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Human Subject Research. View from the IRB Anthony J. Filipovitch Minnesota State University Mankato. OR…. “Experiences from the trenches” “Near-disasters I have known” “I’m from the IRB and I’m here to help you….”. Introductions. State University, with significant applied research focus

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human subject research

Human Subject Research

View from the IRB

Anthony J. Filipovitch

Minnesota State University Mankato

  • “Experiences from the trenches”
  • “Near-disasters I have known”
  • “I’m from the IRB and I’m here to help you….”
  • State University, with significant applied research focus
  • Former administrator of IRB (Institutional Review Board) which oversees @100 research protocols each year
  • Professor & Chair of program with significant graduate focus and substantial applied research activity
institutional review boards
Institutional Review Boards
  • Established by Federal regulation in 1991
    • “Common Rule”— 45 CFR 46
      • Title 45—Public Welfare
      • Part 46—Protection of Human Subjects
  • Any research done with Federal funding which violated rights of human subjects could result in loss of all Federal funding
  • Codified “Belmont Principles”
  • Properly constituted IRB holds institution & individual researcher harmless
the context
The Context
  • Series of scandals from abuse of research subjects
    • Data from Nazi medical “experiments”
    • Tuskegee study
    • Milgram’s “behavioral study of obedience”
  • Realization that understanding of what is ethical in research is a work-in-progress
the belmont report
The Belmont Report
  • “Ethical Principles and Guidelines for the Protection of Human Subjects Research” (1979)
  • Guidelines were voluntary
the belmont principles
The Belmont Principles
  • Respect for Persons
    • Consent (informed consent)
    • Consent vs. Assent (for children)
    • Privacy (confidentiality, anonymity)
  • Beneficence
    • First, minimize risk (primum non nocere)
    • Then balance risks against benefits
    • Always, the subject decides whether the beneifts are worth the risks
belmont principles cont
Belmont Principles (cont.)
  • Justice/Equity
    • Don’t take advantage of people with limited resources
    • Don’t withhold effective treatment for the sake of the experiment
mankato s irb
Mankato’s IRB
  • Available on Web:
    • IRB Home
    • Proposal submission
      • IRBnet
when is it research
When Is It Research?
  • “Systematic investigation…designed to contribute to generalizable knowledge”
  • Does not include:
    • Assessment (classroom assessment or performance assessment)
    • Pedagogical activity (research-like activity carried out so students can practice research techniques)
irb application form
IRB Application Form
  • PI is always a faculty member (institutional control)
  • “Contact “ person will likely be student investigator for thesis
  • Source of funding: Federal grants may have special review requirements
  • “Description of Project” and “Description of Research Subjects” addresses Belmont issues
  • “Protection of Subjects’ Rights” deals mostly with consent form
application form cont
Application Form (cont.)
  • Signature:
    • Comply with letter and spirit of policy
    • Changes submitted for prior approval
    • Records maintained for 3 years
  • Endorsements:
    • PI
    • Student (if applicable)
    • Department Chair
levels of review
Levels of Review
  • 3 Levels:
    • Level I: Minimal risk, no vulnerable subjects
    • Level II: Some risk, or vulnerable subjects
    • Level III: Significant risk and/or impaired subjects
  • Point is not to avoid higher levels of review, but to address appropriately the Belmont principles.
  • Approval required before data can be collected.
level i review
Level I Review
  • 5 categories
    • children in standard educational settings
    • adults at minimal risk
    • public persons
    • proprietary secondary data
    • food quality testing
  • “Sensitive questions”
    • Specified in the Common Rule
continuing review
Continuing Review
  • Permission may only be granted for 1 year
  • PI must request continuation
  • PI should report completion of data collection
issues in research ethics
Issues in Research Ethics
  • Prior approval for field research (e.g., anthropology)
  • Classroom assessment research
  • Research using prisoners or other vulnerable adults
for a copy of this presentation
For a copy of this presentation:
  • Tony Filipovitch, URSI

Minnesota State University Mankato

106 Morris Hall

Mankato MN 56001