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IRB Standard Operating Policies and Procedures Archive

Includes Retired Versions and Full Version of Retired Policies

Revision dates in red

 
1 - Principles and Authority
 
2 - Relationships
 
3 - Committee Membership/Policies for Study Review
 
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
 
12 - Quality Assurances
 
13 - Confidentiality
 
14 - Recruitment Practices
 
15 - Consent
 
16 - Risk/Benefit Analysis: Guidance for Reviewers
 
17 - Special Populations
 
18 - Drugs and Devices
 
19 - Human Genetics Guidance
 
20 - Questions, Concerns, Suggestions and Complaints
 
Full Version of Retired IRB Standard Operating Policies 




1. Principles and Authority
1.1 - Principles Governing the Committee
        11/18/2002 - HTML
        3/5/2004 - PDF
        2/8/2005 - PDF
1.2 - Authority of the Committee
        11/18/2002 - HTML
        3/5/2004 - PDF
        2/8/2005 - PDF
1.3 - Federalwide Assurances
        11/18/2002 - HTML
        3/5/2004 - PDF
        2/8/2005 - PDF - refer to OHRP Web site for current FWA terms
1.4 - Studies Requiring Review
        11/18/2002 - HTML
        3/5/2004 - PDF
        2/25/2005 - PDF
        3/5/2008 - PDF
1.5 - IRB Independence from Undue Influence
        2/8/2005 - PDF
1.6 - Access to General Counsel
        2/8/2005 - PDF
1.7 - Executive Committee
        1/24/2011 - PDF
        2/8/2005 - PDF

2. Relationships
2.1 - To the Administration
        11/18/2002 - HTML
        8/23/2004 - PDF
2.2 - To Other University or Affiliated Committees/Departments
        11/18/2002 - HTML
        1/29/2005 - PDF
        2/8/2005 - PDF
2.3 - To Other Institutions
        11/18/2002 - HTML
        3/5/2004 - PDF
2.4 - To the UAMS Office of Research Compliance
        11/18/2002 - HTML
        3/5/2004 - PDF
        3/5/2004 - PDF
2.5 - To the Office of Research and Sponsored Programs
        11/18/2002 - HTML
        3/5/2004 - PDF
2.6 - To Regulatory Agencies
        11/18/2002 - HTML
        3/5/2004 - PDF
        2/8/2005 - PDF
        4/5/2007 - PDF
        2/8/2005 - PDF
2.7 - Engagement
        7/23/2004 - PDF - the UAMS IRB follows the most current OHRP Guidance on
        Engagement as per the HRPP Plan

2.8 - International Research
        7/23/2004 - PDF
        7/23/2004 - PDF

3. Committee Membership
3.1 - Qualifications of Committees
        11/18/2002 - HTML
        3/5/2004 - PDF
        6/1/2005 - PDF
3.2 - Quorum
        11/18/2002 - HTML
        3/5/2004 - PDF
        2/8/2005 - PDF
        6/1/2005 - PDF
3.3 - Conflict of Interest
        10/10/2002 - HTML
        3/5/2004 - PDF
        2/8/2005 - PDF
3.4 - Chairpersons
        11/18/2002 - HTML
        3/5/2004 - PDF
        3/29/2007 - PDF
3.5 - Vice-Chairpersons
        11/18/2002 - HTML
        3/12/2004 - PDF
        3/12/2004 - PDF
3.6 - Members
        11/18/2002 - HTML
        3/12/2004 - PDF
        2/8/2005 - PDF
        6/1/2005 - PDF
3.7 - Alternate Members
        11/18/2002 - HTML
        3/12/2004 - PDF
        3/12/2004 - PDF
3.8 - IRB Reviewer Training Requirements
        11/18/2002 - HTML
        3/12/2004 - PDF
        2/8/2005 - PDF
        3/29/2007 - PDF
3.9 - Consultants
        11/18/2002 - HTML
        3/12/2004 - PDF
        2/8/2005 - PDF

