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    IRB Training LIU Students A

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    IRB Training LIU Students A

    Uploaded by

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    2 views21 pages

    IRB Training LIU Students A

    Uploaded by

    wickesd

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 21

    Institutional Review

    Board (IRB) Presentation


    Purpose of the IRB
     Protect human subjects during research

     Definitions:
     Research: A systematic investigation designed to
    develop or contribute to generalizable knowledge
     Human Subjects: Living individuals who
    participate in research

    If a project meets the definition of research with


    human subjects, the project must be reviewed by the
    IRB
    The Tuskegee Study
    The Belmont Report
     Created the basic ethical principles underlying
    the acceptable conduct of research involving
    human subjects
     3 Principles:
     Respect for Persons
     Beneficence
     Justice
    Respect for Persons
     Involves recognition of the personal
    dignity and autonomy of individuals,
    and special protection of those persons
    with diminished autonomy
     Informed Consent requires:
     Participants provided with sufficient
    information about the research
     Participants comprehend the research and
    study requirements
     Participation is voluntary
    More on Informed Consent
     Essential components of informed consent are:
     The consent is given in the absence of
    coercion
     The potential participant is provided with all
    information (in language understandable to
    him or her) relevant to making a meaningful
    decision regarding participation
     The potential participant has decision-
    making capacity needed to make a
    meaningful choice about whether to
    participate in the study.
    Beneficence
     An obligation to protect persons from harm by assessing
    the risks and benefits of the research, assuring the
    anticipated benefits are greater than the risks.

    Justice
     Fair or “just” selection of research subjects with regard to
    the purpose and expected outcome of the research. The
    population of subjects should be similar to those who may
    benefit from the outcome of the research.
     Subject should not be chosen simply because they are
    readily available or easily manipulated.
    Risk
     RISK: The probability of harm or injury occurring
    as a result of participation in a research study.
    Harm can be physical, psychological, social,
    or economic.

     MINIMAL RISK: A risk is minimal where the


    probability of harm anticipated in the research is
    not greater than ordinarily encountered in daily
    life- or during the performance of routine physical
    or psychological examinations or tests
    Types of Applications
     Exempt (no risk)

     Expedited (no more than minimal risk)

     Full Board (more than minimal risk)

    How to determine if it is HSR- submit a


    HSR Determination form in IRBManager
    LIU IRB
     Comprised of professors from LIU and
    outside member
     Review and discuss human subject
    research proposals
     Ensure rights of human subjects in
    research are protected according to the
    three principles of the Belmont Report
     Has authority to review, approve, require
    mods, disapprove human subjects
    research
    Exempt Applications
     Research activities that involve no risk to human
    subjects AND
     Fall into specific categories:
     Research conducted in established or commonly
    accepted educational settings, involving normal
    educational practices.
     Research using anonymous or no-risk tests, surveys,
    interviews, or observations.
     Research involving the collection or study of existing
    data if they are publically available or if subjects cannot
    be identified.
     Research examining public benefit or service programs.
    Examples of Exempt
    Applications
     Having participants fill out a
    questionnaire on quality of
    life without obtaining any
    identifying information
    Expedited Applications
     Research activities that present no more than
    minimal risk to human research participants
     In general, research may qualify for expedited review if
    it is judged to involve only minimal risk, does not
    include intentional deception, does not employ sensitive
    populations or topics, and includes appropriate informed
    consent procedures.
     For example, the collection of physical data through non-
    invasive procedures is eligible for an expedited review,
    including:
     Height and weight
     ECG, MRI, Ultrasound
     Moderate exercise
     Blood or other bodily fluids
    Full Board Applications

     Involves more than minimal risk


     Involvesprotected subjects (e.g., children,
    prisoners, individuals with disabilities)
     Involves procedures that are personally intrusive,
    stressful, uses deception, or potentially traumatic

     Theseapplications are reviewed by the IRB


    at a monthly scheduled meeting
    Examples of Full Board
    Applications
     Studyof incarcerated women’s
    mental health (protected
    population)

     Study of drug use among ER


    nurses (could jeopardize
    participants’ employment)
    DECISION STATUS FOR
    FULL REVIEW
    CATEGORY
    Approval
     Conditional approval – requires some minor
    revisions- can be submitted via e mail to
    administrator for final review and approval
     Deferred- requires major revisions and another
    review by the board
     Denial
    The ideal application…
     Has addressed each of the components
    outlined on the application form – this is
    essential!

     Hasbeen edited in its entirety for


    grammar, typos, formatting issues, etc.

     Hasbeen reviewed by faculty sponsor


    and department chair to ensure all
    necessary information, documents,
    materials, and signatures are included.
    Common Challenges
     Items on the application, including the consent forms, are
    not addressed.
    Example: Noting in three different places, three different
    numbers of participants

    Example: Extent to which the participant is at risk is checked


    “no” when there is risk.
    *Talking about past suicidal thoughts in an interview
    puts those participants at risk for triggering events.
    IRBManager and CITI
    Log- on information
     Log on to IRB manager and a contact will be created for you when
    you log on with your single sign-on (SSO). CITI and IRBManager
    communicate with each other, so your CITI trainings will be
    marked as completed in IRBManager for future protocols.
    https://liu.my.irbmanager.com/

    Instructions for CITI:


    Go to the CITI website: https://about.citiprogram.org/
    In the upper right-hand corner, click Register
    Select Long Island University as your affiliate
    Use your LIU.edu email address to complete registration
    Select the RCR and the SBER modules
    WHEN DOES THE DOCTORAL STUDENT
    APPLY FOR IRB APPROVAL AND HOW LONG
    DOES IT TAKE TO GET IRB APPROVAL?

    THE STUDENT SHOULD NOT APPLY FOR IRB


    APPROVAL UNTIL SUCCESSFULLY PASSING THE
    DISSERTATION PROPOSAL DEFENSE.
    THE TIME IT TAKES FOR IRB APPROVAL DEPENDS
    UPON THE NUMBER OF REQUESTS THEY HAVE
    AND THE SCHEDULE OF IRB COMMITTEE
    MEETINGS. THE IRB COMMITTEE MEETS ONCE PER
    MONTH (SEPT-MAY) TO REVIEW ALL FULL BOARD
    PROPOSALS.
    STUDENT HANDBOOK
    Doctor of Education (EdD) Program in
    Transformational Leadership
    202 2 202 3
    If you have questions…..
     IRB LIU Resources:

     https://liu.edu/irb/resources
     Office of Sponsored Projects, IRB support:
    o Theresa Faughnan
    Research Compliance Director
    theresa.faughnan@liu.edu
    516-299-3615
    o Marni Goldner
    Grants Administrator
    marni.goldner@liu.edu
    516-299-3507

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