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 February 2019 
    • 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 February 2019
    • 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 June 2020

    3.1. Policy

    3.2. Procedures

    3.2.1. Electronic Submission System

    3.2.1.1. Mandatory Electronic Submissions

    3.2.2. Human Subjects Research Determination

    3.2.3. Exempt Studies

    3.2.3.1. Limitations on exemptions

    3.2.3.1.1. Children/Prisoners

    3.2.3.1.2.International research

    3.2.3.2. Categories of Exempt Research

    3.2.3.3. 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 February 2019
    • 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 June 2020
    • 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
    • 5.5.General Requirements for Informed Consent
      • 5.5.1 Basic Elements of Consent
      • 5.5.2.Additional Elements of Consent to be Applied, as Appropriate:
      • 5.5.3.Documentation of Consent
        • 5.5.3.1.Short Form Consent Documentation 
        • 5.5.3.2.Consent – Version Control  
      • 5.5.4.Consent Monitoring
      • 5.5.5.Waiver of Consent
      • 5.5.6.Waiver of Documentation of Consent
      • 5.5.7.Obtaining Consent from Non-English-Speaking Subjects
        • 5.5.7.1 Translation Processes

     

  • 6. Vulnerable Populations

    6 Vulnerable Populations February 2019
    • 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 February 2019
    • 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 February 2019
    • 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 February 2019
    • 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 February 2019
    • 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 February 2019
    • 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 February 2019
    • 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 February 2019
    • 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 February 2019
    • 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 February 2019
    • 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 February 2019
    • 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 February 2019
    • 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 February 2019
    • 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 February 2019
    • 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 February 2019
    • 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