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Table of Contents
Think
Assess
Patient: Autonomy
Practitioner: Beneficence & Nonmaleficence
Public Policy: Justice
Conclude
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C. Four Principles
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As a member of the medical profession, I will respect the autonomy and dignity of my patient.
~ Declaration of Geneva
Principled Puzzle
The Mysterious Case of the Ethical Dilemma
It was a foggy night at the prestigious Belmont Medical Institute, as Dr. Veronica Davidson, a brilliant young medical researcher, prepared for a conference on biomedical ethics. The institute, famous for its cutting-edge research and adherence to the highest ethical standards, was buzzing with anticipation for the event.
As Dr. Davidson walked down the hallway, she pondered the Four Principles of biomedical ethics: Autonomy, Beneficence, Nonmaleficence, and Justice. These principles, derived from the Belmont Report, governed human research in the United States and formed the basis of medical standards of care. She knew that the conference attendees, consisting of medical students and healthcare providers, would benefit greatly from understanding the significance of these principles in practice.
During the conference, Dr. Davidson presented an intriguing case involving a patient named Mr. Thompson, a man with a mysterious illness. His symptoms were baffling, and the medical team was divided on the best course of treatment. Dr. Davidson posed a question to the audience: How would they apply the Four Principles to make an ethically sound decision for Mr. Thompson?
First, Dr. Davidson discussed Autonomy, emphasizing the importance of informed consent. The audience considered how they could provide Mr. Thompson with sufficient information about his diagnosis, prognosis, and treatment options, and ensure he had the decisional capacity to choose the best course of action.
Next, she touched on Beneficence, urging the attendees to act in the patient’s best interest while considering his goals, values, and priorities. The medical professionals in the room contemplated how they could maximize Mr. Thompson’s well-being according to his unique circumstances.
Delving into Nonmaleficence, Dr. Davidson explained the duty to minimize harm and the risk of harm. The audience pondered the potential risks and benefits of each treatment option, striving to protect Mr. Thompson from undue suffering.
Lastly, Dr. Davidson explored the concept of Justice, highlighting the role of public policy in promoting fairness and minimizing disparities in healthcare. The attendees considered how their decisions might impact the equitable distribution of benefits and burdens for Mr. Thompson and others like him.
As the conference concluded, Dr. Davidson challenged the medical professionals to reflect on the ethical complexities of the case. Through this engaging murder mystery, they learned the importance of applying the Four Principles to their practice, ensuring a more just, patient-centered, and ethical healthcare system.
The mystery of Mr. Thompson’s illness sparked a lively debate, and the participants left the conference with a renewed commitment to the highest standards of medical ethics. And though the fog still lingered outside the Belmont Medical Institute, the principles of biomedical ethics shone brightly, guiding the way for the next generation of medical professionals.
Abstract
The Belmont Report provides the core principles of biomedical ethics necessary when conducting human research in the US. These principles, which are also known as the Four Principles, are Autonomy, Beneficence, Nonmaleficence, and Justice. Autonomy is the patient’s right to provide informed consent, while Beneficence is the practitioner’s responsibility to act in the patient’s best interest. Nonmaleficence is the responsibility to minimize harm and the risk of harm. Justice involves promoting the equitable distribution of benefits and burdens in healthcare and minimizing disparities. The patient has the legal and moral authority to make medical decisions, the practitioner has a professional obligation to provide patient-centered care, and public policy has a social responsibility to create legislation that promotes fairness in healthcare.
**
[C:1] All research conducted on human subjects is carefully regulated by federal law Common Rule 45CFR46, the legal implementation of the 1979 Belmont Report. The Belmont Report presented the core principles of biomedical ethics necessary when conducting human research. Since the boundaries between research and the practice of medicine are blurry, since the principles of biomedical ethics are sufficient to address most moral issues related to medicine, and since the principles of ethics for research on human subjects are already federally enforced throughout the entire country, these principles have been adopted by the medical profession as part of the medical standards of care. The medical standards of care is a legal definition of how a reasonably competent practitioner in the same or similar community would address the same medical condition. A reasonably competent practitioner is a medical professional who abides by clinical practice guidelines, medical associations standards, and provides the patient with treatment options based on up-to-date, evidence-based medicine and practices.
