Informed consent
Gonzalo Herranz, department Bioethics, University of Navarra
Lecture delivered at the Libero Istituto Universitario, Nursing Sciences
Campus , Rome, November 21, 1996, 9–11 a.m.
Some parts of the text, written in Italian, have been translated into Spanish.
Some ideas have been expressed in a schematic manner.
2. Ethics and Law: An Overview
c. Withdrawal and withdrawal of consent
3. The Specifics of Informed Consent in Nursing
b. Content: consent to nursing procedures
d. Informed consent in day-to-day interactions
e. Informed consent for training
f. Informed consent for research
g. Repeating the same mistake: The birth of research ethics committees
The most significant advance, in human terms, that modern medical ethics has brought about is, in my view, this: the patient has become an active moral agent, standing on equal footing with the doctor and the nurse. They are no longer a minor, as was the case in the now-distant era of harsh paternalism, but a moral, free, and manager person who navigates the crisis of illness by steering the course of their own destiny. They do so with the financial aid healthcare workers, but these workers do not replace them when it comes to accepting, living, and shaping their own destiny.
A very important aspect of the acceptance and experience that comes with the illness is the informed consent that the patient must give for medical and nursing interventions.
I like to start my lessons with an example. Today I’m going to start with two.
The first: John Paul II and the surgery to close the stoma. It’s in Frossard’s book: read the account. The Pope taught the doctors a lesson. He insisted on his right to have his say, to have his opinion taken into account. He actively embraced his role as a moral leader.
Informed and voluntary consent brings intelligence and freedom to the internship .
I like to make the most of stories, tweaking them here and there to draw out more meaning. Let’s not waste this anecdote. Let’s keep all the data one: the patient isn’t John Paul II, but an anonymous, rough, uneducated man who lives in a small village. We can make him uneducated, poor, work. What would we say if he expressed his opinion with the same energy the Pope did? Perhaps we’d consider him arrogant. No meeting experts would be convened. And, deep down, he has the same right as the Pope to be treated as a human being: with the utmost respect.
The second scenario: A patient with breast cancer undergoes surgery (lumpectomy) and radiation therapy. Everything has gone very well. The prognosis is good, but on the day before discharge, the doctor decides fill in patient’s treatment with a protocol chemotherapy and informs the nurse currently caring for the patient of this decision. The doctor speaks privately with the patient to explain the plan and obtain her consent for the treatment. The next day, the nurse asks the patient: “How are you feeling? Are you ready to start chemotherapy?” The patient broke down and asked, “But are they going to give me chemotherapy?” She knew what chemotherapy meant, but evidently the doctor had not employee word when he spoke to her the previous day about the advisability of fill in treatment, nor had he told her that it was necessary to start as soon as possible.
You are the nurse in charge of this case. What would you do in a status ?
Should I do what the doctor didn't do and explain the treatment—its duration, effects, risks, and outcomes—and then ask the patient for her informed consent? Should I go to the doctor and tell him what happened? Should I tell the head nurse the story and work with her to find the best solution? Or should I do none of that and just start the first round of chemotherapy right away?
To help us resolve this issue, let’s take a closer look at informed consent: the professional standards that govern it and the instructions that underpin it. It is also very interesting not only to know the rules and reasons behind them, but also to realize that informed consent is not something reserved solely for major decisions (such as surgical procedures or chemotherapy protocols); rather, it is a sign of respect for people, one that manifests itself in many ways. Thus, we will address three points: professional ethics, ethical foundations, and examples.
First, an overview of nursing ethics. Various perspectives.
Codes that ignore the problem
The Italian Code of Nursing Ethics (1977), which remains in force, contains no reference letter informed consent. Paragraph 9 states that “Nurses have a duty to enhance and update training relation to… new needs arising from social progress.” This could be interpreted as reference letter and vague reference letter to the obligation to obtain informed consent.
The same is true of the Code of Ethics for Nurses issued by committee of Nurses (1973, reaffirmed in 1989), which merely states that “respect for life, dignity, and human rights is inherent in the profession.” However, it does not specify anything regarding informed consent.
