Chapter 12: Patient Consent

Weithorn and Campbell found:

". . .adolescents aged 14 do not differ from persons defined by law as adults in their capacity to provide competent informed consent and refusal for medical and psychological treatment."

Mature Minors Should Have the Right to Refuse Life Support

"...an all too common reality in the United States [is that]...children remain particularly vulnerable to receiving end-oflife medical care that has never been fully explained to them... and... treatment they have never made a decision to accept."

Autonomy

Adult legal right - To refuse medical treatments - To employ all experimental and heroic measures for as long as humanly possible even in view of a fatal diagnosis....

Caring Individuals May Disagree

Caring individuals may make very different decisions on behalf of gravely ill children Therefore, medically same or similar cases may be handled quite differently, depending on the family's values and goals of care

Proof of Consent

Consent can be verbal, written, or implied. The law requires verbal or written consent for the intentional touching that involves medical or surgical procedures. Consent can also be implied in emergency situations.

Guardian

Consent of the patient ordinarily is required before treatment. When a patient is either physically unable or legally incompetent to consent and no emergency exists, consent must be obtained from a person who is empowered to consent on the patient's behalf. A guardian is an individual who by law is invested with the power and charged with the duty of taking care of a patient by protecting the patient's rights and managing the patient's estate. Guardianship is often necessary in those instances in which a patient is incapable of managing or administering his or her private affairs because of physical and/or mental disabilities or because he or she is under the age of majority.

Minors

Emergency care • Self-determination - Statutes (STDs & substance abuse) - Emancipated minors - Mature minors • Limits on decisions (same rationale as adults) • Infants

Paternalism

Four reasons the paternal physician is deficient: - He acts on his own values - Patients know their own interests better than anyone else - Danger of abuse - The patient's substantive and procedural rights to pursue or reject any course of treatment based on subjective preferences

Informed Consent

Legal concept that provides that a patient has a right to know Risks Benefits Alternatives of a proposed procedure Informed consent is predicated on the duty of the physician to disclose to the patient sufficient information to enable the patient to evaluate a proposed medical or surgical procedure before submitting to it.

Proof of Consent pp

Oral: although harder to corroborate, it is as binding as written consent Written: see elements on the next slide Emergency: immediate treatment necessary to save life or limb

Paternalism and Autonomy

Physicians have lost claim to the moral right to act on a patient's behalf, without need of the patient's consent. - Patient has assumed the role of partner who is capable of and interested in participating in all aspects of care

Hope for the Best and Prepare for the Worst

Share a statement like the following with patients: "I have found it helpful to hope for the best and, at the same time, prepare for the worst."

Meaning of the Procedure

Some parents will view the surgery as an opportunity. • Others will view the surgery as a threat. Both of these perspectives are reasonable

Temporary Guardian

The courts can grant temporary guardianship if it is determined necessary for the well-being of the patient.

Different, Equally Appropriate Goals of Care

Sustain life as long as possible • Take the child home • Protect child from pain and suffering

The Legal Landscape is Less Settled

There are no laws either requiring or prohibiting full disclosure of medical information to adolescents. Minors' decision-making authority varies by jurisdiction

Consent

Voluntary agreement by a person who possesses sufficient mental capacity to make an intelligent choice to allow something proposed by another to be performed on himself or herself.

Express consent

can take the form of either a verbal agreement or can be accomplished through the execution of a written document authorizing medical care.

Do we harm patients by causing stress and anxiety when we tell them about the risks of anesthesia and surgery?

"Therapeutic privilege," or the idea that information may harm patients, is often cited as a reason to curtail the discussion of risks with patients about to undergo anesthesia and surgery. Multiple studies have failed to demonstrate differences in the way patients and observers rate the stress levels of patients who receive detailed information when compared with patients who received little or no information about risks.

Informed consent: moral necessity or illusion?

Abstract There is a professional and legal consensus about the clinical duty to obtain informed consent from patients before treating them. This duty is a reflection of wider cultural values about the moral importance of respect for individual autonomy. Recent research has raised practical problems about obtaining informed consent. Some patients have cognitive and emotional problems with understanding clinical information and do not apparently wish to participate in making decisions about their treatment. This paper argues that such research does not undermine their potential to provide informed consent. Rather, suYcient resources are required to create better communication skills among clinicians and more eVective educational materials for patients. Finally, cognitive and emotional inequality among patients is maintained to be a reflection of wider social and economic inequalities. Researchers who take the right to informed consent seriously should also address these.

Right to Refuse Treatment

Adult patients who are conscious and mentally competent have the right to refuse medical care to the extent permitted by law, even when the best medical opinion deems it essential to life. A patient's right to make decisions regarding his own health care is addressed in the Patient Self-Determination Act of 1990.[24] The act provides that each person has a right under state law (whether statutory or as recognized by the courts of the state) to make decisions concerning his or her medical care, including the right to accept or refuse medical or surgical treatment. A competent patient's refusal to consent to a medical or surgical procedure must be adhered to, whether the refusal is grounded in lack of confidence in the physician, fear of the procedure, doubt as to the value of a particular procedure, or mere whim. The U.S. Supreme Court stated that the "notion of bodily integrity has been embodied in the requirement that informed consent is generally required for medical treatment" and the "logical corollary of the doctrine of informed consent is that the patient generally possesses the right not to consent, that is, to refuse treatment."[25] The common-law doctrine of informed consent is viewed as generally encompassing the right of a competent individual to refuse medical treatment. The question of liability for performing a medical or surgical procedure without consent is separate and distinct from any question of negligence or malpractice in performing a procedure. Liability can be imposed for a nonconsensual touching of a patient, even if the procedure improved the patient's health. The courts perform a balancing test to determine whether or not to override a competent adult's decision to refuse medical treatment. The courts balance state interests, such as preservation of life, protection of third parties, prevention of suicide, and the integrity of the medical profession, against a patient's rights of bodily integrity and religious freedom. The most frequently used state right to intervene in a patient's decision-making process is for the protection of third parties. In In re Fetus Brown,[26] the state of Illinois asserted that its interest in the well-being of a viable fetus outweighed the patient's right to refuse medical treatment. The state argued that a balancing test should be used to weigh state interests against patient rights. The appellate court held that it could not impose a legal obligation on a pregnant woman to consent to an invasive medical procedure for the benefit of her viable fetus. Adult patients who are conscious and mentally competent have the right to refuse medical care to the extent permitted by law even when the best medical opinion deems it essential to life. Such a refusal must be honored whether it is grounded in religious belief or straightforward objection to the procedure. Every person has the legal right to refuse to permit a touching of his or her body. Failure to respect this right can result in a legal action for assault and battery. If a patient refuses consent, every effort should be made to explain the importance of the procedure. Coercion through threat, duress, or intimidation must be avoided. A hospital generally has no common-law right or obligation to thrust unwanted medical care on a patient who, having been sufficiently informed of the consequences, competently and clearly declines such care. A patient's common-law right of bodily self-determination is entitled to respect and protection. Before a patient leaves a healthcare facility against medical advice, every attempt should be made to have a release form completed (FIGURE 12-1) and included in the patient's permanent record. All reasonable steps should be taken to (1) inform the patient of the benefits and risks of treatment and (2) secure the patient's written informed consent to refuse examination and treatment. If the patient refuses to sign the "refusal to consent form," documentation of a patient's refusal of care should be placed in the patient's medical record.

Decisional Capacity

And an ability to: • Think about options and reach a conclusion that reflects one's values • Communicate the decision to others (either verbally or non-verbally)

Right to Refuse (Bases)

Common Law - Freedom from nonconsensual invasion • Statutory rights - Living Wills, Durable powers of attorney, Hospice laws • Constitutional rights - Liberty interest protected by due process clause - Freedom of religion (belief vs. exercise) - Right to privacy

What do I do in an emergency, or when the patient is incapable of making a decision?

