Legacy studies are IRB protocols that were approved prior to the implementation of the Cayuse electronic submission system in August 2020.

Legacy studies will be labeled with “Legacy” in front of the study number. Examples include Legacy-12-99 or Legacy-MR10-100.

Due to inconsistencies identified between the initially approved studies and corresponding Cayuse Legacy applications, all active Legacy studies must be closed by April 30^th, 2024. This decision was made based on institutional recommendations to ensure compliance with current UTD / IRB Policies and Procedures. Additionally, a majority of Legacy studies were approved before the Department of Health and Human Services updated regulations (45 CFR 46) and recent National Institutes of Health policy changes took effect.

Please note: If a Legacy study is closed before the new Initial study has been approved, all research activities (e.g., recruitment, consent, procedures, and data analysis) must immediately stop.

April 30^th, 2024. If the Closure request is not submitted for a Legacy study by this date, the HSR will administratively close the study. Once the study has been closed, all research activities (e.g., recruitment, consent, procedures, and data analysis) must immediately stop.

To ensure there is no lapse in IRB approval, the HSR Office recommends that you initiate the new Initial study submission at your earliest convenience to allow time for the review and approval process.

The Closure request can be submitted by clicking on the blue New Submission button and selecting the Closure option.

Guidance: Closing your Study.

A new Initial study can be created by clicking on the blue New Study button and entering the study title. The application can be completed by clicking on the blue New Submission button and selecting the Initial option. Please indicate that the application is a resubmission for a previously approved Legacy study and include the IRB number for the Legacy study.

Guidance: Creating a New Study and Creating a New Submission

If all data collection has been completed, the Data Analysis Only (Retrospective) option can be selected on the Initial application. Please indicate that the application is a resubmission for a previously approved Legacy study and include the IRB number for the Legacy study.

The timeline from submission to approval begins after the pre-review process is finalized and the review process is initiated by the HSR Specialist. Approximate timelines can be found on the HSR website: Review Timelines.

If you have any questions regarding the Legacy resubmissions, please contact HSR@utdallas.edu.

Cayuse IRB is the electronic submission portal that manages all human subjects research protocols from initial submission to closure.

You can log into Cayuse IRB using your UTD NetID and password, and select Cayuse IRB. If you are a new user and are unable to access Cayuse, you can submit a request to be added to the system via this link. Please allow 1-3 business days for processing.

In order to activate your Cayuse account or the Cayuse account for another user, please submit a request via this link. Please allow 1-3 business days for processing.

The Cayuse Dashboard is the homepage for your Cayuse account. You can use the dashboard to access your studies, submissions, and tasks. Please watch the Cayuse Dashboard video for additional guidance.

A UTD NetID is required to be added to Cayuse, but all study personnel that are not affiliated with UTD can be included on the application by attaching a document listing these individuals. The attached document should include their name, role on the study, and institutional affiliation. The application should also include the human subjects protection training certificates for each non-UTD affiliated individual and institutional approval (if applicable) for each institution.

Please see our guidance for submitting a new study. You can select the Class Project option on the Submission Information tab of the initial application to begin the process. We also have a training video for the Class Project submission process that provides additional guidance.

Please note: In order for the students to be able to submit an application or be listed as study personnel on an application, they will need to be added as users to Cayuse. New users can be added to the system by submitting their name and UTD NetID via this link. Please allow 1-3 business days for processing.

Please see our guidance for submitting a new study. You can select the UTDesign Project option on the Submission Information tab of the initial application to begin the process.

Please note: In order for the students to be able to submit an application or be listed as study personnel on an application, they will need to be added as users to Cayuse. New users can be added to the system by submitting their name and UTD NetID via this link. Please allow 1-3 business days for processing.

Principal Investigator (PI), Co-Principal Investigator (Co-PI), and Faculty Sponsor: Individuals listed in these roles can access the study in Cayuse, create/edit submissions (Modifications, Renewals, etc.), and are required to certify all submissions.

Other Personnel: Individuals listed in this role will not have access to the study in Cayuse nor will they be able to create/edit submissions.

Primary Contact: Individuals listed in this role can access the study in Cayuse and create/edit submissions, but they are not required to certify submissions. This role can be used for administrators or study personnel that provide assistance with submissions.

If the Primary Contact is engaged in the research, they should also be listed as personnel on the application (PI, Co-PI, or Other Personnel).

Can my study have more than one Primary Contact?