Explicit codes
Code model the association Nurses association with Interpretive Commentary (1985). 1.1. The fundamental principle of internship is respect for the dignity and intrinsic worth of every client. (...) Truth-telling and the process of making an informed decision emphasize the exercise of self-determination, which is fundamental to respect for individuals.
The Canadian Code of Nursing Practice provides a comprehensive exhibition Value II: Respect for the Client’s Choice. The client’s informed consent is an essential requirement for the provision of health care services. It goes on to include very detailed provisions, much like those in the Spanish Code.
Spain: In the course of their duties, nurses are required to respect the patient’s freedom to choose and control the care provided to them (Art. 6).
The patient’s consent must always be obtained in advance of any intervention by the nurse. This is done in recognition of the moral right that every person has to participate freely and in a validly expressed manner in the care provided to them (Art. 7).
When the patient is not physically or mentally capable of giving consent, the nurse must seek consent from the patient’s family members or close associates (Art. 8).
A nurse shall never use, nor allow others to use, physical or psychological coercion to obtain a patient’s consent. This includes an urgent obligation to report such incidents to the competent authority (Art. 9).
The Code of the Danish Nurses’ Organization (1992) establishes a close cooperative relationship between nurses and patients to develop care plans and address their needs. The Code of Ethics for Australian Nurses (1995) assigns nurses the role of advocates for patients’ rights and, in particular, the right to make decisions about their own well-being based on accurate information provided by healthcare professionals.
The International Code of Midwifery (1993) proposes a model informed consent with a distinct feminist emphasis: midwives respect women’s right to make informed decisions and encourage them to accept responsibility for the consequences of those decisions. They collaborate with women and support their right to actively participate in decisions regarding their care, empowering them to speak on their own behalf about issues affecting their health and that of their families.
For me, the text with the most substance is the staff Charter. First of all, it addresses the dialogical nature of medical care. It reads as follows:
72. In order to perform a medical procedure on a patient, the healthcare provider must have the patient’s express or implied consent. Indeed, the provider “has no separate or independent right vis-à-vis the patient. In general, the provider may act only if the patient authorizes it explicitly or implicitly (directly or indirectly).” Without this authorization, the healthcare provider assumes arbitrary power.
Furthermore, the healthcare relationship is a contact : it is based on dialogue, not on objects. The patient “is not an anonymous individual” upon whom medical knowledge is applied, but “a person manager must be made a partner in the improvement of his own health and in the achievement of healing. It is a moral imperative to place the patient in a position to make personal choices rather than to be subjected to decisions and choices that others have made for him.” (John Paul II, 1982).
It establishes the right to informed consent: To ensure a deliberate choice plenary session of the Executive Council with plenary session of the Executive Council knowledge freedom, the patient must be given an accurate understanding of their illness and the available treatment options, including the risks, difficulties, and consequences involved. (John Paul II, 1980). This means that informed apply for must apply for patient.
It examines an important distinction regarding the presumption of consent. 73. With regard to the presumption of consent, a distinction is made between patients who are competent and those who are incapable of understanding and consenting.
In the first case, consent cannot be presumed: it must be specific and explicit.
In the second case, however, the healthcare provider may—and in extreme situations has the authority to—presume consent to therapeutic interventions, which he or she must perform in accordance with his or her professional judgment and conscience. In the case of a temporary absence of consciousness and volition, based on the principle of therapeutic trust—that is, the original trust with which the patient has placed themselves in the healthcare provider’s care. In the case of a permanent absence of consciousness and volition, based on the principle of responsibility in healthcare, which obligates the healthcare provider to take position the patient’s health.
74. As for family members, they are informed about standard treatments and involved in decisions regarding non-standard and optional treatments.