Conscious, competent patients have the right to make choices regarding their health care in emergencies, just as in routine care. When patients are incapacitated, it is important to seek the advice of appropriate surrogate decision makers and others who know the patient and are aware of his or her usual choices. When such information cannot be obtained, the physician should try to act in the best interest of the patient until such a surrogate can be found.

Forms of Express

Express: verbal and written Implied: presumption that consent has been authorized

The recent literature on informed and shared decision making within clinical care has revealed a pronounced tension between three competing factors: + Paternalistic conservatism about disclosure of information to patients has been eroded by moral arguments now largely accepted by the medical profession. + While many patients may wish to be given information about available treatment options, many also appear to be cognitively and emotionally ill equipped to understand and retain it. + Even when patients do understand information about potential treatment options, they do no necessarily wish to make such choices themselves, preferring to leave final decisions in the hands of their clinicians. The second and third factors are ostensibly at odds with the first. Given the diYculties they pose, should we not recognise the utopian nature of the goal of properly informed consent and return to the more honest and realistic paternalism of the past? This paper argues the contrary. After documenting the professional consensus surrounding the goal of informed consent in clinical practice, the practical obstacles to its achievement will be explored. It will then be shown that these constraints are not convincing as either moral or empirical justifications for questioning the pursuit of informed consent in clinical care. Instead, it will be argued that what does follow from practical problems in obtaining informed consent is the need for specialised clinical training and other resources that will support both clinicians and th

Importance of informed consent: a professional and legal consensus There can be no doubt that respect for the right of patients to make informed choices is now widely accepted as one of the key duties of any good health professional. Whatever practical problems may exist in fulfilling this clinical duty, the institutions that shape the practice of medicine all confirm that patients should accept or reject treatment proposals on the basis of information about what they are for, what they practically involve, and what their risks are. These institutions include professional bodies and the judiciary, as well as the advisory bodies that also influence professional opinion. This paper will focus on regulations within the UK. The most important medical regulatory body in the UK is the General Medical Council which makes the following statement about the importance of the principle of informed consent: "Successful relationships between doctors and patients depend on trust. To establish that trust you must respect patients' autonomy—their right to decide whether or not to undergo any medical intervention . . ."(They) . . . must be given suYcient information, in a way that they can understand, in order to enable them to make informed decisions about their care."1 The GMC has the power to de-register any clinician found to be in breach of this principle. Legally, if patients believe that clinicians have abused their right to make informed choices about their care, they can pursue a remedy in the civil courts for having been deliberately touched without their consent (battery) or for having received insuYcient information about risks (negligence). To avoid the accusation of battery, clinicians need to make clear what they are proposing to do and why "in broad terms". With respect to negligence, the amount of information about risks required is that deemed by the court to be "reasonable" in light of the choices that patients confront.2 3 Legal standards of disclosure concerning informed consent diVer in diVerent jurisdictions.4 For example, the legal standard in the UK is comparatively weak compared, for example, with many parts of North America. Indeed, it is sometimes argued that there is no legal right to informed consent in the UK at all! Despite such claims, the law does give patients the right to basic information about their proposed care and this has been reinforced by the 1998 Human Rights Act.5 Moreover, the law is constantly evolving and there is little doubt about the increasing seriousness with which the judiciary in the UK is underlining the right of patients to adequate information about their proposed care.6 This same respect for the right of patients to informed consent is evidenced in a variety of advisory documents from other bodies concerned about the conduct of good clinical practice.7-9 On the face of it, therefore, there is a professional and legal consensus in the UK about the clinical duty to obtained informed consent for treatment and research, one which is repeated in other parts of the world.10

Can I influence patients during the informed consent process?

Influence can be applied to the information given to patients, and generally falls into three categories: coercion manipulation persuasion Coercion is the application of a credible threat to the patient, and is always unethical. Manipulation involves incomplete or nontruthful presentation of information, such as lying, omitting vital information, or deliberately deceiving. Manipulation is always ethically suspect. Persuasion involves the presentation of a rational argument for a choice, and is permissible, even desirable during the consent process. Patients recognize that physicians have expertise and advice to offer about their care, and expect physicians to be forthright with recommendations.

Informed Consent

Informed consent is a legal concept that provides that a patient has a right to know the potential risks, benefits, and alternatives of a proposed procedure. In order for consent to be effective, the physician should provide the patient both verbally and in writing the following: An explanation and discussion with the patient as to his or her illness or injury. A description of the proposed treatment, as well as alternative treatment options. The risks, benefits, and consequences of each treatment option. The risks, benefits, and prognosis if treatment is refused. The American College of Surgeons (ACS), in its Statements on Principles, aptly describes informed consent as follows: Informed consent is more than a legal requirement. It is a standard of ethical surgical practice that enhances the surgeon/patient relationship and that may improve the patient's care and the treatment outcome. Surgeons must fully inform every patient about his or her illness and the proposed treatment. The information must be presented fairly, clearly, accurately, and compassionately. The surgeon should listen carefully to understand the patient's feelings and wishes and should answer all questions as accurately as possible.[3] The ACS Statement of Principles provides that informed consent conducted by the surgeon with the patient should include: The nature of the illness and the natural consequences of no treatment. The nature of the proposed operation, including the estimated risks of mortality and morbidity. The more commonly known complications, which should be described and discussed. The patient should understand the risks as well as the benefits of the proposed operation. The discussion should include a description of what to expect during the hospitalization and posthospital convalescence. Alternative forms of treatment, including nonoperative techniques. A discussion of the different types of qualified medical providers who will participate in their operation and their respective roles.[4] The right to be free of unwanted medical treatment has long been recognized in this country. An "individual's right to make decisions vitally affecting his private life according to his own conscience ... is difficult to overstate ... because it is, without exaggeration, the very bedrock on which this country was founded."[5] The right to control the integrity of one's own body spawned the doctrine of informed consent.[6] The United States Supreme Court has held that a competent adult patient has the right to decline any and all forms of medical intervention, including lifesaving or life-prolonging treatment.[7] Informed consent is predicated on the duty of the physician to disclose to the patient sufficient information to enable the patient to evaluate a proposed medical or surgical procedure before submitting to it. Informed consent requires that a patient have a full understanding of that to which he or she has consented. An authorization from a patient who does not understand to what he or she is consenting is not effective consent. Hospitals generally do not have an independent duty to obtain informed consent or to warn patients of the risks of a procedure to be performed by a physician who is not an agent of the hospital. It is the treating physician who has the education, expertise, skill, and training necessary to treat a patient and determine what information a patient should have in order to give informed consent. From a paternalistic point of view, some physicians have had a tendency toward providing the patient information he/she wants the patient to know. The degree to which this can occur can vary depending on the tendencies and influences of, for example, the patient, family, friends of the patient, as well as personal biases and motives, such as financial motivations. There are well publicized incidents where the motivation for performing unnecessary procedures such as cardiac cauterizations and placing stents into multiple patients who were not candidates for these procedures—as noted in the news clipping here—indicates. It should be noted here that more current cases are pending before the courts.[9] According to USA Today, one "study found that tens of thousands of times each year, patients undergo surgery they don't need." Both hospitals and physicians have an ever-expanding role to provide patient information beyond the traditional pre-printed consent forms that are generated and generalized for specific procedures. Although there are common risks across the various age groups, the risks for patients undergoing a specific invasive procedure can vary based on a patient's general health status and the concerns associated with one's age. Each patient should be provided with a listing of the common health risks associated with the invasive procedure the patient is consenting to undergo. The experiences and outcomes of patients who have undergone a suggested procedure should be reviewed with the patient. The patient's hopes as to what the surgery will accomplish and the likelihood of success should be discussed. For example, if the patient was a runner, what is the likelihood that the surgery will bring the patient to a level where running is possible again. Informed consent should include information about patient outcomes associated with the suggested procedure, as well as the costs associated with the procedure. Recognizing age and educational differences, the information provided to a patient should be tailored and described in terms of what the patient can understand.

