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. Patients must demonstrate decision-making capacity in order to make decisions about their health care. A surrogate decision-maker may be appointed to make decisions for patients who lack decision-making capacity. In most circumstances, a parent or guardian is required to make decisions for unemancipated minors; exceptions include decisions related to reproductive health, mental health, and substance use disorders. Patients have the right to full disclosure about their health, medical status, medical records, and involvement in research protocols. Physicians are legally and ethically obligated to keep patients' medical information confidential, and may only break this confidentiality in specific scenarios (e.g., if the patient has a reportable disease or they pose a threat to themself or others). Prior to medical interventions, patients should receive information on the options available, including the potential risks and benefits, in order to provide informed consent. External influence (e.g., payment from a pharmaceutical company) on a physician's decision-making process is considered a professional conflict of interest. In addition to the core ethical principles that apply to medical research generally, specific guidelines are in place to ensure that research in vulnerable populations (e.g., pregnant individuals, children) is conducted ethically.

For more information on challenging clinical scenarios, see "Challenging clinical and ethical scenarios." For “End-of-life issues” and, specifically, “Life support,” see the article “Death.”

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 physician 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.
• Physicians are not obliged to treat a patient longitudinally and may end a doctor-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 physician.
  • The physician 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.
• Physicians 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.

• 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:
    • 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 that is 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: An autopsy of the fetus and placenta should be performed (with permission from the grandparents if the parent is a minor) after a confirmed unexplained stillbirth.
• Abortion: Abortion laws vary greatly state-by-state. ^[19]
  • 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 physicians to refuse to perform abortions under the condition that patients are referred to another physician who is skilled and willing to perform abortions.
  • Many states only permit abortions under certain conditions:
    • The mother'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: the legal assessment of a patient's ability to freely make conscious decisions (including those regarding their care) ^[20][21]
• General
  • Assessed by a court of law (with input from the patient's family and physicians as needed)
  • Physicians do not have the authority to pronounce individuals legally incompetent. ^[22]
  • If an individual is determined legally incompetent, the court will assign a guardian to make decisions on their behalf. ; ^[23]
    • The court may waive the appointment of a guardian or grant a limited guardianship if there is a durable power of attorney.
    • Generally, a guardian cannot issue the commitment of their ward to a mental health facility.
    • The directives of a guardian override the directives of family members.
  • Questions of legal competence arise in the presence of reduced mental capacity (e.g., severe mental illness, intoxication, impulsive/constantly changing decisions, decisions that are inconsistent with the patient's values)

Legal competence assesses an individual's global decision-making ability (e.g., relating to financial, property, and health care decisions), whereas decision-making capacity is a functional assessment that can vary depending on the situation. For example, a patient may have the capacity to choose between blood pressure medications but not to consent to complex surgery. ^[24]

Overview ^[22]

• Definition: a patient's ability to understand and communicate a health care decision based on their preferences and values
• Key considerations
  • Generally, a patient must be ≥ 18 years of age or a legally emancipated minor to have decision-making capacity.
  • Capacity should be assessed and determined by the treating physician.
  • A patient may demonstrate capacity to make some health care decisions, but not others.
  • Decision-making capacity is not automatically precluded by intellectual disability (e.g., trisomy 21), mental illness, or low health literacy.
  • Unstable manic or depressive episodes or altered mental status may transiently preclude decision-making capacity.
• Required components: All of the following are required for a patient (or their surrogate) to demonstrate capacity. ^[25]
  • Communication of a choice: the ability to clearly and consistently communicate the decision
  • Demonstration of understanding: the ability to comprehend the information provided, including the different options available
  • Appreciation of relevant facts: the ability to recognize and evaluate the facts relevant to the situation
  • Reasoning in medical decision-making: the ability to describe the thought process behind the decision

Assessing decision-making capacity ^[24][25]

Decision-making capacity for low-risk medical decisions can be assumed if the patient demonstrates understanding during a conversation.

