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HRPP Policies and Procedures

For VUMC only, policies can be accessed here

Policy and Procedure SectionNumberTitleLink
IRB Authority and Institutional CommitmentI.AInstitutional Oversight of AssurancePolicy I.A
IRB Authority and Institutional CommitmentI.A.1Procedure for Institutional Oversight of AssuranceProcedure I.A.1
IRB Authority and Institutional CommitmentI.BActivities Subject to IRB JurisdictionPolicy I.B
IRB Authority and Institutional CommitmentI.B.1Procedure for Activities Subject to IRB JurisdictionProcedure I.B.1
IRB Authority and Institutional CommitmentI.CResearch Involving Performance SitesPolicy I.C
IRB Authority and Institutional CommitmentI.C.1Procedure for Research Involving Performance SitesProcedure I.C.1
IRB Authority and Institutional CommitmentI.DKnowledge of Local Research ContextPolicy I.D
IRB Authority and Institutional CommitmentI.D.1Procedure for Knowledge of Local Research ContextProcedure I.D.1
IRB Authority and Institutional CommitmentI.F.IRB of RecordPolicy I.F
IRB Authority and Institutional CommitmentI.F.1Procedure for Memorandum of Understanding Set-Up (MOU)Procedure I.F.1
IRB Authority and Institutional CommitmentI.GUse of Collaborative Models of IRB Review to Facilitate Review Time and EffortPolicy I.G
IRB Authority and Institutional CommitmentI.G.1Procedure for Use of Collaborative Models of IRB Review to Facilitate Review Time and EffortProcedure I.G.1
IRB Authority and Institutional CommitmentI.HAdditional Requirements for Research Supported by Other Federal DepartmentsPolicy I.H
HRPP ComplianceII.AHRPP Compliance ActivitiesPolicy II.A
HRPP ComplianceII.A.1Procedure for HRPP Compliance ActivitiesProcedure II.A.1
HRPP ComplianceII.BSuspension, or Termination of IRB ApprovalPolicy II.B
HRPP ComplianceII.B.1Procedure for Suspension, or Termination of IRB ApprovalProcedure II.B.1
HRPP ComplianceII.CInvestigating Any Non-Compliance, Serious, or Continuing Non-CompliancePolicy II.C
HRPP ComplianceII.C.1Procedure for Investigating Any Non-Compliance, Serious, or Continuing Non-ComplianceProcedure II.C.1
HRPP ComplianceII.DReporting to the Appropriate Institutional Officials, and the Department or Agency Head(s)Policy II.D
HRPP ComplianceII.D.1Procedure for Reporting to the Appropriate Institutional Officials, and the Department or Agency Head(s)Procedure II.D.1
HRPP ComplianceII.EComplaints Regarding Human Subjects ResearchPolicy II.E
HRPP ComplianceII.E.1Procedure for Complaints Regarding Human Subjects ResearchProcedure II.E.1
HRPP ComplianceII.FReporting Non-Compliance with the ProtocolPolicy II.F
HRPP ComplianceII.F.1Procedure for Reporting Non-Compliance with the ProtocolProcedure II.F.1
IRB Review ProceduresIII.AInstitutional Review Board Committee Review ResponsibilitiesPolicy III.A
IRB Review ProceduresIII.A.1Procedure for Institutional Review Board Committee Review ResponsibilitiesProcedure III.A.1
IRB Review ProceduresIII.BIRB Committee Determinations/MotionsPolicy III.B
IRB Review ProceduresIII.B.1Procedure for IRB Committee Determinations/MotionsProcedure III.B.1
IRB Review ProceduresIII.CIRB Review of Human Subjects Research - ExemptPolicy III.C
IRB Review ProceduresIII.C.1Procedure for IRB Review of Human Subjects Research - ExemptProcedure III.C.1
IRB Review ProceduresIII.DIRB Review of Human Subjects Research - ExpeditedPolicy III.D
IRB Review ProceduresIII.D.1Procedure for IRB Review of Human Subjects Research - ExpeditedProcedure III.D.1
IRB Review ProceduresIII.EIRB Review of Human Subjects Research - Full CommitteeIII.E
IRB Review ProceduresIII.E.1Procedure for IRB Review of Human Subjects Research - Full CommitteeProcedure III.E.1
IRB Review ProceduresIII.E.2Procedure for Initial Application Materials to be Reviewed by the Full CommitteeProcedure III.E.2
IRB Review ProceduresIII.FResearch with Human Tissue, Blood, Genetic Material, and DataPolicy III.F
IRB Review ProceduresIII.F.1Procedure for Research with Human Tissue, Blood, Genetic Material, and DataPolicy III.F.1
