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 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  <Proposal submission  IRBnet

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:  eeches.html eeches.html  Tony Filipovitch, URSI Minnesota State University Mankato 106 Morris Hall Mankato MN