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PRINCIPLES OF AUTONOMY & INFORM CONSENT

PATERNALISM Paternalism is the interference of a state or an individual with another person, against their will, and defended or motivated by a claim that the person interfered with will be better off or protected from harm. The issue of paternalism arises with respect to restrictions by the law such as anti-drug legislation, the compulsory wearing of seatbelts, and in medical contexts by the withholding of relevant information concerning a patient's condition by physicians. At the theoretical level it raises questions of how persons should be treated when they are less than fully rational. PATERNALISM AND BIOETHICS Paternalism is against the informed consent, though informed consent is now the mainstream of the Bioethics. It is literally interpreted as a principle that thinks hightly of paternal warmth. It is derived from "Hippocratic Oath". It insists that patients believe in doctors' conscience and skill and act as doctors tells patients to do. Historically, paternalism was born as a fundamental standard that didn't allow any doctor to violate the human rights of patient on the ground of development of medical science or treatment as a result of the regret over the experiments on human against humanity. Ironically, paternalism became the cause of producing Bioethics represented by imformed consent, which was against paternalism. However, in actual scene of medical treatment, there are still some cases where the doctors' paternalism strongly shows itself. Such doctors say, "We are doing things benefitting patients. Leave it to us." We have developed many useful devices. Above all, the Internet provides us with much infomation. They also tells us much infomation of medical treatment: therefore, we can feel medical treatment in our own backyard. Under such circumstances, the old paternalism can result in our distrust of medical treatment.

Even if one patient is already medically treated in some ways, he/she be informed of the side effects he/she is using and another medical treatment.

FROM THE VIEW POINT OF INFORMED CONSENT Relationship between doctors and patients has been compared to that between fathers and children. "Leave it to me. Keep off the complex things.""Gather the patients, not inform." These are what we call typical Paternalism, which has been considered right. Let's think of paternalism a little more from the viewpoint of informed consent. At present days, informed consent is utilized in medical treatment in many countries. The characteristic that trust doesn't occur to people if doctors don't cope with the stream: patients began to think highly of their self-decision and to claim their rihgts to choose the medical treatment done by doctor. On the other hand, in contrast to patients, some doctors on field strongly paersist, "In present system, time-consuming particular explanation for patients doesn't pay." or "Informed consent was originated in America. America differs in cultural and social aspects from Japan." Certainly there may be remedied without patients' precise and deep knowledge of them. In Japan, there is a prove canot representing it: "Diseases are caused by unbalance" Fumio Funaya, the professor of medical treatment faculty of University of occupational and Environmental Health' Japan, say as an anser to Asahi News Agent, "doctors with abundant expertise should properly inform laypeople of thier knowledge and be so to speak teachers, but actually not a few doctors examine and operate patients." As medical technology such as transplantation, in vitro fertilization, gene theraphy, etc. quickly progress, it came clear that paternalism fail patients to protect their human rights. In medical treatment as well as in home, paternalism is collapsing and being replaced by informed consent. Now, patients as well as doctors are asked to become wise. THE HIPPOCRATIC OATH

I swear by Apollo the Physician, and Asklepios and Hygieia, and all the Gods and Goddesses that, according to my ability and judgment, I will keep this oath and this syngraphe ('contract'): to consider him who taught me this Art as dear to me as my parent, to share my substance with him, and to relieve his necessities if required; to look upon his offspring as equivalent to my own brothers, and to teach them this Art, if they wish to learn it, without fee or stipulation; and that by precept, lecture, and every other form of instruction, I will impart a knowledge of the Art to my own sons, and those of my teachers, and to disciples bound by a stipulation and oath according to the law of medicine, but to none others. I will follow that system of regimen which, according to my ability and judgment, I consider for the benefit of my patients and abstain from whatever is harmful and mischievous. I will give no deadly medicine to anyone if asked, nor suggest any such advice; likewise, I will not give a pessary to a woman to induce abortion. I will live my life and practice my art with purity and holiness. I will not cut persons suffering from 'the stone', but will leave this to be done by men who are practitioners of this skill. Whatever houses I enter, I will enter for the benefit of the sick, and will abstain from every voluntary act of mischief and corruption, and especially from the seduction of females or males, of free persons or slaves. Whatever I see or hear in connection with my professional practice or not in the life of men, which should not be made public, I will not divulge, considering that all such knowledge should remain secret. As long as I continue to keep this Oath inviolate, may it be granted to me to enjoy life and the practice of the Art, respected by all men, at all times. But if I should trespass and violate this Oath, may the opposite be my lot.

