Understanding informed consent

The failure of a physician to disclose all of the risks associated with an operative procedure is considered a breach of professional duty and, therefore, a negligent act. Consent for a procedure does not necessarily have to be written; however, signed forms provide written evidence of the patient's agreement. Documentation is essential, especially in cases where the consent form is incomplete or incorrectly filled out. Any concerns about a patient's consent or lack of consent should be discussed with the surgeon.     

Barriers to informed consent

OBJECTIVES: To provide oncology nurses with a review of barriers that may limit the ability of adults to provide informed consent. DATA SOURCES: Published articles, research studies, and review articles pertaining to informed consent and clinical research. CONCLUSIONS: Patient-centered barriers to informed consent (such as age, education, and illness) and process-centered barriers (such as content and readability of the consent form, timing of discussion, and amount of time allotted to the process) can affect an individual's ability to provide substantial informed consent. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses must be aware and knowledgeable of the various barriers to informed consent to minimize these barriers and to improve and facilitate the informed consent process.     

Understanding informed consent.

Understanding and facilitating the informed consent process is our duty as perioperative nurses. Acting as patient advocates, we must determine if our patients have given "informed consent" prior to surgical treatment. When we witness our patients signing consent forms, we must be sure they are competent to sign; that they have spoken with the physician and have discussed the proposed procedure (including the risks, benefits and alternative treatments) and have had their questions answered; and have read the consent form they are being asked to sign. As nurses, we must become aware of our responsibilities related to informed consent. By understanding the concept of informed consent and its legal implications, we will be able not only to the facilitate informed consent process but also to fulfill our legal responsibilities.     

Approaches to informed consent

Informed consent (IC) is an indicator, or a pivotal point, in broader and more fundamental questions dealing with the way clinical experimentation and, more specifically, randomized controlled trials (RCTs) relate to routine clinical practice; the rules that characterize the doctor-patient relationship; the self-perception of medicine with respect to its capacity, duty, and autonomy in the production of new knowledge; and the role of medicine in society. The asymmetry of knowledge and power that characterizes the usual relationship between care providers and patients does not resolve when something experimental enters the relationship. The real world of clinical investigation is not uniformly distinct from clinical practice. Experimentation is more appropriately considered a continuum with respect to appropriate or recommended care. Fundamental patient rights come first and are more binding than compliance with procedures and regulations. The view that IC is the most important component of the “ethical” aspects of experimentation is highly misleading. The responsibility to foster well-informed decisions shapes the contents, the timing, the validity, and the credibility of IC. Documented, evaluable decisions are the natural substitute for individual IC when the patient is not able to handle information autonomously. Positive examples of IC practices and approaches suggest that IC may be important in improving the way medicine responds to its responsibilities and communicates with society.     

Stay in-the-know regarding informed consent

Informed consent hinges on educating patients about their proposed treatments.     

Genetic testing and informed consent

OBJECTIVES: To discuss unique issues related to cancer predisposition genetic testing and informed consent. DATA SOURCES: Published professional articles, review articles, research articles, clinical practice, position statements, websites, and textbooks. CONCLUSIONS: The discovery of germline mutations that confer a predisposition for the development of cancer will continue. The provision of adequate information is central to the process of genetic counseling and testing so that individuals may give informed consent and make choices appropriate to their own specific circumstances. IMPLICATIONS FOR NURSING PRACTICE: The use of genetic information for the management of cancer will impact the practice of all oncology nurses in the coming years. Knowledge of genes that predispose for cancer and standards that delineate essential components of quality care during the informed consent process is vital.