2. Ethics and Law: An Overview
It is very human and very much in keeping with the Christian spirit to be free and to love freedom. Without freedom, there is no moral life; nothing done in ignorance or under duress has moral merit. The good person and the good Christian make full use of their freedom and their responsibility. A good patient is not one who turns a blind eye to their fate, but one who takes it upon themselves, accepts it, and makes decisions about it to the extent that such decisions can be made.
Furthermore, as doctors and nurses, we must love and respect the freedom of others. This has a lot to do with presenting options and letting them choose. There is a phrase from St. Paul in the Epistle to Philemon: “But I do not want to do anything without your consent: I do not want to impose the good you do on you, but rather I leave it to you to do it with full freedom” (Phil 14). And St. Augustine affirms that God thought his servants would serve him better if they were free to do so.
At the heart of this lies a conviction—both human and rooted in faith—that, in every test, one receives grace and is able to choose among legitimate options, more or less. With the financial aid God and others, it is possible for everyone to live their life, fulfill their destiny, and, to the extent possible, shape it. It is wrong to deprive others of the ability to make and exercise such personal decisions.
In Spain, there's a rush to fill out forms
What informed consent is not
Sometimes, informed consent is reduced to a mere formality: obtaining the signature on a document that outlines certain possibilities and on which signature must signature a sign of agreement to the proposed plan.
You are invited to accept
There are many major human rights documents that, more or less directly, grant individuals the ability to determine the extent to which they allow others to act upon their bodies or access their inner selves. To keep the legal details to a minimum, it suffices to note that article of the Italian Constitution, which deals with healthcare, states: “No one may be compelled to undergo a specific medical treatment except by law. The law may not, under any circumstances, violate the limits imposed by respect for the human person.”
And there are many legal documents (health laws, court rulings) that confirm the general principle that any medical intervention is contingent upon the patient’s consent, which has a specific meaning: it is the tool protecting the patient’s integrity against the physician’s nearly unlimited capacity for intervention.
From a legal perspective, a patient’s consent must be free and informed, and must come directly from the competent patient or from their representative in the case of minors or patients with mental illnesses. It must be firm but revocable. Consent cannot be vitiated by any form of coercion or physical or psychological violence. Today, the general legal trend favors increasingly explicit and informed consent, free from fraud and error, which is becoming less and less compatible with implicit, presumed, or putative consent.
The general principles of informed consent are set forth in the Document on Information and Consent for Medical Procedures, issued by committee Italian committee Bioethics committee (June 20, 1992), particularly in the section , Conclusions, and Proposals.”
summary.
c. Withdrawal and withdrawal of consent
It is important to understand that the standard practice is to consent to the proposed treatment. However, it is equally possible for the patient to deliberately refuse it and object to being treated. Doctors and nurses must not force the patient to undergo treatment they refuse, nor should they give up on continuing to negotiate with the patient to find an alternative solution—if one exists—that, while not ideal, is at least acceptable. It is always possible to provide information in a more understandable way, to dispel misunderstandings and fears, to clarify the meaning of calculated risks, and to overcome temporary moments of panic. Sometimes, seeking a second opinion from another doctor can be persuasive.
However, if a competent patient, after all efforts have been made, refuses to be treated according to the plan proposed by their physician, it is morally and ethically obligatory to respect their decision. The physician must then determine whether, under status , they can continue to care for the patient (for example, with palliative measures) or must terminate their relationship with the patient. The physician must then determine whether the patient Withdrawal receive any further subject for their illness, or whether, on the contrary, they wish to receive treatment from another colleague. In this case, the physician should assist the patient in finding another physician willing to position .
3. The Specifics of Informed Consent in Nursing
There is no doubt that consent to the treatment plan is negotiated and obtained by the physician. But such consent is not the whole story: throughout the course of the illness, the patient, the physician, and the nurse must internship initial plan, which gives rise to a issue immediate decisions about which the patient must be informed so that they can continue to give their consent.