CONCEPTUAL ISSUES The analysis of paternalism involves at least the following elements. It involves some kind of limitation on the freedom or autonomy of some agent and it does so for a particular class of reasons. As with many other concepts used in normative debate determining the exact boundaries of the concept is a contested issue. And as often is the case the first question is whether the concept itself is normative or descriptive. Is application of the concept a matter for empirical determination, so that if two people disagree about the application to a particular case they are disagreeing about some matter of fact or of definition? Or does their disagreement reflect different views about the legitimacy of the application in question? While it is clear that for some to characterize a policy as paternalistic is to condemn or criticize it, that does not establish that the term itself is an evaluative one. As a matter of methodology it is preferable to see if some concept can be defined in non-normative terms and only if that fails to capture the relevant phenomena to accept a normative definition. I suggest the following conditions as an analysis of X acts paternalistically towards Y by doing (omitting) Z: 1. Z (or its omission) interferes with the liberty or autonomy of Y. 2. X does so without the consent of Y. 3. X does so just because Z will improve the welfare of Y (where this includes preventing his welfare from diminishing), or in some way promote the interests, values, or good of Y. Condition one is the trickiest to capture. Clear cases include threatening bodily compulsion, lying, withholding information that the person has a right to have, or imposing requirements or conditions. But what about the following case? A father, skeptical about the financial acumen of a child, instead of bequeathing the money directly, gives it to another child with instructions to use it in the best interests of the first child. The first child has no legal claim on the inheritance.

There does not seem to be an interference with the child's liberty nor on most conceptions the child's autonomy. Or consider the case of a wife who hides her sleeping pills so that her potentially suicidal husband cannot use them. Her act may satisfy the second and third conditions but what about the first? Does her action limit the liberty or autonomy of her husband? The second condition is supposed to be read as distinct from acting against the consent of an agent. The agent may neither consent nor not consent. He may, for example, be unaware of what is being done to him. There is also the distinct issue of whether one acts not knowing about the consent of the person in question. Suppose the person in fact consents but this is not known to the paternaliser. The third condition also can be complicated. There may be more than one reason for interfering with Y. In addition to concern for the welfare of Y there may be concern for how Y's actions may affect third-parties. Is the just for condition too strong? Or what about the case where a legislature passes a legal rule for paternalistic reasons but there are sufficient nonpaternalistic reasons to justify passage of the rule? If, in order to decide on any of the above issues, one must decide a normative issue, e.g. does someone have a right to some information, then the concept is not purely descriptive. Ultimately the question of how to refine the conditions, and what conditions to use, is a matter for philosophical judgment. The term paternalism as used in ordinary contexts may be too amorphous for thinking about particular normative issues. One should decide upon an analysis based on a hypothesis of what will be most useful for thinking about a particular range of problems. One might adopt one analysis in the context of doctors and patients and another in the context of whether the state should ban unhealthy foods. Given some particular analysis of paternalism there will be various normative views about when paternalism is justified. The following terminology is useful. HARD VS. SOFT PATERNALISM

Soft paternalism is the view that the only conditions under which state paternalism is justified is when it is necessary to determine whether the person being interfered with is acting voluntarily and knowledgeably. To use Mill's famous example of the person about to walk across a damaged bridge, if we could not communicate the danger (he speaks only Japanese) a soft paternalist would justify forcibly preventing him from crossing the bridge in order to determine whether he knows about its condition. If he knows, and wants to, say, commit suicide he must be allowed to proceed. A hard paternalist says that, at least sometimes, it may be permissible to prevent him from crossing the bridge even if he knows of its condition. We are entitled to prevent voluntary suicide. BROAD VS. NARROW PATERNALISM A narrow paternalist is only concerned with the question of state coercion, i.e. the use of legal coercion. A broad paternalist is concerned with any paternalistic action: state, institutional (hospital policy), or individual. WEAK VS. STRONG PATERNALISM A weak paternalist believes that it is legitimate to interfere with the means that agents choose to achieve their ends, if those means are likely to defeat those ends. So if a person really prefers safety to convenience then it is legitimate to force them to wear seatbelts. A strong paternalist believes that people may be mistaken or confused about their ends and it is legitimate to interfere to prevent them from achieving those ends. If a person really prefers the wind rustling through their hair to increased safety it is legitimate to make them wear helmets while motorcycling because their ends are irrational or mistaken. Another way of putting this: we may interfere with mistakes about the facts but not mistakes about values. So if a person tries to jump out of a window believing he will float gently to the ground we may restrain him. If he jumps because he believes that it is important to be spontaneous we may not. PURE VS. IMPURE PATERNALISM Suppose we prevent persons from manufacturing cigarettes because we believe they are harmful to consumers. The group we are trying to protect is the group of consumers not

