Introduction to the Columbia Human Research Protection Program

IRB SOPs Version 4.2 Nov. 2, 2012 Table of Contents
SOP Cover Page
Introduction to the Columbia Human Research Protection Program
Institutional Leadership
Institutional Culture
Standard Operating Procedures
Development
Intro
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Rascal
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Process for Revising Standard Operating Procedures
Requirement for Submissions
Definitions of Research and Human Subject
Human Research Protection Program
Institutional Review Boards and IRB Office
IRB Administrative Staff
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d
Committees within the IRB Office
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d
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G
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J
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2)
Organization
Administrative Support to Review Panels
Compliance Oversight Team
Duties
Education and Training
Confidentiality and Conflict of Interest
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IRB SOP V4.2 TOC
Education and Training Committee
Policy Committee
Accreditation Committee
Rascal Committee
Privacy Board
Office of Sponsored Projects Administration
Clinical Trials Office
Research Pharmacy
IND/IDE Assistance Program
Clinical Trials Monitoring Assistance Program
Spanish Translation Center
Office of Research Compliance and Training
Joint Radiation Safety Committee, Radioactive Drug Research Committee, and the
Radiation Safety Office
Institutional Biosafety Office
Protocol Review and Monitoring Committee
Irving Institute for Clinical and Translational Research
NYP Pharmacy
NYP Patient Services Administration
Center for Bioethics
Department Chairs, Investigators, and Departmental Administrators
Institutional Review Boards
Guiding Principles, Regulations, Statutes, Standards, Policies
Structure
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IRB SOPs Version 4.2 Nov. 2, 2012 Table of Contents
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III
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Scope of Authority
Autonomy
Research Conducted by Columbia faculty, employees, and students
Constitution of the Columbia IRBs
Membership
Qualification of Members
Membership Diversity
Alternate Members
Use of Consultants
Appointments, Terms, and Responsibilities of IRB Chairs, Vice Chairs, and Members
Chair/Vice Chair
Selection and Appointment
Length of Term/Service
Duties
Resignation/Removal
Education and Training
Liability Coverage for IRB Chairs and Vice Chairs
Confidentiality and Conflict of Interest
IRB Members
Selection and Appointment
Length of Term/Service
Duties
Attendance Requirements
Removal, Resignation
Liability Coverage for IRB Members
Education and Training
Confidentiality and Conflict of Interest
The Role of Non-Columbia (External) IRBs in the Columbia HRPP
Reliance Agreements
Reliance on a Non-Columbia IRB
Reliance on a Non-Columbia IRB for a multicenter study, consortium, or study program
Columbia Serving as IRB of Record for Non-Columbia Entities
Research Conducted at CU by Investigators Affiliated with Other Institutions
Preparation of Submissions to the IRB
Preparation of Event Submissions
IRB Abbreviated Submission Process
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Industry-sponsored multicenter studies
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Student-initiated research
Grant-funded research
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IRB SOP V4.2 TOC
Personnel
Principal Investigators
Eligibility
Research and Human Subject Determinations
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IRB SOPs Version 4.2 Nov. 2, 2012 Table of Contents
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C
D
E
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3
Roles and Responsibilities
Training
Documents/Information Needed for Each Type of Event
Submission materials: New protocol
Submission materials: Modification
Submission materials: Renewal (Continuing Review)
Submission materials: Report of unanticipated problems involving risks to subjects or
others
Submission materials: Termination (Closure)
Submission materials: Report of Protocol Deviation or Violation
Submission materials: Emergency Use Report
Material Needed for Review of Particular Types of Research or Situations
Submission materials: Drug research
Submission materials: Research with Biologics
Submission materials: Device research
Submission materials: Planned emergency research
Submission materials: Research involving pregnant women, fetuses, and neonates
Submission materials: Research involving prisoners
Submission materials: Research involving children
Submission materials: Research involving other vulnerable adults
Submission materials: Research involving non-English speaking individuals
Submission materials: Research involving students or employees as subjects
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Submission materials: International research
Submission materials: Substudies
Submission materials: Collaborative research that will not be conducted under an IRB
Authorization Agreement
Submission materials: Collaborative Research that will be conducted under IRB
Authorization Agreements
Submission materials: Domestic research conducted at non-CU sites
Submission Materials: Research Conducted at External Sites by CU Researcher
Submission Materials: Transfer of Research when PI is leaving Columbia
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IV
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IRB SOP V4.2 TOC
Processing of Submissions to the IRB: Pre- and Post-IRB or ARC Review
Preliminary review of submitted events
Routing of submissions to IRB per level of review required
Level of Review: Not Human Subjects Research
Level of Review: Exempt determination
Level of Review: Expedited
Level of Review: Facilitative/Administrative/118
Facilitative review
Administrative review
