Review Processes and Checklists
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Review Processes and Checklists
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.
The University of Illinois IRBs fulfill their goals to protect human subjects and support the design and conduct of sound research by reviewing for approval IRB submissions: new applications, amendments to approved studies, and continuing reviews.
All projects that meet the federal definition of research with human subjects must be reviewed and approved, or receive an exempt determination, by an IRB prior to beginning the research. The IRB staff initially screens submissions to determine the completeness and the appropriate type of review. Submissions may be returned to the study team for changes before the review type is assigned. The review type may be reassessed at any time during the review process.
Protocols are processed as they are received by OPRS. They are logged into the internal tracking database and assigned an IRB number within 2 business days. Once protocols are logged in, an email is sent to the PI indicating receipt of the protocol, the designated IRB number, and that it is in the queue for assignment to an OPRS staff member. Assignments of protocols take place on Wednesdays and are pre-reviewed before the following Wednesday.
There are several factors that will determine the time frame for approval. Depending on risk level and subject populations, protocols will proceed for exempt, expedited or full board review. When the reviewer contacts you with any pre-review issues and determines the review type, the processing time is dependent on when you are able to respond to the issues.
Exempt reviews: If your protocol qualifies for one of the exemption categories, once you address any issues we can provide approval. Please allow 2-3 weeks from submission to approval.
Expedited review: The protocol will be sent to one IRB member for their review. Once you have addressed any issues we can provide approval. Please allow 4-5 weeks from submission to approval.
Full Board review: The protocol will be placed on an IRB meeting agenda. Full board protocols must be ready (all pre-review issues addressed) before it may be placed on an agenda at least 2 weeks before the scheduled meeting.
Review time is dependent on the Board’s stipulations and the duration for these to be resolved. Please keep in mind that these timelines may be shorter or longer depending on how busy our office is and how quickly you respond to any issues/questions.