• Indications
  • Informed consent is required (e.g., prior to blood transfusions, invasive procedures).
  • Incapacity is suspected.
• Prior to assessment
  • Address low health literacy and communication barriers (e.g., hearing aids, medical interpreter).
  • Treat reversible causes of incapacity (e.g., intoxication, delirium).
  • Consider the cultural context of the decision and its impact on the patient's values.
• Directed interview: There are four required components.
  • Choice: “What decision have you come to?”
  • Understanding: “In your own words, can you describe the risks and benefits of the available options?”
  • Appreciation
    • “How would you describe your current health situation?”
    • “Do you think you would benefit from some form of medical intervention?”
  • Reasoning: “How did you come to your decision?”
• Further assessment: indicated if capacity remains uncertain after a directed interview
  • Consider using a formal assessment tool. ^[26][27]
  • Repeat the assessment to evaluate for changes in capacity.

Identify and treat reversible causes of incapacity (e.g., delirium, infection, intoxication, medication) before assessing capacity.

Do not mistake pseudoincapacity (i.e., a lack of understanding due to insufficient patient counseling and/or use of jargon) or a decision against medical advice for lack of decision-making capacity. ^[25]

Shared decision-making ^[28]

• Definition: a process in which the patient and clinician work together to make a health care decision
• Indication: nonemergency situations in which there is clinical equipoise
• Goals
  • Patient empowerment by considering their values, cultural beliefs, and preferences when making a medical decision
  • Improved patient satisfaction and buy-in (e.g., medication adherence)

Three-step model for shared decision-making ^[29]

• Choice talk: an introductory discussion in which the patient is informed that there are choices available and that they can be involved in the decision-making process
  • Invite the patient to participate in the decision-making process.
  • Explain that there are different ways to approach the decision.
  • Assess the patient's current knowledge and understanding.
• Option talk: a discussion about all of the available options
  • Discuss the risks and benefits of the available options, using decision aids if available. ^[30]
  • Ask the patient about their preferences.
  • Conclude by checking the patient's understanding of all of the options.
• Decision talk: a discussion in which the patient either makes a decision based on their preferences or defers the decision
  • Ask the patient to confirm or defer their decision.
  • Review the decision using the teach-back method.

If a patient defers a decision, revisit the “decision talk” in subsequent conversations.

Surrogate decision-making ^[31]

• Definition: a model in which another person makes treatment decisions for the patient because they lack decision-making capacity and/or legal competence
• General
  • A surrogate may be appointed by the patient (e.g., medical power of attorney), legally appointed (e.g., court-ordered guardian), or next of kin (if no advance directive exists).
  • Advance directives or surrogates are only used if the patient has lost the ability to make their own decisions. ^[32]
  • Advance directives may be revoked by the patient at any time if they retain decision-making competence.
  • Surrogate decisions should be based on what the patient would have wanted.
• Hierarchy of decision-making ^[33][34]
  1. A mentally competent patient capable of making their own decisions
  2. Advance health care directive: prespecified legal instructions from the patient used to guide medical decision-making
     • Living will: a legal document in which individuals describe their wishes regarding their health care (e.g., to maintain, withhold, or withdraw life-sustaining care) should they become incapacitated
     • Durable medical power of attorney (health care proxy): a legal document through which an individual designates a surrogate to make specific health care decisions
     • Oral advance directive: an oral statement made by a patient regarding their preferences prior to incapacitation
  3. Next of kin
     • Spouse
     • Adult child
     • Parent
     • Adult sibling
     • A close friend (in approx. 50% of US states)
  4. Ethics committee or legal consult
• Caveats: if the patient's preferences cannot be determined and there is a disagreement regarding the course of action (e.g., the wishes of a designated surrogate who is not a family member conflict with the wishes of family members)
  • The physician should facilitate a meeting between the disagreeing parties with the aim of reaching an agreement about what the patient would have desired.
  • No matter what the outcome of the conflict, the wishes of the designated surrogate should be followed.