IRB Review ProceduresIII.HGrant ReviewPolicy III.H
IRB Review ProceduresIII.H.1Procedure for Grant ReviewProcedure III.H.1
IRB Review ProceduresIII.IHuman Subject Research/Non-Human Subject Research DeterminationPolicy III.I
IRB Review ProceduresIII.I.1Procedure for Human Subject Research/Non-Human Subject Research DeterminationProcedure III.I.1
IRB Review ProceduresIII.JAmendments to Previously Approved Applications, Claims for Exemption, or Non-Human Subject/Non-Research DeterminationsPolicy III.J
IRB Review ProceduresIII.J.1Procedure for Amendments to Previously Approved Applications, Claims for Exemption, or Non-Human Subject/Non-Research DeterminationsProcedure III.J.1
IRB Review ProceduresIII.KIRB Continuing ReviewPolicy III.K
IRB Review ProceduresIII.K.1Procedure for Conducting IRB Continuing ReviewProcedure III.K.1
IRB Review ProceduresIII.K.2Procedure for Notification of IRB Continuing ReviewProcedure III.K.2
IRB Review ProceduresIII.K.4Procedure for the Processing of IRB Continuing ReviewProcedure III.K.4
IRB Review ProceduresIII.LReporting of Adverse Events, Serious Adverse Events, and Unanticipated Problems Involving Risk to Participants or OthersPolicy III.L
IRB Review ProceduresIII.L.1Procedure for Reporting of Adverse Events, Serious Adverse Events, and Unanticipated Problems Involving Risk to Participants or OthersProcedure III.L.1
IRB Review ProceduresIII.MCoordinating Center ApplicationsPolicy III.M
IRB Review ProceduresIII.M.1Coordinating Center ProceduresProcedure III.M.1
IRB Review ProceduresIII.NProcedure for Human Subjects Radiation Review in ResearchProcedure-III.N
IRB Review ProceduresIII.N.1Procedure for Web-based Dose Calculator for RadiationProcedure III.N.1
Informed Consent ProcessIV.ALegally Effective and Prospectively Obtained Informed ConsentPolicy IV.A
Informed Consent ProcessIV.A.1Procedure for Obtaining Legally Effective and Prospective Informed ConsentProcedure IV.A.1
Informed Consent ProcessIV.A.2Procedure for Incorporating the Elements of Informed ConsentProcedure IV.A.2
Informed Consent ProcessIV.A.3Procedure for Determining the Health Care Decision-Maker for ResearchProcedure IV.A.3
Informed Consent ProcessIV.BDocumentation of Informed Consent for Human Subjects ResearchPolicy IV.B
Informed Consent ProcessIV.B.1Procedure for Documentation of Informed Consent for Human Subjects ResearchProcedure IV.B.1
Informed Consent ProcessIV.CWaiver of Informed Consent for Human Subjects Research or Exception of Informed Consent for Emergency ResearchPolicy IV.C
Informed Consent ProcessIV.C.1Procedure for Waiver of Informed Consent for Human Subjects Research or Exception of Informed Consent for Emergency ResearchProcedure IV.C.1
Informed Consent ProcessIV.DAssent/Dissent by Children or Cognitively Impaired Adults who Lack Decision-Making CapacityPolicy IV.D
Informed Consent ProcessIV.D.1Procedure for Obtaining Assent/Dissent by Children or Cognitively Impaired Adults who Lack Decision-Making CapacityProcedure IV.D.1
Informed Consent ProcessIV.EApproval and Expiration Dates on Informed Consent DocumentsPolicy IV.E
Informed Consent ProcessIV.E.1Procedure for Stamping IRB Approval and Expiration Dates on Informed Consent Documents and Calculating IRB Expiration DatesProcedure IV.E.1
HRPP Records, Documentation, and FeesV.AHRPP Office RecordsPolicy V.A
HRPP Records, Documentation, and FeesV.A.1Procedure for HRPP RecordsProcedure V.A.1
HRPP Records, Documentation, and FeesV.A.2Procedure for Planning and Implementing IRB Committee Meeting AgendasProcedure V.A.2
HRPP Records, Documentation, and FeesV.A.3Procedure for Documentation of IRB Committee Meeting MinutesProcedure V.A.3
HRPP Records, Documentation, and FeesV.BIRB Fees for Industry-Supported ApplicationsPolicy V.B
HRPP Records, Documentation, and FeesV.B.1Procedure for IRB Fees for Industry-Supported ApplicationsProcedure V.B.1
HRPP Records, Documentation, and FeesV.CDevelopment, Approval, and Maintenance of HRPP Policies and ProceduresPolicy V.C
HRPP Records, Documentation, and FeesV.C.1Procedure for Development, Approval, and Maintenance of HRPP Policies and ProceduresProcedure V.C.1