4. Committee Operations
4.1 - Number of Committees
        11/18/2002 - HTML
        3/12/2004 - PDF
        2/8/2005 - PDF
4.2 - Sub-committees
        11/18/2002 - HTML
        3/12/2004 - PDF
4.3 - Meeting Schedule
        11/18/2002 - HTML
        3/12/2004 - PDF
4.4 - Assignment of Primary Reviewers
        11/18/2002 - HTML
        8/25/2004 - PDF
        2/8/2005 - PDF
4.5 - Functions of the IRB Committee
        11/18/2002 - HTML
        8/25/2004 - PDF - addressed in other IRB policies
4.6 - Duties of IRB Manager or His/Her Designee
        11/18/2002 - HTML
        3/12/2004 - PDF
4.7 - Participant Phone Calls
        2/8/2005 - PDF
4.8 - IRB Staff Member Training
        2/8/2005 - PDF - Administrative Guide Policy 16.1.06 outlines the educational
        requirements for IRB Staff


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5. Records
5.1 - IRB Records
        11/18/2002 - HTML
        8/25/2004 - PDF
        2/8/2005 - PDF
5.2 - Database
        11/18/2002 - HTML
        4/9/2004 - PDF
5.3 - Protocols Reviewed
        11/18/2002 - HTML
        4/9/2004 - PDF
        2/8/2005 - PDF
        9/22/2005 - PDF - addressed in IRB Policy 5.1

6. Documentation
6.1 - Agenda
        2/6/2003 - HTML
        5/7/2004 - PDF
        2/8/2005 - PDF
6.2 - Written Procedures Governing the Committee
        7/31/2002 - HTML
        5/7/2004 - PDF
        2/8/2005 - PDF - addressed in other IRB policies
6.3 - Meeting Minutes
        7/31/2002 - HTML
        5/7/2004 - PDF
        2/8/2005 - PDF
        6/1/2005 - PDF
6.4 - Membership Roster
        7/31/2002 - HTML
        5/7/2004 - PDF

7. Procedures for Study Review
7.1 - Criteria for IRB Approval of Research
        7/31/2002 - HTML
        5/7/2004 - PDF
        2/8/2005 - PDF
7.2 - Investigator and Sub-Investigator Qualifications
        7/31/2002 - HTML
        5/7/2004 - PDF
        2/8/2005 - PDF
7.3 - Studies Exempt from Review
        7/31/2002 - HTML
        5/7/2004 - PDF
        2/8/2005 - PDF
        6/1/2005 - PDF
7.4 - Standard or Full Committee Review
        7/31/2002 - HTML
        5/7/2004 - PDF
        2/8/2005 - PDF
        6/1/2005 - PDF
        3/5/2008 - PDF
7.5 - Expedited Review
        7/31/2002 - HTML
        5/7/2004 - PDF
        2/8/2005 - PDF
        6/1/2005 - PDF
        3/13/2008 - PDF
        7/28/2008 - PDF
7.6 - Continuing Review
        10/11/2002 - HTML
        5/13/2004 - PDF
        2/8/2005 - PDF
        3/5/2008 - PDF
        7/28/2008 - PDF
7.7 - Progress and Final Reports
        7/31/2002 - HTML
7.8 - Data and Safety Monitoring Plan
        7/31/2002 - HTML
        8/18/2004 - PDF
        2/8/2005 - PDF
7.9 - Suspension or Termination of Approval for Cause
        7/31/2002 - HTML
        5/20/2004 - PDF 
        2/8/2005 - PDF

8. Change in Protocol
8.1 - Changing Study Protocol
        11/9/2002 - HTML
        5/20/2004 - PDF
        2/8/2005 - PDF
        6/1/2005 - PDF
        3/5/2008 - PDF       
8.2 - Change in Principal Investigator
        7/31/2002 - HTML
        5/20/2004 - PDF
8.3 - Off-Campus Duty Assignment (Sabbatical) or Leave of Absence
        7/31/2002 - HTML
        5/20/2004 - PDF

