Initial IRB Review
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Types of IRB Review
How to Submit a New Protocol Using the eIRB System
Reminder About Site Approvals (NR3)
All research involving human subjects must be submitted for review and approval by the Institutional Review Board (IRB). Federal regulations divide human subject research into three categories based upon risk to subjects. The three levels are: Exempt, Expedite, and Full Board Review.
All applications are submitted using the Velos and eIRB Systems.
Exempt & Expedited Review
Review of proposed research by an IRB Chair or a designated voting member rather than by the entire IRB Committee. Federal rules permit exempt and expedite review for certain kinds of research. Note: Investigators cannot 'self-exempt” research protocols that meet the exempt criteria.
Exempt & Expedite submissions are first reviewed by the IRB Coordinator. If there are missing documents or if further information is required, the IRB Coordinator will contact the Principal Investigator (PI) and/or Research Coordinator. Once the file is complete, the IRB Chair will review the submission and either verify that the criteria are met, request changes or additional information, or require review under expedited or full-board review procedures.
Review of proposed research at a convened meeting where a valid quorum of IRB members is present. The application process remains the same as for the other levels of review. Investigators should also be aware that the initial Full Board Review process frequently does not result in an outright approval of the research, minor or major revisions, and written clarifications are often requested.
Note: Access to UT Southwestern Medical Center's Internal Research Systems (ERGO; eIRB; Velos) requires an active UT Southwestern Login ID.
If you do not have a UT Southwestern Login ID, then you will need to obtain one. To do this, contact an administrator in the department of your UT Southwestern Sponsor to assist you by first completing the Request Add a New Person (Not Recruited) form in PeopleSoft. Then submit an IAR (Institutional Access Request) form through Information Resources. Each form type requires a minimum 24 work-hours to process.
The eIRB system is designed for online submissions of human subject research protocols, using a web browser. Protocols submitted in eIRB are routed and reviewed electronically. Notification of study approval is sent via email.
Using eIRB, you’ll have …
- Less paper. It is not necessary to submit paper copies with your electronic submission. All of your submission materials will be stored online, and can be accessed anytime.
- Better tracking. Once you submit a study to eIRB, you can track its progress in real-time from your desktop.
- Access to your submission from anywhere. With VPN, a web browser, and an Internet connection – you can access eIRB from any computer.
The UTSW IRB office understands that any new software application can be intimidating at first. Our staff is here to provide you with training and technical assistance to make this transition as easy and convenient as possible. The eIRB represents the beginning of a new and exciting era and we invite you to be part of this future together with us!
Request access to eResearch
Requesting user access to eResearch requires a valid active UT Southwestern ID, Parkland Health & Hospital System ID or Children's Medical Center ID. Request Access Authorization to a Research System
If you are not a UTSW, Parkland or Children's employee, please follow the instructions on the document at this link to obtain a UTSW ID. eResearch User Access Information
Registering the study in Velos
Velos is a study management tool and is the first step to submitting your Protocol through the eIRB System.
Velos Login page:
|1.||From the Login screen, type the following information in the corresponding fields:
Then click Login.
Note:: If you have an earlier version of Internet Explorer 6.0, press the Control key while clicking the Login button. An error screen will display, press Control and click OK again.
|2.||From the home page, click Manage Protocols from the left navigation toolbar. Click New.|
|3.||The Velos required fields on the Summary page should include:
|4.||Enter your e-Signature in the e-Signature field (default is “1234”) and click Submit.|
Changing the Study Status
When a new study is registered in Velos, the study is assigned a default status of “Not Active.” This indicates that the study is still in a draft state. Once you are ready to send the information to eIRB, you must add a new status of “IRB – Submission Initiated” to trigger the transmission of information from Velos to eIRB. Follow these steps to add or edit a study status in Velos:
|1.||From the Summary page, click the Study Status tab|
|2.||Click Add a New Status.|
|3.||Select the Organization, Status Type, IRB|
|4.||Select Study Status of Submission Initiated.|
|5.||Select today’s date|
|6.||Enter your e-Signature in the e-Signature field (default is “1234”) and click Submit. Your study has now been sent to eIRB|
Completing the eIRB Application
Log into eIRB: eresearch.swmed.edu/eIRB
- Type your User Name and Password in the corresponding fields. (These will be the same as your UT Southwestern User Name and Password.)
- Click Login.
- In the right top corner, click My Home.
- In the My Home workspace, click the Studies Tab.
- Click on the Study Name.
If you have several studies you can enter study search criteria such as: Study Number, Name or State, and press Go.
Study Activities you can perform will display on the left.
Click Edit Study to complete the Smart Form to submit your study. (While completing your Smart Form, you will be asked to upload any forms associated with this study. [i.e, consents, protocol, HIPAA forms, questionnaires, etc.])
After you have completed the Smart Form, you will then be able to Submit your study to the IRB for approval.
Human research studies proposed to occur at one or more of our affiliated performance sites require site approval before any research-related activities may begin at the site.
Once you are able to log into ERGO, your level of access in the system will determine if you are able to create or edit forms. Anyone with an active UT Southwestern Login ID will automatically have access to log into ERGO, but will not be able to create or edit forms unless they are a PI or assigned delegate rights by a PI. PI access in ERGO is automatically assigned to faculty. (Once you have access to log into ERGO, if you are a Principal Investigator and do not have the PI access required to create and edit forms, etc., please contact the IR Service Desk at 214-648-7600; or email.) SERVICEDESK@utsouthwestern.edu
Note: Site approval is not required prior to IRB approval.
For questions regarding submission of the NR3, please contact:
- Ambulatory Services: Julie Landesberg at 214-648-2024, mail code 8831 (Attn: Julie Landesberg), or email. email@example.com
- Children's: MaryAnn Byerly, Program Manager at 214-456-1856, or email. firstname.lastname@example.org
- Parkland: David Whiting at 214-590-8966, mail code 7750 (Attn: David Whiting) or email. email@example.com
- Texas Scottish Rite Hospital: Jeremy Howell, Research Program Administrator, at 214-559-7879 or email. firstname.lastname@example.org
- UT Southwestern University Hospitals: Cindy McCalla at 214-645-1121, Mail Code 9238 (Attn: Cindy McCalla) or email. email@example.com