Policies and Procedures

I.A  Institutional Oversight of Assurance

I.A.1  Procedure for Institutional Oversight of Assurance

I.B  Activities Subject to IRB Jurisdiction

I.B.1  Procedure for Activities Subject to IRB Jurisdiction

I.C  Research Involving Performance Sites

I.C.1 Procedure for Research Involving Performance Sites

I.D  Knowledge of Local Research Context

I.D.1 Procedure for Knowledge of Local Research Context

I.E  Retired

I.E.1 Retired

I.F  Coordinating Centers (Formerly IRB of Record)

I.F.1 Retired

I.G  Use of Single IRB Models to Facilitate Review Time and Effort

I.G.1 Procedure for Use of Single IRB Models to Facilitate Review Time and Effort

I.H  Additional Requirements for Research Supported by Other Federal Departments - Department of Defense (DoD)

I.I   Additional Requirements for Research Supported by Other Federal Departments - Department of Education and Other Educational Research

I.J  Additional Requirements for Research Supported by Other Federal Departments - Department of Energy

I.K  Additional Requirements for Research Supported by Other Federal Departments - Department of Justice

II.A  HRPP Compliance Activities

II.A.1 Procedure for HRPP Compliance Activities

II.B  Suspension or Termination of IRB Approval

II.B.1 Procedure for Suspension or Termination of IRB Approval

II.C  Investigating any Non-Compliance, Serious, or Continuing Non-Compliance

II.C.1 Procedure for Investigating any Non-Compliance, Serious, or Continuing Non-Compliance

II.D  Reporting to Appropriate Institutional Officials and the Department or Agency Head(s)

II.D.1 Procedure for Reporting to Appropriate Institutional Officials and the Department or Agency Head(s)

II.E  Complaints Regarding Human Subjects Research

II.E.1 Procedure for Complaints Regarding Human Subjects Research

II.F  Reporting Non-Compliance with the Protocol

II.F.1 Procedure for Reporting Non-Compliance with the Protocol

III.A  Institutional Review Board Committee Review Responsibilities

III.A.1 Procedure for Institutional Review Board Committee Review Responsibilities

III.B  IRB Committee Determinations/Motions

III.B.1 Procedure for IRB Committee Determinations/Motions

III.C  IRB Review of Human Subjects Research - Exempt

III.C.1 Procedure for IRB Review of Human Subjects Research - Exempt

III.D  IRB Review of Human Subjects Research - Expedited

III.D.1 Procedure for IRB Review of Human Subjects Research - Expedited

III.E  IRB Review of Human Subjects Research - Full Committee

III.E.1 Procedure for IRB Review of Human Subjects Research - Full Committee

III.E.2 Procedure for Initial Application Materials to be Reviewed by the Full IRB Committee

III.F  Research with Human Tissue, Blood, Genetic Material, and Data

III.F.1 Procedure for Research with Human Tissue, Blood, Genetic Material, and Data

III.G  Retired

III.G.1 Retired

III.H  Umbrella Review

III.H.1 Procedure for Umbrella Review

III.I  Human Subjects Research/Non-Human Subjects Research Determinations

III.I.1 Procedure for Human Subjects Research/Non-Human Subjects Research Determinations

III.J  Amendments to Previously Approved Applications, Claims for Exemption, or Non-Human Subjects/Non-Research Determinations

III.J.1 Procedure for Amendments to Previously Approved Applications, Claims for Exemption, or Non-Human Subjects/Non-Research Determinations

III.K  IRB Continuing Review

III.K.1 Procedure for Conducting IRB Continuing Review

III.K.2 Procedure for Notification of IRB Continuing Review

III.K.3 Retired

III.K.4 Procedure for the Processing of IRB Continuing Review

III.L  Reporting of Adverse Events, Serious Adverse Events, and Unanticipated Problems Involving Risk to Participants or Others

III.L.1 Procedure for Reporting of Adverse Events, Serious Adverse Events, and Unanticipated Problems Involving Risk to Participants or Others