Why is informed consent so morally important?

One thing is clear. An enormous amount morally hinges on how seriously we take these empirical findings that question the feasibility and relevance of the clinical duty to obtain informed consent. On the one hand, "ought implies can". Morally speaking, it is absurd to impute a duty that cannot be practically fulfilled. On the other hand, great caution must be exercised in any conclusion from the research in question that the duty to obtain informed consent should be foresworn or watered down. To do this would be to give up one of the most cherished moral prizes won over the past two centuries—namely, the right of individuals to exercise control over aspects of their lives that they deem critical for whatever reason.22 23 Thus, if we are to question the right to informed consent on the grounds of practicality, we had better be sure of our ground. On further inspection the grounds for scepticism are not as strong as they might at first appear. Although the research findings in question are somewhat indeterminate, suppose for the sake of argument that they do show that there is little relationship between attempts to obtain informed consent and eVective clinical outcomes.24 If so, why should so much importance be attached to attempting to provide patients with information that most of them will probably not understand? The diYculty with such an argument can be illustrated by imagining a colony of slaves who are of such great instrumental value to their owners that they are provided with the best clinical care available.25 However, the slaves are told nothing about the care they will receive and are certainly not asked to consent to it. Such communication and consent would entail extra work for the hard pressed doctors in the slave colony and would detract from the achievement of optimal clinical outcomes. Would there be anything morally objectionable about such an approach? Of course there would. Slavery is morally wrong precisely because it entails the denial of the right to refuse to allow one's body to be used in specific ways. The immorality of the scenario envisaged has nothing to do with the scientific/technical quality of the medicine practised or its outcomes and everything to do with the moral circumstances in which it is delivered. From one perspective, medical care may well be beneficial and its practical benefit may have little to do with whether or not patients choose it. Yet once the potential for such choice is removed, the care still remains harmful. The harm in question is not physical but moral. Whatever the perceptions and preferences of the slaves themselves—let us assume that they have been brainwashed into passive acceptance of whatever care is provided—the fact remains that, in not providing them with information about their proposed care and not obtaining their consent to it, one of the defining characteristics of their humanity will have been ignored. This is because humans have the ability to conceptualise the future and to make choices about it in ways that animals do not.26 To the degree that medical care ignores rather than nourishes this ability, then it harms through failing to acknowledge the potential that patients have as humans for exercising control over their lives. Thus, if patients are denied the information that they require to consent validly to treatment, they are eVectively turned into slaves for medical purposes. The harm that endures may or may not be accompanied by psychological suVering. Its reality takes the form of the objective indignity to which the patients are subjected

What about the patient whose decision making capacity varies from day to day?

Patients can move in and out of a coherent state as their medications or underlying disease processes ebb and flow. You should do what you can to catch a patient in a lucid state - even lightening up on the medications if necessary - in order to include him in the decision making process.

What if the patient requests not to hear about risks?

Patients have the right to refuse information, but the request must originate from the patient and not the physician.

Adequacy of consent

Requires that consent be informed consent. Varies depending on age, maturity, and mental status. Competent patient Spouse Parental consent Consent by minors Incompetent patients Guardian

Informed consent: a professional and legal illusion?

The consensus about the importance of informed consent for acceptable clinical practice does not sit well with a wealth of recent research findings about the problems of communicating relevant information to patients. Indeed, the problems revealed in these studies suggest that professional and legal demands to obtain informed consent could become vacuous and dangerous moral abstractions. The vacuity relates to the prescription of goals for good communication that seem impossible to deliver in clinical practice. The danger lies in creating unrealistic expectations in patients about clinical communication, thus imperiling the very clinical relationship that informed consent and partnership in care are supposed to foster. The most potentially damaging research suggests that patients are unable to understand or remember the details of the information required for educated choice. Some studies appear to show that patients do not fully comprehend basic information about conditions, prognoses, and treatments.13-15 There are even more profound diYculties concerning the understanding of risks, a crucial category of information that patients require in order to make appropriate future plans and to act in what they believe to be their best interests.16 17 Even when patients do understand information about the nature, purpose, risks, and alternatives of proposed treatments, it is often quickly forgotten—so much so that it is unclear how it could have ever constituted the foundation for coherent deliberation about treatment choices.16 18 The reasons for the cognitive and emotional limitations that lie behind such lack of comprehension and memory are complex. They relate both to specific characteristics of individual patients themselves (maturity, education) and also to the ways in which these have been influenced by their socioeconomic background and environment.19 Yet clinicians have to deal with individuals as they find them. Given the barriers to eVective communication created by the varying potential of many patients to understand and remember what they are told, would not medical care be dramatically improved if clinicians stopped pretending that they could facilitate patient choice that is really educated? Surely, it should be accepted that real informed consent is an illusion and that clinicians should get on with the job of using their expertise to determine and to act upon what is in the best interest of patients.20 This proposal gains credibility from further research which suggests that, even when patients do understand treatment options and associated risks, they do not want the partnership in care embraced by regulatory and advisory bodies. Rather, a significant proportion of patients indicate that they wish their clinicians to make final decisions about the treatment they will receive and the risks they will take in the process.21 To the degree that this is true, it adds further weight to the view that, in the overall process of providing good medical care, the moral importance of the communication of information can be overemphasised. On the face of it the primary reason for this communication is to enable patients to choose for themselves. If they want little part in such choice, then what is the fuss all about?

The potential for informed choice

The prospect for such harm would not exist if there were there no potential for informed choice. However, nothing in the research on the diYculties some patients have in understanding clinical information suggests the absence of such potential. All that the evidence shows is that, in educating patients, clinicians sometimes face serious diYculties. For example, the communication of clinical risks to patients can indeed be fraught with diYculty. A high percentage of patients (and many clinicians) make fundamental errors in risk evaluation, even when presented with the simplest information.16 17 However, the fact that not all patients make such mistakes illustrates the possibility of achieving better results with those who do. Research suggests, for example, that the understanding of risk does improve when information is tailored to the personal characteristics and preferences of individual patients.28 Evidence also indicates that even better results can be achieved by combining a variety of methods of framing and communicating risks rather than presuming that any one approach will suYce.28 29 In short, patients can improve their understanding of risks and other aspects of clinical information. Given the moral unacceptability of doing otherwise, clinicians should do their best to encourage this potential through taking the duty to try to obtain informed consent seriously. Further research demonstrates that many patients do desire information on their options and that, given the opportunity, they will make coherent clinical choices based on their knowledge.30 For example, it has been shown that, over time, the individual patient will reason quite similarly when presented with similar clinical decisions.31 The potential coherence of their decisions is important in light of the tendency of patients to forget clinical information about themselves.16 18 Thus, failure to remember does not constitute a good reason to question the right to informed consent. We all show forgetfulness in our everyday lives. The fact that we may also not remember the exact information upon which we made specific choices in life no way detracts from the moral importance of our having been allowed to make them. Despite these arguments, it might still be argued that serious eVorts to educate patients are not cost eVective. Even if many of the obstacles to good communication and understanding could potentially be overcome, to do so may demand an unreasonable slice of scarce healthcare resources. Such arguments would be weak on their own terms, as well as having unacceptable moral implications. Evidence has shown that the outcomes of clinical treatments can improve when patients have greater understanding of their purposes and risks. To the degree that this is so—and there is still much research to be done here—there will be a direct link between better communication with patients and improvements in both the eYcacy and the cost eVectiveness of care.32 Many patients have the potential for achieving greater clinical understanding and the positive desire to do so. They also have clear preferences which may sometimes threaten their well being and may be in conflict with their clinical advisors.33 This fact underlines the moral importance of honouring the preferences of patients for informed participation in the decision making process, while accepting that this will not necessarily mean that they will always want to take final responsibility for the details of all clinical decisions.34 For example, patients might reasonably assume that clinicians will not proceed with treatments that they decide are dangerous for some reason unknown at the time that consent was given. In short, patients are not stupid. Why then do they so often exhibit such poor comprehension of related issues with such damaging consequences for them and for the perception that clinicians have of them?

