Non-research determination

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Form Version Date Nov. 2016

NCIPC Determination
General Information
Project Title
Rapid Response Suicide Investigation Data Collection

Science Officer(s)Corinne Ferdon

Telephone: (770) 488-0542

Division: DVP

Ethics verification number: 16725

E-mail [email protected]

Division:

Project Officer(s)

Telephone:
Ethics verification number:

E-mail

Proposed Project Dates:
08/01/2018 Ending: 07/31/2021
Start:
Ex: MM/DD/YYYY

Ex: MM/DD/YYYY

Funding Mechanism
• Cooperative Agreement #:
• Grant #:
• Contract#:
• No funding (Specify): Technical assistance

Funding FOA#:
Funding FOA#:

Describe the purpose, methods, and outcomes of the project

CDC requests approval for a 3-year period of a new Generic Information Collection Request (ICR) to
rapidly respond to urgent requests for CDC assistance to investigate an apparent and unexplained
potential cluster or increase in suicidal behavior. Rapid Response Suicide Investigation Data Collections
are specifically designed to inform the implementation of prevention strategies in a state, county,
community, or vulnerable population where a possible suicide cluster or increasing trend has been
observed. Method will vary and depend on the unique circumstances of the urgent and rapid response.
This generic clearance will not be used to conduct research studies or to collect data designed to draw
conclusions about the United States or areas beyond the defined geographic location or vulnerable
population that is the focus of the investigation
Describe the roles and responsibilities of CDC and any partner organizations (e.g., grantee, contractor).

CDC staff and the external partners that determine the specific urgent data collection need will
collaborate on establishing the data collection objectives and methods. External partners may include
local, state, territory, and tribal health authories; local and state leaders; schools; or other partner agencies
and organizations (e.g., other federal agencies, coalition of local organizations, coroner/medical examiner
offices). CDC staff may provide technical assistance to partners with developing data collection materials
(e.g., questionnaires, interview and focus group materials) and a data analysis plan. CDC staff may be
deployed to the field to assist partners in some or all of the operations of the investigation. This can
include conducting training, determining sampling frames, and collecting data. CDC staff may analyze
the data in the field or at CDC. CDC staff may assist in report writing and presenting the final analyses
and prevention recommendations to external partners.
CDC 0.1485 (E), January 2017, CDC Adobe Acrobat DC, S508 Electronic Version, January 2017

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Form Version Date Nov. 2016

NCIPC Determination
Project Title:
Rapid Response Suicide Investigation Data Collection

Proposed Project Dates:
08/01/2018
Start:

Ending:

07/31/2021

Applicability of Human Subjects Regulations
Please check appropriate category:
✔

I. Activity is not research. Primary intent is public health practice: disease/injury control, surveillance,
improvement of programs or services. Objectives focused on a specific population.
✔ A. Epidemic/endemic disease/injury control activity; collected data directly relate to immediate disease
___
control needs (e.g., epi-aid).
___ B. Routine disease/injury surveillance activity; data used for disease control program or policy purposes
for a specific health condition/disease in a specific population and setting. (Includes disease reporting)
___ C. Program evaluation/monitoring activity; data are used primarily for assessing, monitoring or
improving a program, policy, or a communications activity (e.g., message testing) in a specific
population/setting.
___ D. Purchase orders or contracts for services or equipment.

-ORII. Activity is research but does NOT involve human subjects. Primary intent is to develop or contribute to
generalizable knowledge, but data is obtained solely from non-human sources or not living individuals, or anonymous
existing data collected for another purpose are being analyzed:
___ A. Activity is research involving collection/analysis of data about health facilities or other
organizations or units, which are not individual persons
___ B. Activity is research using existing unlinked or anonymous data previously collected for another purpose.
___C. Activity is research involving data and/or specimens from deceased persons.

-ORIII. Activity is research involving human subjects but CDC is not engaged. CDC employees including visiting
scientists, fellows, and on-site contractors (but not off-site contractors or other collaborators
*Will NOT obtain consent or data by intervening or interacting with participants
*Will NOT have access to identifiable (including coded) private data or biological specimens
NOTE: Once local IRB approval has been obtained please forward a copy (electronic preferred) to the NCIPC Human
Subjects Coordinator for records keeping purposes.
-ORIV. Activity is research involving human subjects but exempt according to the categories specified in the
regulations 45 CFR 46.101(b). Educational practices, Educational tests, surveys, interviews, or observation of
public behavior. Existing data, documents, records (e.g., not identifiable, publicly available). Demonstration
projects.
-ORV. Activity is research involving human subjects, CDC is engaged, and CDC IRB approval will be sought.

CDC 0.1485 (E), January 2017, CDC Adobe Acrobat DC, S508 Electronic Version, January 2017

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Form Version Date Nov. 2016

Required Signatures

Branch/Team Official (e.g., Branch chief or Team Lead)

signed by
Kathleen C. Digitally
Kathleen C. Basile -S
Date: 2018.05.04
Basile -S
14:11:23 -04'00'
Division Official (e.g., ADS, Director)

Human Subjects Coordinator

Date

05/04/2018
Date

Date

Office Use Only

CDC 0.1485 (E), January 2017, CDC Adobe Acrobat DC, S508 Electronic Version, January 2017

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Form Version Date Nov. 2016

NCIPC Determination

Project Title:

Rapid Response Suicide Investigation Data Collection

Proposed Project Dates:
Start:
08/01/2018

Ending:

07/31/2021

Applicability of OMB-PRA Regulations
Please check appropriate category:
I. Does the activity involve collecting identical information from 10 or more respondents within a one year period
Including evaluation/monitoring (Examples of collections: Surveys & Interviews (Phone & On-line) - Focus groups –
Surveillance – Program evaluation- Program monitoring).
No
Yes - Type of collection:
Mail-back questionnaire
Testing/assessment form
Evaluation
Comment card
Other (Explain)

On-site questionnaire
Web-based survey
Observation

Personal interview
Focus groups
Workshop

Telephone survey
Record abstractions
Discussion group

II. Is NCIPC Sponsoring the data collection? Check all that apply.
A. NCIPC will initiate or request a data collection.
B. NCIPC will develop or design the data collection.
C. NCIPC will manage or own the data collection.
D. NCIPC will be directing the data collection.
E. NCIPC staff will interact/intervene participants.
F. NCIPC is requesting specific data reports.
G. NCIPC will disseminate the data as an official report or study.
H. NCIPC is not conducting any of the above activities and therefore is not sponsoring the data
collection.

CDC 0.1485 (E), January 2017, CDC Adobe Acrobat DC, S508 Electronic Version, January 2017

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