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Getting Started/Working with the IRB

Working with the IRB -Where do I begin? Click here.

To conduct human subject research at UTMB you will use to two electronic systems - OnCore e-Research and InfoEd. OnCore e-Research is a tool to help investigators and coordinators manage the daily tasks of conducting clinical trials and is the first entry point to initiating a new research protocol involving human subjects. InfoEd is the electronic online submission system used by the UTMB Institutional Review Board to review all human subject research protocols. All protocols are initiated in OnCore, submitted through InfoEd, and then electronically routed to the IRB for review.

How to Get Access to InfoED

Your Trusted Requestor will need to submit a Tivoli request access to InfoED.  The system and role needed is:

NameDescription
InfoED: Human Subjects Investigator Human Subjects Investigator Only

Entering a new Study

  1. Access the Human Subjects New Study Submission Form here.
  2. Complete the questions in the form.
  3. Provide the completed protocol document to Office of Clinical Research (OCR).  Please note you will still need to upload it later in InfoEd for IRB Review.
  4. Email the completed form and the protocol document that will be submitted to the IRB for review to OnCore@UTMB.edu.
  5. OCR will create the study in OnCore and pull it into InfoEd.
  6. The Investigator and form submitter will receive an email from OCR with the IRB #. You will need to login to InfoEd to enter your IRB # in the search field (Top, right corner of screen) in order to start the submission for IRB review.

More Details:

  • Currently the form is an Excel spreadsheet, however, a webform is being built to replace it.
  • The form is interactive to provide definitions and clarifications as well as skip logic.
  • Any forms submitted with blanks or incorrect information will be returned to the submitter for completion or correction prior to creating the study in OnCore.
  • OCR tries to process new studies the same day of receipt, however, this is dependent on staffing and new study volume. It may be 2-3 business days before you receive your IRB #.
  • If your form is returned for completion or correction, OCR will NOT begin entering it in OnCore until it is both complete and correct. Failure to respond or return the form timely will result in delayed study creation.

Additionally, if the individual who will serve as the Principal Investigator is not Faculty, then a Faculty Sponsor will need to be listed in the submission, who will also provide signature on the signature page. Department Chair signature is required for Expedited and Full Board research.

Study Management-OnCore

Researchers who need study subject management will need to obtain access to OnCore.  Please visit the OnCore Resources to make this determination.  Please contact OCR at OnCore@UTMB.edu for questions.

Mandatory Training

You will want to make sure that everyone listed on the submission has completed the required Human Subjects training via the CITI program. Instructions a on how to register for CITI training are available on the Mandatory Training page.  Additionally, all individuals engaged in human subjects research are required to complete COI training, as well file of a statement of financial interests. For COI questions and instructions please email the Office of Institutional Compliance.

Guidance