Informed consent (Salem Health: Cancer)
Informing the patient: Patients receive information about the proposed medical course of action. It should be as nontechnical as possible to ensure that it is understandable. Explanations can be in the following forms:
- Verbal, via the physician or other health care provider
- Written, via patient information handouts or educational booklets
- Short films on video or DVD
- Computer-provided interactive tutorials
After receiving comprehensive information, patients are to have all their questions answered in language that they are able to understand.
Nonsurgical treatments: For treatments, the American Cancer Society recommends that patients include questions about the diagnosis that has prompted the procedure, including how serious the condition is; the recommended treatment methods and possible benefits and risks of having, or not having, the treatment, including the effect on normal functions and everyday activities and possible immediate, short-term, and long-term side effects; other treatment options, if available, and their possible benefits and risks; any potential discomforts associated with the treatments and the methods used to prevent or relieve those discomforts; the treatment’s duration; and the treatment’s cost.
Surgical procedures: For surgical procedures, the American College of Surgeons recommends that patients pose...
(The entire section is 729 words.)
For Further Information (Salem Health: Cancer)
Berg, J. W., P. S. Appelbaum, C. W. Lidz, and L. S. Parker. Informed Consent: Legal Theory and Clinical Practice. New York: Oxford University Press, 2001.
Faden, R. R., and T. L. Beauchamp. A History and Theory of Informed Consent. New York: Oxford University Press, 1986.
U.S. Food and Drug Administration. Guidance for Institutional Review Boards and Clinical Investigators: A Guide to Informed Consent. Rockville, Md.: Author, 1998.
(The entire section is 66 words.)
Other Resources (Salem Health: Cancer)
American Cancer Society. Informed Consent. http://www.cancer.org/docroot/eto/content/eto_1_2x_informed_consent.asp
American College of Surgeons. Giving Your Informed Consent. http://www.facs.org/public_info/operation/consent.html
American Hospital Association. Patient Care Partnership. http://www.aha.org/aha/issues/Communicating-With-Patients/pt-care-partnership.html
National Cancer Institute. A Guide to Understanding Informed Consent. http://www.cancer.gov/ClinicalTrials/AGuidetoUnderstandingInformedConsent
U.S. Food and Drug Administration. Guidances, Information Sheets, and Important Notices on Good Clinical Practice in FDA-Regulated Clinical Trials. http://www.fda.gov/oc/gcp/guidance.html
(The entire section is 92 words.)
Informed Consent (Encyclopedia of Surgery)
Informed consent is a legal document in all 50 states. It is an agreement for a proposed medical treatment or non-treatment, or for a proposed invasive procedure. It requires physicians to disclose the benefits, risks, and alternatives to the proposed treatment, non-treatment, or procedure. It is the method by which fully informed, rational persons may be involved in choices about their health care.
Informed consent stems from the legal and ethical right an individual has to decide what is done to his or her body, and from the physician's ethical duty to make sure that individuals are involved in decisions about their own health care. The process of securing informed consent has three phases, all of which involve information exchange between doctor and patient and are part of patient education. First, in words an individual can understand, the physician must convey the details of a planned procedure or treatment, its potential benefits and serious risks, and any feasible alternatives. The patient should be presented with information on the most likely outcomes of the treatment. Second, the physician must evaluate whether or not the person has understood what has been said, must ascertain that the risks have been accepted, and that...
(The entire section is 1545 words.)
Informed consent (Encyclopedia of Mental Disorders)
Informed consent is a legal document in all 50 states, prepared as an agreement for treatment, non-treatment, or for an invasive procedure that requires physicians to disclose the benefits, risks, and alternatives to the treatment, non-treatment, or procedure. It is the method by which a fully informed, rational patient may be involved in the choices about his or her health. Informed consent applies to mental health practitioners (psychiatrists, psychologists, etc.) in their treatment with their clients in generally the same way as physicians with their patients.
Informed consent stems from the legal and ethical right the patient has to decide what is done to his or her body, and from the mental health provider's ethical duty to ensure that the patient is involved in decisions about his or her own health care. The process of ensuring informed consent for treatment involves three phases, all of which involve information exchange between doctor and patient and are a part of patient education. First, in words the patient can understand, the therapist must convey the details of a treatment or procedure, its potential benefits and serious risks, and any feasible alternatives. The patient should be presented with information on the most...
