UNIVERSITY OF ILLINOIS, COLLEGE OF MEDICINE AT PEORIA INSTITUTIONAL REVIEW BOARD
POLICY & PROCEDURE MANUAL
Version 3.3.1
University of IL. College of Medicine at Peoria-Institutional Review Board / Version 3.3.1Approved By:
Sara L. Rusch, M.D., MACP
Regional Dean
University of Illinois
College of Medicine at Peoria / Signature:
UNIVERSITY OF ILLINOIS
COLLEGE OF MEDICINE AT PEORIA
INSTITUTIONAL REVIEW BOARD
ONE ILLINI DRIVE
PEORIA, IL 61605
University of Illinois, College of Medicine at Peoria (UICOM-P) Institutional Review Board (IRB) Policy and Procedure Manual for Faculty, Staff, and Student Researchers
Section 1: Introduction
1.1 Purpose and Scope of the Policy and Procedure Manual
1.2 Mission Statement of the UICOM-P HSPP
Section 2: Human Subjects Protection Program Components and Roles
2.1 Introduction to the HSPP
2.2 HSPP: Role of the Institutional Official
2.3 HSPP: Role of the Human Protections Administrator
2.4 HSPP: Role of the UICOM-P IRB Liaison Committee
2.5 HSPP: Role of the UICOM-P IRB
2.5.1 Description of the Institutional Review Boards and the Office of Human Research Oversight
2.5.2 Description of the Purposes for the Two UICOM-P IRB Panels
2.5.3 Extension of UICOM-P IRB Oversight Outside of the Affiliated Institutions
2.6 HSPP: Role of the Office for Human Research Oversight (OHRO)
2.7 HSPP: Reporting Lines
2.8 HSPP: Complaints, Feedback, Concerns, and Issues
2.9 HSPP: Reporting Policy for Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO)
2.10 HSPP: Reporting Policy for Protocol Deviation/Violation Reporting to the IRB
2.11 HSPP: Reporting Policy for Serious or Continuing Non-Compliance
2.12 HSPP: Administrative Closure, Suspension and Termination Policy
2.12.1 Administrative Closure by the IRB
2.12.2 Suspension of IRB Approval
2.12.3 Termination of IRB Approval
Section 3: The HSPP: Institutional Responsibilities
3.1 Institutional Commitment: Research Ethics
3.2 Shared and Individual Institutional Responsibilities for the Oversight of Human Subjects Research at Affiliated Institutions
3.3 Required Training in Human Subject Protections
3.4 Resources for Training in Research Ethics
3.5 Training for UICOM-P IRB Members
Section 4: The HSPP: UICOM-P IRB/OHRO Responsibilities and Duties
4.1 The Role of the University of Illinois, College of Medicine at Peoria Institutional Review Board (UICOM-P IRB)
4.2 UICOM-P IRB Authority
4.3 UICOM-P IRB Purview
4.4 Number, Qualification and Diversity of UICOM-P IRB Members
4.5 UICOM-P IRB Chairs and Co-Chairs
4.6 UICOM-P IRB Member Alternates
4.7 Use of Ad Hoc Consultants
4.8 Compensation of UICOM-P IRB Members
4.9 UICOM-P IRB Meetings
4.10 Quorum and Voting Procedures
4.11 Calculating Approval and Expiration Dates
4.12 UICOM-P IRB On-line Submission System
4.13 UICOM-P IRB Meeting Minutes
4.14 Confidentiality of the Review Process
4.15 Reporting of UICOM-P IRB Findings to Investigators and the Institution
4.16 UICOM-P IRB Membership Roster
4.17 UICOM-P IRB Records
