IRB History, Ethical Foundations, & Researcher Responsibilities

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IRB History, Ethical Foundations, & Researcher Responsibilities. Considerations. Basis for review What is reviewed Process and other issues Resources. IRB =. Institutional Review Board. Mission Protect rights and welfare of human research subjects / participants. - PowerPoint PPT Presentation

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  • IRBHistory, Ethical Foundations, & Researcher Responsibilities

    Michael MahoneyAsst. Director - IRBsWIRB Liaisonmmahoney@ufl.eduhttp://irb.ufl.edu/

  • ConsiderationsBasis for reviewWhat is reviewedProcess and other issuesResources

  • IRB =Institutional Review BoardMission Protect rights and welfare of human research subjects / participants

  • People harmed by researchNazi experimentationMilgrams Obedience Study (1963)Willowbrook (1963-66)Radiation experiments (1930s-60s)Stanford Prison Experiment (1971)Tuskegee Syphilis Study (1932-1972)More.http://irb.ufl.edu/ethics/

  • http://www.ushmm.org/research/doctors/indiptx.htm Nazi Experimentation

  • Tuskegee Syphilis Study 1932-1972http://www.cdc.gov/nchstp/od/tuskegee/time.htm

  • Belmont Report Cornerstoneshttp://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htmRespect for PersonsInformed Consent processPrivacy and ConfidentialityBeneficenceRisk/Benefit AnalysisScientific MeritJusticeReview of subject selection

  • Federal Regulations

    OHRP45 CFR 46(1976)FDA21 CFR 50, 54, 56, 312, 812 (1980)OCRHIPAA(2003)VA1200.5 + 38 CFR 16(2003)

  • Problems protecting subjects continueU Penn gene therapy 1999Hopkins hexamethonium bromide 2001 Stratton VA eligibility falsification 2002Criminal conviction in Feb 2006http://ori.dhhs.gov/misconduct/cases/Kornak.shtml

  • Nuremberg Trials 1940s

    US ScandalsTuskegee 1972

    Jesse GeslingerStratton VA

    1940195019601970

    198019902000

    Nuremberg CodeDeclar. HelsinkiOPRRNatl Rsch ActBelmont ReportFDA Regs

    HIPAA VA Accreditation

  • Human SubjectLiving individual about whom an investigator (whether professional or student) conducting research obtains:data through intervention or interaction with the individual, oridentifiable private information.45 CFR 46.102.(f)

  • ResearchA systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.45 CFR 46.102.(d)

  • Examples of researchClinical Trials (therapeutic research) Survey, observational, or educational researchIRB APPROVAL REQUIREDReview of medical records or databasesTissue or dataIdentifiable vs coded vs anonymousExisiting?

  • REQUIRED: All ResearchResearch must be approved before being conducted

  • Review Process

  • Indefinite Plans / Non-humanResearch involves human tissue, data, etc., butNO interaction or intervention with living person, ANDNO exposure to or collection of privately identifiable data

  • ExemptInteraction/intervention with living individual or their identifiable dataSurvey, observational, educational researchEither no risk to subject, orIf potential risk recorded anonymouslySurvey does not collect identifiers

  • ExemptReview of existing data, documents, records or specimens that is recorded anonymously :All data exists BEFORE submissionResearcher sees identifiers, but collects data such that it cannot be linked back to subject17 HIPAA identifiers apply No codes or links, permanent or temporary

  • ExpeditedInteraction/intervention with living individual or their identifiable data

    Prospective minimal risk researchCollection of data from voice, video, digital, or image recordings made for research purposes.Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

  • ExpeditedApproved for a maximum of 1 yearmust obtain approval for Continuing Review Adverse Events

    Researcher can do more, so more protection needed.

  • Full BoardRequired if Greater than Minimal RiskUse of vulnerable populations*Data collection on:Conditions that can affect insurability, employability, reputationCriminal activity, drugs, sexual misconductTherapeutic research / Radiation / X-ray / Genetics

  • Full BoardApproved for a maximum of 1 yearmust obtain approval for Continuing Review Adverse Events

    Researcher can do more, so more protection needed.

  • Full Board vs ExpeditedFull Board IRB-01 = 1st and 3rd Wednesday of each monthIRB-02 = 3rd Thursday of each monthDeadline priorExpedited forwarded daily to chairs

  • REQUIRED: All ResearchAny changes, no matter how minor, must be approved before implementationUnanticipated Problems Adverse EventsLoss of dataBreach of confidentiality

  • Outside IssuesSecondary subjects: anyone you collect data on is a subjectConducting research at other locationsInternational ResearchInvolving outsiders in researchConflict of Interest

  • Privacy & ConfidentialityPrivacy Subjects ability to control how other people see, touch, or obtain information about the subject.