(The entire section is 1199 words.)
Informed Consent (West's Encyclopedia of American Law)
Assent to permit an occurrence, such as surgery, that is based on a complete disclosure of facts needed to make the decision intelligently, such as knowledge of the risks entailed or alternatives.
The name for a fundamental principle of law that a physician has a duty to reveal what a reasonably prudent physician in the medical community employing reasonable care would reveal to a patient as to whatever reasonably foreseeable risks of harm might result from a proposed course of treatment. This disclosure must be afforded so that a patientxercising ordinary care for his or her own welfare and confronted with a choice of undergoing the proposed treatment, alternative treatment, or none at allan intelligently exercise judgment by reasonably BALANCING the probable risks against the probable benefits.
(The entire section is 131 words.)
Informed Consent (Encyclopedia of Nursing & Allied Health)
Informed consent is a legal document in all 50 states, prepared as an agreement for treatment, nontreatment, or for an invasive procedure that requires physicians to disclose the benefits, risks, and alternatives to said treatment, nontreatment, or procedure. It is the method by which a fully informed, rational patient may be involved in choices about his or her health care.
Informed consent stems from the legal and ethical right the patient has to decide what is done to his or her body, and from the physician's ethical duty to make sure that the patient is involved in decisions about his or her own health care. The process of securing informed consent has three phases, all of which involve information exchange between doctor and patient and are part of patient education. First, in words the patient can understand, the physician must convey the details of a planned procedure or treatment, its potential benefits and serious risks, and any feasible alternatives. The patient should be presented with information on the most likely outcomes of the treatment. Second, the physician must evaluate whether or not the person has understood what has been said, must ascertain that the risks have been accepted, and that the patient is giving consent to proceed with the procedure or treatment with full knowledge and forethought. Finally, the patient must sign the consent form, which documents in generic format the major points of consideration. The only exception to this is securing informed consent during extreme emergencies.
It is critical that the patient receive enough information on which to base informed consent, and that the consent is wholly voluntary and has not been forced in any way. It is the responsibility of the physician who discusses the particulars with the patient to detail the conversation in the patient's record. A physician may, at his or her discretion, appoint another member of the health care team to obtain the patient's signature on the consent form, with the assurance that the physician has satisfied the requirements of informed consent.
Paul H. Ting, M.D., Assistant Professor of Anesthesiology at the University of Virginia and editor of the "About Anesthesiology" web site discusses why patients are apprehensive. "I think that people's greatest concerns arehether they will live or diehether they will feel any pain or be uncomfortablehether they will be well taken care of (and I include in this whether their care will lead to a successful result and whether they will be treated with dignity)
"The boilerplate consent form has good intentions; it is comprehensive and therefore should reflect that a comprehensive discussion was completed," said Dr. Ting. "The actual form itself is in place to protect the hospital and the physician. Legally, it is proof that things have been covered and the patient agrees to the procedure, risks, benefits, options, etc. However, the informed consent process (which the form merely is supposed to document) is in place for the protection of the patient. The process is in place to make sure that everything is discussed with the patientll of the options, all of the common risks, the worst thing that can happen, etc."
The law requires that a reasonable physician standard be applied when determining how much information is considered adequate when discussing a procedure or treatment with the patient. There are three approaches to making this discussion: what the typical physician would say about the intervention (the reasonable physician standard); what the average patient would need to know to be an informed participant in the decision (the reasonable patient standard); and what the patient would need to know/understand to make a decision that is informed (subjective standard).
There is a theory that the practice of acquiring informed consent is rooted in the post-World War II Nuremberg Trials. At the war crimes tribunal in 1949, 10 standards were put forth regarding physicians' requirements for experimentation on human subjects. This established a new standard of ethical medical behavior for the post-WW II human rights age, and the concept of voluntary informed consent was established. A number of rules accompanied voluntary informed consent. It could only be requested for experimentation for the gain of society, for the potential acquisition of knowledge of the pathology of disease, and for studies performed that avoided physical and mental suffering to the fullest extent possible.
