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IRB Standard Operating Policies and Procedures

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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