Ethics & Values Final

What is competence? How can it be compromised?

"Competence is very roughly the ability to render decisions about medical interventions." Competence can be compromised by "mental retardation, dementia, psychosis, alcoholism, and . . . being under age." 1. Incompetence can be specific rather than global. 2. Surrogates make decisions for incompetent patients

What is the relationship between the two senses of informed consent, according to Faden and Beauchamp? What effect has this had on the idea of informed consent, according to Katz? What should the relationship between the two senses be, according to Faden, Beauchamp, and Katz?

1. "A sense1 'informed consent' can fail to be an informed consent in sense2 by a lack of conformity to applicable rules and requirements. Similarly, an informed consent in sense2 may not be an informed consent in sense1. The rules and requirements that determine sense2 consents need not result in autonomous authorizations at all in order to qualify as informed consents." 2. So Katz argues that the courts have allowed "the idea of informed consent . . . to wither on the vine." What this means is that "if a physician obtains a consent under the courts' criteria, then an informed consent (sense2) has been obtained. But it does not follow that the courts are using the right standards, or sufficiently rigorous standards in light of a stricter autonomy-based model—or 'idea' as Katz puts it—of informed consent (sense1)." 3. Beauchamp, Faden, and Katz all agree that the conditions of sense1 ought to serve as a test for the moral adequacy of the sense2 definition of informed consent. The goal of informed consent is to allow patients to make autonomous decisions; therefore, the conditions of informed consent in sense2 should increase the likelihood that the sense1 conditions are satisfied. 4. One major problem is to balance the ethical need to obtain genuine informed consent with how the legal obligation to obtain informed consent affects health care professionals, researchers, and patients

Summarize Levine's procedural resolution to the lack of a cross-cultural definition of informed consent.

1. "All plans to conduct research involving human subjects should be reviewed and approved by a research ethics committee." People familiar with the customs of the community in which the research will be done should be on the committee. 2. "Proposals to employ consent procedures that do not conform to the international standard should be justified by the researcher and submitted for review and approval by a national ethical review body." 3. There should be an international ethical review body to "provide advice, consultation, and guidance to national ethical review bodies when such is requested by the latter." 4. With externally sponsored research, "ethical review should be conducted in the initiating country." Its plans for informed consent should be "consistent with the international standard."

Briefly describe the moral issue of the use of placebo in clinical trials.

1. With regard to placebo-controlled trials, "Can this deliberate nontreatment of patients be justified?" 2. Most say that the use of placebo is permissible only when there is no effective treatment. Otherwise, active-controlled trials are required. But some argue that treating a subject with placebo instead of an unproven treatment is wrong if the subject risks serious harm or death. As long as the medical condition is minor, a placebo trial may be permissible even if a proven treatment exists.

Describe the moral controversy over research in developing nations.

1. "As the scientific testing of therapies in developing nations has increased, ethical controversy surrounding the research has also intensified." One case involves the testing of a less expensive dose of AZT in certain African countries and Thailand. Some object to the use of a placebo group when a treatment effective in halting vertical transmission of HIV was already available. Others argue that there was no moral problem with the research since "those in the placebo groups were not deprived of treatment that they would have received under normal circumstances," so no injustice was done. 2. Other critics claim that "researchers used impoverished or desperate subjects to determine the best therapies, and then that information is used to help people in rich countries, not the developing ones." Some argue that such arrangements are not exploitative.

What is the conversation model? What are its advantages? What is the problem with it, according to Brody?

1. "[I]nformed consent consists . . . in a conversation designed to encourage patient participation in all medical decisions to the extent that the patient wishes to be included." a. Advantages:"[M]ost people have a good intuitive grasp of what it means for a conversation to be finished." Informed consent would be seen as mutual process, not a one-way disclosure of information 2. Problem: The inherent subjectivity of the model makes it ill-suited as a legal standard.

What are clinical trials? Describe them. (What two groups are used in clinical trials, and why? What two kinds of control groups are there, and what are their purposes? What is blinding? What is randomization?)

