November 9, 2022 Cayuse HE FAQs

The HRPP has added FAQs for the most common Cayuse HE questions including information on submitting modifications to approved iRIS studies), as well as new features and changes in the application and review processes.

 

November 1, 2022 Cayuse HE Training and Advising available

The HRPP will offer Cayuse Tech help drop-in hours via Zoom for researchers needing technical assistance with using Cayuse HE. Drop-in hours will be held Monday through Thursday 9:00 –10:00 AM & 1:00 –2:00 PM. (The Zoom room will not be monitored outside these hours).

 

October 28, 2022 Cayuse HE is now live and available for submitting IRB applications

Please visit the HRPP home page to learn more about the new system. 

HRPP Preparing for the implementation - Important Dates 

As we prepare to transition studies to Cayuse, here are important deadlines: 

  1. The last day to submit a new application, project revision, or continuing review application is Monday, October 3. Since the last day the HRPP will be able to post approvals in iRIS is October 10, unless you MUST start a new study prior to October 10, we recommend all new study submissions wait to submit in Cayuse. Please reach out to the HRPP if you would like to consult with us about the best course of action for an upcoming submission. 

  1. The last day the HRPP will approve any applications for research is Monday, October 10. If your submission is not approved by this date, it will need to be submitted as a new application in Cayuse.

  2. The expected launch date of Cayuse is Friday, October 28.  

Transitioning legacy applications 

For the HRPP, the transition to Cayuse will also mark the closure of two IRB legacy submission systems; the email-based process (for studies approved prior to 2019, submitted via email) and iRIS. To facilitate a smoother transition, the HRPP evaluated both systems and their current studies to develop a targeted transition process.   

Whether your study will be migrated or not depends on two factors: 1) which system your study is in (email-based or iRIS) and 2) the review level your study received. Please read the following information and refer to the table below for additional clarification. Please note that this transition plan is designed to facilitate ongoing approval for your study - if you are required to submit your study as a new application in Cayuse, your legacy study will not be closed until the new application has been reviewed and approved in Cayuse.  

The HRPP team will communicate directly with PIs on the status of any studies being migrated to Cayuse.  After the data transition occurs to Cayuse, PIs will be able to view studies in a read-only format in iRIS.  Thereafter, any future modifications, renewals or closures will be submitted in Cayuse.

iRIS studies

Submission type

What will happen to your study

.118 determination

You can convert your .118 into a new study application up until October 3. If you don’t submit a new application by October 3, you will need to wait until Cayuse is live and submit a new application.

Expedited study*

Your study will be migrated to Cayuse for you after the go-live date. You will not be allowed to make any changes to your study until the migration is complete. We anticipate the migration process will take two weeks. The HRPP will notify you when your study has been migrated to Cayuse. Thereafter, any future modifications, renewals, or closures will be submitted in Cayuse.

Full Board study*

Your study will be migrated to Cayuse for you after the go-live date. You will not be allowed to make any changes to your study until the migration is complete. We anticipate the migration process will take two weeks. The HRPP will notify you when your study has been migrated to Cayuse. Thereafter, any future modifications, renewals, or closures will be submitted in Cayuse.

Flex or exempt*

Your study will not be migrated to Cayuse. However, you may continue conducting activities as they are currently described in your approved application. You may continue the project as described without interruption as long as you do not need to make changes to your study activities. This table clarifies which changes must be submitted for review for Flex and exempt studies. If you need to make changes to your study after Cayuse is live, you will need to submit a new study application for review and approval in Cayuse. While the new application is under review, you may continue to conduct activities as they are described in your approved iRIS documents, but you must wait to initiate the proposed changes until the new application has been approved in Cayuse. If you do not need to make changes to your study, you may continue research activities but you will need to note your original study expiration date and complete your activities by that date. The HRPP will not be sending expiration reminders for these studies once iRIS is archived and Cayuse is live If you need to continue activities beyond the expiration date, you will need to submit a new study application in Cayuse.

“Deferred”

If OSU IRB ceded review of your study to another institution’s IRB (labeled “Deferred”* in iRIS) your study will not be migrated to Cayuse. You may continue conducting activities as they are described in the reviewing IRB’s approved application. If the reviewing IRB reviews and approves a modification to the application, you will need to submit a new application in Cayuse. You will need to attach the currently approved IRB documents and the current IRB approval letter. If the application does not need to be modified, you may continue research activities, but you will need to note the original expiration date from OSU and complete your activities by that date. The HRPP will not be sending expiration reminders for these studies once iRIS is closed. If you wish to continue activities beyond the expiration date, you will need to submit a new study application for external collaborations in Cayuse.

