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(203) Basics of Human & Animal Research Regulations SCCE Higher Education Compliance Conference 2009

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(203) Basics of Human & Animal Research Regulations SCCE Higher Education Compliance Conference 2009

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(203) Basics of Human & Animal Research Regulations SCCE Higher Education Compliance Conference 2009

  1. 1. Basics of Human andBasics of Human and Animal ResearchAnimal Research RegulationsRegulations Suzanne M. Rivera, Ph.D.Suzanne M. Rivera, Ph.D. Associate Vice PresidentAssociate Vice President UT Southwestern Medical CenterUT Southwestern Medical Center
  2. 2. Research is RegulatedResearch is Regulated  Use of human subjects and animals in researchUse of human subjects and animals in research is a privilegeis a privilege  Numerous regulatory bodies authorize, monitor,Numerous regulatory bodies authorize, monitor, and have authority to halt human and animaland have authority to halt human and animal researchresearch  The public expects (and deserves) researchThe public expects (and deserves) research conducted with integrityconducted with integrity  Effective oversight supports the researchEffective oversight supports the research enterprise (no compliance= no money)enterprise (no compliance= no money)
  3. 3. Ethical PrinciplesEthical Principles BELMONT (Human)BELMONT (Human)  Respect for PersonsRespect for Persons  BeneficenceBeneficence  JusticeJustice SUNDOWNER (Animal)SUNDOWNER (Animal)  Respect for LifeRespect for Life  Non-MaleficenceNon-Maleficence  Societal BenefitSocietal Benefit
  4. 4. Care & Use of AnimalsCare & Use of Animals
  5. 5. What is Animal Care and Use?What is Animal Care and Use?  For purposes of this session, the wordFor purposes of this session, the word “animals”“animals” means live, vertebrate animals used in research,means live, vertebrate animals used in research, testing, teaching, health surveillance, or for relatedtesting, teaching, health surveillance, or for related purposes.purposes.  For purposes of this session, the phraseFor purposes of this session, the phrase ““care and use”care and use” means procurement, housing,means procurement, housing, transport, husbandry, health maintenance,transport, husbandry, health maintenance, experimentation, treatment and humane euthanasia.experimentation, treatment and humane euthanasia.
  6. 6. Animal Rights v. Animal WelfareAnimal Rights v. Animal Welfare
  7. 7. Current U.S. RegulationsCurrent U.S. Regulations  Animal Welfare Act, 1966 [USC Title 7, Sections 2131 to 2156] as amended in 1970,Animal Welfare Act, 1966 [USC Title 7, Sections 2131 to 2156] as amended in 1970, 1976, 1985 and 1990.1976, 1985 and 1990.  Animal Welfare Regulations [Title 9 CFR, Subchapter A, Animal Welfare, Parts 1, 2 andAnimal Welfare Regulations [Title 9 CFR, Subchapter A, Animal Welfare, Parts 1, 2 and 3]3]  Health Research Extension Act, 1985 [Public Law 99-158, November 20, 1985, SectionHealth Research Extension Act, 1985 [Public Law 99-158, November 20, 1985, Section 495]495]  US Government Principles for the Utilization and Care of Vertebrate Animals Used inUS Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, 1985Testing, Research, and Training, 1985  PHS Policy on Humane Care and Use of Laboratory Animals, 1986PHS Policy on Humane Care and Use of Laboratory Animals, 1986  2000 Report of the AVMA Panel on Euthanasia [JAVMA, Vol. 218, No. 5, March 1,2000 Report of the AVMA Panel on Euthanasia [JAVMA, Vol. 218, No. 5, March 1, 2001]2001]  Guide for the Care and Use of Laboratory Animals (Guide for the Care and Use of Laboratory Animals (GuideGuide) [NRC, 5th Ed., 1996]) [NRC, 5th Ed., 1996]  NIH Grants Policy Statement (03/01), Part II: Terms and Conditions of NIH GrantNIH Grants Policy Statement (03/01), Part II: Terms and Conditions of NIH Grant Awards Subpart A: General -- Part 2 of 7Awards Subpart A: General -- Part 2 of 7
  8. 8. EnforcementEnforcement  USDA (regulations)USDA (regulations)  OLAW (regulations)OLAW (regulations)  AAALAC, Int. (voluntary accreditation standards)AAALAC, Int. (voluntary accreditation standards)  States (statutes)States (statutes)  Local Municipalities (laws)Local Municipalities (laws)  Institutions (policies)Institutions (policies)  Attending Veterinarian/Institutional Animal CareAttending Veterinarian/Institutional Animal Care PersonnelPersonnel  Local IACUCs (policies, procedures)Local IACUCs (policies, procedures)
