Effective February 1, 2019, The Office of Research Compliance (ORC) and the Institutional Review Board (IRB) implemented a new Standard Operating Procedure (SOP) titled: Monitoring Informed Consent, HIPAA & Consent Documentation.
The SOP outlines the process to monitor and assess investigator compliance with regulations and Rush policies relating to Informed Consent (IC) in Human Subject Research studies where informed consent is required. SOP: Monitoring Informed Consent, HIPAA & Consent Process
Criteria for review includes the following:
Additional criteria includes:
** NOTE: If unsatisfactory results are obtained during the review process, monitoring will continue until demonstrated successful passing of all elements of proper ICF execution is obtained.
For clinical research studies registered in OnCore™ (CTMS), the ORC will review all documentation uploaded to the system. No additional submissions are necessary, unless requested by the ORC. For individuals new to consenting research subjects at Rush and studies that are not registered in OnCore™(CTMS), research personnel will submit the documentation via email to ORC_ICF_Review@rush.edu.
The following executed documents required for review are:
Questions about the new process can be directed to:
Jennifer Strong, MS, CCRP
Research Compliance Specialist
Jennifer_Strong@rush.edu
Tel: 312-563-2107