manufacturers (who may not be smokers at all). Our reason for interfering with the manufacturer is that he is causing harm to others. Nevertheless the basic justification is paternalist because the consumer consents (assuming the relevant information is available to him) to the harm. It is not like the case where we prevent manufacturers from polluting the air. In pure paternalism the class being protected is identical with the class being interfered with, e.g. preventing swimmers from swimming when lifeguards are not present. In the case of impure paternalism the class of persons interfered with is larger than the class being protected. MORAL VS. WELFARE PATERNALISM The usual justification for paternalism refers to the interests of the person being interfered with. These interests are defined in terms of the things that make a person's life go better; in particular their physical and psychological condition. It is things like death or misery or painful emotional states which are in question. Sometimes, however, advocates of state intervention seek to protect the moral welfare of the person. So, for example, it may be argued that prostitutes are better off being prevented from plying their trade even if they make a decent living and their health is protected against disease. They are better off because it is morally corrupting to sell one's sexual services. The interference is justified, therefore, to promote the moral well-being of the person. This then can be called moral paternalism. Still another distinction within moral paternalism is between interferences to improve a person's moral character, and hence her wellbeing, and interferences to make someone a better personeven if her life does not go better for her as a result. Finally, it is important to distinguish paternalism, whether welfare or moral, from other ideas used to justify interference with persons; even cases where the interference is not justified in terms of protecting or promoting the interests of others. In particular moral paternalism should be distinguished from legal moralism, i.e. the idea that certain ways of acting are morally wrong or degrading and may be prohibited. So, for example, the barroom sport of dwarf tossing (where dwarfs who are paid, and are protected with helmets, etc. participate in contests to see who can throw them furthest) might be thought to be legitimately prohibited. Not because the dwarf is injured in any way, not because the dwarf corrupts himself by agreeing to participate in such activities, but simply because the activity is morally degrading and wrong.

To be sure it is not always easy to distinguish between legal moralism and moral paternalism. If one believes, as Plato does, that acting wrongly damages the soul of the agent, then it will be possible to invoke moral paternalism rather than legal moralism. What is important is that there are two distinct justifications that are possible; one appealing to the mere immorality of the conduct interfered with, the other to the harm done to the agent's character. NORMATIVE ISSUES Is there a burden of proof attached to paternalism? Does the paternalist or anti-paternalist have to give a reason for their action? As we have seen the analysis of paternalism seems to cut both ways. It is an interference with liberty which might be thought to place the burden of proof on the paternalist. It is an act intended to produce good for the agent which might be thought to place the burden of proof on those who object to paternalism. It might be thought, as Mill did, that the burden of proof is different depending on who is being treated paternalistically. If it is a child then the assumption is that, other things being equal, the burden of proof is on those who resist paternalism. If it is an adult of sound mind the presumption is reversed. Suppose we start from the presumption that paternalism is wrong. The question becomes under what, if any, circumstances, can the presumption be overcome? The possible answers are under no circumstances, under some circumstances, and under any circumstances The last seems very implausible. Essentially it is the view that the fact that an act is (intended to be) beneficial for a person, and does not affect or violate the interests of others, settles the question of whether it may be done. Only a view which ignores the means by which good is promoted, and the ethical status of such means, can hold this. Any sensible view has to distinguish between good done to agents at their request or with their consent, and good thrust upon them against their will. So the normative options seem to be just two. Either we are never permitted to do good for others against their wishes, and in ways which limit their liberty, or we are permitted to do so.