Parental Discretion

When the benefits of a proposed procedure are marginal or uncertain, the parents' preference should be honored. This is true whether the care team agrees with the parents' decision or not.

Implied consent

is determined by some act of silence, which raises a presumption that consent has been authorized.

Consent

is the voluntary agreement by a person who possesses sufficient mental capacity to make an intelligent choice to allow something proposed by another to be performed on him- or herself. Consent changes touching that otherwise would be nonconsensual to touching that is consensual. Consent can be either express or implied.

Written Consent pp

nature of the patient's illness or injury • name of the proposed procedure or treatment • purpose of the proposed treatment • risks and probable consequences of the proposed treatment • probability that the proposed treatment be successful • alternative methods of treatment • risks and prognosis if no treatment is rendered • indicate that the patient understands the elements listed above • signature of the patient, physician and witnesses • date the consent was signed

Culture and Religion

• A family's culture and religion may have a significant impact on their values and their treatment decisions. • May be useful to talk to the family about their beliefs. • However, families' values and goals of care are highly individualized. Do not make assumptions based on ethnic, cultural or religious stereotypes.

State Legislatures

• Have not specifically addressed end-oflife decision making by minors. • None of the state living will or surrogate decision-making statutes protect adolescents when their views differ from those of their parents.

Statutory Consent

Age of consent Emergency consent Generally presumed when immediate action is required to prevent death or permanent impairment of a patient's health Documentation justifying the need for treatment

Adults w/Decision Making capacity

Age of majority (18) • Not declared incompetent • Capable of understanding consequences • Limits on Authority to consent - Mayhem - Suicide - Illegal drugs or devices - Inappropriate treatment

Authorization for consent

Competent patient (adult) • Spouse • Parent for a minor • Guardian (Court appointed)

Parent's Values

High value on the quality of the child's life • High value on the child's physiologic existence no matter how diminished. Both of these values are legitimate.

How much information is considered "adequate"?

How do you know when you have said enough about a certain decision? Most of the literature and law in this area suggest one of three approaches: reasonable physician standard: what would a typical physician say about this intervention? This standard allows the physician to determine what information is appropriate to disclose. However, it is probably not enough, since most research in this area shows that the typical physician tells the patient very little. This standard is also generally considered inconsistent with the goals of informed consent as the focus is on the physician rather than on what the patient needs to know. reasonable patient standard: what would the average patient need to know in order to be an informed participant in the decision? This standard focuses on considering what a patient would need to know in order to understand the decision at hand. subjective standard: what would this patient need to know and understand in order to make an informed decision? This standard is the most challenging to incorporate into practice, since it requires tailoring information to each patient. Most states have legislation or legal cases that determine the required standard for informed consent. In the state of Washington, we use the "reasonable patient standard." The best approach to the question of how much information is enough is one that meets both your professional obligation to provide the best care and respects the patient as a person with the right to a voice in health care decisions.

What should occur if the patient cannot give informed consent?

If the patient is determined to be incapacitated/incompetent to make health care decisions, a surrogate decision maker must speak for her. There is a specific hierarchy of appropriate decision makers defined by state law. If no appropriate surrogate decision maker is available, the physicians are expected to act in the best interest of the patient until a surrogate is found or appointed

Healthcare professionals have an important role in the realm of informed consent. They can be instrumental in averting major lawsuits by being observant as to a patient's doubts, changes of mind or confusion, or misunderstandings expressed by a patient regarding any proposed procedures he or she is about to undergo.

Implied consent can be assumed when immediate treatment is required to preserve the life of a patient or to prevent an impairment of the patient's health and it is impossible to obtain the consent of the patient or representative legally authorized to consent for him or her, an emergency exists, and consent is implied. This privilege to proceed in emergencies without consent is accorded to physicians because inaction at this time may cause greater injury to the patient and would be contrary to good medical practice; however, if possible, consultation should be undertaken before a procedure is commenced, and every effort must be made to document the medical need for proceeding with treatment without consent. The patient's record should clearly indicate the nature of the threat to life or health, its immediacy, and its magnitude.

Capacity to Consent

Individuals incompetent to give consent No relatives or other parties from whom consent can be obtained Application should be made for a court order that would allow a needed procedure.

What are some common situations in which a patient's ability to make decisions about surgery and anesthesia may be questioned?

Many situations commonly arise around the time of surgery, in which a patient's ability to make health care decisions may be, rightfully or wrongfully, called into question. Some of them include: the premedicated patient the patient in labor the patient under stress the patient with known mental illness the patient with organic brain disease the immature patient (i.e. patient who is minor in age, or who has immature mental capacity, such as some forms of mental handicap)

Is there such a thing as presumed/implied consent?

The patient's consent should only be "presumed", rather than obtained, in emergency situations when the patient is unconscious or incompetent and no surrogate decision maker is available. In general, the patient's presence in the hospital ward, ICU or clinic does not represent implied consent to all treatment and procedures. The patient's wishes and values may be quite different than the values of the physician's. While the principle of respect for person obligates you to do your best to include the patient in the health care decisions that affect his life and body, the principle of beneficence may require you to act on the patient's behalf when his life is at stake.

Two Considerations

Their decisional capacity to provide consent and The nature of the decision being contemplated

Professional Obligations to Maintain Alliance

• Involve adolescents in their care and in decision making from the beginning • Continuously encourage dialogue with both parents and child • Anticipate the child's likely illness trajectory, so both parents and children have a clear picture of what to expect and what choices they are likely to face • Use advance directives to help adolescents clarify their own values

Stay in Alliance

• Solicit parents' fears and concerns • Clarify the burdens of nondisclosure • Explore the benefits of full disclosure

Incapacitated Adults

• W/ prior directive • W/O prior directive - Next of Kin - Guardian • Substituted judgment - Strive the make the decision the pt would have made • Best interests - What is best for the patient in the view of the decision maker

Professional Obligations

• Work with parents to clarify goals of care. • Anticipate and ensure that the parents fully understand the potential consequences of all treatment options. • Provide your own recommendation and rationale. • Work with parents to devise a treatment plan based on their current decision. • Treat the parents with compassion and respect.

Grisso and Vierling found:

"...generally minors below the age of 11 - 13 do not possess many of the cognitive capacities one would associate with the many psychological elements of 'intelligent' consent." "...there is little evidence that minors of age 15 and above as a group are any less competent to provide consent that are adults."

Trial of Treatments

"Including family in this way helps them come to terms with the impending death of their loved one. Should the goal not be met by the end of the therapeutic trial, the trial is then concluded and the AHN stopped."

When Death is Inevitable

"The decision to accept or refuse life-sustaining medical treatment (LSMT) may determine not only the time of one's death, but also the manner in which that death occurs. Thus, a denial of the mature minor's autonomy to refuse LSMT amounts to denying her the right to decide whether the medical prolongation of life, as it transforms into a prolongation of death, is worth the physical and psychological burdens."

Adolescents with Chronic Conditions

Typically have: Long experience with their own condition Familiarity with the health care system Watched friends grow progressively sick and die This experience should give their views great moral weight.

