Human Subjects, Research and Navigating the IRB Process

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  • When you need an IRB approval or exemption

  • Determine if you are doing Human Subjects ResearchResearch A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge Human subject living individual about whom an investigator obtainsData through intervention or interactionIdentifiable private information

    *If doing FDA research, definitions differ

  • Human Subjects ExamplesChart reviewsEducational researchSurveys, focus groups, interviewsPsychology computer tutorialsBlood drawsTissue collection and analysisClinical trialsExercise studies

  • Collaborate with your AdvisorOversees your researchPrincipal Investigator eligibility

  • Institutional Review BoardMandated by federal government for institutions receiving federal dollarsApplies to all OSU employees and studentsIRB protects rights and welfare of participants in researchIRB diverseNon affiliates, different disciplines, non scientists

  • Complete Institutional Requirements OnlineCollaborative Institutional Training Initiative Basic Human Research Course

    Electronic Conflict of Interest disclosurehttp://orc.osu.edu/coi/ http://www.orrp.osu.edu/humansubjects/citi.cfm

  • Type of ResearchBehavioral/Social Sciences IRBinvestigator initiated researchno invasive biomedical procedures research from variety of disciplines e.g., art, education, business, music, communication, journalism, political science, psychology, sociology, social workinformation technology expertise

  • Type of Research cont.Biomedical IRBInvasive biomedical procedures (including blood drawing)Cancer Biomedical IRBInvasive biomedical procedures (including blood drawing)Prevention or treatment of cancerWestern IRBIndustry-sponsored clinical trials

  • Level of ReviewFull committee reviewConvened IRB meetingExpedited review Minimal risk; specified types of researchExempt reviewOne of six categories; no prisoners, no deception

  • Exempt CategoriesCategory 1: Classroom researchCategory 2: Surveys, Observational studies, interviews, focus groupsCategory 3: #2 with elected officialsCategory 4: Existing data/materialsCategory 5: Federal Agency initiated programsCategory 6: Food quality and taste

  • Expedited Categories-New ProtocolsMust be Minimal RiskCategory 1: Marketed drugs/devicesCategory 2: Blood drawsCategory 3: Non-invasive specimen collectionCategory 4: Non-invasive clinical data collection (e.g., MRI)Category 5: Similar to Exempt #4 (see appendix)Category 6: Audio and video recordingsCategory 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 SubmitCompleted application http://www.orrp.osu.edu/humansubjects/forms.cfm Research proposal http://orrp.osu.edu/documents/GuidelinesforWritingaResearchProtocol.doc Recruitment materialsConsent form or waiver http://orrp.osu.edu/humansubjects/forms.cfm Surveys, Interview/Focus Group Questions

  • Wait for Approval/Exemption Letterbefore recruiting, collecting data, accessing private identifiable information.Exempt process 1-3 weeksExpedited process 5-7 weeksConvened review 8-12 weeks

  • Once Approved/ExemptedNo changes in exempt Submit an amendment form for IRB studieswait 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.edu

  • Office HoursBehavioral 211A PAESWednesdays 1:00 p.m. - 3:00 p.m.

    Biomedical Call 688-8457 for appointment

  • Thank YouDr. Joni BarnardQI Specialist SBS Education and OutreachBarnard.15@osu.edu

    ****

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