Why might one think that at least the state may never do so? One might think so because of various beliefs about the impossibility of in fact doing good for people against their will or because one thinks that although possible to do good it is in fact inconsistent with some normative standard which ought to prevail. With respect to the impossibility question one might believe either that it is not possible to do any good by acting paternalistically or that although it is possible to do some good the process will (almost) always produce bads which outweigh the good. If one thought that almost)always more harm than good is done by the state when it acts paternalistically this raises the question of whether we can distinguish the conditions in which (rarely) more good than harm is done and build that into our guidelines. If this is possible,and so distinguishing does not create further harms which outweigh the good produced, and we think, the only issue is good promotion we should sometimes be paternalists. If it is impossible to distinguish the good from the bad cases then, at least if we are rule consequentialists, we ought not to have such a rule; and we ought not to try and make the distinctions on a case by case basis. But one might believe that the question of whether more good than harm is produced is not simply an empirical one. It depends on our understanding of the good of persons. If the good simply included items such as longer life, greater health, more income, or less depression, then it makes it look like an empirical issue. But if we conceive of the good of individuals as including items such as being respected as an independent agent, having a right to make decisions for oneself, or having one's autonomy not infringed, then the issue of whether the agent is better off after being paternalised is partly a normative matter. One might believe that one cannot make people better off by infringing their autonomy in the same way that some people believe one cannot make a person better off by putting them in a Nozickian experience machine (one in which they are floating in a tank but seem to be having all kinds of wonderful experiences). Compare Mill's statement that a man's mode of laying out his own existence is best not because it is the best in itself, but because it is his own mode (1859, Chapter III).

Kantian views are frequently absolutistic in their objections to paternalism. On these views we must always respect the rational agency of other persons. To deny an adult the right to make their own decisions, however mistaken from some standpoint they are, is to treat them as simply means to their own good, rather than as ends in themselves. In a way anti-paternalism is already incorporated into Kantian theories by their prohibition against lying and forcethe main instruments of paternalistic interference. Since these instrumentalities are already denied even to prevent individuals from harming others, they will certainly be forbidden to prevent them from harming themselves. Of course, one may object to the former absolutism while accepting the latter. If one believes that sometimes paternalism is justifiable one may do so for various kinds of theoretical reasons. The broadest is simply consequentialist, i.e. more good than harm is produced. A narrower justification is that sometimes the individuals (long-run) autonomy is advanced by restricting his autonomy (short-run). So one might prevent people from taking mind-destroying drugs on the grounds that allowing them to do so destroys their autonomy and preventing them from doing so preserves it. This is essentially Mill's argument against allowing people to contract into slavery. Note that if the theory of the good associated with a particular consequentialism is broad enough, i.e., includes autonomy as one of the goods, it can be equivalent to the autonomy theory (assuming that the structure of the autonomy view is a maximizing one). A different theoretical basis is (moral) contractualism. On this view if there are cases of justified paternalism they are justified on the basis that we (all of us) would agree to such interference, given suitable knowledge and suitable motivation. So, for instance, it might be argued that since we know we are subject to depression we all would agree, at least, to shortterm anti-suicide interventions, to determine whether we are suffering from such a condition, and to attempt to cure it. More generally, we might accept what Feinberg called soft paternalism. This is the view that when we are not acting fully voluntarily it is permissible to intervene to provide information, or to point out defects in our rationality, but that if we then do make a voluntary choice it must be respected. Or we might agree to being forced to wear seat-belts knowing our disposition to discount future benefits for present ones. The justification here is neither consequentialist nor based simply on the preservation of autonomy. Rather either kind of

consideration may be taken into account, as well as others, in determining what we would reasonably agree to. CONFIDENTIALITY

Confidentiality is the right of an individual patient to have personal, identifiable medical information kept private; such information should be available only to the physician of record and other health care and insurance personnel as necessary.

DESCRIPTION

Patient confidentiality means that personal and/or medical information given to a health care provider will not be disclosed to others unless the patient has given informed consent. This is becoming extremely difficult to ensure in an age of electronic medical records and third-party insurance payers.

