Expanding the Notion of Informed Consent: Constraints and Freedom Limiting Features

Overview of Corrigan's View

ASSIGNMENT Can you please write a reply to one of my class mates,APA format with references and citations as needed along with web page URL .i am attaching their article along with their question and references below.there is some guidelines noted about how to write after the classmates article .please feel free to call or text in case of any questions . Article from classmate Please discuss Corrigan’s notion that the idea of informed consent should be expanded from its current “’tight and limited’ focus”. Please identify some of the freedom limiting features that constrain the process of obtaining meaningful informed consent A full-fledged informed consent prior to any medical intervention either in clinical or research setting is often viewed as a moral panacea. Corrigan’s article addresses the problem of ‘empty ethics’ in informed consent and advocates for the broadening of constricted debate on informed consent (autonomy versus paternalism). Patients/subjects needs to be fully informed about all the components involved such as nature of treatment, expected benefits, material risks and side effects, alternative course if action and consequences of not having treatment (Yeo et al, 2020). Consent (based on the principle of autonomy) can be considered as an antidote for medical paternalism, which negotiates patient rights (Corrigan, 2003). Any breach in it may be assumed as battery or assault. The qualitative study conducted by Corrigan, substantiates her view about inadequacy of current informed consent. It revealed the tremendous trust of subjects on health care team and lack of clarity on information provided. Also most of the participants were not adequately informed about the likelihood of risk involved and had over expectations on health benefits. Many constraining features often err the consenting process. As paternalism suggests, a power imbalance is inherent in patient-doctor relationship or researcher-subject relationship. Some patients often decide to consent, believing to have some benefits for themselves such as better treatment and diagnosis, a hope of cure, financial rewards (Corrigan, 2003). Corrigan also addresses medias role in contributing misconceptions about those benefits. Individual variations in knowledge, understanding and culture should be respected and adequate time and resources should be provided to make a decision that is best for them (Keatings and Adams, 2019). As such the relevance of the ongoing process of informed consent should be upheld regardless of the practical difficulties involved and autonomy should be respected in all circumstances. References Keatings, M. & Adams, P.(2019).Ethical & Legal Issues in Canadian Nursing(4thed) Toronto: Elsevier.  Yeo et al. (2020). Concepts and Cases in Nursing Ethics (4th ed.). Peterborough, ON:Broadview Press.  Corrigan, O. (2003). Empty Ethics; the Problem with Informed Consent. Sociology of Health & Illness 25 (7), 768-792.Guidelines for Writing •reply to the response of one of your classmates should be 150-175 words. • At the beginning of each reply, please identify to whom you are replying by greeting them explicitly (e.g., “Hi __________”). Your reply should first acknowledge one thing that your classmate has done well in their post (e.g., one point that is particularly insightful or well-supported) suggest one way in which they could improve their post (e.g., by making a point or connection that they have neglected to make). - A good way to close your reply is to ask a question that stimulates further thought or suggests new avenues for investigation. provide in-text citations for any quotes or paraphrases of their ideas, as well as a complete reference list at the end. -all citations and references must be in APA style.please provide website URL were needed. • In general, your posts will focus on specific points in the readings. You should strive to use the terms employed by the authors, but be careful to provide in-text citations for any quotes or paraphrases of their ideas, as well as a complete reference list at the end. • Your posts will be assessed on how well they demonstrate: a solid understanding of the readings; the application of what has been learned to new contexts; the clear articulation and development of a single line of thought; the supporting of your argument with valid disciplinary reasoning and examples; Lesson : Regulation of the Nursing Profession and Consent to set out definitions of the profession of nursing province by province. Section 3 of Ontario’s 1991 Nursing Act, for example, defines the practice of nursing as “the promotion of health and the assessment of, the provision of care for and the treatment of health conditions by supportive, preventive, therapeutic, palliative and rehabilitative means in order to attain or maintain optimal function” (Keatings and Adams, 2019). Section 1 of Nova Scotia’s Registered Nurses Act, meanwhile, defines the scope of nursing practice as “the performance of professional services requiring substantial specialized knowledge of nursing theory and the biological, physical, behavioural, psychological and social sciences as the basis for (i) assessment, planning, intervention and evaluation in (A) the promotion and maintenance of health (B) the facilitation of the management of illness, injury or infirmity (C) the restoration of optimum function, or (D) palliative care, or (ii) research, education, management, or administration incidental to the objectives referred to in subclause (i), and includes the practice of a nurse practitioner” (Keatings and Adams, 2019). All rights reserved. 