III.M  Coordinating Center Applications

III.M.1 Coordinating Center Procedures

III.N  Human Subjects Radiation Review in Research

III.N.1 Procedure for the use of a Web-based Dose Calculator for Radiation

III.O  Transition Provisions for the Common Rule Changes

IV.A. Legally Effective and Prospectively Obtained Informed Consent

IV.A.1 Procedure for Obtaining Legally Effective and Prospective Informed Consent

IV.A.2 Procedure for Incorporating the Elements of Informed Consent

IV.A.3 Procedure for Determining the Health Care Decision-Maker for Research

IV.B. Documentation of Informed Consent for Human Subjects Research

IV.B.1 Procedure for Documentation of Informed Consent for Human Subjects Research

IV.C. Waiver of Informed Consent for Human Subjects Research or Exception from Informed Consent for Emergency Research

IV.C.1 Procedure for Waiver of Informed Consent for Human Subjects Research or Exception from Informed Consent for Emergency Research

IV.D. Assent/Dissent by Children or Cognitively Impaired Adults Who Lack Decision-Making Capacity

IV.D.1 Procedure for Obtaining Assent/Dissent by Children or Cognitively Impaired Adults Who Lack Decision-Making Capacity

IV.E. Approval and Expiration Dates on Informed Consent

IV.E.1 Procedure for Stamping IRB Approval and Expiration Dates on Informed Consent Documents and Calculating IRB Expiration Dates

V.A. HRPP Office Records

V.A.1 Procedure for HRPP Records

V.A.2 Procedure for Planning and Implementing IRB Committee Meeting Agendas

V.A.3 Procedure for Documentation of IRB Committee Meeting Minutes

V.B. IRB Fees for Industry-Supported Applications

V.B.1 Procedure for IRB Fees for Industry-Supported Applications

V.C. Development, Approval, and Maintenance of HRPP Policies and Procedures

V.C.1 Procedure for the Development, Approval, and Maintenance of HRPP Policies and Procedures

VI.A. Investigator Qualifications

VI.A.1 Procedure for Assuring Investigator Qualifications

VI.B. General Responsibilities of Investigators

VI.B.1 Procedure for General Responsibilities of Investigators

VI.B.2 Procedure for Investigator's Use of Deception or Incomplete Disclosure

VI.C  Investigator and Key Study Personnel Conflicts of Interest

VI.C.1 Procedure for Investigator and Key Study Personnel Conflicts of Interest

VI.D. Certificates of Confidentiality

VI.D.1 Procedure for Certificates of Confidentiality

VI.E. Data and Safety Monitoring Plans

VI.E.1 Procedure for Data and Safety Monitoring Plans

VII.A. Composition of IRB Committees

VII.A.1 Procedure for Maintaining Quorum Required for IRB Committee Review

VII.B. Committee Member Compensation and Recognition

VII.B.1 Procedure for Committee Member Compensation and Recognition

VII.C  IRB Committee Member, Consultant, and Regulatory Compliance Analyst Conflicting Interest

VII.C.1 Procedure for IRB Committee Member, Consultant, and Regulatory Compliance Analyst Conflicting Interest

VII.D. The Role of the IRB Optimization Committee

VII.D.1 Procedure for the IRB Optimization Committee Activities

VII.E. IRB Committees' Relation to Other University Committees and External Reviews

VII.E.1 Procedure for Review and Approval from Other University and Medical Center Committees and External Reviews

VII.E.2 Retired

VII.E.3 Retired

VII.E.4 Procedure for Requesting Legal Counsel Opinion

VIII.A  Investigator and Key Study Personnel Training

VIII.A.1 Procedure for Investigator and Key Study Personnel Training

VIII.B  IRB Committee Member Training

VIII.B.1 Procedure for IRB Committee Member Training

VIII.C  HRPP Staff Member Training

VIII.C.1 Procedure for HRPP Staff Member Training

VIII.D  Community Outreach

VIII.D.1 Procedure for Community Outreach

IX.A  Special Categories of Research: Children

IX.A.1 Procedure for Special Categories of Research: Children

IX.A.2 Review of Non-Federally Funded Research Meeting 45 CFR 46.407

IX.B  Special Categories of Research: Prisoners

IX.B.1 Procedure for Special Categories of Research: Prisoners

IX.C  Special Categories of Research: Pregnant Women, Human Fetuses, Neonates, and Transplantation of Fetal Tissue

