FAQ - Cayuse

For general IRB FAQ, click here.

 

Why am I required to use Cayuse IRB?
Cayuse IRB is now the mandatory form of submission for all new studies. You can also use Cayuse IRB to report incidences,submit
modifications, renewals, and close studies that were previously submitted to irb@memphis.edu.  Determination Forms can now be completed through Cayuse IRB in the initial submission as well.

How do I log in?
To access CayuseIRB go to memphis.cayuse424.com, enter your UofM credentials, and select Cayuse IRB (Human Studies Compliance).

What is my username and password?
Cayuse IRB is accessible through single-sign-on with your UofM UUID and password.

Who is able to access and edit my study and submissions?
Detailed roles in Cayuse IRB:

  • Principal Investigator (PI)
    Can submit
    Can view study/submission details
    Can edit when it is reopened, renew, make modifications, report incident, & close
    Can add Co-PIs, Primary Contact, Faculty Advisor (Students), & Co-Investigators
    MUST certify

  • Co-Principal Investigator (Co-PI) & Faculty Advisors (FA)
    Can submit (on behalf of the PI)
    Can view study/submission details (on behalf of the PI)
    Can edit when it is reopened, renew, make modifications, report incident, & close on behalf of the PI (PI still must certify as well)
    Can add PI, Co-PIs, Primary Contact, Faculty Advisor (Students), & Co-Investigators
    Faculty Advisors must certify student-led studies & submissions

    MUST certify

  • Primary Contact
    Can submit on behalf of the Principal Investigator (PI)
    Can view study/submission details
    Can edit when it is reopened, renew, make modifications, report incident, & close on behalf of the PI (PI & Co-PI must certify)
    Can add the PI, Co-PIs, Primary Contact, Faculty Advisor (Students), & Co-Investigators
    Does not certify
  • UofM Co-Investigator
    Can submit on behalf of the Principal Investigator (PI)
    Can view study/submission details
    Can edit when it is reopened, renew, make modifications, report incident, & close on behalf of the PI (PI & Co-PI must certify)
    Does not certify

  • Non UofM Co-Investigator
    No view
    No edit
    PI and/or Research Team can export protocol to PDF document

Whom do I contact for help?
Please feel free to email CayuseSupport@memphis.edu if you have any questions.

I can't log into Cayuse IRB. What's wrong?
Your user information may not be in the Cayuse system.  Send an email to cayusesupport@memphis.edu with your full name and issued UofM email address.  The process may take up to 48 hours depending on work days and weekends. Please follow-up on your request if you do not have access after 48 hours.

I submitted a renewal/continuing review to irb@memphis.edu, why is Cayuse IRB sending messages saying my study is about to expire?
This means that your Legacy study has not been updated in Cayuse IRB yet though the IRB has received and updated your study in our old database.  All Legacy studies will be completely updated on September 1, 2016.  Feel free to contact us if you have ANY questions or concerns regarding your Legacy study/submission.

If you would like to add a new Primary Contact to your Legacy Study, contact the IRB at irb@memphis.edu or (901) 678-2705.

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What is a Legacy Study?
When a study is first imported from a previous IRB system into Cayuse IRB, the study does not have any submissions associated with it. If an investigator wishes to continue working with the study, they (or an IRB Analyst) must first create a Legacy submission for the study. The Legacy submission is used in place of the Initial submission. Once the legacy submission is finalized, you can create additional submissions such as modifications, renewals, etc. and work with the study as you would any other study in Cayuse IRB.

Why is CayuseIRB sending me incorrect notifications?
You may be receiving error notifications because your study has been updated ONLY in our old database and not in Cayuse, yet.  All Legacy studies will be completely updated on September 1, 2016.  Feel free to contact us if you have ANY questions or concerns regarding your Legacy study/submission.

How do I renew, modify, report an incident, and/or close my study if it was approved before CayuseIRB?

The first step: you must complete your Legacy Submission by uploading & submitting all of you last approved documents (See the video: Screenshot Manual).

The second step in the process: you will be able to MODIFY, RENEW, report an INCIDENT, or CLOSE your study(ies) by going back to that same study, click "New Submission", and then select your submission of choice.  Click "edit" and begin following the directions within the submission.  When complete, and ALL checkmarks are by each section, click "Complete Submission".  Lastly, review and "Certify" your submission.

How do I submit an initial submission?
Please see the Quick Start Guide or Detailed Manual for instructions on how to begin an initial submission.

How do I send the submission back to the student?
There is a "RETURN TO INVESTIGATORS" button you can hit to send application back to the student, and reopen it. This can be found on the submission details page.  You or the student could then make changes.  (Unfortunately Advisors can't make comments in the application.)

