Using the DSHS IRB OneAegis System

A researcher dashboard will typically look like something below. There are two tabs in the screenshot below, but a Review tab may appear to HHS staff or IRB members as applicable.

• Projects - All IRB protocols in the system associated with a user (In the example below the researcher has 3 protocols)
• xForms - Applications currently submitted. Applications can be amendments, renewal, study closure, initial applications, etc.. It is possible for a single protocol to have multiple xForms in process. For example, a researcher may have a study team only amendment and renewal application under review by the IRB.
• Reviews - Will appear if a DSHS IRB OneAegis user has been assigned a legal, program, expedited, or chair review of an IRB application. A Review tab is not shown in the screenshot below.

Additionally, there are links to submit applications (xForms) in the system. There is a direct link to an initial application xForm, but clicking “Start Other xForm” will provide forms to add new personnel to the system. Amendment, closure, and UAE (unanticipated or adverse event) forms can be submitted by first clicking on the protocol number.

Clicking on an IRB protocol number in your dashboard opens the Projects Tab. The Projects Tab contains an overview of each protocol that has been started or is currently stored in the DSHS OneAegis IRB system. This can include protocols that have not been submitted for IRB review and closed protocols.

The Projects Tab provides the current status of any applications associated with a protocol, a log of all prior applications for the protocol, and a record of communication between researchers and programs.

Note: Legacy IRB protocols will not have any documentation of email communication, determination letters, or application statuses for any applications submitted prior to the DSHS OneAegis IRB system going live.

An xForm is an application (initial submission, amendments, study closure, etc). Clicking on the xForm links under the Events section of the Projects Tab will provide specific information for each application.

Clicking on the “Initial Submission” xForm shows that the application required multiple revisions with email correspondence sent to the researcher through the DSHS IRB OneAegis system.  The system also tracks the progress of the application. In this example, the application was approved by program staff and eventually sent to the full IRB board on 8/30/2023. Application status information is available to the researcher and program contacts. 

The xForms tab provides information on currently processing xForms. This tab provides information on xForms that require researcher (or program) action. In the example below, the researcher has two xForms that are under review by program staff. Clicking on the Initial Submission link will send the user to the Event details just as if the user clicked on the “Initial Submission” link in the Project Details as seen in the Projects Tab information.

Individuals that have been assigned a review will have a Review Tab. The tab will disappear if you have completed your reviews. In the example below, the reviewer has been assigned a Legal Review (IRB #2023-034-DFT) and a Program Review (IRB #2023-033-DFT). Both of the applications are Initial submission applications. Clicking “Legal Review” or “Program Review” will send the reviewer to the appropriate review form. Clicking “Initial” will send you to the researcher's initial application form. Clicking “Initial Submission” will send you to the Event Details page with information details about the application status.

In the application below, IRB study number 2023-001 has 4 events- an initial submission and 3 amendment applications. The Att column provides information on the number of attachments associated with that event. Attachments could be provided by researchers or could be approval letters generated by the system. You can also see start and end dates if the system recorded that information.

​Clicking on one of the events will allow you to read all email communication with the researcher, get a copy of the application that was submitted, and see application statuses. For protocol 2023-039-DSHS, an amendment was submitted to DSHS on 9/18/2023, reviewed by program staff, reviewed by the IRB administrator, sent for expedited review, and approved. Approved Protocol Amendment Details provides information on what amendment was approved and included in the approval letter.

Clic​king on the email link “Approval of Amendment Application for DSHS #2023-029” will show you a copy of the email sent to the researcher. It will also allow you to view the approval letter sent to the researcher. Other emails will also display here if programs or the IRB requested revisions to the application.

The amendment application that was submitted on 9/18/2023 can be accessed by clicking xForms(1) in the top left of the page.

For applications originally submitted to the DSHS IRB through the DSHS OneAegis IRB System, amendments will use “Copy for Amend." Copy for Amend tracks changes from a previously approved application. With Copy for Amend all sections of an amendment application will be filled based on the previously approved submission except for 1) the amendment summary page and 2) the Acknowledgement of DSHS IRB Requirements page. 

Note: You can only have one amendment application under review (except for research team changes) for non-legacy amendment applications. Contact the IRB administrator if you need to submit more than one amendment application so that we can determine the best way to process the amendment.

Step 1. Log into the IRB website. 

Your dashboard will show your approved applications. You cannot amend a protocol that has not been approved by the IRB.

Step 2. Click on the protocol number to get details about the application. 

From the protocol details you can see information about the expiration date, study members, and previous submissions associated with the protocol. 

Step 3. Click on the icon of two pages to the left of the word “Application Form”.

Step 4. Update the Amendment Summary page by checking appropriate amendment options and providing a summary of the amendment.

