Research Informed Consent Creation and Guidance
OCRICC has created a guidance document for research teams on how to prepare and submit the Informed Consent Form for OCRICC review
Documenting Consent and HIPAA Authorization
Froedtert Health is required by law to retain any signed patient authorizations and be able to provide the individual with a copy when requested. A procedure or treatment that involves potential risk to the patient requires that the hospital have a written, signed informed consent documented in the legal health record.
Additionally, a copy of the research Informed Consent has been the required documentation for FH patients participating in research. The Health Insurance Portability and Accountability Act (HIPAA) privacy rule allows for a combined research consent reflecting both consent to the research and consent for the use or disclosure of PHI needed for the research. This format is what is standardly used on the FH/MCW campus for research. The hospital retains all of our authorization forms in EPIC.
Facilitating Research-Related Claims Management Post-Approval
FH OCRICC requires timely subject status updates in either OnCore or EPIC, as well as timely consent notification to trigger the regulatory and operational processes necessary for research participant claims management. This includes invoicing needs and/or routine care claims modification needs based on the agreed-upon financial (MCA or SIG).
FH OCRICC instructs that, within 24 hours of enrollment, Research Staff must:
- Update their subject status either via OnCore or manual entry in EPIC. Subject status must be updated to ensure compliant billing & invoicing for your study subject. Missed associations will result in escalation as this is a critical area for documentation compliance.
- E-mail a PDF copy of the signed research informed consent form to the OCRICC program e-mail [email protected]. Research staff must place the patient name and MRN (handwritten, typed or a cadence label) on the bottom of every page. If the forms are two sided, this labeling must be on each page. Incomplete or inaccurate consent forms cannot be accepted and will be returned to the research staff to rectify.
Process if Patient Withdraws Consent
If a patient withdraws consent, is removed from the study by the investigator or sponsor, or is lost to follow-up at a later date, research staff must update their subject status either via OnCore or manual entry in EPIC for the purposes of accurate hospital billing.
