Principles of medical law and ethics

Best medical practice is founded upon the ethical principles that guide health care providers who care for patients or perform research. The core ethical principles of medicine are autonomy, beneficence, nonmaleficence, and justice. Medical research is also subject to core ethical principles and to specific guidelines and processes to ensure that research in vulnerable populations (e.g., pregnant individuals, children) is conducted ethically. Many laws govern a wide variety of medical situations. A small selection of laws applicable in the United States is described in this overview article, while several other laws are detailed in more specific articles. Local laws can vary significantly. Clinicians must be familiar with the laws that govern practice in their region.

For more specific ethics and laws, see “Capacity, competence, and consent,” “Ethics of communicating medical information,” “Medical professionalism and codes of conduct,” and “Death.”

For ethical and medicolegal dilemmas, see “Challenging clinical and ethical scenarios.”

Core ethical principles ^[1]

Overview

• Medical ethics is founded on a set of core principles that are based on respect to patients as individuals.
• Ethical dilemmas arise when respecting one of these principles becomes impossible without compromising another.
• Ethical responsibilities usually align with legal precedence, but the two systems remain distinct.

Principles

• Autonomy
  • Provide sufficient information for the patient to be able to make their own decisions regarding their care (i.e., informed consent).
  • Honor the patient's choices to accept or decline care.
• Beneficence
  • Advocate for the patient and act in their best interest (fiduciary relationship).
  • May conflict with autonomy
• Nonmaleficence
  • Avoid causing injury or suffering to the patient.
  • May conflict with beneficence: The balance of risks and benefits must be favorable to the patient.
  • Frequently discussed in reference to drugs and surgical procedures
• Justice
  • Treat patients fairly and equitably.
  • Equity is not the same as equality.

Obligation to treat

• A clinician is legally obligated to treat a patient when failing to provide treatment would immediately endanger the patient's life. ^[2]
  • This law was established in the Emergency Medical Treatment and Labor Act (EMTALA).
  • Any hospital with an emergency department is required to screen for emergency medical conditions if requested and, if such a condition exists, provide treatment until that condition is stabilized.
• Clinicians are not obliged to treat a patient longitudinally and may end a clinician-patient relationship if they wish. ^[3]
  • The patient or their surrogate must be notified and have the ability (e.g., time, money) to establish care with another clinician.
  • The clinician is also obligated to facilitate the transfer of care.

Principle of proportionality

• Definition
  • A bioethical principle stating that an intervention's potential benefits should be proportionately greater than its potential harm or burden ^[4]
  • Benefit, harm, and burden should be considered not only in terms of patient health, but also holistically in terms of, e.g., costs for the patient, costs for the health care system as a whole, and the safety of providers and other patients.
• Aim: to minimize patient harm proportionately to maximizing treatment efficiency
• Examples
  • Using physical restraints if a patient poses a threat to themselves or others.
  • Reassessment of resource allocation during a health crisis when providing maximum benefit to select patients would overburden the system as a whole.

Role of institutional review boards

• Definition: An institutional review board (IRB) is a committee that reviews designs of studies involving humans to ensure participant safety, participant confidentiality, and compliance with medical ethics.
• IRB composition ^[5][6]
  • The composition of an IRB can vary across institutions but it should include at least five members with at least one scientist and one non-scientist.
  • IRBs that review studies conducted on vulnerable populations should include representatives of the corresponding populations.
• IRB approval ^[7]
  • For most forms of primary research involving human subjects, an IRB should review and approve the study proposal and informed consent protocols before the research activity is started.
  • Any amendment to an approved research protocol must be reevaluated and reapproved by the IRB before the research activity can continue.
  • Examples of studies that do not require IRB review and approval include:
    • Surveys or interviews about products or policies
    • Educational tests
    • Secondary research involving publicly available nonidentifiable information

Informed consent for research ^[8][9][10]

