Types of Review
What level of review do I need?
There are three levels of review defined by the federal regulations (Exempt, Expedited, and Convened Review). Additionally, there is a fourth option listed in the CAP system (Collaborative Review) for projects where IRB oversight is being handled by another institution.
When you start a project in CAP, you must select the type of review it will receive. This page will help you determine which is correct for your project, but if it is not clear, contact ORS for assistance.
The level of review is determined by the level of risk the research presents to participants, but determining risk is not always straightforward. See our page on Risks and Benefits to help determine the level of risk presented by your project.
Applications that are submitted for expedited review or confirmation of exemption typically take 10-15 business days for an IRB initial decision (approved, conditional approval or deferred). Principal Investigators can check the status of their submitted application in the online CAP system. If it is determined to need convened review, please refer to the timeline under convened review.
Exemption
Under the federal regulations, there are certain common types of research, typically considered low risk, that are exempted from full IRB review. Projects that fall into these categories must still be submitted through CAP.
For the researcher, in many ways, the application process will be very similar to an expedited review. However, the IRB will not conduct a full review. Instead, they determine if the project meets the exemption criteria or not. If not, they will ask the researcher to revise the application and submit for an expedited or convened review. If the project does meet the exemption criteria, it will not be considered IRB approved, but instead determined exempt. An official letter will be available through CAP stating that determination.
Only research falling into the specific Exemption Categories can be exempted. The federal government has created a flow chart to help you determine if your research falls into one of these categories. At Lakeside, the most common exemption categories are Category 1 (Normal Educational Practice), Category 2 (Educational Tests, Surveys, Interviews, or Observation of Public Behavior), Category 3 (Benign Behavioral Interventions), Category 4 (Secondary Use of Identifiable Private Information). Each of these categories have specific requirements and limits (for instance, individual interviews may be eligible for exemption, but focus groups are not), so follow the links for flow charts that will help determine if your research meets these requirements.
Projects that are exempted do not have to submit continuing review applications as there is no expiration date to exemption. However, researchers still must submit amendments if there are changes to research materials, personnel, or procedures as changes could affect the exemption status of the project. Likewise, researchers should submit a closure application when the project is finished.
Expedited Review
For projects that do not fall into any of the specific exemption categories, and present no more than minimal risk to participants, expedited review is likely appropriate.
When you select expedited review for your project you will also need to select a category. Most LUC Lakeside research falls into Category 7. If audio or video recordings will be part of the research, Category 6 must also be selected. Some secondary data analysis projects may fall into Category 5.
Expedited projects are reviewed on a rolling basis. An approval expires after two years, and a continuing review application must be submitted before that deadline passes to continue any research activity past that date. Any changes to research personnel, materials, or procedures must be approved in advance by the IRB via an amendment application. Once the project is completed a closure application should be submitted.
Convened Review
If your project presents more than minimal risk then it will need to be reviewed by the Board at a convened meeting.
The Lakeside IRB meets once a month and the application must be submitted two weeks in advance of the meeting to give the Board time to review. See the IRB schedule so you can plan your submission.
It is possible that your application will require revisions and need to be reviewed by the Board again. Therefore, we recommend allowing a minimum of two months lead time for convened reviews.
A convened review approval expires after one year. A continuing review must be submitted before that deadline passes to continue any research activity past that date. Continuing reviews must also be reviewed by the convened board, so researchers submitting a continuing review will need to be mindful of the IRB schedule.
Any changes to research personnel, materials, or procedures must be approved by the IRB via an amendment application. Amendments will typically be reviewed through the expedited process, and are therefore not tied to the IRB schedule.
Once the project is completed a closure application should be submitted.
Collaborative Review
This type of review is conducted by LUC when the project in question is already being covered by an IRB at another institution. If all Loyola personnel are listed on that project and all of their research activities are covered by that approval, then you should submit your project under Collaborative Review.
The collaborative review application is shorter than the other applications, but you will need to list all LUC personnel, your funding sources, where the research will be conducted, information on the IRB responsible for oversight of the project (including their approval letter), and a brief summary of the project. If the IRB responsible for oversight requires a signed IRB Authorization Agreement (IAA), the agreement should also be attached to the application.
If it's unclear whether IRB review is needed or if a collaborative application is sufficient, reach out to ORS and we will help you determine the appropriate path.
