Office of Research and Health Sciences

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The IRB protocol application process will be transitioning to an electronic protocol management system, iRIS
This transition has NOT occurred.  The iRIS beta system is available for training purposes only. 
Please continue to submit the IRB protocol application via the pdf application/link below under "Current IRB Forms."  Continue to visit this page for updates regarding the iRIS transition. 

 

Please read the detailed email communication that has been sent to all PIs.

The IRB office has organized training hours and handouts to facilitate this transition. If you would like to attend a training session, please register below for a date and time that works for you.

Welcome to iRIS

What is iRIS?

iRIS is an online protocol management system used to submit protocols and all subsequent IRB protocol submissions.   iRIS enables transparent, real time, online tracking, review, post-approval compliance activities and supports data management. The system also functions as a document repository, providing easy access to protocol records and documents. iRIS can be used anywhere where there is Internet access.

What are the benefits of using iRIS?

  • Protocol Submission Guidance- Never miss any required information with the updated protocol submission guidance. With the new system you do not have to guess what information needs to be provided for each field as there are clear descriptions and prompts to help you complete your protocol application.
  • Intuitive application – With the new protocol management system, drafting and submitting the IRB application is easier as the programming will allow for the system to branch out based on how you answer key questions, so you won't have to figure out what supplementary documents you need to submit.
  • Complete Submission- The system helps you to submit a completed protocol application packet. It will remind you when you forget attachments or missed checking a box. The system also allows you to upload all the attachments in one place and in the precise order you want the reviewers to read it.
  • Up to date Protocol information at your fingertips – The protocol system is updated in real time. You don’t have to call or email the IRB Office to know the status of your protocol. Where you have Internet access, you have access to your protocol information.
  • Faster review process and communication of status – In the cloud-based protocol management system, no attachments are lost, or no versions need to be verified. Electronic submission will reduce processing time and speed up the time to approval. PIs and study contacts will receive approval letters by email immediately after they are prepared.
  • Improved document management – The system enables you to keep track of the versions of your recruitment materials and enables you to easily locate the latest approved version of the documents, helping you use the correct versions.
  • Documentation of submission for sponsors – Whenever you have a request from the sponsors for the documents, you can provide the record without having to reach out to the IRB office. Be assured that IRB Office will never provide any documents to any agency without your consent.
  • Easier access to IRB approval records – Protocol approval records will be accessible to PIs, study staff, and key departmental administrators. Everyone having the same version of the protocol goes a long way in ensuring research compliance.

iRIS Frequently Asked Questions:

Do I need to request an account to access iRIS?  Your network username and password can be used to log into iRIS.  

Who needs to sign the initial submission of an application in iRIS?  The Principal Investigator (PI) and all key study personnel listed on the application are required to electronically sign the initial application.  Contact persons and study authors are not required to sign the form if they have no other role in the study. 

Who needs to sign other types of submissions in iRIS?  Continuations, Amendments, Adverse Event Forms and Closure Forms:  Only the PI’s electronic signature is required for the submission types of continuation, amendments, Adverse Events form or study closure.  If necessary, manually uncheck the names of the personnel who are not required to provide a signature.  When new personnel are being added to the study, they will be asked to sign the form by the IRB as a contingency for approval.

Who do I need to list as a research contact in the iRIS application?  The research contacts automatically receive all system generated correspondence (e.g. reminders to request continuations, notifications of lapses in approval, IRB approval letters).  The Principal Investigator should always be listed in this section.

How do I know if the IRB has received a submission I completed in iRIS?  To confirm that your submission has been routed by the system to the IRB you can go to your Protocol Assistant tab and click on “My Studies.”  Then open the study/protocol you have completed and submitted. Once you are in the Submission tab, click on the Submission History and then on the Track Location. If the submission has arrived to the IRB queue, you will see the following statement: “TAMU-SA IRB has received the submission.”

What types of documents can I submit in iRIS?  You can attach a variety of document types, however iRIS can only stamp/approve documents that are submitted in Microsoft Word or PDF formats.  Furthermore, different document types sometimes cause problems on the IRB review side, such as corrupting system generated pdf files.  Study personnel are strongly encouraged to convert other document types (e.g., excel, jpg, gif, ppt) to a PDF file prior to attaching them to a submission.

 

iRIS Help

How to access and create my iRIS profile

How to Create a New Protocol

Minor and Major Amendments

Register for training here:  iRIS Training

You can also contact the IRB Office at irb@tamusa.edu or call (210) 784 -2317. 

 The Office of Research Compliance strongly encourages all PIs to initiate the learning. Please review the provided resources and or schedule iRIS training with IRB staff if you have questions or need assistance with the iRIS.

 

 


Current IRB Forms

Please Note: The IRB Office will not accept any other versions of IRB forms.

Initial Submission Packet Forms:

IRB Protocol Application 

Information Sheet Template

Informed Consent Template

Signature Assurance

Assent Form

School Authorization to Conduct Research

Post Approval Forms:

IRB Continuing Review

IRB Study Closure Report

Other Forms:

Reporting Adverse Event

Resources:

Informed Consent Checklist

Office for Human Research Protection IRB Basics

Human Subjects Regulations Decision Chart 

 

 

 

 

 

Contact Us

All Institutional Review Board inquiries must be emailed to:
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