• Researchers performing a study involving an intervention on or interaction with human subjects should obtain informed consent from potential participants unless an informed consent waiver has been obtained from the institutional review board.
• The process of obtaining informed consent is initiated by performing the following steps with a potential participant:
  • Provide sufficient information verbally and in writing (as a part of the informed consent for research form).
    • All aspects of the experimental protocol (i.e., the trial design, purpose, and duration of the research)
    • Any foreseeable hazards to the participant
    • The likelihood of direct benefit to the participant
    • All alternative treatment options, if applicable
    • Details about the funding and financial incentives for the researchers, including the sources of such funds
    • A statement about the confidentiality of collected information and how records identifying the subject will be maintained
    • For research involving more than minimal risk, information on whether any compensation or medical treatments are available in case of injury
    • Information on whom to contact regarding questions about the trial and participant rights
    • A statement that participation is voluntary at all times and that the participant can withdraw at any time without penalty, loss of benefits to which the participant is otherwise entitled, or obligation to explain the decision.
  • Facilitate potential participants' understanding of the provided information and clarify potential misunderstandings.
    • Therapeutic misconception: an individual participating in research believes that they are receiving individualized medical treatment or care rather than participating in research. ^[11]
    • Therapeutic misestimation: an individual misjudges the risk or benefit of participating in research. ^[12]
  • Provide adequate time and opportunity for potential participants to decide whether or not to participate.
  • Minimize the possibility of coercion or undue influence.
    • Coercion: an overt or implicit threat of harm made to obtain compliance
    • Undue influence: the offer of an inappropriate reward to obtain compliance
• The process of obtaining informed consent is formalized by the participant signing an informed consent for research form that has been approved by the responsible research institutional review board.
• The process of obtaining informed consent is not finalized upon formal enrollment and the signing of an informed consent for research form, but instead extends for the entire duration of the trial.

Study participants should be updated on information relevant to them throughout the duration of the trial or study. Participants have the right to withdraw consent for research at any time.

Research funding ^[13][14]

• Before accepting funding for research, the researcher should contractually ensure that the research sponsor cannot influence, delay, or obstruct the publication of the findings.
• Clinicians should not accept any form of compensation for directing patients to participate in research studies.
• The source of funding should be disclosed as a part of the informed consent process and when publishing the research findings.
• A researcher should refuse to accept financial compensation that surpasses the value of their input in the research and doesn't align with the current market rate.

Compensation for enrolled participants ^[9]

• The type and amount of compensation should be determined prior to study enrollment and should be just and fair for all participants.
  • Prorated compensation: Participants receive a predetermined compensation for the completion of each trial activity (e.g., visit, procedure) or compensation that scales up with the duration of enrollment.
  • Completion-contingent compensation: Participants receive a predetermined compensation for the completion of all trial activities.
• The amount of compensation should be adequate in relation to the risks, time, and inconveniences demanded by study participation, but should not be excessive or tied to conditions that may affect voluntary consent and thereby constitute coercion or undue influence.
• The participant can withdraw at any time without loss of benefits to which the participant is otherwise entitled.
• If a participant experiences adverse events as a result of participation in the study, the participant is eligible for financial support for medical treatment and may be eligible for additional compensation. ^[13]

Offering compensation that is excessive or contingent on completing all trial activities may constitute coercion or undue influence.

Research in vulnerable populations ^[15]

• Vulnerable population: a population that has insufficient ability to protect or advocate for their interests
• In addition to the requirement of obtaining informed consent from study participants, special protections exist for vulnerable populations in research.
• The policy on the protection of vulnerable populations is regulated by the Office for Human Research Protection (OHRP).
• Regulatory and ethical checks are enforced to ensure the protection of populations that are at increased risk of harm in clinical trials.
• Applications and proposals must fulfill OHRP requirements in order to receive federal department or agency support.

Pregnant individuals and fetuses

• Permitted research: Clinical trials or research studies on pregnant individuals and fetuses must fulfill the following requirements:
  • Preclinical studies involving pregnant animals and clinical studies involving nonpregnant individuals have been conducted prior to the study in question.
  • Adequate data regarding the potential risks to pregnant individuals and fetuses is available.
  • The clinical trial has the potential to directly benefit the pregnant individual and/or their fetus.
  • There are no other means of answering the research question, and the research poses minimal risk for the pregnant individual or fetus.
• Requirements
  • The investigators may not have any role in determining the viability of the fetus.
  • No incentive may be offered to terminate a pregnancy.
  • If the research is only beneficial to the fetus, paternal consent must also be obtained unless the father is unavailable, temporarily incapacitated, or the pregnancy resulted from rape or incest.

Neonates

• Permitted research: Clinical trials or research studies on neonates must fulfill the following requirements:
  • The research question is crucial and cannot be answered by other means.
  • The research provides a direct benefit to the neonate at no additional risk.
• Requirements
  • For neonates of uncertain viability, the research must increase the probability of their survival.
  • Nonviable neonates may only be involved in research if:
    • Vital functions of the neonate are not artificially maintained.
    • The heartbeat and respiration of the neonate will not be terminated by the research.
  • Legally effective informed consent must be obtained from the parents, guardians, or legally authorized representatives.

