Frequently Asked Questions

When applications are submitted to our office, they first undergo training verification, where CITI training for all collaborators is checked for completion. Any outstanding courses that need to be taken will be sent to the research team via email. These will need to be done prior to final approval of the study, but will not delay the review process.

The application will then be sent to our IRB office for pre-review to determine that the application is complete and all supporting documents are included. If items are missing, the application will be sent back to the research team with a list of requests. When the application is ready to move forward, the IRB office will then determine the level of review as one of the following:

• Non-Research/Not Human Subjects Research protocols (including class projects and oral history projects) will be sent directly to the chair for final approval.
• Exempt protocols will be sent directly for the chair for final approval. A list of exemption categories can be found here.
• Expedited protocols will be sent to a member of the IRB committee for an additional review prior to approval. If the reviewer has additional edits for the research team to make an email will be sent to the research team through IRBManager. Once the stipulations have been addressed the application will go to the chair for final approval. A list of expedited categories can be found here.
• Some protocols may need to go to the full board for review. The IRB meets infrequently, so if it is determined that a protocol needs to be reviewed by the board the IRB office will work with both the research team and the committee to set up a meeting time.

If there are any questions about the IRB process, please contact the IRB office at (785) 532-3224 or contact the IRB administrator at makenna@ksu.edu.

To check the current status of an application, you will need to log into IRBManager and locate the form on your dashboard - it should be listed under the "xForms" tab. On this screen, each box represents an application in progress. The current stage of the form will be listed directly under the principal investigator's name.

• If the status is "Data Entry," it means the form has not yet been submitted. You can reopen the form to edit by clicking the "IRB Application for Approval" hyperlink in the box. Once the application is complete and ready for submission, be sure to navigate to the last page and click both next and submit to send the form forward.
• If the status is "PI Signature for Non-PI Submission," it indicates that the form was submitted by someone other than the principal investigator (PI), and the application is now with the PI to review, sign, and submit to the IRB office for review.
• Any other status will indicate that the form is with the IRB office and is undergoing review.

If you have any questions about the current status of your form or estimated timeline for approval, please don't hesitate to reach out to our office.

If your protocol went through expedited review and was approved after 2019, it was likely approved for a three year period. At the end of those three years, if you would like to keep the protocol active and continue to collect data, you will need to submit a new protocol to take the place of the expiring one. More information on how to start a new application can be found on the IRBManager page, or in the FAQs listed below. You will also receive an email from IRBManager with a triannual review form, which you can use to indicate if you plan to submit a new IRB application or if the study can be inactivated.

Protocols that went through the expedited review process prior to 2019 are approved on a year-by-year basis. You should receive an email from IRBManager with a link to a continuing review form. On that form, you can indicate if the project is completed or if it needs to remain active for another year.

If you have any questions about the status of your protocol or what you need to do to keep it active, please contact the IRB administrator at makenna@ksu.edu.

There are two main CITI courses that all researchers will an IRB protocol will need to complete:

• IRB Researchers and personnel on IRB protocols
• Responsible Conduct of Research

There is one additional course that will need to be completed by all full-time K-State employees, principal investigators, and anyone involved with an international research activity:

• Export Compliance

CITI also offers study-specific training that may only apply to certain protocols depending on the nature of their study. These are listed near the end of the application form, and can also be found within CITI.

More information on CITI training and how to create an account or add courses can be found on this page.

To start a new application, log into IRBManager and select "IRB" from the switchboard; this will take you to your dashboard. On your dashboard, you will see a button that reads "Click here to start IRB Application for Approval"; clicking this will start a new application form.

Note: You may need select either the "Protocols" or the "xForms" tab in order to see this option.

If you would like a visual of this process, please view the below video:

In progress applications will be kept on your dashboard.

To locate, log into IRBManager and select "IRB" from the initial switchboard. This will take you to your dashboard. On your dashboard, click on the xForms tab; this will display all forms that are currently in progress, with each box or square representing a separate form.

