In order to assist investigators to prepare complete, accurate and thorough IRB applications, it is strongly encouraged that investigators obtain a pre-review of research proposals prior to submission to the IRB for full board review.

Pre-review includes a review of all draft documents to assure they are completed correctly, and the information presented is consistent between the study documents.  In addition, the protocol review will include analysis of the research question(s), background information (previous work, literature references), use of a study drug or device, comparison to standard of care, use of a placebo, inclusion and exclusion criteria, recruitment procedures, data collection, risks, safety precautions, protection of confidentiality, potential benefits and biostatical analysis.

In order to receive pre-review, please submit the following documents via email to IRB.Prereview@utsouthwestern.edu

Please note: pre-review requests must be e-mailed from the Principal Investigator's e-mail address to verify they have reviewed the documents and have cleared them for submission.

Please note: If you have difficulty sending the email by clicking on the above address, please try typing the address manually into your email; we are unsure what causes the problem for some people, but this is usually a simple solution to the trouble.

• Pre-Review Request Form

   

• Form NR-1   (signatures not required for pre-review)

   

• Investigator’s Brochure (if available in electronic form)

   

• Protocol (if available in electronic form)

   

• Project Summary (For a tissue procurement service or cell/tissue/DNA repository, do not submit a project summary. Instead, submit a protocol following the protocol template (for tissue procurement services or cell/tissue/DNA repositories).

   

• Consent Form(s)*

   

• HIPAA Form(s) * (HIPAA Authorization Form if applicable / HIPAA Waiver (if applicable)

   

*Please do not submit documents translated into languages other than English for pre-review.

Once submitted, you will receive a “Clinical Sciences Pre-Review of Research Proposal IRB Submission Memorandum” via email within 2 business days of your pre-review submission providing editorial suggestions and feedback to help minimize stipulations during the full board review.

If you have questions, regarding the pre-review process please contact one of the following individuals: