The Project Page
Setting up your project
Creating a New Study and Initial Submission in Cayuse
The Human Ethics module is used to create and submit IRB applications for review. To begin a new initial submission, log into Cayuse using the Loyola Single Sign-On function and select Human Ethics from the Products menu.
Please note that prior to submission/certification, the system may populate a pop-up notification regarding “sponsor/attachments”; please Confirm to continue
草莓社区 on submitting a Human Ethics Initial Submissions in :
Step 1: Create a New Study
From the Human Ethics dashboard, select +New Study. Enter the study title and save.
Use a clear, descriptive title that matches the title used in your study documents, consent materials, recruitment materials, and other attachments. This title cannot be changed in the future.
Step 2: Start an Initial Submission
After the study is created, select +New Submission, then choose Initial. To complete the application/submission, select Edit, Assign PI, or Complete Submission.
Step 3: Complete the Getting Started Section
Review the introductory information before beginning the application. This section explains how uses your responses to guide the submission and provides resources.
Step 4: Complete Application Sections
In the General Information section, select the appropriate IRB; be sure to choose the option that best matches your study type and campus. Some selections may require additional confirmations, such as whether the study involves FDA-regulated activities or Loyola Medicine patients or data.
Then, enter the submission title and lay abstract/summary. Note that the Submission Title may/not differ from the Study Title. Often, they will be identical.
Choose the correct review type requested, such as Exempt, Expedited, Convened/full board, Collaborative Research, Classroom Assurance, or Not Human Subjects Research determination. Select the radio dials for information on Exempt and Expedited review types/categories and help make your selection.
In the Personnel section, identify the Principal Investigator (PI), Primary Contact, Co-Investigators, Affiliated Personnel, and any Non-Loyola Personnel, as applicable. Note that the individual completing the submission is automatically listed at the Primary Contact and if the PI is a student or University staff person a Faculty Sponsor field will populate and must be filled in.
Use Find People to search for and select study team members. Confirm that required personnel have appropriate training documentation. Attach supplemental training documentation when needed.
If any study personnel have a financial conflict of interest related to the project, disclose it in this section and upload any required management plan.
Research Funding must be identified in the next section. is a holistic research administration system that houses all of Loyola’s research platforms, including Sponsored Projects records. To find the Proposal Number(s) for any Sponsored Projects associated with the current Human Ethics submission, navigate to the Products drop-down menu and select Sponsored Projects.
Continue through each section listed on the left side of the screen. Depending on your responses, sections may include:
- Research Sites
- Procedures/Summary
- Risks and Benefits
- Population/Research Subjects
- Informed Consent
- Privacy and Confidentiality
- Compensation
- Attachments
Use the question mark icons within for additional instructions and field-specific guidance. Click Save regularly as you complete the application.
Step 5: Save and Review Before Submission/Certification
Before submitting, review each section for completeness and confirm that all required documents are attached. Use Create PDF if you would like to review a PDF copy of the submission before finalizing.
Once all required sections are complete, proceed to the final submission section and submit the application for IRB review. If the PI is not completing the application, they will be sent notification to certify the submission in Cayuse and it will not be submitted until certified.
IMPORTANT: You may find a pop-up notification at the end of the submission process, prior to certification. It may say something like: “Are you sure you want to continue, the hidden/unselected components like Sponsor/Attachments will not be part of the submission?”; Simply Confirm and continue towards certification.
I STARTED REVISING OLD WEBPAGE LANGUAGE HERE: DO NOT USE
Creating an Initial Study Submission
Setting up your New Study
When you start a New Study in , the first thing you will do is create your Study Title. Note that this cannot be changed after entered. The Study Details page provides a quick overview of the study and gives the option to create new submissions (Initial, Modification, Renewal, etc.) under the study.
Creating a New Submission under a Study
Selecting PI and Faculty Sponsor
The person creating the application in will automatically be listed as Primary Contact. Principal Investigators who are students or University staff also require a Faculty Sponsor.
Project Summary
This is where you will put a brief summary of your project. It's best to think of this as an abstract and keep it relatively brief - you will be able to provide a detailed description of your research procedures later in the application process.
Additionally, because the project page will lock once an application has been approved, it is best practice to provide a general overview here, especially if you think specifics (such as recruitment numbers or locations) might change later in the project.
Types of Research
The CAP system is used to manage various types of research compliance (not just IRB), so the next few questions determine which committees will review. Since you are here on the IRB website, you are probably going to answer "Yes" to "Are you engaging in Human Subject research?" and "No" to the other questions.
Review Type
In this section you will select the type of IRB review is needed and, for exempt and expedited reviews, which categories apply. See our page on鈥�Types of Review for more information.