Human Participants in Research

IRB UPDATES

• New application
• New education requirements
• Send in those final reports!  Studies should be closed by the investigator, not the IRB.  Please do not allow your studies to expire.
• Paperless: The IRB will no longer accept hard copies of IRB applications or training certificates.  Please send all documents via email.
• Track changes:  When revising documents, please use the track change function in MS Word. Help with track changes.
• Shorter continuing review form for exempt studies.
• IRB Office hours for students (see below).

Institutional Review Board (IRB)

The mission of the IRB is to:

• promote the rights and welfare of human research participants
• facilitate ethical research
• provide guidance and support to the research community in the conduct of research with human subjects
• assist the research community in ensuring compliance with the standards set forth in the Code of Federal Regulations by the U.S. Department of Health and Human Services

If the proposed research activity is a systematic investigation designed to develop or contribute to generalizable knowledge and it involves human participants, then the activity will require review and approval by the OSU IRB before any recruitment or research activities may begin.
  
Investigations designed to develop or contribute to generalizable knowledge are those conducted with the intention of:

• eventual dissemination of information by means of publication or presentation outside of the OSU community, or
• applying the results to a larger population or entity outside of the specific study population being studied

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.

Student Hours: The IRB office hosts Student Hours for OSU students with questions or concerns about the IRB process.  We encourage students to attend as early on in their application process as possible, but we will gladly provide support at any point during the lifecycle of a study.  Please join us in B308 Kerr on Wednesdays from 11:00am to noon and Thursdays from 2:00pm to 3:00pm.   No appointment necessary.

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
• Protocol Instructions
• Attachment A: Radiation
• Attachment B: Human Materials
• Continuing Review
• Continuing Review of Exempt Research
• 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)

IRB Educational Requirement

• OSU Educational Requirement Policy - updated
• CITI Course
• NIH Course

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)
• DHHS Policy for IRB Review of Applications for HHS Support
• NIH Policy for IRB Review of Human Subjects Protocols in Grant Applications
• Investigator Responsibilities

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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