Research & Economic Development

Office of the Vice Chancellor

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IRB Standard Operating Procedures

  • 1. Human Research Protection Program (HRPP)

    1 Human Research Protection Program July 2016 Web
    • 1.1.Policy                                                                                                                           
    • 1.2.Mission
    • 1.3.Institutional Authority
    • 1.4.Definitions
    • 1.5.Ethical Principles
    • 1.6.Regulatory Compliance
    • 1.7.Research Covered by the HRPP
    • 1.8.Written Policies and Procedures
    • 1.9.HRPP Organization
      • 1.9.1.University Chancellor
      • 1.9.2.Institutional Official (IO)
      • 1.9.3.Director of the RCO
      • 1.9.4.University Research Compliance Officer (CO)
      • 1.9.5.Research Compliance Specialist
      • 1.9.6.Institutional Review Board (“IRB”)
      • 1.9.7.The Principal Investigator (“PI”)
      • 1.9.8.Other Related Entities & Units to HRPP
        • 1.9.8.1.UMKC Sponsored Programs
        • 1.9.8.2.Truman Medical Center (TMC)
          • 1.9.8.2.1.Office of Research Administration (ORA)
    • 1.9.8.3.Office of General Council
    • 1.9.9.Relationship Between Components
    • 1.9.10.Research Compliance Office (“RCO”)
    • 1.9.11.Selection, Supervision and Evaluation of RCO Supporting Staff
      • 1.9.11.1.Selection Process:
      • 1.9.11.2.Supervision:
      • 1.9.11.3.Evaluation:
    • 1.9.12.RCO & IRB Resources
    • 1.10.Research Quality Assurance/Quality Improvement Activities
      • 1.10.1.Institutional Audits and Compliance Reviews
      • 1.10.2.Reporting and Disposition
    • 1.10.3.Internal Compliance Reviews
    • 1.10.4.Quality Improvement
  • 2. Institutional Review Board

    2 Institutional Review Board July 2016
    • 2.1.Policy
    • 2.2.IRB authority
    • 2.3.Number of IRBs
    • 2.4.Roles and Responsibilities--Chair of the IRB
    • 2.5.Roles and Responsibilities - Vice Chair of the IRB
    • 2.6.Chair of IRB Subcommittee
      • 2.6.1.Subcommittees of the IRB
    • 2.7.IRB membership
      • 2.7.1.Definitions
      • 2.7.2.Composition of the IRB
      • 2.7.3.Nomination & Appointment of IRB Members
        • 2.7.3.1.Nomination of New IRB Members
        • 2.7.3.2.Appointment of New IRB Members
        • 2.7.3.3.Documentation and Information for New IRB Members
        • 2.7.3.4.Periodic Review of IRB Composition and Membership
    • 2.7.4.Alternate IRB Members:
    • 2.8.IRB Member Conflict of Interest
    • 2.9.Use of Consultants
    • 2.10.Duties of IRB Members
    • 2.11.Attendance Requirements
    • 2.12.Training & education
      • 2.12.1.New IRB Members-Orientation
      • 2.12.2.New IRB Members—Initial Education
      • 2.12.3.IRB Members—Continuing Education
      • 2.12.4.RCO Staff – Orientation & Initial Education
      • 2.12.5.RCO Staff—Continuing Education
    • 2.13.Insurance Coverage For Research Oversight Activity
    • 2.14.Review of IRB Member Performance
    • 2.15.Reporting and Investigation of Allegations of Undue Influence
  • 3. IRB Review Process

