Introduction
All research involving human subjects that is conducted by any employee or agent of the University of Illinois at Urbana–Champaign (UIUC), or otherwise conducted at or sponsored by the UIUC, irrespective of the risks, scope, funding, or location of the research, must comply with federal and campus policies for the protection of human subjects (see the UIUC Investigator Handbook, Part I: Research Subject to IRB Review). The Institutional Review Board and authorized departmental review bodies share responsibility for ensuring that all UIUC research activities meet these requirements.
For all human subjects research, review must occur and approval must be granted by a UIUC IRB, the IRB Office, or an approved departmental review committee prior to any involvement of human subjects in the research. Figure 2, below, outlines the acceptable application routes for obtaining approval of human subjects research at UIUC:
TopFor all projects, an IRB-1 application, with relevant attachments, must be submitted to the appropriate body for review. The IRB-1 asks for information about the investigator(s), the nature of the research, the funding source, targeted subject groups, how subjects will be recruited, how informed consent will be obtained, how confidentiality will be protected, and the risks and benefits of the proposed research. More information about these topics is provided in the UIUC Investigator Handbook. In completing their application, investigators should avoid the use of acronyms, abbreviations, and jargon that might not be familiar to reviewers.
Upon completion of the review, a letter is sent to the responsible project investigator (RPI), either authorizing initiation of the project or containing stipulations that must be met before approval is granted. The involvement of human subjects may begin only after stipulations have been satisfactorily addressed and formal, written approval is provided.
Continuation Reviews
The UIUC IRBs and IRB-approved departmental review bodies conduct continuing reviews of nonexempt research at intervals appropriate to the degree of risk, but at least once per year.
Levels of Case Review
The IRB will determine the criteria for approval of human subjects research and the frequency of continuing review. The IRB Office has been delegated the day-to-day authority for determining the level of review needed for each case and for reviewing responses to the Board's stipulations for approval.
New cases are categorized as follows:
Exempt
New cases that clearly meet one of the categories for exempt research, as provided in the federal regulations and as determined by the IRB or its Office, are not sent to a convened Board for review. These cases are reviewed and approved in the IRB Office only after the IRB application is satisfactorily completed by the investigator. The investigator may not make the determination of exemption—all human subjects research must be submitted for review before approval under an exemption can be made.
Expedited
An expedited review consists of a review by the IRB Chair or designee. Cases that satisfy HHS guidelines may be given an expedited review, as determined by the IRB Office. Assigned reviewer(s) make their recommendation(s) to the IRB Office. If the case is approved, the decision will be communicated to the investigator and also is reported at the next IRB meeting. IRB members may ask for discussion of expedited cases during any meeting. If the review decision is for disapproval or a major change, the case will be placed on the agenda for full IRB discussion at the next available meeting.
Full Board
New cases that are neither exempt nor expedited are sent to the full Board for review and are assigned both a primary and a secondary reviewer by the IRB Office. See Case Review Procedures for more information on the review process.
Continuing Cases are categorized as follows:
Renewal, Minimal Risk—Expedited without Full Board Review
Ongoing minimal risk projects receive annual, expedited, continuing reviews. Each of these has been previously reviewed and approved as a new project according new case procedures. The expedited continuing review is performed by the IRB Chair or designee(s). Approved cases are listed on the staff report of the next IRB meeting and IRB members may ask for discussion of these cases during the meeting.
Renewal, More than Minimal Risk—Full Board Review
The Board has decided that all ongoing projects of more than minimal risk must receive full Board review and approval at least every year. These cases are assigned primary and secondary reviewers from the Board.
Minor Modification—Expedited without Full Board Review
An investigator who makes a minor modification to an ongoing project must receive approval before involving human subjects in the revised protocol. All modifications to approved protocols must be submitted with a completed Research Amendment form that outlines the changes being made. If changes are pervasive, a new IRB-1 form should be submitted. Minor modifications include minor wording changes in a consent form or minor changes in compensation, time of participation, or subject recruitment, or the use of a new site that is not materially different from a previously approved site. They may also include changes to other parameters, whereby the investigator provides the subjects with more accurate information as a result of additional experience with the protocol. Approval of a minor modification does not change the approval expiration date for a protocol. These cases are given an expedited review in the IRB Office, and the results are communicated to the investigator. Approved cases are listed on the staff report of the next IRB meeting and IRB members may ask for discussion of these cases during any meeting.
Major Modification—Full Board Review
Any investigator who proposes a major modification to an approved protocol must submit a new IRB-1 form and must receive approval before involving human subjects in the revised protocol. Major modifications include significant protocol changes that would cause subjects to engage in activities not previously approved, or involving an increased level of risk to the physical, emotional, or psychological well-being of participants, especially in relation to the loss of confidentiality. These cases are reviewed either by the full Board or, if permitted under federal policy, by expedited review. Approval of a major modification changes the approval expiration date for a protocol.
Case Review Procedures—Full Board
The IRB Office will provide written notice to each principal investigator following the review of their protocol. If the protocol is approved, the letter will include the expiration date of the approval. The letter will also include the requirements for reporting any problems involving human subjects, the requirement for prior review of changes in procedures, and any other special terms and conditions. If the Board stipulates changes, or if it disapproves the protocol, the written notification will state the basis for this decision. The IRB Office may approve the investigators' response to stipulations unless the IRB directs that the response shall be returned to the IRB for full Board review. The Board may also designate one or more Board members to join the IRB Office in reviewing a response to stipulations. For any necessary monitoring of the research or of the consent process, the Board will determine the nature and extent of the monitoring activities.
The IRB is responsible for the continuing review system and may perform site visits, interviews, or other activities to monitor the research and consent processes. Research activities that present no more than minimal risk to human subjects, and that involve only procedures listed in one or more of the federally specified categories (as described by federal regulations) may be given a continuing review through the expedited review procedure.
IRB Meetings are run by the Chair. In the absence of the Chair, an Interim Chair may be appointed from among the regular members of the IRB. Minutes are recorded by the IRB Office staff. The IRB Office is responsible for maintaining adequate documentation of all IRB activities, including minutes of the IRB meetings. These minutes will be kept in sufficient detail to show attendance at the meetings, actions taken by the IRB, the vote on the actions, the basis for requiring changes in or disapproval of protocols, and a written summary of the discussion of controversial issues and their resolution.