The Infusion Nurses Guide to Informed Consent

The Infusion Nurses Society's Infusion Therapy Standards of Practice, 9th Edition (2024) outlines comprehensive guidelines for obtaining informed consent in infusion therapy. These standards emphasize the ethical and legal imperatives of informed consent, ensuring patient autonomy and safety.

INS Standards on Informed Consent

Standard 9: Informed Consent

1. Requirement for Informed Consent: Informed consent must be obtained for all infusion and vascular access-related procedures, aligning with jurisdictional laws and organizational policies. 
2. Clinician Responsibility: The clinician performing the invasive procedure (e.g., central vascular access device insertion) is responsible for facilitating and ensuring the informed consent process. 
3. Patient Rights: Patients or their surrogates have the right to accept or refuse treatment. 
4. Research Participation: Informed consent is mandatory for human subject participation in research, adhering to relevant laws and regulations. 

Practice Recommendations:

• Educational Process: Obtaining informed consent is a collaborative educational process involving dialogue between the patient/surrogate and the clinician.
• Documentation: The process concludes with the patient/surrogate signing a consent document or providing verbal consent, as per organizational policy.
• Ongoing Treatments: Continued confirmation of informed consent may be necessary for ongoing treatments like hemodialysis or antineoplastic administration.
• Jurisdictional Variations: Clinicians must follow requirements for obtaining informed consent, recognizing that regulations vary across jurisdictions. 
• Key Elements of Informed Consent:
  • Voluntary consent, free from coercion.
  • Patient/surrogate comprehension of relevant information.
  • Provision of necessary information about the procedure, including risks, benefits, and alternatives.

Additional References on Informed Consent

Centers for Medicare & Medicaid Services (CMS) Updates:

As of April 1, 2024, CMS revised its Hospital Interpretive Guidelines for Informed Consent to reinforce hospitals' obligations. Key points include:

• Ensuring informed consent is obtained before allowing practitioners or students to perform sensitive examinations, especially on anesthetized patients.
• Hospitals must have clear policies and processes that allow patients or their representatives to make fully informed decisions about their care.

AABB Guide to Informed Consent in Transfusion Medicine:

The AABB emphasizes that informed consent is more than just a signed form; it's an educational process involving clear communication between the patient and healthcare provider. The guide outlines legal and ethical foundations, key elements for both donors and recipients, and the responsibilities of physicians overseeing transfusion procedures.

Healthcare Ethics and Informed Consent:

A comprehensive guide by the American Institute of Health Care Professionals (AIHCP) highlights the ethical foundations of informed consent, emphasizing patient autonomy and shared decision-making. It outlines the key elements and challenges of informed consent, advocating for effective communication techniques and proper documentation to enhance patient understanding and participation.

In summary, the INS standards, along with updates from CMS and guidance from organizations like AABB and AIHCP, underscore the critical importance of informed consent in healthcare. These guidelines ensure that patients are fully informed, their autonomy is respected, and ethical standards are upheld in clinical practice.