1. A clinical trial is "a scientific study designed to test a medical intervention in humans." The purpose of a clinical trial is to determine whether a medical intervention is safe and effective. 2. Clinical trials typically involve two groups of subjects: an experimental group that receives treatment, and a control group that does not. The control group resembles the experimental group. "With a control group, researchers can be more confident that relevant effects in the experimental group were brought about by the treatment and not by some extraneous element." 3. There are two kinds of control groups. Subjects in a placebo group receive a placebo; subjects in an active group receive the standard treatment. Placebo-controlled trials are generally more trustworthy, though active-controlled trials can be useful in determining which of two treatments is better. 4. Most clinical trials include blinding, "a procedure for ensuring that subjects and researchers don't know which interventions the subjects receive." Double-blind studies are preferable. 5. Subjects should also be randomly assigned to experimental and control groups. Randomization helps to eliminate bias and ensure that the two groups are comparable.

How do Faden and Beauchamp further clarify sense2 of informed consent? What are the two problems with informed consent in this sense?

1. Informed consent in this sense refers to "a legally or institutionally effective . . . authorization from a patient or a subject. Such an authorization is 'effective' because it has been obtained through procedures that satisfy the rules and requirements defining a specific institutional practice in health care or research." 2. Consent in this sense does not "focus on the autonomy of the act of giving consent . . . but rather on regulating the behavior of the consent-seeker and on establishing procedures and rules for the context of consent." 3. So it is possible for a patient or subject to autonomously authorize an intervention in sense1 but not effectively authorize the intervention in sense2. (See the Carol and Martie example.) 4. "Medical and research codes, as well as case law and federal regulations, have developed models of informed consent that are delineated entirely in sense2 format, although they have sometimes attempted to justify the rules by appeal to something like sense1." 5. The legal doctrine of informed consent focuses on disclosure, but the legal requirement of disclosure is not a condition of informed consent in sense1, and may even be relevant to giving informed consent in sense1. "If a person has an adequate understanding of relevant information without the benefit of disclosure, then it makes no difference whether someone discloses that information."

Briefly describe the barriers to joint decision-making Katz mentions.

1. Medical Uncertainty: "The problem of uncertainty poses the most formidable obstacle to disclosure and consent." Medical uncertainty constitutes a formidable obstacle to joint decisionmaking for a number of reasons: Sharing uncertainties requires physicians to be more aware of them than they commonly are. They must learn how to communicate them to patients and they must shed their embarrassment over acknowledging the true state of their own and of medicine's art and science. Thus, sharing uncertainties requires a willingness to admit ignorance about benefits and risks; to acknowledge the existence of alternatives, each with its own known and unknown consequences; to eschew one single authoritative recommendation; to consider carefully how to present uncertainty so that patients will not be overwhelmed by the information they will receive; and to explore the crucial question of how much uncertainty physicians themselves can tolerate without compromising their effectiveness as healers. a. Since doctors think of themselves as authoritative and superior, it is difficult for them to conduct themselves as they should. 2. Patient incompetence: Earlier, I touched on physicians' convictions that illness and medicine's esoteric knowledge rob patients of the capacity to participate in decisionmaking. Yet we do not know whether this is true. The evidence is compromised by the groping, half-hearted, and misleading attempts to inform patients about uncertainty and other matters which can make doctors' communications so confusing and incomprehensible. If patients then appear stupid and ignorant this should come as no surprise. 3. Patient autonomy: I appreciate that mine is a radical proposal and constitutes a sharp break with Hippocratic practices. If informed consent, however, is ever to be based on the postulate of joint decisionmaking, the obligation "to respect the autonomous choices and actions of others," as Childress has put it, must be honored. Otherwise, informed consent is reduced to doctors providing more information but leaving decisionmaking itself to the authority of physicians.

How did the age of medical science make informed consent morally imperative, according to Katz?

1. Medical science provided physicians with treatment options and made it possible for physicians to know which treatment options would actually work. 2. Thus, for the first time in medical history it is possible, even medically and morally imperative, to give patients a voice in medical decisionmaking. It is possible because knowledge and ignorance can be better specified; it is medically imperative because a variety of treatments are available, each of which can bestow great benefits or inflict grievous harm; it is morally imperative because patients, depending on the lifestyle they wish to lead during and after treatment, must be given a choice. 3. Unfortunately, "the physician-patient relationship—the conversations between the two parties—was not altered with the transformation of medical practice during the twentieth century.

Why does allowing physicians to make decisions for patients often lead to worse outcomes, according to Katz?