Midwest Bioethics Guidelines

"Treatments involving significant risks to the health or well-being of the minor require a greater certainty about the capacity of the minor than routine treatment." "Honoring the minor's refusal of a treatment believed to be of clear benefit will also require greater confidence about the minor's decisional capacity on the part of providers and parents."

Time-Limited Trials of Treatment

"When people disagree about whether to withhold or withdraw artificial hydration and nutrition, conflict may become so severe as to impact the quality of the patient's dying process. Before turning to the institutional ethics committee or courts for resolution, a simpler solution may be possible, one that focuses on the goals of the patient and the family."

Informed Consent powerpoint

A decision reached by a competent patient to accept a medical treatment or course of treatment. An "individual's right to make decisions vitally affecting his private life according to his own conscience...is difficult to overstate...because it is, with exaggeration, the very bedrock on which this country was founded."(Wons v. Public Health Trust)

"C.G."

A 15-year-old with End-Stage Cystic Fibrosis "During the last year of his life, he was hospitalized four times in a critical care unit for pneumonia and respiratory distress. He repeatedly expressed fear that his life would end in a a slow, agonizing death. He realized that he was dying and stated that he did not want to 'smother' or die on a ventilator. On his last admission, he experienced increasing respiratory distress and became disoriented as his carbon dioxide rose. However, his parents were adamant, insisting to the attending physician that 'everything possible' be done to keep C.G. alive, including prolonged intubation and mechanical ventilation."

Competent Patient

A competent adult patient's wishes concerning his or her person may not be disregarded. The court in In re Melideo [19] held that every human being of adult years has a right to determine what shall be done with his or her own body and cannot be subjected to medical treatment without his or her consent. When there is no compelling state interest that justifies overriding an adult patient's decision, that decision should be respected. State interests include preserving life, preventing suicide, safeguarding the integrity of the medical profession, and protecting innocent third parties.

Benito Agrela

Born with an Enlarged Liver and Spleen "He received a liver transplant when he was eight years old, had a second liver transplant when he was fourteen, and then stopped taking his medication several months after the second transplant because he could not tolerate the side effects. When the Florida Department of Social Services discovered that he was not taking his antirejection medications, they forcibly removed him from his parents' home and admitted him to a transplant floor of a Miami hospital." "After he refused further treatment, his case was taken to court; the circuit court judge spent several hours with Benito and his physicians, then ruled that Benito had a legal right to refuse the medications and return home. Before his death at the age of 15, Benito said: 'I should have the right to make my own decision. I know the consequences, I know the problems.'"

INTRODUCTION

Consent must be obtained from the patient or from a person authorized to consent on the patient's behalf before any medical procedure can be performed. Every individual has a right to refuse to authorize a touching. This chapter reviews many of the issues surrounding consent in the healthcare setting.

Other Options When Conflict Seems Intolerable

Discussion with child and parent at same time and place • Requesting consultation with other professional disciplines • Requesting ethics committee review • Investigate legal status of mature minors in your jurisdiction • Helping adolescent gain access to the courts

PICU Survey

Levetown et al. surveyed 16 PICUs and found that 50% of the patients for whom there had been recent decisions to forgo or withdraw life support in the final days or hours of life had had no prior discussion of advance directives nor any anticipation of death prior to the PICU admission.

Involuntary Treatment

Threats to the Community • Impaired Capacity • Life of Others • Dependents • Criminal Law Enforcement • Civil Law Discovery • Other: - Preservation of Life - Prevention of Irrational Self-destruction - Protection of the Ethical Integrity of Health Care Providers - No Family Veto

Parents Understanding of Prognosis

Wolfe et al. abstracted medical records and surveyed parents and physicians of 103 children who died of cancer to examine the parents understanding of prognosis. "Parents first recognized that the child had no realistic chance for cure a mean (SD) of 106 (150) days before the child's death, while the physician recognition occurred earlier at 206 (330) days before death."

Oral consent

is as binding as written consent. There is no legal requirement that a patient's consent be in writing; however, oral consent is more difficult to corroborate.

The Federal Patient SelfDetermination Act (PSDA)

• Applies only to those aged 18 and older • Nevertheless, while not necessarily offering legal protection, advance directives do carry moral weight and may have an influence on legal proceedings

Javed - 15-year-old boy

• Cerebral palsy, severe mental retardation and seizures • Born full term, developed normally until strep pneumoniae meningitis at 6 months • Responds to pain • Lives with family and mom is caretaker • Hospitalized 3 times this year • GI work-up revealed Grade IV gastroesophageal reflux • Nissen fundoplication and gastrostomy being

A Varied Legal Landscape

• Emancipated minors • Mature minor doctrine • Minor treatment statutes

Javed's Parents' Decision

Javed's parents refuse to give consent for the surgical procedure stating that Javed has been through enough painful procedures. They accept that he may die sooner as a result of their decision, but they believe that it is not in his interest to prolong the dying process, given the extent of his neurological damage. They just want him to be back at home

Is the surgical consent sufficient to cover anesthesia care?

Principles involving the informed consent process require that the best available information about procedures and risks be provided to patients. Just as anesthesiologists lack the expertise to discuss risks of surgery, surgeons lack expertise to discuss the nature and risks of anesthesia. While the surgical consent form does contain a phrase regarding consent for anesthesia care, the informed consent process requires that a separate discussion of anesthesia risks be carried out by the anesthesia provider.

Poor clinical communication: what should be done?

There is good evidence that many clinicians are themselves poor communicators.35 Patients have consistently protested about the failure to communicate eVectively and this is believed to be one of the key causes of increasing patient litigation and even more time consuming formal complaints. Poor communication about risks can lead to patients making potentially dangerous decisions about their medical treatment.36 Equally, clinicians have themselves revealed how inadequate their communication is with patients, even in circumstances where it should be of a high standard—for example, obtaining informed consent for participation in research.37 Indeed, the evidence of poor communication in medicine is so widespread that it is unclear what sense to make of the research that suggests that patients are themselves poor recipients of information. What is clear is that, if the potential of patients for better understanding is to be realised, clinicians need to receive better training in communication skills. Ample evidence now exists to confirm the eVectiveness of teaching communication skills to medical students and doctors.37 Through such teaching, clinicians have improved their ability both to collect the information required from patients for eVective diagnosis and treatment and also to educate them about their treatment choices. Most clinicians have not been properly trained in this regard, at least in the UK. It is vital that they become so. Finally, even the best trained clinician will require more than good communication skills to improve the standard of patient comprehension of clinical information and thus the process of informed consent itself. Good communication requires time and resources. When average consultation times are so short and there is a paucity of well designed and produced literature and other informational aids for patients, even the best communicators will be hard pressed to educate patients to their full potential.38 39 Time and educational materials cost money in circumstances where the resources of health services are or may be increasingly stretched. In determining the level of planning the funding of health care that is morally fit for autonomous citizens, it is crucial that the requirements of informed consent are allocated the moral importance that they deserve.