4.18 Record Retention
Section 5: Initial UICOM-P IRB Review of a Research Proposal Involving Human Participants
5.1 Initial Review Policy
5.2 Departmental Sign-Off
5.3 Research Site Designation
5.4 Pre-review by OHRO Staff
5.5 Determinations of Research and Human Subjects Research
5.6 Not Human Subjects Research Determination Process
5.7 Review of Claims of Exemption
5.7.1 Exempt Review Process
5.7.2 Categories of Human Subject Research that may be Approved as Exempt
5.7.3 Exemption Certification Guidelines
5.8 Review of Research Through Expedited Review Process
5.8.1 Expedited Review Guidelines
5.8.2 Categories of Research that may be Approved Through Expedited Procedures
5.8.3 Expedited Review Procedures for an Initial Review
5.9 Minor Modifications to the Research That May Be Reviewed and Approved through Expedited Procedures
5.10 Amendments
5.11 Review of Investigator’s Response to Request for Modifications
5.12 Convened Review of Research
5.13 Approval Criteria
5.14 Privacy and Confidentiality
5.15 Review of Modifications After Convened Review
5.16 Greater Than Minor Modifications to Previously Approved Research
Section 6: Continuing Review of a Research Project
6.1 Continuing Review of Human Subjects Research
6.2 Content of Continuing Review
6.3 Continuing Review Approval Criteria
6.4 Continuing Review Under Convened Review Procedures
6.5 Continuing Review under Expedited Review Procedures
6.6 Lapsed Continuing Reviews as New Studies
6.7 Determining When Research Requires Continuing Review More Often than Annually
6.8 Determining When Research Projects Need Verification from Sources Other than the Investigator that No Material Changes Have Been Made Since the Last UICOM-P IRB Review
6.9 Review of Final Reports
Section 7: Informed Consent, Parental Permission and Assent
7.1 Informed Consent
7.2 Parental Permission/Assent
7.3 Elements of a Consent / Authorization Using Personal Health Information (PHI)
7.4 Waiver or Alteration of Informed Consent
7.5 Waiver of Authorization for the Use and Disclosure of Personal Health Information (PHI)
7.6 Documentation of Informed Consent
7.7 Waiver of Documentation of Informed Consent
7.8 IRB Review of Recruitment Materials
Section 8: Unanticipated Problems Involving Research Subjects or Others (UPIRSO)
8.1 Reporting and UICOM-P IRB Review of Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs)
8.2 UPIRSO or AE Review Process
Section 9: Procedures for Research with Vulnerable Populations
9.1 Enrolling Vulnerable Populations
9.2 Inclusion of Pregnant Women, Human Fetuses, and Neonates in Research (In Vitro Fertilization)
9.2.1 Research Involving Pregnant Women or Fetuses
9.2.2 Research Involving Neonates
9.2.3 Research Involving, After Delivery, the Placenta, the Dead Fetus, or Fetal Material
9.2.4 Research Not Otherwise Approvable Which Presents an Opportunity to Understand, Prevent, or Alleviate a Serious Problem Affecting the Health or Welfare of Pregnant Women, Fetuses, or Neonates.
