Things to Do and Know Before Preparing your IRB Application
[NOTE: Where this document refers to contacting the IRB, such contacts should usually be done via the CAP system unless an urgent situation requires immediate attention by the IRB Chair or the Assistant Director for Research Compliance.]
Before you are ready to prepare your Application there are a number of things you should know and do. You will need to:
- Determine whether your project requires IRB review
While the IRB must review all research involving human subjects, not all projects meet the IRB's definitions of research with human subjects. Often program evaluations and classroom projects do not meet the definitions of 'research with human subjects', and therefore do not need to be submitted for IRB review. Please review the IRB's Guidance on Determining whether IRB Review is required. If you are at all unsure whether your project requires IRB review, please consult the Human Subject Regulations Decision Charts or contact the Assistant Director for Research Compliance at (773) 508-2689.
- Complete the Research with Human Subjects Training Course (CITI Course)
All Investigators, Faculty Sponsors, and research assistants must complete the certification course every three years. The IRB will not review any applications where the Investigators, Co-Investigators, or Faculty Sponsor have not completed the course within the last three years. If you have completed the CITI course in the last three years you do not need to re-take it before you submit to the IRB.
The IRB will send out reminders to Investigators who have current IRB approval for any projects when they need to renew their Human Subjects Training.
Please review the CITI Instructions for more information.
- Be familiar with the IRB review process
Review the entire Investigator's Guide to the IRB Review Process to make sure you are familiar with the IRB review process and your responsibilities as an Investigator. Reviewing the entire guide before you begin the IRB review process will help you plan your project and prepare your application.
Read through the IRB's Special Guidance and Informed Consent sections of the website. These policies and guidance documents have been created to aid Investigators as they develop their protocol applications and research materials. Reviewing these policies and guidance documents should help you to avoid common problems that the IRB would ask you to address after initially reviewing your project.
- Be familiar with the Criteria for IRB Approval
In order to approve a protocol, the IRB must determine that the research meets all of the Criteria for IRB Approval. In order to determine that the research satisfies all the criteria the IRB must have sufficient information to determine that each criterion has been met. A research project will not be approved until the IRB has determined that all criteria have been satisfied.
- Identify when you want to start your research and make sure you plan enough time for the IRB to review your project
The time required for IRB review may vary depending on the type of review mechanism (full, expedited, or exempt). Should a project be conditionally approved or tabled (which is often the case), the investigator will need sufficient time to submit a response to the IRB chairperson or the Board. All members of the IRB understand that Investigators are anxious to begin their research. Every effort is made to respond to investigators in a timely fashion. The IRB's duty to review projects thoroughly and in accordance with Federal and ethical guidelines overrides all other considerations.
The IRB advises Investigators to plan to allow approximately 2 months to obtain Approval. Although many projects are reviewed and approved by the IRB in less than two months, planning on 2 months for the IRB to review a project helps to ensure that a project will have IRB approval by the time you plan to start your research. If you do not believe that you can plan to allow approximately 2 months for the IRB review process, please contact the Compliance Manager to discuss the timeline for your project.
Regardless of the type of review, however, the Investigator must take into account that approval is not guaranteed at the time of review, or at all.
If you are submitting a project for external funding:
- Be familiar with your funding agencies’ requirements regarding IRB Approval
External funding agencies have various deadlines for when IRB approval is necessary. Some funding agencies may only require Investigators to have IRB Approval before funds are awarded, while others may require IRB Approval before an application can be submitted. If you are submitting a project to an external funding agency the IRB recommends that you submit your application to the IRB at least 2 months before the agency would require you to have Approval.
If you are a Student, you must also:
- Find a Faculty Sponsor
All Applications by LUC students must have a faculty sponsor who agrees to supervise the student and bear responsibility for the project. This applies to all projects that are being conducted for the purpose of a degree as well as to all independent research projects.
If the purpose of the research project is towards the completion of a Masters or Dissertation:
- The project must be approved by your committee before the project is submitted for IRB review. You must submit a copy of your Proposal Ballot that has been signed by your committee members to the IRB with your application for review.
PLEASE NOTE: The Graduate School requires IRB approval before approving a Thesis or Dissertation Proposal. After the committtee members have approved the proposal, the committee members should sign the Ballot for the Approval of a Thesis/Dissertation Proposal. A copy of this form should be submitted both to the Graduate School and to the IRB. The IRB will notify the Graduate School when a student's protocol has received final IRB approval. After the Graduate School is notified that the student's protocol has received final IRB approval the Graduate School will approve the Thesis/Dissertation proposal, provided everything else is in order.
Once you have finished all of these steps and familiarized yourself with the IRB's policies, you are ready to prepare your Application for IRB Review.
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