Oral advance directives may pose problems of interpretation, as oral statements are not as specific or easy to confirm as written statements. The validity of an oral advance directive increases if the patient has made an informed choice, the instructions were specific, and the directive was confirmed by multiple people.

Patients with decision-making capacity and competence have the right to provide or withdraw informed consent at any time (even during a procedure).

The Spouse ChiPS in: Spouse, Children, Parents, Siblings, other relatives/close friends (priority of surrogate decision-making)

Special situations ^[35]

• Harm to others: A decision to decline treatment may be disregarded if that decision endangers others.
• Pregnant individuals
  • A person has the right to refuse certain treatments even if their decision poses a risk to the unborn fetus (e.g., declining a cesarean section). ^[36]
  • For patients with severe mental health disorders, a psychiatric professional should be integrated into the care team to ensure the core ethical principles are upheld. ^[37]
• Changes in capacity: If a patient with capacity makes a decision, it cannot be reversed if the patient becomes incapacitated unless a designated surrogate weighs in to reverse the decision.

Medical decision-making in pediatrics

• Pediatric definitions ^[38]
  • Minor: any person < 18 years of age (in most states)
  • Emancipated minor: a minor who fulfills at least one of the following criteria
    • Lives separately from parents and is financially self-reliant
    • Is married
    • Is on duty in the armed forces
  • Mature minor
    • An unemancipated minor who is deemed to have capacity
    • The status of a mature minor is decided by individual state courts.
    • The exact definition of a mature minor varies state-by-state.
• General ^[39]
  • Unemancipated minors do not possess decision-making capacity.
    • The consent for medical procedures or treatments of unemancipated minors is given by the patient's surrogates (i.e., parents or caretakers).
    • See “Informed consent” below for exceptions and more information.
  • Emancipated minors are considered to be capable of medical decision-making.
  • Mature minor doctrine: a common-law rule that allows mature minors to consent to treatment under certain conditions ^[40]
    • The minor is an older adolescent (the age varies by state law).
    • The minor is capable of understanding the information regarding the medical procedure.
    • The benefits of the procedure clearly outweigh the risks, and the risks are not high.

Overview ^[41]

• Definition: the process of attaining the patient's authorization for a medical test, treatment, or procedure
• Key considerations
  • Ensure that there is sufficient time before the intervention for the patient to make a well-considered decision.
  • A patient with decision-making capacity is free to provide or revoke their consent at any time; it does not need to be in writing.
• Required components: applies to the patient or their surrogate ^[42]
  • Voluntariness: The decision must be made without coercion.
  • Capacity: Decision-making capacity must be demonstrated before consenting to the intervention.
  • Comprehension: The decision-maker must demonstrate understanding of the ramifications of the proposed intervention.
  • Disclosure: Relevant medical information regarding the intervention must be disclosed.

Obtaining informed consent ^[35]

Informed consent should be obtained by the health care provider performing the intervention.

1. Inform the patient of the benefits, risks, alternatives, and indications of the intervention and the nature of their illness, including:
   • Known complications and estimated risk of death and morbidity
   • Alternative interventions
   • The expected nature of the disease course without any intervention
   • If any aspect of the proposed intervention is experimental
2. Notify the patient about the identity and level of training of each potential participant in the intervention, allowing them to either give or withhold informed consent.
3. Assess the patient's decision-making capacity ; (e.g., using the teach-back method) and ability to consent voluntarily.
4. Document the decision that the patient (or their surrogate) has clearly articulated.

Use your BRAIN when obtaining informed consent: Benefits, Risks, Alternatives, Indications, Nature

Performing an intervention without having obtained informed consent may legally constitute battery and/or negligence. ^[43]

The amount of information shared when obtaining informed consent depends on the frequency and severity of the risks involved, e.g., less information needs to be disclosed for venipuncture than for cardiac catheterization. ^[35]

Exceptions to standard informed consent ^[44]

• Life-threatening emergencies (e.g., an unconscious trauma patient without a surrogate present)
• The patient lacks decision-making capacity, but their surrogate has authorized intervention.
• The patient decided to waive the legal right of informed consent.
• Disclosing may pose a threat to the patient or affect their decision-making capacity (i.e., therapeutic privilege).

