Prior to undergoing certain medical procedures or participating in a research study or patient registry, patients will go through a process of providing their informed consent. The process includes the signing of a consent form that spells out a number of issues surrounding a treatment the patient will be undergoing. It is an important process that recognizes the patient’s fundamental right to understand treatments, options, their associated risks, and their right to take an active role in deciding whether to participate in research or pursue a particular treatment.
Informed consent is both a legal and ethical requirement. It is based on the concept that patients have the right to know their medical options, understand the potential consequences of those choices, and make informed decisions about their own healthcare.
The legal requirements for informed consent vary from state to state, and federal regulations provide minimum requirements for informed consent that providers and researchers must meet. In some instances, state laws require specific information be provided to patients as part of an informed consent process. These laws may also dictate the types of procedures that require informed consent from patients. In other cases, states provide general requirements and may call for the disclosure of “reasonable” information or call for “full and complete disclosure,” according to the American Cancer Society.
Understanding Complex Medical Issues
Fundamental to the process of informed consent is that patients understand what their medical provider is telling them about their condition, the treatment options, and the risks associated with these options. The ability of patients to understand the information their physician provides during the informed consent process will vary greatly. As many as nine out of 10 Americans have limited health literacy skills, according to the U.S. Department of Health and Human Services (HHS).
Health literacy is defined by HHS as “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.” Healthcare literacy can be affected by the patients’ language skills, education, cognitive impairment, learning disabilities, hearing or vision impairment, as well as such things as stress and feelings of intimidation.
Informed consent is more than a document. It is a process. As part of this process, patients should be able to gain access to the information they need to make an informed decision about their own care. This includes being able to ask questions of their doctor, access to supplemental information that explains a particular medical condition or procedure, and adequate time to review the information and reach a decision. It is critical that patients feel as if they have the information they need to make a decisions about treatment and that they get answers to any questions or concerns they have prior to providing their consent to treatment.
Even when patients provide written consent for a procedure, researcher have found that they often do not understand the information in the consent form, according to the National Quality Forum, a Washington, D.C.-based nonprofit working to improve healthcare. After signing a consent form, the organization reports that as many as 45 percent of patients can’t identify a major risk of surgery and many cannot answer basic questions about the procedures they have agreed to receive. In fact, 60 to 69 percent did not read or understand the information in the informed consent form even though they signed it. This suggests that despite ongoing efforts to improve the informed consent process, it remains flawed and that both providers and patients need to do a better job of ensuring a comprehensive understanding of all elements of a procedure.