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Table of Contents
Think
Assess
Patient: Autonomy
Practitioner: Beneficence & Nonmaleficence
Public Policy: Justice
Conclude
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D. The Belmont Report — Abridged
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As a member of the medical profession, I will maintain the utmost respect for human life.
~ Declaration of Geneva
Principled Pursuit
The Mysterious Case of the Four Principles
In the small town of Principilia, known for its prestigious medical school, students and faculty eagerly awaited the start of the new semester. Professor Ethos arrived on campus with an unusual teaching method in mind, a mysterious case designed to educate students on the four principles of Principlism: autonomy, beneficence, nonmaleficence, and justice.
The story began with the disappearance of a brilliant researcher named Dr. Eureka, who had made a groundbreaking discovery. The students were tasked with finding her and uncovering the truth behind her disappearance, all the while applying their knowledge of ethical principles to the complex situation they would uncover.
As the investigation unfolded, the students discovered that Dr. Eureka’s research involved experimental treatments that blurred the lines between medical practice and research. They had to distinguish between the two by examining the hypothesis, objectives, and procedures of Dr. Eureka’s work.
During their search, the students encountered a patient named Mr. Autonomy, who had been treated by Dr. Eureka. They learned that Mr. Autonomy had given informed consent for his treatment. They realized the importance of the principle of autonomy in ethical medical practice and research, and delved deeper into the requirements for obtaining valid informed consent, such as ensuring the patient’s comprehension and voluntariness.
As the students continued their investigation, they discovered that Dr. Eureka’s experimental treatments had potential risks and benefits. They had to weigh these factors to determine whether the treatment was ethically justifiable. The students explored the concept of risk-benefit assessment and how it played a crucial role in medical decision-making.
The trail led the students to a group of research subjects who had been part of Dr. Eureka’s study. They found that the selection process for these subjects was not entirely fair. The students delved into the principle of justice and how it applied to the selection of research subjects and the distribution of benefits and burdens.
After an arduous journey, the students finally found Dr. Eureka. They learned that she had gone into hiding to protect her patients and research subjects from potential harm. The students used their understanding of the four principles to evaluate Dr. Eureka’s actions and the ethical implications of her research. They concluded that, while her intentions were good, certain aspects of her work did not adhere to the principles of Principlism.
Upon returning to Principlia Medical School, the students had gained newfound knowledge and a deeper understanding of the ethical principles that guide medical practice and research. They recognized the importance of autonomy, beneficence, nonmaleficence, and justice in ensuring a morally sound healthcare environment. The mysterious case of the four principles had been resolved, and the students were now better equipped to face the ethical challenges that lay ahead in their medical careers.
Abstract
Principlism is an ethical framework used in medical decision-making based on four principles: autonomy (informed consent), beneficence (do good), nonmaleficence (do no harm), and justice (be fair). These principles are widely accepted as common ground for moral decision-making and are reflected in federal law for human subjects research (45 Code of Federal Regulations 46). The Belmont Report outlines the differences between medical practice and research and the application of these principles, such as the importance of informed consent, favorable risk-benefit assessment, and fair selection of research subjects.
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Preamble
[D:1] Principlism is an ethical decision-making approach used in the medical profession. It was first formalized in The Belmont Report and put into federal law for all research on human subjects by 45 Code of Federal Regulations 46 (45CFR46), also known as the Common Rule. The four principles of medical ethics are autonomy (informed consent), beneficence (do good), nonmaleficence (do no harm), and justice (be fair).
[D:2] The principles of biomedical ethics are considered comprehensive enough to address a large portion of medical moral decision-making. The principles are regarded as common ground in that they are socially agreed-upon moral principles that are derivable from, consistent with, or at least not in conflict with the majority of ethical, theological, and social approaches towards moral decision-making.
[D:3]
THE BELMONT REPORT
Abridged & Edited - Bulger
A. MEDICAL PRACTICE VS RESEARCH
The term “practice” refers to interventions designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment, or therapy to particular individuals. When a practitioner departs significantly from the medical standards of care, the innovation does not, in and of itself, constitute research. The fact that a procedure is “experimental,” in the sense of new, untested or different, does not automatically place it in the category of research.
By contrast, the term “research” designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.
B. BASIC ETHICAL PRINCIPLES
The expression “basic ethical principles” refers to those general judgments that serve as a primary justification for the many particular ethical prescriptions and evaluations of human actions. The basic principles that are particularly relevant to the ethics of research involving human subjects and the medical standards of care are: autonomy (informed consent), beneficence (do good), nonmaleficence (do no harm), and justice (be fair).