Difficulties in obtaining consent should not delay life-saving procedures.

Language and use of an interpreter ^[44][45]

• Discuss health care decisions with patients in terms they can relate to.
• Communicate in a language that the patient understands.
• Request an interpreter if you are unable to communicate with the patient in a language in which you can have a comprehensive discussion and assess the patient's understanding of the relevant information.
  • Both in-person and remote (e.g., phone, video) interpreter services are appropriate.
  • Communicating without an interpreter can result in patients unknowingly consenting to unwanted procedures, misunderstanding their diagnosis, and/or complying poorly with medical advice.
• For more information about particular instances of the use of medical interpretation, see “General concepts of patient counseling” in the “Patient communication and counseling” article.

Multilingual relatives are not acceptable alternatives to professional interpreters in the nonemergency medical setting.

Parental consent for minors ^[46]

• Overview
  • Minors are considered legally incompetent to make medical decisions.
  • Parental consent is generally required before a minor receives medical care; exceptions are listed below.
  • Although not legally mandatory, it is recommendable that physicians obtain the minor's approval for medical care.
  • For children to participate in medical research, documented consent must be obtained from parents or guardians and assent must be obtained from minors. ^[47]
  • If the parents of the patient are themselves minors, grandparents may give consent for their grandchildren.
  • For minors who have been removed from their parental care and whose parent's right to consent has been revoked by a juvenile court, the court must assign a guardian (e.g., grandparent) who can provide consent.
  • In the absence of another guardian, child protective services authorize all health care services for children whose parents have had their parental rights terminated.
• Exceptions to the requirement of parental consent
  • Emergency and/or life-saving interventions (e.g., severe trauma, suicidal ideation, blood transfusion for life-threatening hemorrhage). ^[48]
  • The minor is legally emancipated.
  • Care regarding sex (e.g., contraception, STIs, pregnancy care except for abortion in most states) ^[49][50]
  • Addiction care (e.g., health services to treat drug and/or alcohol dependency) ^[49][51]
  • Minors who are parents themselves or who are married
  • Minors should be encouraged to discuss medical issues with their parents regardless of the exceptions that apply.
• Refusal to consent ^[52]
  • Generally, parents and legal guardians may refuse any treatment for a minor under their care in non-life-threatening situations.
    • A parent cannot refuse an emergency life-saving intervention for a minor for any reason (e.g., religious refusal). ^[48]
    • This refusal is only acceptable if that decision does not pose a risk of serious harm to the minor. Legal intervention (e.g., court order) may be necessary to mandate treatment for a non-emergency but fatal medical condition against the parent's or legal guardian's refusal to consent. ^[53]
    • Physicians should always attempt to address concerns motivating the refusal of treatment (e.g., misunderstanding of the procedure, fear of potential side effects).
    • Physicians should respect religious beliefs and/or cultural values of patients that may affect treatment and make therapeutic decisions accordingly within the legal scope of what treatment may be refused.
  • Parents are legally permitted to refuse vaccinations for their children. ^[54]
    • In rare cases, it may be appropriate to overrule a parental decision to decline immunization (e.g., in emergencies such as a child with a contaminated puncture wound and signs of life-threatening tetanus infection). ^[55]
    • Efforts should be made to understand the parents' refusal to vaccinate their children and, where possible, to help them understand the advantages of vaccination.

Unexpected findings during surgery ^[56]

• The patient should be informed about the possibility of intraoperative findings that may require more intervention than originally planned.
• If consent was not obtained
  • If a finding requires immediate action (e.g., appendicitis is found during surgery for ectopic pregnancy), the procedure can be performed without obtaining the patient's consent.
  • If a finding does not require immediate action (e.g., findings concerning for pulmonary malignancy during surgery for tension pneumothorax), the patient should give informed consent before any other procedures are performed.

