Exempt by huanghengdong


									                                          Institutional Review Board (IRB)
                                      Human Research Protections Program
                  1600 S. Andrews Avenue, Ft. Lauderdale, FL 33316  (954) 355-4941 FAX (954) 355-4930

        Request for Exempt Research & Protected Health Information                                   IRB Use Only
                               Application                                                           IRB CPA

  Submission Type: [ ] New Request                      [ ] Renewal     [ ] Change in activities

  How long with this study last?______________

Project Title:

  To qualify for exempt status project activities may not be more than minimal risk, Minimal risk mean
  that the probability and magnitude of harm or discomfort anticipated in the research are not greater in
  and of themselves than those ordinarily encountered in daily life or during the performance of routine
  physical or psychological examinations or tests.

  Research activities conducted under the jurisdiction of the Food and Drug Administration (FDA) does
  not qualify for exempt status.

  Project Investigator(s)
     Name (Last name, First name MI):                                       Professional/ Degree Title:

     Mailing Address:                                                       Office Phone Number:

                                                                            Pager or Cell Phone Number:


     Are you a Broward Health Employee?                                     Email:

     If yes, facility where you work:                                       Department (if applicable):

     Occupational Position:
       Broward Health Staff       Affiliate Physician     Nursing Research      Student Research      Other:        :

     Training is required prior to the initiation of research activities
     Indicate type research training / education received:

     Human Subjects Training          HIPAA Training Module (required)     Data/ Collection Module (required) –To
     obtain training visit CITI On Line Training Modules at http://www.CITI Program.org

     *Submit training certificate(s), licenses, resume / curriculum vitae with this application

                         Facility / Departmental Project Clearance is Required
  Check                  Facility where you intend to recruit patients, collect data, and or use institution resources
                         Broward General Medical Center / Chris Evert Children’s Hospital
                         North Broward Medical Center
                         Imperial Point Medical Center
                         Coral Springs Medical Center
                         Children’s Diagnostic and Treatment
                         Community Health Services
                         Physician Practices

                                          FINANCIAL CONFLICT OF INTEREST
  Does project investigator (including key personnel, or their immediate family members have a financial                 Yes
  interest (including salary or other payments for services, equity interests, or intellectual property rights) that     No
  would reasonably appear to be affected by the research, or a financial interest in any entity whose financial
  interest would reasonably appear to be affected by the research?

  List other researchers involved in this project.
  Are there other researchers involved in this research study? [ ] Yes [ ] No
  If yes, please list research team members who will be involved in this project.

       Project Team Member(s) Name                                  Job Title            Phone Number          CITI Training
                                                                                                                Yes or No

  Student / Resident Research (additional information required)
Name of University / College:
(Submit Letter of Support)
Advisor / Preceptor (Last name, First name MI):                                 Department

Mailing Address:                                                                Phone Number:


_____________________________________                                   __________________________________
Signature of Advisor / Preceptor                                                  Date

  1. Does this project involve the following vulnerable populations?

                     [    ] Yes    [   ] No        Children, adolescents
                     [    ] Yes    [   ] No        Prisoners, fetuses, pregnant women, or human in vitro fertilization
                     [    ] Yes    [   ] No        Cognitively impaired subjects

  2. Is this project a systematic investigation designed to develop or contribute to generalizable knowledge?
  Yes ______       No ____

  3. Are the human subjects in this study living individuals?              Yes ______       No ____

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4. If you answered yes to question 2 and 3 STOP here. This study is not “Exempt” from further IRB review.
You cannot use this form: Unless, the research and/or demonstration projects will be conducted by appropriate Federal
Department or Agency heads which are designed to study, evaluate, or otherwise examine public benefit or service programs; or
procedures for obtaining benefits or services under those programs;

5. What is your research question, or the specific hypothesis?

6. What are the potential benefits of the proposed project to the field?

7. What are the potential risks of the proposed project to the field?

8. Describe your research population –

            Sample Size
            Age Range

9. Provide description of the proposed activity – submit full copy of project proposal. (Include data, survey
instruments, and all materials that will be used to conduct this project).

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                     Check Appropriate Categories of Research which are Exempt
                     Research conducted in established or commonly accepted educational settings, involving normal
                     educational practices, such as:
    (√) if apply          1.   research on regular and special education instructional strategies, or
                          2.   research on the effectiveness of or the comparison among instructional techniques, curricula, or
  45 CFR 46.101                classroom management methods.

                     Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
                     procedures, interview procedures or observation of public behavior unless:
      B2:                 1.   information obtained is recorded in such a manner that human participants can be identified,
                               directly or through identifiers linked to the participants; AND,
     _______              2.   any disclosure of the human participants' responses outside the research could reasonably place
    (√) if apply               the participants at risk of criminal or civil liability or be damaging to the participants' financial
  45 CFR 46.101                standing, employability, or reputation.
                     NOTE: Survey and interview techniques that include minors are not exempt, EXCEPT observation of the
                     public behavior of minors, if the researcher is not a participant, is exempt.
                     Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
                     procedures, interview procedures, or observation of public behavior that is not exempt under Category 2,
      B3:                                                                    IF:

   (√) if apply           1.   the human participants are elected or appointed public officials or candidates for public office, OR
  45 CFR 46.101           2.   federal statute(s) require(s) without exception that the confidentiality of the personally identifiable
       (b)(3)                  information will be maintained throughout the research and thereafter.

      B4:            Research, involving the collection or study of existing data, documents, records, pathological specimens, or
                     diagnostic specimens, if these sources are publicly available or if the information is recorded by the
     _______         investigator in such a manner that participants cannot be identified directly or through identifiers linked to the
    (√) if apply     participants.