VIEWPOINTS

Because the disclosure of personal information could cause professional or personal problems, patients rely on physicians to keep their medical information private. It is rare for medical records to remain completely sealed, however. The most benign breach of confidentiality takes place when clinicians share medical information as case studies. When this data is published in professional journals the identity of the patient is never divulged, and all identifying data is either eliminated or changed. If this confidentiality is breached in any way, patients may have the right to sue.

The greatest threat to medical privacy, however, occurs because most medical bills are paid by some form of health insurance, either private or public. This makes it difficult, if not impossible, to keep information truly confidential. Health records are routinely viewed not only by physicians and their staffs, but by insurance companies, medical laboratories, public health departments, researchers, and many others. If health insurance is provided by an employer, they

too may have access to their employees files.

LEGAL FRAMEWORK

Each state, and the federal government, has enacted laws to protect the confidentiality of health care information generally, with particular attention paid to information about communicable diseases and mental health. For example, through the 1960s substance and alcohol abuse were treated as mental illnesses, with patient confidentiality determined by the laws in each state, since at the time the state was responsible for mental health care and treatment.

In the early 1970s, however, the rising numbers of those needing substance abuse treatment came to the attention of the federal government, because drug-related activity, including the treatment for substance abuse, could be the basis for criminal prosecution on a federal level. Congress concluded that this might stop many who needed treatment from seeking it. They enacted a strict confidentiality law to limit disclosure of information that could reveal a patient's identity.

Confusion ensued when practitioners who were treating substance abusers were required to follow two practices for patient confidentialityone mandated by the state, the other dictated by the federal government. With the varying degrees of protection provided by state mental health laws, the confusion grew further still. While all states specify exceptions to confidentiality, few have spelled out the necessary elements of valid consent for disclosure of mental health information. Some states allow disclosure of the following types of mental health information without client consent: disclosures to health care services payers or other sources of financial assistance to the patient disclosures to third parties that the mental health professional feels might be endangered by the patient

disclosures to researchers disclosures to agencies charged with oversight of the health care system or the system's practitioners disclosures to families under certain circumstances disclosures to law enforcement officials under certain circumstances disclosures to public health officials

Providers are increasingly concerned that these exceptions are not addressed uniformly, particularly when providers and payers do business across state lines. This results in open-ended disclosures that specify neither the parties to whom disclosure is to be made nor the specific information allowed to be revealed. The critical nature of confidentiality

Both the ethical and the legal principles of confidentiality are rooted in a set of values regarding the relationship between caregiver and patient. It is essential that a patient trust a caregiver so that a warm and accepting relationship may develop; this is particularly true in a mental health treatment.

TRUTHFULLNESS AND CONFIDENTIALITY

CONFIDENTIALITY

The patient's privacy is consistent with the Hippocratic oath and with the law as part of the constitutional right to privacy. Although the professional nurse should assure the patient of confidentiality, limits on this standard must be clarified and discussed with the patient at the earliest opportunity. It is imperative to clearly understand the process of informed consent and the legal standard for disclosure of confidential patient information to others. The Medical Record Confidentiality Act of 1995, a federal statute, is the primary federal

law governing the use of health treatment and payment records. Several practical guidelines include: o Respecting the individual's right to privacy when requesting or responding to a request for patient's medical records. o Always requiring a signed medical authorization and consent form to release medical records and information to protect and respect patient-provider privilege statutes. o Discussing confidentiality issues with the patient and establish consent. Address concerns or special requests for information not to be disclosed.

Enacted in August 1996, The Health Insurance Portability and Accountability Act of 1996 (HIPAA, commonly misabbreviated as HIPPA) was designed to make health insurance more affordable and accessible and recognize the need for national patient record privacy standards. The law places limits on pre-existing condition exclusions in group health plans, gives new enrollees credit for prior coverage, makes it illegal to use health status as a reason for denying coverage, guarantees group coverage for employers with 50 or fewer employees, and guarantees renewability of group health plans. The law included provisions designed to save money for health care businesses by encouraging electronic transactions and requires new safeguards to protect the confidentiality and security of that information. The law gave Congress until August 21, 1999 to pass comprehensive health privacy legislation. However, Congress did not enact such legislation and the law required that after 3 years, the Department of Health and Human Services (DHHS) enact such protections by regulation. In December 2000, DHHS issued a final rule to protect the confidentiality of individually identifiable health information. The rule: o Limits the use and disclosure of certain individually identifiable health information. o o Gives patients the right to access their medical records. Restricts most disclosure of health information to the minimum needed for the

intended purpose. o Establishes safeguards and restrictions regarding the use and disclosure of records for certain public responsibilities, such as public health, law enforcement and research. o Provides for criminal or civil sanctions for improper uses or disclosures.