  9. 9. IACUC (What is it?)IACUC (What is it?)  The institutional body with responsibility for reviewThe institutional body with responsibility for review and oversight of the institution’s program for theand oversight of the institution’s program for the humane care and use of animals.humane care and use of animals.  IACUC supports, facilitates, and promotes ethical andIACUC supports, facilitates, and promotes ethical and humane use of animals by upholding the standards sethumane use of animals by upholding the standards set forth in all applicable laws, policies & guidance.forth in all applicable laws, policies & guidance.  Per PHS Policy, must consist of no fewer than fivePer PHS Policy, must consist of no fewer than five members, including a Veterinarian, one practicingmembers, including a Veterinarian, one practicing scientist experienced in research involving animals, onescientist experienced in research involving animals, one member whose primary vocation is in a non-scientificmember whose primary vocation is in a non-scientific area, and one member unaffiliated with the institution.area, and one member unaffiliated with the institution.
  10. 10. IACUC AuthoritiesIACUC Authorities  Review animal care and use program 2x/yr.Review animal care and use program 2x/yr.  Inspect animal facilities, laboratories, and other areas whereInspect animal facilities, laboratories, and other areas where animals are used 2x/yr.animals are used 2x/yr.  Provide IACUC program evaluations and facility inspections toProvide IACUC program evaluations and facility inspections to the IO.the IO.  Review and approve, require modifications in (to secure approval)Review and approve, require modifications in (to secure approval) or withhold approval of proposed and continuing animal activities.or withhold approval of proposed and continuing animal activities.  Review and approve, require modifications in (to secure approval)Review and approve, require modifications in (to secure approval) or withhold approval of all proposed changes (modifications) toor withhold approval of all proposed changes (modifications) to approved protocols.approved protocols.
  11. 11. IACUC Authorities, cont.IACUC Authorities, cont.  Notify investigators in writing of its decision toNotify investigators in writing of its decision to approve, require modifications in (to secure approval)approve, require modifications in (to secure approval) or withhold approval of proposed animal activities.or withhold approval of proposed animal activities.  Investigate concerns involving the care and use ofInvestigate concerns involving the care and use of animals.animals.  Suspend animal activities that are not being conductedSuspend animal activities that are not being conducted in accordance with applicable requirements.in accordance with applicable requirements.  Make written recommendations to the IO regardingMake written recommendations to the IO regarding any aspect of the institution’s animal care and useany aspect of the institution’s animal care and use program.program.
  12. 12. IACUC ReviewIACUC Review  Importance of research question justifies use of animals?Importance of research question justifies use of animals?  Study personnel have training in species/techniques?Study personnel have training in species/techniques?  RRefine- consider alternatives to any procedure thatefine- consider alternatives to any procedure that causes more than momentary pain or distresscauses more than momentary pain or distress  RReduce- the number of animals used should be theeduce- the number of animals used should be the minimum consistent with aims of the experimentminimum consistent with aims of the experiment  RReplace- use non-animal models when possibleeplace- use non-animal models when possible
  13. 13. ModificationsModifications  Any change in an ongoing study must beAny change in an ongoing study must be approved prior to implementation*approved prior to implementation*  Most common changes: personnel, procedures,Most common changes: personnel, procedures, animal numbersanimal numbers  Significant changes reviewed by Full CommitteeSignificant changes reviewed by Full Committee *except to avoid an immediate apparent hazard*except to avoid an immediate apparent hazard
  14. 14. Continuing ReviewContinuing Review  OLAW covered species are reviewedOLAW covered species are reviewed de novode novo everyevery three years.three years.  USDA covered species are reviewed at least annually.USDA covered species are reviewed at least annually.  Most universities look at all protocols annually, withMost universities look at all protocols annually, with more in-depth (or “from scratch”) review every threemore in-depth (or “from scratch”) review every three years.years.  PI’s responsibility to request continuing reviewPI’s responsibility to request continuing review sufficiently prior to expiration of approval to avoid asufficiently prior to expiration of approval to avoid a lapse.lapse.
