Cayuse Human Ethics  

In the spring, we transitioned from the IRBIS platform to Cayuse Human Ethics. All human subjects actions – new submissions, modifications, renewals, reporting adverse events – now occur in this platform. To access the site/login: https://cayuse.uncg.edu/modules/human-ethics/. You can also find the link on the Research Integrity home page under resources. A training video and help documents are available here.

If you have specific questions not addressed by these resources, email Melissa Beck, Associate Director, Office of Research Integrity at mdbeck@uncg.edu. She is incredibly responsive.

Extraordinary efforts were made to automatically transition needed information from IRBIS to Cayuse, but there are many cases in which investigator action is needed. Essentially, some attachments did not move over due to an inability to match content to location given a lack of standard naming conventions and/or the required items/questions in the standard protocol have changed over time, and anything that is required now must be completed. This led to the most recent status update copied verbatim below — you only see this if you login to Cayuse or if you happen to be monitoring the Research Integrity Website, so it is being brought to your attention.

UPDATED INFORMATION!! (7/9/2021)

• • • The migration of studies from IRBIS to Cayuse is now complete. Some information was unable to be transferred over from IRBIS due to the IRBIS and Cayuse applications not being completely identical. In the sections of the legacy application where there are no check marks next to the section, the PI will need to provide the missing information – for most sections, this is simple information such as “yes/no” responses and inputting dates.
    • IMPORTANT: The legacy application must be completed as the study is currently approved. Please do not incorporate any modifications into the legacy application. If you have a modification to the study, a modification application must be submitted after the legacy application is completed and submitted.
    • Once the missing information has been inputted into the legacy application and each section has a check mark, the legacy application can be finalized.
    • IMPORTANT: It is important to understand that legacy applications and modification and renewal submissions are separate actions. A legacy application is not a renewal or modification submission.
    • The Legacy Application should be completed as the study is currently approved. Any changes to the study would need to be submitted via a modification sent once the legacy application is complete.

REQUESTED ACTION FROM FACULTY

For anyone who conducts human subjects research, please do the following: login to Cayuse and see if you have any applications in the legacy status and complete those submissions. Note that no additional actions related to a project in this status can be taken until the legacy submission is completed. Here are the needed steps:

1. 1. Click the link for any such protocols (see protocol number);
   2. Click complete submission under required tasks;
   3. Answer any questions noted with a red asterisk and provide any attachments* noted with a red asterisk.  (red asterisk = required);
   4. On the left side of the screen in the blue section, you will see a checkmark next to a section when it is completed; if there is not a checkmark, there is missing required information;
   5. Once you have completed all required information, the option to certify your legacy application will appear in the bottom of the blue area on the left of the screen and you can select it;
   6. Voila–you will be done.

Why do this now? There are two reasons to do this now:

1. 1. To save you time later. Modifications are often urgent, and completing this process now will prevent any urgent completion requests later because this step was skipped.
   2. You may need to download attachments currently in IRBIS to add to Cayuse, and this option is only available to us through December. After that, we will not have access to IRBIS anymore.

*Note: There may be a compromise for attachments in some cases. Dr. Esther Leerkes had the following experience which may assist you with this; here is Dr. Leerkes’ description:

“I had a study in data analysis only-no active data collection, and all data collection instruments and site agreements were noted as required attachments. This would have involved uploading approximately 30 documents. Given the status of the study, I was allowed to create a brief document for each section that simply stated: “Study in data analysis only. All data collection materials (site approvals) were provided in the original protocol” — uploaded that and moved on. This is NOT an option if your study is in active data collection. This is also NOT an option if your study is relatively old and attachments that are required now were not required in IRBIS at the time. If unsure, contact Melissa Beck.”

Cayuse Sponsored Projects

We transitioned to Cayuse Sponsored Projects (replacing RAMSeS) on July 1.

Login, training information and FAQs are available here. You can also locate this from the OSP (Office of Sponsored Programs) home page, bottom under Proposal Preparation, Cayuse SP.

Where to find information about applications/awards prior to implementation of Cayuse

Although the plan is for most applications and awards that were in RAMSeS to migrate over to Cayuse, this has not happened yet. Thus, if you are looking for information about submissions and awards that were not submitted prior to Cayuse implementation, for now they are still available in Cayuse Research Suite, and we still have access to all records; simply click on the ‘Continue to Login’ button at the bottom of the box. Updates will be sent if this changes. If you type RAMSeS login in the UNCG search bar, a link to that page will appear readily.

