, suicide deaths in Q1 of 2022 had increased by 550% in one county, 67% in another county, and 8% in Ohio overall. Several additional counties of interest were identified using syndromic surveillance as well. ODH requested assistance from CDC/NCIPC/DIP to conduct an Epidemiologic Assistance Investigation (Epi-Aid) to investigate this increase in suicide in Ohio. In this investigation we will provide technical assistance to ODH to help identify additional counties and populations experiencing an increase in suicide, investigate potential contributors to the increase in suicide, describe the epidemiologic characteristics of those who have died by suicide in Ohio in 2022 compared to previous years, and identify prevention strategies to reduce future suicide deaths.

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

Yes

IMS Activation Name

Not selected

Select the primary priority of the project

Not selected

Select the secondary priority(s) of the project

Not selected

Select the task force associated with the response

Not selected

CIO Emergency Response Name

Not selected

Epi-Aid Name

Investigation of an increase in suicide in Ohio, 2022

Lab-Aid Name

Not selected

Assessment of Chemical Exposure Name

Not selected

Goals/Purpose

This is an Epi-Aid (non-research) response project with the following purpose: to understand the epidemiologic characteristics of those who have died by suicide or experienced self-harm injuries in Ohio, since 2020

Objective

1. Identify increases in suicide and self-harm injuries by geography and demographic characteristics. 2. Describe the epidemiologic characteristics of those who had died by suicide in recent months compared to recent years and identify risk and protective factors. 3. Examine current suicide prevention initiatives and recommend strategies to prevent future suicides.

Does this project include interventions, services, or policy change work aimed at improving the health of groups who have been excluded or marginalized and/or decreasing disparities?

Yes

Project does not incorporate elements of health equity science

Not selected

Measuring Disparities

Yes

Studying Social Determinants of Health (SDOH)

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; Secondary Data or Specimen Analysis

Target Population to be Included/Represented

Other-Ohio Counties

Tags/Keywords

Suicide; Epidemiologic Methods; Ohio

CDC's Role

CDC employees or agents will obtain data by intervening or interacting with participants; 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

Individual Interview (Quantitative); Secondary Data Analysis

Methods

For objective 1, CDC will provide technical assistance to ODH as they conduct analyses to identify geographies and populations experiencing an increase in suicide. These analyses will include examining mortality data (from death certificates) and non-fatal self-harm acute care visits (syndromic surveillance data) for long- and short-term trends overtime to the present (from 2011 and 2020 respectively) to trends overtime from 2020 to the present. Statistical testing will be used to identify potential counties and populations of interest in which current counts of suicide and nonfatal self-harm injuries are higher than expected, compared to previous years. In objective 2, we will use data from the Ohio Violent Death Reporting System (OH-VDRS), death certificate records, and other sources as needed, to further characterize the suicides and self-harm injuries in 2022 that led to the Epi-Aid request. Statistical tests and analysis will determine if there have been changes in the association of suicide with a variety of independent variables, including, but not limited to, mechanism of suicide, socio-demographic characteristics, medical history, and precipitating factors known to be associated with suicide. For objectives 2 and 3, key informant interviews and possibly small group discussions will be conducted to better understand possible factors associated with observed increases in suicide deaths, current self-harm prevention strategies in Ohio, and intervention gaps and opportunities. The interview guide will be developed by the Ohio Department of Health, with CDC providing technical assistance. The Ohio Department of Health will have final say over the interview guide. Key informants will be identified by the Ohio Department of Health, and will likely include Ohio Department of Health, and the Ohio Suicide Prevention Foundation and the Ohio Department of Mental Health and Addiction Services, who initially contacted ODH about the increase in suicide in certain counties. Additional key informants may be identified during the deployment of the Epi-Aid and CDC will be participating in the interviews/group discussions. All activities, including data collection, will be conducted under the direction and supervision of the Ohio Department of Health, and the state of Ohio will retain ownership of all data involved in this Epi-Aid.

Collection of Info, Data, or Bio specimens

Key informant interviews and data abstraction from free-text narratives OH-VDRS data; all other data have already been collected by the respective entities. While in Ohio, EIS officers will use their CDC laptops to temporarily house and analyze data; however, no data will be housed in the CDC environment after the two weeks in the field (i.e., two weeks in Ohio).

Expected Use of Findings/Results and their impact

The findings of this investigation will be used to inform the Ohio Department of Health and other entities involved in suicide prevention efforts of the epidemiology of suicide across counties in Ohio. These findings can be used to inform future public health interventions to prevent suicide across the state. The analysis will lead to a report for the state, and possibly wider dissemination in collaboration with the Ohio Department of Health, such as a peer-reviewed manuscript.

Could Individuals potentially be identified based on Information Collected?

No



Funding






Funding Type

Funding Title

Funding #

Original Fiscal Year

# of Years of Award

Budget Amount



HSC Review

HSC Attributes

Epi-Aids

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 #

Ohio Dept of Hlth

FWA00001963

01/29/25

Ohio Dept of Hlth IRB #1

01/15/24




Staff









Staff Member

SIQT Exp. Date

Citi Biomedical Exp. Date

Citi Social and Behavioral Exp. Date

Citi Good Clinical Exp. Date

Staff Role

Email

Phone #

Organization/

Institution

Asha Ivey

12/20/2022


11/28/2021


Co-Investigator

[email protected]

770-488-0940

SUICIDE TEAM

Eva Trinh

09/20/2025


09/21/2024


Co-Investigator

[email protected]

770-488-4010

SUICIDE TEAM

Jing Wang

07/07/2023

05/31/2022



Statistician

[email protected]

770-488-1193

SUICIDE TEAM

Keisha Lindsay

09/22/2025


09/21/2025


Co-Investigator

[email protected]

770-488-1234

OFFICE OF MINORITY HEALTH & HEALTH EQUITY

Michael Ballesteros

11/09/2023


10/13/2024


Co-Investigator

[email protected]

770-488-1481

DIVISION OF INJURY PREVENTION

Zerleen Quader

07/26/2025

07/18/2025

07/18/2025


Program Lead

[email protected]

- -

EPIDEMIOLOGY AND SURVEILLANCE BRANCH



DMP


Proposed Data Collection Start Date

10/31/22

Proposed Data Collection End Date

11/11/22

Proposed Public Access Level

Non-Public

Reason for not Releasing the Data

Country/Jurisdiction owns the data with protections under their laws and regulations

Public Access justification

CDC has been asked by the state to support an Epi-Aid investigation. Data are owned by the Ohio Department of Health, not CDC.

How Access Will Be Provided for Data

Access to data will not be provided to the public

Plans for archival and long-term preservation of the data

Decisions regarding data archival and long-term preservation to be decided by the Ohio Department of Health, not CDC.



Spatiality (Geographic Location)



Country

State/Province

County/Region

United States

Ohio






Determinations

Determination

Justification

Completed

Entered By & Role

HSC:
Does NOT Require HRPO Review

Not Research / Other

45 CFR 46.102(l)

Epi-Aids

10/07/22

Shaw_Kate M. (atk6) CIO HSC

PRA:
PRA Applies


10/07/22

Shaw_Kate M. (atk6) OMB / PRA



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