3 Template version: 2019-08-06 In eight Canadian provinces and all three territories there is a single-tiered regulatory system which “has a complete legislative mandate to regulate entry of candidates into the nursing profession” (Keatings and Adams, 2019). In Ontario and Quebec a two-tiered system is in place. The first tier consists of a regulatory body, as in the other provinces and territories. In Ontario, the second tier is known as the Health Professions Appeal and Review Board (HPARB), the primary responsibility of which is to deal with appeals “from complaints, registration, and accreditation committees of the lower-tier health professions colleges” (Keatings and Adams, 2019). In Quebec, the primary responsibility of the second-tier Office des Professions is not to hear appeals but to ensure that “the province’s 45 self-regulated professions,” of which nursing is one, “carry out their legal responsibilities in accordance with their governing legislation, that they self-regulate in the public interest, and that they adopt proper regulatory and professional standards for their respective professions” (Keatings and Adams, 2019). Disciplinary matters, meanwhile, are referred to the Professional Tribunal, “a government-appointed administrative tribunal that closely resembles Ontario’s HPARB” (Keatings and Adams, 2019). As Keatings and Adams note “[o]ne of the distinctive features of the regulation systems of health professions in several provinces and territories is that the law specifically defines certain medical actions and procedures that may be performed and which professional groups may perform and delegate them” (Keatings and Adams, 2019). In Ontario these are referred to as “controlled acts”: the Regulated Health Professions Act (RHPA) “strictly regulates controlled health care acts…and states who may preform and delegate them” (Keatings and Adams 2019). “For example, if an RN is authorized to administer a particular substance via injection…then he or she may delegate the act to an LPN, provided that the regulations under the Nursing Act allow such a delegation and that all procedures for delegation set out in the regulations are followed” (Keatings and Adams, 2019). Nurse Practitioners (NPs), meanwhile may preform additional acts “provided they have met certain standards of education” (Keatings and Adams, 2019). Throughout Canada, legislation “allows nurses to delegate the performance of specific controlled acts to another regulated professional or an unregulated provider…provided that the employer policies support this and that the responsibilities of the organization, the nurse and the unregulated provider are clear” (Keatings and Adams, 2019). The fact that that such acts can be delegated “facilitates the care of patients in the home. For example, to ensure the pain of a terminally ill patient is controlled, it may be appropriate for the RN coordinating care to teach a member of the family to administer morphine by injection” (Keatings and Adams, 2019). When a nursing student graduates from an accredited Canadian program he or she “must apply to a regulatory body for registration in the profession in order to be authorized to practice as a nurse” (Keatings and Adams, 2019). Through registration, “the member is recognized as a person  Lesson 3: Regulation of the Nursing Profession and Consent to Treatment Lesson 3: Regulation of the Nursing Profession and  particular province or territory. Registration allows the regulatory body to record the nurse’s contact information, educational background, and qualifications” (Keatings and Adams, 2019). The credentialing process “assures the public and employers that nurses meet the appropriate standards of the profession and can safely practice nursing” (Keatings and Adams, 2019). In many provinces this process involves criminal background checks the primary purpose of which is to exclude persons “with a history of inappropriate conduct” or those who “would pose a threat to the safety of vulnerable patients” from the practice of nursing (Keatings and Adams, 2019). While the rationale governing the performance of such checks may be generally sound, it nevertheless raises a number of ethical and legal issues. As Keatings and Adams note: One noteworthy pitfall of a criminal record check that should be borne in mind is that it reveals a record of a criminal act committed at a past point in time. It may not reveal ongoing issues, such as substance abuse or lack of trustworthiness. It might also note criminal activity that occurred a very long time ago, during an applicant’s youth, which may not be relevant to his or her nursing practice (Keatings and Adams, 2019). Internationally Educated Nurses (IENs) have restricted access to the profession of nursing in Canada. Keatings and Adams note: “[r]ecognizing that not all international education programs will meet Canadian standards, regulatory bodies have initiated methods of evaluating credentials and experience” (Keatings and Adams, 2019). The standards used to assess the competency of IENs vary widely across Canada. British Columbia’s College of Registered Nurses provides one of the more detailed assessment procedures. Requirements include proficiency in English, registration in the country in which the nurse studied, and registration in any other country in which he or she practiced. Applicants are further required to disclose information pertaining to disciplinary or competency issues, postsecondary nursing education, and criminal records (Keatings and Adams, 2019). Professional standards of practice are of particular interest to nurses as they “outline the kinds of specialized knowledge that nurses must have and contribute to nurses’ unique ability to be able to foresee potential benefits, harms, and risks of particular actions or omissions. Thus, when a nurse fails to do this, she or he can be considered to be negligent” (Burkhardt, Nathaniel and Walton, 2014). Practice and professional standards are used to “evaluate the actions of any nurse who is the subject of a complaint or disciplinary process within the regulatory body of a legal proceeding” and “are of great relevance in terms of negligence and malpractice issues” (Keatings and Adams, 2019). They also serve as “relevant evidence of the standard of care a nurse is expected to meet and against which the nurse’s actual conduct will be judged in a professional. All rights reserved. 