Transcript Human Subject Research

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
 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
 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
 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
 “Ethical Principles and Guidelines for the
Protection of Human Subjects Research” (1979)
 Guidelines were voluntary
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.)
 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
 Available on Web:
< IRB Home
 http://grad.mnsu.edu/irb/
< Proposal submission
 IRBnet http://irbnet.org
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
 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.)
 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
 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
 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
 Permission may only be granted for 1 year
 PI must request continuation
 PI should report completion of data collection
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:
 http://krypton.mankato.msus.edu/~tony/webpage/sp
eeches.html
 Tony Filipovitch, URSI
Minnesota State University Mankato
106 Morris Hall
Mankato MN 56001
507-389-5035