  15. 15. Animal CareAnimal Care  Attending VeterinarianAttending Veterinarian  Animal Care Staff: vet techs, husbandry techs,Animal Care Staff: vet techs, husbandry techs, procurement staff, transport staff, cagewashprocurement staff, transport staff, cagewash personnel, etc.personnel, etc.  Compliance/post-approval monitoringCompliance/post-approval monitoring (may reside with IACUC)(may reside with IACUC)
  16. 16. Animal Care DutiesAnimal Care Duties  HousingHousing  Daily Health ChecksDaily Health Checks  Pathogen ControlPathogen Control  Feed, BeddingFeed, Bedding  TransportTransport  Monitoring of Surgery/Other ProceduresMonitoring of Surgery/Other Procedures  NecropsyNecropsy  Physical Plant UpkeepPhysical Plant Upkeep  Equipment MaintenanceEquipment Maintenance  Scientific/Clinical Input on IACUC ReviewScientific/Clinical Input on IACUC Review  IACUC’s “eyes and ears” in the FieldIACUC’s “eyes and ears” in the Field
  17. 17. Training Is RequiredTraining Is Required  Federal law mandates that all individuals who workFederal law mandates that all individuals who work with animals in biomedical research be appropriatelywith animals in biomedical research be appropriately qualified and trained.qualified and trained.  Training program should be available to allTraining program should be available to all investigators, fellows, students, and technicians whoinvestigators, fellows, students, and technicians who work with research animals.work with research animals.  Various media can be used: web-based, in-person,Various media can be used: web-based, in-person, brochure, hands-on, classroom style, etc.brochure, hands-on, classroom style, etc.
  18. 18. Compliance ActivitiesCompliance Activities  Lab Inspections at least twice annuallyLab Inspections at least twice annually  Post-approval Monitoring (not for cause)Post-approval Monitoring (not for cause)  Investigations (for cause)Investigations (for cause)  Semi-annual Program EvaluationsSemi-annual Program Evaluations  Report to OLAW (and UDSA, if covered)Report to OLAW (and UDSA, if covered) serious/continuing problems in a timely fashion;serious/continuing problems in a timely fashion; summarize for AAALAC annual reportsummarize for AAALAC annual report
  19. 19. Keep Good Records!!Keep Good Records!!
  20. 20. What is AAALAC?What is AAALAC?  AAALAC, International is a private, nonprofitAAALAC, International is a private, nonprofit organization that promotes the humane treatment oforganization that promotes the humane treatment of animals in science through a voluntary accreditationanimals in science through a voluntary accreditation program.program.  Formal site visits are conducted at three-yearFormal site visits are conducted at three-year intervals and are a method of ensuring that animalintervals and are a method of ensuring that animal care and use programs maintain high standards.care and use programs maintain high standards.
  21. 21. What Does AAALAC Do?What Does AAALAC Do?  AAALAC site visitors evaluate all aspects of anAAALAC site visitors evaluate all aspects of an animal care and use program, including conformanceanimal care and use program, including conformance with established procedures and overall performancewith established procedures and overall performance in the area of animal care and use in research,in the area of animal care and use in research, education, testing or breeding.education, testing or breeding.  The basic components of a program that are evaluatedThe basic components of a program that are evaluated include (but are not limited to) institutional/IACUCinclude (but are not limited to) institutional/IACUC policies, animal husbandry, veterinary care, and thepolicies, animal husbandry, veterinary care, and the physical plant.physical plant.