As of 2001, most of the 50 United States had legislation that spells out the required standards for informed consent. For example, the State of Washington employs the second approach outlined as the reasonable patient standard. This ensures that the doctor fulfills all professional responsibilities and provides the best care possible and that the patient has a choice in decisions about his or her health care. However, the patient's competence in making a decision is considered. This points to the issue of the patient's "capacity." Anyone suffering from an illness, anticipating surgery, or undergoing treatment for a disease is under a great deal of stress and anxiety. It may be natural for a patient to be confused or indecisive. When the attending physician has serious doubts about the patient's understanding of the intervention and its risks, the patient may be referred for a psychiatric consultation. This is strictly a precaution to ensure that the patient understands what has been explained; declining to be treated or operated on does not necessarily mean the person is incompetent. It could mean that the person is exercising the right to make his or her own health care decisions.
Although it is the law to formally present the procedure or treatment to the patient, physicians do express doubt as to its wisdom. Some believe that informing patients of the risks of treatment might scare them into refusing it when the risks of non-treatment are even greater. But patients might have a different view. Without the complete story, for example, a patient might consent to beginning a particular course of chemotherapy. Convinced by the pressures from a pharmaceutical company, it is conceivable that a doctor will use an agent less effective than a newer treatment. By withholding information about treatment alternatives, the physician may be denying the patient a choice and a chance of an extended life of greater quality.
The international community has also had much to say in this regard. Martin Tattersall, professor at the Sydney University Cancer Medicine Department, and Alan Langslands, professor in Radiation Oncology at Westmead, said in the August 1995 issue of the Medical Journal of Australia, "Our findings indicate the extent of variation in the practice of providing information to cancer patients commencing treatment The current double standard between former clinical trials (where ethics committees require that patients be given a 'plain language statement,' as well as giving their signed consent) and the 'usual' practice outside such trials, is apparently narrowing. The reasons for this may relate to the fear of litigation, rather than recognition of the need to provide full information." A litigious society such as the United States might be plagued by an even greater number of lawsuits than at present if informed consent were not legally mandated.
Undeniably, physicians in surgery, anesthesia, oncology, infectious diseasehe list is endlessre faced with issues regarding Informed Consent. As the federal government takes a more active role in deciding the extent to which patients must be informed of treatments, procedures, and clinical trials in which they voluntarily become enrolled, more and more health care providers must become educated in what needs to be conveyed to patients. This is emphasized by the report of a case in which a federal court (Hutchinson vs. United States [91 F2d 560 (9th Cir. 1990)]) ruled in favor of the physician, despite his failure to advise his asthmatic patient (for whom he had prescribed the steroid, prednisone), of the well-known risk of developing aseptic necrosis (bone death), which did occur. The practitioner neglected to inform the patient that there were other drugs available with a much less serious side effect profile that could have treated the asthma. However, and despite this "neglect," a higher, appellate court reversed the ruling and found the physician guilty. Apparently the patient had used more conservative drugs in the past with good results. The court believed that if the physician had merely advised the patient of the more serious side effects of prednisone and offered the patient more conservative treatment, the physician would have avoided liability.
Nursing professionals have a greater role in evaluating whether the consent is informed or not than they might believe. When a nurse witnesses the signature of a patient for a procedure, or surgery, he or she is not responsible for providing its details. Rather, the role is to be the patient's advocate; to protect the patient's dignity; identify any fears; and determine his or her degree of comprehension and approval of care to be received. Each patient is an individual, and each one will have a different and unique response depending on his or her personality, level of education, emotions, and cognitive status. If the patient can restate the information that has been imparted to him or her, then that will help to confirm that he or she has received enough information and has understood it. The nurse is obligated to report any doubts about the patient's understanding regarding what has been said, or any concerns about his or her capacity to make decisions.
Dunn, Debra. "Exploring the Gray Areas of Informed Consent." Nursing (1999). <<a href="http://www.findarticle.com">http://www.findarticle.com>.
Lehman, C. M., and G. M. Rodgers. "To IRB or Not to IRB?" American Journal of Clinical Pathology 115, no. 2(2001):187-191.
Lutz, S., and S. J. Henkind. "Recruiting for Clinical Trials on the Web." Healthplan 41, no. 5(2000):36-43.
"Nuremberg Code (1947): standards for medical experimentation." British Medical Journal 7070, no. 313 (1996). Circumcision Information and Responses Position?lt;<a href="http://www.cirp.org/library/ethics/nuremberg">http://www.cirp.org/library/ethics/nuremberg>.