How do I submit an amendment (modification)?
After your initial submission has been approved, you will be able to select "Modification" under the "New Submission" button on your study page. See further instructions.

Where are my stamped approval documents?
Approval documents through Cayuse are not stamped.  IRB@memphis.edu will no longer email approval documents for submissions submitted through Cayuse IRB. You receive the email from irb@memphis.edu and will be able to access your approved documents by viewing your submission in Cayuse IRB. Your approval letter will be sent to you via email.

I need to submit a Renewal or an Incident application soon.  Can I do it in Cayuse IRB? 
Studies approved in Cayuse IRB will be reminded to submit renewals in Cayuse IRB prior to expiration.  A submission requesting a modification of your study can be accepted in Cayuse if your study was already submitted in the system.

What is the protocol for student-led studies?
Students who are leading a research study should be identified as the Principal Investigator and Primary Contact on the IRB submissions.  After a student selects their "Student" classification, they will be prompted to enter their Faculty Advisor's information.

Why am I having trouble accessing Cayuse IRB during weekends?
Evisions schedules maintenance for the Cayuse system on Saturdays or Sundays. If you find you cannot access the system on a weekend, try later in the day or the next day.

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Will I be notified via email regarding my study updates?
Notifications are sent:

  • To the PI when the submission has been sent to them for certification.
  • To the PI and PC, when their submission has been received by the IRB.
  • To the Organizational Approver(s) when a submission requires approval.
  • To the IRB Analyst when a new submission requires Analyst assignment.
  • To the previous IRB Analyst, when a submission is reassigned to another Analyst
  • To the IRB Analyst when an expedited review is complete.
  • To the board members or reviewers when a submission requires their review.
  • To the PI and PC when a study is expiring or has expired.
  • To the primary and/or secondary reviewer(s), when an Analyst has added a comment to the submission.

Many of these notifications are also sent via email to ensure the recipient sees the message in a timely manner. In particular, the PI and other contacts listed on the submission receive emailed notifications whenever the submission moves to a new step in the workflow (when it is reviewed and approved, returned to the PI, etc.).

Clicking on a notification takes you to the submission that notification pertains to. Viewed notifications are no longer highlighted in the Notifications list. You can delete notifications from the list by clicking the X icon next to that notification, or use the ... menu to mark all notifications read or to delete all notifications.

How can I delete a study in Cayuse IRB?
You may only withdraw, close, and archive a study.  There are only certain circumstances under which you can delete a study in Cayuse IRB. Please see our guide on how to delete a study in Cayuse IRB.

Why do I keep getting expiration reminders after completing a Renewal submission?
The Cayuse system is set to send notices of IRB approval expiration starting 90 days in advance of expiration, and once every two weeks thereafter.  Those reminders continue going out even after a renewal submission has been created. Their behavior is tied directly to the expiration date of the study and so those notifications will continue to go out until the review on the renewal is complete.

How do I know what review category my research study follows?
Studies are categorized as either Exempt, Expedited or Full Board in your Study's Submission Details.

Is the terminology used in the old paper system the same in Cayuse IRB?
No. Evisions is a software company that develops over-the-counter software for a variety of different genres across the nation. The terminology they use is common to the IRB industry in other parts of the country. In order to facilitate understanding and continuity, we will be using the terminology they use for Cayuse IRB.

Cayuse IRB Glossary of Terms

New (CayuseIRB) Terminology

Old Terminology

Initial Submission

Initial Review Request

Study

Protocol

Modification

Amendments

Renewal

Continuation/Continuing Review

Incident

Adverse Event

Closure

Completion

 

My project involves children (minors under age 18). What do I need to know?
Children are a protected population in human subjects research. The federal regulations (45 CFR 46.401...Subpart D) provide guidance. Most human subjects research protocols involving children will be submitted for Expedited review. An assent form will be required along with the parental consent form. Research involving schools may require school administrative approval.  Also check FERPA rules. Remember that human subjects research protocols that involve children require two reviews and will possibly require a longer review time frame.

What is the protocol review time?
The IRB Analyst will pre-screen your protocol within 20 business days of receipt. Your initial submission may be sent back to In-Draft status asking for revisions or it may be assigned directly to the IRB reviewer. Notifications and emails are sent to PIs, Primary Contacts, and other co-investigators at each review stage. Review times will vary over the course of the year depending on reviewer availability. Full Board protocols have a different time line.  Refer to IRB Board Meeting Calendar.

My research will be conducted outside the continental United States. Are there any special considerations?
Yes. Researchers should access the Office of Human Research Protection (OHRP) website for information on the country where the research will be conducted. Certain locations may have special requirements for conducting research. This information should be included in the Cayuse IRB submission. The UofM Export Control website should also be reviewed.

Parts of Cayuse IRB do not appear to be working correctly. What am I doing wrong?