    3 IRB Review Process July 2016
    • 3.1.Policy
    • 3.2.Procedures
      • 3.2.1.EProtocol from Key Solutions
        • 3.2.1.1.Mandatory Electronic Submissions
    • 3.2.2.eProtocol Reference Materials
    • 3.2.3.Human Subjects Research Determination
    • 3.2.4.Exempt Studies
      • 3.2.4.1.Limitations on exemptions
        • 3.2.4.1.1.Children:
        • 3.2.4.1.2.Prisoners:
        • 3.2.4.1.3.International research:
    • 3.2.4.2.Categories of Exempt Research
    • 3.2.4.3.FDA Exemptions
    • 3.3.Additional Protections
      • 3.3.1.Procedures for Exempt Review
        • 3.3.1.1.Exempt Research Activities
        • 3.3.1.2.Determination Process
          • 3.3.1.2.1.Amendments
          • 3.3.1.2.2.Expiration
    • 3.4.Expedited Review
      • 3.4.1.Categories of Research Eligible for Expedited Review
      • 3.4.2.Expedited Review Procedures
        • 3.4.2.1.Informing the IRB
    • 3.5.Convened IRB Review
      • 3.5.1.IRB Meeting Schedule
      • 3.5.2.Screening
      • 3.5.3.Reviewers
      • 3.5.4.IRB Agenda
      • 3.5.5.Pre-meeting Distribution of Documents to IRB Members
      • 3.5.6. Pre-meeting Distribution of Documents to Reviewers
      • 3.5.7. Quorum
      • 3.5.8.IRB Meeting Procedures
        • 3.5.8.1.Call to Order and Quorum
        • 3.5.8.2.Conflict of Interest of IRB Members
        • 3.5.8.3.Review & Acceptance of Prior Meeting Minutes
        • 3.5.8.4.Initial & Continuing Review & Requests for Modification
        • 3.5.8.5.Recording of Proceedings
        • 3.5.8.6.Consultant Advice – Children
        • 3.5.8.7.Consultant Advice – Vulnerable Populations
        • 3.5.8.8.Prisoner Representatives
    • 3.5.9.Guests & ex officio Guests
    • 3.6.Criteria for IRB Approval of Research
      • 3.6.1.Risk-Benefit Assessment
        • 3.6.1.1.1.Scientific Merit
    • 3.6.2.Equitable Selection of Subjects
      • 3.6.2.1.Recruitment of Subjects
    • 3.6.3.Consent
    • 3.6.4.Safety Monitoring
    • 3.6.5.Privacy and Confidentiality
      • 3.6.5.1.Definitions
      • 3.6.5.2.Privacy
      • 3.6.5.3.Confidentiality
    • 3.6.6.Vulnerable or Potentially Vulnerable Populations
    • 3.7.Additional Considerations During IRB Review and Approval of Research
      • 3.7.1.Determination of Risk
      • 3.7.2.Frequency of Review
      • 3.7.3.Review More often than Annually
      • 3.7.4.Independent Verification that no Material Changes have Occurred
      • 3.7.5.Consent Monitoring
      • 3.7.6.Investigator Conflicts of Interest
      • 3.7.7.Significant New findings
      • 3.7.8.Advertisements
      • 3.7.9.Payment to Research Subjects
      • 3.7.10.Recruitment Incentives
    • 3.8.Compliance with all Applicable Laws and Regulations
    • 3.9.Possible IRB Actions
      • 3.9.1.Approval
      • 3.9.2.Deferred with minor modifications
        • 3.9.2.1.Definitions
        • 3.9.2.2.Policy
    • 3.9.3.Tabled for Major Modifications
      • 3.9.3.1.Definitions
      • 3.9.3.2.Policy
      • 3.9.3.3.Time Limit for Submitting Requested Changes for New Research Protocol Application Deferral or Tabling
    • 3.9.4.Tabled (for reasons other than major modification)
    • 3.9.5.Disapproved
    • 3.9.6.Approved in Principle
    • 3.10.Study Suspension, Termination and Investigator Hold
      • 3.10.1.Suspension or Termination
        • 3.10.1.1.Procedures
    • 3.10.2.Protection of Currently Enrolled Participants
    • 3.11.Continuing Review
      • 3.11.1.Approval Period
      • 3.11.2.Continuing Review Process
      • 3.11.3.Expedited Review of Continuing Review
      • 3.11.4.Lapse in Continuing Review Approval
      • 3.11.5.Calculating the “date of IRB approval”
        • 3.11.5.1.Approval at a convened meeting.
        • 3.11.5.2.Approval pending changes at a convened IRB committee meeting.
        • 3.11.5.3.Expedited review.
        • 3.11.5.4.Continuing review.
          • 3.11.5.5.Amendments.
    • 3.12.Amendment of an Approved Protocol
      • 3.12.1.Expedited Review of Protocol Amendments/Modifications
      • 3.12.2.Convened IRB Review of Protocol Modifications
      • 3.12.3.Changes in the Consent Document
    • 3.13.Closure of Protocols
    • 3.14.Notice to PI of IRB Actions
    • 3.15.Appeal of IRB Decision to Disapprove
  • 4. Documentation and Records

