Informed Consent Quality Improvement Plan

DHHS OHRP Training ResourcesInformed Consent is a fundamental aspect of human subject protections.  To ensure the protection of autonomy is upheld, a new initiative related to informed consent began in FY19 and will continue in FY20.  This includes the Informed Consent Form (ICF), the Consent Process, and Consent Documentation.  The initiative creates many opportunities for research personnel to advance their knowledge and ensure compliance with Rush policy, Federal regulations and Good Clinical Practices (GCP). 

Standard Operating Procedure (SOP):  Monitoring Informed Consent, HIPAA & Consent Documentation

The Monitoring Informed Consent, HIPAA & Consent Documentation SOP established a review process to assess gaps related to obtaining Informed Consent and Process Documentation.  When gaps are detected individuals will be referred for training.  The training is multifaceted and individuals will be directed to the following learning opportunities. 

LEAP Online ICF Training Modules:  Several modules have been developed to address the Informed Consent process.  The following modules are role based scenario driven in a setting that is common place when obtaining informed consent.  These short (10-15 minute) modules demonstrate a practical application of  human subject protections.   

  • Anatomy of the Informed Consent Form
  • Informed Consent Process
  • Informed Consent Documentation
  • Common Consent Issues and Best Practices

ICF Live Education Sessions:  These face-to-face sessions provide an opportunity to gain information and to answer questions raised by research personnel in a safe environment. These sessions welcome hypothetical scenarios.  Sessions are held monthly on the 2nd Thursday of every month.

For more information on these initiatives, please click on the appropriate link on the side bar.