The Copy for Amend application will start by asking you what is being amended. Check the appropriate boxes for Research Change Type. Provide a summary of all changes.

Note: Checking Adding or Removing Team Members will provide you with a link to the Research Team Change Form. Use that form for all non-PI team changes. 

Step 5. Update the application.

Make all appropriate changes to your most recently approved protocol. Make sure that the boxes you selected on the first page accurately reflect the changes you make in the protocol or attachment documents.

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If your application has been previously amended you can select the View Audit link next to the questions to see a history of your submissions. You will see the phrase “xForm Copied for Amendment” for each question every time a new amendment application was started regardless of whether that specific part of the application was changed or not. Items in green were considered new for that submission. In the example below, the researcher updated and submitted the application multiple times before it was approved by the IRB. After initial approval, the application was amended 4 times before the current amendment application.

Step 6: Complete the acknowledgement of DSHS IRB requirements.

Researchers are expected to re-acknowledge DSHS IRB requirements with every amendment. A non-PI staff member completing the form will not see the acknowledgement of DSHS IRB requirements page.

Step 7: Submit

Upon completion of the application, the researcher can submit (if the PI) or send the application to the PI for their submission.

Amending a legacy IRB application (ie. an application that was initially submitted outside the online IRB system) requires a different submission process. It starts the same as a non-legacy application in that you need to click on the IRB protocol number to start the application. Once you are in the details screen click Start xForm in the top left of the screen.

Select the appropriate xForm to start your amendment application. Note: from the page you can also submit a renewal application or amend your research team. Clicking Amendment will start the legacy amendment application.

The legacy amendment form includes a number of checkboxes that should be selected, if appropriate. Checking Add Research Team Member(s) or Remove Research Team Member(s) will create a link to the Changes to Research Team Amendment form. Please provide summary information for each proposed amendment. 

At the bottom of the screen you need to attach all appropriate documents. Please attach copies of all documents with and without tracked changes.

For tracked changes documents- start with your most recently approved protocol (or other IRB document) document in Word. To turn on Tracked Changes in Word first select the Review Ribbon, then click the Track Changes icon, and select either “For Everyone” or “Just Mine”. 

Make all appropriate changes to your document. Save your document when you are done making all changes. 

Click “Accept All Changes and Stop Tracking". Once you have accepted all of the tracked changes save that document with a different name. Both files need to be submitted to the DSHS IRB as attachments to your amendment application.

Like non-legacy amendment applications, researchers are expected to acknowledge DSHS IRB requirements with every amendment. Upon completion of the application, the researcher can submit (if the PI) or send the application to the PI for their submission.

Step 1: Log Into the DSHS OneAegis IRB website

The first step in starting a Research Team Change amendment is to log into the IRB website. Your dashboard should show your approved applications.

Step 2: Click on the protocol number to get details about the application. 

From the protocol details you can see information about the expiration date, study members, and previous submissions associated with the protocol. 

Step 3: Click Start xForm in the top left of the screen. 

Step 4: Select the appropriate xForm to start your Research Team Change application. 

Note: from this page you can also submit a renewal application or amend your protocol. Clicking Changes to Research Team Amendment will start the team change amendment application.

The Changes to Research Team Amendment form provides the researcher with information on:

• The current program contacts
• The currently approved study personnel. In this example, Betsy Cox is an approved Research Team Member.
• Checkboxes to update human subjects protection training certificates and to add or remove personnel 
• A link to a form to create new contacts in the online system

 To update human subjects protection training certificates or to add or remove personnel first check the appropriate box.

Note: if you are changing a team member's role you should “Remove” the individual from the study and “Add” them back with their new role. By Removing then Adding you create a record of when they changed roles in the project. If an individual is changing from a research team member to the PI then you should get approval to change the PI by submitting an Amendment application (not this form) before requesting to remove them from their current study role.

Step 1: You must enter each individual's email address into the Personnel to be Removed field. 

If the individual's email address is identified in the system, their email address and name will be displayed below the box.

Step 2: Specify their Role

Step 3: Specify their End Date

Step 4: Click Save. 

If an individual's name does not appear in the system their email address may have been entered incorrectly or the application may be a legacy application. Prior to creation of the DSHS OneAegis IRB system, DSHS did not digitally store personnel logs for non-PI team members. Consequently, non-PI team members do not have contact information in the IRB online system. To create a record of their study removal, you will need to create a contact for them with the Create New Contact link (see below in Adding Personnel for more information) before you can remove them.

Adding personnel is likely to take more time than removing them because you will probably need to create a new Contact for each new person in the DSHS IRB OneAegis system.

Check Add Personnel to start adding individuals to your research team.

Step 1: For each person to be added, first type their email address into the Personnel to be Added field. 