1. Patient: Autonomy (informed consent)
An autonomous human subject or patient is an individual capable of deliberation about their reasonable goals, values, and priorities and acting under the direction of such deliberation. Autonomy (informed consent) demands that subjects and patients are voluntary and provide informed consent.
2. Practitioner: Beneficence (do good) & Nonmaleficence (do no harm)
Persons are treated in an ethical manner not only by respecting their autonomy (informed consent) but also by the legal and professional responsibility of nonmaleficence (do no harm) and beneficence (do good).
The Hippocratic maxim of nonmaleficence (do no harm) has long been a fundamental principle of medical ethics. Further, the Hippocratic Oath requires beneficence (do good), the practitioner’s responsibility to promote their patient’s best interests per the practitioner’s best medical judgment using the medical standards of care.
3. Public Policy: Justice (be fair)
Justice addresses “fairness in distribution” or “what is deserved.” An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly.
C. APPLICATIONS
1. Autonomy (informed consent)
Autonomy requires that human subjects and patients, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them.
2. Risks and Benefits
Research and clinical practice must be justified based on a favorable
risk/benefit assessment.
3. Selection
The principle of justice (be fair) gives rise to moral requirements of fair procedures and outcomes in selecting human research subjects and outcomes for patients.
A) Information. Most research and medical practice codes establish specific items for disclosure to assure that human subjects and patients are given sufficient information.
1) Procedures
2) Purposes
3) Risks & Benefits
4) Alternatives
5) Answer questions
6) Withdrawal at any time
B) Comprehension. Because the human subject’s or patient’s ability to understand is a function of intelligence, rationality, maturity, and language, it is necessary to adapt the presentation of the information to the human subject’s or patient’s capacities.
C) Voluntariness. An agreement to participate in research or clinical treatment constitutes informed consent only if voluntarily given, free of coercion and undue influence.
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[D:4]
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D. Review Questions
1. The Belmont Report was put into federal law, 45CFR46 and is known as the Common Rule.
2. The principles of bioethics are regarded as common ground in that they are socially agreed-upon moral principles that are derivable from, consistent with, or at least not in conflict with the majority of ethical, theological, and social approaches towards moral decision-making.
3. If a practitioner does a procedure on a patient that is “experimental” in the sense of providing a treatment that is new, untested or different, then that treatment is automatically in the category of research.
4. The Hippocratic maxim of autonomy (informed consent) has long been a fundamental principle of medical ethics.
5. When disclosing the diagnosis, prognosis, treatment options, risks & benefits of the options and answering patient questions, the practitioner must adapt the presentation of the information per the subject’s or patient’s capacities.
6. Coercion is defined as what a patient would consider to be a credible threat.
7. A patient subjected to coercion or manipulation cannot be considered free, thereby invalidating any type of informed consent.
CORRECT! 🙂
[D:1] Principlism is an ethical decision-making approach used in the medical profession. It was first formalized in The Belmont Report and put into federal law for all research on human subjects by 45 Code of Federal Regulations 46 (45CFR46), also known as the Common Rule. The four principles of medical ethics are autonomy (informed consent), beneficence (do good), nonmaleficence (do no harm), and justice (be fair).
Wrong 😕
[D:1] Principlism is an ethical decision-making approach used in the medical profession. It was first formalized in The Belmont Report and put into federal law for all research on human subjects by 45 Code of Federal Regulations 46 (45CFR46), also known as the Common Rule. The four principles of medical ethics are autonomy (informed consent), beneficence (do good), nonmaleficence (do no harm), and justice (be fair).
CORRECT! 🙂
[D:2] The principles of biomedical ethics are considered comprehensive enough to address a large portion of medical moral decision-making. The principles are regarded as common ground in that they are socially agreed-upon moral principles that are derivable from, consistent with, or at least not in conflict with the majority of ethical, theological, and social approaches towards moral decision-making.
Wrong 😕
[D:2] The principles of biomedical ethics are considered comprehensive enough to address a large portion of medical moral decision-making. The principles are regarded as common ground in that they are socially agreed-upon moral principles that are derivable from, consistent with, or at least not in conflict with the majority of ethical, theological, and social approaches towards moral decision-making.
CORRECT! 🙂
A. MEDICAL PRACTICE VS RESEARCH
… The fact that a procedure is “experimental,” in the sense of new, untested or different, does not automatically place it in the category of research.
Wrong 😕
A. MEDICAL PRACTICE VS RESEARCH
… The fact that a procedure is “experimental,” in the sense of new, untested or different, does not automatically place it in the category of research.