[C:2]
1. Autonomy (informed consent)
[C:3] Autonomy is the patient’s right to provide informed consent authorizing the practitioner to provide medical care per the medical standards of care and in accordance with the patient’s reasonable goals, values and priorities. For informed consent, the patient must be able to:
- a) demonstrate knowledge about their diagnosis & prognosis,
- b) demonstrate knowledge of the various treatment options,
- c) demonstrate knowledge of the purpose of the various treatment options, including foregoing any treatment,
- d) weigh & balance the benefits & risks of the various treatment options, including no treatment,
- e) provide reasons for treatment or no treatment decisions, and
- f) authorize the preferred treatment option or no treatment.
[C:4]
[C:5] To meet all the informed consent requirements, the practitioner must effectively communicate and educate the patient about their diagnosis & prognosis, treatment options, treatment purposes, benefits & risks, and answer the patient’s questions. This patient-practitioner interaction is why informed consent is categorized as a shared decision-making activity within the patient-practitioner relationship.
Autonomy Terms
[C:6]
a) Decisional Capacity: The medical practitioner determines the patient’s ability to provide informed consent.
b) Voluntary: The patient is not subjected to manipulative or coercive influences.
(1) Manipulation: Selective information disclosure that unduly influences the patient’s medical decision.
(2) Coercion: Credible threat that unduly influences the patient’s medical decision.
c) Substituted Judgment: Surrogate is obligated to use the patient’s reasonable goals, values, and priorities when making medical decisions for a patient without decisional capacity. If the patient’s reasonable goals, values, and priorities are not known, then the surrogate must focus on:
(1) the patient’s best interests,
(2) the medical standards of care, and
(3) provide clear communication with all parties of interest.
2. Beneficence (do good)
[C:7] Beneficence is the practitioner’s professional responsibility to maximize the patient’s best interests per the medical standards of care, and in accordance with the patient’s reasonable goals, values and priorities.
3. Nonmaleficence (do no harm)
[C:8] Nonmaleficence is the practitioner’s professional responsibility to maximize the patient’s best interests by minimizing both harm and the risk of harm per the medical standards of care, and in accordance with the patient’s reasonable goals, values and priorities.
4. Justice (be fair)
[C:9] Justice is public policy legislation for the equitable distribution of individual and social benefits & burdens by minimizing public healthcare disparities.
B. Three Categories of Moral Responsibility
1. Patient
[C:10] The patient has the legal and moral authority to autonomously provide informed consent authorizing the practitioner to provide care per medical standards of care, and in accordance with the patient’s reasonable goals, values and priorities.
2. Practitioner
[C:11] The practitioner has the professional obligation to provide patient-centered care that maximizes the patient’s best interests, as determined by the patient’s reasonable goals, values and priorities, and without violating the principles of nonmaleficence (do no harm), beneficence (do good), and the medical standards of care.
3. Public Policy
[C:12] Public policy has the social responsibility and authority to create legislation for minimizing healthcare disparities by promoting the equitable distribution of benefits and burdens, actualizing the social and moral principle of justice (be fair).
***
ETHICS For MEDICINE
Responsible
Application
Principles
Patient-Practitioner
(informed consent)
AUTONOMY
BENEFICENCE
Practitioner
(do good)
NONMALEFICENCE
Practitioner
(do no harm)
JUSTICE
Public Policy
(be fair)
INFORMED CONSENT
Patient demonstrates knowledge about their diagnosis and prognosis
DIAGNOSIS & PROGNOSIS
Patient demonstrates knowledge of the various treatment options, including no treatment
OPTIONS
Patient demonstrates knowledge of the purpose of the various treatment options
PURPOSE
Patient is able to weigh & balance the benefits & risks of the various treatment options, including no treatment, using the patient’s own goals, values, and priorities
BENEFITS & RISKS
Patient can provide logical reasons for their treatment or no treatment authorization that are in line with the patient’s reasonable goals, values, and priorities
RATIONAL
Patient can communicate the authorization for treatment option
CONSENT
C. Review Questions
1. All research conducted on human subjects is carefully regulated by federal law Common Rule 45CFR46, the legal implementation of the 1979 Belmont Report.