If an individual's name does not appear below the box then their email address may have been entered incorrectly or the individual is not in the system. Click the “Create a New Contact” link if the individual to be added to your team is not currently in the system.

Step 2: Specify their role on the study

Step 3: Provide their start date

Step 4: Provide the date when their human subjects protection training expires

Step 5: Attach their training certificate

Step 5: Click Save

Per DSHS IRB rules, the IRB will not accept training certificates that are expired or exceed three years from the issuance date . If you have any questions about the appropriateness of a training certificate please refer to the IRB FAQ page or contact the IRB administrator.

Each individual on a research team needs to have contact information in the DSHS IRB system. A new contact can be created by starting the Create New Study Contact form or by clicking a link that says “Create New Contact.”

Note: When an individual's contact information is entered into the DSHS IRB OneAegis system an account is created for them, but they will not receive an email telling them about the account nor will they be able to log into the DSHS IRB OneAegis system. Individuals can only log into the system if they have been verified and an account has been created in the HHSC IAmOnline system. If a person gets an IAmOnline account, the DSHS IRB OneAegis and IAMOnline systems will link the accounts by email address.

Creating a new contact in the IRB system is a matter of typing in the appropriate information and submitting.

The following information is requested of all new contacts:

• First Name
• Last Name
• Credentials (optional)
• Street Mailing Address (work address)
• City (work address)
• State (work address)
• Zipcode (work address)
• Organization
• Phone Number (optional work phone)
• Phone Type (optional work phone)
• Country (work address)
• Email Address

The first step in starting a new initial application is to log into the DSHS OneAegis IRB website on IAMOnline. All individuals who submit or create an initial application will need to have an IAMOnline account with the Health and Human Services.

Note: Anyone with an IAMOnline account can create an application on behalf of a Principal Investigator (PI), but only the PI can submit the application. 

Once logged in, your dashboard should provide you with a link to submit an “Initial Submission Form." If that link is not visible then click “Start Other xForm” to find a link to the Initial Submission Form.

All initial applications contain the following sections:

• Study Information
• Data and Biospecimens
• Research Design and Statistical Analysis
• Information Storage and Security
• Informed Consent and Recruitment
• Personnel
• Attachments
• Acknowledgements
• Signature

Additional sections may be added to an application automatically depending on the researcher's selections. For example, informed consent form checklists will be included in the application if the researcher indicates that they have informed consent documents. All sections are expected to be completed, but if there are issues with application questions please email the Institutional Review Board.

The system will check to see if you have completed all required questions before you can proceed to the next page. If a question does not apply to you, please indicate that the question is “Not applicable.” 

All applications are required to have a Principal Investigator (PI) who will be responsible for the research. If the PI does not have an associated email account in the IRB system, then a new contact will need to be created. The contact will identify the PI in the system but does not grant login rights. The PI will still need to create an IAMOnline account. Research team members can enter application details into the online system, but only the PI can ultimately submit the application for review by the IRB.

All applications are expected to select at least one of the following options relating to informed consent:

• Written Informed Consent Document(s) to be Signed by Subjects
• Waiver of Informed Consent
• Waiver of Documentation of Informed Consent
• Alteration of Informed Consent

Typically, researchers select one, but some multi-stage studies may require multiple selections. Each selection will add a new section. For example, selecting “Waiver of Informed Consent” will require a researcher to provide reasons for waiving informed consent.

All informed consent documents are expected to be included with the application in the Attachments section.

The DSHS IRB Frequently Asked Questions provides guidance on who should be included on the research team for IRB submissions.

Each research team member will need to be entered individually. If a member of your research team does not have a contact in the system, you will be required to create a new contact.

a. Enter the team member's email. If the individual is in the system, then their name will be provided in the form.

b. If a team member is not in the online system, create a new contact with the “Create new Contact” link.

c. Make sure to click “Save” after each research team member's information and a copy of their training certificate has been added.

The following documents are required if applicable to the study and/or investigators:
 

• DSHS/HHSC Program Data Checklist (if required by DSHS/HHSC program)
• Other IRB Determination Letters (most recent date)
• Conflicts of Interest Disclosure Letter
• Academic Letter of Support (if principal investigator is a student)
• Principal Institution Protocol (most recent version)
• Vendor Information Form (if an initial application)

Researchers are required to provide a Vendor Information Form for all institutions represented in the research team log. You can provide a name or the system will default to the filename.

PIs are required to acknowledge all IRB requirements. If a non-PI research team member is entering application details into the online system they will not see the acknowledgements. When a non-PI submits the application, the PI will receive an email indicating that an application is ready for their review and submission.

Add a Conflicts of Interest Letter in the attachments section for all individuals with a conflict of interest.