  22. 22. Worker Protection & Occ. HealthWorker Protection & Occ. Health
  23. 23. Risks for Animal UsersRisks for Animal Users  AllergiesAllergies  AsthmaAsthma  Skin RashesSkin Rashes  Burns, cuts, needle sticksBurns, cuts, needle sticks  Chemical exposuresChemical exposures  Infectious agentsInfectious agents  Repetitive stress, overexertionRepetitive stress, overexertion
  24. 24. Worker Protection ProgramWorker Protection Program  Employee Health ClinicEmployee Health Clinic  BrochureBrochure  Health History QuestionnaireHealth History Questionnaire  Tutorial on risks for animal users and bystandersTutorial on risks for animal users and bystanders  Access to hazards limited pendingAccess to hazards limited pending assessment/tutorialassessment/tutorial  Consultation and referral to specialistConsultation and referral to specialist  Case management for Worker’s CompensationCase management for Worker’s Compensation claimsclaims
  25. 25. Questions?Questions?
  26. 26. Use of Human SubjectsUse of Human Subjects
  27. 27. What is Human Research?What is Human Research? ““anyany systematicsystematic investigation that isinvestigation that is designeddesigned toto develop or contribute to generalizeabledevelop or contribute to generalizeable knowledgeknowledge, and which, and which uses living humansuses living humans oror identifiable informationidentifiable information about living humansabout living humans”” - 45CFR Part 46 (“The Common Rule”)- 45CFR Part 46 (“The Common Rule”)
  28. 28. ExamplesExamples  analyses of existing biological specimensanalyses of existing biological specimens  chart reviewschart reviews  clinical trialsclinical trials  cognitive and perceptual experimentscognitive and perceptual experiments  evaluations of social or educational programsevaluations of social or educational programs  interviews and focus groupsinterviews and focus groups  surveys and questionnairessurveys and questionnaires  treatment outcome studiestreatment outcome studies
  29. 29. Current RequirementsCurrent Requirements  45 CFR Part 46 (PHS)45 CFR Part 46 (PHS)  21 CFR Part 56 (FDA)21 CFR Part 56 (FDA)  45 CFR Parts 160 & 164 (HIPAA)45 CFR Parts 160 & 164 (HIPAA)  State statutesState statutes  Local ordinancesLocal ordinances  Institution/Campus policies and proceduresInstitution/Campus policies and procedures  Community standardsCommunity standards
  30. 30. 45 CFR Part 4645 CFR Part 46  ““The Common Rule”: Federal Policy for theThe Common Rule”: Federal Policy for the Protection of Human SubjectsProtection of Human Subjects  DHHS subpartsDHHS subparts  Subpart B: Pregnant women, Fetuses andSubpart B: Pregnant women, Fetuses and NeonatesNeonates  Subpart C: PrisonersSubpart C: Prisoners  Subpart D: MinorsSubpart D: Minors
  31. 31. 21 CFR Parts 50 and 56 (FDA)21 CFR Parts 50 and 56 (FDA)  IDEs- New DevicesIDEs- New Devices  INDs- New Drugs/ BiologicsINDs- New Drugs/ Biologics  Emergency Use of Test ArticleEmergency Use of Test Article
  32. 32. 45 CFR Parts 160 & 164 (HIPAA)45 CFR Parts 160 & 164 (HIPAA)  Privacy BoardPrivacy Board  AuthorizationAuthorization  Waiver of AuthorizationWaiver of Authorization  De-identified Data SetDe-identified Data Set
  33. 33. EnforcementEnforcement  DHHS- OHRPDHHS- OHRP  DHHS- FDADHHS- FDA  AAHRPP (voluntary accreditation)AAHRPP (voluntary accreditation)  State and Local GovernmentsState and Local Governments  Institutions (e.g., universities, hospitals)Institutions (e.g., universities, hospitals)  Local IRBsLocal IRBs
  34. 34. IRB (What is it?)IRB (What is it?)  Institutional body with responsibility for review andInstitutional body with responsibility for review and oversight of the human subject protection program.oversight of the human subject protection program.  IRB supports, facilitates, and promotes ethical use of humanIRB supports, facilitates, and promotes ethical use of human subjects by upholding the standards set forth in allsubjects by upholding the standards set forth in all applicable laws, policies & guidance.applicable laws, policies & guidance.  Per federal Policy, must consist of no fewer than fivePer federal Policy, must consist of no fewer than five members, including one practicing scientist, one membermembers, including one practicing scientist, one member whose primary vocation is in a non-scientific area, and onewhose primary vocation is in a non-scientific area, and one member unaffiliated with the institution.member unaffiliated with the institution.
