How to submit a new IRB study in Cayuse

You can also see the attached PDF tutorial for images and comments for submitting your IRB study case:  Tutorial - Submitting a new study (PDF)


To submit a new IRB study using Cayuse, login to Cayuse at https://united.cayuse424.com

Once logged in, click on Cayuse IRB.  This will take you to your dashboard where you will be able to submit your study.

Cayuse IRB link

Cayuse IRB link

 

From your dashboard, click on New Study in the upper right hand area.

Cayuse IRB dashboard

 

Cayuse Dashboard - New Study

Click on the check box to create your study.

On the Study Details screen, click on the New Submission button.

You created a Study but not a Submission.  Sometimes your project changes, or you have to make changes later.  You will do that by creating a Submission.  For now, you need to create your Initial Submission.  Click New Submission.  On the drop-down box that displays, select Initial.

Now that you have created an Initial Submission, you can proceed to complete it by clicking Edit.


1 - Getting Started

Once you have read through the Getting Started information, click on the Yes button.  Use the > to go to the next page.


2 - Submission Information

Are other institutions involved in this study?  Sometimes other institutions are involved in what you’re doing and United will have to coordinate with them.  Are other institutions reviewing your research? If so (e.g. if you are doing a project in a hospital or prison), you should pick Yes.

Most people will just pick No and the arrow at the bottom of the screen to move on.


3 - Project Information

  1. Click on Doctoral Student and the Study Personnel questions will appear.  All the fields with a red star next to them need to be filled out for your study to be completed.
  2. Click on Find People for the Principal Investigator.  Type in the first and last name to search for Principal Investigator.  Click Save when finished.  Complete Primary Contact, Faculty Mentor, and Faculty Consultant.  Select all before saving.
  3. Select the location of the study.  Scroll down and enter the information about the location(s) where your project will take place.
  4. Enter the current date as the start of the project, and the end of the semester in which you intend to have your defense as the end date.

When complete, click on > to go to the next page.


4 - Project Design

Give a description of your project, beginning with the theme.

Enter your hypothesis.  Make sure your hypothesis is verifiable or falsifiable.

Enter your Expected Impact.  Why will people want to work with you on your project?

Research Methods.  Note: this should be a brief description. We will ask for more details about your surveys and interviews later on.

Participant Selection.  Here we need to know about how and why you selected the particular participants you selected. Who did you include and why?

Exclusion Criteria.  Here we need to know about who would not qualify for participation in your study. Who did you exclude and why?

Click on > to go to the next page.


5- Human Subject Recruitment

This page will ask for more information about your participants.

Ages.  If you check the box Less than 18 years old, more questions will open. The blue letters link to relative pages from the US Health and Human Services website.

Risk to Children.  Here we need to know more about how you are protecting children involved in your study.  Minimal risk is a VERY low bar when working with minors.

Vulnerable Reputations.  Check all that apply.  If you are not working with any vulnerable populations, your consent form will need to certify they are not pregnant, under 18, living in prison, or are cognitively impaired.  If you think you might have another vulnerable population, select “Other” and describe.


6 - Project Process

So far you’ve given a high level description of what you want to do, why you want to do it, and who is going to work with you.

Process Description.  Now you need to get into the nitty gritty. Notice the controls can allow you to create multiple levels of tasks.

Process Details

Describe the duration of the project participation.   Here you should give an overarching timeline for all the ways your participants will be engaged in the project, from recruitment to follow-up.

Describe the length and number of project sessions.  Here you will give more specifics about the sessions you will hold with your participants.

Describe the location(s) for project implementation.  Now that you’ve told us what you will do and when you will do it, we need to know more about where you will implement your project.

Describe your recruitment procedures and any material inducements given for participation.  Describe how you will recruit your participants. We want to make sure that no one is 
coerced to participate and can opt out at any time.

Add any recruitment documents.  Click the Attach button and then, by pressing the + sign, you can link any materials you will use for recruitment. Be sure to click Apply once you’ve uploaded your files.

Describe the information to be gathered and the means for collecting and recording data.  This is where you explain the types of data you are going to collect.  Below there will be questions about these types.  Will you use surveys, interviews, questionnaires, or other instruments? Will you gather 
records? What data will you gather, and how will you gather it?

Survey, questionnaire, or Interview.  You will need to attach copies of surveys, questionnaires, and
interview questions here. Follow the same process you followed for uploading your recruitment materials.

Will the survey, questionnaire, or interview record any information that can identify the participants?  Is there any possible way your data could identify the participants in your study?

Justify why the survey, questionnaire, or interview needs to record identifiable information.  If the answer to the previous question is yes, you need to (1) justify why you need to gather personally
identifiable data, and (2) tell us how you will keep the data secure.

Other project instruments.  This question covers any data gathering instruments that you did not personally create for your project.  When done, click the right arrow.


7 - Participant Protection

Here we want to ensure that you are not subjecting your participants to any unnecessary risks, and if
there are any risks involved, they are necessary and minimized.

Potential Risks.  If you select Yes for the prior question (Do you anticipate study participants will be subject to any risks), you will be asked to explain and justify the risks here.

Describe any potential legal, financial, social, or personal impacts on subjects of accidental data disclosure.  What happens if your study instruments get compromised?  Be sure to think carefully about any risks that might arise if you accidentally disclose your data.

Expected Benefits.  You should expect benefits for your subjects and/or society as a result of your study.

Will deception be used as a method of data gathering?  Ask Do your data-gathering methods (surveys, interviews, etc.) intentionally deceive participants?

Deception Justification.  Deceiving people is only ethical if it results in a greater good.  If yes, you need to explain why you are intentionally deceiving your participants for the sake of your study.

Safeguarding the Identity of the Participants.  In these two questions we want to know more about how you will gather your data, use it, and safeguard it.

Voluntary Participation.

How will you ensure your participants have enough time and information to make a non-coerced decision to participate?  The assumption is that volunteers are more likely to provide reliable data than conscripts.  Now we are asking more detailed questions about how you will ensure people are not coerced to participate in your study.

Informed Consent

Describe the procedures for obtaining informed consent.  Tell us about when, where, and how you will distribute and gather informed consent forms, then use the Attach button below to upload or link your informed consent forms.

When done, click the right arrow at the bottom  of the page.


8 - Conflict of Interest

Do you or any investigator(s) participating in this study have a financial interest related to this research project?

If someone at United is making money from your project then they  have to be documented in this system.  Most times the answer to this question is NO.

Provide the name(s) of the person(s) with financial interests to disclose.

If necessary, use the Find People button, then click the right arrow.


9 - Attachments

If another IRB board is looking at your project then we need to make sure the things you told them are the same things you told us. If not, you don’t need to upload anything.

Note:  At this point, all sections on the left side of the page should be checked.  If not, go back to the incomplete section and complete it.


Submit / Confirm

When everything is complete, click on Complete Submission.  Be sure to Confirm your submission.

When finished, click on the Certify button.  Read through the certification page and Confirm.

You can use the Menu in the upper left hand area to return to the dashboard.  Your study will be waiting authorization.  You will receive e-mail notifications at each phase from this point forward as your submission is processed.

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