2. The principles of medical ethics were adopted by the medical profession as part of the medical standards of care because:
3. Medical standards of care is defined by:
4. To meet all the informed consent requirements, the practitioner must effectively communicate and educate the patient about their diagnosis & prognosis, treatment options, treatment purposes, benefits & risks, and answer the patient’s questions.
5. Informed consent is a patient’s autonomous responsibility, not a shared decision-making process.
6. A patient’s decisional capacity is a legal determination not a clinical determination.
7. Autonomy (informed consent), Beneficence (do good), and Nonmaleficence (do no harm) should be exercised only within the boundaries of medical standards of care.
8. The three categories of moral responsibility as presented in ETHICS For Medicine are:
CORRECT! 🙂
[C:1] All research conducted on human subjects is carefully regulated by federal law Common Rule 45CFR46, the legal implementation of the 1979 Belmont Report. The Belmont Report presented the core principles of biomedical ethics necessary when conducting human research. Since the boundaries between research and the practice of medicine are blurred, since the principles of biomedical ethics are sufficient to address most moral issues related to medicine, and since the principles of ethics for research on human subjects are already federally enforced throughout the entire country, these principles have been adopted by the medical profession as part of the medical standards of care. Medical standards of care is based on peer-reviewed evidence-based medicine that the medical community has generally recognized.
Wrong 😕
[C:1] All research conducted on human subjects is carefully regulated by federal law Common Rule 45CFR46, the legal implementation of the 1979 Belmont Report. The Belmont Report presented the core principles of biomedical ethics necessary when conducting human research. Since the boundaries between research and the practice of medicine are blurred, since the principles of biomedical ethics are sufficient to address most moral issues related to medicine, and since the principles of ethics for research on human subjects are already federally enforced throughout the entire country, these principles have been adopted by the medical profession as part of the medical standards of care. Medical standards of care is based on peer-reviewed evidence-based medicine that the medical community has generally recognized.
CORRECT! 🙂
[C:1] All research conducted on human subjects is carefully regulated by federal law Common Rule 45CFR46, the legal implementation of the 1979 Belmont Report. The Belmont Report presented the core principles of biomedical ethics necessary when conducting human research. Since the boundaries between research and the practice of medicine are blurred, since the principles of biomedical ethics are sufficient to address most moral issues related to medicine, and since the principles of ethics for research on human subjects are already federally enforced throughout the entire country, these principles have been adopted by the medical profession as part of the medical standards of care. Medical standards of care is based on peer-reviewed evidence-based medicine that the medical community has generally recognized.
Wrong 😕
[C:1] All research conducted on human subjects are carefully regulated by federal law Common Rule 45CFR46 which is the legal implementation of the 1979 Belmont Report. The Belmont Report presented the core principles of biomedical ethics necessary when conducting human research. Since the boundaries between research and the practice of medicine are blurred, since the principles of biomedical ethics are sufficient to address most moral issues related to medicine, and since the principles of ethics for research on human subjects are already federally enforced throughout the entire country, these principles have been adopted by the medical profession as part of the medical standards of care. Medical standards of care is based on peer-reviewed evidence-based medicine that the medical community has generally recognized.
CORRECT! 🙂
[C:1] The medical standards of care is a legal definition of how a reasonably competent practitioner in the same or similar community would address the same medical condition. A reasonably competent practitioner is a medical professional who abides by clinical practice guidelines, medical associations standards, and provides the patient with treatment options based on up-to-date, evidence-based medicine and practices.
Wrong 😕
[C:1] The medical standards of care is a legal definition of how a reasonably competent practitioner in the same or similar community would address the same medical condition. A reasonably competent practitioner is a medical professional who abides by clinical practice guidelines, medical associations standards, and provides the patient with treatment options based on up-to-date, evidence-based medicine and practices.