Wirshing D. A., W. C. Wirshing, S. R. Marder, R. P. Liberman, and J. Mintz. "Informed Consent: assessment of comprehension." American Journal of Psychiatry 155, no. 11 (1998):1508-11.
"Cancer treatment and informed consent." Sydney University Cancer Medicine Department. <<a href="http://jinx.sistm.unsw.edu/au/~greenlft/1996/216/216p13.htm">http://jinx.sistm.unsw.edu/au/~greenlft/1996/216/216p13.htm>.
"Health Information for surgical procedures, family health, patient education"<<a href="http://www.docs4patients.com/informed-consent.asp">http://www.docs4patients.com/informed-consent.asp>.
"Informed consent." <<a href="http://www.nocirc.org/consent">http://www.nocirc.org/consent>.
"Informed Consent." The University of Washington. <<a href="http://eduserv.hscer.washington.edu/bioethics/topics/consntc1.html">http://eduserv.hscer.washington.edu/bioethics/topics/consnt... >.
"Informed Consent." Risk Management Handbook. Yale-New Haven Hospital & Yale University School of Medicine. <<a href="http://info.med.yale.edu/cim/risk/handbook/rmh_informed_consent.html">http://info.med.yale.edu/cim/risk/handbook/rmh_informed_con... >.
"Medical-Legal Issues in HIV Treatment." <<a href="http://www. medscape/SCP/TAR4/2001">http://www. medscape/SCP/TAR4/2001>.
"Risk Management Issues: Improved Informed Consent." <<a href="http://www.rmf.harvard.edu/rmLibrary/rmissues/infconsent/body.html">http://www.rmf.harvard.edu/rmLibrary/rmissues/infconsent/bo... >.
Randi B. Jenkins
Informed Consent (Encyclopedia of Public Health)
The concept of informed consent originated with the recognition of individuals' rights to freedom and human dignity. People reduced to conditions of slavery were subjected without their consent to interferences with their freedom. Children and other dependent persons may also be treated in ways to which they do not consent, but those responsible for their care, such as parents or other legal guardians, are bound by ethical and legal limits in the procedures they can authorize.
The ethical principle of respect for autonomy requires that people capable of responsible independence should not be subjected to others' interventions with their bodily freedom or comfort unless they have consented in advance. Similarly, autonomous people who consent to a procedure that affects them should not be liable to another person's veto or prohibition because the other person considers the procedure to be not in their best interests.
Consent has particular significance concerning health care, because medical or other health care interventions can affect persons' bodies, comfort, and lives in very invasive and irreversible or long-lasting ways. public health initiatives designed to protect or promote the health of individuals as members of population groups or residents of communities can also be intrusive and long-lasting, but consent is often given to these through political or democratic means, such as by legislation permitting inspection of health records to find the incidence and prevalence of preventable diseases. However, some public health strategies, such as vaccination programs, affect individuals so personally that their own consent, or that of their legal guardians, is required before procedures can be undertaken on them.
CONSENT IN LAW
In law, the physical touching of a person's body without authorization or consent is an offense, often called assault in criminal law and battery in civil law directed toward compensation. The person's consent to the touching neutralizes or removes the offense. Consent is an important concept in medical and related health care. Health care personnel act unethically, unprofessionally, and illegally if they directly interfere with a person's body without consent by undertaking unauthorized procedures on the person, exceeding consent the person has given, or performing procedures different from those the person has approved. Consent is often spoken in deliberate language, and for more invasive procedures such as surgery and for research procedures may have to be given or confirmed in writing. For minor procedures, however, consent may be implied by a person's behavior, for example, by consciously permitting an intervention such as vaccination or blood-drawing to occur. Further, because in law "peril invites rescue," emergency interventions when life or enduring health are endangered are considered to have implied consent if they are reasonable under the circumstances.
Law and ethics sometimes require more than compliance alone to render an intervention acceptable. The consent must be adequately informed for it to satisfy legal and ethical standards. In medical care law, consent continues to remove liability for assault and battery, but the physician or other care provider has a legal duty to ensure that the person whose consent is required receives information that is material to the choice whether or not to consent. Reasonable efforts must also be made to ensure that the person understands the information to his or her satisfaction. Failure to provide adequate information to a person deciding whether to consent to a proposed intervention or to refuse it constitutes legal negligence when injury results, often called malpractice. This is so even when no assault and battery occurs because the person refuses treatment. "Informed consent" includes informed dissent and is better understood as informed choice or informed decision-making.