    4 Documentation and Records July 2016
    • 4.1.Policy
    • 4.2.Definitions
    • 4.3.IRB Records
    • 4.4.Procedures
      • 4.4.1.IRB Study Files
    • 4.5.IRB Membership Roster
    • 4.6.The IRB Minutes
    • 4.7.Documentation of Exempt Review Findings
    • 4.8.Documentation of Expedited Reviews
    • 4.9.Access to IRB Records
    • 4.10.IRB Record Retention 
    • 4.11.Investigator Records
    • 4.12.Records for FDA-Regulated Studies
      • 4.12.1.Investigational Drugs and Devices
  • 5. Obtaining Consent from Research Subjects

    5 Obtaining Consent from Research Subjects July 2016
    • 5.1.Policy
    • 5.2.Definitions
    • 5.3.Basic Requirement 
    • 5.4.Procedures
      • 5.4.1.Securing and Documenting Consent 
      • 5.4.2.Consent Process
    • 5.4.3.Basic Elements of Consent
    • 5.4.4.Additional Elements of Consent to be Applied, as Appropriate:
    • 5.4.5.Documentation of Consent
      • 5.4.5.1.Short Form Consent Documentation 
      • 5.4.5.2.Consent – Document Stamp Date 
    • 5.4.6.Consent Monitoring
    • 5.4.7.Waiver of Consent
    • 5.4.8.Waiver of Documentation of Consent
    • 5.4.9.Obtaining Consent from Non-English-Speaking Subjects
  • 6. Vulnerable Populations

    6 Vulnerable Populations July 2016
    • 6.1.Policy
      • 6.1.1.Definitions
    • 6.2.Specific Policies
      • 6.2.1.Applicability
      • 6.2.2.Research Involving Pregnant Women, Human Fetuses and Neonates
        • 6.2.2.1.Definitions
        • 6.2.2.2.Pregnant Women or Fetuses may be Involved in Research if All of the Following Conditions are Met

          6.2.2.3.            Research Involving Neonates

        • 6.2.2.4.Neonates of Uncertain Viability  
        • 6.2.2.5.Nonviable Neonates
        • 6.2.2.6.Viable Neonates
        • 6.2.2.7.Research Involving, After Delivery, the Placenta, the Dead Fetus, or Fetal Material.
    • 6.2.3.Research Involving Prisoners
      • 6.2.3.1.Definitions
      • 6.2.3.2.Applicability
      • 6.2.3.3.Exempt Research
      • 6.2.3.4.Composition of the IRB
      • 6.2.3.5.Additional Duties of the IRB
      • 6.2.3.6.Research Conducted or Supported by DHHS
      • 6.2.3.7.When Subjects Become Prisoners During Research

        6.2.4.      Research Involving Children

      • 6.2.4.1.Definitions
      • 6.2.4.2.Exempt Research
      • 6.2.4.3.Allowable Categories of Research
      • 6.2.4.4.Parental Permission and Assent
        • 6.2.4.4.1.Parental Permission 
        • 6.2.4.4.2.Assent from Children
        • 6.2.4.4.3.Consent from Pregnant Minors
        • 6.2.4.4.4.Assent Form
        • 6.2.4.4.5.Children Who are Wards of the State

          6.2.5.      Research Involving Other Potentially Vulnerable Populations

    • 6.2.5.1.Persons with Impaired Decision Making Capacity
      • 6.2.5.1.1.Determination of Decision-Making Capacity
      • 6.2.5.1.2.Consent by a Third Party
    • 6.2.5.2.Research in Mental Health Facilities
    • 6.2.5.3.Research with Students or Employees of the Institution
    • 6.2.5.4.Other Vulnerable Populations
    • 6.2.5.5.IRB Composition 
  • 7. Investigational Drugs and Devices in Research