1. Physicians are driven by their desire to diagnose and cure disease and their fear of failure. This creates "a need to control that exceeds in magnitude what most people would find reasonable." Kindness and consideration are consequently shoved aside. Physicians are not trained to understand their patients' expectations and values either. For these reasons, allowing physicians to determine what is best for their patients often leads to worse outcomes. 2. Meaningful collaboration between physicians and patients cannot become a reality until physicians have learned (1) how to treat their patients not as children but as the adults they are; (2) how to distinguish between their ideas of the best treatment and their patients' ideas of what is best; (3) how to acknowledge to their patients (and often to themselves as well) their ignorance and uncertainties about diagnosis, treatment, and prognosis; [and to all this, I now want to add, (4) how to explain to patients the uncertainties inherent in the state of the art and science of medicine which otherwise permits doctors on the basis of their clinical experience to leave unacknowledged that their colleagues on the basis of their clinical experience have different beliefs as to which treatment is best].

Universalists are defined as people who believe that "all research . . . should be justified according to universally applicable standards."

1. Pluralists believe that some standards "must be adapted to accommodate the mores of particular cultures." Universalists call pluralists ethical relativists; pluralists call universalists "ethical imperialists." 2. Universalists argue that Western standards deter exploitation of subjects in developing nations, The Declaration of Helsinki is widely accepted. 3. Pluralists argue that "The imposition of ethical standards for the conduct of research by a powerful country on a developing country [is] another form of exploitation", The Declaration of Helsinki reflects "a uniquely Western view of the nature of the person."

What are the community practice and reasonable patient standards, and what is wrong with them, according to Brody?

1. Respect for patient autonomy requires that certain information relevant to treatment decisions be disclosed to patients. Standards tell us how to determine what information ought to be disclosed.2. Community practice standard: The physician should disclose what similarly situated colleagues would disclose in similar circumstances. Problem. What other physicians do may not serve patients' needs. 3. Reasonable patient standard: The physician ought to disclose what any reasonable patient would consider it material to know. Problem. The standard encourages the physician to lay out all possible risks, benefits, and alternatives. This isn't practical in a primary care setting. 4. "To the physician obtaining informed consent, you never know when you are finished," e.g., a. A list of risks may omit significant ones b. The patient may not understand the information.

Very briefly summarize the legal history of informed consent.

1. Schloendorff v. Society of New York Hospital (1914): "Every human being of adult years and sound mind has a right to determine what shall be done with his own body;" did not require that consent be informed. 2. Salgo v. Leland Stanford Junior University Board of Trustees (1957): The term "informed consent" is introduced. "A physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment." 3. Canterbury v. Spence (1972): "The scope of the physician's communication to the patient . . . must be measured by the patient's need, and that need is the information material to the decision." The patient, not the medical profession, determines whether the information is sufficient. 4. Unfortunately, "many critics see huge discrepancies between the ethical ideal of informed consent and the laws or rules meant to implement it." Critics also allege that paternalism is still rampant in medical practice.

Prior to the 1950s, what was the attitude of physicians toward informed consent?

1. Since ancient times, informed consent has been inconsistent with accepted medical practice, and physicians have believed that they ought to make treatment decisions for their patients. 2. While physicians were expected to care for their patients' medical needs and "abstain from whatever is deleterious and mischievous," patients were not considered "'autonomous human beings, entitled to being partners in decision-making."

How can participation in clinical trials conflict with a physician's duty to act in the interest of patients?

1. Some argue that in clinical trials, physicians give some patients treatments that they do not believe are best, and this conflicts with a duty to act in the best interests of patients. Defenders of randomized studies respond that there is no breach of duty since physicians don't know which treatment is best. 2. While some say a physician is not in equipoise if she believes one treatment to be better than another, others say that equipoise depends on disagreement in the scientific community, not on the physician's mental states. 3. "Many see no conflict between (1) physicians revealing to patients their honest preferences regarding treatments and (2) giving those patients the chance to enter a clinical trial."

How do the Japanese conceive of persons, according to Levine? What customs can be attributed to this conception? What concerns would Westerners raise about these customs?

1. The cultures Levine studied are Western Africa, China, and Central American Mayan culture. 2. Our radically individualist concept of the person is a minority viewpoint. The Japanese conceive of persons as being interdependent parts of relationships that involve a "continuous, gift-exchange-structured flow of material and nonmaterial 'goods' and 'services.'" The cycle of giving, receiving, and repaying binds persons together. "Status, rank, and hierarchical order" in relationships are also important. 3. In the West, these customs would raise questions about conflicts of interest, "undue inducement," and "other ulterior form(s) of constraint or coercion."