Each form will indicate both what stage the form is currently in, the date it was started, and if it has been assigned a protocol number (forms that have not yet been submitted will not yet have a number).

Forms that have not yet been submitted will be listed as in "Data Entry." From there, you should be able to narrow down which form you are looking for based on when you started the new application. Clicking on the hyperlink "IRB Application for Approval" a the top of the box will reopen the form so you can continue work.

To submit a modification in IRBManager, you will need to do the following:

1. Log into IRBManager and select "IRB" on the initial switchboard to be taken to your dashboard.
2. Find and click on the "Protocols" tab, then click on the number of the study you want to modify. This will take you to the study's information page.
3. Near the middle/bottom of the information page will be a header that reads "Reference xForms (1)". Below that header will be a small icon that looks like two pieces of paper with a green plus sign. Click that icon to open the form to modify.
4. Make the desired updates to the form.
5. On the last page, click "next" and then "submit" to send to our office for review and approval. If you are not the principal investigator of the study, it will first go to them to sign off on the modification before being sent to our office.

If you would like a visual of this process, please view the below video:

Note: If your study was approved prior to the implementation of IRBManager, on the original PDF application form, you will need to submit your modification manually by updating the PDF and emailing a copy into comply@ksu.edu. If you have any questions or need an editable version of your application, please contact our office.

To update the list of collaborators, you will need to submit a modification as detailed in the FAQ above this one. When a modification has been started, there will be a question on the first page that asks if you are changing/amending personnel identified on the protocol (question 10.80). Answering "yes" to this question will walk you through the process to add or remove members of your research team.

Note: This process only applies to individuals affiliated with K-State. To add or remove non-KSU collaborators, you will need to navigate to page 14 of the application and answer the question/update the table on that page.

To change your principal investigator, you will need to submit a modification as detailed in the FAQ above. When a modification has been started, there will be a question on the first page that asks if you are changing/amending personnel identified on the protocol (question 10.80). Answering "yes" to this question will pull up an option to change the PI. Follow those steps and submit the modification to send that change for approval.

Yes. To do so, you will need to open the application and navigate to the bottom of the page. There will be a button that says "More," and clicking on that button will give the option to view the application as a PDF.

If you are wanting to save a copy of your approved IRB as a PDF, the below steps will assist you in reopening the approved application form to save the file.

1. Log into IRBManager and select "IRB" on the initial switchboard to be taken to your dashboard.
2. Find and click on the "Protocols" tab, then click on the number of the study you want to modify. This will take you to the study's information page.
3. Near the middle/bottom of the information page will be a header that reads "Reference xForms (1)". Below that header will be a hyperlink that reads "IRB Application for Approval." Clicking this link will open up the form - and it will always be the most recently approved version of the form.
4. As mentioned above, you will then need to navigate to the very bottom of the page and find the "More" button, which will give the option to view as a PDF.

If you would like a visual of this process, please view this video.

Investigators have the ability to grant editing access to other users as long as they are affiliated with K-State (have a K-State eID).

To share the form, open the application and click the "Share Form Access" hyperlink at the top left-hand corner of the form. This will pull up a new window where you will then input the name/email of the individual you want to share with along with what level of access you would like to give them.

The access levels are:

• View Only - The individual will be able to see the application, but not make any edits to it.
• Edit - The individual will be able to make edits to the application.
• Edit and Manage - The individual will be able to make edits and grant editing access to others via this process.
• Edit, Manage and Submit - The individual will be able to make edits, grant editing access to others, and submit the completed form for review/approval.

For most, granting "edit" access is plenty. However, it is worth reviewing the different types of access in case you'd like the individual to have more abilities within the form.

If you would like a visual of this process, please view this video.

This is likely either due to the department being named/abbreviated differently in the IRBManager system, or it is a new/renamed department that has not yet been updated in IRBManager.

Adding new departments is something that our office will have to do manually, so if you are trying to input a department that will not appear, please contact the IRB adminstrator at makenna@ksu.edu to resolve the issue.

