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” • “I’m from the IRB and I’m here to help you….”

3. 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

4. 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

5. 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

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 • Don’t take advantage of people with limited resources • Don’t withhold effective treatment for the sake of the experiment

9. Mankato’s IRB • Available on Web: • IRB Home • http://grad.mnsu.edu/irb/ • Proposal submission • IRBnet http://irbnet.org

10. 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)

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/speeches.html • Tony Filipovitch, URSI Minnesota State University Mankato 106 Morris Hall Mankato MN 56001 507-389-5035