Guideline for Patient Data Request and Management

Washington University Department of Emergency Medicine

 

All patient data requests for the purposes of quality improvement/assurance, research, education, or administration will be initiated through the use of the Emergency Medicine IT Data Request Portal.  All resident requests will need to specify a faculty mentor.

These requests will be routed for approval by the division IT group as well as the relevant directors related to the purpose of the request such as the EM Research Director, EM Residency Program Director, EM Patient Safety Director, or EM Business Manager.

For research project requests, IRB approval documents as well as a copy of the approved IRB application will need to be provided.  A comparison of the IRB approved project and the data requests will be performed prior to data being released.  Special caution should be taken in the case of quality improvement/assurance projects which may turn into research projects or be published in the future.  At the time the project moves from quality improvement/assurance to research, IRB approval as well as the IRB approved application will need to be submitted.  No additional data queries will be performed until IRB approval is obtained in this circumstance.

For projects being performed by students or residents, the faculty member mentor should be the listed principal investigator in the IRB application.

Data query outputs will be placed in specific project folders in WUSTL Box. We will send you links to the file folders that contain your data set. WUSTL Box allows you to easily share and collaborate across campus, across the country, and around the world with a few simple steps. The data should remain housed in WUSTL Box folders to ensure compliance with university policies for HIPAA information security.  In rare circumstances in which it is absolutely necessary to download the data to other devices, please discuss with the division research director and/or IT group to be sure you remain in compliance with university policies for encryption and data security.  The division IT group will also assist with any needs to share the data with other investigators outside the division.

Per Washington University IRB regulations, subject data and documents from research studies must be saved and accessible for at least seven years after the final closure of the study in the IRB to allow for auditing.  The EM Research Director should be notified of closure of research studies in myIRB to allow for a review of the data storage plan including both electronic and paper documentation.

LINKS TO GENERAL WU POLICIES & WUSTL Box

Office of Information Security, Policies, Standards & Guidelines

HIPAA Privacy Office, Policies & Procedures

WUSTL Box