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Human Research Protection Program April 2022 (PDF)
  • 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.Other Related Entities & Units to HRPP
      • 1.9.7.1.UMKC Sponsored Programs
      • 1.9.7.2.University Health (UH)
        • 1.9.7.2.1.Office of Research Administration (ORA)
  • 1.9.7.3.Office of General Council
  • 1.9.8.Relationship Between Components
  • 1.9.9.Research Compliance Office (“RCO”)
  • 1.9.10.Selection, Supervision and Evaluation of RCO Supporting Staff
    • 1.9.10.1.Selection Process:
    • 1.9.10.2.Supervision
    • 1.9.10.3.Evaluation
  • 1.9.11.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

Institutional Review Board June 2022 (PDF)

  • 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

IRB Review Process January 2023 (PDF)

  • 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 Administrative Review of Changes
      • 3.4.2.2 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

Documentation and Records March 2023 (PDF)

  • 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

Obtaining Consent from Research Subjects March 2022 (PDF)

  • 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

Vulnerable Populations March 2023 (PDF)

  • 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

Investigational Drugs and Devices in Research March 2023 (PDF)

  • 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)

Unanticipated Problems Involving Risks to Subjects or Others February 2019 (PDF)

  • 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 

Protocol Violations February 2019 (PDF)

  • 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

Complaints and Non-Compliance February 2019 (PDF)

  • 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

Investigator Responsibilities February 2019 (PDF)

  • 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 

Sponsored Research February 2019 (PDF)

  • 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

Conflict of Interest February 2019 (PDF)

  • 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

Subject Outreach February 2019 (PDF)

  • 15.1.Policy
  • 15.2.Outreach Resources and Educational Materials
  • 15.3.Questions, Concerns, and Complaints
  • 15.4.Evaluation

Health Insurance Portability and Accountability Act (HIPAA) February 2019 (PDF)

  • 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 

Collaborative Research and Off Site Research February 2021 (PDF)

  • 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

Special Topics February 2019 (PDF)

  • 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

Computer and Internet Based Human Participant Survey Research February 2019 (PDF)

  • 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

Audit Procedures February 2019 (PDF)

  • 20.1.Policy
    • 20.1.1.Who Can Perform an Audit?
    • 20.1.2.Federal Oversight
  • 20.2.Procedures

Research Data Security February 2019 (PDF)

  • 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