Investigator ResponsibilitiesVI.AInvestigator QualificationsPolicy VI.A
Investigator ResponsibilitiesVI.A.1Procedure for Assuring Investigator QualificationsProcedure VI.A.1
Investigator ResponsibilitiesVI.BGeneral Responsibilities of InvestigatorsPolicy VI.B
Investigator ResponsibilitiesVI.B.1Procedure for General Responsibilities of InvestigatorsProcedure VI.B.1
Investigator ResponsibilitiesVI.B.2Procedure for Use of Deception or Incomplete DisclosureProcedure VI.B.2
Investigator ResponsibilitiesVI.CInvestigator and Key Study Personnel Conflicts of InterestPolicy VI.C
Investigator ResponsibilitiesVI.C.1Procedure for Investigator and Key Study Personnel Disclosure of Conflicts of InterestProcedure VI.C.1
Investigator ResponsibilitiesVI.DCertificates of ConfidentialityPolicy VI.D
Investigator ResponsibilitiesVI.D.1Procedure for Certificates of ConfidentialityProcedure VI.D.1
Investigator ResponsibilitiesVI.EData and Safety Monitoring PlansPolicy VI.E
Investigator ResponsibilitiesVI.E.1Procedure for Data and Safety Monitoring PlansProcedure VI.E.1
Committee Roles and ResponsibilitiesVII.AComposition of IRB CommitteesPolicy VII.A
Committee Roles and ResponsibilitiesVII.A.1Procedure for Maintaining Quorum Required for IRB Committee ReviewProcedure VII.A.1
Committee Roles and ResponsibilitiesVII.BCommittee Member Compensation and RecognitionPolicy VII.B
Committee Roles and ResponsibilitiesVII.B.1Procedure for Committee Member Compensation and RecognitionProcedure VII.B.1
Committee Roles and ResponsibilitiesVII.CIRB Committee Member, Consultant, and Regulatory Compliance Analyst Conflicting InterestPolicy VII.C
Committee Roles and ResponsibilitiesVII.C.1Procedure for IRB Committee Member, Consultant, and Regulatory Compliance Analyst Conflicting InterestProcedure VII.C.1
Committee Roles and ResponsibilitiesVII.DThe Role of the IRB Optimization CommitteePolicy VII.D
Committee Roles and ResponsibilitiesVII.D.1Procedure for the IRB Optimization Committee ActivitiesProcedure VII.D.1
Committee Roles and ResponsibilitiesVII.EIRB Committees' Relation to Other University Committees and External ReviewsPolicy VII.E
Committee Roles and ResponsibilitiesVII.E.1Procedure for Review and Approval from Other University and Medical Center Committees and External ReviewsProcedure VII.E.1
Committee Roles and ResponsibilitiesVII.E.2Procedure for Obtaining Institutional Biosafety Committee (IBC) ApprovalProcedure VII.E.2
Committee Roles and ResponsibilitiesVII.E.3Procedure for Obtaining Biologicals and Human Subjects Subcommittee (BHSS) ApprovalProcedure VII.E.3
Committee Roles and ResponsibilitiesVII.E.4Procedure for Requesting Legal Counsel OpinionProcedure VII.E.4
IRB Education and TrainingVIII.AInvestigator and Key Study Personnel TrainingPolicy VIII.A
IRB Education and TrainingVIII.A.1Procedure for Investigator and Key Study Personnel TrainingProcedure VIII.A.1
IRB Education and TrainingVIII.BIRB Committee Member TrainingPolicy VIII.B
IRB Education and TrainingVIII.B.1Procedure for IRB Committee Member TrainingProcedure VIII.B.1
IRB Education and TrainingVIII.CHRPP Staff Member TrainingPolicy VIII.C
IRB Education and TrainingVIII.C.1Procedure for HRPP Staff Member TrainingProcedure VIII.C.1
IRB Education and TrainingVIII.DCommunity OutreachProcedure VIII.D.1
IRB Education and TrainingVIII.D.1Procedure for Community OutreachPolicy VIII.D
Vulnerable PopulationsIX.ASpecial Categories of Research: ChildrenPolicy IX.A
Vulnerable PopulationsIX.A.1Procedure for Special Categories of Research: ChildrenProcedure IX.A.1
Vulnerable PopulationsIX.A.2Review of Non-Federally Funded Research Meeting 45 CFR 46.407Procedure IX.A.2
Vulnerable PopulationsIX.BSpecial Categories of Research: PrisonersPolicy IX.B
Vulnerable PopulationsIX.B.1Procedure for Special Categories of Research: PrisonersProcedure IX.B.1
Vulnerable PopulationsIX.CSpecial Categories of Research: Pregnant Women, Human Fetuses, Neonates, and Transplantation of Fetal TissuePlease call the HRPP for this policy.