Conclusions

This paper has argued that it does not follow from research showing that patients have problems understanding and remembering information that clinicians should not do their best to obtain informed consent for treatment. On the one hand, much of this research reveals a self-fulfilling prophecy with patients. If clinicians treat patients like children who should basically do as they are told, the consequence may well be patients who are unable to mobilise the skills to deal with clinical information and who lack the confidence to participate in and to take responsibility for clinical choices about themselves.40 On the other hand, the evidence that has been reviewed demonstrates the ways in which this pattern of paternalism can be broken. EVective training in communication skills can make a genuine diVerence to the success that clinicians have in educating their patients. What has not been argued, however, is that good communication skills and improved educational material will completely resolve the cognitive and emotional problems that patients face. As is evidenced by the variability of rates of understanding in relation to socioeconomic background, much more profound social and political change will be required for significant reductions in such diVerences. This is hardly surprising. Since the poor and uneducated are disadvantaged in so many other walks of life, it would be extraordinary if health care were an exception. This is why the struggle for more social equality is a prerequisite for improving the moral quality of all aspects of health care provision, including the provision of information to patients and their ability to articulate their preferences and to participate in decision making about their care

Capacity to Consent

A patient is considered competent to make medical decisions regarding his or her care unless a court determines otherwise. Generally speaking, medical personnel make the determination of a patient's decision-making capacity. The clinical assessment of decision-making capacity should include the patient's ability to understand the risks, benefits, and alternatives of a proposed test or procedure; evaluate the information provided by the physician; express his or her treatment options/plan; and voluntarily make decisions regarding his or her treatment plan without undue influence by family, friends, or medical personnel. If a patient is unable to make decisions by reason of age or incapacity, a patient-appointed decision maker may "substitute his or her judgment" on behalf of the patient. Before declaring an individual incapacitated, the attending physician must find with a reasonable degree of medical certainty that the patient lacks capacity. A notation should be placed in the patient's medical record describing the cause, nature, extent, and probable duration of incapacity. Before withholding or withdrawing life-sustaining treatment, a second physician must confirm the incapacity determination and make an appropriate entry on the medical record before honoring any new decisions by a healthcare agent.

Caring Individuals Disagree

Caring individuals may make very different decisions on behalf of gravely ill children. Therefore, same or similar cases may be handled quite differently, depending on the family's values and goals of care.

What information should be provided to surgical patients in the consent process?

General rules to follow in consent for surgery and anesthesia are to inform the patient of common risks even if they are not serious, and very serious risks, such as death, even if they are not common. By asking the patient if they have any specific concerns, you can invite the patient to let you know of any "special" informational needs that they may have which are not obvious to you. When discussing risks with patients, understand that mere recitation of statistical risks may mean little to patients, and it can be helpful to relate the information to risks which have some meaning for the patient. The approximately one in 50,000 risk of death during general anesthesia in a healthy patient can be compared to that of the risk of death in an automobile accident (about twice that), as a way of putting perspective on the information being provided.

One Child Receives Treatment The Other Does Not

If two cases are clinically identical, is it permissible for one child to receive treatment and not the other? Why or why not? • In most of these cases, there is not going to be a "good" outcome. The child is definitely going to die. The decisions are really about "how" and, in some cases, "how soon?" • Logical consistency can be found in equally honoring every family's reasonable preferences, values, and goals of care

Javed's Parents' Decision

Javed's parents are now faced with the decision whether to consent to the surgery or forgo it. What arguments could be made in favor of the surgery? What arguments might be made against it?

Two Distinct Kinds of Treatments

• Decisions to forgo treatments that could reverse underlying disease and restore child to a reasonable status quo • Decisions to use life supports that are only capable of prolonging the dying process

Written consent provides visible proof of a patient's wishes. Because the function of a written consent form is to preserve evidence of informed consent, the nature of the treatment, the risks, benefits, and consequences involved should be incorporated into the consent form. States have taken the view that consent, to be effective, must be "informed consent." An informed consent form should include the following elements:

The nature of the patient's illness or injury The name of the proposed procedure or treatment The purpose of the proposed treatment The risks and probable consequences of the proposed treatment The probability that the proposed treatment will be successful Any alternative methods of treatment along with their associated risks and benefits The risks and prognosis if no treatment is rendered An indication that the patient understands the nature of any proposed treatment, the alternatives, the risks involved, and the probable consequences of the proposed treatment The signatures of the patient, physician, and witnesses The date the consent is signed

Patient Self-Determination Act (PSDA)

• Genesis Louis Kutner coined the term "living will" in 1969 California passed the Natural Death Act in the mid-seventies • PSDA implemented through Medicare/Medicaid Providers • Written info at time of admission. - the person's rights under law to make health care decisions, including the right to accept or refuse treatment and right to complete state-allowed advanced directives, and - the provider's written policies concerning implementation of those rights; • document in the patient's medical record whether or not the person has completed an advance directive; • not discriminate or condition care based on whether or not the person has completed an advance directive; • ensure compliance with state laws concerning advance directives • provide education for staff and the community on issues concerning advance directives.

Limits on Treatment

• Inappropriate treatment • Medically unnecessary treatment • "Futile treatment" • Refusal to leave

Professional Obligations

Work with parents to clarify goals of care. • Anticipate and ensure that the parents fully understand the potential consequences of all treatment options. • Provide a recommendation and rationale. • Work with parents to devise a treatment plan based on their current decision. • Treat the parents with compassion and respect.

Adequacy of Consent

A physician should provide as much information about treatment options as is necessary based on a patient's personal understanding of the physician's explanation of the risks of treatment and the probable consequences of the treatment. The needs of each patient can vary depending on age, maturity, and mental status. Some courts have recognized that the condition of the patient may be considered to determine whether the patient has received sufficient information to give consent. The individual responsible for obtaining consent must weigh the importance of giving full disclosure to the patient against the likelihood that such disclosure will seriously and adversely affect the condition of the patient. When questions do arise as to whether adequate consent has been given, some courts take into consideration the information that is ordinarily provided by other physicians. A physician must reveal information to his or her patient just as a skilled practitioner of good standing would provide under similar circumstances. A physician must disclose to the patient the potential of death, serious harm, and other complications associated with a proposed procedure. The physician has the ultimate responsibility of providing the patient informed consent according to the Supreme Court of Pennsylvania, where it held that "a physician may not delegate his or her obligation to provide sufficient information in order to obtain a patient's informed consent. Informed consent requires direct communication between physician and patient, and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patient's informed consent belongs solely to the physician."

Refusal of Care Based on Religious Beliefs

As part of their religious beliefs, Jehovah's Witnesses generally have refused the administration of blood, even in emergency situations. Case law over the past several decades has developed to a point where any person, regardless of religious beliefs, has the right to refuse medical treatment. Competent adolescents have the right to deny treatment according to Skagit County Superior Court Judge John Meyer when he had to decide if a 14-year-old patient with leukemia had the right to refuse a blood transfusion. The patient, Dennis Lindberg, a Jehovah's Witness, had denied the transfusion based on his religious beliefs. Ethics experts and Jehovah's Witness officials said such a court case is unusual these days. Most cases involving transfusions stem from surgical cases, and current policy at Children's is to inform parents that while the hospital will do everything it can to avoid transfusions, it will not let a child die for want of blood, said Dr. Doug Diekema, an ethics consultant there.[31] Judge John Meyer's decision should by no means be applied as a standard for all similar cases involving a minor patient's right to refuse treatment. The courts of various jurisdictions may have reached a different decision than that of Judge Meyer of the Skagit County Superior Court. In future cases of this sort, no court can use a customized cookie cutter approach to stamp out decisions because every case is composed of a different set of facts and circumstances to which the law must be applied. It seems to be an oxymoron to prohibit minors from obtaining treatment for most medical conditions without first obtaining parental consent on the one hand and on the other hand allowing the minor to deny lifesaving treatment. It is unclear how the courts will respond to the same or similar cases as they arise in other jurisdictions. Interestingly, Dr. James L. Bernat wrote in Neurology Today, a publication of the American Academy of Neurology: One memorable experience in which I performed an ethics consultation on a minor patient whose Jehovah's Witness parents refused consent for blood transfusion yielded an unexpected outcome. After the bioethics committee requested and obtained a court order mandating treatment, rather than being angry or resentful with us for superseding their parental authority through the judiciary, the parents were relieved that their child would survive. It became clear to us in retrospect that they felt compelled to refuse blood transfusions on behalf of their child for them to remain true to their religious beliefs.[32]

Step-wise Process for Conducting a Trial of Treatment

Define a therapeutic goal • Gain a firm and clearly stated commitment to that goal by all the parties • Try intervention for an agreed-upon period of time • Observe effects of treatment closely • Encourage family to observe closely

Unconscious patients are presumed under law to approve treatment that appears to be necessary. It is assumed that such patients would have consented if they were conscious and competent; however, if a patient expressly refuses to consent to certain treatment, such treatment may not be instituted after the patient becomes unconscious. Similarly, conscious patients suffering from emergency conditions retain the right to refuse consent. If a procedure is necessary to protect one's life or health, every effort must be made to document the medical necessity for proceeding with medical treatment without consent. It must be shown that the emergency situation constituted an immediate threat to life or health.

