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Office of Protocol Research

Office of Protocol Research "Study Overview Document for Informed Consent"


1.) Purpose of the Presentation:
Two OPR scientific editors and an IRB member from GU Medical Oncology research will discuss how to create the Study Overview document in PDOL and how best to use it in the clinic.  This optional document for patients is designed to be a quick 1-2 page guide to what they may expect on study.  It briefly outlines the study’s tests/procedures and summarizes the PI’s opinion of the most clinically important side effects.

2.) Which regulations or institutional policies are relevant to the discussion?
The Executive IRB recently approved this document template for use in the clinics along with the full informed consent document (ICD).  The concept was developed by a multidisciplinary IRB ad-hoc committee that implemented strategies to shorten and simplify MD Anderson ICDs, particularly the side effect section.
3.) Who will it impact?
The Study Overview is optional for all clinical studies and is designed to improve the informed consent process by simplifying the key elements presented to potential participants.

4.) How and when will the form be available?
The document template is now available in PDOL.  Any clinical researchers interested in creating a Study Overview for their new or ongoing studies may work with the OPR scientific editors to prepare a study-specific document for the IRB to review.  As a service provided to researchers, the editors will write the document with input from the PI after the first draft.  For more information, please send an email to “OPR Consent Editors.”

Date: 8/13/12, 12pm to 1pm
Time: 8/13/12, 12pm to 1pm
Location: Cancer Prevention Building, Floor 8, Rooms 1-8
Format: All Employee Meeting
Contact: Leola Griffin - (713) 563-5450 -