5 Template version: 2019-08-06 negligence law suit or disciplinary action undertaken by the regulatory body” (Keatings and Adams, 2019). In the event a nurse is deemed to be deficient or when “a complainant has concerns about a nurse’s practice, or conduct, a complaint can be submitted to the provincial or territorial regulatory body” (Keatings and Adams, 2019). Complaints “must be in writing and, in some settings, in audio; must be signed and dated by the person making the complaint, and should name the nurse concerned” (Keatings and Adams, 2019). It is the ethical and, in many cases, legal obligation of nurses to report (to the employer or to the College) improper professional conduct or incidents that involve a nursing colleague’s failure to meet the standard of professional practice, whether that colleague has acted in an unprofessional manner, has shown a lack of skill, knowledge, or judgement that poses a threat to the safety of patients in the nurse’s care; or is, by reason of addiction to alcohol or drugs, or mental or physical illness, unable to discharge his or her nursing duties competently or safely (Keatings and Adams, 2019). The duty to disclose “unprofessional conduct or incompetence is an exception to the general prohibition on the communication of confidential information disclosed by the patient in the course of treatment and the provision of nursing care” (Keatings and Adams, 2019). Once a complaint has been filed, the matter will be investigated by a complaints committee, investigator, or registrar to determine whether the case has merit. The subject of the investigation must be notified and is entitled to make submissions to the committee or individual conducting the investigation. Nurses must recognize that they are “under a legal duty to cooperate with an investigator and to allow examinations without interference” (Keatings and Adams, 2019). If the nurse’s professional organization does not provide legal counsel as a matter of course he or she may be obliged to retain the services of a lawyer. “If a complaint is well founded, the concern is reviewed by a panel of nurses and lay members, and usually chaired by a member of the College’s Board or Council” (Keatings and Adams, 2019). If it “becomes immediately clear to the panel that the allegations show that the nurse being investigated poses a threat to the safety or security of patients, the committee has the power to order that the nurse’s right to practice be suspended or restricted pending the conclusion of the disciplinary proceedings” (Keatings and Adams, 2019). If remedial or rehabilitative actions are unsuccessful and the College refers the matter to a disciplinary committee, that committee must notify the nurse and his or her lawyer. After NURS 330: LEGAL AND ETHICAL ISSUES IN NURSING Lesson 3: Regulation of the Nursing Profession and Consent to Treatment Lesson 3: Regulation of the Nursing Profession and Consent to Treatment Copyright © 2021 Continuing & Distance Education, St. Francis Xavier University. All rights reserved. 6 Template version: 2019-08-06 presentation of the evidence the committee will render its verdict. As Keatings and Adams note, a number of different conclusions are possible: • That the nurse is innocent of any wrongdoing. • That the nurse involved is incompetent, unskilled, or otherwise lacking in essential knowledge. • That he or she is guilty of professional misconduct. • That the nurse is habitually impaired by the use of alcohol or drugs such that he or she is unable to discharge nursing duties and obligations safely (Keatings and Adams, 2019). The penalties that may be assigned to the nurse who has been found guilty of professional misconduct or incompetence include: • A fine or award of costs. • Censure or reprimand before the committee or in writing. • Conditions placed on the nurse’s right to practise, including a requirement that he or she take additional courses or education and pass further examinations. • Suspension from practise for a specified period of time (e.g., for the completion of such additional training or education). • Revocation of the nurse’s right to practise and expulsion from the nursing association (Keatings and Smith, 2010). Chapter 6 in Keatings and Adams’ Ethical & Legal Issues in Canadian Nursing is devoted to a detailed discussion of the ethical duties associated with obtaining informed consent. These include: the duty to provide patients with the information they need to make informed decisions about their health and well-being; the duty to protect those who are incapable of making their own decisions due to age or other limiting factors; the duty to respect the wishes of patients who choose to forego recommended treatments or procedures; and the duty to respect the wishes made by patients prior to incapacity by way of advance directives or living wills. As discussed in the preceding lessons, the duty of the nurse to ensure that informed consent is obtained from the patient or proxy decision maker is inextricably linked with respect for patient autonomy. The nurse who fails to obtain informed consent before proceeding with treatment may be liable for battery, which is legally defined as the touching of another person without his or her consent. As previously noted, the concept of informed consent first emerged as a result of the war crimes trials at Nuremberg in 1947. Both the American Medical Association and the Canadian Medical Association incorporated the doctrine of informed consent into their codes of ethics in the 1980’s. The [U.S.] President’s Commission for the Study of Ethical Problems in Medicine and NURS 330: LEGAL AND ETHICAL ISSUES IN NURSING Lesson 3: Regulation of the Nursing Profession and Consent to Treatment Lesson 3: Regulation of the Nursing Profession and Consent to Treatment Copyright © 2021 Continuing & Distance Education, St. Francis Xavier University. All rights reserved. 7 Template version: 2019-08-06 Biomedical and Behavioral Research emphasized the importance of including patients in the decision-making process in its 1983 report. To do otherwise, the Commission argued: Is unjustifiable, since it demeans the patient by barring self-determination and allows others to shorten the patient’s life or to establish a burden under which it will be lived without the assurance (which could be obtained) that the patient concurs in the judgement. Although there may be times when a competent patient would prefer not to be involved in these choices, it is impossible to know in advance which patients would come to this conclusion. And the risk of wrongly abrogating decision-making for many patients seems generally more grievous than the pain of confronting some seriously ill patients with the choices that they would rather not face. The only time that…it is justified for a patient who would be informed and involved to be excluded is when that patient freely and knowingly transfers some decision-making authority to another (President’s Commission, 1983). As noted by Yeo and colleagues, the Ontario Health Care Consent Act of 1996, the most comprehensive legislation on the subject currently on the books in Canada, consists of four elements: 1. The consent must relate to the treatment; 2. The