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Legally speaking: The nurse and informed consent for chemotherapy

Wednesday April 16, 2014
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Informed consent for chemotherapy is an essential prerequisite to the administration of any oral or parenteral chemotherapeutic agent in any healthcare setting. Obtaining the patient’s informed consent for treatment with antineoplastic agents is the oncologist’s responsibility, and all the information the oncologist and patient share and agree to in this process is documented in the patient’s medical record. The oncology nurses’ role in patients’ informed consent also is fundamental.

Initially, an RN must be certain that the informed consent document is complete and accessible in the patient’s record and that both the patient, or his or her legal representative, and the oncologist have signed and dated the document. The nurse also may need to clarify points the oncologist may or may not have emphasized when obtaining informed consent for chemotherapy. For example, the nurse may need to discuss follow-up appointments and lab tests, which should be noted on the informed consent form, to avoid any undue anxiety about treatment and what happens after treatment is completed.

If a patient has concerns about treatment, the nurse, as an advocate, must bring those concerns to the oncologist’s attention for a resolution. Nurses will need to document any issues raised and resolved in the patient’s record. If the patient seems hesitant to begin chemotherapy, or if he or she clearly decides not to begin chemotherapy, the informed consent previously obtained is null and void. The nurse must contact the oncologist about the patient’s retraction of consent and document the retraction, that the oncologist was informed, and any resolutions or changes to a patient’s decision about discontinuing chemotherapy treatment.

Before initiating chemotherapy, the nurse needs to confirm the chemotherapy order is in place and meets prescribing standards. No verbal orders should be allowed, except when it is necessary to hold or stop chemotherapy. All orders must be documented in the patient record and include such information as the patient’s full name (and second patient identifier); dosage; allergies; route and rate of administration; and the chemotherapeutic agent(s) to be administered in the regimen and their respective dosing parameters, time limitations for the treatment, and supportive care treatment, such as hydration and premedication.

Selected fundamental elements of informed consent for chemotherapy

Oncologists discuss the following topics with patients to make sure patients make informed decisions about chemotherapy:
• What treatment will involve — what chemotherapy agents will be used, frequency and length of treatment, etc.
• Goals of treatment
• Anticipated benefits
• Results or consequences if patient refuses treatment
• Risks of treatment
• Alternatives to treatment
• Side effects of chemotherapy (e.g., fatigue, low red blood cell count, risk of infection, mouth and throat sores)
• Complications of chemotherapy
• Stopping chemotherapy

Source: American Society of Clinical Oncology (2008).
Available at ASCO.org/qualityguidelines/informed-consent-chemotherapy-administration

Another important duty for the oncology nurse before treatment begins is patient and family education concerning the chemotherapeutic regimen. The nurse should discuss issues such as food and other drug interactions with the antineoplastic agent(s), how the treatment plan will be adjusted if a treatment or dose is missed, supportive measures, and patient and family education if they will be managing the treatment at home.

The nurse’s role in the informed consent process for chemotherapy is an important and essential one. With your guidance, the patient’s right of providing informed permission to undergo this particular treatment may be fully realized.

To see what else is trending in cancer care, visit www.Nurse.com/Cancer.


2013 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards Including Standards for the Safe Administration and Management of Oral Chemotherapy,” 40(3) Oncology Nursing Forum

American Nurses Association (2001). Code of Ethics for Nurses With Interpretive Statements. Silver Springs, MD, Provision 1.4

Nancy J. Brent, RN, MS, JD, is Nurse.com's legal information columnist and an attorney in private practice. This article is for educational purposes only and is not to be taken as specific legal or other advice. Post a comment below or email specialty@nurse.com.