What You Need to Know About Obtaining Informed Consent

The American Society of Clinical Oncology/ONS Chemotherapy Administration Safety Standards (https://doi.org/10.1200/JOP.2016.017905) explain that informed consent provides a patient with “sufficient information about the disease diagnosis and treatment options so that the individual can make a reasonable decision about treatment on the basis of an understanding of the potential risks and anticipated benefits of the treatment.”

Answers to many of the common questions about informed consent, including what types of treatment options require it, who must provide the education and sign consent forms, and the frequency at which patients should be reconsented depend on whether a patient is being treated with investigational agents in the setting of a clinical trial or approved, on-label drugs.

Care Setting

Prior to enrollment on a clinical trial involving any treatment modality, patients are required to sign an approved informed consent document (https://www.ons.org/store/books/chemotherapy-and-biotherapy-guidelines-and-recommendations-practice-fourth-edition) that outlines treatment plan, testing requirements, known and expected side effects, and expected duration of treatment. When receiving approved cancer treatment regimens, informed consent practices are more vague and depend on institutional policy and procedures. Clear policies will ensure consistency across care settings.

Approaches

Because the informed consent process indicates that patients or caregivers understand the treatment, including its risks and benefits, they must also understand and agree to any change in the treatment plan. This may be by way of signing a consent form or documenting the conversation in the progress notes. Because practitioners take different approaches, each work setting needs to determine its own policies and ensure they are being followed.

Multiple approaches may be used to obtain informed consent, and institutions are not held to one standard or requirement. Historically, the following approaches have been used:

• The patient signs a consent form designed specifically for the administration of antineoplastic medications and is part of the medical record.
• A general procedure consent form is used for antineoplastic medications.
• The general hospital “consent to treat” document serves as the signed permission to provide antineoplastic medications.
• A specific form is not signed, but consent is documented in the medical record.

Institutions must also consider which agents will require informed consent. Some classes of antineoplastics (e.g., biologics, hormonal therapy, targeted therapy, immunotherapy) are not necessarily “chemotherapy”; they are used in cancer treatment plans either independently or in combination with chemotherapy to augment cell kill and treatment efficacy. Those differences factor into a patient’s comprehensive understanding of treatment plans.

Similarly, institutions must decide which staff can obtain informed consent. Different settings will have varying policies regarding nursing’s role in obtaining informed consent. However, what is universal is the nurse’s role as an advocate in ensuring patients’ or caregivers’ comprehension and agreement to the treatment plan, providing the education needed to make informed decisions involving health care and treatment options, and communicating questions and concerns to the healthcare team.