The problem may lie in your web browser. Evisions recommends using Mozilla Firefox as the web browser for Cayuse IRB.  Other supported browsers include Internet Explorer 9 or higher, Google Chrome, or Apple Safari. (Note: Safari is only provisionally supported at this time.)

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What about Mac users? Can we get into Cayuse IRB using Safari?
Yes, but Evisions recommends downloading and using Mozilla Firefox as the browser.

Can we still use the templates from the website for consent forms, assent forms, etc.?
Yes. You can still save them as a file, make the appropriate changes specific to your study and copy & paste the contents to the text fields or attach them as a MS Word or Adobe .pdf document file in the appropriate field.

Can multiple research team members be added? If so, what is the process?
Yes. Multiple co-investigators can be added using the Find People button (if they are in the system). Click on Find People. When the window comes up, type the last name of the person in the search field. The names will populate below. Click the name and that name will post to the Selected Records field at the bottom of the window. Go back to the top and type in the name of the next research team member and repeat the process. When you click on the name in the menu, it moves to the bottom. When all names have been added, click on the Save button at the bottom of the window and the names will post back to the Research Team screen.

How does Cayuse IRB work when I, as the PI, collaborate with a researcher from another institute – do they have access and do I type in their name as a member of the research team?
Only UofM faculty, staff, and students will have access to Cayuse IRB.  Enter the names and organizations of your external co-investigating team in the Co-Investigators text box.

In Cayuse IRB can we copy & paste?
Yes. There will be free text fields available for you to cut and paste wording.

Is the Cayuse IRB form editable?
Yes, but only under certain conditions if the study is the In-Draft stage. Any time the submission has been forwarded to the PI for certification, to the IRB Analyst for pre-screening or assigned to the IRB reviewer, nothing can be edited. Only after the submission has been returned to the PI for changes can anything be edited.

How do I submit changes to my approved Submission (protocol)?
Changes to an approved protocol are considered modifications (amendments) and must undergo review by the IRB. Modifications to an already approved study may be made through Cayuse IRB, including Legacy protocols. (Legacy protocols are your current active IRB protocols from the old system).

  • Locate the IRB study through the Dashboard under your Approved Studies.
  • Once located, click on the IRB number.
  • In Study Details screen, click on New Submission and then Modification.
  • Provide a summary of your proposed changes or additions.
  • Make the changes to the appropriate section(s) and field(s). For example, if you wish to increase your population number, then you will go to the Human Subjects section and make the change.
  • Attach any revised documents that are relevant to your requested changes. Such as, revised surveys, additional recruitment messages, explanations of a different subject population.
  • Save the screen and click on Complete Submission at the bottom of the menu.
  • Then click Confirm.

Modifications to approved protocols must be minor with limited changes. If numerous changes are requested or the changes requested are complicated, the IRB may request the researcher submit a new protocol for review.

What happens when no action is taken by the PI?
Normally if a submission has been sent to the PI for certification, no further editing can occur. In addition, it cannot go forward to the IRB Analyst for pre-screening and/or IRB assignment until it has been certified.

How does a person "unlock" a submission – referring to the editing process by co-investigators who cannot certify?
Once a submission has been forwarded to the next level, it cannot be "unlocked" or edited. For any changes to take place, the study must be showing up at the In-Draft level. Researchers may notify the IRB Analyst by email asking that the submission be returned back.

How do I find out the status of the protocol review?
In Cayuse IRB, the status of your study can be found under the Submissions icon on the left side menu. You can also click on the specific submission for more details.

  • In-Draft: The submission has not been completed and/or submitted for PI approval.
  • Awaiting Approval: The submission is awaiting PI review and certification.
  • Pre-Review: The submission is with the IRB Analyst office for pre-screening.
  • Under Review: The submission has been sent to the IRB Reviewer.


How do I delete a submission (modification, renewal, closure) on an approved study?
There is a point at which researchers can delete an initial submission, a modification, a renewal request and a closure request.  The system allows the user to delete any submissions if they have not been sent forward to the next level in the review process. Once an action has been performed at another review level, the submission cannot be deleted.

How long will the research study be accessible in Cayuse IRB after it has been closed?
Once a study has been closed, it will be accessible to the PI and members of the research team for a period of three (3) years at which time it may be purged from the system per 45 CFR 46.115(b).

What are Incident Reports?
Incident reports relate to issues of non-compliance, adverse events and unanticipated problems within a study. 45 CFR 46 and institutional policy require researchers to report events associated with the research study that could possibly lead or has led to the harm of human subjects. The incident reports in Cayuse IRB allow researchers to self-report such events through the software application. Persons wishing to remain anonymous can still report any complaints or problems to the IRB Analyst.

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