Human Subject Research

1
Human Subject Research

• View from the IRB
• Anthony J. Filipovitch
• Minnesota State University Mankato

2
OR

• Experiences from the trenches
• Near-disasters I have known
• Im from the IRB and Im here to help you.

3
Introductions

• State University, with significant applied
  research focus
• Former administrator of IRB (Institutional Review
  Board) which oversees _at_100 research protocols
  each year
• Professor Chair of program with significant
  graduate focus and substantial applied research
  activity

4
Institutional Review Boards

• Established by Federal regulation in 1991
• Common Rule 45 CFR 46
• Title 45Public Welfare
• Part 46Protection 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

5
The Context

• Series of scandals from abuse of research
  subjects
• Data from Nazi medical experiments
• Tuskegee study
• Milgrams behavioral study of obedience
• Realization that understanding of what is ethical
  in research is a work-in-progress

6
The Belmont Report

• Ethical Principles and Guidelines for the
  Protection of Human Subjects Research (1979)
• Guidelines were voluntary

7
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

8
Belmont Principles (cont.)

• Justice/Equity
• Dont take advantage of people with limited
  resources
• Dont withhold effective treatment for the sake
  of the experiment

9
Mankatos IRB

• Available on Web
• IRB Home
• http//grad.mnsu.edu/irb/
• Proposal submission
• IRBnet http//irbnet.org

10
When Is It Research?

• Systematic investigationdesigned 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)

11
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

12
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

13
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.

14
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

15
Continuing Review

• Permission may only be granted for 1 year
• PI must request continuation
• PI should report completion of data collection

16
Issues in Research Ethics

• Prior approval for field research (e.g.,
  anthropology)
• Classroom assessment research
• Research using prisoners or other vulnerable
  adults

17
For a copy of this presentation

• http//krypton.mankato.msus.edu/tony/webpage/spee
  ches.html
• Tony Filipovitch, URSI
• Minnesota State University Mankato
• 106 Morris Hall
• Mankato MN 56001
• 507-389-5035