Create an Initial Submission

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

• Confirm you can log in to Cayuse Human Ethics. If you cannot, request an account using the Cayuse Account Request
• Please see policy for whom may serve as Principal investigator
• If you are a student, before you start filling out the Initial Submission form, work closely with your faculty sponsor to finalize your research plan. Note that only faculty are automatically eligible to serve as Principal Investigator on submissions. Your faculty mentor will need to be listed as Principal Investigator and certify the submission, and you as the student will be listed as Co- Investigator and/or primary contact.
• 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 Research Personnel page 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 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 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, request an account using the Cayuse Account Request Form.
• From the Product drop-down menu, select Human Ethics
• Select the “+ New Study” button.
• Enter the study title and select the check mark button.
• 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.
• When the submission is complete, follow the instructions for submitting.
• The PI will be sent emails with instructions for certifying the submission in Cayuse. Once the PI certification is entered, the submission will be routed to ORC.
• Once ORC 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. Ensure you update the application as well as responding to comments.

• Be sure to check your email (Cayuse will use your @tcu.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.