After the PI submits an application to the IRB, the IRB Administrator will assign the application to appropriate programs for their review. Programs are likely to request modifications for the application. If appropriate, the PI will receive emails with instructions on any changes necessary for programmatic approval. After programmatic review, the IRB administrator will review the application to assess completeness and to determine the appropriate path for IRB review.

The current status of an application is available on the PI's dashboard. 

Most Initial applications are reviewed by the DSHS IRB Full Board and the DSHS Research-Executive Steering Committee. Approved IRB applications by non-DSHS staff will require an executed Memorandum of Understanding (MOU) with DSHS before any data are released. Applications exclusively utilizing HHSC data (i.e. Medicaid enrollment data) may require an executed MOU with HHSC before data are released. HHSC programs can provide guidance on whether any data release will require an MOU. 

The first step in starting a Final Report application is to log into the DSHS OneAegis IRB website. Your dashboard should show your approved applications. Click on the protocol number to get details about the application. 

Once you are in the details screen click Start xForm under Actions in the top left of the screen.

Select the appropriate xForm to start your Final Report application. Note: from the page you can also submit a renewal application or amend your research team. 

The Final Report form requests information on:

• The reason for closing the study
• Final count of the number of subjects whose records or biospecimens the researcher received from DSHS or HHSC
• Information about recruitment and study contact
• Unforeseen or unanticipated problems
• Summary of research findings
• Acknowledgements on protection and confidentiality of data and biospecimens
• Certificate of Destruction
• Optional Attachments

The application will already have Principal Investigator, study title, IRB submission number, and program contact information. Researchers are expected to provide all other information. 

Please include all published products as an attachment to the Final Report.

Please click Next and Submit upon completion of the form.

After the PI submits a Final Report to the IRB, the IRB Administrator will route the Report to appropriate programs for their review. Programs may request modifications of the Report to ensure that they have proper documentation of data destruction. If appropriate, the PI will receive emails with instructions on any changes necessary for programmatic approval. After programmatic review, the IRB administrator will review the application to assess completeness. If the application is approved, the protocol will be closed on the IRB website and the PI will receive an email with documentation that the study is closed.

The first step in starting a Renewal Progress Report application is to log into the DSHS OneAegis IRB website. Your dashboard should show your approved applications. Click on the protocol number to get details about the application. 

Once you are in the details screen click Start xForm under Actions in the top left of the screen.

Select the appropriate xForm to start your Renewal Progress Report application. Note: from the page you can also submit an amendment application, update your research team, or provide the final report (study closure).

The Renewal Progress form requests information on:

• A synopsis of the study using plain language
• Current status
• A description of the subject population(s)
• An update on subject enrollment, complaints, and withdrawals for contact studies
• Unanticipated Problems
• All published products using the data or biospecimens for this study since the last DSHS IRB review
• Attachments

Note: Amendment applications must be submitted separately from renewal progress reports.

The application will already have Principal Investigator, study title, IRB submission number, and currently approved personnel. Researchers are expected to provide all other information. See information on research team personnel below.

Please include all published products as an attachment to the Renewal Progress Report.

Please click Next and Submit upon completion of the form.

Non-Legacy Renewal Progress Report Submissions

For applications originally submitted to the DSHS IRB through the new DSHS OneAegis IRB website, researchers do not need to provide protocol detail documents as they are already in the system.

Required documents for non-legacy renewal progress reports include:

• Other IRB Determination Letter(s) (most recent date or application)
• Conflicts of Interest Disclosure Letter (if reportable interests have changed)

Legacy Renewal Progress Report Submissions

For applications originally submitted to DSHS before the adoption of the DSHS OneAegis IRB System, researchers will need to provide all protocol detail documents as attachments to their application. Attachments for HRP-302, HRP-305, HRP-304, and HRP-303 should reflect previously approved IRB applications. If changes are required to these documents then researchers should submit a separate Amendment application.

Required documents for legacy renewal progress reports include:

• HRP-302 Protocol
• Informed Consent Documentation (at least one of the following)
  • HRP-305 Informed Consent Document Checklist and Informed Consent Document(s)
  • HRP-304 Waiver or Alteration of Informed Consent Form
• HRP-303 Recruitment Protocol (for Recruitment and Contact Studies)
• Other IRB Determination Letter(s) (most recent date or application)
• Conflicts of Interest Disclosure Letter (if reportable interests have changed)

Research team personnel information is stored in the DSHS IRB OneAegis system and can be updated through the Changes to Research Team Amendment application. PI and co-PI information was automatically migrated into the IRB system for legacy applications; however, no other research team personnel are in the system.

PIs are requested to enter into the DSHS IRB OneAegis system all current (or new) research team members for legacy applications. Once updated, researchers will only need to submit changes to their research team as amendments and when updating human subject protection training documents.

When renewing an application, PIs are expected to provide updated human subject protection training for all research staff with expired training.