The exceptions or limits to confidentiality include situations in which society has judged that the need for information outweighs the principle of confidentiality. However, legal counsel should be consulted because these decisions are made on a case-by-case basis, and broad generalizations cannot be assumed. It may be appropriate to breach confidentiality on a limited basis in situations such as the following: o If a patient reveals intent to harm himself or another individual, it is imperative to protect the patient and third parties from such harm. o A clinician employed by a company, school, military unit, or court has split allegiances, and the patient should be so advised at the appropriate time. o Court orders, subpoenas, and summonses in some states may require the clinician to release records for review or testify in court. However, legal counsel should be consulted first to assure that complying with the court order, subpoena or summons would not violate HIPAA. o Most insurance companies, health maintenance organizations, and governmental payers require participants to sign a release of their records to the payers. o When a patient places his or her medical condition at issue, such as in personal injury cases, workman's compensation, or in various other cases of patients claiming injuries for which they are seeking compensation from any entity or organization. o Many states have laws requiring clinicians to report the incidence of certain diseases, deaths, and other vital statistics.

Criminal codes in many states require reporting gunshot wounds, incidents of rape, and incidents of child, spouse, or elder abuse if they have reasonable cause to suspect abuse.

RESPONSIBILITIES OF THE NURSE TO THE PATIENTS

1. Give him/her the kind of care his/her condition needs regardless of his/her race, creed, color, nationality or status. 2. The patients care shall be based on needs, the physicians orders, and the ailment. 3. The nurse shall involve the patient and/or his/her family so that he/she or any of the family can participate in his/her care. 4. Know the patients Bill of Rights. 5. Be patient advocate. Treat patient in a manner that will show concern whether the patient is rich or poor. 6. Nurses should not leave a patient or any agency without proper permission or resignation or without relief. 7. Nurses should commit themselves to the welfare of those entrusted to their care. PATIENTS BILL OF RIGHTS

1. The patient has the right to considerate and respectful care. 2. The patient has the right to obtain from his physician complete and current information concerning his diagnosis, treatment, and prognosis in terms the patient can be reasonably expected to understand. 3. The patient has the right to receive from his physician information necessary to give informed consent prior to the start of any procedure and/or treatment. 4. The patient has the right to refuse treatment and to be informed of the medical consequences of his action. 5. The patient has the right to every consideration of his privacy concerning his own medical care program. 6. The patient has the right to expect that all communications and records pertaining to his care should be treated as confidential.

7. The patient has the right to expect within its capacity, a hospital must make reasonable response to the request of a patent for services. 8. The patient has the right to obtain information as to any relationship his hospital has to other health care and educational institutions insofar as his care is concerned. 9. The patient has the right to be advised if the hospital proposes t engage in or perform human experimentation affecting his care or treatment. 10. The patient has the right to expect reasonable continuity of care. 11. The patient has the right to examine and receive an explanation of his bill. 12. The patient has the right to know what hospital rules and regulations apply to his conduct as a patient. PATIENTS RESPONSIBILITIES

1. Providing information 2. Complying with instructions 3. Informing the physician of refusal to treatment 4. Paying hospital charges 5. Following hospital rules and regulations 6. Showing respect and consideration NURSES BILL OF RIGHTS

1. Nurses have the right to practice in a manner that fulfills their obligations to society and to those who receive nursing care. 2. Nurses have the right to practice in environments that allow them to act in accordance with professional standards and legally authorized scopes of practice. 3. Nurses have the right to a work environment that supports and facilitates ethical practice, in accordance with the Code of Ethics for Nurses and its interpretative statements. 4. Nurses have the right to freely and openly advocate for themselves and their patients, without fear of retribution. 5. Nurses have the right to fair compensation for their work, consistent with their

knowledge, experience and professional responsibilities. 6. Nurses have the right to a work environment that is safe for themselves and their patients. 7. Nurses have the right to negotiate the conditions of their employment, either individuals or collectively, in all practice settings. NURSES RESPONSIBILITIES IN RESEARCH ON HUMAN SUBJECTS