ELEMENTS OF INFORMED CONSENT
Whether or not to consent to proposed medical treatment is not itself a medical decision. It is a personal decision that someone makes when adequately informed of medical and nonmedical options and their relevant implications. Health care providers do not have to explain all the physiological, biological, pharmaceutical, and other processes that constitute the procedures among which the person may choose. But they must distill the elements the person will want to understand in order to exercise judgment about what will best serve his or her interests and preserve or promote personal values and goals. For instance, the effect of prospective treatments on capacity to work is often important. A person intending to have a child must understand the impact of treatment options on future fertility and child-rearing. A person who devoutly feels that life must be preserved to the last possible moment must be informed whether a treatment will lead to or risk earlier loss, and a person fearful of pain should be informed whether and how future comfort can be provided.
Accordingly, information must focus on the sort of individual the decision-maker is. This cannot usually be known in intimate detail and must initially be based on a representative reasonable or prudent person in the decision-maker's circumstances. Information may be amplified in light of the person's response, particularly the questions the person asks on initial receipt of information. Informing is often best regarded not as a single event but rather as a continuing process that begins with the provider asking the decision-maker questions about lifestyle, preferences, and intentions in order to direct information toward his or her needs, give information and explanation to serve such needs, answer uncertainties and questions the decision-maker has, and supply material information throughout the course of treatment.
Items to be addressed usually include:
- Implications of going without treatment and of treatment being postponed for different periods
- The range of accessible diagnostic or treatment options
- The extent of public or private insurance coverage for each option and costs patients would personally incur
- The benefits each option offers
- The possibilities of diagnostic false results or treatment failures
- The risks and discomforts of diagnostic or treatment options even when successful
- Short-term injuries that diagnostic or treatment failures may cause
- Long-term effects of diagnostic or treatment options, favorable and unfavorable, separating probabilities from possibilities
The more invasive or risk-laden a procedure, the more information should be provided. For the low-risk procedure of blood-sampling, for instance, disclosure of liability to sudden pain, bruising, and easily treated infection is usually adequate in itself, with greater information given about why sampling is proposed and what it may show.
COLLECTIVE OR GROUP CONSENT
Consent is usually requested from individuals proposed to be physically affected by health care procedures, but some decisions justify collective or group consent, such as fluoridation of a municipal drinking water supply. Information is made available, for instance, to democratically elected representatives authorized to make decisions on behalf of local residents. Community hospitals' decisions on what services to offer and what types of equipment to purchase are made by hospitals' boards of governors or trustees. Governors or trustees may be appointed by governments, but are often elected from among residents of areas the hospitals serve who choose to become members of the hospital associations. The decisions affect the water local residents consume and the health services they may receive, but individual consent is replaced by democratic or otherwise political consent. In some communities, hereditary or traditional leaders who make decisions with the permission of those they govern can consent to public health measures. Hereditary or traditional authority to make decisions affecting such groups is legitimate when groups' members identify themselves with each other and acknowledge an internal group structure and hierarchy that appoints chiefs or leaders. However, consent from such leaders to public health programs does not compel individuals to give their consent to personally invasive procedures such as vaccination. When group members do not possess a sense of community with each other but simply meet criteria of a particular study, such as on the effects of giving different dietary combinations to hospitalized single or widowed women aged 65 to 75, there is no representative group member with authority to make decisions on behalf of others.
REFUSAL OF INFORMATION
Competent persons have the autonomous right to consent without information. They have the right, not the duty, to receive information. They must state their preferences for overall care, but they may forgo detailed information that health-service providers prepare to offer. Providers incur no liability for risks that patients freely assume by refusal of offered information.
BERNARD M. DICKENS
(SEE ALSO: Autonomy; Beneficence; Codes of Conduct and Ethics Guidelines; Ethics of Public Health; Nonmaleficence; Paternalism; Public Health and the Law)
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Rozovsky, F. A. (1990). Consent to Treatment: A Practical Guide. Boston: Little, Brown.