Patient Autonomy and Informed Consent



Patient Autonomy and Informed Consent




Learning Objectives


After completing this chapter, the reader will be able to perform the following:


• Describe the relationship between autonomy, the respect for autonomy, and informed consent.


• Identify the stresses involved in granting informed consent and autonomy.


• List methods of verifying informed consent.


• Define surrogacy.


• Compare and contrast competence and incompetence.


• Correlate coercion, paternalism, and therapeutic privilege.


• Explain why emergency situations and certain facilities may alter informed consent processes.


• Identify ethical theories that may be implemented to facilitate problem solving.


• Give examples of the difference between intentional and unintentional torts and ways the perception of intent rather than the actual intent may be the basis for allegations.


• Provide examples of simple consent as it relates to assault, battery, and false imprisonment.


• Define informed consent.


• Differentiate standards of care with regard to the duty of informed consent.


• Define and contrast the roles of the physician and the imaging professional in informed consent.


• Identify the important but limited role of the consent form.



Key Terms




Professional Profile



A client with cancer comes to the radiotherapy clinic at a most challenging time in his or her life. For many, it is a time filled with emotional anxiety, social disruption, physical strain, and uncertainty. My primary role as a radiation therapist is to deliver a precise amount of radiation to the cancer, and in doing so try to bring about a positive change and a return to normalcy for the client. How my goal is achieved depends on many ethical and legal issues that provide the framework for all of my professional responsibilities.


Within my scope of practice I need to be intimately familiar with the protocols, codes, guidelines, and legislation that outline the specific techniques I perform as a radiation therapist but also what I ought to do as a health care provider. There are many scenarios in radiation therapy where there are ethical and legal concerns. These issues may be very clear but at times may be elusive and complex. Here are some situations from my experience that demonstrate these concerns:



• Signing my initials in a logbook for a daily quality assurance procedure that was performed on a treatment unit


• Ensuring that I have the correct client when retrieving him or her from the waiting room


• Asking a client for permission for a student to participate in his or her simulator planning procedure and then balancing the needs for student learning, client comfort, and efficiency


• Reporting unusual or unexpected variances in the treatment process


• Counseling a client at his or her level within my scope of practice, such as educating a client on the anticipated side effects, offering emotional support, and providing referrals to other departments


• Covering up all patient lists and hospital records when the family of a client watches the client on a CCTV monitor in the control area during treatment


• Deciding during portal imaging if a field border deviating 3 mm away from the expected position is acceptable and whether or not to proceed with irradiation


• Communicating with the family members of a client from a non-Western culture who does not speak English and is unaware that he or she is being treated for cancer


• Treating a comatose client for an oncologic emergency without having prior written consent for treatment from either the client or a substitute decision maker (in radiotherapy it is rare not to have written consent at the time of treatment)


These situations are related to concepts of informed consent, client confidentiality, or professional practice, all of which have ethical and legal considerations. As an instructor, I emphasize to students that poorly made decisions can potentially have serious implications. To the client, these consequences could be disastrous: breach of confidentiality, physical harm, severe and debilitating radiation side effects, and radiation-induced death. To the hospital, damage to its reputation could be irreparable. To the therapist, it could mean the end of a professional career, loss of income, and criminal convictions. Health care workers are fully accountable for their actions (or inactions) and must always exercise diligence and vigilance in the care of the client.


The perspectives of care can vary, and I have learned that what is important to me as a radiation therapist may be much less important to the client. For example, I value the client’s compliance in attending daily treatments because daily fractions help to increase tumor cell kill. However, for some clients, visiting the clinic every day for treatment may not be a priority because of other competing interests such as work obligations, family schedules, and transportation issues. Having cancer is only another part of the client’s life. The ethical and legal considerations become more apparent when the standard policies and procedures do not fit the needs or expectations of the client. I have a moral obligation to ensure not only that the client is being cared for, but also that the client feels cared for.


While I work within a multidisciplinary team of highly trained health care workers and support staff, the clients are the leaders of the team. They rightfully demand superb health care while expecting good outcomes and positive experiences. For the health professional, this comes about through exercising good judgment, employing the appropriate skills, and carefully reflecting upon one’s own limitations and strengths.




ETHICAL ISSUES


Informed consent is a common concern in all the imaging modalities. Imaging professionals must be proficient in the recitation of facts and figures required to inform the patient. Health care providers, however, should also be able to provide patients with a process that renders them truly knowledgeable about procedures and their alternatives.




During the early stages of development within the medical community, the patient’s autonomy was not a serious consideration. Physicians were expected to be omniscient and were rarely questioned. They acted as the “fathers” of their clientele. This paternalism and the invocation of therapeutic privilege were standard professional philosophies. As years passed and patients became more aware of their rights and privileges, however, the medical community developed new methods of informing patients. The emphasis on patient autonomy and informed consent has come from many areas (Box 4-1).



