Before applying
There are some steps that should be addressed before you even open CAP. This section will help you prepare to submit a complete application.
Figure out your timeline
The time it takes the IRB to review an application varies depending on several factors. One is the level of review. For exempt and expedited reviews you should hear back from a reviewer within two weeks (although they may request changes, so the final approval may require more time), but convened review applications are only reviewed once a month.
For any type of review, changes may be requested by both ORS staff and your reviewers. The timeline to approval will depend the responsiveness of the research team. If you are too busy to respond to the IRB comments, then the process will naturally take longer, so it's a good idea to give yourself lead time when planning the IRB approval process.
Decide who can edit the application
In some cases, a researcher may want someone else to make the edits to the project. CAP allows a researcher to add up to two proxies who will be allowed to edit applications. Keep in mind that the PI will still need to make the final submission. See our step-by-step guide for how to assign a proxy.
CITI Training
One of the federal requirements is basic IRB/ethics training for all researchers. LUC uses the CITI program to meet this requirement. Without completed CITI training, you will not be able to access CAP, so make sure to complete this step first.
All researchers (including those outside of LUC) who will be listed on the application must have up-to-date CITI training. If a researcher has never completed CITI training, you will not be able to add them to the project.
CITI training expires after three years, and the IRB will not approve a project where any of the researchers have expired CITI training, so check with your research team. See our page on CITI training for more information.
Other preliminary steps
Some projects, such as student projects, or projects recruiting from certain locations, may require additional preliminary steps. See the sections below for more information.
Student Researchers and Faculty Sponsors
All students that want to act as a Principal Investigator, whether undergraduate or gradate, must have a faculty sponsor (some staff members conducting research will also need a faculty sponsor).
The person you pick for your faculty sponsor needs to be an active faculty member. They should be someone who is familiar with your work, and who has the time to provide ongoing supervision and monitor the progress of the project. This includes the IRB review process.
Students will need to find a faculty sponsor before they are able to complete their CAP application. An application can only be submitted to the IRB after review and approval from the faculty sponsor. Faculty sponsors can go here for information on their role in this process.
Graduate Student Theses or Dissertations
Graduate students submitting an IRB application for their thesis or dissertation research must have evidence that the student’s committee has approved the proposal. The IRB will not be able to review prior to that approval. For students in programs under The Graduate School, this information should be automatically linked in CAP once the committee and graduate program director have approved the proposal in the Graduate Student Progress System (GSPS). For students not using the GSPS, a scanned, signed copy of the approval ballot should be uploaded to the Attachments section of the application.
Permissions and Letters of Cooperation
When approval from a cooperating institution is necessary to recruit participants, access information, or conduct data collection, that approval must be documented in writing by the appropriate signatory official. This can be a physical letter or an email from the appropriate official email account. Appropriate documentation would include the content requirements listed below.
1. The signatory official should reference the researcher by name and the title of the project being approved.
2. The content should demonstrate that the signatory official has a clear understanding and approves of the research procedures outlined in the research protocol, (e.g., recruitment, consent, and data collection).
3. If archival data/documents about human subjects are being used in the research, the signatory official must approve their use and verify whether data will be released to the researcher with or without identifying information.
4. Letters of approval must bear the original signature of the appropriate signatory official at each institution or come from the appropriate official email account. The researcher should upload a copy to CAP and keep a copy for their records as well.
Many Investigators find it helpful to provide Cooperating Institutions with a copy of the requirements for letters or to draft the language for the letter of cooperation.
Gathering letters of permission can also be done later in the process. If a letter is not completed at the time of initial IRB approval, it must be added to the project later via an amendment.
Outside IRB or Ethics Review
If you have non-LUC personnel, their home institutions may also require IRB review. Additionally, for some sites, additional IRB or Ethics review will be required.
Examples that may require additional review are projects done within the Chicago Public Schools and other school districts, and research being conducted abroad or on tribal lands.
It is the responsibility of the researcher to determine when additional review is required and to provide the LUC IRB with a copy of the approval.
This step can also be done later in the process. If the project approval is pending at the time of initial LUC IRB approval, the approval letter must be added to the project later via an amendment.
There are some steps that should be addressed before you even open CAP. This section will help you prepare to submit a complete application.
Figure out your timeline
The time it takes the IRB to review an application varies depending on several factors. One is the level of review. For exempt and expedited reviews you should hear back from a reviewer within two weeks (although they may request changes, so the final approval may require more time), but convened review applications are only reviewed once a month.
For any type of review, changes may be requested by both ORS staff and your reviewers. The timeline to approval will depend the responsiveness of the research team. If you are too busy to respond to the IRB comments, then the process will naturally take longer, so it's a good idea to give yourself lead time when planning the IRB approval process.
Decide who can edit the application
In some cases, a researcher may want someone else to make the edits to the project. CAP allows a researcher to add up to two proxies who will be allowed to edit applications. Keep in mind that the PI will still need to make the final submission. See our step-by-step guide for how to assign a proxy.
CITI Training
One of the federal requirements is basic IRB/ethics training for all researchers. LUC uses the CITI program to meet this requirement. Without completed CITI training, you will not be able to access CAP, so make sure to complete this step first.
All researchers (including those outside of LUC) who will be listed on the application must have up-to-date CITI training. If a researcher has never completed CITI training, you will not be able to add them to the project.
CITI training expires after three years, and the IRB will not approve a project where any of the researchers have expired CITI training, so check with your research team. See our page on CITI training for more information.
Other preliminary steps
Some projects, such as student projects, or projects recruiting from certain locations, may require additional preliminary steps. See the sections below for more information.