Human Subjects, Research and Navigating the IRB Process

Download Human Subjects, Research and Navigating the IRB Process

Post on 18-Jul-2015

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When you need an IRB approval or exemptionDetermine 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 differHuman Subjects ExamplesChart reviewsEducational researchSurveys, focus groups, interviewsPsychology computer tutorialsBlood drawsTissue collection and analysisClinical trialsExercise studiesCollaborate with your AdvisorOversees your researchPrincipal Investigator eligibilityInstitutional 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 scientistsComplete Institutional Requirements OnlineCollaborative Institutional Training Initiative Basic Human Research CourseElectronic Conflict of Interest disclosurehttp://orc.osu.edu/coi/ http://www.orrp.osu.edu/humansubjects/citi.cfmType 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 expertiseType 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 trialsLevel of ReviewFull committee reviewConvened IRB meetingExpedited review Minimal risk; specified types of researchExempt reviewOne of six categories; no prisoners, no deceptionExempt 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 tasteExpedited 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 QuestionsWait 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 situationNeed More Guidance? www.orrp.osu.eduOffice HoursBehavioral 211A PAESWednesdays 1:00 p.m. - 3:00 p.m.Biomedical Call 688-8457 for appointmentThank YouDr. Joni BarnardQI Specialist SBS Education and OutreachBarnard.15@osu.edu****

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