In Luka v. Lowrie,[13] involving a 15-year-old boy whose left foot had been run over and crushed by a train, consultation by the treating physician with other physicians was an important factor in determining the outcome of the case. On the boy's arrival at the hospital, the defending physician and four house surgeons decided that it was necessary to amputate the foot. The court said that it was inconceivable that had they been present, the parents would have refused consent in the face of a determination by five physicians that amputation would save the boy's life. Thus, despite testimony at the trial that the amputation may not have been necessary, professional consultation before the operation supported the assertion that a genuine emergency existed and could have implied consent.

When is it appropriate to question a patient's ability to participate in decision making?

In most cases, it is clear whether or not patients are competent to make their own decisions. Occasionally, it is not so clear. Patients are under an unusual amount of stress during illness and can experience anxiety, fear, and depression. The stress associated with illness should not necessarily preclude one from participating in one's own care. However, precautions should be taken to ensure the patient does have the capacity to make good decisions. There are several different standards of decision making capacity. Generally you should assess the patient's ability to: understand his or her situation, understand the risks associated with the decision at hand, and communicate a decision based on that understanding. When this is unclear, a psychiatric consultation can be helpful. Of course, just because a patient refuses a treatment does not in itself mean the patient is incompetent. Competent patients have the right to refuse treatment, even those treatments that may be life-saving. Treatment refusal may, however, be a flag to pursue further the patient's beliefs and understanding about the decision, as well as your own

What is informed consent?

Informed consent is the process by which a fully informed patient can participate in choices about her health care. It originates from the legal and ethical right the patient has to direct what happens to her body and from the ethical duty of the physician to involve the patient in her health care.

How does medication affect a patient's ability to give valid consent to a procedure?

It is common to encounter patients who have received sedation and/or pain medication prior to coming to surgery, and it is also common for such medications to be deliberately withheld prior to surgery in anticipation of the necessity to obtain consent. When pain medications are withheld, patients may feel pressured to consent in order to obtain medication to relieve their suffering. In some instances, premedication may actually enhance a patient's ability to make decisions, by providing pain relief or relief from emotional distress, so that they can focus on the choices they are making. Clearly, if premedication has rendered the patient unable to listen, to understand their situation, the need for care, the risks, and alternatives, or to communicate a decision, then it has negated the informed consent process. But pain medication should never be withheld from a suffering patient under the guise of obtaining informed consent.

How does the physical or mental stress of the OR affect the informed consent process?

Many studies have examined the ability of laboring patients to give informed consent. While many patients do not later remember the informed consent process, laboring patients in general demonstrate the capacity to understand their situation, understand proposed care, risks, and alternatives, and express consent. Legal cases have recognized the complex voluntary physical control required from a laboring woman to permit epidural placement, and cite the physical cooperation of the woman in the process as an indication of motivation and consent for the procedure. While many, if not most patients coming to the OR are experiencing stress, there is little evidence that most are not able to meet the standards mentioned on the main topic page (Informed Consent) to make decisions regarding their health care. Patient immaturity can be relevant when the patient is of a very young age (minor) and presumed to not have the cognitive development to make meaningful decisions, or when the patient suffers from mental handicap which impairs her cognitive development. Once again, neither condition in itself precludes participation of the patient in decision making, but expert consultation may be needed to determine whether the patient is capable of understanding their situation and options, and making a decision based on them. In the case of minor patients, legal precedents determine when a minor can give legal consent, but do not address the issues of when a minor patient should be invited ethically to participate in the informed consent process. A more detailed discussion of these issues will occur in the Pediatrics Clerkships.

What sorts of interventions require informed consent?

Most health care institutions, including UWMC, Harborview, and VAMC have policies that state which health interventions require a signed consent form. For example, surgery, anesthesia, and other invasive procedures are usually in this category. These signed forms are really the culmination of a dialogue required to foster the patient's informed participation in the clinical decision. For a wide range of decisions, written consent is neither required or needed, but some meaningful discussion is needed. For instance, a man contemplating having a prostate- specific antigen screen for prostate cancer should know the relevant arguments for and against this screening test, discussed in layman's terms.

Right to refuse treatment

Often based on religious beliefs. Complexities occur when the consent for a minor's treatment is involved. Generally because states interests are at issue, as in the case of a minor. Patients refusing care should be requested to sign a release form. Documentation should be placed in the patient's medical record as to their refusal of treatment.

Bashirah, Same Diagnosis, Same Options

On the very same day, two rooms down from Javed is another child, Bashirah, whose diagnosis, prognosis and current status are virtually identical to Javed's. Bashirah's parents consent to the fundoplication and nasogastrostomy tube, saying that they want their daughter to live as long as possible and not be connected to a ventilator if it can be avoided.

Consent by Minors

Parental consent is not required when a minor is married or otherwise emancipated. Most states have enacted statutes making it valid for married and emancipated minors to provide effective consent. Several courts have held the consent of a minor to be sufficient authorization for treatment in certain situations. In any specific case, a court's determination that the consent of a minor is effective and that parental consent is unnecessary will depend on such factors as the minor's age, maturity, mental status, and emancipation and the procedure involved, as well as public policy considerations. The courts have held, as a general proposition, that the consent of a minor to medical or surgical treatment is ineffective and that the physician must secure the consent of the minor's parent or someone standing in loco parentis; otherwise, he or she will risk liability. Although parental consent should be obtained before treating a minor, treatment should not be delayed to the detriment of the child. The various states have laws allowing children to be treated without consent in order to protect the minor (e.g., provision of emergency care, protect the minor from child abuse, abortion, treat venereal diseases) and safeguard the public health of the community (e.g., communicable diseases)

Parental Consent

Parents generally have the right to authorize medical care for minor children, generally under the age of 18. Consent laws for minors often vary from state to state and should be referenced as necessary. Children who are emancipated have a right to make their own medical care decisions. Although parents may have a right to refuse medical care in certain instances, such refusal is reportable by the caregiver to the state if such refusal can result in harm to the child.

Statutory Consent

The age of consent is the minimum age at which a person is considered to be legally competent to consent to medical care. Many states have adopted legislation concerning emergency care. An emergency in most states eliminates the need for consent. When a patient is clinically unable to give consent to a lifesaving emergency treatment, the law implies consent on the presumption that a reasonable person would consent to lifesaving medical intervention; this is defined as statutory consent. When an emergency situation does arise, there may be little opportunity to contact the attending physician, much less a consultant. The patient's records, therefore, must be complete with respect to the description of the patient's illness and condition, the attempts made to contact the physician as well as relatives, and the emergency measures taken and procedures performed. If time does not permit a court order to be obtained, a second medical opinion, when practicable, is advisable.