Children

• Permitted research: clinical trials that pose no greater risk of harm to children than to adults and pose no other ethical reasons for the exclusion of children
• Requirements
  • If the intervention being tested poses a greater risk of harm to children than adults, the trial may only be conducted if the research question cannot be answered by any other means and the research has the potential to directly benefit the individual subjects or is likely to provide generalizable knowledge about the condition being studied.
  • Investigators must obtain assent from the child as well as informed consent from the parents.

Prison inmates

• Permitted research: The research investigates health issues directly related to the prison inmate population.
• Requirements
  • The risks associated with the research may not:
    • Be greater for prisoners than for nonprison volunteers
    • Pose more than minimal risk
    • Be an inconvenience to the subjects
  • At least one member of the institutional review board (IRB) that reviews the ethical validity of the study should be a prison inmate or a representative.
  • None of the nonprisoner members of the IRB may have any affiliation with the prison.
  • Any potential advantages offered to the prison inmates through participation in the research may not be so great that they affect the prison inmate's ability to weigh the risks of participation against the benefits.

In research, special protections exist for vulnerable populations.

Participant data protection ^[16]

• The HIPAA Privacy Rule establishes guidelines for protecting participant data.
• A covered entity may always use or disclose deidentified health information for research.
• If a covered entity wishes to obtain, generate, use, or disclose individually identifiable health information for research, at least one of the following criteria must be met:
  • Participant authorization
  • Waiver from an IRB or Privacy Board
  • Only the health information of deceased individuals is used or disclosed.

Participant withdrawal from research ^[17]

• A participant can withdraw from a study at any time without penalty, loss of benefits to which the participant is otherwise entitled, or obligation to explain the decision.
• If a participant wishes to terminate their participation in a clinical trial:
  • Researchers may enquire if the participant is willing to share their reasons for wishing to withdraw after reemphasizing to the participant that they are under no obligation to explain the decision.
  • Researchers may offer participants to opt-in to select components of the trial only.
• Withdrawal from the trial must be documented.
• Already collected data relating to the participant may be kept and analyzed.
• Data collected for research conducted under FDA regulations may not be destroyed or omitted from the analysis.

• See “Capacity, competence, and consent” for laws related to decision-making capacity, legal competence, and informed consent.
• See “Ethics of communicating medical information” for laws related to disclosure, confidentiality, and reportable conditions (e.g., HIPAA, duty to protect laws).
• See “Medical professionalism and codes of conduct” for laws related to malpractice, clinician impairment, conflicts of interest, and referral of patients (e.g., Stark law).
• See “Death” for laws related to:
  • Death determination, e.g., legal death definition, Uniform determination of death act
  • Investigation of death, e.g., autopsy, reportable types of death
  • Medical assistance in dying
• See “Goals of care” for legal terms related to end-of-life issues, e.g., code status, withdrawal of care, and forms such as MOLST, NEOT, DNR, and DNI
• See “Health care system” for laws related to health insurance funding (e.g., Medicare, Medicaid) and health care access (e.g., EMTALA, Affordable care act).
• See “Transplantation” for laws related to organ donation.

• Definition: a legal intervention through which an individual who experiences symptoms of a severe mental disorder can be detained in a mental health facility for involuntary treatment or receive such treatment in outpatient settings ^[18]
• Regulations ^[18]
  • The criteria differ state-by-state but generally include the following components:
    • Mental illness
    • Grave disability (e.g., inability to self-feed or shelter)
    • Danger to self or others
    • Need for treatment
  • The commitment settings should be the least restrictive option possible.
  • Proceedings for commitment are usually initiated by a family member or health care provider.
  • Individuals can typically be held for some period of time specified by the state law without a court order given that the admission is medically certified.

• Stillbirth: Offering an autopsy of the fetus and placenta is recommended after a confirmed unexplained stillbirth. ^[19][20]
• Abortion: Abortion laws vary greatly state-by-state. ^[21][22][23]
  • Most states require that parents of minors undergoing an abortion procedure are notified and/or sufficiently informed to provide consent.
  • Patient counseling prior to abortion procedures is mandatory in some states.
  • Most states allow clinicians to refuse to perform abortions under the condition that patients are referred to another clinician who is skilled and willing to perform abortions.
  • Many states only permit abortions under certain conditions:
    • The pregnant individual's life or health is at risk because of the pregnancy.
    • The procedure is performed by a licensed physician.
    • The fetus is below a certain gestational age.

