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


<ul><li><p>IRBHistory, Ethical Foundations, &amp; Researcher Responsibilities</p><p>Michael MahoneyAsst. Director - IRBsWIRB Liaisonmmahoney@ufl.edu</p></li><li><p>ConsiderationsBasis for reviewWhat is reviewedProcess and other issuesResources</p></li><li><p>IRB =Institutional Review BoardMission Protect rights and welfare of human research subjects / participants</p></li><li><p>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. </p></li><li><p> Nazi Experimentation</p></li><li><p>Tuskegee Syphilis Study 1932-1972 </p></li><li><p>Belmont Report Cornerstones for PersonsInformed Consent processPrivacy and ConfidentialityBeneficenceRisk/Benefit AnalysisScientific MeritJusticeReview of subject selection</p></li><li><p>Federal Regulations</p><p>OHRP45 CFR 46(1976)FDA21 CFR 50, 54, 56, 312, 812 (1980)OCRHIPAA(2003)VA1200.5 + 38 CFR 16(2003)</p></li><li><p>Problems protecting subjects continueU Penn gene therapy 1999Hopkins hexamethonium bromide 2001 Stratton VA eligibility falsification 2002Criminal conviction in Feb 2006 </p></li><li><p>Nuremberg Trials 1940s</p><p>US ScandalsTuskegee 1972</p><p>Jesse GeslingerStratton VA</p><p>1940195019601970</p><p>198019902000</p><p>Nuremberg CodeDeclar. HelsinkiOPRRNatl Rsch ActBelmont ReportFDA Regs</p><p>HIPAA VA Accreditation</p></li><li><p>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)</p></li><li><p>ResearchA systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.45 CFR 46.102.(d)</p></li><li><p>Examples of researchClinical Trials (therapeutic research) Survey, observational, or educational researchIRB APPROVAL REQUIREDReview of medical records or databasesTissue or dataIdentifiable vs coded vs anonymousExisiting?</p></li><li><p>REQUIRED: All ResearchResearch must be approved before being conducted</p></li><li><p>Review Process</p></li><li><p>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</p></li><li><p>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</p></li><li><p>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</p></li><li><p>ExpeditedInteraction/intervention with living individual or their identifiable data</p><p>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. </p></li><li><p>ExpeditedApproved for a maximum of 1 yearmust obtain approval for Continuing Review Adverse Events</p><p>Researcher can do more, so more protection needed.</p></li><li><p>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</p></li><li><p>Full BoardApproved for a maximum of 1 yearmust obtain approval for Continuing Review Adverse Events</p><p>Researcher can do more, so more protection needed.</p></li><li><p>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</p></li><li><p>REQUIRED: All ResearchAny changes, no matter how minor, must be approved before implementationUnanticipated Problems Adverse EventsLoss of dataBreach of confidentiality</p></li><li><p>Outside IssuesSecondary subjects: anyone you collect data on is a subjectConducting research at other locationsInternational ResearchInvolving outsiders in researchConflict of Interest</p></li><li><p>Privacy &amp; ConfidentialityPrivacy Subjects ability to control how other people see, touch, or obtain information about the subject. </p><p>Confidentiality the ways identifiable information will be stored and shared </p></li><li><p>Non-complianceConducting research prior to initial approvalConducting research after approval expiresImplementing revisions without prior IRB approvalOver-enrollingEnrolling subjects not approved by IRBVulnerable populations</p></li><li><p>Non-complianceEnrolling subjects who do not fit enrollment criteria in protocolNeed approval from Sponsor &amp; IRBFailure to obtain/document consentLosing copies of signed consentsFailure to document proceduresIf its not documented it didnt happen</p><p>Regulatory non-compliance is reported by the institution to the appropriate Federalagencies</p></li><li><p>Local Info: </p><p></p></li><li><p>Local Info: </p><p></p></li><li><p>Other Offices: VA R&amp;DIBCHURRCPharmacyCTSIResearch atUFShandsNF/SG VHS</p></li><li><p>HELP! Page</p></li><li><p>Researcher To doRequired Reading Belmont Report45 CFR 46IRB-01 Policies &amp; ProceduresResearcher responsibilities HIPAA required training every year</p></li><li><p>ResourcesIRB researcher listserv Ethics Links Assistance with NEW studiesRenee Collins 273-8788</p></li><li><p>DSRDivision of Sponsored Research Grants &amp; Contracts Judy