Submitting Documents for IRB Review
Description
Documents Section in IRBOnline
The IRB reviews and approves supporting documents to the IRB application for the following purposes:
- Information included in the document is necessary for the IRB to determine if the study meets the Criteria for IRB Approval of Research, as well as other applicable federal regulations.
- The document will be provided to the research participants and will assist them in making an informed choice about participation in the study.
Most IRB applications have accompanying documents that must be submitted to the IRB for review and approval.
General Notes on Attaching Documents
- Documents are attached to the IRBOnline application in the Documents section, which is the last section of every type of application.
- Documents must be attached to the correct category, or the researcher will be required to revise the application and move the document to the correct category.
- Categories are:
- Consent Documents
- Recruitment Materials & Advertisements
- Surveys, Questionnaires, etc.
- Grant Application/Documents
- Investigator's Brochure, Package Insert, Instructions for Use
- Literature Review/Cited References
- Other Documents
- Each separate file or document should be attached as an individual file. For example, if the study includes two difference consent forms, each consent form should be attached as its own file.
Attaching Revised Documents
If you are attaching a document that OPRS/IRB has previously reviewed and requested revisions or was previously approved and you are now updating via amendment, you must attach:
- A tracked copy of the document showing the changes you've made (include "tracked" in the file name)
- A clean copy of the document that will be processed with your approval (includ "clean" in the file name)
Why are tracked changes required with revised documents?
The University of Illinois Urbana-Champaign IRB has thousands of active protocols, each with several documents that require review, and each application is reviewed on its own timeline. This means that at any given time, the OPRS staff is reviewing documents for hundreds of different studies.
Each application often has multiple versions of documents, different revision requests in process, etc. Tracking changes made to documents previously reviewed can help the OPRS staff and IRB members streamline and speed up the review process.
Please note - highlighting changes is not the same as tracking changes. Highlighting changes show where changes have occurred, but not necessarily what those changes are. Tracked changes show what was deleted and what was added. This is critical information for IRB review.
It is the researcher's responsibility to attach both the Tracked version and a Clean version for the IRB approval process.