As a researcher, you can create a new study from your Dashboard or the Studies page within Human Ethics. A Study is a container for all of your submissions, actions, and changes on a particular research activity. You must create a study before creating your initial submission. 

1. Click the New Study button in the upper right-hand corner of your Dashboard or the Studies pages. 
2. Enter the title of your study. The title can be up to 600 characters long. 
3. Click the blue checkmark to save your study. 

After creating your study, you will be taken to the Study Details page. Here, you will see where important study information will populate once you begin your submission.

The person who creates the study is added as the primary contact by default. 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.

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.

An initial submission is the first submission that you create when you enter a new study in the system. The initial submission describes the research you intend to do and the methodology you intend to use. The initial submission must be approved before any research can begin.

After you create a new study, you can begin completing forms for your initial submission by clicking on New Submission, and then clicking Initial from the drop-down menu.

Submission information will populate beneath the Submission Details tab. The person who creates the study is added as the Primary Contact by default, but this can be changed when editing the submission.  Make sure to not remove yourself from all roles and Save, or you will not be able to access your submission once you leave.

Click on the Edit button to begin your submission forms. You will always be able to return to your incomplete submission by clicking this button. Once on the initial submission form, you can return to the Submission Details page by clicking on Study in the upper left-hand corner of the screen.

Use the arrow buttons to toggle between sections. You can also click on a section name in the menu at left to jump to that section. 

Follow the directions within the initial submission form to complete your IRB application. Be prepared to upload required documents, such as proof of human ethics training, informed consents, data instruments, and others as needed. Required questions will be marked with a red asterisk next to it. 

Most importantly, remember to Save your changes by clicking the Save button in the upper right-hand corner. 

Once there are checkmarks next to all of your section names, you have completed the submission forms and are ready for routing. Please note that if one of your sections doesn’t have a check mark and you aren’t sure why, search the section for any required questions you may have missed. 

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. After clicking Complete Submission, you will be prompted to Confirm or Cancel. Upon confirmation, you will see the status of your submission change on the Submission Details page.

Your completed submission then is sent to the PI for certification. The PI will receive an email letting them know that the submission needs to be certified. 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 the submission, the submission will be routed to the IRB Manager/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 the submission right away.

Co-PIs: UM requires 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. 

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 within the Submission Details. 

Deleting a Study or Submission

Deleting a study or submission can be done from either the Study Details page, or the Submission Details page. 

You can only delete a study if it has no submissions attached. To delete a study, click Delete on the Study Details page. On the confirmation page, click Delete. 

You can only delete a submission prior to its submission to the IRB office. To delete a submission, click on Delete on the Submission Details page. On the confirmation page, click Delete. 

If a submission can’t be deleted, it can be withdrawn from IRB review instead. A withdrawal submission notifies the UM IRB office that you no longer wish to submit your initial submission and want to withdraw the study. Withdrawn studies are marked as finalized and can no longer be modified. You may create a withdrawal submission at any point once an initial submission has been created, until it has been approved. If the initial submission has been approved, you must create a closure submission in order to close the study if you no longer wish to conduct the research.

When a submission has been certified by a PI and sent to the IRB Manager, the Manager or other individuals reviewing the submission may comment on various questions within the submission forms. The Manager 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.

Accessing Comments

To locate the comments, you can look for the little bubbles next to each section of the application.

The little bubbles indicate which sections have comments, and the number in the bubble indicates how many comments are in that section. Once you have located the comments, you can click on Expand Comments to review the requested information.

Addressing Comments 

You can address the comments by making the requested changes to the application / study materials and selecting the address button on the comment.

While you can reply to the comments, the requested changes must be made to the application form as well. When the study materials need to be updated (such as the recruitment materials or consent form), the old versions should be removed from the application and the updated versions should be attached to the application. The updated versions should be the clean versions without tracked changes.

Please note: Each comment must be addressed in order to be able to complete the resubmission process.

Once all comments on the submission have been addressed and the submission has been completed, the PI will need to re-certify the submission to return it to the Analyst.

If you wish to change any of the details of the study after it has been approved, you must submit a modification which must be approved before you can proceed with the changes. A study Modification Submission is required when any change is made to the originally-approved study. 

This includes, but is not limited to: adding study personnel; changing the Principal Investigator; adding or removing already-approved study procedures, such as surveys, interview questions, or other data instruments; adding or making changes to any recruitment materials, such as flyers, email invites, or social media messages; making changes to compensation; adding, subtracting, or otherwise modifying an informed consent form; and any other major changes to a study. 

