"Irb Proposal Document - Sample" - Florida

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SAMPLE IRB PROPOSAL DOCUMENT
This document was prepared for informational purposes only.
Do not rely solely on this sample packet for information regarding the Institutional Review
Board’s policies/protocols/regulations. Download the full DJJ IRB Handbook and review it
thoroughly prior to submitting a proposal.
Direct any questions to:
IRB Director
Department of Juvenile Justice
Office of Research and Data Integrity
2737 Centerview Drive
Tallahassee, FL 32399
Telephone: (850) 717-2633
Email: IRB.Director@djj.state.fl.us
SAMPLE IRB PROPOSAL DOCUMENT
This document was prepared for informational purposes only.
Do not rely solely on this sample packet for information regarding the Institutional Review
Board’s policies/protocols/regulations. Download the full DJJ IRB Handbook and review it
thoroughly prior to submitting a proposal.
Direct any questions to:
IRB Director
Department of Juvenile Justice
Office of Research and Data Integrity
2737 Centerview Drive
Tallahassee, FL 32399
Telephone: (850) 717-2633
Email: IRB.Director@djj.state.fl.us
IRB COVER SHEET
FLORIDA DEPARTMENT OF JUVENILE JUSTICE
Institutional Review Board
Cover Sheet
Project Title:
An Analysis of Factors Contributing to the Utility of Foot-Powered Automobiles
Name of Principal Investigator: Frederick Flintstone, Ph.D. Title: Assistant Professor
University/Research Institution: University of Bedrock
Department: Mechanical Engineering
Mailing Address: 5678 College Loop, Suite A, Bedrock, Bedrock 12345
Email Address: fredflintstone@u.bedrock.edu Telephone #: (123) 456-7890
Purpose of this study? __x__ Dissertation ____ Thesis ____ Grant ____ Other: ____
I approve this protocol for submission to the Institutional Review Board.
_____________________________________________________________________________
Dissertation/Thesis Chairperson
Date
Co-Investigators: ______________________________________________________________
What are the research questions? ________________________________________________
______________________________________________________________________________
______________________________________________________________________________
The following items have been included in the application packet (N/A, if not
applicable):
_____ Introductory Questionnaire
_____ 5-page Research Background and Protocol
_____
Research Acknowledgement Form for the DJJ program(s)
involved
(Above Dotted Line Only)
_____ Copies of all forms/instruments
_____ University/Agency Human Subjects Approval Letter
_____ Data Request Form
The principal investigator has read the Institutional Review Board handbook:
Yes
No
__
__
The undersigned accepts the responsibility to comply with Federal, State, and Department of
Juvenile Justice policies related to the protection of the rights and welfare of human subjects.
________________________________________________________________
Signature of Principal Investigator
Date
2737 Centerview Drive
Tallahassee, Florida 32399-3100
(850) 488-1850
http://www.djj.state.fl.us
The mission of the Department of Juvenile Justice is to increase public safety by reducing juvenile delinquency through effective
prevention, intervention and treatment services that strengthen families and turn around the lives of troubled youth.
IRB QUESTIONNAIRE
FLORIDA DEPARTMENT OF JUVENILE JUSTICE
Introductory Questionnaire
Institutional Review Board
Name of Principal Investigator: Frederick Flintstone
Project Title:
An Analysis of Factors Contributing to the Utility of Foot-Powered Automobiles.
1. Characteristics of the research (check all that apply):
Archival Data Study Method (requires Data Request Form)
Identified Data
De-identified Data
Non-Archival Data Study Method
Survey/Questionnaire
Intervention
Experimental
Behavioral or Psychological Study
Exercise or Nutrition Study
Deception of Subjects
Use of Impaired Subjects*
Collection of Physical Specimens (e.g., blood, urine, hair)
Use of Placebos
Non-Approved Indication for Approved Drug
Non-Approved Dose for Approved Drug
Experimental/Marketed Drug: IND # ____________________________________________
Experimental/Marketed Drug: IND Exempt
Other, please specify: _________________________________________________________
*Impaired subjects include those who have physical or mental limitations which restrict their ability to
understand, or who are dependent on the individuals who may be consenting for them. The subjects
include, but are not limited to, people who are in one of the following categories: mentally or emotionally
impaired, illiterate, or those who require certain care. Some subjects are permanently impaired by definition
of their circumstances; others are temporarily impaired.
