human subjects, research and navigating the irb process

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

Thank You

Dr. Joni Barnard

QI Specialist – SBS Education and Outreach

Barnard.15@osu.edu