Full disclosure ^[57]

• Patients have the right to full medical disclosure.
• Family members do not have the right to ask a physician to withhold information from a patient with decision-making capacity and competence without good reason. ^[58].
• Exceptions
  • The patient requests that the physician withhold information from them.
  • Therapeutic privilege: The physician determines that full disclosure would cause severe psychological harm to the patient (e.g., it may be reasonable to postpone disclosure of full diagnosis to a patient who is diagnosed with multiple sclerosis during a concurrent major depressive episode with suicidal ideation).

Medical error

• A medical error is a preventable adverse effect of medical care (e.g., due to the improper choice of medical care methods or failure to perform the proper method correctly), regardless of whether or not it causes the patient harm or becomes evident.
• Health care providers must inform patients about any errors that occur under their management.
• It is unethical to blame other providers for medical errors or to downplay errors to patients.
• Medical errors by another provider ^[59][60][61]
  • If the individual suspecting the error is not involved in the patient's treatment, they must seek the patient's permission to look into the matter (e.g., look at medical records, discuss details with the treating physician).
  • Once an error has been confirmed, its cause has been determined, and the person(s) responsible (if any) have been identified, the physician currently responsible for the patient's care should inform the patient about the error. The implications of the error and further course of action should be discussed with the patient in a separate meeting including all persons involved in the patient's care at the time of the error.
  • The individual who suspects the error should try to establish whether and why an error has occurred by privately speaking to the person they believe is responsible in a nonjudgmental manner.
  • Consider the circumstances and whether the root cause may be a systems error or patient factor (e.g., failure to follow dosage instructions or keep appointments) rather than an individual error.
  • Follow the chain of events that led to the adverse event (e.g., incomplete medical records being responsible for providing the wrong treatment). ^[62]
  • Communication in a supportive setting helps both providers to learn and prevent similar incidents from recurring.
• If a medical treatment complication occurs, the same principles apply. ^[63]
  • Disclosure should take place in a quiet, comfortable, and private environment.
  • The responsible physician should inform the patient about the complication and give an explanation.
  • If the responsible physician is unavailable, the covering physician should disclose and briefly explain the complication and inform the patient that a definitive explanation will be given by the responsible physician.
• For more information, see “Medical error” in "Quality and safety.”

Overview

• The physician is ethically and legally obligated to keep the patient's medical information (including information disclosed by the patient to the physician) confidential.
• Confidentiality upholds patient autonomy and privacy.
• The patient may waive the right to confidentiality (e.g., if an insurance company requests patient information or the patient allows the physician to disclose information to a family member).
  • Verbal or written consent is needed before releasing medical information.
  • Individual hospitals or physician practices may have additional policies to verify the identity of the receiver (e.g., via phone call) before sharing information.
• If the patient loses capacity, health information should be disclosed according to the patient's best interest (e.g., the physician will disclose relevant health information to friends, family, or the health care proxy to help guide medical decisions).
• Health care providers should make their best efforts to ensure the safety of patient information (e.g., patient information should not be discussed in public areas, even within the hospital setting).

Special exceptions to confidentiality ^[64]

• The patient has suffered penetrating wounds from an assault (e.g., a stab or gunshot wound).
• The patient may endanger the public (e.g., driving while impaired or with epilepsy).
• The patient has a transmissible infectious disease (see “Notification of diseases” below).
  • The physician may be legally obliged to notify a public health official.
  • The patient should be encouraged to inform any third parties that may have been infected (e.g., sexual partners).
  • In most states, the physician does not have the right to inform third parties without the patient's consent.
• The patient intends to cause harm to others or commit violence (e.g., planned homicide or assault).
  • Tarasoff decision: California Supreme Court ruling that established that health care providers have a duty to protect the intended victim of a violent crime.
  • Duty to protect laws require the health care provider to evaluate aspects such as the identity of the victim, imminence and certainty of the harm, and type of harm (e.g., physical harm, death) before breaching patient confidentiality.
  • Law enforcement authorities should be notified and/or the person at risk should be warned.
• The patient poses a threat to themselves (e.g., suicidal intent).
• Older adult abuse
• Child maltreatment
• The patient is a minor and care does not involve sexual or addiction treatment (see “Parental consent for minors” above).