  35. 35. IRB AuthoritiesIRB Authorities  Review and approve, require modifications in (to secureReview and approve, require modifications in (to secure approval), or disapprove all research activities covered byapproval), or disapprove all research activities covered by the regulations;the regulations;  Require that information given to subjects as part ofRequire that information given to subjects as part of informed consent is in accordance with the regulations;informed consent is in accordance with the regulations;  Require documentation of informed consent or may waiveRequire documentation of informed consent or may waive documentation in accordance with the regulations;documentation in accordance with the regulations;  Notify investigators and the institution in writing of itsNotify investigators and the institution in writing of its decision to approve or disapprove proposed research or ofdecision to approve or disapprove proposed research or of modifications required to secure IRB approval of themodifications required to secure IRB approval of the research activity;research activity;
  36. 36. IRB Authorities, cont.IRB Authorities, cont.  Conduct continuing review of research covered byConduct continuing review of research covered by the regulations at intervals appropriate to the degreethe regulations at intervals appropriate to the degree of risk, but not less than once per year;of risk, but not less than once per year;  May observe or have a third party observe theMay observe or have a third party observe the consent process and the research; andconsent process and the research; and  May suspend or terminate approval of research that isMay suspend or terminate approval of research that is not being conducted in accordance with the IRB'snot being conducted in accordance with the IRB's requirements or that has been associated withrequirements or that has been associated with unexpected serious harm to subjects.unexpected serious harm to subjects.
  37. 37. IRB ReviewIRB Review  Risks justified and reduced to fullest extent?Risks justified and reduced to fullest extent?  Benefits maximized to fullest extent?Benefits maximized to fullest extent?  Importance of research question justifies risks inImportance of research question justifies risks in light of anticipated benefits?light of anticipated benefits?  Selection of subjects is equitable?Selection of subjects is equitable?
  38. 38. IRB Review, cont.IRB Review, cont.  Proposed subject population not unduly harmed?Proposed subject population not unduly harmed?  Method, content, and documentation of consentMethod, content, and documentation of consent appropriate?appropriate?  Provision for monitoring the data collected to ensureProvision for monitoring the data collected to ensure the safety of subjects?the safety of subjects?  Provisions to protect subjects’ privacy and maintainProvisions to protect subjects’ privacy and maintain confidentiality of data?confidentiality of data?
  39. 39. Informed Consent Must Be:Informed Consent Must Be:  consistent with regulations re: required elements;consistent with regulations re: required elements;  obtained from subject or legally-authorizedobtained from subject or legally-authorized representative;representative;  presented in language understandable to the subject/ rep.;presented in language understandable to the subject/ rep.;  in writing (unless IRB approved verbal or waiver); andin writing (unless IRB approved verbal or waiver); and  obtained in circumstances that offer the subject/rep.obtained in circumstances that offer the subject/rep. sufficient opportunity to consider whether to participate.sufficient opportunity to consider whether to participate.