IX.C.1 Procedure for Special Categories of Research: Pregnant Women, Human Fetuses, Neonates, and Transplantation of Fetal Tissue

IX.D  Special Categories of Research: Cognitively Impaired

IX.D.1 Procedure for Special Categories of Research: Cognitively Impaired

X.A  Health Insurance Portability and Accountability Act (HIPAA)

X.A.1 Procedure for Health Insurance Portability and Accountability Act (HIPAA)

X.B  Requested Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Authorization Language for VUMC Research Participants

X.B.1 Procedure for Requested Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Authorization Language for VUMC Research Participants

X.C  Compensation or Medical Treatment if Injury Occurs During Participation in Research

X.C.1 Procedure for Compensation or Medical Treatment if Injury Occurs During Participation in Research

X.D  The Role of an Ombudsman and/or Participant Advocate

X.D.1 Procedure for Use of an Ombudsman and/or Participant Advocate

X.E  HIV Testing in Human Research Participants

X.E.1 Procedure for HIV Testing in Human Research Participants

X.F  Payments to Research Participants

X.F.1 Procedure for Payment to Research Participants

X.G  Recruitment/Advertising

X.G.1 Procedure for Recruitment/Advertising

X.G.2 Procedure for Recruitment of Students and Employees as Research Participants

X.H  Research Conducted at International Sites

X.H.1 Procedure for Research Conducted at International Sites

X.I  Research Involving the Use of the Internet

X.I.1 Procedure for Research Involving the Use of the Intranet

X.J  Applicable State Laws

XI.A  Storage, Handling, and Dispensing of Investigational Drugs, Agents, and/or Biologics in Clinical Trials

XI.A.1 Procedure for the Storage, Handling, and Dispensing of Investigational Drugs, Agents, and/or Biologics in Clinical Trials

XI.B  Investigational Drugs, Agents, and Biologics

XI.B.1 Procedure for the Use of Investigational Drugs, Agents, and Biologics

XI.C  Investigational Devices

XI.C.1 Procedure for the Use of Investigational Devices

XI.D  Humanitarian Use Devices

XI.D.1 Procedure for Using Humanitarian Use Devices

XI.E  Emergency Use of FDA Regulated Products

XI.E.1 Procedure for the Emergency Use of FDA Regulated Products

XII.A - XII.B.2 Has moved to III.N and III.N.1

XII.C  Establishment of the Radioactive Drug Research Committee (RDRC)

XII.D  Radioactive Drug Research Committee Review

XII.D.1 Procedure for the Radioactive Drug Research Committee Review

XII.D.2 Procedure for Reporting Adverse Events and/or Unanticipated Problems Involving Risk to Participants or Others to the RDRC

XIII.A  Vanderbilt Institutional Human Pluripotent Cell Research Oversight Committee (VIHPCRO) Establishment and Function

XIII.A.1 Procedure for Obtaining Human Pluripotent Cell Research Oversight Committee Approval

XIV.A  Establishment of the Institutional Biosafety Committee for Human Subjects (IBC-HS)

XIV.A.1 Functions of the Institutional Biosafety Committee for Human Subjects

XIV.A.2 Procedure for Reporting Adverse Events and/or Unanticipated Problems Involving Risk to Participants or Others to the IBC-HS

XIV.A.3 Procedure for Reporting Incidents Involving Recombinant or Synthetic Nucleic Acid Molecules to the NIH Office of Science Policy (OSP)

X.V.A Establishment of the Decedent and Organ Donation Research Oversight Committee

XV.A.1 Functions of the Decedent and Organ Donation Research Oversight Committee

XV.A.2 Procedure for Reporting of Serious Adverse Events and/or Unanticipated Problems Involving Risk to Participants or Others to the Decedent and Organ Donation Research Oversight Committee