All new initial applications can have multiple Primary Contacts listed on the application. Studies that were submitted prior to September 2020 are limited to one Primary Contact.

Please watch the roles and certification video for additional guidance.

Each submission and resubmission must be certified by the appropriate personnel before the request can be submitted to the HSR. For example: If a new application is returned to the study team with feedback, the application will need to be certified again during the resubmission process. Please watch the roles and certification video for additional guidance.

Who needs to certify each submission?

The PI, Co-PI(s), and/or Faculty Sponsor are required to certify all submissions and resubmissions. 

How can I determine who needs to certify a submission?

You can view the certification status via the Submission Details page. This section includes the individuals that must certify the submission and indicates if they have certified or if the submission is pending their certification.

The Study Details page is the main page for the overall study and includes the approval/expiration dates and all submissions related to the study. The Submission Details page is the main page for each individual submission and includes the status of the submission and all approved study materials for the submission.

You can check the status of the submission via the Dashboard or the Submission Details page. Please watch the status of submissions video for additional guidance.

What does each status mean?

• The In-Draft status indicates that the submission is pending completion by the study team. These studies could have been drafted but not submitted to the HSR yet, or they could have been submitted to the HSR office and returned to the study team for updates.
• The Awaiting Authorization status means that the submission is pending approval certification from at least one of the key researchers on the study (PI, Co-PI, and/or Faculty Sponsor).
• The Pre-Review status indicates that the submission is being reviewed by the HSR, and an HSR Specialist is in the process of reviewing the submission.
• The Under Review status shows that the submission is under review by the IRB or HSR Reviewers.

When comments have been added to an application, it is returned to the study team so they can provide the requested information in the application / study materials. These comments can be provided by the HSR during the pre-review process or the Reviewers during the review process. Please watch the addressing comments video for additional guidance.

How can I access the comments?

To locate the comments, you can look for the little bubbles next to each section of the application.

The little bubbles indicate which sections have comments, and the number in the bubble indicates how many comments are in that section. Once you have located the comments, you can click on Expand Comments to review the requested information.

How can I address the comments on my submission?

You can address the comments by making the requested changes to the application / study materials and selecting the address button on the comment.

While you can reply to the comments, the requested changes must be made to the application form as well. When the study materials need to be updated (such as the recruitment materials or consent form), the old versions should be removed from the application and the updated versions should be attached to the application. The updated versions should be the clean versions without tracked changes.

Please note: Each comment must be addressed in order to be able to complete the resubmission process.

The CITI training can be linked with Cayuse for HSR submissions, but the preferred email address must be listed in the [YourNetID]@utdallas.edu format in order for the systems to link together. Once the course has been completed, your training records will automatically pull into Cayuse for all applications on which you are listed. This step eliminates the need to upload your CITI completion certificate as a separate document into the application form. Additional information about this process can be found here.

If you completed the training via UTD eLearning within three (3) years prior to 2/28/2022, your completion certificate must be attached to the application for all submissions.

The application template in Cayuse is frequently updated to best capture information needed to ensure compliance with changes in Federal and State requirements and UTD / IRB Policies and Procedures. To confirm that studies submitted for approval utilize the most current application template, all unapproved studies that have been inactive for 6 months will be administratively withdrawn (closed) and a new Initial application must be submitted for review / approval to ensure the protection of participants in research studies. This includes all studies that have not been submitted to the HSR within 6 months of initiation (Unsubmitted status) or within 6 months of submission (Reopened status).

Studies that have not been submitted to the HSR can be deleted by selecting the Delete button on the Study Details page.

Submissions (Initial, Modification, etc.) that have not been submitted to the HSR can be deleted by selecting the Delete button on the Submission Details page.

Studies and submissions cannot be deleted once they have been submitted to the HSR. These submissions can remain in draft status until they are ready to be submitted to the HSR.

Example: If a Modification has been submitted and then the study team decides that they do not want to make the changes now, the Modification can remain in draft status until the study team decides to modify the study in the future.

A study can be withdrawn by clicking on the New Submission button and selecting the Withdraw option. A withdrawal submission indicates that you no longer wish to submit your initial submission and have chosen to withdraw the study. Withdrawn studies are marked as finalized and can no longer be modified/submitted. You may create a withdrawal submission at any point once an initial submission has been created until it has been approved. Once the initial submission has been approved, you must submit a Closure request in order to close the study if you no longer wish to conduct the research.