CORRECT! 🙂
[C:5] To meet all the informed consent requirements, the practitioner must effectively communicate and educate the patient about their diagnosis & prognosis, treatment options, treatment purposes, benefits & risks, and answer the patient’s questions. This patient-practitioner interaction is why informed consent is categorized as a shared decision-making activity within the patient-practitioner relationship.
Wrong 😕
[C:5] To meet all the informed consent requirements, the practitioner must effectively communicate and educate the patient about their diagnosis & prognosis, treatment options, treatment purposes, benefits & risks, and answer the patient’s questions. This patient-practitioner interaction is why informed consent is categorized as a shared decision-making activity within the patient-practitioner relationship.
CORRECT! 🙂
[C:5] To meet all the informed consent requirements, the practitioner must effectively communicate and educate the patient about their diagnosis & prognosis, treatment options, treatment purposes, benefits & risks, and answer the patient’s questions. This patient-practitioner interaction is why informed consent is categorized as a shared decision-making activity within the patient-practitioner relationship.
Wrong 😕
[C:5] To meet all the informed consent requirements, the practitioner must effectively communicate and educate the patient about their diagnosis & prognosis, treatment options, treatment purposes, benefits & risks, and answer the patient’s questions. This patient-practitioner interaction is why informed consent is categorized as a shared decision-making activity within the patient-practitioner relationship.
Wrong 😕
Autonomy Terms
[C:6]
a) Decisional-Capacity: The medical practitioner determines the patient’s ability to provide informed consent.
b) Voluntary: The patient is not subjected to manipulative or coercive influences.
(1) Manipulation: Selective information disclosure that unduly influences the patient’s medical decision.
(2) Coercion: Credible threat that unduly influences the patient’s medical decision.
c) Substituted Judgment: Surrogate is obligated to use the patient’s reasonable goals, values, and priorities when making medical decisions for a patient without decisional capacity. If the patient’s reasonable goals, values, and priorities are not known, then the surrogate must focus on:
(1) patient’s best interests,
(2) medical standards of care, and
(3) clear communication with all parties of interest.
CORRECT! 🙂
Autonomy Terms
[C:6]
a) Decisional-Capacity: The medical practitioner determines the patient’s ability to provide informed consent.
b) Voluntary: The patient is not subjected to manipulative or coercive influences.
(1) Manipulation: Selective information disclosure that unduly influences the patient’s medical decision.
(2) Coercion: Credible threat that unduly influences the patient’s medical decision.
c) Substituted Judgment: Surrogate is obligated to use the patient’s reasonable goals, values, and priorities when making medical decisions for a patient without decisional capacity. If the patient’s reasonable goals, values, and priorities are not known, then the surrogate must focus on:
(1) patient’s best interests,
(2) medical standards of care, and
(3) clear communication with all parties of interest.
CORRECT! 🙂
[C:3] Autonomy: Patient’s right to provide informed consent authorizing the practitioner to provide medical care per the medical standards of care, and in accordance with the patient’s reasonable goals, values and priorities. …
[C:7] Beneficence: Practitioner’s professional responsibility to maximize the patient’s best interests per the medical standards of care, and in accordance with the patient’s reasonable goals, values and priorities. …
[C:8] Nonmaleficence: The practitioner’s professional responsibility is to maximize the patient’s best interests by minimizing both harm and the risk of harm per the medical standards of care, and in accordance with the patient’s reasonable goals, values and priorities.
Wrong 😕
[C:3] Autonomy: Patient’s right to provide informed consent authorizing the practitioner to provide medical care per the medical standards of care, and in accordance with the patient’s reasonable goals, values and priorities. …
[C:7] Beneficence: Practitioner’s professional responsibility to maximize the patient’s best interests per the medical standards of care, and in accordance with the patient’s reasonable goals, values and priorities. …
[C:8] Nonmaleficence: The practitioner’s professional responsibility is to maximize the patient’s best interests by minimizing both harm and the risk of harm per the medical standards of care, and in accordance with the patient’s reasonable goals, values and priorities.