BOX 4-1   CRUCIAL ELEMENTS IN PATIENT AUTONOMY AND INFORMED CONSENT






Some physicians still find the model of patient education difficult because they believe that the informational process complicates health care and brings their expertise into question. Fortunately, however, most physicians and institutions understand the relevance of informed consent and patients’ rights.


Maintaining patient autonomy and obtaining valid informed consent are vital in the vascular imaging laboratory. Imaging professionals routinely visit patients before procedures and explain the processes, contrast media involved, and physical sensations to which the patient will be subjected. They may also discuss imaging procedures with patients during transportation and preparation. These are important parts of the informational process and are vital to the maintenance of patient autonomy. Occasionally the imaging professional may be required to witness the signing of a written informed consent form. Other imaging procedures, including fluoroscopic studies, vascular studies, and a variety of other noninvasive and invasive examinations, often require the technologist to facilitate the informed consent process. Imaging professionals must decide on the basis of personal and professional parameters whether this is appropriate, and they must remember that the physician is ultimately responsible for the informed consent process.




PATIENT CARE PARTNERSHIP


The patient’s right to information is important in considerations of autonomy. The American Hospital Association has established a patient care partnership document (see p. 255),2 which is to be given to hospitalized patients to help them understand the expectations, rights, and responsibilities regarding their health care.


Expectations should include high-quality hospital care delivered with skill, compassion, and respect. Patients have the right to know the identity of physicians, nurses, and other health care providers. They also have the right to know if they are being treated by students, residents, or other trainees. Patients should expect a clean and safe environment, including special policies and procedures to avoid mistakes in care and ensure freedom from abuse or neglect.


Patients should expect to be involved in decision making regarding care. This includes discussing medical conditions and information about medically appropriate treatment choices. Patients should be informed of the benefits and risks of each treatment, whether that treatment is experimental or part of a research study, what can reasonably be expected from the treatment, and any long-term effects it might have. The financial consequences of using noncovered services or out-of-network providers should be explained. Patients should expect to be informed of what they and their families will need to do upon leaving the hospital.


When entering the hospital, the patient signs a general consent-for-treatment form. Specific treatments such as surgery, invasive procedures, or experimental treatments may require specific consent, called informed consent, which confirms in writing what is planned and the patient is agreeing to as part of that plan. This process protects the patient’s right to consent to or refuse a treatment. The physician must also explain the consequences of refusing recommended treatment.


To make good decisions regarding care, caregivers need complete and correct information from patients about their health and coverage. The patient is responsible for delivering this information, which includes past medical history, past allergic reactions, medicines and dietary supplements, and specific health plan information, as well as health care goals, values, or spiritual beliefs important to the patient’s well-being. Patients should make available to the physician and the hospital any documents such as a living will or advance directive regarding health care decisions.


Patients’ privacy is protected by state and federal laws, as well as hospital operating policies. Patients receive a notice of privacy practice document that outlines the way information is used, disclosed, and safeguarded. This also explains how a patient can obtain a copy of the information regarding care.


Patients can expect assistance with treatment plans when leaving the hospital, including arrangement of follow-up care and disclosure of any financial interest in any such referrals. They can also expect hospitals to file claims with health insurers, Medicare, and Medicaid, as well as provide help with needed documentation, explanation of hospital bills, and insurance coverage.



INFORMATION DELIVERY


The way in which information is given depends on the criteria used to inform the patient. The following four potentially conflicting rules may guide the physician or other health care provider in explaining information to patients1:



Institutional rules must also be taken into account.





Prudent Person Rule


The prudent person rule, or reasonable patient standard, measures the physician’s disclosure to the patient based on the patient’s need for information to make decisions regarding treatment.1 The imaging professional must consider the information the patient needs to make informed decisions concerning a procedure. In the previous examples, the imaging professional or physician would have to decide how much the patient needs to know before he or she can make an adequate informed consent decision.



Subjective Substantial Disclosure Rule


The subjective substantial disclosure rule encourages the physician to disseminate all information important to the individual patient. In responding to the previous examples, the physician would feel obliged to explain all the possible ramifications of the examinations to the patient.


The prudent person rule addresses many of the important elements of informed consent. A combination of the prudent person rule and the subjective disclosure rule, which requires the physician to communicate meaningfully with the patient, provides the information the patient needs to make an informed decision. Such a combination ensures that the physician has adequate knowledge about the patient and the patient has adequate knowledge about the procedure (Box 4-2).



