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. Turn-around time for administrative approval may be impacted if the ICF guidelines are not followed. Contact the OCRICC clinical consultant assigned to your study with any questions or concerns.

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 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 study MCA and/or Billing Plan.

Researchers are instructed that within 24 hours of enrollment, research staff must email a pdf copy of the signed research informed consent form to the OCRICC program email 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 inform OCRICC within 24 hours of status change for the purposes of accurate hospital billing. Information from the research study staff must include the patient participant name/MRN, study short title, PRO #, OCRICC # and the effective date of the patient's withdrawal from the study.

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