What is the transparency standard? How does it define a reasonably informed patient? What are the advantages of the account, according to Brody?

1. The key idea: "disclosure is adequate when the physician's basic thinking has been rendered transparent to the patient." 2. "[A]dequate informed consent is obtained when a reasonably informed patient is allowed to participate in the medical decision to the extent that [the] patient wishes." 3. "Reasonably informed": "the physician disclosed the basis on which the proposed treatment, or alternative possible treatments, have been chosen"; "the patient is allowed to ask questions suggested by the disclosure of the physician's reasoning, and those questions are answered to the patient's satisfaction." 4. Advantages: The physician knows when she is finished obtaining informed consent—when she has: Shared her thinking with the patient, Encouraged and answered questions, Found out how participatory the patient wants to be and facilitated that level of participation. a. Better than listing often irrelevant risk factors. b. Patient retains right to ask for exhaustive lists of risks and alternatives. c. Revealing the physician's thinking is more likely to elicit patient participation than is a list of risks and benefits

Under what conditions is research with children considered acceptable?

1. The only way to devise safe and effective treatments for disease in children is to perform clinical trials with children as subjects. This reality raises many ethical questions. 2. "Most official policies assert or assume that properly designed research in children is morally acceptable if it is conducted for their sake, if it is done to generate the therapies they need." Consent is required, and risks and benefits must be properly balanced. Ethicists disagree over the details of these requirements. 3. Parents or guardians typically give consent; children may if they have reached the age of consent, but there is no agreement over when that age is reached. In some circumstances, children have additional authority to decide. 4. Some oppose nontherapeutic research on children since it involves risk but does not benefit them. Vaughn argues that "This position would rule out a great deal of science that could yield effective treatments for childhood diseases." Most official guidelines allow nontherapeutic research if the risk to subjects is "minimal or close to it." 5. "Most of the pressing questions about research on children also apply to studies on the mentally impaired, and many of the answers are the same." 6. Attempting to obtain voluntary informed consent can be undermined if the subjects are institutionalized for various reasons.

How is the conflict between beneficence and clinical trials commonly minimized?

1. There is a "solid" consensus on the ethical requirements of clinical trials: a. Subjects must give voluntary informed consent b. The study "must be designed to minimize risks to subjects and offer an acceptable balance of risks and benefits" c. "Subjects must be selected fairly to avoid exploiting or unjustly excluding them" d. "The subjects' privacy must be protected, and the confidentiality of research data must be preserved" e. An independent panel must approve the research before it is conducted. 2. The principles of autonomy, beneficence, and justice apply to human research.

What reasons are there to think that the consent of subjects may not be voluntary?

1. There is a standard checklist for disclosure (see text). 2. Some have worried whether the consent of subjects can be truly informed or voluntary. There are the paternalistic worries that subjects may not be able to understand the disclosure due to their lack of scientific expertise or that they may volunteer out of "desperation, fear, wishful thinking, or hope." 3. Some also argue that large monetary inducements to become subjects may be coercive.

What, according to Brody, is the problem with the way in which the literature on informed consent approaches the topic?

1. Thesis: The majority of doctor-patient interactions occur in primary care settings, but in those settings, "benign paternalism" reigns and "respect for patient autonomy is almost completely absent." The transparency standard of informed consent ought to be adopted. Other standards "send physicians the wrong message about what is expected of them." 2. Crucial assumptions: "Respect for patient autonomy" is "a central feature of good medical care." But physicians still consider it a "bureaucratic legalism." "There are important differences between the practice of primary care medicine and the tertiary care settings that have been most frequently discussed in the literature on informed consent." But informed consent is important in primary care settings also.

What are the conditions for valid consent according to the Nuremberg Code?

According to the Nuremberg Code, valid consent requires that consent is voluntary, legally competent, free from deception or coercion, informed, and comprehending.

What do the following theories likely say about informed consent? Act utilitarianism, rule utilitarianism, Kantian ethics.

Act utilitarianism. Whether informed consent is required in a particular instance depends on the long-term consequences for everyone considered. "There is both good and bad to weigh." Rule utilitarianism. The morality of the requirement would depend of the long-term consequences of adopting a rule that would require it in ordinary cases. Kantian ethics. Informed consent "can be derived directly from Kantian ethics." Therapeutic privilege would never be permissible, but waiver would be allowed.

What is a universal ethical standard, according to Levine?

