Directories

Academics
Areas of Study

Resources for Researchers

Creating a New Study

line of buttons, including Create Study, which is highlighted As an IRB Researcher, you can create a new study within Cayuse IRB from your Dashboard or the Studies page. Cayuse IRB Dashboard menu, with cursor pointing to Studies tab

Creating a Study

Click picture of button bearing a plus sign and the words New Study in the upper right-hand corner of your Dashboard or the Studies page. Enter the title of your study. picture of text field where a user has typed 'The Effects of Blue Light on Sleep'

Click picture of checkmark button to save your study. Afterwards, you will be taken to the Study Details page.  Study Details page The person who creates the study is added by default as the primary contact. You can change this when editing the submission. You can rename your study up until the completion of a withdrawal or admin closure submission. From the Study Details screen, hover over the study title and click within the field to edit. animation showing how to edit the title of a study by clicking on it, then saving the change by clicking the checkmark Once you create your study, you can begin your initial submission. Click on New Submission in the upper right-hand corner to start completing your forms. Close-up of New Submission button

Creating an Initial Submission

line of buttons, including Initial Submission, which is highlighted Once you’ve created a new study, you can begin completing forms for your initial submission by clicking first on New Submission, and then Initial from the drop-down menu. Submission information will populate beneath the Submission Details tab. The person who creates the study is added by default as the primary contact, but this can be changed when editing the submission. Make sure to not remove yourself from all roles, or you will not be able to access your submission once you leave. Click on Edit button to begin your submission forms. You will always be able to return to an incomplete submission by clicking this button. On your initial submission form, you can return to the Submission Details page by clicking on Study in the upper left-hand corner of the screen. close-up of the Study button with a cursor hovering over it Use the  left-angle bracket and right-angle bracket buttons buttons to toggle between sections. You can also click on a section name in the menu at left to jump to that section. Close-up of Sections with a cursor hovering over an item called Research Team

Completing Submission Forms

There are several types of questions that you may need to answer on the submission forms:

  • Radio Buttons: Select one of the available options.sample of radio button question
  • Check Boxes: Select one or more of the available options.sample of checkbox question
  • Date Picker: Click within the field to browse for a date.sample of date picker question
  • Text Box: Provide a short answer to the stated question (200-character limit). If you need to enter multiple lines of text, the box will expand to fit.sample of text box question
  • Text Area: Provide a detailed answer to the stated question. You can use formatting such as bold, italics, underline, strikethrough, bulleted lists, numbered lists, and hyperlinks.sample of text area question You can also add PNG or JPG images using the image button showing the image button. Once your image is inserted, you can edit the image by clicking on the image and then clicking Edit. Close-up of the Edit button on an image
  • Person and Sponsor Finders: While every initial submission will require you to add a Primary Contact and Principal Investigator, you may have to add other people or sponsors to different sections within your submission. Click on the finder button to bring up a search dialogue.Close-up of the Principal Investigator box, with a cursor hovering over Find People Search for the individual or sponsor that you wish to add, select them, and click Save. Animation showing the user typing in a name, selecting a person, which creates a green highlight, and clicking Save
  • Attachments: Upload one or more files to the study by clicking Attach button.Cayuse IRB supports the following file types: picture of a table showing Files (Text, Adobe, Raster image formats, Vector image formats, Microsoft Word, Microsoft Excel, and Microsoft PowerPoint) and Extensions You can also include hyperlinks as “attachments” by choosing Add Link from the + drop-down menu. Close-up of the drop-down menu with a cursor hovering over the plus sign to reveal Add Link and Add File as options To delete an attachment, click the X button icon next to the attachment.

Saving Your Changes

Sections with unsaved changes have an asterisk next to the section name. Close-up of a section menu with a red asterisk signifying that Research Locations is not saved To save your changes, click Save button in the upper right-hand corner.

Help with Questions

If there is help text for a question, you can click on the Question Markbutton to view it. Example of question mark button revealing help text, with an arrow hovering over the question mark Once there are green check marks next to all of your sections, you have completed the submission forms and are ready for routing. With every section completed, you can complete your submission and send it to the PI for certification. Close-up of Routing section, with cursor hovering above 'Complete Submission' Please note: Cayuse IRB will warn you with a red lock icon if another user is currently editing a section. You won’t be able to edit that section until that person is done making edits. Close-up of Sections list, with red asterisk next to '1 General Information' and a red lock next to '6 Data Collection, St...'