Vulnerable PopulationsIX.C.1Procedure for Special Categories of Research: Pregnant Women, Human Fetuses, Neonates, and Transplantation of Fetal TissueProcedure IX.C.1
Vulnerable PopulationsIX.DSpecial Categories of Research: Cognitively ImpairedPolicy IX.D
Vulnerable PopulationsIX.D.1Procedure for Special Categories of Research: Cognitively ImpairedProcedure IX.D.1
Conduct of ResearchX.AHealth Insurance Portability and Accountability Act (HIPAA)Policy X.A
Conduct of ResearchX.A.1Procedure for Addressing Compliance with the Health Insurance Portability and Accountability Act (HIPAA)Procedure X.A.1
Conduct of ResearchX.BRequested Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Authorization Language for VUMC Research ParticipantsPolicy X.B
Conduct of ResearchX.B.1Procedure for Requested Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Authorization Language for VUMC Research ParticipantsProcedure X.B.1
Conduct of ResearchX.CCompensation or Medical Treatment if Injury Occurs During Participation in ResearchPolicy X.C
Conduct of ResearchX.C.1Procedure for Compensation or Medical Treatment if Injury Occurs During Participation in ResearchProcedure X.C.1
Conduct of ResearchX.DThe Role of an Ombudsman and/or Participant AdvocatePolicy X.D
Conduct of ResearchX.D.1Procedure for the Use of an Ombudsman and/or Participant AdvocateProcedure X.D.1
Conduct of ResearchX.EHIV Testing in Human Research ParticipantsPolicy X.E
Conduct of ResearchX.E.1Procedure for HIV Testing in Human Research ParticipantsProcedure X.E.1
Conduct of ResearchX.FPayments to Research ParticipantsPolicy X.F
Conduct of ResearchX.F.1Procedure for Payment to Research ParticipantsProcedure X.F.1
Conduct of ResearchX.GRecruitment/AdvertisingPolicy X.G
Conduct of ResearchX.G.1Procedure for Recruitment/AdvertisingProcedure X.G.1
Conduct of ResearchX.G.2Procedure for Recruitment of Students and Employees as Research ParticipantsProcedure X.G.2
Conduct of ResearchX.HResearch Conducted at International Performance SitesPolicy X.H
Conduct of ResearchX.H.1Procedure for Research Conducted at International Performance SitesProcedure X.H.1
Conduct of ResearchX.IResearch Involving the Use of the InternetPolicy X.I
Conduct of ResearchX.I.1Procedure for Research Involving the Use of the InternetProcedure X.I.1
Conduct of ResearchX.JApplicable State LawsPolicy X.J
Investigational Drugs, Biologics, and DevicesXI.AStorage, Handling, and Dispensing of Investigational Drugs, Agents, and/or Biologics in Clinical TrialsPolicy XI.A
Investigational Drugs, Biologics, and DevicesXI.A.1Procedure for the Storage, Handling, and Dispensing of Investigational Drugs, Agents, and/or Biologics in Clinical TrialsProcedure XI.A.1
Investigational Drugs, Biologics, and DevicesXI.BInvestigational Drugs, Agents, and BiologicsPolicy XI.B
Investigational Drugs, Biologics, and DevicesXI.B.1Procedure for the Use of Investigational Drugs, Agents, and BiologicsProcedure XI.B.1
Investigational Drugs, Biologics, and DevicesXI.CInvestigational DevicesPolicy XI.C
Investigational Drugs, Biologics, and DevicesXI.C.1Procedure for the Use of Investigational DevicesProcedure XI.C.1
Investigational Drugs, Biologics, and DevicesXI.DHumanitarian Use DevicesPolicy XI.D
Investigational Drugs, Biologics, and DevicesXI.D.1Procedure for Using Humanitarian Use DevicesProcedure XI.D.1
Investigational Drugs, Biologics, and DevicesXI.EEmergency Use of FDA Regulated ProductsPolicy XI.E
Investigational Drugs, Biologics, and DevicesXI.E.1Procedure for the Emergency Use of FDA Regulated ProductsProcedure XI.E.1
Radioactive Drug ResearchXII.A-XII.B.2Please refer to III.N for external beam radiation for research
Radioactive Drug ResearchXII.CEstablishment of the Radioactive Drug Research Committee (RDRC)Policy XII.C
Radioactive Drug ResearchXII.DRadioactive Drug Research Committee ReviewPolicy XII.D
Radioactive Drug ResearchXII.D.1Procedure for Radioactive Drug Research Committee ReviewProcedure XII.D.1
Radioactive Drug ResearchXII.D.2Procedure for Reporting Adverse Events and/or Unanticipated Problems Involving Risk to Participants or Others to the RDRCProcedure XII.D.2
Human Pluripotent Cell Research OversightXIII.AVanderbilt Institutional Human Pluripotent Cell Research Oversight Committee (VIHPCRO) Establishment and FunctionPolicy XIII.A
Human Pluripotent Cell Research OversightXIII.A.1Procedure for Obtaining Human Pluripotent Cell Research Oversight Committee ApprovalProcedure XIII.A.1