Human Subject Research
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Transcript of Human Subject Research
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Human Subject ResearchView from the IRB
Anthony J. Filipovitch
Minnesota State University Mankato
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OR…
“Experiences from the trenches”
“Near-disasters I have known”
“I’m from the IRB and I’m here to help you….”
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Introductions
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
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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
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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
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The Belmont Report
“Ethical Principles and Guidelines for the Protection of Human Subjects Research” (1979)
Guidelines were voluntary
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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
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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
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Mankato’s IRB
Available on Web:< IRB Home
http://grad.mnsu.edu/irb/ < Proposal submission
IRBnet http://irbnet.org
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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)
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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
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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
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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.
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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
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Continuing Review
Permission may only be granted for 1 year
PI must request continuation
PI should report completion of data collection
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Issues in Research Ethics
Prior approval for field research (e.g., anthropology)
Classroom assessment research
Research using prisoners or other vulnerable adults
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For a copy of this presentation:
http://krypton.mankato.msus.edu/~tony/webpage/speeches.html
Tony Filipovitch, URSIMinnesota State University Mankato
106 Morris Hall
Mankato MN 56001
507-389-5035