BOX 4-2   RULES FOR EXPLAINING PROCEDURES






COMPLICATIONS OF AUTONOMY, INFORMED CONSENT, AND RIGHT OF REFUSAL


After examining the issues included in defining patient autonomy and protecting patient rights, imaging professionals should be able to recognize the dilemmas involved in ensuring informed consent. Whether a patient may ever give truly informed consent is open to question. To be totally informed, the patient would need to be educated in many areas from anatomy to imaging procedures. Imaging professionals may consider whether this is possible or whether informed consent is simply an idealistic (although necessary) ritual. They must also recognize their responsibility in the process of obtaining informed consent. Even if the procedure is complicated to explain, imaging professionals should make every effort to help patients become more knowledgeable. Until patients become responsible for providing and obtaining information concerning their medical procedures, a truly informed, educated consent that ensures autonomy may never be realized.


The Patient Self-Determination Act of 1991 helps ensure patient autonomy3:


Heeding the principle of autonomy … means that imaging professionals should respect a patient’s choice to refuse treatments. The basic human right of all patients to refuse treatment was formally legislated by the Omnibus Budget Reconciliation Act (1990). The Patient Self-Determination Act became effective December 1, 1991, and requires all health care institutions receiving Medicare or Medicaid funds to inform patients that they have the right to refuse medical and surgical care and the right to initiate a written advance directive (i.e., a written or oral statement by which a competent person makes known his or her treatment preferences and/or designates a surrogate decision maker in the event he or she should become unable to make medical decisions on his or her own behalf [Box 4-3]). Hospitals, home health care agencies, and managed care organizations are required to make this information available, in writing, at the time the patient comes under an agency’s care.



BOX 4-3


REQUIREMENTS OF THE PATIENT SELF-DETERMINATION ACT




From the Omnibus Budget Reconciliation Act of 1990, Sections 4206 and 4751, Public Law 101-508, November 5, 1990.



VERIFICATION OF INFORMED CONSENT


One ethical challenge inherent in many imaging procedures is the appropriateness of the verification of informed consent. Imaging professionals should always be available to answer patients’ questions concerning their procedures. However, questions concerning specifics of informed consent such as alternative therapies, failure rate, risks, or other subjects should always be directed to the patient’s physician.


The physician has a crucial role in the process of obtaining informed consent. Because of their knowledge and expertise, physicians bear the responsibility for informing patients concerning procedures. To facilitate the informed consent process, the imaging professional should refer the patient to the physician if the professional feels questions about the procedure are out of his or her field of expertise.


An important ethical consideration is whether imaging professionals should allow themselves to be placed in the position of witnessing the patient’s signature on the informed consent form. Imaging professionals are commonly given the responsibility of getting the patient to sign the imaging procedure consent form. If they are not present when the patient’s physician presumably gives the necessary instructions and explanations to the patient, they are qualified only to witness the fact that the patient has signed the form.


Many imaging professionals involved in carrying out informed consent procedures find themselves in the difficult situation of determining how much of the responsibility for informed consent is theirs. Nevertheless, probably few have ever questioned this process. Many student imaging professionals are required to explain the injection of contrast media and possible reactions to patients as part of their clinical objectives. Although students must learn this skill, imaging professionals may need to consider whether this important patient education duty should be left to students and whether this is conducive to the patient’s truly informed consent and the imaging professional’s protection from liability.


An example of the difficulties inherent in ensuring patient autonomy and eliciting truly informed consent may be observed in a fluoroscopic imaging suite in which gastrointestinal procedures are performed. The patient may have been informed, but can anyone ever be ready for an air contrast colon examination? Patients subjected to this procedure are already afraid, sick, and in pain and may feel as though they have no control over their care. Imaging professionals need to consider ways of facing this challenge and informing patients as fully as possible about an often dehumanizing procedure without completely discouraging them from an examination that may have enormous diagnostic benefits. Throughout all of this, the dignity and autonomy of the patient must be preserved.


An imaging professional may overhear a co-worker speaking disrespectfully about an unconscious or deaf patient. Because respect for freedom and privacy is ultimately rooted in the dignity of each person, the maintenance of autonomy requires health care providers to respect all individuals, even those who are not currently capable of free choice.1 In short, people do not lose their dignity because they are unconscious, in a coma, or out of contact with reality. Such patients present special difficulties, but they must nevertheless be respected. Dignity and autonomy do not stem from a person’s ability to function in an imaging suite; instead, the clinical area should accommodate itself to the individual’s limitations.



COMPETENCE AND INCOMPETENCE SURROGACY


Competence is a necessary element in informed consent. In the medical setting, competence entails the ability to make appropriate choices and consider their consequences. A patient’s competence may be temporarily compromised by prescription or over-the-counter drugs. In this condition of short-term incompetence, the patient may require a surrogate or postponement of the procedure until the patient is competent. Incompetence is difficult to prove. An evaluation of the patient’s ability to make decisions is an important component in determining competence.

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Feb 27, 2016 | Posted by in GENERAL RADIOLOGY | Comments Off on Patient Autonomy and Informed Consent

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