Human Subject ResearchView 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/speeches.html

Tony Filipovitch, URSIMinnesota State University Mankato

106 Morris Hall

Mankato MN 56001

507-389-5035