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Operating Procedures

**NEW, February 2018:  Addendum to the IRB Operating Procedures for Review of Non-Federally Funded, Non-FDA Regulated Human Subject Research**

This Standard Operating Procedure (SOP) is an addendum to the UTA IRB Operating Procedures below and describes the variation in requirements and procedures that UTA's IRB will adhere to for non-federally funded, non-FDA regulated human subject research. These procedures are designed to reduce burden for investigators and the IRB, improve efficiency of protocol reviews, and enhance the overall quality of the human subject protection program. Research that is federally funded and/or FDA regulated must continue to comply with the existing IRB Operating Procedures detailed below. 

Click here to view the newly added addendum.

Click here to view the newly added IRB Flex Flowchart

I. Institutional Authority

II. Purpose

III. Principles

IV. Scope and Authority of the IRB

  1. Scope
  2. Authority
  3. Authority of Institutional Officials

V. Relationship of UT Arlington IRB to Other Agencies, Institutions and Committees

  1. Compliance with Federal Regulations
  2. Review of Research Activities by Other University Committees
  3. External Requests for Recruitment/Involvement of UTA Students as Human Subjects

VI. Membership on the UT Arlington IRB

  1. Appointment of Members
  2. Regular Members
  3. Responsibilities
  4. Compensation of IRB Members
  5. Member Liability
  6. Alternate Members
  7. Non-Voting Members
  8. Consultants/Ad Hoc Reviewers
  9. Conflicts of Interest

VII. Management of the IRB Process

  1. IRB Chair
  2. IRB Staff
  3. Principal Investigator
  4. Faculty Advisor / Supervising Investigator
  5. Resources

VIII. Functions of the IRB

  1. Scope of Review
  2. Special Consideration for Projects Involving Vulnerable Populations
  3. Suspension or Termination of IRB Approval
  4. Noncompliance Investigations and Actions
  5. Reporting to Federal Oversight Agencies

IX. Operations of the IRB

  1. Scheduling of Meetings
  2. Submission of New Applications
  3. Determination of Type of Review
  4. Consultants
  5. Notification of Meetings and Distribution of Materials
  6. Urgent Review of Applications
  7. Meeting Procedures
  8. Meeting Minutes
  9. Approval of Research
  10. Appeal of IRB Decisions
  11. Length of Approval
  12. Monitoring Approved Projects
  13. Study Closure and Protocol Expiration

X. Notification of IRB Activities

XI. Informed Consent Document

  1. General Requirements for Informed Consent
  2. Waiver of Consent or Elements of Consent
  3. Waiver of Documentation of Consent
  4. Record Retention Policy

XII. Education and Training

  1. Educational Activities Aimed at the Research Community at Large
  2. Educational Activities Aimed at Members of the IRB
  3. Educational Activities Aimed at Investigators/Research Personnel

XIII. Human Subject Payments

  1. UT Arlington Business Affairs
  2. IRS Considerations
  3. Informed Consent Information

XIV. Collaborative Research Projects

XV. Definitions