1. Employment in settings where research is conducted. 2. Vigilant protection of human subjects rights 3. Scope of Application 4. Supporting accrual of knowledge 5. Informed consent 6. Representation of Human Rights Committee

BASIC HUMAN RIGHTS OF RESEARCH SUBJECTS

1. Right to informed Consent 2. The right to refuse and/or withdraw from participation 3. Right to privacy 4. Right to confidentiality or anonymity of data 5. Right to be protected from harm

EXPERIMENTAL SUBJECTS BILL OF RIGHTS

1. To be told about the nature and purpose of the study. 2. To be told about the procedures to be followed in the research study, and whether any of the drugs, devices, or procedures is different from what would be used in standard practice. 3. To receive a description of any side effects, discomforts, or risks that you can reasonably

expect to occur during the study. 4. To be told of any benefits that you may reasonably expect to from the participation in the study, if applicable. 5. To receive a description of any alternative procedures, drugs, or devices that might be helpful, and their risks and benefits compared to the proposed, drugs or devices. 6. To be told of what sort of medical treatment, if any, will be available if any complications should arise. 7. To be given a chance to ask any questions concerning the research study both before agreeing to participate and at any time during the course of the study. 8. To refuse to participate in the research study. Participation is voluntary. You may refuse to answer any question or discontinue your involvement at any time without penalty or loss of benefits to which you might otherwise be entitled. Your decision will not affect your right to receive the care you would receive if you were not in the experiment. 9. To receive a copy of signed and dated written consent form and a copy of this form. 10. To be given the opportunity to freely decide whether or not to consent to the research study without any force, coercion, or undue influence.

RESPONSIBILITIES OF THE NURSE TO THE PHYSICIAN

Section 28(a) of RA 9173 states that: It shall be the duty of the nurse to: (a) Provide nursing care through utilization of the nursing process. Nursing care includes, but not limited to, traditional and innovative approaches, therapeutic and innovative approaches, therapeutic use of self, executing health care techniques and procedures, comfort measures, health teachings, and administration of written prescription for treatment, therapies, oral, topical and parental medications, internal examination during labor in the absence of antenatal bleeding and delivery. In case of suturing or perineal laceration, special training shall be provided according to protocol established.

RESPONSIBILITIES OF NURSES TO THEIR COLLEAGUES

1. Establish good working relationships with co-workers. 2. Nurses shall adjust themselves to the organization and know its policies and procedures.

RESPONSIBILITIES OF NURSES TO THEMSELVES

1. Develop their own skills. 2. Their conduct must bring credit to the profession. 3. They shall endeavor to live a life that will uphold their self-respect. 4. Wear uniform with respect and dignity (clean, neat hair style, moderate make-up, without jewelries) 5. Must act in a manner that is worth emulating especially while they are on duty.

The Good Samaritan Law It is based on the biblical story of a man who aided an injured person who was waylaid by thieves and was left half-dead. A nurse, therefore, who renders first aid or treatment at the scene of an emergency and who does so within the standard of care, acting in good faith, is relieved of the consequences of the act.

TRUTHFULLNESS When physicians communicate with patients, being honest is an important way to foster trust and show respect for the patient. Patients place a great deal of trust in their physician, and may feel that trust is misplaced if they discover or perceive lack of honesty and candor by the physician. Yet there are situations in which the truth can be disclosed in too brutal a fashion, or may have a terrible impact on the occasional patient. The goal of this summary is to be able to discern the difference. DO PATIENTS WANT TO KNOW THE TRUTH ABOUT THEIR CONDITION?