The doctor leaves, and the nurse stays behind. The patient continues to mull over their problems, noticing new aspects and experiencing fresh anxieties or concerns. It is the nurse whom the patient turns to with questions. The illness takes its course: unwanted side effects from medication may arise, and unexpected, urgent crises may occur that leave no time for the doctor to arrive. The nurse may find herself in situations where she needs to provide additional information, modify the treatment plan, or respond to the patient’s requests or demands. She may even have to make the decision to fail .
Nurses may face a conflict of loyalty between the doctor and the patient. As we have seen, the patient’s consent to the doctor’s treatment plan is not fixed or irrevocable: it can be modified. If the doctor is not present, can the nurse agree to the changes the patient wishes to make?
b. Content: consent to nursing procedures
The right to be informed about one’s condition (nursing diagnosis), the available treatment options (nursing interventions), and the prognosis regarding health, well-being, and life expectancy (nursing prognosis).
The right to consent to or refuse treatment.
It is traditionally believed that simply knocking on the doctor’s door or agreeing to be admitted to the hospital implies that the patient tacitly and implicitly consents to the treatment. But this can lead to abuse. The ethical relationship is best maintained when explanations are provided regarding what will be done, why, how, where, and when.
In Harper Lee’s *To Kill a Mockingbird*, Dr. Reynolds, a general practitioner of great humanity, appears in only a few scenes. His actions are a model of professionalism. The novel’s protagonist, young Stout, offers two descriptions of him: “His car pulled up in front of the house. I knew the sound of Dr. Reynolds’ footsteps as well as I knew my father’s. Dr. Reynolds had delivered Jem and me, had treated us for every childhood illness known to man, had healed Jem when he fell from the treehouse, and had never lost our friendship.” And she adds elsewhere: “He told us what he was going to do, and he did it. He never deceived us.”
A wonderful testimonial.
Speak with dignity: to children and the elderly, not as if they were children. Seriousness, discretion.
d. Informed consent in day-to-day interactions
Informed consent is an excellent procedure foster engagement and cooperation, and to strengthen the partnership between patients and caregivers. There is a close relationship between the quality of care and informed consent. final, obtaining consent is a sample respect; it means that the patient is treated as a person. The way consent is obtained influences the culture of department and the practices of doctors and nurses. Neglecting it fosters a careless environment. It is also possible that overemphasizing it could create an status rigid status .
The capacity for sensitivity—for showing thoughtful gestures of humanity—depends on the ability to consider others, to take their wishes into account, and to anticipate their needs. This is a wonderful exercise in respect, closely related to the concept of informed consent. There are many styles and approaches to nursing: some show greater respect for the patient, while others show less. Informed consent is not a legal matter; it is an ethical category: taking the other person into account.
When consent is not only not sought but also ignored, many opportunities for friendliness, politeness, and courtesy are lost. It’s always a good idea to ask for permission.
The Tale of Two Wards: Experiences in Two Departments Conflicting Approaches to Patient Care. A patient with a broken leg had a terrible experience. He suffered severe pain due to nerve compression.
In the first conference room, everything is forbidden; everything is sacrificed to order. A prison-like regime is enforced, with discipline , where the patient has nothing to do but obey instructions and remain silent. From 10 p.m. to 6 a.m., lights out, complete bed rest, without waking up during the night. Mandatory wake-up call at 6 a.m. to take the temperature. After that, nothing to do until breakfast at 8 a.m. The question is: “Are you in pain?” If the answer is yes, a mandatory painkiller is administered. No questions are asked about the intensity or nature of the pain. There is an obsession with uniformity everywhere. The consequences: hours and hours of pain without relief, endless hours without distractions at night.
In the second conference room, the affirmative response “I’m in a lot of pain” is followed by a application describe the nature of the pain. The treatment is appropriate, pain relief is nearly perfect, allowing the patient to read while awake, and their morning sleep is respected.
There were also differences in attention between the head nurse, her subordinates, and the students. On the surface, everything appeared highly efficient, but the atmosphere was mechanical and lifeless. From the patients’ perspective, the second conference room infinitely better than the first. It offered more freedom, more compassion, more humanity, and the nurses were sensitive to the pain of the patients—each and every one of them. Order, adherence to protocols, and discipline are good things: they prevent the hospital from descending into chaos. But order is for the people.
