When you need an IRB approval
or exemption
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
Human Subjects Examples
• Chart reviews• Educational research• Surveys, focus groups, interviews• Psychology computer tutorials• Blood draws• Tissue collection and analysis• Clinical trials• Exercise studies
Collaborate with your Advisor
• Oversees your research• Principal Investigator eligibility
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
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
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
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
Level of ReviewFull committee review
• Convened IRB meeting
Expedited review• Minimal risk; specified types of research
Exempt review• One of six categories; no prisoners, no deception
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
Expedited Categories-New ProtocolsMust 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)
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.
What to Submit• Completed application
http://www.orrp.osu.edu/humansubjects/forms.cfm • Research proposal
http://orrp.osu.edu/documents/GuidelinesforWritingaResearchProtocol.doc
• Recruitment materials• Consent form or waiver
http://orrp.osu.edu/humansubjects/forms.cfm • Surveys, Interview/Focus Group Questions
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
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
Need More Guidance?
www.orrp.osu.eduwww.orrp.osu.edu
Office Hours• Behavioral
211A PAESWednesdays1:00 p.m. - 3:00 p.m.
• Biomedical Call 688-8457 for appointment
