Transcript HEALTH LAW AND BIOETHICS Professor Helena Padeira
HEALTH LAW AND BIOETHICS
Professor Helena Pereira de Melo
Informed consent and patient autonomy
2 nd CYCLE – YEAR 2013/2014 ALEXANDRA PATKOVÁ - 003889 Lisbon, 23th April 2014
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Content
1. What is Patient Autonomy 2. What is informed consent 3. Components of Informed Consent • 2.1 Decision making capacity • 2.2 Disclosure 4. Documentation of Consent 5. The right to refuse treatment 6. Clinical Trials and Research 7. Children and Consent 8. Problems with Informed Consent 9. Is the right to consent absolute right?
10. Model Case
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Medical ethics
- a system of moral principles that apply values and judgments to the practice of medicine maleficence,justice)
1.What is Patient Autonomy?
(4 principles: autonomy,beneficence, non •
Principle of Respect for Autonomy
– autonomy - the capacity for self-determination person’s right to make choices on own values – person should be free from coercion in deciding to act + others are obligated to protect confidentiality, respect privacy, and tell the truth.
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Patient Autonomy
– the right of patients to make decisions about their medical care without their health care – – refers to the capability and right of patients decision-making process. –
• Autonomy - the patient has the right to refuse or choose their treatment • Justice - fairness and equality • Beneficence - taking actions that serve the best interests of patients • Non-maleficence - "first, do no harm„ ; not absolute, and balances against the principle of beneficence as the effects of the two principles together often give rise to a double effect (the use of morphine in the dying patient – 1.beneficial effect of easing the pain – 2.maleficent effect of shortening the life)
Conflicts between autonomy and beneficence/non-maleficence
• When the patient's interests conflict with the patient's welfare. (western medicine - patient make his own decisions/many other societies - prioritize beneficence over autonomy) • when a patient does not want a treatment because of, for example, religious or cultural views. • The role of surrogate medical decision makers is an extension of the principle of autonomy.
• autonomy and beneficence/non-maleficence may also overlap
2. What is informed consent
• Information about a particular treatment or test - to decide whether or not you wish to undergo such treatment or test. • Part of Universal Declaration of HR, The European Charter of HR • Truthfulness and honesty • Process of understanding the risks and benefits.
• Explicit (written) consent-for more invasive tests with significant risks or alternatives •
Exceptions:
– an emergency – incompetence
3. Components of Informed Consent
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4 components:
A- the capacity (or ability) to make the decision B- disclosure of information on the by medical provide with the expected benefits and risks C- comprehension D- voluntarily grant consent (no coercion/duress)
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3.1 Decision making capacity
referred to the legal term competency (=legal term used to indicate that a person has the ability to make and be held responsible for decisions. Person can only be declared "incompetent" by a court of law) • •
The components:
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The ability to understand the options
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The ability to understand the consequences of the options The ability to evaluate the personal cost and benefit of each of the consequences
not able to do all of the components – e.g family members = "surrogate decision-makers„
3.2 Disclosure
• Before giving your informed consent - health care provider must give (disclose) to you enough information • Not every detail - only the information that would be expected by a reasonable person to make an intelligent decision. • Include the risks and probability of the risks, and the benefits • Questions - explained in language you understand
4. Documentation of Content
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consent
Components in the written consent: – An explanation of the medical condition – – – – An explanation of the purpose and benefits An explanation of the proposed test/procedure/treatment + possible complications A description of alternative treatments + relative benefits and risks A discussion of the consequences of not accepting
5. The right to refuse treatment
• patients (legally competent to make medical decisions) have the legal and moral right to refuse treatment. • „Against Medical Advice“ (AMA) form - a provement with the option of obtaining a recommended treatment or test - to protect the health care provider from legal liability • If a health care provider decides that a patient does not able to refuse treatment. • Advance directives and living wills = documents that you can complete before an emergency occurs - prevent patient from having decision-making capacity
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6. Clinical Trials and Research
Clinical research trials = important part of health care research • • Clinical studies = determine whether new drugs are more effective Enrolment in a clinical study - opportunity to receive a new drug or treatment before it is widely available.
– – – Informed consent - needed before you may be enrolled in clinical research trials (the purpose - to allow you to learn enough about the study to decide whether or not to participate) Informed consent for a research study (clinical trial) should include: • Why the research is being done, What the researchers hope to accomplish, A description of what will be done during the study, The risks, The benefits, Verification that you have the right to leave the study at any time, ...
Informed consent document must be signed before enrollment in a study.
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7. Children and Consent
little direct application on children.
• Minors - do not have legal empowerment to give informed informed permission ( parents are assumed to act in the best interest of their child) - But - a conflict between what the parents and the health care providers feel is in the best interest.
- Other disagreements in care - court orders- specify what treatment should occur • Most states - have laws - certain minors are emancipated and entitled to the full rights, including in these situations: – Self-supporting and/or not living at home – – – – Married Pregnant or a parent In the military Declared emancipated by a court
8. Problems with Informed Consent
• An uninformed person is at risk of mistakenly making a choice not reflective of his or her values or wishes • A medical intervention without valid informed consent is a
criminal offence
• • To ensure effective communication between the researchers and the participants is necessary to cut:
1. Language barriers 2. Religious influences 3. False expactations
Possible improvements: demographic analysis, professional translators, increasing explanation time,
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9. Is the right to consent absolute right?
Philosopical+Ethical+Legal+Practical consideration
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There are several restrictions – it means that cannot be absolute
– e.g. in the UK – restrictions on minors, patients with incapacity, patients suffering from severe mental illness
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10. Model Case
Question 1:
A 64-year-old woman with Multiple Sclerosis is hospitalized. The team feels she may need to be placed on a feeding tube soon to assure adequate nutrition. They ask the patient about this in the morning and she agrees. However, in the evening (before the tube has been placed), the patient becomes disoriented and seems confused about her decision to have the feeding tube placed. She tells the team she doesn't want it in. They revisit the question in the morning, when the patient is again lucid. Unable to recall her state of mind from the previous evening, the patient again agrees to the procedure.
• Is this patient competent to decide? Which preference should be honored?
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Answer 1:
This patient's underlying disease is impairing her decision-making capacity. If her wishes are consistent during her lucid periods, this choice may be considered her real preference and followed accordingly. However, as her decision-making capacity is questionable, getting a surrogate decision maker involved can help determine what her real wishes are.
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Question 2:
A 55-year-old man has a 3-month history of chest pain and fainting spells. You feel his symptoms merit cardiac catheterization. You explain the risks and potential benefits to him, and include your assessment of his likely prognosis without the intervention. He is able to demonstrate that he understands all of this, but refuses the intervention.
• Can he do that, legally? Should you leave it at that?
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Answer 2:
This patient understands what is at stake with his treatment refusal. As he is competent to make this decision, you have a duty to respect his choice. However, you should also be sure to explore his reasons for refusing treatment and continue to discuss your recommendations. A treatment refusal should be honored, but it should also not be treated as the end of a discussion.