“118” reviews
Level of Review: Full Board
Primary Reviewer system
Primary reviewer system: Initial review
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Primary reviewer system: Continuing review (renewal)
Primary reviewer system: Modifications, Unanticipated Problem reports
Primary reviewer system: Terminations (closures)
Post-Review Procedures
Notification to Researcher: General Process
Notification: Approval and Outcome of Review
Notification: Disapproval
Notification: Suspension
Documentation of review and approval
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2
3
IRB Pre-review and Review Criteria
Pre-review of Submitted Events
Pre-review: New Protocols
Pre-review: Renewals (Continuing Review)
Pre-review: Modifications
Pre-review: Unanticipated Problem Reports
Pre-review: Termination (Closure) Requests
IRB Criteria for Review
Risks to Subjects are Minimized (applies the principle of beneficence)
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IRB SOP V4.2 TOC
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9)
Risk/Benefit Ratio is Acceptable (applies the principle of beneficence)
Selection of Subjects is Equitable (applies the principle of justice)
Informed Consent Process is Appropriate (applies the principle of autonomy)
Special Consent Situations
Consent from Non-English Speaking Subjects
Consent for Audio- and Video Recording
Consent for Live Case Procedures
Same Day Consent for Elective Procedures
Consent from Women in Labor
Enrolling Illiterate Subjects
Enrolling Individuals with Physical Limitations Related to Writing
Obtaining Consent for Future Use of Specimens
Obtaining Consent for Future Contact for Research
Waiver of Some or All of the Elements of Informed Consent
Documentation of Informed Consent is Appropriate (applies the principle of autonomy)
Waiver of Written Documentation of Consent
Data and Safety will be Monitored (applies the principle of beneficence)
Privacy and Confidentiality will be Protected (applies the principle of beneficence)
Recruitment Methods and Advertising Material are Appropriate (applies the principles of
autonomy and justice)
Additional Protections are in Place for Vulnerable Subjects (applies the principle of
beneficence)
Potential Conflict of Interest of Investigators is Eliminated, Mitigated or Managed
IRB Review of Specific Events, Types of Research, and Types of Documents
IRB Review of Specific Events
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IRB SOP V4.2 TOC
Initial Review (Review of a New Protocol)
Review of Modifications
Review of Reports of Unanticipated Problems Involving Risks to Subjects or Others
Review of Reports of Protocol Deviations or Violations
Examples of major protocol violations:
Examples of minor protocol violations
Review of Emergency Use Requests
Initial Notification to the IRB
Consent Requirements for Emergency Use of a Test Article
Documentation Required
Facilitative Review
Continuing Review (Renewal)
Continuation Past Expiration of IRB Approval
Procedures for Determining Which Projects Require Review More Often Than Annually
Review of Termination (Closure) Requests
Suspension and IRB-initiated For-cause Termination of Research
Review of Specific Types of Research
Review of Research involving Investigational Drugs
Review of Research involving Medical Devices
Review of Humanitarian Use Devices
Review of Research involving Pregnant Women, Neonates, and Fetuses (45 CFR 46,
Subpart B)
Review of Research involving Prisoners (45 CFR 46, Subpart C)
Review of Research involving Children (45 CFR 46, Subpart D)
Determination of Risk/Benefit Category
Assent Determination
Inclusion of Wards in Research
Review of Research involving Other Vulnerable Adults
Review of Research involving Non-English Speaking Subjects
Review of Research involving International Sites
Review of Planned Emergency Research
Emergency Research Consent Waiver
Review of Research that involves Human Embryonic Stem Cells
Review of Research Conducted by Students
Review of Specific Types of Documents
Review of Recruitment Material
Review of Funding Documentation
Review of Investigational Drug Brochure
Review of Payments to Participants
IRB Convened Meetings: Organization and Management
Schedule of Meetings
Agenda Preparation
Primary Reviewer Assignments
Voting Requirements
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VIII
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Review of Unanticipated Problems Involving Risks to Subjects or Others (including
Adverse Events)
Data and Safety Monitoring
Reviews or Monitoring by the Research Pharmacy, Radiation Safety Committees, or
Institutional Biosafety Committee
Reviews by Research Administration Offices
Compliance Oversight
A
Education and Training
Research Community
B
C
D
Board Members and Chairs
Administrative Staff
Researchers
A
B
Quality Assurance and Improvement
Assessment and Improvement Initiatives of Internal Processes
Assessment and Improvement of External Processes
A
B
C
Subject Outreach
Information for Potential Subjects
Information from Research Subjects and the Community
Compliance Hotline
C
D
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XII
App.
Record Retention and Documentation
Records Maintained
IRB Files
Record Retention Term
Research Records
IRB Records
Procedures if PI Leaves Columbia
Confidentiality of Records
Inspection of Records
Off-site Storage of IRB Files
Oversight Monitoring
Renewal (Continuing Review)
B
X
Minutes
Recording of Minutes at the Convened Meeting
Board Approval of Minutes
Notification of IRB Action
Appeal of IRB Decision
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Abbreviations and Terms Used in Columbia University IRB Standard Operating
Procedures 2012
Alphabetical Order
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IRB SOPs Version 4.2 Nov. 2, 2012 Table of Contents
App.
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In Order of Appearance
Referenced Regulations, Laws, Standards
SOP Revision History
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