Submit an Application

Beginning February 1, 2023, the Cal Lutheran IRB will begin to use the web-based product Cayuse Human Ethics for managing human subjects research studies. Cayuse Human Ethics is an electronic protocol management platform that is cloud-based, user-friendly, and secure.

Cayuse Human Ethics enables collaboration and increases efficiency among investigators, IRB administration, and IRB committee members. It allows investigators to prepare, submit, and route human subjects research studies with secure electronic document technology.

Cayuse Human Ethics is used to prepare and submit all initial human subjects research studies, as well as make modifications, request renewals, and report incidents. To access Cayuse Human Ethics, log into your MyCLU portal and click on the Cayuse icon under Tools & Support. Read below to access instructions on how to create an initial submission in the Cayuse system. All studies submitted or approved prior to February 1, 2023, will continue to be processed and reviewed outside of the Cayuse system. Please email the IRB at irb@CalLutheran.edu if you have any questions.

Initial Submission:
Choose and Submit an Application Form

The Initial Submission electronic form in Cayuse Human Ethics is used for multiple purposes:

• Requesting IRB review
• Requesting an evaluation of whether a study involves human subjects research
• Requesting a reliance on an external IRB

Preparing to Create an Initial Submission

Cayuse IRB Application

• Confirm you can log in to Cayuse Human Ethics by clicking on the link above. If you cannot, please contact the IRB at irb@CalLutheran.edu.
• Please see the Investigator Manual for information regarding who may serve as a Principal Investigator.
• If you are a student, before you start filling out the Initial Submission form, work closely with your Faculty Advisor to finalize your research plan. Note that only Graduate Students and Regular, full time Faculty are eligible to serve as Principal Investigator on submissions. For undergraduate students, your faculty advisor will need to be listed as Principal Investigator and certify the submission, and you as the student will be listed as Primary Contact. Special Faculty (lecturer, senior lecturer, instructor, adjunct, visiting professor, senior mentor, or professor emeritus) and Staff can apply for PI status by completing the PI Eligibility Exception Request Form.
• Please note whoever creates the initial submission will automatically be listed as the Primary Contact. If you do not want to serve as Primary contact make sure to add yourself elsewhere on the Key Study Personnel section before you delete yourself from the Primary Contact. If you don’t, you’ll lock yourself out of the submission.
• Make sure that all research personnel have met the Human Subjects Research Study training requirement via CITI Training. Studies cannot be approved by the IRB, or certified as exempt from IRB approval, until all study team members have met the appropriate training requirements.
• Be prepared to describe:
  • the plan to contact and recruit participants;
  • the inclusion/selection criteria;
  • the research hypothesis;
  • what participants will be asked to do, including materials and methodologies that will be used (interview or survey questions, focus groups, recruitment scripts, etc.); and
  • how data will be collected and protected.
• Depending on the specifics of the study, be prepared to attach some or all of the following supplemental materials to the submission:
  • subject recruitment materials (emails, flyers, scripts, letters);
  • consent documents (adult consent form, parental permission form, adolescent and child assent forms, verbal or online consent scripts) as applicable;
  • questionnaires (surveys), interview guides;
  • online content, screenshots, and/or links, as applicable;
  • debriefing materials or scripts;
  • consent documents translated into a foreign language, as applicable

Creating an Initial Submission

• Log in to Cayuse Human Ethics. If you cannot, please contact the CLU IRB at irb@CalLutheran.edu.
• From the Product drop-down menu, select Human Ethics
• Select the “+ New Study” button.
• Enter the study title and select the check mark button. You can rename your study up until the completion of a withdrawal or admin closure submission. From the Study Details screen, hover over the study title and click the "pencil" icon or within the field to edit.
• Select the “+ New Submission” button.
• Select the type “Initial.”
• Select the “Complete Submission” link and follow the instructions to fill out the submission.
• When completing the submission:
  • Use language that could be understood by a layperson. Avoid jargon, and when unavoidable provide explanations.
  • Be sure the descriptions of human subjects research activities are consistent with the information provided in any related grant or contract applications.
• Any question with a red asterisk * is required to be completed.
• Once all sections have a white check mark noted on the left-hand side, the application will be ready for submission.
• When the submission is complete, follow the instructions for submitting.
• The PI and Faculty Advisor (if applicable) will be sent emails with instructions for certifying the submission in Cayuse. Once the PI and FA (if applicable) certification is entered, the submission will be routed to the CLU IRB.
• The Faculty Advisor (FA) has the ability to “Return to Investigators” if further revisions need to be made. However, the comments will need to be made outside Cayuse, since the FA is not able to comment directly in the submission.
• Once the CLU IRB has received the submission, you will receive an acknowledgment email.

After Completing a Submission

• Submissions are reviewed according to date received. The time it takes to receive initial feedback depends on several factors such as:
  • the volume of protocols already under review at the time your submission is received,
  • completeness of the submission, and
  • the complexity of the research.

We recommend allowing ample time for IRB review and responding promptly to IRB feedback. A submission’s approval/exempt determination is dependent on your timely and sufficient response to comments.

Responding to Comments

• After logging into Cayuse, you will see comment bubbles with a number inside the bubble indicating how many comments have been made for a particular section.
• Go to that section and find “Expand Comment”, click on it, or the comment may already be expanded. The comment will be for the information entered/answered above the Comment.  You can do any of the following when responding:
  • Update information directly in the submission
  • Reply in the comment text box
  • Update and re-attach a document
• Once you have responded to the comment, click on the drop-down and change to “Address”.
• You must have all the white check marks to the left to be able to re-submit your submission.
• Once you re-submit, you and your Faculty Advisor (if applicable) will also need to re-Certify the submission.
• It must be Certified to be moved to the IRB side of the workflow.
• Be sure to check your email (Cayuse will use your @CalLutheran.edu address) on a regular basis, as you may receive important information and/or questions regarding the submission. Responding promptly to these emails ensures that the submission can be reviewed as quickly as possible.
• You will receive an email from Cayuse once a determination has been made regarding the submission.