Certain international guidelines strike a balance between these two perspectives: they require that the research protocol conform to the initiating country's ethical standards, but they allow for "accommodation to the mores of the culture within the 'host country.'" "The conduct of research involving human subjects must not violate any universally applicable ethical standards." Levine believes that Kant's statement of respect for persons is universally applicable: So act as to treat humanity, whether in thine own person or in that of any other, in every case as an end withal, never as a means only."

When is consent voluntary?

Consent is voluntary when it is "given freely, without undue (autonomy-robbing) pressure from others. Coercion and manipulation are the most obvious examples of such pressures." "Physicians can influence patients through reasoning, emotional appeals, and authority—yet these pressures are not necessarily undue." "Consent is more than assent."

How does Parsons object to informed consent requirements? How does Katz respond to his objections?

In the early 1950s, sociologist Talcott Parsons, who echoed physicians' views, argued that the competence and judgment of physicians "cannot be competently judged by the layman and that the latter must take doctors' judgments and measures on 'authority'" for the following reasons: 1. "Physicians' esoteric knowledge, acquired in the course of arduous training and practical experience, cannot be comprehended by patients." Katz argues that it is possible to communicate "'esoteric knowledge' to patients in plain language." 2. "Patients, because of their anxieties over being ill and consequent regression to childlike thinking, are incapable of making decisions on their own behalf." Katz objects that these "regressive manifestations" may be caused by the way in which authoritarian physicians treat their patients. 3. "Physicians' commitment to altruism is a sufficient safeguard for preventing abuses of their professional authority." Katz argues, however, that "altruism cannot promise that physicians will know, without inquiry, patients' needs."

What is informed consent?

Informed consent "refers to the action of an autonomous, informed person agreeing to submit to medical treatment or experimentation."

What are the conditions of informed consent?

Informed consent exists if and only if: 1. The patient is competent to decide, 2. She gets an adequate disclosure of information, 3. She understands the information, 4. She decides about the treatment voluntarily, and 5. She consents to the treatment.

How do Faden and Beauchamp further clarify sense1 of informed consent? What conditions are met when informed consent in this sense is obtained?

Informed consent requires authorization, not assent, which "may be a mere submission to the doctor's authoritative order." So informed consent in sense1 is defined thus: "An informed consent is an autonomous action by a subject or a patient that authorizes a professional either to involve the subject in research or to initiate a medical plan for the patient (or both)." In this sense, informed consent is given "if a patient or subject with (1) substantial understanding and (2) in substantial absence of control by others (3) intentionally (4) authorizes a professional (to do intervention I)."

What is required for understanding? What factors can impede understanding?

It's not clear what understanding amounts to. At a minimum, informed consent seems to require that patients be able to take in the relevant information and assess it well enough to appreciate the consequences of their choices. They need not completely fathom all the information given, but they should comprehend what is most relevant to their decision. And their refusal to submit to a recommended treatment should not be taken as evidence of a lack of understanding. Understanding can be impeded if a physician overloads a patient with information or frames it in misleading ways. A patient's "fear, denial, wishful thinking, magical thinking, and false beliefs" can also impede understanding.

On what grounds did judges argue that informed consent was legally required? What conditions did Judge Schroeder add to informed consent, and what "fault lines" does Katz find in Schroeder's doctrine?

Judges determined that informed consent was necessary: "Without any disclosure of risks, new technologies had been employed which promised great benefits but also exposed patients to formidable and uncontrollable harm." In 1960, Judge Schroeder provided these conditions to informed consent: To disclose and explain to the patient, in language as simple as necessary, the nature of the ailment, the nature of the proposed treatment, the probability of success or of alternatives, and perhaps the risks of unfortunate results and unforeseen conditions within the body." Several "fault lines" are "inherent" in this doctrine: 1. The doctrine was "designed to specify those minimal disclosure obligations that physicians must fulfill to escape legal liability for alleged non-disclosures" and was thus limited in scope. It was based also in negligence law rather than battery law and therefore "permits doctors to invoke many defenses." 2. "The doctrine of informed consent was not designed to serve as a medical blueprint for interactions between physicians and patients." So, in practice, the purpose of disclosure has been to escape legal liability. 3. The legal doctrine assumes that "patients and physicians must make decisions jointly." But some physicians believe that they have a right to decide unilaterally for their patients and that patients must "trust doctors silently." 4. "The idea of joint decisionmaking is one thing, and its application in practice another. . . . To translate social policy into medical policy is an inordinately difficult task." "Turning now to these problems, I wish to highlight that, in the absence of such reassessments, informed consent will remain a charade, and joint decisionmaking will elude us."

