01 Principles and Authority
- Institutional Review Board Policy 1.1: Principles Governing the UAMS IRB 6.24.25
- Institutional Review Board Policy 1.2: Authority of the UAMS IRB 6.24.25
- Institutional Review Board Policy 1.3: Federalwide Assurances (see archive)
- Institutional Review Board Policy 1.4: Studies Requiring Review and Human Research Determinations — 6.24.25
- Institutional Review Board Policy 1.5: IRB Independence from Undue Influence 6.24.25
- Institutional Review Board Policy 1.6: Access to General Counsel (see archive)
- Institutional Review Board Policy 1.7: Human Research Protection Program Advisory Committee (renamed July 27, 2021) 6.24.25
02 Relationships
- Institutional Review Board Policy 2.1: To the Administration — 8.15.22
- Institutional Review Board Policy 2.2: To Other University or Affiliated Committees / Departments — 6.24.25
- Institutional Review Board Policy 2.3: Use of Central Institutional Review Boards — 6.24.25
- Institutional Review Board Policy 2.4: To the UAMS Office of Research Compliance — 6.24.25
- Institutional Review Board Policy 2.5: To the UAMS ORSP — 6.24.25
- Institutional Review Board Policy 2.6: Reporting to Appropriate Federal Oversight Bodies, the Institutional Official, Research Sponsors/Funders, and Human Research Protection Program Accrediting Bodies — 6.24.25
- Institutional Review Board Policy 2.7: Engagement (see archive)
- Institutional Review Board Policy 2.8: International Research — 6.24.25
03 Committee Membership
- Institutional Review Board Policy 3.1: Qualifications of Committees 6.24.25
- Institutional Review Board Policy 3.2: Quorum 6.24.25
- Institutional Review Board Policy 3.3: IRB Reviewer and Consultant Conflict of Interest 6.24.25
- Institutional Review Board Policy 3.4: IRB Chair and Vice-chair 6.24.25
- Institutional Review Board Policy 3.5: IRB Vice-chair (See archive; now incorporated into Policy 3.4)
- Institutional Review Board Policy 3.6: IRB Reviewers and Alternates 6.24.25
- Institutional Review Board Policy 3.7: Alternate Members (see archive; incorporated into Policy 3.6)
- Institutional Review Board Policy 3.8: IRB Reviewer Training Requirements (see archive; incorporated into Policy 3.6)
- Institutional Review Board Policy 3.9: Consultants 6.24.25
04 Institutional Review Board Operations
- Institutional Review Board Policy 4.1: Institutional Review Board Committees and Subcommittees — 6.24.25
- Institutional Review Board Policy 4.2: Sub-committees (archived; combined with Policy 4.1)
- Institutional Review Board Policy 4.3: Meeting Schedule (archived; replaced by Policy 6.3)
- Institutional Review Board Policy 4.4: Assignment of Reviewers (see archive)
- Institutional Review Board Policy 4.5: Functions of the Institutional Review Board Committee (see archive)
- Institutional Review Board Policy 4.6: Institutional Review Board Staff Responsibilities — 6.24.25
- Institutional Review Board Policy 4.7: Participant Contact — 6.24.25
- Institutional Review Board Policy 4.8: Institutional Review Board Staff Member Training (see archive)
05 Records (Retired)
- Institutional Review Board Policy 5.1: Institutional Review Board Records (see archive) (Moved to policy 6.5)
- Institutional Review Board Policy 5.2: Database (see archive)
- Institutional Review Board Policy 5.3: Individual Protocol Records (see archive)
06 Documentation
- Institutional Review Board Policy 6.1 — Agenda — June 24, 2025
- Institutional Review Board Policy 6.2 — Written Procedures Governing the Committee (see archive)
- Institutional Review Board Policy 6.3 — Meeting Minutes — June 24, 2025
- Institutional Review Board Policy 6.4 — Membership Roster — June 24, 2025
- Institutional Review Board Policy 6.5 — Institutional Review Board Records — June 24, 2025
07 Procedures for Study Review
- Institutional Review Board Policy 7.1 — Criteria for Institutional Review Board Approval of Research 6.24.25
- Institutional Review Board Policy 7.2 — Principal Investigator Qualifications (see archive; moved to policy section 10)
- Institutional Review Board Policy 7.3 — Exempt Categories of Research 6.24.25
- Institutional Review Board Policy 7.4 — Review by Convened Institutional Review Board 6.24.25
- Institutional Review Board Policy 7.5 — Expedited Review 6.24.25
- Institutional Review Board Policy 7.6 — Continuing Review 6.24.25
- Institutional Review Board Policy 7.7 — Progress and Final Reports (see archive)
- Institutional Review Board Policy 7.8 — Data and Safety Monitoring Plans 6.24.25
- Institutional Review Board Policy 7.9 — Suspension or Termination of Approval for Cause 6.24.25
- Institutional Review Board Policy 7.10 — Cooperative Protocol Research Program (CPRP) Protocols (see archive)
- Institutional Review Board Policy 7.11 — Risk/Benefit Analysis 6.24.25
- Institutional Review Board Policy 7.12 — Limited Institutional Review Board Review 6.24.25
- Institutional Review Board Policy 7.13 — Department of Defense-Conducted and -Supported Research 6.24.25
- Institutional Review Board Policy 7.14 — Flexible Institutional Review Board Review 6.24.25
08 Change in Protocol
- Institutional Review Board Policy 8.1 — Modifications to Previously Approved Research — 6.24.25
- Institutional Review Board Policy 8.2 — Change in Principal Investigator (see archive)
- Institutional Review Board Policy 8.3 — Off-campus Duty Assignment (Sabbatical) or Leave of Absence (see archive)
- Institutional Review Board Policy 8.4 — Study Closure — 6.24.25
