IRB Determination

0920-0841_Attachment 5. IRB determination.pdf

Management Information System for Comprehensive Cancer Control Programs

IRB Determination

OMB: 0920-0841

Document [pdf]
Download: pdf | pdf
Print Date: 7/14/23

Title:

Data Collection and Analysis of Factors that Contribute to Effective Cancer Prevention and Control Programming

Project Id:

0900f3eb82088585

Accession #:

NCCDPHP-CCCB-1/12/23-88585

Project Contact:

Angela R Moore

Organization:

NCCDPHP/DCPC/CCCB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

09/01/2023

Estimated Completion Date:

08/31/2028

CDC/ATSDR HRPO/IRB Protocol #:
OMB Controln#0920-0841

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

3/1/23

Redmond Leonard_Joan (jrl3) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

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

PRA:
PRA does not apply

Exclusion: No Information being collected
Justification: Analysis of secondary data.

3/2/23

Still-LeMelle_Terri (cse6) OMB / PRA

Description & Funding
Description
Priority:

Standard

Date Needed:

01/20/2023

Determination Start Date:

01/12/23

Description:

This project supports the evaluation of the National Comprehensive Cancer Control Program. This project is intended to assess the
current program cycle of this program to facilitate program improvements efforts and determine program outcomes. Proposed
methodology for this evaluation includes: content analyses of cancer control plans, progress reports, and evaluation reports;
performing statistical analysis of program data abstracted from the Awards Management Platform (AMP), a web-based program
monitoring system; collecting and analyzing online survey data that will be collected twice within a five-year program period; and
conducting a case study of 12 CCC programs which will include in-depth interviews of program implementers and partners. This
project uses cancer control plans, progress reports, and evaluation reports which are secondary data, as well as survey and
interview data which are collected specifically for the proposed project. CDC is involved in the data collection and analysis of this
data; however, we will also work with contractors who will assist us in completing these activities.

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 evaluation is to improve the National Comprehensive Cancer Control Program (NCCCP) by using these findings
to assure that the all 66 recipients NCCCP sustain multi-sector partnership networks and implement data-informed cancer control
plans. This project is a program evaluation that will: examine how programs have developed and implemented a CCC plan that
addresses cancer burden; assess the extent to which the CCC plan implements interventions that are responsive to responsive to
local decision makers and has an impact on public health; describe CCC partnerships and how well the CCC plan is being
implemented by partner organizations; and articulate the achievement of cancer prevention and control outcomes including those
related to the leveraging of resources, population reach, and access to public health programs. This project does not involve
interacting with human subjects or identifiable data/specimens.

Objective:

This project has the following objectives: 1) implement a utilization-focused evaluation in which CDC, comprehensive cancer control
program practitioners, and CCC partners can make actionable steps towards improving the program and 2) implement an
evaluation that yields findings that characterizes program capacity, articulates outcomes, and identifies significant lessons learned
that are needed for program improvement. This project requests that nonfederal institutions to respond to a third party (contractor
assisting with data collection and analysis) through online surveys and in-depth interviews. For the survey, at least 66 respondents
will be asked to answer the same structured questions at least twice within a five year period. At least 24 individuals who work in
comprehensive cancer control will be interviewed on annual basis for the term of four years. While CDC will oversee data collection
and analysis, this work will be done directly through a contractor. We will use an existing, approved OMB information collection
request titled #Management Information System for Comprehensive Cancer Control Programs# (#0920-0841).

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):

Not Selected

Assessing Impact:

Yes

Methods to Improve Health Equity Research and
Practice:

Not Selected

Other:

Not Selected

Activities or Tasks:

Programmatic Work

Target Populations to be Included/Represented:

Other - Program implementers of the National Comprehensive Cancer Control Program

Tags/Keywords:

Program Evaluation

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:

Individual Interviews (Qualitative); Secondary Data Analysis; Survey

Methods:

Information regarding the implementation of the NCCCP will be gathered and analyzed via: 1) document review of program
documents which will undergo a content analysis; 2) a web-based survey that will be conducted twice within the five-year project
period; and 3) a case study of NCCCP recipients which will include document reviews and in-depth interviews from program
implementers. For the survey and case study interviews, we will use an existing, approved OMB information collection request titled
#Management Information System for Comprehensive Cancer Control Programs# (#0920-0841).

Collection of Info, Data or Biospecimen:

Program data will be abstracted from a pre-existing web-based platform used for program monitoring, also known as, the Awards
Management Platform. Web-based survey will be designed and executed using RedCAP. In-depth interviews will be conducted
virtually using videoconferencing software such as Zoom or Microsoft Teams.
Key outcomes of this evaluation include but are not limited to: facilitation of short-term and long term in improvements with the
NCCCP program, communication of program strategies and outcomes that have been sustained over the course of the program#s

Expected Use of Findings/Results and their impact:

existence, and identification of program models that may be applied broadly across comprehensive cancer control programs and
other chronic disease programs.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding
Type

Funding Title

Funding #

CDC
Contract

Data Collection and Analysis of Factors that Contribute to Effective Cancer Prevention and Control
Programming

DCPC230008

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

Yes

Estimated number of study participants

200

Population - Children

N/A

Protocol Page #:

Population - Minors

N/A

Protocol Page #:

Original Budget
Yr

# Years
Award

Budget
Amount

2023

4

800000.00

Population - Prisoners

N/A

Protocol Page #:

Population - Pregnant Women

N/A

Protocol Page #:

Population - Emancipated Minors

N/A

Protocol Page #:

Suggested level of risk to subjects

Minimal

Do you anticipate this project will be exempt
research or non-exempt research

Exempt

Category 1: Educational Practices

No Selection

Category 2: Educational tests, surveys, interviews,
or observation of public behavior

No Selection

Category 3: Benign Behavioral Interventions and
Collection of Information

No Selection

Category 4: Secondary Research for Which Consent No Selection
is not Required
Category 5: Research and Demonstration Projects

Conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads
designed to study, evaluate, improve or otherwise examine public benefit or service program

Category 6: Taste and Food Quality Evaluation and
Consumer Acceptance Studies

No Selection

Category 7: Storage or Maintenance for Secondary
Use for Which Broad Consent is Required

No Selection

Category 8: Secondary Research for Which Broad
Consent is Required

No Selection

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

Staff
Staff
Member

SIQT Exp.
Date

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

Floyd
Bonner

12/29/2023

10/29/2013

Technical
Monitor

10/29/2013

kfz5@cdc.
gov

770-4882799

PROGRAM EVALUATION AND
PARTNERSHIP TEAM

Data
DMP
Proposed Data Collection Start Date:

10/2/23

Proposed Data Collection End Date:

7/31/28

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - Data is not considered public health data

Public Access Justification:

This project assesses the NCCCP for the purposes of using the findings of the evaluation to improve program implementation. A
DMP is not needed because the project will not collect or generate public health data.

How Access Will Be Provided for Data:

n/a

Plans for Archival and Long Term Preservation:

n/a

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

Supporting Info
Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Moore_Angela
R. (cyq6)
Division ADS

02/27/2023

Approved concept clearance

Other

Concept-Clearance-OASIS for
Moore_2022_REVISED_2152023.docx

Moore_Angela
R. (cyq6)
Division ADS

02/27/2023

Track changed edits and
comments on initial STAR entry.

Other

STAR Project_comments.docx

Moore_Angela
R. (cyq6)
Division ADS

01/19/2023

Concept clearance

Other

Concept-Clearance-OASIS for Moore 2022.docx


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