consent must be informed; 3. The consent must be given voluntarily; 4. The consent must not be obtained through misrepresentation or fraud (Yeo et al., 2020). As the authors discuss [t]hese elements together articulate the concept of informed consent, and are consistent with elements for consent across all Canadian provinces/territories. The requirement of voluntariness pertains to the consent aspect of informed consent. What constitutes a truly voluntary decision? Voluntariness exists on a spectrum; cases at one end are more or less involuntary, and at the other more or less voluntary. For example, coercion or threats undermine voluntariness. Inducements to some lesser extent undermine voluntariness, as can persuasion to the extent it is manipulative. Other elements speak to the informed aspect of informed consent. The doctrine of consent evolved over time from simple consent (Yeo et al., 2020). Ethical codes and guidelines such as the HCCA do not arise ex nihilo but are nearly always the result of years of important precedent-setting legal decisions, a number of which are described in the following. The salient points of the case Reibl v Hughes (1980) may be summarized as follows: The plaintiff was 44 years old and was having surgery…for the removal of an occlusion in the left internal carotid artery which prevented more than 15% of blood flowing through  All rights reserved. 8 Template version: 2019-08-06 the vessel. The operation was performed competently by the defendant neurosurgeon. Immediately following the surgery [the plaintiff] had a stroke which left him paralyzed on the right side of his body. The plaintiff had originally consented to this operation but argue[d] that this consent was not informed and…therefore [sued] for damages for both battery and negligence. http://canliiconnects.org/en/summaries/33190 At issue was the question: How specific must the information to the patient be, in a case such as this, to enable him to make an “informed” choice between surgery and no surgery…In this case, stroke was a material risk in either circumstance. The plaintiff was [at] risk of a stroke as a result of the surgery, and further he was [at] risk of…a stroke if he refused to have the surgery.The case was heard in 1980 by the Supreme Court of Canada, which, in its decision, stated that Canadian healthcare providers must, without being asked, disclose to the “average prudent person” what he or she would want to know before granting informed consent to treatment. Chief Justice Bora Laskin elaborated on this statement, insisting that health care providers must not only obtain informed consent but should also endeavor to apprise themselves of the “subculturally unique” aspects of the patient’s value system. Justice Laskin reasoned that the cultural milieu of the patient could be a freedom-limiting barrier that must be transcended before proper informed consent can be obtained. Thus, the most appropriate standard that should be used to obtain informed consent is not merely that of the “average prudent person” but the “average prudent person in the patient’s particular position” (Reibl v Hughes, 1980). An important aspect of informed consent that was also highlighted in Reibl v Hughes is that it is not a duty but a right and, as such, can be waived. As the Supreme Court justices reasoned: a patient may “wave aside any question of risks and be quite prepared to submit to surgery or treatment, whatever they be. If the physician is prepared to accept the decision-making burden such a situation presents no difficulty” (Reibl v. Hughes, 1980). This may seem paradoxical insofar as the basic parameters of informed consent are information and freedom. After all, a patient must have adequate information about a proposed course of treatment before informed consent can be given; the lack of such information compromises a patient’s fundamental personal autonomy and prohibits him or her from making reasonable, informed choices. Similar cases, such as Malette v Shulman and Ciarlariello v Schacter, have added to the body of Canadian legal precedent regarding informed consent. In Malette v Shulman (1990), an Ontario woman who was involved in a motor vehicle accident and taken to hospital was given multiple All rights reserved. 9 Template version: 2019-08-06 blood transfusions despite the presence of a card in her wallet identifying her as a Jehovah’s Witness and detailing the fact that she was unwilling to accept blood transfusions in keeping with her religious beliefs. After recovering from her injuries, the woman brought a lawsuit for battery, negligence, and religious discrimination against the hospital and the attending physician who had ordered the transfusions. The woman was awarded damages “on the grounds that blood transfusions had been administered against her specific wishes and that this constituted battery on her” (Keatings and Adams, 2019). The physician appealed the verdict in the Ontario Court of Appeal, which ruled in favour of the plaintiff and upheld the finding of liability for battery. In the case of Ciarlariello v Schacter, meanwhile, the plaintiff, while undergoing an angiogram to explore a suspected aneurysm, began to moan, cry, and hyperventilate and ordered the physician conducting the procedure to stop. The plaintiff complained that her right hand was numb and her left hand was weak. Eventually, these symptoms abated and the plaintiff verbally indicated that she was willing to proceed. During the final injection of dye the plaintiff “suffered an immediate reaction, which ultimately resulted in quadriplegia” (Keatings and Adams, 2019). While the patient died shortly thereafter, her family pursued the case. The judge that heard the case found that the informed consent requirements mandated in Reibl v Hughes had been met and that the physicians involved had not been negligent in explaining the risks of the procedure to the deceased. At issue was the question of whether “the risks ha[d] changed materially during the procedure and whether a reasonable patient would wish to know of such changes” (Keatings and Adams, 2019). The judge found that “there was no evidence that the patient’s condition had deteriorated to the point that she could not properly consent to the resumption of the treatment” and found in favor of the defendant” (Keatings and Adams, 2019). On the basis of these precedents, Canadian nurses and physicians must ensure that the consent obtained from patients