Incompetent Patients

The attending physician, who is in the best position to determine if a patient is incompetent, should become familiar with his or her state's definition of legal incompetence. In any case in which a physician doubts a patient's capacity to consent, the consent of the legal guardian or next of kin should be obtained. If there are no relatives to consult, application should be made for a court order that would allow the procedure. It may be the duty of the court to assume responsibility of guardianship for a patient who is non compos mentis. The most frequently cited conditions indicative of incompetence are mental illness, mental retardation, senility, physical incapacity, and chronic alcohol or drug abuse. A person who is mentally incompetent cannot legally consent to medical or surgical treatment; therefore, consent of the patient's legal guardian must be obtained. When no legal guardian is available, a court that handles such matters must be petitioned to permit treatment. Subject to applicable statutory provisions, when a physician doubts a patient's capacity to consent, even though the patient has not been judged legally incompetent, the consent of the nearest relative should be obtained. If a patient is conscious and mentally capable of giving consent for treatment, the consent of a relative without the consent of the competent patient would not protect the physician from liability.

Codes of Ethics

The first American Medical Association Code of Medical Ethics was written in 1847. Section I of the 1998-1999 edition, titled "Fundamental Elements of the Patient-Physician Relationship," provides "the patient has the right to receive information from physicians and to discuss the benefits, risks, and costs of appropriate treatment alternatives." Because the American Medical Association is an organization composed of experts in the field of medicine, its code of ethics and the duties of physicians prescribed therein should be understood to reflect the standard of care of the profession on the issue of informed consent. Social policy does not accept the "paternalistic" view that the physician may remain silent because divulgence might prompt the patient to forgo needed therapy. The American Dental Association Code of Ethics also reflects the standard of care for the dental profession. Part III, Section 1, of the American Dental Association Code of Ethics, titled "Principle: Patient Autonomy," provides "the dentist has a duty to respect the patient's rights to self-determination and confidentiality," and Section 1A provides that "the dentist should inform the patient of the proposed treatment, and any reasonable alternatives, in a manner that allows the patient to become involved in treatment decisions." These American Medical Association and American Dental Association ethical standards embrace the doctrine of informed consent. The American Nurses Association code of ethics for nurses provides in part in Provision 1.4 the following as to a patient's right to self-determination: Patients have the moral and legal right to determine what will be done with their own person; to be given accurate, complete, and understandable information in a manner that facilitates an informed judgment; to be assisted with weighing the benefits, burdens, and available options in their treatment, including the choice of no treatment; to accept, refuse, or terminate treatment without deceit, undue influence, duress, coercion, or penalty; and to be given necessary support throughout the decision-making and treatment process.

What are the elements of full informed consent?

The most important goal of informed consent is that the patient have an opportunity to be an informed participant in his health care decisions. It is generally accepted that complete informed consent includes a discussion of the following elements: the nature of the decision/procedure reasonable alternatives to the proposed intervention the relevant risks, benefits, and uncertainties related to each alternative assessment of patient understanding the acceptance of the intervention by the patient In order for the patient's consent to be valid, he must be considered competent to make the decision at hand and his consent must be voluntary. It is easy for coercive situations to arise in medicine. Patients often feel powerless and vulnerable. To encourage voluntariness, the physician can make clear to the patient that he is participating in a decision, not merely signing a form. With this understanding, the informed consent process should be seen as an invitation to him to participate in his health care decisions. The physician is also generally obligated to provide a recommendation and share her reasoning process with the patient. Comprehension on the part of the patient is equally as important as the information provided. Consequently, the discussion should be carried on in layperson's terms and the patient's understanding should be assessed along the way. Basic consent entails letting the patient know what you would like to do and asking them if that will be all right. Basic consent is appropriate, for example, when drawing blood. Decisions that merit this sort of basic informed consent process require a low-level of patient involvement because there is a high-level of community consensus.

Spouse

The patient in Greynolds v. Kurman [20] suffered a transient ischemic attack, a sudden loss of neurological function caused by vascular impairment to the brain. He was taken to an emergency department. Because of the patient's prior medical history, which included transient ischemic attacks, he was at high risk for a stroke. After receiving the results of noninvasive tests, Dr. Rafecas, a consulting physician, ordered a cerebral angiogram. Dr. Kurman performed the angiogram, and the patient suffered a stroke during the procedure that left him severely disabled. The patient and his wife filed a medical malpractice action against Rafecas and Kurman, asserting that Rafecas had negligently recommended the procedure and that Kurman had performed the procedure without obtaining informed consent. The court of appeals held that the evidence was sufficient to support a judgment in favor of the patient and his wife. The jury needed to determine that the risks involved in the cerebral angiogram were not disclosed, that the risks involved in the procedure materialized and caused the stroke, and that a reasonable person in the position of the patient would have decided against having the angiogram had the risks associated with the procedure been disclosed. The jury concluded that the patient did not consent to the angiogram because he "was not ... capable of comprehending the consent form" and further noted that Kurman should have sought consent from the next of kin, specifically the spouse. Given the evidence of the patient's condition when he signed the consent forms, his past medical history, and his increased risk of suffering complications during an angiogram, the court found that evidence supported a finding of lack of informed consent.

Informed Consent in the Operating Room

What are some common situations in which a patient's ability to make decisions about surgery and anesthesia may be questioned? How does medication affect a patient's ability to give valid consent to a procedure? How does the physical or mental stress of the OR affect the informed consent process? What information should be provided to surgical patients in the consent process? Can I influence patients during the informed consent process? Do we harm patients by causing stress and anxiety when we tell them about the risks of anesthesia and surgery? What do I do in an emergency, or when the patient is incapable of making a decision? Is the surgical consent sufficient to cover anesthesia care? What if the patient requests not to hear about risks? The informed consent process for surgery usually begins long before the patient enters the operating room environment, with the patient's first visit to the surgeon's office. In contrast, the informed consent for anesthesia is often obtained in the minutes before surgery in which the anesthesiologist and patient meet for the first time.

ETHICS IN MEDICINE University of Washington School of Medicine Informed Consent

What is informed consent? What are the elements of full informed consent? How much information is considered "adequate"? What sorts of interventions require informed consent? When is it appropriate to question a patient's ability to participate in decision making? What about the patient whose decision making capacity varies from day to day? What should occur if the patient cannot give informed consent? Is there such a thing as presumed/implied consent? Opportunities to "consent" a patient abound on the wards. The aim of this section is to provide you with the tools required for the "basic minimum" as well as providing a more complete picture of the ideal informed consent process. You will find that the particular circumstances (e.g. the patient's needs or the procedure) will determine whether a basic or complete informed consent process is necessary

Consent also can be implied in nonemergency situations. For example, a patient may voluntarily submit to a procedure, implying consent, without any explicitly spoken or written expression of consent. In the Massachusetts case of O'Brien v. Cunard Steam Ship Co.,[14] a ship's passenger who joined a line of people receiving injections was held to have implied his consent to a vaccination. The rationale for this decision is that individuals who observe a line of people and who notice that injections are being administered to those at the head of the line should expect that if they join and remain in the line they will receive an injection. The plaintiff entered the line voluntarily. The plaintiff had opportunity to see what was taking place at the head of the line and could have exited the line but chose not to do so. The jury appropriately determined this to be consent to the injection. The O'Brien case contains all of the elements necessary to imply consent to a voluntary act: The procedure was a simple vaccination. The proceedings were visible at all times, and the plaintiff was free to withdraw up to the instant of the injection.

Whether a patient's consent can be implied is frequently asked when the condition of a patient requires some deviation from an agreed-on procedure. If a patient expressly prohibits a specific medical or surgical procedure, consent to the procedure cannot be implied. The same consent rule applies if a patient expressly prohibits a particular extension of a procedure even though the patient voluntarily submitted to the original procedure.

Some Arguments For Fundoplication and G-Tube

• Eliminating the gastroesophageal reflux will prevent recurrence of the aspiration pneumonia • Javed will be spared the hospital admission and discomfort associated with the pneumonia • Javed may live longer • This fairly common procedure has a high success rate Quality of Javed's life is questionable given his severe neurological damage • Surgery will not prevent Javed's death, although it may prolong the dying process • Procedure itself will impose burdens on Javed