*To find out the review level of your study, please expand the Frequently Asked Questions section below.

Email-based studies

Submission type

What will happen to your study

Expedited* or Full Board *

Your study will not be migrated into Cayuse and you will need to submit a new study application in Cayuse for review and approval once Cayuse is live. You may continue conducting activities as they are currently described in the approved application while your new application is under review. Once your study is approved in Cayuse, your legacy study will be closed and any modifications, renewals or closures will be submitted in Cayuse.

Flex* or exempt*

Your study will not be migrated, but you may continue conducting activities as they are currently described in the approved application. You may continue to conduct your research without interruption as long as you do not need to make changes to your study. This table clarifies which changes must be submitted for Flex and exempt studies. If you need to make changes to your study after Cayuse is live, you will need to submit a new study application in Cayuse. While the new application is under review, you may continue to conduct activities as they are described in your approved documents, but you must wait to initiate the proposed changes until the new study has been reviewed and approved in Cayuse. If you do not need to make changes to your study, you may continue research activities, but you will need to note your original study expiration date and complete your activities by that date. The HRPP is no longer sending expiration reminders for these studies. If you need to continue activities beyond the expiration date, you will need to submit a new study application in Cayuse.

“Oversight Deferred”

Your study will not be migrated to Cayuse. You may continue conducting activities as they are described in the reviewing IRB’s approved application. If the reviewing IRB reviews and approves a modification to the application, you will need to submit a new application to OSU in Cayuse. You will need to attach the currently approved IRB documents and the current IRB approval letter. If the application does not need to be modified, you may continue research activities, but you will need to note the original study expiration date from OSU and complete your activities by that date. The HRPP is no longer sending expiration reminders for these studies. If you wish to continue activities beyond the expiration date, you will need to submit a new study application for external collaborations in Cayuse.

*To find out the review level of your study, please expand the Frequently Asked Questions section below.

FAQs

*Q: How do I find out the review level of my study; Flex, exempt, expedited or full Board?
A1: If your study is in iRIS:
1. Log in to iRIS
2. Click on "View Current Approvals for one of my Studies"
3. Click on the study you wish to view and click on the approval document. The "Review level" box will contain the review level for your study. 
A2: If your study is email-based:
Locate the most recent approval letter you received from the IRB in your files. In the header information of the letter, you will see a line item marked “Review Level”. If you cannot locate the most recent approval letter you received from the IRB, please send an inquiry and include your IRB study number, e.g. #8765 and we will provide it for you.
 
Q: What other changes has the HRPP made recently to the application and review process?
A: The HRPP has made several changes to the submission and review process, primarily pertaining to exempt review. You can read more about those changes here in News and Updates. 
 
Q: Why is the IRB transitioning to Cayuse?
A: The IRB is transitioning to Cayuse to provide a better user experience. The new system will streamline the IRB submission process, provide a much simpler process for requesting exemptions, and provide increased transparency and improved access to review status information. You can read more about the benefits of Cayuse on the Research Office website: https://research.oregonstate.edu/osraa/research-administration-systems-improvement
 
Q: When will you stop accepting submissions in iRIS?
A: The last day to submit any materials in iRIS is Monday, October 3.  The last day the HRPP will post approvals for any submissions in iRIS is Monday, October 10.
    
Q: When will Cayuse go live?
A:  We anticipate Cayuse will go live October 28. If the launch is delayed, we will post an update on the IRB web site.
 
Q: I am still actively recruiting participants and/or collecting data from participants; how do I ensure I maintain approval throughout this transition to Cayuse?
A: Please refer to the table above to determine what actions, if any, you need to take to maintain approval for your ongoing study. Any action you need to take is based on which legacy system your study is in (iRIS or email-based) and the review level of your study (exempt, flex, expedited, or full).

Q: Why can't email-based studies be migrated into Cayuse?

A: The email-based studies were reviewed using an older version of the human subject regulations, which is now outdated. In 2018, federal regulators updated what’s known as the Common Rule- the regulatory basis for conducting IRB reviews. The “New” Common Rule was implemented at the same time the OSU HRPP adopted iRIS; therefore, all email-based studies were reviewed under the “Old Rule”, while iRIS applications were reviewed under the “New Rule”. This means that information in iRIS applications matches the new application in Cayuse much more closely, since they are both based on the New Rule. As a bonus, the new Common Rule expanded the categories of exempt research, so email-based studies that were not eligible for exemption under the “Old Rule” may now qualify for a category of exempt research that was not available under the Old Rule.
 
Have a question you’d like to see here? Please email us at irb@oregonstate.edu and tell us your question! We’ll add it to this FAQ section with a response.