9.3 Inclusion of Prisoners in Research
9.4 Inclusion of Children in Research
9.5 Inclusion of Adults who Lack Decision-Making Capacity in Research
9.6 Informed Consent for Subjects Whose Primary Language is Not English or Who are Illiterate
9.7 Informed Consent for Subjects Physically Unable to Talk or Write
Section 10: UICOM-P IRB Conflict of Interest
10.1 Conflict of Interest
10.1.1 Policy
10.1.2 Procedure
10.2 UICOM-P IRB Member Conflict of Interest
Section 11: Investigational Drugs and Devices
11.1 Research Using Investigational New Drugs, Biologics, and Devices
11.2 Expanded Access to Investigational Drugs
11.3 Emergency Use of Investigational Drugs
11.4 Emergency Use of Unapproved Medical Devices
11.5 Planned Emergency Research
11.6 Expanded Access to Investigational Devices
11.7 Off-Label Use of Approved Medications/devices
11.8 Humanitarian Use Devices (HUDs)
Section 12: Central Institutional Review Board (CIRB) Initiative
12.1 How the Initiative Works
12.2 Facilitated Review Item Types and Submission Requirements
12.3 Facilitated Review Process
12.4 Transferring of ongoing studies to NCI CIRB
Section 13: Research Involving Department of Defense (DoD) Funding
13.1 Purpose, Scope and Applicability
13.2 Background
13.3 Definitions
13.4 Specific Considerations and Procedures for DoD Research
13.5 Additional DoD Review Required Prior to Initiation of Study
Section 14: Other UICOM-P IRB Policies and Procedures
14.1 Non-Compliance with UICOM-P IRB Polices, Procedures, or Decisions
14.2 Training Grants, Center Grants
14.3 Continuous Quality Improvement (CQI) & Monitoring
14.4 Policy & Procedures for Data Safety Monitoring Plans (DSMP)
Section 15: Appendix
Section 16: Revision Log
Section 1: Introduction
1.1 Purpose and Scope of the Policy and Procedure Manual
This policy and procedure manual, and any additional relevant standard operating procedures, describes the Human Subject Protections Program (HSPP) at the University of Illinois, College of Medicine at Peoria (UICOM-P). The HSPP encompasses the UICOM-P Office of Human Research Oversight (OHRO), the University of Illinois, College of Medicine at Peoria Institutional Review Board (UICOM-P IRB), the Institutional Official (IO), the Human Protections Administrator (HPA), and the University of Illinois at Chicago (UIC) Vice Chancellor for Research and the Liaison Committee. This manual also describes the policies and procedures followed by the UICOM-P IRB that are integral to the UICOM-P HSPP. This policy governs the UICOM-P HSPP and the UICOM-P IRB as they oversee any and all activities that engage UICOM-P in human subject research.
This manual includes the policies and procedures required under the terms of UICOM-P Federalwide Assurance FWA00005172. In addition, the manual includes the Institutional Review Board (IRB) policies and procedures governing the University of Illinois, College of Medicine at Peoria IRBs that are registered with the Office of Human Research Protections (OHRP) as IRB00000688 and IRB00000689. These IRBs are registered as the University of Illinois, College of Medicine at Peoria IRB #I, and IRB #II. IRB I meets once a month and reviews all protocols. IRB II meets immediately after IRB I and was established for those studies that include mandatory contraception. Consent forms reviewed in IRB II do not contain the PIRB approved language for women of child-bearing potential.
Peoria IRBs #I and #II are registered with the Office of Human Research Protections (OHRP) (45CFR46.501) and the Food and Drug Administration (FDA) (21CFR56.106), which require registration of institutional review boards (IRBs) conducting reviews of human research studies conducted or supported by HHS or involving the use of FDA-regulated products. .
Subsequent use of the term UICOM-P IRB will refer to both UICOM-P IRBs as a unit.
1.2 Mission Statement of the UICOM-P HSPP
The mission of the UICOM-P HSPP is to ensure that there are adequate mechanisms developed and maintained to maximize the protection of the rights and welfare of all human subjects involved in research. The HSPP works with the institution, affiliated institutions (i.e., those institutions holding an FWA and UICOM-P IRB Authorization Agreement), investigators, research staff, students, and the UICOM-P IRB as equal stakeholders in this goal. It is also the mission of the UICOM-P HSPP to be an exemplary and innovative HSPP fulfilling the mandate to uphold the public's trust to respect and protect people who participate as subjects of human research in the Central Illinois region.
Section 2: Human Subjects Protection Program Components and Roles
2.1 Introduction to the HSPP
The HSPP has several components that work together to protect the rights, welfare and safety of human subjects involved in research. These components include the Institution (University of Illinois, College of Medicine at Peoria), the IO, the HPA, the OHRO, the UICOM-P IRB, and the Liaison Committee.