    7 Investigational Drugs and Devices in Research July 2016
    • 7.1.Policy
      • 7.1.1.Investigational Drug Policy
      • 7.1.2.Definitions
      • 7.1.3.FDA Exemptions
      • 7.1.4.IND Requirements
        • 7.1.4.1.IND Exemption
        • 7.1.4.2.Responsibilities
          • 7.1.4.2.1.Principal Investigator
            • 7.1.4.2.1.1.Drug accountability record
            • 7.1.4.2.1.2.Drug storage
            • 7.1.4.2.1.3.Drug Administration 
            • 7.1.4.2.1.4.For Research Involving Investigational New Drugs
            • 7.1.4.2.1.5.Investigator-Sponsor or Investigator-Initiated Studies
    • 7.1.4.2.2.IRB
    • 7.1.5.Emergency Use
      • 7.1.5.1.Definitions 
      • 7.1.5.2.Emergency Exemption from Prospective IRB Approval
      • 7.1.5.3.Emergency Waiver of Informed Consent
    • 7.1.6.Expanded Access of Investigational Drugs
      • 7.1.6.1.Compassionate Use
      • 7.1.6.2.Group C Treatment Investigational New Drug
      • 7.1.6.3.Open-label Protocol
      • 7.1.6.4.Parallel Track
      • 7.1.6.5.Treatment IND or Biologics 
      • 7.1.6.6.Single-patient Use
      • 7.1.6.7.Emergency IND 
    • 7.1.7.Emergency Waiver of IND
    • 7.1.8.Waiver of Informed Consent for Planned Emergency Research
      • 7.1.8.1.For Research Subject to FDA Regulations 
      • 7.1.8.2.Research not Subject to FDA Regulations
    • 7.1.9.Investigational Devices in Research
      • 7.1.9.1.Policy 
      • 7.1.9.2.Definitions
      • 7.1.9.3.IDE Requirements
      • 7.1.9.4.Exempted IDE Investigations
      • 7.1.9.5.Responsibilities
        • 7.1.9.5.1.Principal Investigator (“PI”) 
          • 7.1.9.5.1.2.IRB
    • 7.1.9.6.Emergency Use of Unapproved Medical Devices
    • 7.1.9.7.Humanitarian Use Devices (HUD)
  • 8. Unanticipated Problems Involving Risks to Subjects or Others

    8 Unanticipated Problems Involving Risks to Subjects or Others July 2016
    • 8.1.Policy
    • 8.2.Definitions
    • 8.3.Procedures
      • 8.3.1.Reporting
      • 8.3.2.Submission of Reports
        • 8.3.2.1.Internal Site Reporting
        • 8.3.2.2.External Site Reporting (within 3 days of notification from the sponsor/site)
    • 8.3.3.IRB Procedures for Handling Adverse Events and Possible Unanticipated Problems
      • 8.3.3.1.Review by IRB Staff and Chair
      • 8.3.3.2.IRB Review 
  • 9. Protocol Violations

    9 Protocol Violations July 2016
    • 9.1.Policy
    • 9.2.Definitions
    • 9.3.Planned Changes to Research Protocol
    • 9.4.Unplanned Changes to Research Protocol
    • 9.5.Protocol Deviations
      • 9.5.1.Protocol Violation
        • 9.5.1.1.Reportable Protocol Violation
        • 9.5.1.2.Non-Reportable Protocol Violations
    • 9.5.2.Protocol Exception
    • 9.6.IRB Review Process
      • 9.6.1.Non-Reportable Protocol Violations
      • 9.6.2.Protocol Exceptions
  • 10. Complaints and Non-Compliance

    10 Complaints and Non Compliance July 2016
    • 10.1. Policy
    • 10.2. Definitions
    • 10.3. Complaints
    • 10.4. Non-Compliance
      • 10.4.1. Review of Allegations of Non-Compliance
      • 10.4.2. Review of Findings of Non-Compliance
        • 10.4.2.1 Non-Compliance is Not Serious or Continuing
        • 10.4.2.2 Serious Non-Compliance or Continuing Non-Compliance
    • 10.5 Inquiry Procedures
    • 10.6 Final Review
  • 11. Reporting to Regulatory Agencies and Institutional Officials

  • 12. Investigator Responsibilities

    12 Investigator Responsibilities July 2016
    • 12.1.Policy
    • 12.2.Definitions
    • 12.3.Investigators
      • 12.3.1.Principal Investigators
      • 12.3.2.Change in Principal Investigator
      • 12.3.3.Student Investigators
      • 12.3.4.Study Personnel 
    • 12.4.Responsibilities
    • 12.5.Training / Ongoing Education of Investigators and Study Personnel
      • 12.5.1.Orientation
      • 12.5.2.Initial education
      • 12.5.3.Continuing Education and Recertification
      • 12.5.4.Additional Resources
      • 12.5.5.Investigator Concerns 
  • 13. Sponsored Research

