Att 7_Human Subject Determination

Clear

Save

Print

Form Version Date Nov. 2016

NCIPC Determination
General Information
Project Title
Rape Prevention and Education Program: Using the Best Available Evidence for Sexual Violence
Prevention
Science Officer(s)Linda Vo, MPH

Telephone: (770) 488-0046

Division: DVP

Ethics verification number: 18231

E-mail [email protected]
Project Officer(s)Dawn Fowler

Division: DVP

Telephone:

(770) 488-3974

Ethics verification number:

E-mail [email protected]

Proposed Project Dates:
02/01/2019 Ending: 01/31/2024
Start:
Ex: MM/DD/YYYY

Ex: MM/DD/YYYY

Funding Mechanism
• Cooperative Agreement #: CE19-1902
• Grant #:
• Contract#:
• No funding (Specify):

Funding FOA#:
Funding FOA#:

Describe the purpose, methods, and outcomes of the project (Use space provided - Abstract of purpose, methods and outcomes)

The RPE Program is a national initiative to address sexual violence through funding and technical assistance to
health departments in all 50 states, the District of Columbia, and four U.S. territories. The present cooperative
agreement (CDC-RFA-CE19-1902) restructures the RPE Program and includes new data collection and reporting
requirements for recipients using a new online data system. PURPOSE: CDC will develop online Annual Progress
Report (APR) forms for RPE Recipients. The goal of this information collection is to track recipients'
implementation and program evaluation activities for the purpose of program monitoring and assessing the
impact of the program across the program recipients. METHODS: The 55 recipients will complete APR forms
annually directly in the online data system. Recipients will be able to download information entered in the
system to submit to CDC officials as part of their required annual reporting and continuation application.
OUTCOMES: CDC will use the information collected to monitor recipients' progress and to identify facilitators
and barriers to program implementation and achievement of outcomes. In addition, CDC will examine the
aggregate impact of program activities on program outcomes across grantees.

Describe the roles and responsibilities of CDC and any partner organizations (e.g., grantee, contractor).
CDC will develop the APR forms with help from an IT contractor, and will pre-populate as much information as possible before
sending to the recipient to complete 120 days before the end of their first year of funding. After year 1, the recipients will
continue to complete the tool on an annual basis and send to CDC. CDC and the IT contractor will then import the data from
the tool into an integrated database.
CDC will provide guidance and technical assistance to recipients around the completion of the APR forms and will be available
to answer any questions that recipients have. CDC's contractor will be responsible for ensuring recipients' access to the online
systems, SAMS authentication (required by HHS) and to address any technical issues with entering information into the system
CDC 0.1485 (E), January 2017, CDC Adobe Acrobat DC, S508 Electronic Version, January 2017

Next Page

Previous Page

Form Version Date Nov. 2016

NCIPC Determination
Project Title:
Rape Prevention and Education Program: Using the Best Available Evidence for Sexual Violence
Prevention

Proposed Project Dates:
02/01/2019
Start:

Ending:

01/31/2024

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

Next Page

Previous Page

Form Version Date Nov. 2016

Required Signatures

Digitally signed by
Kimberley E. Freire -S
Date: 2019.01.03
11:36:59 -05'00'
Branch/Team Official (e.g., Branch chief or Team Lead)

Kimberley
E. Freire -S

signed by
Kathleen C. Digitally
Kathleen C. Basile -S
Date: 2019.01.08
Basile -S
11:12:22 -05'00'
Division Official (e.g., ADS, Director)

Human Subjects Coordinator

01/03/2019
Date

01/08/2019
Date

Date

Office Use Only

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

Next Page

Previous Page

Form Version Date Nov. 2016

NCIPC Determination

Project Title:

Rape Prevention and Education Program: Using the Best Available Evidence for Sexual Violence
Prevention

Proposed Project Dates:
Start:
02/01/2019

Ending:

01/31/2024

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:
On-site questionnaire
Mail-back questionnaire
Testing/assessment form
Web-based survey
Evaluation
Observation
Comment card
✔ Other (Explain) Online Annual Progress Reporting

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

Print

Save

Clear