9. IRB Decisions
9.1 - Range of IRB Decisions
        7/31/2002 - HTML
        8/26/2004 - PDF
        2/8/2005 - PDF
        6/1/2005 - PDF
        4/5/2007 - PDF
        3/5/2008 - PDF
        7/28/2008 - PDF
9.2 - IRB Notification of Meeting Decisions
        7/31/2002 - HTML
        8/26/2004 - PDF)

10. Principal Investigator Responsibilties
10.1 - Principal Investigator Training
          10/10/2002 - HTML
          6/10/2004 - PDF
          6/1/2005 - PDF - Administrative Guide Policy 16.1.06 outlines the educational
          requirements for Research Personnel

10.2 - Unanticipated Problems Involving Risks to Participants or Others and Imminent
          Threat of Adverse Event -- Investigator Reporting Requirements and IRB Actions
          10/10/2002 - HTML
          7/7/2004 - PDF
          2/8/2005 - PDF
          6/1/2005 - PDF
          3/5/2008 - PDF
          7/28/2008 - PDF
10.3 - Principal Investigator IRB General IRB Reporting Requirements
          3/11/2005 - PDF

11. Appeals and Reconsiderations
11.1 - Appeals and Reconsiderations
          7/31/2002 - HTML
          6/10/2004 - PDF


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12. Quality Assurances
12.1 - Educational Activities for IRB Reviewers
          7/31/2002 - HTML
          6/10/2004 - PDF - Administrative Guide Policy 16.1.06 and IRB Policy 3.8 outline
          the educational requirements for IRB Reviewers

12.2 - IRB Monitoring or Audits
          7/31/2002 - HTML
          6/10/2004 - PDF
          2/8/2005 - PDF
          6/1/2005 - PDF - addressed in other IRB policies
12.3 - Food and Drug Administration Monitoring or Reviews of the IRB -- Information
          for the Reviewer and Investigator
          7/31/2002 - HTML
          6/10/2004 - PDF - refer to current FDA guidance
12.4 - Non-compliance with Human Research Protection Program Requirements
          2/8/2005 - PDF
          6/1/2005 - PDF
          4/5/2007 - PDF
          10/5/2007 - PDF
          3/5/2008 - PDF - addressed in IRB Policy 12.5
12.5 - Reports of Potential Non-compliance
          3/5/2008 - PDF

12.6 - Findings of Non-compliance Under IRB Policy 12.5
          3/5/2008 - PDF

13. Confidentiality
13.1 - Certificates of Confidentiality
          10/10/2002 - HTML
          6/10/2004 - PDF
          6/10/2004 - PDF
13.2 - Confidentiality in Archived Data -- Social Science
          10/10/2002 - HTML
          6/10/2004 - PDF
13.3 - HIPAA Privacy Rule
          6/10/2004 - PDF - addressed in Administrative Guide Policy 3.1.27
13.4 - Criteria for the Release of an FDA 483
          9/10/2004 - PDF - contact the Office of Research Compliance for issues related to
          the release of an FDA 483


14. Recruitment Practices
14.1 - Selection of Subjects
          10/10/2002 - HTML
          6/24/2004 - PDF
14.2 - Subject Compensation
          10/10/2002 - HTML
          6/24/2004 - PDF
          2/8/2005 - PDF
14.3 - Advertising for Study Subjects
          10/10/2002 - HTML
          6/24/2004 - PDF
          2/8/2005 - PDF
14.4 - Compensation to Investigators and Health Care Workers for Enrolling Subjects
          10/10/2002 - HTML
          6/24/2004 - PDF
          6/24/2004 - PDF