09 Institutional Review Board Decisions
- Institutional Review Board Policy 9.1 — Range of Institutional Review Board Decisions 6.24.25
- Institutional Review Board Policy 9.2 — Institutional Review Board Notification of Meeting Decisions 8.25.20
10 Principal Investigator Responsibilities
- Institutional Review Board Policy 10.1 — Principal Investigator Training
- Institutional Review Board Policy 10.2 — Events That Must Be Reported to the Institutional Review Board and Institutional Review Board Actions 6.24.25
- Institutional Review Board Policy 10.3 — Protocol Content and Institutional Review Board Submissions 6.24.25
- Institutional Review Board Policy 10.4 — Principal Investigator Responsibilities 6.24.25
11 Appeals and Reconsiderations (retired)
- Institutional Review Board Policy 11.1 — Appeals and Reconsiderations (see archive)
12 Quality Assurances
- Institutional Review Board Policy 12.1 — Educational Activities for Institutional Review Board Reviewers (see archive)
- Institutional Review Board Policy 12.2 — Institutional Review Board Monitoring or Audits (see archive)
- Institutional Review Board Policy 12.3 — Food and Drug Administration Monitoring or Reviews of the Institutional Review Board — Information for the Reviewer and the Investigator (see archive)
- Institutional Review Board Policy 12.4 — Non-compliance with Human Research Protection Program Requirements (see archive)
- Institutional Review Board Policy 12.5 — Reports of Potential Non-compliance 6.24.25
- Institutional Review Board Policy 12.6 — Findings of Non-compliance under Institutional Review Board Policy 6.24.25
13 Confidentiality
- Institutional Review Board Policy 13.1 — Confidentiality Protections 6.24.25 (see document)
- Institutional Review Board Policy 13.2 — Confidentiality in Archived Data (see archive)
- Institutional Review Board Policy 13.3 — HIPAA Privacy Rule (see archive)
- Institutional Review Board Policy 13.4 — Criteria for the Release of an FDA 483 (see archive)
14 Recruitment Practices
- Institutional Review Board Policy 14.1 — Equitable Subject Selection 6.24.25 (see document)
- Institutional Review Board Policy 14.2 — Subject Compensation 6.24.25 (see document)
- Institutional Review Board Policy 14.3 — Subject Recruitment Materials 6.24.25 (see document)
- Institutional Review Board Policy 14.4 — Compensation to Investigators & Health Care Workers for Enrolling Subjects 6.24.25 (see document)
- Institutional Review Board Policy 14.5 — Subject Enrollment Defined 6.24.25 (see document)
15 Consent
- Institutional Review Board Policy 15.1 — Elements of Informed Consent — 6.24.25 (see document)
- Institutional Review Board Policy 15.2 — Consent Exceptions: Planned Emergency Situations (retired; see archive)
- Institutional Review Board Policy 15.3 — Waivers of Signed Informed Consent Documents and Waivers of Informed Consent Elements — 10.15.24 (see document)
- Institutional Review Board Policy 15.4 — Non-English Speaking Research Subjects and When Short Form of Consent Documentation is Allowed — 6.24.25 (see document)
- Institutional Review Board Policy 15.5 — Informed Consent Process — 6.24.25 (see document)
- Institutional Review Board Policy 15.6 — Posting of Consent Forms — Aug. 15, 2022 (see document)
16 Risk / Benefit Analysis (moved)
- Institutional Review Board Policy 16.1 — Risk / Benefit Analysis (now under Procedures for Study Review)
17 Special Populations
- Institutional Review Board Policy 17.1 — Children in Research 6.24.25 (see document)
- Institutional Review Board Policy 17.2 — Person with Diminished Functional Capacity 6.24.25 (see document)
- Institutional Review Board Policy 17.3 — Economically and Educationally Disadvantaged (see archive)
- Institutional Review Board Policy 17.4 — Subjects in Long Term Care 6.24.25 (see document)
- Institutional Review Board Policy 17.5 — International Research (see archive)
- Institutional Review Board Policy 17.6 — Minorities (Retired; see archive)
- Institutional Review Board Policy 17.7 — Non-English Speaking (see archive)
- Institutional Review Board Policy 17.8 — Pregnant Women, Human Fetuses and Neonates Involved in Research 6.24.25 (see document)
- Institutional Review Board Policy 17.9 — Prisoners Involved in Research 6.24.25 (see document)
- Institutional Review Board Policy 17.10 — Students, Employees and Healthy Volunteers 6.24.25 (see document)
- Institutional Review Board Policy 17.11 — Stored Data or Tissues in Research 6.24.25 (see document)
- Institutional Review Board Policy 17.12 — Terminally Ill Patients (see archive)
- Institutional Review Board Policy 17.13 — Legally Authorized Representatives 6.24.25 (see document)
- Institutional Review Board Policy 17.14 — Planned Emergency Research at UAMS 6.24.25 (see document)
18 Drugs and Devices
- Institutional Review Board Policy 18.1 — Review of Investigational New Drug (IND) Studies 6.24.25 (see document)
- Institutional Review Board Policy 18.2 — Investigational Devices 6.24.25 (see document)
- Institutional Review Board Policy 18.3 — Emergency Use of a Test Article — 6.24.25 (see document)
- Institutional Review Board Policy 18.4 — Emergency Use of an Unapproved Medical Device (see archive)
19 Human Genetics Guidance
- Institutional Review Board Policy 19.1 — Human Genetics — 6.24.25 (see document)
20 Questions, Concerns, Suggestions and Complaints
- Institutional Review Board Policy 20.1 — Questions, Concerns, Suggestions and Complaints 6.24.25 (see document)