    13 Sponsored Research July 2016
    • 13.1.Policy
    • 13.2.Definitions
    • 13.3.Specific Policies
      • 13.3.1.PI Responsibilities
      • 13.3.2.ORS Review
      • 13.3.3.IRB Review
      • 13.3.4.IRB Fees
    • 13.4.Procedures
  • 14. Conflict of Interest

    14 Conflict of Interest July 2016
    • 14.1.Policy
    • 14.2.Definitions
    • 14.3.Specific Policies
    • 14.4.COI by Institution
      • 14.4.1.Royalties
      • 14.4.2.Non-publicly traded equity
      • 14.4.3.Publicly traded equity
      • 14.4.4.Governance/fiduciary roles
      • 14.4.5.Gifts from companies/sponsors
    • 14.5.COI by Investigators and Research Team
      • 14.5.1.IRB Responsibilities
      • 14.5.2.Research Compliance Office (RCO) Responsibilities
      • 14.5.3.Institutional Responsibilities
    • 14.6.COI by IRB Committee Members
      • 14.6.1.Procedure for Identifying and Managing IRB Member and Consultant Conflicting Interest
        • 14.6.1.1.IRB Responsibilities
        • 14.6.1.2.RCO Responsibilities:
    • 14.7.COI by RCO Staff and Others
    • 14.8.IRB Review of COI
  • 15. Subject Outreach

    15 Subject Outreach July 2016
    • 15.1.Policy
    • 15.2.Outreach Resources and Educational Materials
    • 15.3.Questions, Concerns, and Complaints
    • 15.4.Evaluation
  • 16. Health Insurance Portability and Accountability Act (HIPAA)

    16 Health Insurance Portability and Accountability Act July 2016
    • 16.1.Historical Background
    • 16.2.Health Care Component
    • 16.3.Policy
    • 16.4.Definitions
    • 16.5.Effects of HIPAA on Research
    • 16.6.Privacy Board
    • 16.7.Permitted Uses and Disclosures of Research PHI
    • 16.8.Research Under HIPAA
      • 16.8.1.Waiver of Authorization for Use or Disclosure of PHI in Research
        • 16.8.1.1.Background
        • 16.8.1.2.Procedure for Uses & Disclosures without an authorization
          • 16.8.1.2.1.Uses and Disclosures of Research PHI without an Authorization
          • 16.8.1.2.2.Uses and Disclosures of Research PHI Under Waiver/Alteration of HIPAA Authorization
            • 16.8.1.2.2.1.Waiver/Alteration Criteria
            • 16.8.1.2.2.2.Effect of Prior Authorizations:
            • 16.8.1.2.2.3.Retention Requirements:
    • 16.8.2.Review Preparatory to Research
      • 16.8.2.
      • 16.8.3.Research on PHI of Decedents
      • 16.8.4.Limited Data Sets with a Data Use Agreement
    • 16.9.Transition Provisions
    • 16.10.Patient Rights and Research
    • 16.11.HIPAA and Existing Studies 
  • 17. Collaborative Research and Off-Site Research

    17 Collaborative Research and Off Site Research July 2016
    • 17.1.Background
    • 17.2.Policy
    • 17.3.Definitions
    • 17.4.Types of Collaborations
    • 17.5.Research Involving Non-UMKC Performance Sites:  Cooperative Research
      • 17.6.Research Projects Involving Multiple Sites Where UMKC is the Lead Site/Lead Investigator
      • 17.7.Research at Geographically Separate Off-Site Location with No Cooperating Institution/Facility/Organization
      • 17.8.Research at Geographically Separate UMKC-Owned Site with Non-UMKC Employees
    • 17.9.Sites Operating Under a Formal Agreement with UMKC’s IRB
      • 17.10.Negotiation of Federal Assurances for Collaborating Institutions (Applicable to Federally Funded Research)
    • 17.11.Negotiation of an IRB Authorization Agreement with Collaborating Institutions
    • 17.12.IRB Knowledge of Local Research Context
    • 17.13.Responsibilities of Reviewing & Relying IRB & PI
      • 17.13.1.Reviewing IRB
      • 17.13.2.Relying IRB
      • 17.13.3.PI Duties
    • 17.14.Special Topic—International Research
      • 17.15.Additional Requirements for Department of Defense (DOD) or Department of Navy (DON) Collaborative Research
  • 18. Special Topics