  45 CFR 46.101
      B5:            Research and demonstration projects which are conducted by or subject to the approval of appropriate
                     Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:

     _______              1.   public benefit or service programs; or
    (√) if apply          2.   procedures for obtaining benefits or services under those programs; or
                          3.   possible changes in or alternatives to those programs or procedures; or
  45 CFR 46.101           4.   possible changes in methods or levels of payment for benefits or services under those programs.

                     Taste and food quality evaluation and consumer acceptance studies,
                          1.   if wholesome foods without additives are consumed, or
     _______              2.   if a food is consumed that contains a food ingredient at or below the level and for a use found to be
    (√) if apply               safe, or agricultural chemical or environmental contaminant at or below the level found to be safe,
                               by the Food and Drug Administration or approved by the Environmental Protection Agency or the
  45 CFR 46.101                Food Safety and Inspection Services of the U.S. Department of Agriculture.

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                                     Privacy and Protected Health Information

    1. Will you obtain data through intervention or interaction with individuals? ___YES
    (Note: “Intervention” includes both physical procedures by which data are gathered [for example,
    measurement of heart rate or venipuncture] and manipulations of the subject or the subject’s
    environment that are performed for research purposes. “Interaction” includes communication or
    interpersonal contact between the investigator and subject [for example, surveying or interviewing].)

    2. Will you obtain identifiable private information about these individuals?                    ___YES
    (Note: "Private information" includes information about behavior that occurs in a context in which an
    individual can reasonably expect that no observation is taking place, or information which the
    individual can reasonably expect will not be made public [e.g., a medical record]. "Identifiable" means
    that the identity of the subject may be ascertained by the investigator or associated with the
    information [e.g., by name, code number, pattern of answers, etc.].)

    3. Is this proposal a student research project defined as a project which is a normal part of
    the student's course work; is supervised by a faculty member; and its primary purpose is the
    development of the student's research skills; does not present more than minimal risk to participants;
    does not deal with issues of a sensitive nature; and is not genuine research? ___YES ____NO.

    4. Is this proposal a quality assurance project designed to improved performance supervised
    by a manager/ employee or designee of Broward Health; with its primary purpose to improve quality
    care methods and procedures conducted in the organization; does not present more than minimal
    risk to participants? ___YES ____NO.

                                   PRIVACY OF PARTICIPANTS
a. Does this project require access to personally identifiable private information?
      Yes     No
    If Yes  Describe the personally identifiable private information involved in the research. List the
    information source(s) (e.g., educational records, surveys, medical records, etc.).

b. People or organization who may receive this information?

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                                     CONFIDENTIALITY OF DATA
 a. Explain how information will be handled, including storage, security measures (as necessary), and
    who will have access to the information. Include both electronic and hard copy records.

 b. Indicate what will happen to the identifiable data at the end of the study.

            Identifiers permanently removed from the data and destroyed (de-identified)
            Identifiable/coded (linked) data are retained
            Identifiable data not collected

                                               HIPAA Waiver
Will individually identifiable Protected Health Information (PHI) subject to the HIPAA Privacy Rule
requirements be accessed, used, or disclosed in the research study? ___Yes _____ No
Yes No      Check all that apply:

            1. The use or disclosure of PHI involves no more than minimal risk to the participants.
            2. Granting of waiver will not adversely affect privacy rights and welfare of the individuals whose
            information will be used.
            3. The project could not practicably be conducted without a waiver.
            4. The project could not practicably be conducted without access to and use of the PHI.
            5. The privacy risks are reasonable relative to the anticipated benefits of the research.
            6. An adequate plan to protect identifiers from improper use and disclosure is included in the
            research proposal.
            7. An adequate plan to destroy the identifiers at the earliest opportunity, or justification for
            retaining identifiers, included in the IRB approved research proposal; or such retention is
            otherwise required by law.
            8. Whenever, appropriate, the subjects will be provided with additional pertinent information
            after participation.
            9. This project includes written assurances that PHI will not be re-used or disclosed to any other
            person or entity for any purpose than that approved by the IRB as part of this research, except as
            required by law.

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                                                     Statement of assurance

By signing this statement I am providing written assurance that only information essential to the purpose
of this research project will be collected, and access to the information will be limited to the greatest
extent possible. Protected health information will not be re-used or disclosed to any other person or

I have evaluated this protocol and determined that I have the resources to conduct this project. I will
seek and obtain prior written approval from the IRB for any substantive modifications in the proposal,
including changes in procedures, co-investigators, funding agencies, etc. I will promptly report any
unexpected or otherwise significant adverse events or unanticipated problems or incidents that may
occur in the course of this study. I will report in writing any significant new findings, which develop during
the course of this study which may affect the risks and benefits to participation. I will not begin my
research until I have received written notification of final IRB approval. I will comply with all IRB requests
to report on the status of the study. I will maintain records of this research according to IRB guidelines.. If
these conditions are not met, I understand that approval of this project may be suspended or terminated.

Print name of Project Investigator

Signature of Project Investigator                                                               Date

                                                     Broward Health Official Use Only

                                                [ ] APPROVE [ ] PEND [ ] DENY

Facility ID: Broward General Medical Center ( ) Christ Evert Children’s Hospital ( ) North Broward Medical Center
( ) Imperial Point Medical Center ( ) Weston Regional ( ) Community Health Services ( ) Children’s Diagnostic and
Treatment Center ( )

____________________________________________                                            _____________________
Administrator /Regional Manager                                                                Date

____________________________________________                                            ______________________
Departmental Manager                                                                          Date

____________________________________________                                            _____________________
Human Protections Administrator Signature                                                      Date

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