If you have an approved study, but need to create a Modification Submission, you can do so from the Study Details page.

Creating a Modification 

1. From your Researcher Dashboard, click on Studies. 
2. Search for the study for which you wish to create a modification, and click on the study number. Please note that the study must have been approved to create a modification. 
3. In the top right-hand corner of the Study Details page, click on the New Submission drop-down menu, and click Modification. Submission information will populate beneath the Submission Details tab. The person who creates the study is added as the Primary Contact by default, but this can be changed when editing the submission.
4. Click Edit to begin your submission. 

Filling out your Modification is a lot like filling out your Initial Submission with some key differences:

• Some sections may be modification specific, and are meant to show reviewers what changes have been made within the other sections.
• The other sections are from the approved Initial Submission, and where the modifications are made. Since a Modification is a request for changes, changes do not go into effect until a Modification has been approved.

When you’re finished, click Complete Submission. 

When a study is nearing its expiration date, you must submit a renewal request in order to continue with the research. The renewal will need to be approved before you can continue with the study. A study renewal may be required for certain studies and under certain circumstances. All Full-Board approved studies are required to be renewed not less than once a year and are issued an expiration date. Most Expedited and Exempt studies are not required to be renewed and are not issued an expiration date unless the IRB decides there is a reason to monitor a study. 

All Expedited and Full Board studies approved before January 1^st, 2019 will have been issued an expiration date and must be annually renewed or formally closed. All studies approved before January 1, 2024 that have been issued an expiration date will continue to use the previous paper/email submission system. 

Projects for which approval has expired are in non-compliance with federal regulation and UM IRB policy, and all work must cease.

Creating a Renewal 

1. From your Researcher Dashboard, click on Studies. 
2. Search for the study for which you wish to create a Renewal Submission, and click on the study number.
3. In the top right-hand corner of the Study Details page, click on the New Submission drop-down menu, and click Renewal. Submission information will populate beneath the Submission Details tab. The person who creates the study is added as the Primary Contact by default, but this can be changed when editing the submission. 
4. Click Edit to begin your submission. 
5. Fill out your submission form, and when you’re finished, click Complete Submission to begin the routing process 

A closure submission indicates that the research is complete and will not be continuing. Closed studies are marked as finalized and can no longer be modified.

If your study was issued an expiration date, then it must be formally closed when at least one of the following situations occurs: the research is completed; when analysis is limited to de-identified data only; or if the project has been abandoned or significantly postponed. If you need to close your study, you can do so by completing a Study Closure submission. 

Creating a Closure Report

1. On the Study Details page of your study, click on New Submission in the top right-hand corner. In the drop-down menu, click Closure. 
2. On the new Submission Details page, click Edit. 
3. Fill out the submission form, including all required fields, and click Complete Submission. 

As required by federal regulations and UM IRB policy, a project’s Principal Investigator or others involved in research projects will promptly (within 5 working days of the event) report to the IRB Chair or Manager any substantial changes in activities of the project that was approved by the IRB, any unanticipated problems, unexpected events, or any serious or continuing non-compliance with the study protocol. 

You must submit an incident report to inform the IRB office of any unanticipated problems, adverse incidents, or research non-compliance. Incident reports may be submitted at any time after a study has been approved, including after it has been closed. More than one incident report may be created for a given study, as needed. Please refer to our “Reporting Unanticipated Problems, Adverse Events, and Non-Compliance” page (LINK TO COME) for more information about these issues and what happens after an incident report is submitted.

Creating an Incident Report 

1. From your Researcher Dashboard, click on Studies. 
2. Search for the study for which you wish to create an incident report, and click on the study number. 
3. In the top right-hand corner of the Study Details page, click on the New Submission drop-down menu, and click Incident. Submission information will populate beneath the Submission Details tab. The person who creates the study is added as the Primary Contact by default, but this can be changed when editing the submission.
4. Click Edit to begin your submission. 

Investigators engaged in human subjects research must be overseen by an IRB. Typically, this is the IRB of his or her own institution.

However, when multiple IRBs are involved in a protocol, an IRB Authorization Agreement (IAA), or Reliance Agreement may be needed. A Reliance Agreement is a formal, written agreement that provides a mechanism by which one institution or individual engaged in research delegate IRB oversight to an independent IRB, or an IRB of another institution.

The University of Montana will not enter into a Reliance Agreement when UM or the Reviewing IRB has determined the protocol to be Exempt. All investigators must submit an IRB application to their own IRB in this case. 

