Includes Human Research Protection Program Plan (January
2011), UAMS Administrative Guides 3.1.27 and 16.1.06
All PDF Format (Archived Policies in HTML and PDF Formats)
1 - Principles and Authority
2 - Relationships
3 - Committee Membership
4 - Committee Operations
5 - Records
6 - Documentation
7 - Procedures for Study
Review
8 - Change in Protocol
9 - IRB Decisions
10 - Principal Investigator
Responsibilities
11 -
Appeals and
Reconsiderations (see archive)
12 - Quality Assurances
13 - Confidentiality
14 - Recruitment Practices
15 - Consent
16 - Risk/Benefit Analysis
17 - Special Populations
18 - Drugs and Devices
19 - Human Genetics Guidance
20 - Questions, Concerns, Suggestions and
Complaints
Full Version of IRB Standard
Operating Policies
Archived Full
Version of Retired IRB
Standard Operating Policies
Human Research Protection Program Plan (January
2011)
UAMS Administrative Guide 3.1.27
- HIPAA Research Policy
UAMS Administrative Guide 16.1.06
(Education Policy for Research Staffs)
1. Principles
and Authority
1.1 - Principles
Governing the Committee
1.2 - Authority
of the Committee
1.3 - Federalwide
Assurances (see archive)
1.4 - Studies
Requiring Review and Human Research Determinations
1.5
- IRB Independence from Undue Influence
1.6 - Access to General Counsel (see archive)
1.7 -
IRB 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 (see archive)
2.8
- International Research
3. Committee
Membership
3.1
- Qualifications of Committees
3.2
- Quorum
3.3
- IRB Reviewer and Consultant Conflict of Interest
3.4
- IRB Chair
3.5
- IRB Vice Chair
3.6
- IRB Reviewers
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 Reviewers
4.5 - Functions of the IRB Committee (see archive)
4.6
- Duties of IRB Staff
4.7 - Participant Phone
Calls
4.8 - IRB Staff
Member Training (see archive)
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5. Records
5.1 -
IRB Records
5.2
- Database
5.3
- Individual Protocol Records (see archive)
6. Documentation
6.1
- Agenda
6.2
- Written Procedures Governing the Committee (see archive)
6.3
- Meeting Minutes
6.4
- Membership Roster
7. Procedures for
Study Review
7.1
- Criteria for IRB Approval of Research
7.2
- Principal Investigator Qualifications
7.3
- Exempt Categories of Research
7.4
- Review by Convened IRB
7.5
- Expedited Review
7.6
- Continuing Review
7.8
- Data and Safety Monitoring Plans
7.9
- Suspension or Termination of Approval for Cause
7.10
- Cooperative Protocol Research Program (CPRP) Protocols
8. Change in
Protocol
8.1
- 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 Responsibilties
10.1
- Principal Investigator Training (see archive)
10.2
- Information That Must Be Reported to the IRB and IRB Actions
10.3 - Protocol
Content and IRB Submissions
12. Quality
Assurances
12.1
- Educational Activities for IRB Reviewers (see archive)
12.2
- IRB Monitoring or Audits (see archive)
12.3
- Food and Drug Administration Monitoring or Reviews of the IRB -- Information
for the Reviewer and Investigator (see archive)
12.4 -
Non-compliance with Human Research Protection Program Requirements (see
archive)
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
- Confidentiality Protections
13.2 - Confidentiality in
Archived Data
13.3
- HIPAA Privacy Rule (see archive)
13.4 - Criteria for the Release of an FDA 483 (see archive)
14. Recruitment
Practices
14.1
- Selection of Subjects
14.2
- Subject Compensation
14.3
- Advertisements for Study Subjects
14.4
- Compensation to Investigators & Health Care Workers for Enrolling Subjects
14.5
- Subject Enrollment Defined
15. Consent
15.1 - Elements of Informed Consent
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 and When Short Form of
Consent Documentation Is Allowed
15.5 - Informed Consent Process
16. Risk/Benefit
Analysis
16.1
- Risk/Benefit Analysis
17. Special
Populations
17.1
- Children in Research
17.2
- Cognitively Impaired Persons
17.3 - Economically and Educationally Disadvantaged (see archive)
17.4
- Subjects in Long Term Care
17.5 - International Research (see archive)
17.6 - Minorities
17.8
- Pregnant Women, Human Fetuses and Neonates Involved in Research
17.9 - Prisoners Involved 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
Test Article
18.4 - Emergency Use of an
Unapproved Medical Device (Source: FDA Information Sheets Guidance for
Institutional Review Boards and Clinical Investigators 1998 Update) (see
archive)
19. Human
Genetics Guidance
19.1 - Human Genetics
20. Questions, Concerns, Suggestions
and
Complaints
20.1 - Questions, Concerns,
Suggestions and Complaints
Full
Version of IRB Standard Operating Policies
Human Research Protection Program Plan (January 2011)
UAMS Administrative Guide 3.1.27 - HIPAA Research Policy
UAMS Administrative Guide 16.1.06 - Mandatory Education Policy for
Investigators/Study Personnel Participating in Human Subject Research
Projects
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