"Introductory Questionnaire Form - Institutional Review Board" - Florida

Introductory Questionnaire Form - Institutional Review Board is a legal document that was released by the Florida Department of Juvenile Justice - a government authority operating within Florida.

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  • Released on April 18, 2014;
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FLORIDA DEPARTMENT OF JUVENILE JUSTICE
Introductory Questionnaire
Institutional Review Board
Name of Principal Investigator: ___________________________________________________________________________
Project Title: ________________________________________________________________________________________________
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.
FLORIDA DEPARTMENT OF JUVENILE JUSTICE
Introductory Questionnaire
Institutional Review Board
Name of Principal Investigator: ___________________________________________________________________________
Project Title: ________________________________________________________________________________________________
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. ___________________________________________________________________________________
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
8. Describe the youth assent/parent consent process?
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
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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): ____________________________________________________________________________
12. Will any services, tests, medical procedures, etc., be performed that are in addition to the
routine rehabilitative regimen or overlay services for the participants, including drug testing?
Yes
No
(If No, skip to #13)
12a. Who will have access to the results? ____________________________________________________________
_____________________________________________________________________________________________________
12b. If the study involves pharmacological intervention, will any of the drugs, devices, etc., be
given to the participants free of charge? If so, please specify. ________________________________
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
12c. Who or what agency will pay for them? _________________________________________________________
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13. All individuals, including the principal and co-investigators, who will have access to juveniles,
their parents, department employees, or contract providers or individuals who will have access
to confidential information must undergo background screenings. Please identify all individuals
who will require background screenings and your time frame to complete DJJ background
checks on each individual. *
Background Screenings submitted to the Department without the title of the IRB
submission and the email address of the principal investigator included on the documentation will be discarded. Please
refer to DJJ’s IRB Handbook for the specific process.
___________________________________________________________
__________________________________________________________
__________________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
14. What measures will be taken to protect the confidentiality of the information (e.g., tapes,
pictures, personal documentation) obtained? Specifically address how the principal
investigator will store, handle, and destroy the information.
14a. During the research study: _______________________________________________________________________
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
14b. After completion of the research study: ________________________________________________________
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
15. Will research participants be compensated?
Yes
No (If No, skip to #16)
15a. Reimbursement of Expenses?
Yes
No
If yes, specify the expenses for which the participant will be reimbursed.
_______________________________________________________________________________________________________
15b. Monetary Compensation?
Yes
No
If yes, amount: $__________
If monetary compensation is provided, a pro-rated payment is required. Please outline
the amount and schedule of all payments. If a pro-rated payment scheme is not
applicable, an explanation must be provided below. __________________________________________
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
Given the group of participants you will recruit, could the monetary compensation
unduly influence a subject to participate in this study or remain in this study when other
factors in the subject’s health/environment would keep the subject from doing so?
(Please specify). __________________________________________________________________________________
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
16. Is there an oversight committee that reviews safety data for this research study?
Yes
No
If yes, please specify: ______________________________________________
____________________________________________________________________________________________________________
Updated 4/18/14
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