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Institutional Review Board
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Cayuse IRB Submission Process

New Study Submission

New Study Submission

NEW! View our.

To create a new study, click theNew Studybutton in the upper right of either the Studies page or your Dashboard.

After creating the new study, you will be taken to the Study Details page for that study, which displays important information regarding the study.

To begin working on your study, clickNew Submissionto add the initial submission for your study.

The initial submission appears below the study details. The person who creates the study is added as the PC by default. You can change this when editing the submission, if needed. Click theEditbutton to begin working on the initial submission.

Making IRB Requested Changes
  • You will likely have to make revisions to your initial submission based on comments from the IRB reviewer and/or the IRB staff
  • This may involve responding to comments within the submission sections
  • Sections with unresolvedcommentshave a comment bubble icon to their right indicating the total number of unresolvedcommentsin that section
    • Questions with newcommentsshow a gray comment bubble and the number ofcommentsfor that particular item underneath the question
  • Select the sections that are highlighted with comment boxes and search for “Expand comments”
  • Click on the “Expand Comments”to view thecommentsassociated with each question
  • Click “Reply”to open a text box to write your comment
  • Type in your comment
  • Click “Save”to saveyour comment
  • Once you have resolved an issue, change the status drop-down from “Not Addressed” to“Addressed”. Addressedcommentshave a green sidebar and the comment count no longer appears on the comment bubble icon for that question (unless there are other unaddressedcommentsfor that question). You must mark allcommentsas addressed before the submission can be re-certified.
  • Your submission is ready to re-certify once all check marks appear as green next to each section
  • The PI will need to re-certify the submission to return it to the IRB Office
Submitting Modifications

Step 1: Go to your study details page. Click the blue “+ New Submission” button and select “Modification”

Go to your study details page. Click the blue "+ New Submission" button and select "Modification."

Step 2: Select Edit on the Submission details page to begin the submission

Step 3: Answer the Modification type question and make your requested changes directly in the corresponding section of the submission

Answer the Modification type question and make your requested changes directly in the corresponding section of the submission.

Step 4: Complete and certify your submission

Complete and certify your submission.
Complete and certify your submission.

dzٱ:Remember you can compare your current submission to the immediately preceding version by selecting “Compare” at the top of the page

Submitting Modifications vs. New Initial Protocol

When proposing changes to an existing approved protocol, it is important to consider whether the changes may warrant submission of a new protocol rather than a modification. Please consider the following:

  • Did the study aims, research questions, or hypotheses change?
  • Are there more than just 1 or 2 changes to the procedures or method?
  • When was your initial approval? Was your study designed as a longitudinal study?
  • Did your compensation change (i.e., you gave out the first 100 gift cards and now you are using a different type of compensation strategy)?

If one or more of these apply to your modification, it is likely you should submit a new application for a new proposed study. If you are still unsure, please review the checklist below regarding when to submit a modification versus a new application.

Modification submissions are not necessarily easier or faster for you as the PI than submitting a new application.

Montclair’s IRB must examine any modification using the same standards for review and approval as any other submission. A modification that does not adequately explain changes, includes inconsistencies, or does not provide the appropriately revised materials will slow the review process and result in follow-up communications with the IRB.

Please note, if you do need to submit a new application, you will also need to submit a closure for the original study.

Submitting Modifications vs. New Initial Protocol Checklist
Do the proposed changes alter the research hypothesis? Is there a change in the study purpose and/or aims?
  • If the focus or research question has changed, even if it builds on the knowledge learned in an existing study, this would be considered a substantial change and a new protocol would be warranted.
  • If the original study was a pilot study and now you are ready to implement a full scale study, this would be considered a substantial change and would warrant a new protocol.
Did the procedures/methods change substantially?
  • If the only changes involve substituting one questionnaire for another similar questionnaire or adding different stimuli of the same type, this would not be considered a substantial change.
  • If the study now has multiple new arms, you are changing from a quantitative method to a qualitative method, you have added a new participant group that has significantly different recruitment strategies, this would be considered a substantial change in method and would warrant a new protocol.
Was the initial study submitted more than 3 years ago?
  • If the study was intended to be a longitudinal study, this question may not be valid for use in determining if a new application is needed.
Will the study utilize a new compensation structure?
  • For example, if your initial study had the “first 100 people get a gift card” or “will be entered into a raffle,” these studies are somewhat time sensitive, as the awarding of these amounts should take place within a semester or one academic year.
Is this a new grant?
  • Have you received a new grant number even if it is a continuation of a previously approved protocol with the same funder?

Adapted from University of Oregon IRB

If you answered yes to one or more of the questions above, then you will need to submit a new application for your study. Please note you will also need to submit a closure to the previous study as well.

If you have any questions or concerns please email us at reviewboard@montclair.edu.

Changing Study Title
  1. Go to your Study Details page
  2. Hover over your study title
    Hover over study title
  3. Click and type in new study title
  4. Click the blue check
    Click blue check