CORRECT! 🙂
B. Three Categories of Moral Responsibility
1. Patient
[C:10] Patient has the legal and moral authority to autonomously provide informed consent authorizing the practitioner to provide care per medical standards of care, and in accordance with the patient’s reasonable goals, values and priorities.
2. Practitioner
[C:11] Practitioner has the professional obligation to provide patient-centered care that maximizes the patient’s best interests, as determined by the patient’s reasonable goals, values and priorities, and without violating the principles of nonmaleficence (do no harm), beneficence (do good), and the medical standards of care.
3. Public Policy
[C:12] Public Policy has the social responsibility and authority to create legislation for minimizing healthcare disparities by promoting the equitable distribution of benefits and burdens, actualizing the social and moral principle of justice (be fair).
Wrong 😕
B. Three Categories of Moral Responsibility
1. Patient
[C:10] Patient has the legal and moral authority to autonomously provide informed consent authorizing the practitioner to provide care per medical standards of care, and in accordance with the patient’s reasonable goals, values and priorities.
2. Practitioner
[C:11] Practitioner has the professional obligation to provide patient-centered care that maximizes the patient’s best interests, as determined by the patient’s reasonable goals, values and priorities, and without violating the principles of nonmaleficence (do no harm), beneficence (do good), and the medical standards of care.
3. Public Policy
[C:12] Public Policy has the social responsibility and authority to create legislation for minimizing healthcare disparities by promoting the equitable distribution of benefits and burdens, actualizing the social and moral principle of justice (be fair).
C. Clinical Vignettes
1. A researcher is conducting a study on the efficacy of a new medication for treating depression. The study involves administering the medication to a group of participants and comparing their symptoms to a control group who will receive a placebo. Which of the following best describes the regulations that apply to this study?
2. Heather Patel, a 27-year-old architect is being treated by a practitioner and raises a concern about the ethical principles guiding the medical profession. The practitioner explains that the principles of biomedical ethics were adopted by the medical profession as part of the medical standards of care because:
3. Mr. Armando Esparza, A 47-year-old artist presents with symptoms of a medical condition. The clinician must determine the most appropriate course of treatment based on the current medical standards of care. What is the best definition of "medical standards of care"?
4. Ms. Eliza Brown, a 52-year-old firefighter has been diagnosed with a chronic medical condition and has come to the clinic seeking information about their treatment options. In order to meet all informed consent requirements, the practitioner must effectively communicate and educate the patient regarding their diagnosis and prognosis, treatment options, purposes, benefits and risks, and answer any questions they may have. Which of the following actions by the practitioner would best meet the informed consent requirements in this situation?
5. Mr. Horacio Gonzalez 22-year-old construction worker is scheduled for a routine medical procedure. They have been engaged in a collaborative process with their practitioner to understand the risks and benefits of the procedure, and have ultimately made a shared decision to undergo it. Which of the following best describes the process that the individual has undergone in agreeing to the procedure?
Wrong 😕
Explanation: The Common Rule 45CFR46 is a federal law that governs all research conducted on human subjects in the United States [C:1]. It is the legal implementation of the 1979 Belmont Report, which outlines the ethical principles for conducting human subjects research, such as respect for persons (autonomy: informed consent), beneficence (do good), and nonmaleficence (do no harm) [C:2]. The regulation ensures that human subjects are protected from harm and their rights are respected throughout the research process [C:1].
CORRECT! 🙂
Explanation: The Common Rule 45CFR46 is a federal law that governs all research conducted on human subjects in the United States [C:1]. It is the legal implementation of the 1979 Belmont Report, which outlines the ethical principles for conducting human subjects research, such as respect for persons (autonomy: informed consent), beneficence (do good), and nonmaleficence (do no harm) [C:2]. The regulation ensures that human subjects are protected from harm and their rights are respected throughout the research process [C:1].
