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Full
Version and Archive
1. Principles and Authority
1.1 - Principles
Governing the Committee
1.2 - Authority
of the Committee
1.3 - Federalwide
Assurances
1.4 - Studies
Requiring Review
1.5
- IRB Independence from Undue Influence
1.6 - Access to General Counsel
1.7 - Executive Committee
2. Relationships
2.1 -
To the Administration
2.2 -
To Other University or Affiliated Committees/Departments
2.3 -
To Other Institutions
2.4 -
To the UAMS Office of Research Compliance
2.5 -
To the Office of Research and Sponsored Programs
2.6 - Reporting to Appropriate
Federal Oversight Bodies, Institutional Officials and Research Sponsors
2.7
- Engagement
2.8
- International Research
3. Committee Membership
3.1
- Qualifications of Committees
3.2
- Quorum
3.3
- IRB Member and Consultant Conflict of Interest
3.4
- Chairpersons
3.5
- Vice-Chairpersons
3.6
- Members
3.7
- Alternate Members
3.8
- IRB Reviewer Training Requirements
3.9
- Consultants
4. Committee Operations
4.1
- Number of Committees
4.2
- Sub-committees
4.3
- Meeting Schedule
4.4 - Assignment of Primary Reviewers
4.5 - Functions of the IRB Committee
4.6
- Duties of IRB Staff
4.7 - Participant Phone
Calls
4.8 - IRB Staff
Member Training
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5. Records
5.1 -
IRB Records
5.2
- Database
5.3
- Individual Protocol Records
6. Documentation
6.1
- Agenda
6.2
- Written Procedures Governing the Committee
6.3
- Meeting Minutes
6.4
- Membership Roster
7. Procedures for Study Review
7.1
- Criteria for IRB Approval of Research
7.2
- Investigator Qualifications
7.3
- Exempt Categories of Research
7.4
- Standard or Full Committee Review
7.5
- Expedited Review
7.6
- Continuing Review
7.8
- IRB Oversight of Activities for Data Safety Monitoring
7.9
- Suspension or Termination of Approval for Cause
7.10
- Cooperative Protocol Research Program (CPRP) Protocols
8. Change in Protocol
8.1
- Changing Study Protocol/Modifications to Previously Approved Research
8.2
- Change in Principal Investigator
8.3
- Off-Campus Duty Assignment (Sabbatical) or Leave of Absence
8.4 - Study Closure
9. IRB Decisions
9.1 - Range of IRB
Decisions
9.2 -
IRB Notification of Meeting Decisions
10. Principal Investigator Responsibilities
10.1
- Principal Investigator Training
10.2
- Unanticipated Problems Involving Risks to Participants or Others -- Investigator Reporting Requirements and IRB Actions
10.3 - Principal Investigator IRB General
Reporting Requirements
12. Quality Assurances
12.1
- Educational Activities for IRB Reviewers
12.2
- IRB Monitoring or Audits
12.3
- Food and Drug Administration Monitoring or Reviews of the IRB -- Information
for the Reviewer and Investigator
12.4 -
Non-compliance with Human Research Protection Program Requirements
12.5 - Reports of Potential
Non-compliance
12.6 - Findings of Non-compliance
Under IRB Policy 12.5
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13. Confidentiality
13.1
- Certificates of Confidentiality
13.2 - Confidentiality in
Archived Data -- Social Science
13.3
- HIPAA Privacy Rule
13.4 - Criteria for the Release of an FDA 483
14. Recruitment Practices
14.1
- Selection of Subjects
14.2
- Subject Compensation
14.3
- Recruitment of Study Participants
14.4
- Compensation to Investigators and Health Care Workers for Enrolling Subjects
14.5
- Subject Enrollment Defined
15. Consent
15.1 - Elements of Informed Consent
Documents and Process
15.2
- Consent Exceptions: Planned Emergency Situations
15.3
- Waivers of Signed Informed Consent Documents and Waivers of Informed Consent
Elements
15.4 - Non-English-Speaking Research Subjects
15.5 - The Informed Consent Process
16. Risk/Benefit Analysis: Guidance for Reviewers
16.1
- Risk/Benefit Analysis
17. Special Populations
17.1
- Children in Research
17.2
- Cognitively Impaired Persons
17.3 - Economically and Educationally Disadvantaged
17.4
- Subjects in Long Term Care
17.5 - International Research
17.6 - Minorities
17.8
- Pregnant Women, Fetus, and Human In Vitro Fertilization
17.9 - Prisoners in Research
17.10 - Students, Employees and Healthy Volunteers
17.11 - Stored Data or Tissues
17.12 - Terminally Ill Patients
17.13 - Legally Authorized Representatives
18. Drugs and Devices
18.1
- Review of Investigational New Drug (IND) Studies
18.2 -
Investigational Devices
18.3 - Emergency Use of a Drug or Biologic
(Source: FDA Information Sheets Guidance for Institutional Review Boards
and Clinical Investigators 1998 Update)
18.4 - Emergency Use of an
Unapproved Medical Device (Source: FDA Information Sheets Guidance for
Institutional Review Boards and Clinical Investigators 1998 Update)
19. Human Genetics Guidance
19.1 - Human Genetics
20. Questions, Concerns, Suggestions and
Complaints
20.1 - Questions, Concerns,
Suggestions and Complaints
Full
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