Learning Center
Plans & pricing Sign in
Sign Out



									                                                                                                  Attachment 1
                                                                                                  AD-DR 16-9.01-1
                                                                                                  New 7/1/04
                            Institutional Review Board
                                Project Cover Sheet
Project Title: _____________________________________________________________

Name of Investigator: _________________________________ Title: _______________

                      Telephone #: ________________________ Fax #: __________________

                      Mailing Address: _____________________________________________

           University/Research Institution: _______________________________________

                      Department: _________________________________________________

Department Chair, Dissertation\Thesis Chair (if applicable): _______________________

I approve this protocol for submission to the Institutional Review Board.

                                               Chairperson or Director of Department Date

Co-Investigators: _________________________________________________________

Purpose of this study? Dissertation              Thesis     DIS      Grant      other:______________

Please check all that apply:
    New Submission to the IRB
    Resubmission
    Expedited
    Exempt (Must complete section 16)
    Multi-site study
    Training Grant
                                         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.


Florida Department of Juvenile Justice                  1                            Bureau of Research and Data
                                         Signature of Principle Investigator (P.I.)         Date
                                         Introductory Questionnaire

Keep answers concise and to the point. If necessary, attach additional pages for your responses.

1. Characteristics of the Research (check all that apply):

       Investigator’s Protocol Submitted to IRB (1copy)
       Sponsor’s Protocol (1 copy)
      Deception of Subjects
      Behavioral/Psychological Research (Experimental)
      Use of Impaired Subjects*
      Exercise or Nutrition Study
      Observation of Disease Progression
      Collection of Physical Specimens (e.g., blood, urine, hair, etc.)
      Non-Therapeutic Research
      Use of Placebos
      Non-Approved Indication for Approved Drug
      Non-Approved Dose for Approved Drug
      Experimental\Marketed Drug: IND # ____________________
      Experimental\Marketed Drug: IND Exempt
      Experimental\Marketed Device: IDE # ___________________
      Experimental\Marketed Device: IDE Exempt
      Other, please specify:

     *Impaired subject include those who have physical or mental limitations which restrict their
     ability to understand, or who are dependant 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 emotional impaired, illiterate, or those who require certain care. Some
     are permanently impaired by definition of their circumstances; others are temporarily

2. Where did this study originate?
     at the Florida Department of Juvenile Justice.

          at another Florida State governmental institution or agency (please specify).

          An academic institution (please specify) In State _____________________________
                                                      Out of State __________________________
          A research institution (please specify) ___________________________________

          from a grant proposal.

          from the principle investigator.

          other (please specify):

Florida Department of Juvenile Justice                   2                            Bureau of Research and Data
*Note that protocols and informed consent forms have to be adapted to the standards of the Florida Department of
Juvenile Justice Institutional Review Board (IRB).

3. Is financial or material support required for this study? (please circle)

                      Yes               No

                      If yes complete 3a.

Source of Funding                                Funding Obtained                       Applied for Funding

(check column which applies)

           Grant Institution                              __                                        __

           (please list): _____________________________________________________________
           NIJ                                  __                          __
           OJJDP                                __                          __
           BJA                                  __                          __
           DJJ                                  __                          __
           State of Florida                     __                          __
           University or Department             __                          __
           Other:                               __                          __
           No Funding required                  __                          __

4. Expected dates of the study, beginning: _________________ and ending _________________

5. Expected location of the study? __________________________________________________

6. Expected duration of the study for each individual subject: ____________________________

7. How will participants be recruited for the study?

Florida Department of Juvenile Justice                    3                                 Bureau of Research and Data
8. Participant Information:

           a. Type of participants to be studies (e.g., normal controls, serious habitual offenders,
              sexual offenders, etc.). Please explain.

           b. Estimated number of participants at this site: ____________ other sites: __________.

           c. Age range: ____________________

           d. Is selection of participants based on gender:                __ Yes          __ No
              (if Yes, complete the remainder of this question)

                __________ Males                         __________ Females
                Reason for selection:

                                            Only the gender selected has the condition.

                                       Other, please specify:
           Participant Information (continued):

           e. Is the selection of participants based on a racial/ethnic basis? __ Yes               __ No
              (if Yes, complete the remainder of the question)

                      List which race(s) will be entered into the study.

                      Reason for selection:

           f. Will pregnancy test be required if individuals of child-bearing potential are to be
              included in the study?

              __ Not Applicable          __ Yes    __ No (If no, please comment)

           g. If participants are pregnant, explain why it is essential to use these particular

           h. How do you plan to deal with youth that cannot read or are developmentally disabled?
           Please explain.

Florida Department of Juvenile Justice                  4                           Bureau of Research and Data
           i. Describe any predominant relationship between the investigator(s) and any of the
              participants in the study. Check all that apply:
                      teacher/student
                      researcher/participant
                      contractor provider/delinquent
                      department provider/ delinquent
                      health care provider/patient
                      employer/employee
                      friend or family
                      victim/offender
                      other (please explain):
           j. Are you currently or have you ever worked for the Florida Department of Juvenile
           Justice or a provider?
                     yes No

           If yes please explain and discuss possible conflicts of interest that may occur.

9. Compensation to Research Participants:

           a. Monetary: __Yes __No Amount: $_______

           b. Reimbursement of expenses: __Yes __No

           c. If there is to be monetary compensation, 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.

                      1) Pro-rated payment scheme:

                      2) No pro-rated payment, please explain:

           d. If study involves pharmacological intervention, will any of the drugs, devices, etc. be
              given to the participants free of charge? If so, please list.

           e. If appropriate, please comment on the following questions: 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

Florida Department of Juvenile Justice               5                            Bureau of Research and Data
                subject’s health/environment would keep the subject from doing so? If yes, please

10. 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 (eg: 911)

          Other (please explain):

11. If you are planning to interact with youth or staff at a DJJ facility or property where they may
receive information about possible abuse to a youth, what is your plan to be in compliance with
Florida Statute 39.201 for mandated reporting.

12. Testing Procedures:

           a. Will any services, tests, medical procedures, etc., be performed which are additional
              to the routine rehabilitative regimen or overlay services for the participants (this
              includes all drug testing)?

                      __ Yes __ No


           b. Who will have access to the results?

           c. Who or what agency will pay for them?

Florida Department of Juvenile Justice             6                           Bureau of Research and Data
13. What measures will be taken to protect the confidentiality of the information obtained?
    (Specify what will be done with all tapes, pictures, and personal documentation of the
    participants both during and at the completion of the research).

           a. During the research:

           b. After completion of the research:

           c. Please identify all individuals that will have access to identifying data and your time
              frame to complete DJJ background checks on each of them.

14. Who will request the participation of the participants in the study? [Please note that if the IRB
    determines that participants will be placed at more than minimal risk, informed
   consent/assent must be obtained directly by the investigators involved with the research.]

Florida Department of Juvenile Justice             7                            Bureau of Research and Data
15. Informed consent/assent will be obtained from (check all that apply): In most cases DJJ IRB
will require parental consent for contact with youth unless the youth is placed at minimal risk.

          The participant

          The participant’s parent

          The participant’s guardian

          A surrogate

          A durable power of attorney

          A proxy

          Other, please explain:

16.Is there an oversight committee that reviews safety data for this research study?

           __ Yes      __ No

           If yes, please indicate what their specific role is, how often they meet, and how often they
           produce a report that can be shared with the IRB office.

Florida Department of Juvenile Justice              8                            Bureau of Research and Data

To top