Submission Process

Initial Submissions

An initial submission should be created when you are submitting a research protocol for review and approval for the first time. Montclair researchers may not begin any type of human-subjects research without first receiving initial submission approval from the IRB. 

In order to create and submit an initial submission in Cayuse IRB, please follow the instructions outlined in the Cayuse Initial Submission Training PowerPoint: Initial Instructions Here!

Making Requested Changes to you Initial Submission

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 and then resubmitting your submission. Directions for making the requested changes to your initial submission can be found on slide 25 of the Cayuse Initial Submission Training PowerPoint. 

Please respond to ALL comments left by the IRB reviewer/staff to either provide the clarification being asked for and/or acknowledge that the requested change was made where appropriate. 

You will only be able to resubmit your initial submission once all of the IRB reviewer/staff comments are addressed. If you are unable to resubmit your initial submission after making changes, please ensure that there are no comment bubbles within the section of your submission listed on the left hands side of the page.  

Modification Submissions

You will have to submit a modification submission in Cayuse when you are looking to make changes to your IRB protocol. Modification submissions can only be submitted when you have an already approved initial submission. If you are making ANY change to your submission, no matter how big or small, it must first be submitted for approval in Cayuse before the change can be employed in your research. 

Directions for submitting a modification submission in Cayuse can be found in the Cayuse Supplemental Submission Training PowerPoint: Supplemental Instructions Here!

Submitting a Modification vs. a New Initial Submission

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 regarding whether your study change requires an Initial or Modification submission, please email us at reviewboard@montclair.edu.

Administrative Check-In/Renewal Submissions

An administrative check-in/renewal submission is required when your study administrative check-in/expiration date is upcoming and you would like to keep your study open. Whether you submit an administrative check-in or renewal submission depends on the review category of your study. 

Directions for how to submit an administrative check-in/renewal submission, and in which case either is appropriate, can be found in the Cayuse Supplemental Submission Training PowerPoint, beginning on slide 10.

Closure Submissions 

Researchers should submit a study closure when their research is no longer active and they are no longer in data collection, analysis, or write up stages. If you submit a study closure, it means that you are no longer working with the study data, and all dissemination efforts are final. 

Directions for how to submit a closure submission can be found in the Cayuse Supplemental Submission Training PowerPoint, beginning on slide 19.