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 Patient: Autonomy

 Practitioner: Beneficence & Nonmaleficence

 Public Policy: Justice


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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


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.



[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.



Abridged & Edited - Bulger


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.


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. 


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.




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. 


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?



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