If they are affiliated with K-State, and have a K-State eID, this is likely because they are not yet a contact in the system.

To remedy this, they will need to log into IRBManager once with their K-State eID. The system will then automatically create a contact for them.

This means that the application has been submitted, so is no longer in data entry, and is in a subsequent stage of review.

The specific stage the form is currently in can be found in the box, directly under the principal investigator's name. Most of these stages will mean the form is currently with our office, undergoing review, and you should receive an update shortly. However, the "PI Signature for Non-PI Submission" stage will indicate that the form is currently with the principal investigator to sign and submit to our office.

If you have any questions about the current status of your form or estimated timeline for approval, please don't hesitate to reach out to our office.

An informed consent should be designed to convey details about the study to potential participants so that they are aware of what they will be asked to do and can make an informed decision on whether to participate. Consent statements may contain different elements depending upon the study and the information that needs to be relayed, and they may be presented in a variety of ways (written, electronic, oral) depending on the study.

The IRB office has developed an Informed Consent Template (doc) that researchers may find useful in drafting consent forms to ensure that all required elements are included.

At a minimum, each consent statement should include the following:

• Name and contact information for the principal investigator (and other members of the research team, if desired).
• Contact information for the IRB office, which can be found on the first page of the consent template linked above.
• A statement that the study is research.
• An explanation of the purposes of the research.
• A detailed description of the study procedures (i.e. what the participants will be asked to do), including the expected duration of their participation.
• A description of any risks or discomforts the participant may experience during the study.
• A description of potential benefits, both for individual participants and society.
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
• A statement informing participants of the research team's plans for future use of the data.
• For applicable studies, a statement that informs participants if compensation or medical treatment is available in case of injury.
• A statement that participation is voluntary, and that participants can withdraw at any time without penalty or loss of benefit that they may be entitled.

Yes. All consent forms will need a statement informing participants of if and how their data may be used in the future.

The two future use of data statements are listed on the informed consent template, as well as in lines 13 and 14 of the informed consent checklist on the application. They are as follows:

• Identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent.

• The subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

The first statement indicates that data collected, after being deidentified, may be used for future studies or shared with other researchers without obtaining additional consent from participants. The second statement indicates that will not happen.

These statements can be edited somewhat - for example, if the research team is not using biospecimens those words can be removed - but the sentiment should be conveyed on the informed consent.

The following are suggested items to include in the debriefing statement. Item #1 is required for all debriefing statements, and some of the following items may also be required by the IRB depending on the nature of the study.

1. Name and contact information for the principal investigator and the IRB chair.
2. Title of the study.
3. A brief summary of the nature and purpose of the study.
4. If deception was part of the study design, an explanation of that deception, the reason it was used, and the true purpose of the study.
5. Information on how participants can withdraw from the study if they no longer want to participate.
6. Any preliminary findings or results of the study so far, as applicable, along with information on if/how participants may be informed of the results of the final study.
7. Additional resources that participants may find useful or helpful.
8. A statement thanking individuals for their participation.

The informed consent, debreifing statement (if your research team is using one), and recruitment materials (flyers, emails, etc.) should include contact information for the principal investigator of the study. If you would like to include contact information for other study collaborators, including the responsible graduate student, that is acceptable as well.

Additionally, the informed consent and debriefing statement should include contact information for the IRB chair and the ORICS office:

Lisa Rubin, Chair, Committee on Research Involving Human Subjects, 203 Fairchild Hall, Kansas State University, Manhattan, KS 66506, (785) 532-3224, rubin@ksu.edu

Brad Woods, Associate Vice President for Research Compliance, 203 Fairchild Hall, Kansas State University, Manhattan, KS 66506, (785) 532-3224, comply@ksu.edu.

Recruitment materials (flyers, emails, study postings, etc.) can be customized by the research team to fit their needs. At a minimum, these should include an overview of the study along with instructions on how the potential participants can enroll if they are interested.

Contact information for the research team should also be provided. Name and contact information of the principal investigator is a requirement, however, other study collaborators can also be included if desired.