Paying attention to the details. That is the ethos of a hospital, of work there. It may seem excessive to ask for permission or seek input: when making the bed, choosing the menu, or performing each procedure. Saying: “May I take a sample ? I need to draw it from the vein in your arm, as Dr. So-and-so wants to check your cardiac enzymes today. That’s the only way we’ll know how the heart attack is progressing.” But that is exactly what you should say to a patient.
Every procedure, every action, should be explained. This includes any mistakes, such as having to re-insert the needle to find a more suitable vein. It is always important to explain the reasons behind instructions—to remain still, not to get up—with sincerity and honesty. It is not right to deceive. Especially when patients are unnecessarily required to do things that are not justified: not moving, having to eat, drink, defecate, or sweat in a damp bed. It is not easy, and there are people who feel humiliated and degraded by having to do so under such conditions.
It is important to provide the most appropriate solution for each individual.
e. Informed consent for training
One of the rights of patients is to decide whether or not to allow themselves to be observed and examined by students and to allow students to perform more or less invasive procedures on them. It is necessary to obtain the patient’s consent: explain what we are asking of them, request their cooperation, and give them complete freedom to say yes or no.
A respectful invitation. Freedom that does not depend on whether you pay or not. Immunity from any reprisal or advantage.
It should be part of the atmosphere, part of the culture—all other things being equal—that a professor hospital is better and safer professor one that isn't. There may be local traditions: it is well known that attending a university hospital implies a willingness to participate in teaching.
Doctors and supervisors must tell patients: “She is a nursing student” (never mislead them). A student must never introduce herself as, or allow herself to be regarded as, a licensed nurse. That constitutes fraud and is a crime of unauthorized practice. The Degree of supervision work must be maintained. This is very important. A student cannot assume full responsibility, even if they have the full technical ability to perform the procedure. In this case, they should not perform it, as they are not qualified.
Respect the patient. Never abuse their trust. Thank them for their cooperation. Never deceive them, in order to preserve the educational institution’s greatest asset: the mutual trust between teacher, student, and patient.
f. Informed consent for research
In 1947—50 years ago next year—an American military tribunal tried Nazi doctors in Nuremberg for their criminal research . In its ruling, known as the Nuremberg Code, it established once and for all that science alone—not even good science—is sufficient to guarantee the moral integrity of research. Experiments conducted on human beings must be subject to universal standards of respect for humanity. It stated it this way:
“The voluntary consent of human subjects is absolutely essential. This means that the person concerned must have the legal capacity to consent; must be in status exercise full freedom of choice, without any impediment arising from force, fraud, deception, intimidation, promise, or any other form of coercion or threat; and must have knowledge information and knowledge of the elements of the experiment so that they can understand what they are deciding. This last element requires that, before accepting an affirmative response from a research subject, the researcher informed the subject of the nature, duration, and purpose experiment; the methods and means by which it will be carried out; the inconveniences and risks that can reasonably be expected; and the effects that may result for the subject’s health or person from participation in the experiment.”
With these demanding words, the principle of free and informed consent was established for the first time. The Nuremberg Code is the fundamental charter of the rights of research subjects. It states that it is the subject—and not the researcher society—who is the primary ethical agent in experimentation: only the subject can say yes or no to the conduct of the experiment.
The Nuremberg Code states that the experimenter is responsible for ensuring the validity of the subject’s consent:“The duty and responsibility for assessing the validity of consent rest with each and every individual who initiates, directs, or participates in the experiment. This is a staff obligation staff cannot be delegated to another without consequence.”
