Online IRB Submissions:
Seton Institutional Review Board (SIRB) submissions are currently being accepted electronically via TOPAZ. Please read through the important guidelines below and click on the provided link to begin working on your study submissions.
Please read the following tips and guidelines before you begin using TOPAZ:
- Access: You must be behind the Seton firewall in order to access the application. You can do so by logging directly onto a computer connected to the Seton network, logging in via VPN, or logging into Citrix (web address: citrix.seton.org) anywhere that you have Internet access.
- User Accounts: You will use your Seton username and password to log into TOPAZ. If you have not logged in before, please provide the IRB Project Coordinator(s) with the following information prior to logging in: Full Name (including middle initial), Credentials (i.e., MD, RN, PhD, etc.), Email Address, Work Phone Number, Position/Title at Seton (or other institution), Will you be a PI or not?, and your Seton username. Any user without a Seton account (e.g., an external researcher) will need to have one created. If you know of anyone that needs an account, please email the IRB Project Coordinator(s) for further assistance.
- Current Studies: All currently opened (paper) studies will need to be inputted into TOPAZ using an Initial Submission Form. We ask that you input all of the study information as it currently stands with the IRB. Once everything is current and accurate, the study will be administratively set to "Approved", and all subsequent submissions for that study should be completed via TOPAZ (i.e., no more paper submissions for continuing reviews, amendments, etc. will be accepted for that study.)
- Final Study Closures: If within the next year (through October 2013) the only IRB action that is submitted for a study is a Final Study Closure, then you will still be able to submit the closure documents via paper. However, if you have any renewal, amendment, etc. submissions before then, you will have to submit the study electronically in TOPAZ.
- TOPAZ Submission Workshops: Starting Monday, October 29th, we will be holding ongoing, weekly TOPAZ Submission Workshops every Monday from 1:00pm - 3:00pm in one of the ORA conference rooms. These will be held for any researchers who would like to come to the ORA and work on IRB submissions while the IRB Project Coordinators (Loc-Uyen Vo and Jenny Koenig) remain available during that time to answer any questions and provide direct assistance/feedback.
- Please expect and plan for a slight delay in the processing of IRB submissions during this transition from our paper system into TOPAZ. We will, of course, do our best to work with researchers to ensure that current, ongoing studies do not lapse due to processing delays related to the electronic transition. To help with this, please begin working on your continuing review submissions well in advance of a study&'s IRB approval expiration date.
Online IRB Submission Guidance Documents
|TOPAZ User FAQ|
TOPAZ: User Guide for Amendments
|TOPAZ: User Guide for PI Certifications|
Paper IRB Submissions:
The Seton IRB will only accept paper submissions for the following action items:
- Reports of Noncompliance (not related to a particular study);
- Emergent Use Requests/Notifications.
Please be sure to include a Seton IRB Action Request Form with any paper submission. All other requests to the Seton IRB must be made within the electronic submission system, TOPAZ.
|Paper IRB Submission Forms|
SIRB Action Request Form
|Request for Emergent Use||Download pdf|
|Noncompliance Report Form||Download pdf|
|Translator's Declaration||Download pdf|
|IRB Protocol/Consent Templates|
Research Proposal Template
Adult Informed Consent Template
Pediatric Informed Consent Template
|Brief Informed Consent Form Template||Download doc|
Pediatric Assent Form Template
|HUD Informed Consent Template|
|Subject Informed Consent Checklist Template||Download doc|
|Model language for IRB Consent Clauses Regarding the use of Contraception|
|Emergent Use Informed Consent Form Template||Download doc|