includes the following elements. The consent must: • Be voluntary and genuine. • Be given with the knowledge that agreeing to treatment is not consent. • Be specific. • Specify the person providing treatment. • Be obtained by the person providing treatment. • Be given by a capable client. • Be given by a mentally competent client (Keatings and Adams, 2019). (For a more detailed explanation of each of these elements of informed consent please consult table 6.2 on p. 143 of Keatings and Adams’ Ethical and Legal Issues in Canadian Nursing). All rights reserved. In terms of the actual consent to treatment, it may take two forms: expressed or implied. Expressed consent is “either verbal or written consent specifically articulating the patient’s agreement to a particular treatment or procedure” (Burkhardt, Nathaniel and Walton, 2014). Implied consent, meanwhile, “is less concrete—but quite often encountered. It is inferred from a person’s presence and actions, as well as the context of the situation. In other words. A pregnant woman who admits herself to the hospital to give birth under the care of her obstetrician implies consent for the obstetrician to examine her” (Burkhardt, Nathaniel and Walton, 2014). Nevertheless, as Yeo and colleagues note, “relying on implied consent can be problematic”. As they argue, [i]n one of the cases considered in the chapter on end-of-life, a patient opening her mouth upon a spoon being placed before her was taken as evidence of consent. Since implied consent involves the provider making an inference about the patient’s agreement, it can be more ambiguous and open to interpretation than explicit consent. Generally, the more serious the nature of the intervention, the more explicit the consent should be to reduce the possibility of misunderstanding or disagreement about whether in fact a consent was valid. To further reduce this possibility, and to protect providers and institutions from legal liability, explicit consent is often recorded in a document signed by the patient (Yeo et al., 2020). In both Reibl v Hughes and Malette v Shulman the plaintiff charged the defendant with battery. The terms battery and assault are often used interchangeably but the two are not identical. To be guilty of assault, the healthcare worker does not need to have engaged in actual physical contact with the patient; it is sufficient that a patient feels threatened by the actions of the healthcare worker. Generally speaking, threatening words are insufficient grounds for a charge of assault. When words are accompanied by physical actions that make the patient apprehensive of bodily harm then an assault may be alleged to have taken place. A battery, by contrast, is “the unlawful, harmful, or unwarranted touching of another, or the carrying out of threatened physical harm. Battery can include any willful, angry, violent, or negligent touching of a person’s body or clothes, or of anything held by or attached to the person” (Guido, as cited by Burkhardt, Nathaniel and Walton, 2014). At this point, we will turn to the subject of competence. Competence is, of course, a prerequisite of consent but it is not a yes/no proposition. Rather, competence is a complex, multi-layered affair in which volitions, emotions, and values (both personal and societal) come into conflict and can potentially render the judgments or decisions of a seemingly rational, intelligent person temporarily invalid. Some experts on the subject describe competence as a “continuum concept” light of which one cannot judge patients to be completely competent or completely incompetent but more or less competent depending on specific circumstances or combinations of events. In an attempt to define the constitutional elements of informed consent lawyers, philosophers, and healthcare professionals have tended to settle on the following five analytical components: disclosure; understanding; voluntariness; competence; and consent. Discussions of competence, therefore, are generally subordinate to the larger process of assessing informed consent. Yet, as Beauchamp and Childress note, “[c]ompetence...might be more appropriately described as a presupposition of the practice of obtaining informed consent than as an element of informed consent, because competence is used to refer to a pre-condition of being able to authorize autonomously” (Beauchamp & Childress, 1989). In other words, if incompetence prevents patients or subjects from being able (either psychologically or legally) to make rational decisions then it makes no sense to speak of it after disclosure, understanding and voluntariness. It should, instead, function as a “threshold notion”, i.e., one used to distinguish between those who should or should not be asked to make important decisions on their own (Beauchamp & Childress, 1989). Generally speaking, competence refers to someone’s ability to perform a given task. Yet, the criteria germane to assessment vary by context. Different types of competence should not be conflated by healthcare professionals as they are by lawyers. When the law prevents someone from making decisions in one area because he or she has shown an inability to make decisions in another it usually does so in order to protect property. This must never be the case in health care; just because someone is unfit to drive at night does not mean that he or she is incapable of making important medical decisions. As previously noted, competence can be understood as a “continuum concept”; people are more or less competent in light of their differing levels of ability. A calm, intelligent person presented with a medical dilemma is more likely to be deemed competent than another patient, similarly afflicted, who is frightened and restless. As Beauchamp and Childress argue: “[n]ot all competent individuals are equally competent and not all incompetent persons equally incompetent, but the function of any competency determination is to sort persons into these two basic classes, and thus to treat persons as either competent or incompetent in particular contexts” (Beauchamp & Childress, 1989). With regard to the element of disclosure, Beauchamp and Childress note that “the legal doctrine of informed consent…has been primarily a requirement of disclosure based on a physician’s general obligation to exercise reasonable care by providing information”  From a moral standpoint, however, “informed consent has less to do with the liability of professionals