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Human Subjects, Research and Navigating the IRB Process

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Presentation given by Joni Barnard, PhD, at the 2015 Nursing Research Conference at Ohio State

Published in: Healthcare
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Human Subjects, Research and Navigating the IRB Process

  1. 1. When you need an IRB approval or exemption
  2. 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. 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. 4. Collaborate with your Advisor • Oversees your research • Principal Investigator eligibility
  5. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 16. Need More Guidance? www.orrp.osu.eduwww.orrp.osu.edu
  17. 17. Office Hours • Behavioral 211A PAES Wednesdays 1:00 p.m. - 3:00 p.m. • Biomedical Call 688-8457 for appointment
  18. 18. Thank You Dr. Joni Barnard QI Specialist – SBS Education and Outreach Barnard.15@osu.edu

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