Nurse's Role in Medication Informed Consent
Nurses cannot initiate the medication informed consent form on behalf of healthcare providers, as informed consent is a nondelegatable duty that must be performed by the prescribing physician. 1
Legal and Ethical Framework
The informed consent process is based on three fundamental ethical principles:
- Beneficence (acting in the patient's best interest)
- Autonomy (respecting patient's right to make decisions)
- Justice (treating patients fairly and responsibly) 2
The process requires:
- Disclosure of material risks, benefits, and alternatives
- Patient comprehension of the information
- Voluntary decision-making without coercion
- Documentation of the consent conversation 1
Physician vs. Nurse Responsibilities
Physician Responsibilities:
- Providing information about diagnosis, treatment options, and risks
- Ensuring patient understanding of material risks and benefits
- Answering questions and addressing concerns
- Obtaining and documenting informed consent 1
Nurse Responsibilities:
- Supporting patient education
- Verifying patient understanding
- Assisting with documentation
- Preparing consent forms for the physician to complete with the patient 1
Documentation Requirements
Proper documentation of medication informed consent should include:
- Evidence that the physician discussed the medication with the patient
- Material risks and benefits explained
- Alternatives presented
- Patient's questions addressed
- Patient's decision to proceed with treatment 1
Clinical Applications
The American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration standards explicitly state: "Informed consent for chemotherapy must be documented by a physician in the practice prior to chemotherapy administration." 2 This standard clearly establishes that physicians, not nurses, are responsible for obtaining informed consent.
Similarly, the American Academy of Allergy, Asthma & Immunology guidelines state that informed consent should be obtained before beginning treatments like Xolair (omalizumab), emphasizing the physician's role in discussing risks, benefits, and alternatives with patients 2.
Common Pitfalls to Avoid
Confusing documentation with consent: The consent form merely documents that a process has taken place; it is not the consent itself 1
Delegating the consent process: While nurses can assist with education and documentation, they cannot legally obtain informed consent on behalf of the provider 1
Inadequate time for patient consideration: Patients should have sufficient time to consider their options and discuss with family when possible 2
Failing to assess patient understanding: Simply having a signed form without ensuring comprehension does not constitute valid informed consent 1
Special Circumstances
In emergency situations, modified consent protocols may apply, but this does not transfer the responsibility of obtaining consent from the physician to the nurse 1. The Code of Ethics for Emergency Physicians notes that emergency physicians may treat without securing informed consent when immediate intervention is necessary to prevent death or serious harm, but this is a limited exception 2.
While nurses play a crucial role in the healthcare team and can support the informed consent process through patient education and documentation preparation, the legal and ethical responsibility for obtaining informed consent remains with the prescribing healthcare provider.