What are commonly thought to be the ethical requirements of clinical trials?

Many studies are typically required to establish the safety and effectiveness of an intervention. Drugs are tested in three and sometimes even four phases.

What conflict is present when research subjects are vulnerable?

Much objectionable research has been performed on the vulnerable. There is a conflict between "(1) the duty to shield the vulnerable from abuse and (2) the aspiration to benefit them or society through needed research."

What principles are used to justify informed consent requirements, and how do they do so?

Philosophers justify informed consent by appealing to the principles of autonomy and beneficence. Beneficence applies because it is argued that "knowledgeable, autonomous patients who choose for themselves will advance their own interests as they themselves conceive them."

Why is informed consent "largely a charade," according to Katz?

Physicians must respect the idea of informed consent. But often they do not: rather than participate in joint decisionmaking, they make a treatment decision and then "present their disclosures in ways that lead patients to agree" with them. For that reason, "informed consent in today's world is largely a charade which misleads patients into thinking that they are making decisions when indeed they are not." Respect for autonomy forces physicians to treat patients as persons; beneficence does not.

What two senses of informed consent do Faden and Beauchamp distinguish?

Sense1 is "a particular kind of action by individual patients and subjects: an autonomous authorization" Sense2 is "analyzable in terms of the web of cultural and policy rules and requirements of consent that collectively form the social practice of informed consent in institutional contexts where groups of patients and subjects must be treated in accordance with rules, policies, and standard practices."

What is the shared decision-making model of informed consent? What is wrong with the model, according to Faden and Beauchamp?

Some people "equate the idea of informed consent with a model of 'shared decision-making' between doctor and patient." But "it is a confusion to treat informed consent and shared decision-making as anything like synonymous." 1. "Informed consent is not restricted to clinical medicine." 2. "In clinical contexts, the social and psychological dynamics involved in selecting medical interventions should be distinguished from the patient's authorization." 3. "Although the patient and physician may reach a decision together, they need not." "In authorizing, one both assumes responsibility for what one has authorized and transfers to another one's authority to implement it. There is not informed consent unless one understands these features of the act and intends to perform that act.

Briefly describe the moral issue of the use of control groups in clinical trials.

The use of control groups is a moral issue since control group subjects receive either the less effective and safe treatment or no treatment at all. Some argue that control group subjects are used as a mere means to the end of scientific knowledge. Some respond by saying that, while such subjects are being used as a means, they are not being used as a mere means, since they give voluntary informed consent.

Why doesn't Levine offer a cross-cultural definition of informed consent?

There can be no cross-cultural definition of informed consent since informed consent involved the concept of personhood, and views of the nature of persons vary from culture to culture. So Levine offers a "procedural approach to dealing with the problem."

What is wrong with Western standards of informed consent, according to Levine?

This concept of autonomy is "consistent with the prevailing perception of the nature of the 'moral agent' in Western civilization." The National Commission was surely influenced by Immanuel Kant and Benjamin Cardozo. Those seeking informed consent tend to emphasize disclosure and understanding. Levine has argued that "the informed consent standards of the Declaration of Helsinki are not universally valid" because they will not guide physicians in their efforts to show respect for persons because they do not reflect adequately the views held in these cultures of the nature of the person in his or her relationship to society.

What two values shape medical science?

Two values shape medical science: beneficence and knowledge. "These dual purposes do not fit together easily."

What is disclosure, and when is it adequate? What items are generally required? What exceptions to the disclosure requirement have been proposed?

What is an adequate disclosure? What kind and amount of information are sufficient? The ethical doctrine of informed consent says that disclosure is adequate if it allows patients to weigh intelligently the risks and benefits of available choices. But how to achieve this idea in practice is not obvious. Physician-based, patient-based, and subjective standards have been proposed, but all three have their shortcomings. The following items are generally required:1. The nature of the procedure 2. The risks of the procedure 3. Alternatives to the proposed procedure 4. Expected benefits of the proposed treatment. Disclosure is not required in certain emergencies, when a patient has waived the right to informed consent, and in cases of therapeutic privilege, "the withholding of relevant information from a patient when the physician believes disclosure would like do harm." The final exception is, of course, controversial. Some worry that therapeutic privilege can be and is being abused and weakening informed consent requirements.