as agents of disclosure and more to do with the autonomous choices of patients and subjects” (Beauchamp and Childress, 2001). In the effort to determine which norms should govern the disclosure of information, two competing standards of disclosure have emerged: the professional practice standard and the reasonable person standard. The professional practice standard “holds that a professional community’s customary practices determine adequate disclosure” (Beauchamp & Childress, 2001). Like treatment, disclosure is considered to be a “task that belongs to the physician because of their professional expertise and commitment to the patient’s welfare” (Beauchamp & Childress, 2001). While there are a number of objections that can be made to the use of this standard of disclosure the most significant is the fact that it essentially subverts the right of autonomous choice. “Professional standards in medicine are fashioned for medical judgments, but decisions for or against medical care, which are nonmedical decisions, are rightly the province of the patient” (Beauchamp & Childress, 2001). The reasonable person standard, by contrast, shifts the determination of informational needs from the physician to the patient. As Yeo and colleagues note, the reasonable person standard superseded the prior “reasonable physician test,” which asked what the reasonable physician in the same circumstances would disclose. This change marked a shift in the balance of power away from the medical community in the direction of greater patient control. The Ontario legislation codifies the reasonable person standard by stating that a consent is properly informed only if, prior to giving it, “the person received the information … that a reasonable person in the same circumstances would require in order to make a decision about the treatment” (11.2). The general information contents that, presumably, would be relevant or material to the decision of a reasonable person in the circumstances of a patient, and that should be disclosed to the patient, is listed at section 11.3: 1. The nature of the treatment. 2. The expected benefits of the treatment. 3. The material risks of the treatment. 4. The material side effects of the treatment. 5. Alternative courses of action. 6. The likely consequences of not having the treatment (Yeo et al., 2020). There are practical limitations associated with the use of this standard as well, including the NURS 330: LEGAL AND ETHICAL ISSUES IN NURSING Lesson 3: Regulation of the Nursing Profession and Consent to Treatment Lesson 3: Regulation of the Nursing Profession and Consent to Treatment Copyright © 2021 Continuing & Distance Education, St. Francis Xavier University. All rights reserved. 13 Template version: 2019-08-06 difficulty of predicting just what sort of information the hypothetical reasonable person would want to know. Empirical studies regarding how patients use the information disclosed to them by physicians indicate that “although 93% of the patients surveyed believed they benefited from the information disclosed, only 12% used the information in their decisions to consent” and that “patients generally make their decisions prior to and independent of the process of receiving information” (Beauchamp and Childress, 2001). With regard to the element of understanding, both clinical experience and empirical data reveal that “patients and subjects exhibit a wide variation in their understanding of information about diagnoses, procedures, risks and prognoses” (Beauchamp and Childress, 2001). Some patients, particularly those who are frightened or distracted, may be incapable of understanding enough of the information presented to them to adequately consent to treatment. Nevertheless, information overload can be as much of a problem as lack of information and studies of “nonacceptance” reveal that “decision-making can be compromised by a breakdown in a person’s ability to accept information as true or untainted, even if he or she adequately comprehends the information” (Beauchamp and Childress, 2001). Thus, waivers of consent in both therapeutic and research settings are generally deemed to be acceptable, and paternalism may sometimes by called for if ignorance precludes informed consent and the imposition of unwelcome information is required to preserve or promote patient autonomy. The element of voluntariness should be construed narrowly in order to avoid conflating it with autonomy. Beauchamp and Childress therefore propose analyzing voluntariness according to three categories of influence, namely, coercion, persuasion, and manipulation. Coercion, they argue, “occurs if and only if one person intentionally uses a credible and severe threat of harm or force to control another. The threat of force used by some police, courts, and hospitals in acts of involuntary commitment for psychiatric treatment is a typical form of coercion” (Beauchamp and Childress, 2001). Coercion thus voids autonomy and “renders even intentional and wellinformed behavior nonautonomous” (Beauchamp and Childress, 2001). In persuasion, meanwhile, “a person must come to believe in something through the merit of reasons another person advances” (Beauchamp and Childress, 2001). Manipulation, finally, involves forms of influence that are neither coercive nor persuasive. The “essence of manipulation is swaying people to do what the manipulator wants by means other than coercion or persuasion” (Beauchamp and Childress, 2001). In health care “the key form of manipulation is informational manipulation, a deliberate act of managing information that nonpersuasively alters a person’s understanding of a situation and thereby motivates him or her to do what the agent of influence intends” (Beauchamp and Childress, 2001). A clinician’s use of therapeutic privilege—the legal exception to the rule of informed consent that allows healthcare professionals to proceed All rights reserved. 