CORRECT! 🙂
Explanation: The principles of biomedical ethics were adopted by the medical profession as part of the medical standards of care for several reasons. Firstly, the principles are sufficient to address most moral issues related to medicine and provide a comprehensive framework for addressing ethical dilemmas in the medical field [C:1]. Secondly, the principles are already federally enforced throughout the entire country, meaning they have been adopted as law by the government and are mandatory for all healthcare providers to follow [C:2]. Lastly, the boundaries between research and the practice of medicine are blurred, and the principles provide guidance for ethical conduct in both research and patient care, as the two are often interrelated [C:3].
Wrong 😕
Explanation: The principles of biomedical ethics were adopted by the medical profession as part of the medical standards of care for several reasons. Firstly, the principles are sufficient to address most moral issues related to medicine and provide a comprehensive framework for addressing ethical dilemmas in the medical field [C:1]. Secondly, the principles are already federally enforced throughout the entire country, meaning they have been adopted as law by the government and are mandatory for all healthcare providers to follow [C:2]. Lastly, the boundaries between research and the practice of medicine are blurred, and the principles provide guidance for ethical conduct in both research and patient care, as the two are often interrelated [C:3].
Wrong 😕
Explanation: "Medical standards of care" refers to the best practices and guidelines that are recognized and followed by the medical community in the diagnosis and treatment of a medical condition. This includes practices that are evidence-based, meaning they are supported by scientific evidence and research, as well as practices that are peer-reviewed in the medical literature, meaning they have been evaluated and approved by experts in the field [C:1]. Additionally, medical standards of care are generally recognized by the medical community, meaning they are widely accepted as the most appropriate and effective methods for treating a particular condition [C:1]. By following the medical standards of care, the clinician is able to ensure that the patient receives the most appropriate and effective treatment for their condition [C:1].
CORRECT! 🙂
Explanation: "Medical standards of care" refers to the best practices and guidelines that are recognized and followed by the medical community in the diagnosis and treatment of a medical condition. This includes practices that are evidence-based, meaning they are supported by scientific evidence and research, as well as practices that are peer-reviewed in the medical literature, meaning they have been evaluated and approved by experts in the field [C:1]. Additionally, medical standards of care are generally recognized by the medical community, meaning they are widely accepted as the most appropriate and effective methods for treating a particular condition [C:1]. By following the medical standards of care, the clinician is able to ensure that the patient receives the most appropriate and effective treatment for their condition [C:1].
CORRECT! 🙂
Explanation: "Spending the necessary amount of time to discuss the diagnosis, prognosis, treatment options, benefits and risks, and answer the patient’s questions" ensures that the patient fully understands their condition, treatment options, and any potential risks and benefits, and is able to make an informed decision about their care [C:5]. "Simply providing a brochure" does not meet the requirement for effective communication and education [C:5], "Quickly reviewing the information without allowing questions" does not allow for a thorough understanding [C:5], and "not providing information at all" goes against the informed consent requirements [C:1].
Wrong 😕
Explanation: "Spending the necessary amount of time to discuss the diagnosis, prognosis, treatment options, benefits and risks, and answer the patient’s questions" ensures that the patient fully understands their condition, treatment options, and any potential risks and benefits, and is able to make an informed decision about their care [C:5]. "Simply providing a brochure" does not meet the requirement for effective communication and education [C:5], "Quickly reviewing the information without allowing questions" does not allow for a thorough understanding [C:5], and "not providing information at all" goes against the informed consent requirements [C:1].
CORRECT! 🙂
Explanation: Informed consent is a collaborative process where the individual is actively involved in decision-making about their medical treatment. This involves discussing the risks and benefits of the procedure, as well as alternative options, with their practitioner [C:5]. In this case, the individual was engaged in a shared decision-making process with their practitioner, indicating that they were an active participant in the decision to undergo the procedure [C:5].
Wrong 😕
Explanation: Informed consent is a collaborative process where the individual is actively involved in decision-making about their medical treatment. This involves discussing the risks and benefits of the procedure, as well as alternative options, with their practitioner [C:5]. In this case, the individual was engaged in a shared decision-making process with their practitioner, indicating that they were an active participant in the decision to undergo the procedure [C:5].