The principal means by which the human subject protection program at UICOM-P ensures that the rights and welfare of research subjects are adequately safeguarded is through its UICOM-P IRB review and oversight. In addition to this primary mechanism, the HSPP employs other elements. One responsibility includes developing educational programs and monitoring compliance to ensure that educational requirements regarding the protection of research subjects are met and maintained by UICOM-P faculty, staff, students, UICOM-P IRB board members, and affiliated investigators/key personnel. This includes completing initial training in human subject protections and research privacy protections before investigators are allowed to participate in the conduct of research, and then completing continuing education as required by this policy. The human subject protection program also includes means to ensure that financial conflicts of interest are reviewed and managed, and that appropriate information is provided to the UICOM-P IRB for its review so it may include elements of disclosure in the informed consent process or might consider other mechanisms that may be appropriate to ensure that the conflicts are adequately managed.
Based upon the organizational structure of the UICOM-P HSPP and the UICOM-P IRB, the UICOM-P IRB policies and procedures, and any modifications to those policies, will be approved by the Regional Dean of the University of Illinois, College of Medicine at Peoria. The Dean will involve the members of the Liaison Committee, UICOM-P IRB Chairs, and other UICOM-P IRB and OHRO staff members for advice and guidance before approving these policies, or any modifications thereto. Before implementation, all policies will be sent to the UIC Vice Chancellor for Research (VCR). The affiliated institutions are expected to incorporate the UICOM-P IRB policies and procedures in this manual in order to fulfill the terms of their own Assurances.
2.2 HSPP: Role of the Institutional Official
The Institutional Official (IO) at UICOM-P, the Regional Dean of the University of Illinois, College of Medicine at Peoria, is ultimately responsible for the conduct of research when UICOM-P is engaged in the research. The IO must understand the responsibilities of this role as specified by the terms of the Assurance and by educational materials available on the website of the Office for Human Research Protections (OHRP). The IO will designate an HPA who becomes the second institutional official responsible for oversight of the human subject protections program at UICOM-P.
2.3 HSPP: Role of the Human Protections Administrator
As required under the terms of its Assurance, the UICOM-P will have a designated Human Protections Administrator (HPA), who is the second institutional official on the UICOM-P FWA. The HPA is the primary contact person for human subject protections issues for the UICOM-P. The HPA will exercise operational responsibility for the OHRO and UICOM-P’s human subject protections program. The HPA must have comprehensive knowledge of all aspects of the UICOM-P’s system of protections for human subjects, as well as be familiar with the institution’s commitments and responsibilities under its FWA. The HPA must be prepared to fulfill these responsibilities for all research covered under the FWA00005172.
2.4 UICOM-P IRB Liaison Committee
The UICOM-P Institutional Official and Human Protections Administrator participate in a larger advisory Committee that assists in the oversight and direction for the UICOM-P IRBs. The Liaison Committee consists of one research leader selected by each affiliated institution, the Chair(s) of the IRB, and the Regional Dean at UICOM-P. The Regional Dean of University of Illinois, College of Medicine at Peoria chairs this committee. The Committee is consulted regarding appointments of UICOM-P IRB board members and Chairs. In addition, the Liaison Committee may be approached by an investigator if there are complaints regarding a determination by the UICOM-P IRB or the operation of the OHRO. The Liaison Committee may choose to appoint a subcommittee of the UICOM-P IRB to review the complaint or determination in question, and provide a written report of its findings and recommendations to the UICOM-P IRB and the UIC VCR.
2.5 HSPP: Role of the UICOM-P IRB
The role of UICOM-P IRB is to ensure the adequacy of proposed research plans and to minimize risks and maximize the potential for benefit from human subjects’ participation in research. It is also the UICOM-P IRB’s role to oversee the ongoing conduct of the research, that the protections approved by the UICOM-P IRB are implemented, and that human subjects are only allowed to participate in research after providing legally effective, fully informed consent (except when it is ethically appropriate to approve a waiver of this requirement).