Completing a Submission

line of buttons, including Complete Submission, which is highlighted The Complete Submission button will appear only when you have green check marks next to all of your sections. If one of your sections doesn’t have a check mark, click on the section to search for any required questions you may have missed. Animation showing missing checkmark next to Purpose and Rationale, where a required question was not answered Once you have filled out every section of your submission and have added all required attachments, a Complete Submission option appears beneath Routing within the menu. Close-up of Sections menu with cursor hovering over Complete Submission After clicking Complete Submission, you will be prompted to Confirm or Cancel. Dialog window asking, 'Are you sure you want to continue?' with Cancel and Confirm as options Upon confirmation, you will see the status of your submission change on the Submission Details page. Close-up of status change, with In-Draft checked and Awaiting Authorization highlighted

Certification

Your completed submission is sent to the PI for certification. The PI will be notified by email. When the PI certifies the submission, they are asserting the submission is complete and accurate and are accepting their PI responsibilities. If the PI decides that changes need to be made, they will send the submission back. All research team members will receive an email notifying them of the change in status so they can make the necessary edits and complete the submission once more. Once the PI has certified it, the submission will be reviewed by the organizational approver, if any, and then routed to the IRB Analyst. The submission may be returned at any point for edits or clarification. Completing Submission as a PI: If you are a PI completing your submission, you should be able to then certify it right away. Co-PIs: Your institution’s settings may require that any Co-PIs on the study also certify the submission. These individuals also have the ability to return to the submission to the research team. IRB Administrators can specify this behavior in the Application Settings. Recertification: If the submission does get returned to the research team, all previous certifications are cleared. All individuals who were required to certify the submission in previous rounds of routing must recertify every time the submission is returned before it can move forward.

Reopening Your Submission

To reopen the submission and make edits, click on the Edit button button within Submission Details.

Submission Routing

Flow chart showing possible paths between the submission beginning and the analyst preparing for review

Viewing and Downloading Letters

line of buttons, including Reopen Submission, which is highlighted During the submission process, the compliance office may send communication to the PI in the form letters notifying the PI of status changes, approvals, and needed information. Letters are sent via email and are available to download directly from Submission Details in Cayuse IRB. Close-up of Submissions window, with a cursor hovering over a hyperlinked line that says Initial The Letters tab appears for a submission when there is at least one letter associated with that submission. To view a letter, click on the letter tab. Details for a submission, with a box around the word 'Letters' You will be able to view the subject, send date, and recipient(s) for each letter. You can click anywhere on the line to open a PDF of the letter in a new window. Within the letters tab, the cursor hovers over a hyperlinked document To save the letter to a file:

  • Chrome: Right-click within the opened PDF and select Save As.Dialog window showing right-click options, with a box around 'Save as...'
  • Firefox: Right-click within the opened PDF and select Save Page As.Dialog window showing right-click options, with a box around 'Save Page as...'
  • Internet Explorer: In the menu bar, click on gear icon > File > Save As.Dialog window showing File options, with cursor hovering over 'Save as...'

Addressing Comments

line of buttons, including Reopen Submission, which is highlighted When a submission has been certified by a PI and sent to the IRB Analyst, the Analyst or other individuals reviewing the submission may comment on various questions within the submission forms. The Analyst will return the submission to the investigators, and the investigators will need to address any of the comments. Sections with unresolved comments have a comment bubble icon indicating the total number of unresolved comments in that section. Click on the section to see which questions have a comment attached. Sections menu with a cursor hovering over a comment bubble, with the number 3 in it, next to Research Team Depending on how far the submission progressed, you may see comments from the IRB Analyst, your Organizational Approver, or from the IRB member(s) reviewing the submission.

Addressing Comments

You must mark all comments as addressed before the submission can be completed. Once all comments on the submission have been addressed and it has been completed, the PI will need to re-certify the submission to return it to the IRB Analyst.

  • Click on the numbered comment bubble to view the unaddressed comments associated with each question.Box showing comment window, with cursor hovering over a comment bubble, with the number 1 in it, next to Expand Comments
  • Click Reply. Enter your reply and click Save.Animation showing expanded comment window, with user typing a reply to a comment bubble and then clicking Save
  • Once you have resolved an issue, change the status drop-down from Not Addressed to Addressed.Box showing comment window with reply and a status drop-down list; the cursor is hovering over 'Address'

Viewing Submission Details and History

line of buttons, including Complete Submission and Reopen Submission, which are highlighted You can access all details and history for a submission within the Submissions tab on the Study Details page, or from the menu on your Dashboard.

From Study Details

From the Study Details page, click on the Submissions tab. Close-up of Study Details window, with a cursor hovering over the Submissions tab  Click on the submission you wish to view. Close-up of Submissions tab, with the cursor hovering over a linked document titled 'Initial' At the bottom of the Submission Details screen, you’ll see tabs that vary depending on the submission stage. Tabs may include Approvals, Task History, Letters, Meetings, Decisions, and Linked Proposals. Click on the desired tab to locate the required information. Close-up of Submissions window, with the tab options highlighted by a box and Task History showing

Contact Us

Institutional Review Board

Hall Memorial Building S242B

Select what best describes your relationship to Gallaudet University so we can effectively route your email.
By submitting this form, I opt in to receive select information and deaf resources from Gallaudet University via email.
This field is for validation purposes and should be left unchanged.