    Confidentiality the ways identifiable information will be stored and shared

  • Non-complianceConducting research prior to initial approvalConducting research after approval expiresImplementing revisions without prior IRB approvalOver-enrollingEnrolling subjects not approved by IRBVulnerable populations

  • Non-complianceEnrolling subjects who do not fit enrollment criteria in protocolNeed approval from Sponsor & IRBFailure to obtain/document consentLosing copies of signed consentsFailure to document proceduresIf its not documented it didnt happen

    Regulatory non-compliance is reported by the institution to the appropriate Federalagencies

  • Local Info: IRB-01352-846-1494irb1@grove.ufl.edu

    http://irb.ufl.edu/irb01/

  • Local Info: IRB-02352-392-0433irb2@ufl.edu

    http://irb.ufl.edu/irb02/

  • Other Offices: VA R&DIBCHURRCPharmacyCTSIResearch atUFShandsNF/SG VHS

  • HELP! Pagehttp://irb.ufl.edu/irb01/help/

  • Researcher To doRequired Reading http://irb.ufl.edu/education/trainreq.htm Belmont Report45 CFR 46IRB-01 Policies & ProceduresResearcher responsibilities http://irb.ufl.edu/irb01/researcherresponsibilities.htm HIPAA required training every year

  • ResourcesIRB researcher listservhttp://irb.ufl.edu/irb01/april04announce.htmNewsletterhttp://irb.ufl.edu/education/InvestiGATORS.htm Ethics Linkshttp://irb.ufl.edu/ethics/ Assistance with NEW studiesRenee Collins rbcollins@ufl.edu 273-8788

  • DSRDivision of Sponsored Researchhttp://rgp.ufl.edu/research/ Grants & Contracts Judy Harris Grinter Hall room 207 (352) 392-9267 jaharris@ufl.edu

  • HURRCHuman Use of Radioisotopes and Radiation Committeehttp://www.ehs.ufl.edu/Rad/RCGuide/HURRC.htm http://www.ehs.ufl.edu/Rad/ Don Munroe Box 118340 Gainesville, FL 32611-8340 (352) 392-7359 don@ehs.ufl.edu

  • Shands PharmacyUF - Susan Beltz, PharmD Box 100316 Gainesville, FL 32610-0486 beltze@shands.ufl.edu

  • IBCInstitutional Biosafety CommitteeStudies involving Human Gene Therapyhttp://www.ehs.ufl.edu/Bio/default.asp Dr. Phillip S. Collis Box 112190 (352) 392-1591 pcollis@ehs.ufl.edu

  • CTSIClinical and Translation Science InstituteVariety of resources open to all researchershttp://www.ctsi.ufl.edu/ Kathryn St. Croix Box 100219 (352) 273-8770 stcroixk@ufl.edu

  • NF/SG VHSNorth Florida / South Georgia Veterans Health SystemR&D = Research & Development CommitteeSCI = Subcommittee for Clinical Investigationshttp://www1.va.gov/visn8/nfsg/Research/Separate submission requirements

    Hattie Grant 376-1611 ext 4956 Hattie.Grant@va.gov

  • SummaryIRB = Protect rights and welfare of subjects

  • SummaryIRB = protect rights and welfare of subjectsNeed approval BEFORE starting researchOn-going approval requiredHost of requirementsWere here to help!

  • RememberThe ends do NOT justify the means

    Research is a privilege

  • *

  • Institutional Animal Care & Use Committee

    IACUC

    www.iacuc.ufl.edu

    Dorian LuceyCoordinator, Training & Quality AssuranceIACUC, University of Floridaluceydg@ufl.edu

  • Main office: Communicore Bldg CB-151BMain number: (352) 392-9917Fax: (352) 392-9919Email: iacuc@grove.ufl.eduWeb site: www.iacuc.ufl.eduList-serv: http://www.iacuc.ufl.edu/IACUCmail.htmIACUC contact information:

  • OutlineHistoryRole of the IACUCAnimal Care & Use ProtocolsProtocol ReviewTrainingInspectionsQuality AssuranceQuestions?

  • From Mid 1800s on, increased use of animals in medical researchPublic concerned about animal welfare

    British Cruelty to Animals Act of 1876

    Establishment of several Antivivisection Societies (late 1800s-early 1900s)

    Following World War IIEconomic boom, large increase in scientific researchHygienic Laboratory renamed National Institutes of Health (NIH)Huge Increase (approx 40x) in NIH budget

    Setting the stage

  • 1961, The Guide was created which was supported by National Institutes of Health. http://grants.nih.gov/grants/olaw/olaw.htm

    1963, The Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) was formed. UF has been AAALAC accredited since 1965.

    IACUC History

  • 1966, article in Life magazine prompted creation of the Laboratory Animal Welfare Act (USDA).

    Established minimum standards in 8 areas: housing, feeding, watering, sanitation, shelter, separation of species, ventilation, & adequate veterinary care.IACUC History (cont.)

  • 1970 amendmentreport animals by pain categoryrequire appropriate use of a

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