This document provides guidance on obtaining IRB approval or exemption for human subjects research at Ohio State University. It outlines what constitutes human subjects research and when IRB review is required. It describes the different types of IRB review - full committee review, expedited review, and exempt review. The six categories of research that may be exempt from IRB review are listed. Instructions are provided on completing required training, developing the research proposal and forms, and submitting materials to the appropriate IRB for review and approval before beginning research. Key steps of the IRB process like amendments, continuing review, and final reports are also summarized.

1. When you need an IRB
approval
or exemption

2. Determine if you are doing
Human Subjects Research
• Research – A systematic investigation,
including development, testing, and
evaluation, designed to develop or
contribute to generalizable knowledge
• Human subject – living individual about whom
an investigator obtains
• Data through intervention or interaction
• Identifiable private information
*If doing FDA research, definitions differ

3. Human Subjects Examples
• Chart reviews
• Educational research
• Surveys, focus groups, interviews
• Psychology computer tutorials
• Blood draws
• Tissue collection and analysis
• Clinical trials
• Exercise studies

4. Collaborate with your Advisor
• Oversees your research
• Principal Investigator eligibility

5. Institutional Review Board
• Mandated by federal government for
institutions receiving federal dollars
• Applies to all OSU employees and
students
• IRB protects rights and welfare of
participants in research
• IRB diverse
– Non affiliates, different disciplines, non
scientists

6. Complete Institutional Requirements
Online
• Collaborative Institutional Training Initiative
– Basic Human Research Course
• Electronic Conflict of Interest disclosure
http://orc.osu.edu/coi/
http://www.orrp.osu.edu/humansubjects/citi.cfm

7. Type of Research
Behavioral/Social Sciences IRB
– investigator initiated research
– no invasive biomedical procedures
– research from variety of disciplines
e.g., art, education, business, music,
communication, journalism, political science,
psychology, sociology, social work
– information technology expertise

8. Type of Research cont.
Biomedical IRB
– Invasive biomedical procedures (including blood
drawing)
Cancer Biomedical IRB
– Invasive biomedical procedures (including blood
drawing)
– Prevention or treatment of cancer
Western IRB
– Industry-sponsored clinical trials

9. Level of Review
Full committee review
• Convened IRB meeting
Expedited review
• Minimal risk; specified types of research
Exempt review
• One of six categories; no prisoners, no deception

10. Exempt Categories
• Category 1: Classroom research
• Category 2: Surveys, Observational studies,
interviews, focus groups
• Category 3: #2 with elected officials
• Category 4: Existing data/materials
• Category 5: Federal Agency initiated programs
• Category 6: Food quality and taste

11. Expedited Categories-New Protocols
Must be Minimal Risk
• Category 1: Marketed drugs/devices
• Category 2: Blood draws
• Category 3: Non-invasive specimen collection
• Category 4: Non-invasive clinical data
collection (e.g., MRI)
• Category 5: Similar to Exempt #4 (see
appendix)
• Category 6: Audio and video recordings
• Category 7: SBS catchall (see appendix)

12. Minimal Risk
The probability and magnitude of harm or
discomfort anticipated in the research are
not greater in and of themselves than those
ordinarily encountered in daily life or
during the performance of routine physical
or psychological examinations or tests.

13. What to Submit
• Completed application
http://www.orrp.osu.edu/humansubjects/forms.cfm
• Research proposal
http://orrp.osu.edu/documents/GuidelinesforWritin
gaResearchProtocol.doc
• Recruitment materials
• Consent form or waiver
http://orrp.osu.edu/humansubjects/forms.cfm
• Surveys, Interview/Focus Group Questions

14. Wait for Approval/Exemption Letter
• …before recruiting, collecting data, accessing
private identifiable information.
• Exempt process 1-3 weeks
• Expedited process 5-7 weeks
• Convened review 8-12 weeks

15. Once Approved/Exempted
• No changes in exempt
• Submit an amendment form for IRB
studies
– wait for approval before making the change*
http://www.orrp.osu.edu/humansubjects/irb
/amend.cfm
• Fill out continuing review application (IRB)
• Fill out final study report (IRB)
*Exception is when there is a life-threatening situation

16. Need More Guidance?
www.orrp.osu.eduwww.orrp.osu.edu

17. Office Hours
• Behavioral
211A PAES
Wednesdays
1:00 p.m. - 3:00 p.m.
• Biomedical
Call 688-8457 for appointment

18. Thank You
Dr. Joni Barnard
QI Specialist – SBS Education and Outreach
Barnard.15@osu.edu