SOP: Monitoring Informed Consent, HIPAA & Consent Process

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:

• The study is newly approved by the IRB
  • The first three consents will be reviewed.
• Individuals obtaining consent are new to Rush or new to obtaining research consent (The study site is responsible for initiating this process.)
  • The first three consents will be reviewed.
• A COI Management Plan was issued and requires the ICF to be amended
  • The first consent will be reviewed

Additional criteria includes:

• Upon receipt of the decision/request by the IRB following review of an amendment, continuing review or non-compliance issues by the IRB
  • The first two consents will be reviewed
• Upon receipt of the IRB decision that past and/or currently enrolled subjects must be re-consented
  • The first two consents will be reviewed

** 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:  

• Informed Consent Form (ICF)
• Documentation of the Informed Consent Process (signed and dated by the individual obtaining consent)
• HIPAA Authorization Form (when applicable)
• Short Form (when applicable)
• Assent Form (when applicable)
• Subject’s Demographics Page from the medical record
  • For subjects reviewed via the OnCore™ system, this additional document is not necessary.

Questions about the new process can be directed to:

Jennifer Strong, MS, CCRP
Research Compliance Specialist
Jennifer_Strong@rush.edu
Tel: 312-563-2107