The Code extends full responsibility for informed consent regarding their actions to all members of the research team, as it calls on them not only to take the research subjects very seriously, but also—and very significantly—to take themselves very seriously as moral agents. None of them—whether the sponsor, the director a mere assistant—can claim that the ethics of the experiment are not their concern: this responsibility falls equally on all of them, and it is embodied in being, and acting as, advocates and guardians of the experimental subject’s consent. Nuremberg established once and for all that it is neither legally nor ethically valid to absolve one’s own conscience of guilt or responsibility by claiming that one acted merely as an executor of orders from superiors. In the ethics of human experimentation, every researcher, regardless of their position in the hierarchical or organizational structure, is fully manager the subjects they work with and must assume before them the inescapable responsibility of being the protector of their human dignity.
It has been argued that this rule of the Nuremberg Code is nearly impossible to uphold, since obtaining clear and fully voluntary consent from subjects is goal in many partner contexts, as well as in many experimental situations considered ethically acceptable. There is no shortage of those who wish to modify these standards, making them less absolute. Such a claim should not be granted: when it comes to listing principles, it is better to err on the side of caution than to fall short. Routine tends to wear down the sharp edges of the rules. The firmness of the formulations is necessary to put things back in their proper place. The basic Nuremberg doctrine is valid and must continue to be formulated with its original rigor.
Among other reasons, here is one: in theory, informed consent can only be given by a competent individual who has not only received all the necessary information but has also understood it, asked the appropriate questions to dispel doubts and clarify misunderstandings, reflected on all of this, and reached a final decision of their own free will, that is, without any form of deception, coercion, intimidation, promises, or rewards having intervened at any time. This is not easy to achieve, because it is not easy for many potential subjects—not only children, preteens, or the mentally ill, but also well-educated adults—to understand the complex design some clinical trials; it is not easy to grasp the dissociation experienced by the medical staff themselves—in whom thegoal places full trust—when, in the course of essay ,goal act as researcher goal a rigid protocol did not design. Nor is it easy for some researchers to provide information free of bias in favor of their patients’ participation in a essay, or to refrain from any action that might in any way influence the patient’s decision. Precisely because, as explained below, informed consent is inherently imperfect and susceptible to abuse, it must be applied with the utmost care and safeguards. To prevent its erosion, it requires a complement: the review and approval of the aims, methods, and circumstances of the experiment by an committee competent to judge its ethical implications. A few years were enough to demonstrate that research ethics committees research not merely convenient in theory. Reality itself has shown that they are necessary.
g. Repeating the same mistake: The birth of research ethics committees
Over time, it became clear that the strong ethical principles of the Nuremberg Code were insufficient to eradicate abusive experimentation from hospitals and public health institutions. In the late 1960s, barely twenty years after the Code was enacted, reports of abusive, inhumane experiments came to light, revealing that the spirit of Nuremberg had been forgotten. Beecher’s article “Ethics and Clinical Research,” published in 1966, and Pappworth’s book *Human Guinea Pigs: Experimentation in Man*, which appeared the following year, caused a major stir in the academic community among the general public.
The World association , which in 1964 had issued its initial, modest Helsinki Declaration to guide physicians in research human subjects, was compelled to revise it with renewed vigor eleven years later in Tokyo. The new Declaration reiterates and expands upon the Nuremberg doctrine of informed consent in three of its basic principles. The Declaration of Helsinki insists that the most essential requirement of human experimentation is that the physical and mental integrity staff be respected; that staff not be subjected to risks that are unpredictable or disproportionate to the potential benefits; that the subject’s freedom to participate or not be protected; that the subject’s privacy not be violated; and that the subject’s interests not be subordinated to the interests of science or society. These requirements supersede the criminal, civil, and professional responsibilities established by the laws and regulations of each nation.
However, the Declaration adds an original requirement intended to ensure the ethical quality of all human experimentation: it mandates the involvement of an committee to evaluate and approve research approve . Basic Principle 2 of the Helsinki Declaration, in its latest version (Hong Kong, September 1989), states: The project the method of conducting any procedure on human subjects must be clearly formulated in the protocol , which must be submitted to a committee appointed for this purpose, and independent of researcher the sponsor, for review, comment, and guidance. This committee must comply with the laws and regulations of the country in which the research is to be conducted.