Harris Grinter Hall room 207 (352) 392-9267 </p></li><li><p>HURRCHuman Use of Radioisotopes and Radiation Committee Don Munroe Box 118340 Gainesville, FL 32611-8340 (352) 392-7359 </p></li><li><p>Shands PharmacyUF - Susan Beltz, PharmD Box 100316 Gainesville, FL 32610-0486 </p></li><li><p>IBCInstitutional Biosafety CommitteeStudies involving Human Gene Therapy Dr. Phillip S. Collis Box 112190 (352) 392-1591</p></li><li><p>CTSIClinical and Translation Science InstituteVariety of resources open to all researchers Kathryn St. Croix Box 100219 (352) 273-8770 </p></li><li><p>NF/SG VHSNorth Florida / South Georgia Veterans Health SystemR&amp;D = Research &amp; Development CommitteeSCI = Subcommittee for Clinical Investigations submission requirements</p><p>Hattie Grant 376-1611 ext 4956 </p></li><li><p>SummaryIRB = Protect rights and welfare of subjects</p></li><li><p>SummaryIRB = protect rights and welfare of subjectsNeed approval BEFORE starting researchOn-going approval requiredHost of requirementsWere here to help!</p></li><li><p>RememberThe ends do NOT justify the means</p><p>Research is a privilege</p></li><li><p>*</p></li><li><p>Institutional Animal Care &amp; Use Committee</p><p>IACUC</p><p></p><p>Dorian LuceyCoordinator, Training &amp; Quality AssuranceIACUC, University of</p></li><li><p>Main office: Communicore Bldg CB-151BMain number: (352) 392-9917Fax: (352) 392-9919Email: iacuc@grove.ufl.eduWeb site: www.iacuc.ufl.eduList-serv: contact information:</p></li><li><p>OutlineHistoryRole of the IACUCAnimal Care &amp; Use ProtocolsProtocol ReviewTrainingInspectionsQuality AssuranceQuestions?</p></li><li><p>From Mid 1800s on, increased use of animals in medical researchPublic concerned about animal welfare</p><p>British Cruelty to Animals Act of 1876</p><p>Establishment of several Antivivisection Societies (late 1800s-early 1900s)</p><p>Following World War IIEconomic boom, large increase in scientific researchHygienic Laboratory renamed National Institutes of Health (NIH)Huge Increase (approx 40x) in NIH budget</p><p>Setting the stage</p></li><li><p>1961, The Guide was created which was supported by National Institutes of Health.</p><p>1963, The Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) was formed. UF has been AAALAC accredited since 1965.</p><p>IACUC History</p></li><li><p>1966, article in Life magazine prompted creation of the Laboratory Animal Welfare Act (USDA).</p><p>Established minimum standards in 8 areas: housing, feeding, watering, sanitation, shelter, separation of species, ventilation, &amp; adequate veterinary care.IACUC History (cont.)</p></li><li><p>1970 amendmentreport animals by pain categoryrequire appropriate use of anestheticsinclude all warm-blooded animals except rats of the genus Rattus, mice of the genus Mus, and birds bred for research. </p><p>IACUC History (cont.)</p></li><li><p>Made into law by the 1985 Health Research Extension Act and is applicable to all PHS-supported activities involving animals conducted in any US territory. It includes all vertebrate animals.</p><p>The Office of Laboratory Animal Welfare (OLAW) at the NIH has the responsibility of enforcing PHS Policy</p><p>Require an Institutional Animal Care &amp; Use Committee (IACUC) composed of at least 5 members (must include a veterinarian, scientist, non-affiliated member)Public Health Service (PHS) Policy on Humane Care &amp; Use of Laboratory Animals</p></li><li><p>PHS requires use of the Guide, USDA refers to the Guide, AAALAC uses the Guide as a standard.</p><p>PHS guidelines required by CDC, FDA, NIH. Last year, UF received $580M for sponsored research (over half from federal sources, half of this from the NIH)</p><p>Ag Guide: Guide for the Care and Use of Agricultural Animals in Agricultural Research and TeachingThe Guide for the Care and Use of Laboratory Animals</p></li><li><p>19 members at UF: Ph.D., D.V.M., community members, consultants (J.D., EH&amp;S, D.V.M.)6 alternate membersSupport Staff (Office &amp; Coordinators)Meet 1st &amp; 3rd Tuesday of each month for Full-Committee protocols &amp; any IACUC business~450 researchers, over 1300 active protocols</p><p>IACUC at UF</p></li><li><p> The IACUC at the University of Florida is committed to ensuring that all animals used for experimental purposes are treated humanely and that pain and stress are minimized. </p><p> Why are we here?