IRB Procedures, Policies, and Processes
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IRB Procedures, Policies, and Processes
Authority of the IRB
The IRB ensures that appropriate safeguards exist to protect the rights and welfare of research subjects [45 CFR 46.111]. In fulfilling these responsibilities, the IRB reviews all the research documents and activities that bear directly on the rights and welfare of the subjects of proposed research. The application or protocol, the consent/assent document(s), research equipment form, tests, surveys, questionnaires and similar measures, and recruitment documents are examples of documents that the IRB reviews.
Before any human subject is involved in research in relationship to this institution, the IRB will give proper consideration to:
- The risks to the subjects;
- The anticipated benefits to the subjects and others;
- The importance of the knowledge that may reasonably be expected to result; and
- The informed consent process to be employed.
The IRB has the authority to approve, require modifications to secure approval, and disapprove all research activities overseen and conducted by the organizations. The IRB has the authority to suspend, place restrictions, or terminate approval of research activities that fall within its jurisdiction that are not being conducted in accordance with IRB requirements or that have been associated with serious harm to subjects. The IRB has the authority to observe or have a third party observe the consent process and/or the research if the IRB determines it to be indicated.
Jurisdiction of the IRB
The IRB jurisdiction extends to ALL research (funded and not funded) involving human subjects conducted at Illinois, as well as research conducted elsewhere by the University of Illinois faculty, staff, and students, except research where the only involvement of human subjects is in one or more exempt categories (see 7.2.1 Categories of Research Permissible for Exemption).
If an IRB chair, IRB member, or OPRS staff person feels that the IRB has been unduly influenced by any party, they shall make a confidential report to the Vice Chancellor for Research and/or Chancellor, depending on the circumstances. The official receiving the report will conduct a thorough investigation and corrective action will be taken to prevent additional occurrences.
OPRS and IRB Relationships
The OPRS functions independently of, but in coordination with, other institutional regulatory committees. The IRB, however, makes its independent determination whether to approve or disapprove a protocol based upon whether or not human subjects are adequately protected. The OPRS has review jurisdiction over all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that has adopted the human subjects regulations.
Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the institution. However, those officials may NOT approve research if it has been disapproved by the IRB.
Relationships with other institutions: The University of Illinois may choose, on a case-by-case basis, to provide human research protection oversight for another institution. In order for the University to provide this oversight, a formal relationship must be established between the University and the other institution through a Cooperative Agreement, Authorization Agreement or a Memorandum of Understanding. This relationship must be formalized before the University will accept any human research proposals from the other institution.
In the conduct of cooperative research projects, Illinois acknowledges that each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with applicable federal regulations. When an authorization agreement exists, the University of Illinois may enter into a joint review arrangement, rely on the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.
• When the U of I relies on another IRB, the Director of the OPRS (or designee) will review the policies and procedures of the IRB to ensure that they meet Illiinois standards. If the other IRB is part of an accredited Human Subject Protection Program (HRPP), then it will be assumed that the Urbana-Champaign campus standards are being met.
• When the U of I reviews research conducted at another institution, the particular characteristics of each institution’s local research context must be considered, either (i) through knowledge of its local research context by the Illinois OPRS or (ii) through subsequent review by appropriate designated institutional officials, such as the Chairpersons and/or other IRB members.
• When Illinois is the coordinating center for a multi-center protocol, the OPRS will require the Urbana campus RPI to ensure that IRB approval has been obtained at each participating site prior to initiation of the research at that site. At the time of initial review, the OPRS will assess the procedures for dissemination of protocol information (e.g. unanticipated problems involving risks to participants or others, protocol modifications, interim findings) to all participating sites.
• For research sponsored by the Department of Defense, when conducting multi-site research, a formal agreement between organizations is required to specify the roles and responsibilities of each party.
Roles and Responsibilities
Chairperson of the IRB:
the University of Illinois at Urbana-Champaign Institutional Official (Vice Chancellor for Research), in consultation and approval with the IRB members, and the Director of the OPRS, appoints a Chair and Vice Chair (as needed) of the IRB to serve for renewable three-year terms. The IRB Chair should be a highly respected individual, from within the University, fully capable of managing the IRB, and the matters brought before it with fairness and impartiality. The task of making the IRB a respected part of the institutional community will fall primarily on the shoulders of the Chair. The IRB must be perceived to be fair, impartial and immune to pressure by the institution's administration, the investigators whose protocols are brought before it, and other professional and nonprofessional sources. The IRB Chair may designate other IRB members to perform duties, as appropriate, for review, signature authority, and other IRB functions, e.g., the Vice Chair and Director of the OPRS. The IRB Chair advises the Institutional Official and the Director of the OPRS about IRB member performance and competence.
Vice Chair of the IRB:
The Vice Chair serves as the Chair of the IRB in the absence of the Chair and has the same qualifications, authority, and duties as Chair.
Subcommittees of the IRB:
The Chair, in consultation with the Director of the OPRS, may designate one or more other IRB members, i.e. a subcommittee, to perform duties, as appropriate, for review, signature authority, and other IRB functions. Duties of a subcommittee may include the following:
1. Serve as designees by the IRB Chair for the expedited review of new or continuing protocols, and/or modifications of continuing protocols. The subcommittee must be experienced in terms of seniority on the IRB, and must be matched as closely as possible with their field of expertise to the study.
2. Review and approve the revisions requiring only simple concurrence submitted by investigators for a protocol given provisional approval, i.e. “Approval Pending Revisions”, by the convened IRB.
3. Conduct an inquiry. A subcommittee is appointed consisting of IRB members, and non-members if appropriate, to conduct an inquiry into allegations of non-compliance. The subcommittee is given a charge by the IRB, which can include any or all of the following:
- Review of protocol(s) in question;
- Review of any relevant documentation, including consent documents, case report forms, subject's investigational and/or medical files etc., as they relate to the investigator's execution of her/his study involving human subjects;
- Interview of appropriate personnel if necessary;
- Preparation of either a written or oral report of the findings, which is presented to the full IRB at its next meeting;
- Recommend actions if appropriate.
4. Conduct on-site review. Determination of the review interval and the need for additional supervision and/or participation is made by the IRB on a protocol-by-protocol basis. For example, for an investigator who is performing particularly risky research, or for an investigator who has recently had a protocol suspended by the IRB due to regulatory concerns, an on-site review by an IRB subcommittee might occur or approval might be subject to an audit of study performance after a few months of enrollment, or after enrollment of the first several subjects.