What level of review do I need?
There are three levels of review defined by the federal regulations (Exempt, Expedited, and Convened Review). Additionally, there is a fourth option listed in the CAP system (Collaborative Review) for projects where IRB oversight is being handled by another institution.
When you start a project in CAP, you must select the type of review it will receive. This page will help you determine which is correct for your project, but if it is not clear, contact ORS for assistance.
The level of review is determined by the level of risk the research presents to participants, but determining risk is not always straightforward. See our page on Risks and Benefits to help determine the level of risk presented by your project.
Applications that are submitted for expedited review or confirmation of exemption typically take 10-15 business days for an IRB initial decision (approved, conditional approval or deferred). Principal Investigators can check the status of their submitted application in the online CAP system. If it is determined to need convened review, please refer to the timeline under convened review.
Exemption
Under the federal regulations, there are certain common types of research, typically considered low risk, that are exempted from full IRB review. Projects that fall into these categories must still be submitted through CAP.
For the researcher, in many ways, the application process will be very similar to an expedited review. However, the IRB will not conduct a full review. Instead, they determine if the project meets the exemption criteria or not. If not, they will ask the researcher to revise the application and submit for an expedited or convened review. If the project does meet the exemption criteria, it will not be considered IRB approved, but instead determined exempt. An official letter will be available through CAP stating that determination.
Only research falling into the specific Exemption Categories can be exempted. The federal government has created a flow chart to help you determine if your research falls into one of these categories. At Lakeside, the most common exemption categories are Category 1 (Normal Educational Practice), Category 2 (Educational Tests, Surveys, Interviews, or Observation of Public Behavior), Category 3 (Benign Behavioral Interventions), Category 4 (Secondary Use of Identifiable Private Information). Each of these categories have specific requirements and limits (for instance, individual interviews may be eligible for exemption, but focus groups are not), so follow the links for flow charts that will help determine if your research meets these requirements.
Projects that are exempted do not have to submit continuing review applications as there is no expiration date to exemption. However, researchers still must submit amendments if there are changes to research materials, personnel, or procedures as changes could affect the exemption status of the project. Likewise, researchers should submit a closure application when the project is finished.
Expedited Review
For projects that do not fall into any of the specific exemption categories, and present no more than minimal risk to participants, expedited review is likely appropriate.
When you select expedited review for your project you will also need to select a category. Most LUC Lakeside research falls into Category 7. If audio or video recordings will be part of the research, Category 6 must also be selected. Some secondary data analysis projects may fall into Category 5.
Expedited projects are reviewed on a rolling basis. An approval expires after two years, and a continuing review application must be submitted before that deadline passes to continue any research activity past that date. Any changes to research personnel, materials, or procedures must be approved in advance by the IRB via an amendment application. Once the project is completed a closure application should be submitted.
Convened Review
If your project presents more than minimal risk then it will need to be reviewed by the Board at a convened meeting.
The Lakeside IRB meets once a month and the application must be submitted two weeks in advance of the meeting to give the Board time to review. See the IRB schedule so you can plan your submission.
It is possible that your application will require revisions and need to be reviewed by the Board again. Therefore, we recommend allowing a minimum of two months lead time for convened reviews.
A convened review approval expires after one year. A continuing review must be submitted before that deadline passes to continue any research activity past that date. Continuing reviews must also be reviewed by the convened board, so researchers submitting a continuing review will need to be mindful of the IRB schedule.
Any changes to research personnel, materials, or procedures must be approved by the IRB via an amendment application. Amendments will typically be reviewed through the expedited process, and are therefore not tied to the IRB schedule.
Once the project is completed a closure application should be submitted.
Collaborative Review
This type of review is conducted by LUC when the project in question is already being covered by an IRB at another institution. If all Loyola personnel are listed on that project and all of their research activities are covered by that approval, then you should submit your project under Collaborative Review.
The collaborative review application is shorter than the other applications, but you will need to list all LUC personnel, your funding sources, where the research will be conducted, information on the IRB responsible for oversight of the project (including their approval letter), and a brief summary of the project. If the IRB responsible for oversight requires a signed IRB Authorization Agreement (IAA), the agreement should also be attached to the application.
If it's unclear whether IRB review is needed or if a collaborative application is sufficient, reach out to ORS and we will help you determine the appropriate path.