Definition ^[24][25]

Good Samaritan laws afford protection to individuals providing emergency medical assistance under the following conditions:

• The individual providing care has no preexisting medical responsibility to the individual being treated.
• There is no expectation of compensation.

General principles ^[24]

Familiarize yourself with local Good Samaritan laws, which vary by jurisdiction.

• Most states have laws protecting clinicians who are licensed in any state.
• The extent of protections varies but generally does not extend to gross negligence.
• Some states have failure-to-act laws, mandating citizens or professionals to render aid.
• See “Legal considerations” in “Inflight medical emergencies” for considerations specific to aviation.

General principles ^[26][27]

• Aims of medical liability
  • Reduce unsafe practices
  • Compensate injured patients
  • Provide corrective justice (e.g., monetary damages)
• Any health care provider may be sued, including residents.
• Requirements for a malpractice suit (all must be fulfilled)
  • The defendant had a duty to care for the patient.
  • There was a breach of duty (i.e., deviation from standard of care).
  • The breach of duty caused damages.
  • There is proof that damages were sustained due to the breach of duty.

Mitigation ^[27][28]

Follow best practices in documentation and ensure accuracy, coherence, and legibility of medical notes. See also “Daily life of the intern” and “Error prevention.”

• Specific topics requiring detailed documentation include (but are not limited to):
  • Reasoning behind presumed diagnosis and differential diagnoses.
  • Informed consent, especially for procedures
  • Patient decisions made against medical advice, including preceding discussion and evaluation of patient's decision-making capacity
  • Specialist consultation, including consultant name, time of consultation, and recommendations
  • Discharge instructions
  • Details related to conditions that frequently lead to legal disputes, e.g., acute myocardial infarction, appendicitis, fractures ^[28]
• Ensure the documentation is consistent with that by other providers or provide reasoning for any deviation.
• Check for errors in transcription by scribes or dictation software.
• Avoid language that suggests a bias against the patient (e.g., judgmental language, unnecessary detail or quotations).
• Do not alter prior documentation. If an addendum must be made, document when and why changes were made.
• Refrain from using nonstandard abbreviations and acronyms, e.g., “MgSO4,” “qd,” or “IU.”

Early patient departure ^[29]

Early patient departure is associated with increased medicolegal risk.

Definitions

Patients who leave before completion of treatment may be classified as one or more of the following:

• Left without being seen (LWBS)
• Left without treatment (LWOT)
• Left before treatment complete (LBTC)
• Left or discharged against medical advice (DAMA)

Management of AMA discharges

When informed of the patient's desire to self-discharge, perform and document the following steps to assess the patient and reduce risk of adverse events and/or liability:

• Assess the patient's decision-making capacity.
• Determine the clinical urgency and severity of the patient's condition.
• Identify the reason(s) for wanting to leave the hospital, which may include:
  • Personal or family obligations outside of the hospital
  • Long wait times
  • Dissatisfaction with care
• Try to identify alternative solutions for care.
• Arrange appropriate follow-up. ^[30]
  • If patients require further medical therapy, e.g., antibiotics, provide them with a supply of medication to continue after leaving the hospital.
  • For patients with outpatient primary care or other providers: Contact the outpatient providers to arrange for close follow-up.
  • For patients without outpatient providers: Arrange for them to establish primary or specialty care as needed, and/or provide them with a list of potential providers.
• Ensure the following: ^[31][32]
  • The patient understands their diagnosis, prognosis, and risks and benefits of being discharged AMA.
  • Alternatives (and their risks and benefits) have been discussed with the patient.
  • The patient has the capacity to make decisions and can provide a rationale for their choice.

Ensure documentation is thorough, as hospital AMA discharge forms may not provide protection against liability. ^[33][34]

Professional liability insurance ^[35][36]

• The majority of health care providers are required to have liability insurance to practice.
• Liability insurance may be purchased individually, as a group practice, or may be provided by a hospital.
• Clinicians should be aware of what policy they obtain.
  • Claims-made
    • Only covers claims if insured by the same company both at the time of the incident and the time of the lawsuit
    • Policy termination leaves a “tail” in which incidents that occurred while the policy was active are no longer covered if a claim is filed after termination of the policy.
  • Occurrence-made: covers malpractice claims at any time if the policy was active during the event in question