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  • Pre-Conference Program: IRB 201: An In-Depth Analysis of the Criteria for Review

    Institutional Review Board (IRB) 201: An In-Depth Analysis of the Criteria for Review will provide attendees with the tools and knowledge they need to become effective IRB chairs, members, and staff. This didactic educational program will review and analyze each of the eight regulatory criteria that the IRB must consider during protocol review, examine the ethical principles that underlie these criteria, and discuss how the criteria are applied. This course has been designed for those who conduct reviews as part of a convened IRB or through the expedited procedure, and who understand the fundamentals of IRB operations. Please note that this course will not cover administrative issues.

    This program is eligible for 6.5 continuing education (CE) credit hours.

    Download a PDF version of this agenda >>

    Meet the faculty >>

    7:30-8:30 AMRegistration (breakfast on your own)
    8:30-10:30 AMIntroduction to Case and Overview of Ethical Principles 

    Overview of Regulations and Criteria for Approval of Research

    Criterion 1: Risks to Participants are Minimized
    10:30-10:45 AMBreak
    10:45 AM-12:00 PMCriterion 2: Risks are Reasonable in Relation to Anticipated Benefits

    Criterion 3: Selection of participants is Equitable 
    12:00-1:00 PMLunch (provided)
    1:00-2:30 PMCriterion 4: The Informed Consent Process

    Criterion 5: Documentation of Informed Consent  
    2:30-2:45 PMBreak
    2:45-4:15 PMCriterion 6: Provision for Monitoring Safety of Participants

    Criterion 7: Privacy and Confidentiality

    Criterion 8: Additional Safeguards for Vulnerable Participants
    4:15-4:30 PMWrap-up
    4:30 PMAdjournment

    Please note this agenda is subject to change.