15. Consent
15.1 - Elements of Informed Consent Documents and Process
          10/11/2002 - HTML
          8/25/2004 - PDF
          2/8/2005 - PDF
          6/1/2005 - PDF
          9/22/2005 - PDF
          4/5/2007 - PDF
          5/13/2008 - PDF
          7/28/2008 - PDF
          1/29/2010 - PDF
          2/1/2010 - PDF
          6/3/2010 - PDF
15.2 - Consent Exceptions: Emergency Use of a Test Article
          10/11/2002 - HTML
          8/24/2004 - PDF
15.3 - Waivers of Signed Informed Consent Documents and Waivers of Informed
          Consent Elements
          10/11/2002 - HTML
          6/24/2004 - PDF
          2/8/2005 - PDF
          6/1/2005 - PDF
          3/13/2008 - PDF
15.4 - Non-English-Speaking Research Subjects
          8/25/2004 - PDF
          7/28/2008 - PDF
15.5 - Documentation of Informed Consent
          4/5/2007 - PDF
          3/5/2008 - PDF

16. Risk/Benefit Analysis: Guidance for Reviewers
16.1 - Risk/Benefit Analysis
          7/31/2002 - HTML
          6/24/2004 - PDF
          2/8/2005 - PDF

17. Special Populations
17.1 - Children in Research
          10/10/2002 - HTML
          6/24/2004 - PDF
          2/8/2005 - PDF
          6/11/2008 - PDF
17.2 - Cognitively Impaired Persons
          10/10/2002 - HTML
          6/24/2004 - PDF
          2/8/2005 - PDF
17.3 - Economically and Educationally Disadvantaged
          10/10/2002 - HTML
          8/26/2004 - PDF - addressed in other IRB policies
17.4 - Institutionalized Persons/Subjects in Long Term Care
          10/10/2002 - HTML
          6/24/2004 - PDF
          2/8/2005 - PDF
17.5 - International Research
          7/31/2002 - HTML
          8/24/2004 - PDF -- addressed in IRB Policy 2.8
17.6 - Minorities
          10/10/2002 - HTML
          8/24/2004 - PDF
17.7 - Non-English Speaking
          11/18/2002 - HTML
17.8 - Pregnant Women, Fetus, and Human In Vitro Fertilization
          11/18/2002 - HTML
          7/9/2004 - PDF
          2/8/2005 - PDF
17.9 - Prisoners in Research
          11/18/2002 - HTML
          8/24/2004 - PDF
          2/8/2005 - PDF
17.10 - Students, Employees and Healthy Volunteers
            10/10/2002 - HTML
            8/25/2004 - PDF
17.11 - Stored Data or Tissues
            7/31/2002 - HTML
            8/25/2004 - PDF
17.12 - Terminally Ill Patients
            11/18/2002 - HTML
            4/15/2004 - PDF
17.13 - Traumatized and Comatose Patients (the archived version of 17.13 differs in
            subject from 2/25/2005 policy no. 17.13 [Legally Authorized Representatives])
           
11/18/2002 - HTML
            2/25/2005 - PDF

18. Drugs and Devices
18.1 - Drug Trials
          7/31/2002 - HTML
          4/15/2004 - PDF 
          2/8/2005 - PDF
18.2 - Investigational Devices
          7/31/2002 - HTML
          4/15/2004 - PDF
          2/8/2005 - PDF
18.3 - Emergency Use of a Test Article or Drug or Biologic (Source: FDA Information
          Sheets Guidance for Institutional Review Boards and Clinical Investigators 1998
          Update)
         
7/31/2002 - HTML
          8/26/2004 - PDF
          2/8/2005 - PDF
          3/5/2008 - PDF
18.4 - Emergency Use of an Unapproved Medical Device (Source: FDA Information
          Sheets Guidance for Institutional Review Boards and Clinical Investigators 1998
          Update)
         
7/31/2002 - HTML
          8/26/2004 - PDF
          2/8/2005 - PDF
          3/5/2008 - PDF - addressed in IRB Policy 18.3
18.5 - Emergency Use of an Investigational Drug (IND) or Biologic
          7/31/2002 - HTML 

19. Human Genetics Guidance
19.1 - Human Genetics
          7/31/2002 - HTML
          1/30/2004 - PDF

20. Questions, Concerns, Suggestions and Complaints
20.1 - Questions, Concerns, Suggestions and Complaints
         
9/1/2007 - PDF


Full Version of Retired IRB Standard Operating Policies (all policies in this full version designated by the last revision date)

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