2. Where did this study idea/request originate?
At the Florida Department of Juvenile Justice
At another State of Florida agency (please specify): _______________________________
An academic institution (please specify): ________________________________________
A research institution (please specify): __________________________________________
From a grant proposal
Other (please specify): ________________________________________________________
2737 Centerview Drive
Tallahassee, Florida 32399-3100
(850) 488-1850
http://www.djj.state.fl.us
The mission of the Department of Juvenile Justice is to increase public safety by reducing juvenile delinquency through effective
prevention, intervention and treatment services that strengthen families and turn around the lives of troubled youth.
3. Is financial or material support required for this study?
Yes
No (If No, skip to #5)
Source of Funding:
Applied for
Obtained
Grant Institution
Yes
Yes
(please specify) _______________
NIJ
Yes
Yes
OJJDP
Yes
Yes
BJA
Yes
Yes
DJJ
Yes
Yes
State of Florida
Yes
Yes
University
Yes
Yes
(please specify) _______________
Other
Yes
Yes
(please specify) _______________
4. Expected dates of the study: Start Date: _____/_____/_____ End Date: _____/_____/_____
5. Expected location(s) of the study? (please specify)
(Researcher fills out top portion of Research Acknowledgement Form at this time)
__________________________ Research Acknowledgement Form Filled Out
Yes
No
Signature Obtained (DJJ Process)*
Yes
No
__________________________ Research Acknowledgement Form Filled Out
Yes
No
Signature Obtained (DJJ Process)*
Yes
No
__________________________ Research Acknowledgement Form Filled Out
Yes
No
Signature Obtained (DJJ Process)*
Yes
No
*
Refer to DJJ’s IRB Handbook for the specific process on obtaining signatures for the Research Acknowledgement Form
6. Describe any significant relationship between the investigator(s) and any of the participants
in the study. Check all that apply:
Researcher/Participant
Teacher/Student
Contract or Department Provider/Delinquent
Health Care Provider/Patient
Employer/Employee
Friend or Family
Other (please specify) _________________________________________________________
7. Are you currently or have you ever been employed by the Florida Department of Juvenile
Justice or a DJJ provider?
Yes
No
If yes, explain any possible conflicts of interest or explain why this situation will not result
in a conflict of interest. ___________________________________________________________
________________________________________________________________________________
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8. Describe the youth assent/parent consent process?
___________________________________________________________________________________
___________________________________________________________________________________
___________________________________________________________________________________
9. Participant Information
9a. Estimated number of participants __________ Age Range: ______ to ______ years of age
9b. Describe participant types (e.g., normal controls, habitual offenders, sexual offenders)
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
9c. Are participants selected based on gender?
Yes
No If yes:
Males/
Females
If yes, specify reason. _________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
9d. Are participants selected based on race/ethnicity?
Yes
No
If yes, specify races/ethnicities: _________________________________________________
If yes, specify reason: _________________________________________________________
____________________________________________________________________________
9e.
Describe the plan for dealing with youth who cannot read or are developmentally disabled.
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
10. If you are planning to interact with youth or staff at a DJJ facility or property where they
may receive information about possible abuse of a youth, how do you plan to comply with
Florida Statute 39.201 regarding mandatory reporting?
Incidents of abuse will be reported to 1-800-96ABUSE
Other (please explain): ________________________________________________________
11. In the event of a psychological or medical emergency, plans for management are:
Normal provisions of the DJJ program.
On-site physician with emergency medications and equipment provided by investigators.
Public or community emergency services (e.g., 911).
Other (please explain): ________________________________________________________
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