    18 Special Topics July 2016
    • 18.1.Certificate of Confidentiality (COC)
      • 18.1.1.Statutory Basis for Protection
      • 18.1.2.Usage
      • 18.1.3.Limitations
      • 18.1.4.Application Procedures
    • 18.2.Mandatory Reporting of Abuse and Neglect
      • 18.2.1.Definitions
      • 18.2.2.Reporting Obligation of Abuse & Neglect
    • 18.3.UMKC Students and Employees as Subjects
    • 18.4.Student Research
      • 18.4.1.Human Subjects Research and Course Projects
      • 18.4.2.Individual Research Projects Conducted by Students
      • 18.4.3.Independent Study, Theses and Dissertations
    • 18.5.Oral History
    • 18.6.Public Registration of Clinical Trials
      • 18.6.1.Who Must Register?
      • 18.6.2.Which Studies Must be Registered?
      • 18.6.3.When Must the Information be Submitted?
      • 18.6.4.How to Register a Clinical Trial?
      • 18.6.5.What Information Must be Submitted?
      • 18.6.6.Who Receives the Submitted Information?
      • 18.6.7.Who Can Access the Registered Information?
      • 18.6.8.Must Information be Included about Foreign Trial Sites?
      • 18.6.9.Can Intermediaries Act on Behalf of a Sponsor?
      • 18.6.10.Can Sponsors Designate Multiple Individuals to be Data Providers?
      • 18.6.11.What are the NIH Requirements for Clinicaltrials.Gov Registration Information in Applications and Progress Reports?
      • 18.6.12.How do the FDA Registration Requirements Affect NIH Funded Studies?
      • 18.6.13.Do the FDA Regulations have any Special Requirements for IND, IDE or Biologics License Application (BLA) Studies?
    • 18.7.Genetic Studies
    • 18.8.Research Involving Coded Private Information or Biological Specimens
      • 18.8.1.Who Determines if Coded Private Information (or Specimens) Constitutes Human Subjects Research?
    • 18.9.Case Reports Requiring IRB Review
    • 18.10.Audio, Video, Photographic Recording
  • 19. Computer and Internet Based Human Participant Survey Research

    19 Computer and Internet Based Human Participant Survey Research July 2016
    • 19.1.Policy
    • 19.2.Online Surveys
    • 19.3.Data Storage/Disposal
    • 19.4.Allowable Survey Software Based on Study Risk
      • 19.4.1.For All Non-Exempt Online Survey Methods
      • 19.4.2.Depending on the Risk Level and the Specific Circumstances of the Study
    • 19.5.Recruiting Participants
    • 19.6.Consent information
      • 19.6.1.Special Requirements
    • 19.7.Skipping Portions of/Withdrawing from the Survey
    • 19.8.Survey Software Checklist
  • 20. Audit Procedures

    20 Audit Procedures July 2016
    • 20.1.Policy
      • 20.1.1.Who Can Perform an Audit?
      • 20.1.2.Federal Oversight
    • 20.2.Procedures
  • 21. Research Data Security

    21 Research Data Security July 2016
    • 21.1.Policy
    • 21.2.Definitions
      • 21.2.1.A human research data set
      • 21.2.2.Private information
      • 21.2.3.Identifiable information
      • 21.2.4.Personal identifiers
      • 21.2.5.A de-identified data set
      • 21.2.6.A coded data set
      • 21.2.7.An identity-only data set
      • 21.2.8.Secure location
      • 21.2.9.Data encryption
    • 21.3.Specific Policies
    • 21.4.Applicable Regulations
    • 21.5.Additional Guidance
      • 21.5.1.Electronic Data
      • 21.5.2.Physical Data
      • 21.5.3.International Research
      • 21.5.4.Mobile Storage
        • 21.5.4.1.General Security
        • 21.5.4.2.Transmission Security
        • 21.5.4.3.Application and Data Security
    • 21.5.5.Questions for investigators and Research Staff to Ask Themselves