  40. 40. ModificationsModifications  Any change in an ongoing study must beAny change in an ongoing study must be approved prior to implementation*approved prior to implementation*  Most common changes: personnel, procedures,Most common changes: personnel, procedures, subject populations, recruitment methodssubject populations, recruitment methods  Mods that affect risk/benefit ratio or increaseMods that affect risk/benefit ratio or increase subject safety reviewed by Full Boardsubject safety reviewed by Full Board *except to avoid an immediate apparent hazard*except to avoid an immediate apparent hazard
  41. 41. Adverse Events/Safety DataAdverse Events/Safety Data  All AEs must be reported to the IRB within 10 days.All AEs must be reported to the IRB within 10 days. All deaths and hospitalizations also must be reportedAll deaths and hospitalizations also must be reported by phone, fax or e-mail within 48 hours.by phone, fax or e-mail within 48 hours.  IRB Chair/designeee reviews serious local AEsIRB Chair/designeee reviews serious local AEs between meetings.between meetings.  AE data provided to IRB members at time of CR.AE data provided to IRB members at time of CR.  PIs submit copies of DSMB reports at time of CR.PIs submit copies of DSMB reports at time of CR.
  42. 42. Continuing ReviewContinuing Review  Expedited and Full Committee studies reviewed at leastExpedited and Full Committee studies reviewed at least annually.annually.  Opportunity to reevaluate importance of researchOpportunity to reevaluate importance of research question, appropriateness of risks, AEs.question, appropriateness of risks, AEs.  IRB may request modifications to protocol/consent.IRB may request modifications to protocol/consent.  PI’s responsibility to request continuing reviewPI’s responsibility to request continuing review sufficiently prior to expiration of approval to avoid asufficiently prior to expiration of approval to avoid a lapse.lapse.
  43. 43. ComplianceCompliance  Policy for Regulatory NoncompliancePolicy for Regulatory Noncompliance  Staff conduct Administrative AuditsStaff conduct Administrative Audits  IRBs (or subcommittees) perform reviewsIRBs (or subcommittees) perform reviews  Efforts made to resolve informally whenever possibleEfforts made to resolve informally whenever possible  IRBs empowered to impose corrective actionsIRBs empowered to impose corrective actions  Report to OHRP (and FDA, if covered)Report to OHRP (and FDA, if covered) serious/continuing problems in a timely fashionserious/continuing problems in a timely fashion
  44. 44. What is AAHRPP?What is AAHRPP?  AAHRPP is a private, nonprofit organization thatAAHRPP is a private, nonprofit organization that promotes the protection of human subjects through apromotes the protection of human subjects through a voluntary accreditation program.voluntary accreditation program.  Formal site visits are conducted at three-yearFormal site visits are conducted at three-year intervals and are a method of ensuring that humanintervals and are a method of ensuring that human subjects protection programs maintain high standards.subjects protection programs maintain high standards.
  45. 45. What Does AAHRPP Do?What Does AAHRPP Do?  AAHRPP site visitors evaluate all aspects of a humanAAHRPP site visitors evaluate all aspects of a human subjects protection program, including conformancesubjects protection program, including conformance with established procedures and overall performance.with established procedures and overall performance.  The five domains that are evaluated include:The five domains that are evaluated include:  OrganizationOrganization  Research Review Unit (including IRBs)Research Review Unit (including IRBs)  InvestigatorInvestigator  Sponsored ResearchSponsored Research  Participant OutreachParticipant Outreach
  46. 46. Effective Compliance: Human andEffective Compliance: Human and Animal ResearchAnimal Research  Have a policy and procedures for monitoring andHave a policy and procedures for monitoring and enforcement (avoid S.L.A.G.I.A.T. method)enforcement (avoid S.L.A.G.I.A.T. method)  Honor due process, document actionsHonor due process, document actions  Keep the Institutional Official informedKeep the Institutional Official informed  Emphasize training over punishment (an ounce ofEmphasize training over punishment (an ounce of prevention…)prevention…)
  47. 47. Questions?Questions?
  48. 48. Thank you!Thank you! suzanne.rivera@utsouthwestern.edusuzanne.rivera@utsouthwestern.edu

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