Contrary to what many physicians have thought in the past, a number of studies have demonstrated that patients do want their physicians to tell them the truth about diagnosis, prognosis, and therapy. For instance, 90% of patients surveyed said they would want to be told of a diagnosis of cancer or Alzheimer's disease. Similarly, a number of studies of physician attitudes reveal support for truthful disclosure. For example, whereas in 1961 only 10% of physicians surveyed believed it was correct to tell a patient of a fatal cancer diagnosis, by 1979 97% felt that such disclosure was correct. HOW MUCH DO PATIENTS NEED TO BE TOLD? In addition to fostering trust and demonstrating respect, giving patients truthful information helps them to become informed participants in important health care decision. Thus, patients should be told all relevant aspects of their illness, including the nature of the illness itself, expected outcomes with a reasonable range of treatment alternatives, risks and benefits of treatment, and other information deemed relevant to that patient's personal values and needs. Treatment alternatives that are not medically indicated or appropriate need not be revealed. Facts that are not important to the patients ability to be an informed participant in decision making, such as results of specific lab tests, need not be told to the patient. Also, complete and truthful disclosure need not be brutal; appropriate sensitivity to the patient's ability to digest complicated or bad news is important. WHAT IF THE TRUTH COULD BE HARMFUL? There are many physicians who worry about the harmful effects of disclosing too much information to patients. Assuming that such disclosure is done with appropriate sensitivity and tact, there is little empirical evidence to support such a fear. If the physician has some compelling reason to think that disclosure would create a real and predictable harmful effect on the patient, it may be justified to withhold truthful information. WHAT IF THE PATIENT'S FAMILY ASKS ME TO WITHHOLD THE TRUTH FROM THE PATIENT?

Often families will ask the physician to withhold a terminal or serious diagnosis or prognosis from the patient. Usually, the family's motive is laudable; they want to spare their loved one the potentially painful experience of hearing difficult or painful facts. These fears are usually unfounded, and a thoughtful discussion with family members, for instance reassuring them that disclosure will be done sensitively, will help allay these concerns. In unusual situations, family members may reveal something about the patient that causes the physician to worry that truthful disclosure may create real and predictable harm, in which case withholding may be appropriate. These occasions, however, are rare. WHEN IS IT JUSTIFIED FOR ME TO WITHHOLD THE TRUTH FROM A PATIENT? There are two main situations in which it is justified to withhold the truth from a patient. As noted above, if the physicians has compelling evidence that disclosure will cause real and predictable harm, truthful disclosure may be withheld. Examples might include disclosure that would make a depressed patient actively suicidal. This judgment, often referred to as the "therapeutic privilege," is important but also subject to abuse. Hence it is important to invoke this only in those instances when the harm seems very likely, not merely hypothetical. The second circumstance is if the patient him- or herself states an informed preference not to be told the truth. Some patients might ask that the physician instead consult family members, for instance. In these cases, it is critical that the patient give thought to the implications of abdicating their role in decision making. If they chose to make an informed decision not to be informed, however, this preference should be respected. WHAT ABOUT PATIENTS WITH DIFFERENT SPECIFIC RELIGIOUS OR CULTURAL BELIEFS?? Patient with certain religious beliefs or ethnic or cultural backgrounds may have different views on the appropriateness of truthful disclosure. For instance, Caresses and colleagues found that many people with traditional Navajo beliefs did not want to hear about potential risks of treatment, as their beliefs held that to hear such risks was to invite them to occur. Thus, dialogue must be sensitive to deeply held beliefs of the patient. One should not, however, assume that

someone of a particular ethnic background holds different beliefs. Rather, a culturally sensitive dialogue about the patient's role in decision making should take place. IS IT JUSTIFIABLE TO DECEIVE A PATIENT WITH A PLACEBO? A placebo is any substance given to a patient with the knowledge that it has no specific clinical effect, yet with the suggestion to the patient that it will provide some benefit. The placebo effect is powerful, in many cases providing measurable improvement in symptoms in 20-30% of patients. In general, the deceptive use of placebos is not ethically justifiable. Specific exceptions should be rare and only considered if the following conditions are present:

the condition is known to have a high placebo response rate the alternatives are ineffective and/or risky the patient has a strong need for some prescription

Pamantasan Ng Lungsod Ng Maynila (University of the City of Manila) Intramuros, Manila

College of Nursing

PATERNALISM, PRINCIPLES OF AUTONOMY & INFORM CONSENT


Submitted By: Alba, Arnaldo Jr. A. Aasco, Rachel Kimberly S. Aquino, Paul Gerald C. Cao, Ma. Angelica F. Dionisio, Ma. Ernette B. Medidas, Elaiza Mae Group 2 BSN II-4 Submitted to: Prof. Mary Pauline Saquing