CORRECT! 🙂
“The Hippocratic maxim of nonmaleficence (do no harm) has long been a fundamental principle of medical ethics.” Although the Hippocratic Oath focuses on nonmaleficence (do no harm) and beneficence (do good) there is no mention of autonomy (informed consent). The Belmont Report was instrumental in bringing autonomy (informed consent) as a necessary condition for all research on human subjects, and the medical profession has also adopted the importance of patient autonomy as expressed by informed consent.
Wrong 😕
“The Hippocratic maxim of nonmaleficence (do no harm) has long been a fundamental principle of medical ethics.” Although the Hippocratic Oath focuses on nonmaleficence (do no harm) and beneficence (do good) there is no mention of autonomy (informed consent). The Belmont Report was instrumental in bringing autonomy (informed consent) as a necessary condition for all research on human subjects, and the medical profession has also adopted the importance of patient autonomy as expressed by informed consent. .
CORRECT! 🙂
Because the human subject’s or patient’s ability to understand is a function of intelligence, rationality, maturity, and language, it is necessary to adapt the presentation of the diagnosis, prognosis, treatment options, risks & benefits of the options, and answering patient questions per the subject’s or patient’s capacities.
Wrong 😕
Because the human subject’s or patient’s ability to understand is a function of intelligence, rationality, maturity, and language, it is necessary to adapt the presentation of the diagnosis, prognosis, treatment options, risks & benefits of the options, and answering patient questions per the subject’s or patient’s capacities.
Wrong 😕
6. Coercion is defined as what a patient would consider to be a credible threat.
Coercion is whatever a patient would consider to be a credible threat.
CORRECT! 🙂
C) Voluntariness. An agreement to participate in research or clinical treatment constitutes informed consent only if voluntarily given, free of coercion and undue influence.
Wrong 😕
C) Voluntariness. An agreement to participate in research or clinical treatment constitutes informed consent only if voluntarily given, free of coercion and undue influence.
D. Clinical Vignettes
1. Ms. Phoebe Thompson, a 37-year-old social worker is seeking to participate in a research study involving human subjects. Before being enrolled in the study, the patient is informed about the principles outlined in the Belmont Report, which have been put into federal law as 45CFR46, also known as the Common Rule. What is the purpose of the Belmont Report and the Common Rule?
2. A healthcare team is discussing the care of Mr. Gage Kissinger, a 62-year-old locomotive engineer who has been admitted to the hospital with a serious illness. The patient is unconscious and unable to make any decisions regarding their own medical care, and the patient's next of kin is also unavailable to provide any guidance or decisions. The healthcare team is trying to reach a consensus on the best course of action to take. Which of the following principles of bioethics is the healthcare team most likely considering as the common ground in their decision-making process, in that they are socially agreed-upon moral principles that are derivable from, consistent with, or at least not in conflict with the majority of ethical, theological, and social approaches towards moral decision-making?
3. Ms. Xena Flores, a 58-year-old chef presents with a rare form of cancer that has not responded to conventional treatments. The patient is informed by their practitioner that a new and untested treatment option is available, but it is considered "experimental." The practitioner explains to the patient that the experimental treatment may or may not be considered research, depending on the circumstances. The practitioner further explains that research involves a systematic investigation, including clinical trials, to gain new knowledge or to establish the safety and efficacy of a treatment.Is the experimental treatment considered research?
4. Ms. Trinity Patel, a 24-year-old engineer is being treated for a chronic illness and is considering enrolling in a clinical trial to test a new treatment option. The patient expresses concern about the potential risks and benefits of the trial and the practitioner assures them that the trial has been thoroughly vetted and approved by the necessary ethical committees. Although the Hippocratic Oath failed to mention any concept of autonomy or informed consent, the principle of informed consent and respect for persons in medical research and treatment has been reinforced by a number of historical events, including the Belmont Report (1979), the Nuremberg Trials (post-World War II), and the Declaration of Geneva (1948). Which historical event was most instrumental in establishing informed consent as a principle in biomedical ethics?
5. Mr. Curtis Parker, a 66-year-old lawyer comes to the clinic with complaints of fatigue, headaches, and blurred vision. After a thorough examination and laboratory tests, the practitioner determines that the patient has been diagnosed with a serious medical condition. The practitioner must now communicate the diagnosis, prognosis, treatment options, risks, and benefits of the options to the patient. Which of the following is the most appropriate approach for the practitioner to take when communicating this information to the patient?
Wrong 😕
Explanation: The Belmont Report and the Common Rule aim to ensure the ethical treatment of human research participants by addressing issues related to their safety, confidentiality, and the validity of research findings. These principles serve as guidelines for the conduct of research involving human subjects and are an important consideration for both the research team and potential participants.