</p></li><li><p>Oversight and evaluation of all aspects of animal care and use programAssure compliance with all federal, state, and local laws &amp; regulationsEvaluate animal care &amp; use program (ACS, IACUC, EH&amp;S)Inspect facilitiesReview Animal Use ProtocolsReview animal welfare concernsSuspend ActivityThe role of the IACUC</p></li><li><p> The role of the IACUCReviews all animal care and use protocolsIt is a formal request from the investigator to the university to use vertebrate animals and tissues in experiments.It is a contract between the PI and the universityNo work on a protocol can be started without approvalAll personnel contacting animals must be listed on the protocolAll changes and/or additions must be approved by the IACUC</p></li><li><p>Original/initial protocol submission (approved for up to 3 years)Addendums (minor changes to existing protocol)Annual review of protocol (report of what has been done in past year)Triennial review of protocol (protocols already approved for 3 years, needs to be approved for up to 3 more years)Major Revision Administrative (title, room, and/or funding change)myIACUC loginVeterinary Consultation All new protocols, triennial reviews, major revisions, and addendums must be reviewed by a veterinarian. </p><p>Animal care and use protocols</p></li><li><p>When reviewing protocolsPain, distress and discomfort</p><p>Cat. A No live animal use, observational field studies or use of cadavers not euthanized for study</p><p>Cat. B Breeding or observation only</p><p>Cat. C - Minimal pain, distress, discomfort associated with protocol, and no pain relieving drugs or treatments are necessary</p><p>Cat. D Pain, distress, discomfort associated with protocol and appropriate pain relieving drugs or treatments are provided</p><p>Cat. E - Pain, distress, discomfort associated with protocol, but pain relieving drugs or treatment are withheld because use would interfere with study objectives. </p></li><li><p>Alternatives to animal use/duplication (3 Rs)Replacement: when non-animal or in-vitro models are availableReduction: minimize number of animals used while still being consistent with sound scientific and statistical standards. Refinement: procedures should have the least amount of potential pain, discomfort, distress, &amp; morbidity (PDDM). PDDM should be minimized through pharmacological and other means.</p><p>Justification for species used and any deviations from standard practicesEndpoints and criteria for euthanasia</p><p>When reviewing protocols (cont.)</p></li><li><p>Post procedural careTreatments (doses, volumes, routes of administration)Qualifications/training</p><p>When reviewing protocols (cont.)</p></li><li><p>ACS VetsIACUC Office checks training requirements, room inspections, grant correlationMember ConsiderationAdministrative, Designated Review (DR) or Full CommitteeReview time-frame</p><p>The protocol review process</p></li><li><p>All non-human primate studiesAll Category 3 studies involving unrelieved pain, distress or discomfortDeviations from The GuideAny member can call any protocol if he/she feels full committee discussion is required</p><p>Full committee review:</p></li><li><p>**IFAS Food &amp; Fiber research does not need IACUC approval unless the funding agency or journal of publication requires it**</p><p>**Tissue studies may or may not need IACUC approval. Funding sources or publishers may require an IACUC approval.**</p><p>**Protocols that involve field studies and teaching must be submitted for IACUC approval**</p><p>Information to note:</p></li><li><p>Complete all UF IACUC training requirements ( Fill out a Health Risk Assessment from Environmental Health &amp; Safetys (EH&amp;S) Animal Contact Program ( If applicable, complete all UF Animal Care Services training requirements ( </p><p>So, you will be working with animals</p></li><li><p>IACUC training requirementsWorking With the UF IACUC modulesAALAS training modules for specific species and proceduresWorking with IACUC</p></li><li><p>ACS Requirements</p><p>Animal Awareness SeminarBlackboard Training &amp; ExamsContact ACS at 392-2977 or </p></li><li><p>USDA, PHS/OLAW, AAALAC require Semi-annuallyWhat are we looking for?Deficiencies: Minor or Significant. Written corrective action or plan of action with a time frame.IO &amp; OLAW: receives semi-annual report, IO signs Letter of Assurance</p><p>Inspections</p></li><li><p>Whistle-blower Policy </p><p>Possible Non-Compliance</p><p>Suspension/Corrective Action (Reportable...</p></li></ul>


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