Design and implementation of an informed consent process before liver transplantation

Area of Science:

• Transplantation Medicine
• Patient Education
• Informed Consent

Background:

• Historically, patient education content for organ transplantation varied significantly between centers.
• The Department of Health and Human Services and Centers for Medicare and Medicaid Services mandated standardized educational materials in 2007.

Purpose of the Study:

• To describe the development and implementation of a standardized informed consent form and educational process.
• To ensure adherence to new federal regulations for potential liver transplant recipients.

Main Methods:

• Development of a standardized informed consent form.
• Implementation of a structured educational process for patients undergoing evaluation for liver transplantation.
• Adherence to guidelines from the Department of Health and Human Services and Centers for Medicare and Medicaid Services.

Main Results:

• Successful development and use of a standardized informed consent form and educational process.
• Compliance with federal regulations for patient education in liver transplantation.

Conclusions:

• The developed informed consent process and educational materials meet regulatory requirements.
• This model can be adopted nationally to standardize patient education for liver transplant candidates.