14 Template version: 2019-08-06 without consent in cases of emergency, incompetence or waiver—to withhold information to manipulate patients into consenting to a medically desirable procedure constitutes informational manipulation (Beauchamp and Childress, 2001). When it is clear that the patient is unable to give informed consent to treatment, there are a number of special precautions that must be taken. In Ontario, the Substitute Decisions Act (1992) and the Health Care Consent Act (1996) specify who is able to give proxy consent to treatment for mentally incompetent patients. The Health Care Consent Act (1996) specifies the hierarchy of alternative decision makers. These include (in descending order): • A guardian appointed by the court under the Substitute Decisions Act (1992) • An attorney for personal care acting under a validated power of attorney for personal care that confers that authority • The incapable person’s representative, appointed by the Board, if the representative has authority to give or refuse consent • The incapable person’s spouse or partner… • The incapable person’s child, or parent, or the CAS (Children’s Aid Society) or other person lawfully entitled to give or refuse consent in place of the parent… • The person’s parent with only a right of access • The person’s brother or sister • Any other relative of the incapable person (Health Care Consent Act (Ontario), 1996). When the patient is a young child, consent will normally be sought from the child’s parents. When dealing with an older child who is mature enough to understand the risks and benefits associated with treatment, some provinces will allow the minor to consent to treatment. In Ontario mature minors are allowed to give consent provided that information pertaining to the following is furnished: • The nature of the treatment • The expected benefits of the treatment • The material risks of the treatment • The material side effects of the treatment • Alternative courses of action • The likely consequences of not having the treatment (Health Care Consent Act (Ontario), 1996). As Yeo and colleagues clarify. All rights reserved. 15 Template version: 2019-08-06 [a] mature minor is someone between the ages of twelve and eighteen who is considered to be capable of understanding the scope of his or her illness and the consequences of accepting or rejecting treatment for that illness. As with a person of any age, an adolescent’s capacity to consent needs to be individually determined based on their ability to understand and appreciate pertinent information. Challenges can arise, though, when adolescents thought to be capable of making treatment decisions by accepted legal standards are not seen as such by their parents or guardians (Yeo et al., 2020). The preceding discussion is meant to highlight the challenges facing nurses attempting to respect patient autonomy, evaluate competence, and ensure that patients are furnished with all of the information required to provide valid informed consent for treatment. We will conclude with the following observation: Consent policies, rules, and legislation are very much based on the principle of autonomy, which recognizes that a capable and competent individual is free to determine and act in accordance with a self-chosen plan. Other equally important ethical principles, such as beneficence and nonmaleficence, that nurses must consider, at times may compete with this principle…There are many complex dynamics involved in dealing with ill, vulnerable patients whose capacity to make informed choices in the context of a confusing bureaucratic setting may be challenged. Nurses must give serious consideration to their role in caring for and supporting these clients, and making sure that clients have the time and resources to make the decision [that is] best for them. In doing so, nurses ensure clients’ rights are respected and that they are protected from harm (Keatings and Adams, 2019). As noted above, obtaining informed consent includes a number of important duties, including: the duty to disclose relevant information, to protect the vulnerable from exploitation and to respect the wishes of patients whose cultural or personal values systems differ from our own. As Oona Corrigan notes in her article entitled “Empty Ethics; the Problem with Informed Consent”, the growth of principlism in bioethics and the “centrality awarded to the moral dictate ‘respect for autonomy’” has “triumphed in relation to other bioethical principles” and has become “progressively more important over time” (Corrigan, 2003). Conceptual issues associated with obtaining informed consent have arisen, for example, with regard to “the acceptability of research[ers] to collect genetic samples from the population of the South Pacific island of Tonga because of islanders’ opposition to the individual informed consent procedures, which they criticize for ignoring the traditional Tongan role of the extended family in decisionAll rights reserved. A medical sociologist by training, Corrigan believes that we are mistaken in our belief that informed consent is an “ethical panacea” and that the debate surrounding the centrality of informed consent in health care needs to be broadened from its current “’tight and limited’ focus” to more fully examine the “often dependent relationship between patient and doctor” (Corrigan, 2003). “Empty Ethics” describes Corrigan’s interview-based study of the understanding and perceptions of 26 experimental drug trial participants in the U.K. Her study calls attention to the degree of trust placed in the physicians and medical staff conducting experimental treatments on a variety of patients ranging from those with relatively benign conditions to those awaiting surgery for advanced breast cancer. By examining the process of obtaining informed consent from these often vulnerable patients, Corrigan makes the case that the process itself “is not situated outside the realm of power, but rather [that] such decisions are made in contexts where prevailing discourses and norms shape the field of freedom and choice” (Corrigan, 2003). Apart from the power imbalance inherent in the patient-caregiver or patient-researcher relationship other freedom-limiting factors that may complicate the process of obtaining informed consent are the clarity of the information presented, the language used and the role of the media in shaping patients’ perceptions of the likely benefits associated with participation in biomedical research. As Corrigan argues, “individuals draw upon wider cultural perceptions of science and medicine, and information relating to the trial is interpreted against background stocks of prevailing dominant cultural beliefs and norms” while studies of patient advocacy groups in the U.S. “highlight the crucial role played by the media in contributing to therapeutic misconceptions about the likely benefit to patients from their participation in biomedical research” (Corrigan, 2003). As discussed above, the