The University of Montana and Montana State University have a standing IAA for all research with human subjects covered by the respective university’s Federal Wide Assurance. Notification via a copy of the approval memo to the PI from the IRB should be sent to the non-reviewing IRB. This relieves a PI from having a proposal reviewed by both the UM IRB and Montana State University IRB.

Federal regulations and the UM IRB consider researchers to be “engaged” in human subjects research when: the UM investigator receives funding from a federal department or agency for the research; the UM investigator is obtaining informed consent; the UM investigator is obtaining data about subject through intervention or interaction for research purposes; and/or the UM investigator is obtaining identifiable private information about subjects for research purposes.

An IAA may be needed in the following situations: 

• You are collaborating with anyone, including faculty, students, and staff, at another university or hospital with its own IRB; 
• You are conducting research on an Indian reservation or specifically with Native American participants; 
• The research is being conducted at multiple sites that are participating in a research study using the same research protocol (ex. clinical trials);
• Your project otherwise meets the Common Rule’s “Single IRB” requirements. 

Creating a Reliance Agreement Request

1. Follow instructions to create a New Study and an Initial Submission. Fill out the Project Personnel and Basic Information as normal.
2. On the Basic Information page, indicate that additional IRB oversight is going to be required. On the left-hand menu, click on the tab called “IRB Oversight and Collaboration Information.”  
3. Indicate how IRB oversight is going to be organized for your study. You will have several options: 
   • Study involving more than 1 site where each site will conduct their own IRB review
   • Study involving more than 1 site where the University of Montana is the Reviewing IRB (IRB of Record) for other sites\
   • Study involving more than 1 site where the University of Montana is Relying on an External IRB
   • Multi-site study (multiple US sites participating in a research study using the same protocol) where the University of Montana is the Reviewing IRB (IRB of Record) for all sites (ex. clinical trials)
   • Multi-site study (multiple US sites participating in a research study using the same protocol) where the University of Montana is Relying on an External IRB
4. If UM is the Reviewing IRB (IRB of Record), then you will fill out and submit the online IRB application as normal. You will be asked to indicate who your external collaborators are and they will be required to upload proof of human ethics training. 

If UM is the Relying IRB, you will be asked to provide the name and point of contact for the Reviewing IRB, the name of the Lead PI, and to upload all study documents, consent/assent forms, and any Reviewing IRB approval letters and/or determinations. 

1. Once all the information is complete and there are white checkmarks next to all of the section names in the left-hand menu, you can submit your request for a reliance agreement. The IRB office will be in touch via email with further instructions/information. 

If you are unclear whether your research meets the definition of human subjects research, you may want to complete a “Human Subjects Research Determination” application via Cayuse HE so that the IRB office can gather more information about your proposed project. You should complete this application if you are not sure if your project requires IRB oversight, or if you need a formal determination from the IRB on if the project requires IRB oversight. 

Creating a Not Human Subjects Research (NHSR) Application

1. Follow instructions to create a New Study and an Initial Submission. Fill out the Project Personnel and Basic Information as normal.
2. On the Basic Information page, indicate under Project Type that you are completing a Human Subjects Research Determination. On the left-hand menu, click on the tab called “NHSR or Not Engaged in Research.”
3. You will be asked a series of questions to determine if your project meets the definition of “human subjects research.” Give as much detail as possible. You will also be asked if your project involves HIPAA. 
4. Once all the information is complete and there are white checkmarks next to all of the section names in the left-hand menu, you can submit your request for a Human Subjects Research Determination. The IRB office will give you a formal determination either way. If your project is determined to be Human Subjects Research, you will be asked to complete an IRB application. 

A Section 118 Determination application should be submitted if your research project will involve or may involve human subjects in the future, but future protocol development must take place first AND you need documentation of IRB review in order to release your grant funds. This is not an IRB approval of a proposed project; rather, a Section 118 determination allows grant funds for future human subjects research to be released on the condition that a formal IRB protocol will be submitted before any work with human subjects begin. 

Creating a Section 118 Determination Application 

1. Follow instructions to create a New Study and an Initial Submission. Fill out the Project Personnel and Basic Information as normal.
2. On the Basic Information page, indicate under Project Type that you are completing a Section 118 Determination. On the left-hand menu, click on the tab called “118 Determination/Future Human Research.”
3. You will be asked to provide a project description, a description of what must be done before human subjects are involved in the research project, an estimated timeline for the involvement of human subjects, and any relevant supporting documents (such as the grant application). 
4. Once all the information is complete and there are white checkmarks next to all of the section names in the left-hand menu, you can submit your request for a Section 118 Determination. The IRB office will give you a formal determination.