Completing and routing external submissions

In most cases, the HHS Office of Research staff complete the bulk of the Cayuse application/information in consultation with the Principal Investigator and let Principal Investigators know which sections/questions they must address (e.g., location, human subjects). Then, Principal Investigators need to review and certify/approve the submission when it comes to them (see the following section for details.)

In the event a Principal Investigator has not adhered to the HHS OOR timeline for effective grant submission and our workload prohibits us from providing our full suite of services in the needed time frame, the Principal Investigator is expected to complete the Cayuse application in its entirety. This would likely require watching the training video and/or reading the documentation, completing the budget in the required format, answering all questions, uploading all needed documents, etc. Our goal is to shield investigators from this burden, but this may not be possible if there are tight time constraints, and we are in a period of peak submissions. Should this happen, be prepared to devote a substantial amount of time to this. We estimate this could take an entire business day or more.

Reviewing and certifying external submissions.

Principal Investigator: You will receive an automated email from do-not-reply@cayuse.com with the subject heading: ACTION NEEDED: Authorization Request – xx-xxxx (the proposal number.) The email is pretty clear on needed steps and includes a link that will take you directly to Cayuse SP. Should you ever need further direction, please see this document. The HHS Office of Research staff can also answer questions about this process. You can either reject the proposal and leave a note as to why (e.g., perhaps corrections are needed), or certify the proposal (you may also leave notes if you certify).  Typically, if a small correction is needed, you can simply contact Verna Leslie about the needed correction.

Department Chairs must review and approve Cayuse submissions by their departmental faculty. Department Chairs have received written instructions and training for this process.

The HHS Office of Research must also review and approve all proposals, and they review and approve on behalf of the HHS Dean as well.

*Please note, if you are not the PI, but are a co-investigator or other key personnel, you are not included in the approval process, but review and approval is needed from your department chair and from the HHS Office of Research and HHS Dean. Please ensure that all HHS approving parties know about the proposal and know the agreement you reached regarding allocation of credit and time/effort devoted to the grant, so we can be sure what is stated is consistent with your expectation. According to Dr. Esther Leerkes, HHS Associate Dean for Research, it is best practice to have clear discussions about allocation of credit and percent effort and to have a written record of what was agreed to within a research team. Never hesitate to request this when working as part of a team.

Completing Project-Specific COI information

All investigators and key personnel named in a Cayuse application must complete the Conflict of Interest section prior to the contract/grant being submitted to the sponsor. Cayuse does not send an automated email notifying them that this needs to be done. Verna Leslie is working hard to make sure people are aware of this when submissions originate in HHS. We are not certain how this is being handled in other units. So, it is important everyone involved in a key role is aware of this and completes this step so no contract/grant is jeopardized. In other words, if you are part of a team in which the Principal Investigator is from another unit and that unit is charged with routing the Cayuse application, make sure you complete your project-related COI! Directions on how to do so are available here. This involves using the module Cayuse Outside Interests, further explained below.

Please note, you will need to know the following information to complete the project specific COI. If you need our assistance locating this information, please email Verna Leslie in the HHS Office of Research. Hannah Hawks and Lisa Walker, both in the HHS Office of Research, can also access this information if needed. Here are the items you will need to complete your project specific COI:

• • • • Cayuse SP Proposal Number
      • Project Title
      • Sponsor
      • Your Role on the Project

Cayuse Outside Interests

Text verbatim from https://cayuse.uncg.edu/modules/outside-interests/:

“Conflicts of Interest in the academic environment arise when there are situations in which financial or other personal considerations may directly and significantly affect, or have the appearance of directly and significantly affecting, a person’s judgment in exercising their University responsibilities. Learn more about conflicts of interest and what you should disclose at coi.uncg.edu.

Cayuse Outside Interests allows investigators to make conflict of interest disclosures including:

• • • annual disclosures
    • research-based or project-specific disclosures
    • external activities for pay disclosures
    • Federal “other support” disclosures”

To access a training video, instructions and FAQs or to login to Cayuse Outside Interests go to:  https://cayuse.uncg.edu/modules/outside-interests/

In short, once you login

• • • Select new disclosure
    • Then select either annual disclosure (this has a subsequent option to select EPAP: External Professional Activities for Pay or annual disclosure) or research-based disclosure (please see details above for the latter)
    • Then provide requested information and submit.

Please do not hesitate to reach out to the HHS Office of Research staff if you have any questions or need assistance with Cayuse.