Ontario Health Care Consent Act contains a provision wherein capacity is defined in terms of the individual’s ability “to understand the information that is relevant to making a decision about treatment” and to “appreciate the reasonably foreseeable consequences of a decision or lack of decision”(Health Care Consent Act (Ontario), 1996). The Canadian Supreme Court case of Starson v Swayze examined the legality of the criteria used by the Consent and Capacity Board of Ontario to impose unwanted treatment on psychiatric patients who may be capable of understanding the nature of their illness but nevertheless refuse treatment that their healthcare professionals deem to be necessary and effective. At the time of the trial (2003) all of the parties involved believed that the patient in question, Starson, suffered from bipolar disorder, a diagnosis which was subsequently changed to one of schizoaffective disorder. Starson had been in and out of hospital since 1985 and during the NURS 330: ensuing decades it was not disputed by anyone that he suffered from a long-standing mental illness and that his condition would continue to deteriorate without medication. Starson’s treating psychiatrist appealed the decision of the Court of Appeal to the Supreme Court of Canada, which found that considerations of the efficacy of treatment “have no relevance to the question of the patient’s capacity” and that the only consideration that bears on capacity “is whether the patient is able to understand the information received regarding the proposed medication’s effectiveness and to appreciate the foreseeable consequences of his or her decision” (Starson v Swayze, 2003). While a minority of Supreme Court justices argued that Consent and Capacity Board had not erred in its judgments and that the absence of understanding and appreciation of his condition “rendered Scott Starson unable to understand the factors relevant to making a decision about treatment” the majority disagreed. Writing for the majority, Justice Major argued that the “legislative mandate of Ontario’s Consent and Capacity Board was to adjudicate solely upon a patient’s mental capacity” and that “the Board’s conception of the patient’s ‘best interests’ was irrelevant to that determination” (Starson v Swayze, 2003). Ronald Sklar’s article “Starson v Swayze: The Supreme Court Speaks Out (Not all that Clearly) on the Question of ‘Capacity’” examines the effects of the decision handed down by the Supreme Court in the Starson case on the authority of physicians and psychiatrists as well as on the interpretation of freedoms enshrined in the Canadian Charter of Rights and Freedoms. “By specifically including mental disability as a recognized ground of discrimination, the Charter established the federal government as the champion of the rights of persons with a psychiatric disability and dictated that the federal and provincial governments were obligated to protect and promote equality rights” (McKenzie, 2008). Regulation of the Nursing Profession and Consent to Treatment Lesson 3: Regulation of the Nursing Profession and Consent to Treatment Copyrigh. All rights reserved. 18 Template version: 2019-08-06 One of the main topics of discussion in this lesson had been that of informed consent, which lies at the heart of virtually every interaction between healthcare professionals and patients. Yet, in the past year virtually every developed country on earth has had to make tough decisions about rationing treatment to patients diagnosed with COVID-19. In the Spring of last year, hospitals were overwhelmed in Lombardy, Madrid and New York City. Ice skating rinks and refrigerated trucks served as temporary morgues and doctors were forced to make the sort of triage decisions that are normally only seen during wartime. Family members of those who needed to be admitted to ICU and placed on ventilators were excluded from contact with loved ones in order to ensure their own safety. And even in Canada, staff at long-term care facilities abandoned their patients and refused to report to work out of fear for their own safety and that of their families. Early in the Pandemic, the Italian College of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI) published guidelines for the criteria that doctors and nurses should follow as these already extraordinary circumstances worsen. The document begins by likening the moral choices Italian doctors may face to the forms of wartime triage that are required in the field of “catastrophe medicine.” Instead of providing intensive care to all patients who need it, the authors suggest, it may become necessary to follow “the most widely shared criteria regarding distributive justice and the appropriate allocation of limited health resources.” The principle upon which they based their decision was Utilitarianism. “Informed by the principle of maximizing benefits for the largest number,” they suggested that “the allocation criteria need[ed] to guarantee that those patients with the highest chance of therapeutic success [would] retain access to intensive care.”  The authors, medical doctors, then deduce[d] a set of concrete recommendations for how to manage these impossible choices, including this: “It may become necessary to establish an age limit for access to intensive care”… Those who are too old to have a high likelihood of recovery, or who have too low a number of “life-years” left even if they should survive, would be left to die. This sounds cruel, but the alternative, the document argues, is no better. “In case of a total saturation of resources, maintaining the criterion of ‘first come, first served’ would amount to a decision to exclude late-arriving patients from access to intensive care.”  In addition to age, doctors and nurses were also advised to take a patient’s overall state of health into account: “The presence of comorbidities needs to be carefully evaluated.” This is in part because early studies of the virus seem to suggest that patients with serious preexisting health conditions are significantly more likely to die. But it is also because patients in a worse state of overall health could require a greater share of scarce resources to survive: “What might be a relatively short treatment course in healthier people could be longer and more resource-consuming in the case of older or more fragile patients.”  As the author of the article concludes, My academic training is in political and moral philosophy.