Human Participants in Research

Institutional Review Board (IRB)

The research community has a responsibility to ensure that the treatment of human participants in research meets the highest ethical standard. If the proposed research activity involves human participants and may contribute (e.g., through publication, presentation, or dissemination outside the OSU community) to "generalizable knowledge", then the activity will require review and approval by the OSU Institutional Review Board (IRB) before any recruitment or research involving human participants may begin. IRB review and approval is required for all research projects involving human participants, regardless of the source of funding for the project or the level of risk posed to participants.

Institutional Review Board (IRB)

• IRB Members
• Meeting Dates and Deadlines

Human Research Handbook & Guidance

IRB Forms

These forms are accessible in MS Word format. For technical problems, contact researchsupport@oregonstate.edu.

• Initial Application
• Initial Application Instructions
• Attachment A: Radiation
• Attachment B: Human Materials
• Certification of Education
• Certification of Education Instructions
• Continuing Review
• Project Revision
• Exception/Deviation Report
• Adverse Event
• Final Report

Informed Consent

These forms are accessible in MS Word format. For technical problems, contact researchsupport@oregonstate.edu.

• Informed Consent Document Template
• Assent Document Template
• Sample Cover Letter for a Mailed Survey
• Types of Consent Waivers
• Informed Consent Checklist (OHRP)
• Tips on Informed Consent (OHRP)
• Informed Consent -- Legally Effective and Prospectively Obtained (OHRP)
• Informed Consent for Subjects Who Do Not Speak English (OHRP)
• Informed Consent Tutorial (University of Minnesota)

IRB Educational Requirement

• OSU Educational Requirement Policy
• CITI Course (registration and log in site for users)
• NIH Course (registration and log in site for users)
• Certification of Education Form

Ethical Principles

• The Belmont Report
• Declaration of Helsinki
• The Nuremberg Code

Other Resources

• Office for Human Research Protections (OHRP)
• IRB Guidebook (OHRP)
• HIPAA (DHHS)
• International Compilation of Human Subject Research Protections (OHRP)
• Inclusion of Women and Minorities (NIH)
• Data and Safety Monitoring Policy (NIDDK)
• Protecting Human Subjects Video Series (DHHS)

HIPAA

• Office for Civil Rights - HIPAA (DHHS)
• What is HIPAA? (PRIM&R)
• HIPAA and the Common Rule
• HIPAA PowerPoint (DHHS)
• The HIPAA Privacy Rule, Research, and IRBs

ClinicalTrials.gov

Federal Regulations

• 10 CFR 745 - US Department of Energy
• 21 CFR 50 - US Food and Drug Administration
• 34 CFR 97 - US Department of Education
• 34 CFR 98 – US Department of Education (PPRP)
• 34 CFR 99 – US Department of Education (FERPA)
• 45 CFR 46 - US Department of Health and Human Services

Frequently Asked Questions

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