CORRECT! 🙂
Explanation: The Belmont Report and the Common Rule aim to ensure the ethical treatment of human research participants by addressing issues related to their safety, confidentiality, and the validity of research findings. These principles serve as guidelines for the conduct of research involving human subjects and are an important consideration for both the research team and potential participants.
CORRECT! 🙂
Explanation: The principles of bioethics are considered common ground in that they reflect socially agreed-upon moral principles that are derivable from, consistent with, or at least not in conflict with the majority of ethical, theological, and social approaches towards moral decision-making. In this scenario, the healthcare team is primarily focused on providing treatment and care to the patient, which aligns with the principle of beneficence. Beneficence requires healthcare professionals to act in the best interest of the patient and provide appropriate care and treatment. The principle of nonmaleficence, which requires healthcare professionals to not cause harm to their patients, is also relevant in this scenario as the team must balance the need to provide care with the need to avoid causing harm. The principle of autonomy, which allows patients to make decisions about their own medical care, does not apply in this situation as the patient is unconscious and the next of kin is unavailable to provide any guidance or decisions. The principle of justice, which requires healthcare professionals to treat all patients equally, is not the focus of the decision-making process in this specific scenario.
Wrong 😕
Explanation: The principles of bioethics are considered common ground in that they reflect socially agreed-upon moral principles that are derivable from, consistent with, or at least not in conflict with the majority of ethical, theological, and social approaches towards moral decision-making. In this scenario, the healthcare team is primarily focused on providing treatment and care to the patient, which aligns with the principle of beneficence. Beneficence requires healthcare professionals to act in the best interest of the patient and provide appropriate care and treatment. The principle of nonmaleficence, which requires healthcare professionals to not cause harm to their patients, is also relevant in this scenario as the team must balance the need to provide care with the need to avoid causing harm. The principle of autonomy, which allows patients to make decisions about their own medical care, does not apply in this situation as the patient is unconscious and the next of kin is unavailable to provide any guidance or decisions. The principle of justice, which requires healthcare professionals to treat all patients equally, is not the focus of the decision-making process in this specific scenario.
Wrong 😕
Explanation: The experimental treatment of a rare form of cancer, may or may not be considered research, depending on the circumstances. According to her practitioner, research involves a systematic investigation, including clinical trials, to gain new knowledge or to establish the safety and efficacy of a treatment. Thus, whether the experimental treatment is considered research or not is dependent on the specific details and characteristics of the treatment itself and the way it is being conducted.
CORRECT! 🙂
Explanation: The experimental treatment of a rare form of cancer, may or may not be considered research, depending on the circumstances. According to her practitioner, research involves a systematic investigation, including clinical trials, to gain new knowledge or to establish the safety and efficacy of a treatment. Thus, whether the experimental treatment is considered research or not is dependent on the specific details and characteristics of the treatment itself and the way it is being conducted.
CORRECT! 🙂
Explanation: The Belmont Report, issued in 1979, is considered the most instrumental historical event in establishing informed consent and respect for persons as principles in biomedical ethics and practice. The report emphasized the importance of these principles and helped to establish them as cornerstones of modern biomedical ethics, filling the gap left by the Hippocratic Oath which failed to mention any concept of autonomy or informed consent. The Nuremberg Trials and the Declaration of Geneva also reinforced the principle of informed consent, but the Belmont Report is considered the key event that established it as a principle in biomedical ethics.
Wrong 😕
Explanation: The Belmont Report, issued in 1979, is considered the most instrumental historical event in establishing informed consent and respect for persons as principles in biomedical ethics and practice. The report emphasized the importance of these principles and helped to establish them as cornerstones of modern biomedical ethics, filling the gap left by the Hippocratic Oath which failed to mention any concept of autonomy or informed consent. The Nuremberg Trials and the Declaration of Geneva also reinforced the principle of informed consent, but the Belmont Report is considered the key event that established it as a principle in biomedical ethics.
Wrong 😕
Explanation: The most important aspect of communicating medical information to a patient is ensuring that they are able to fully understand the information. This requires the practitioner to adapt their approach based on the patient's abilities and needs, including their intelligence, rationality, maturity, and language. By adapting the discussion to the patient's needs, the practitioner can ensure that the patient is able to fully comprehend the diagnosis, prognosis, treatment options, risks, and benefits of the options, which will allow them to make informed decisions about their health.
CORRECT! 🙂
Explanation: The most important aspect of communicating medical information to a patient is ensuring that they are able to fully understand the information. This requires the practitioner to adapt their approach based on the patient's abilities and needs, including their intelligence, rationality, maturity, and language. By adapting the discussion to the patient's needs, the practitioner can ensure that the patient is able to fully comprehend the diagnosis, prognosis, treatment options, risks, and benefits of the options, which will allow them to make informed decisions about their health.