Health Insurance Portability and Accountability Act (HIPAA) ^[65]

• The HIPAA was passed by the U.S. Congress to protect the privacy of electronic health information.
• The HIPAA establishes rules for the protection of individually identifiable health information, including information about the individual's physical and mental condition at any point in time, provision of health care, and related payments.
• HIPAA rules apply to all instances of the use of patient information for medical education.

Minimum necessary standard ^[66][67]

• The HIPAA Privacy Rule establishes the standard policy for the disclosure of health information.
• Accessibility and disclosure of protected health information to outside parties must be limited to the minimum necessary to accomplish a particular task.

Patient privacy and permitted information disclosures

• The information can be fully disclosed to the patient themselves.
• It is not necessary to gain the patient's consent for disclosure to the following parties:
  • Health care workers and service providers that are immediately involved in the patient's care (e.g., as required for a referral to another health care provider or requesting a consultation)
    • Any other requests by health care workers to share information should be denied.
  • Parties that process health care payments
  • Health care operations providers (e.g., audits, legal services, administrative activities)
• The patient should give informal permission for the disclosure of their health information for the following unless the patient is incapacitated, in an emergency situation, or unavailable:
  • Information about the patient's health status and location in the health care facility for anyone who asks for them by name
  • If a patient doesn't want their family/friends to know their health status or that they are in the hospital, the physician should not disclose any information or attempt to contact them.
  • Notification of authorities in case of disaster if doing so would aid relief efforts
• Health information may be shared without the patient's consent if it is in the public interest (see examples in “Special exceptions to confidentiality” above).

WAIT a SEC: Wounds, Automobile-driving impairment, Infections, Tarasoff decision, Suicidal intention, Elder abuse, Child abuse (cases that override confidentiality).

Access to patient health records ^[68]

• According to the HIPAA, health care providers must provide individuals with a copy of their protected health information upon request, with the following exceptions:
  • Information gathered in expectation of a probable civil, criminal, or administrative claim or process
  • Notes documented by a mental health care provider during psychotherapeutic counseling
• Once requested, the medical record must be received within 30 days.
• Outstanding medical bills do not affect an individual's right to access their medical records.

Under the HIPAA, patients have a legal right to obtain copies of their medical records within 30 days of submitting the request.

Correction principle ^[69][70]

• According to the HIPAA (45 CFR 164.526):
  • Individuals have a right to have their protected health information amended by a covered entity (e.g., a health plan) in a designated record set (e.g., medical records).
  • The covered entity must act on the individual's request for amendment within 60 days, whether it denies the request or grants it.
  • The covered entity may deny amendment under certain conditions, e.g., if the information is accurate and complete.

Electronic information safety

• All health care personnel authorized to use electronic medical records should receive proper training on data safety.
• Health information on electronic devices must be secured by technical safety measures such as firewalls, passwords, and antivirus protection. ^[71]

Notification of diseases

• General ^[72]
  • Many infectious diseases must be reported to public health officials (e.g., CDC) when diagnosed.
  • The patient must be informed that their disease is reportable, and they should be encouraged to inform any recent contacts at risk of infection.
  • Public health officials are typically responsible for notifying third parties if the patient refuses to inform them.
• Reportable diseases
  • HIV/AIDS ^[73][74]
    • All HIV cases must be reported to the local health department and the CDC.
    • Many states have partner notification laws (i.e., if the patient tests positive, either they or the physician are legally obligated to inform their partner).
    • Specific laws vary state-by-state.
    • If the patient refuses to disclose their HIV status to their partner, the physician should employ confidential partner notification procedures. ^[75]
    • The physician's right to disclose a patient's HIV status is dependent on the state in which they practice.
  • HIV in the pediatric population ^[76][77]
    • Most commonly acquired perinatally
    • Parents have an ethical obligation to disclose a positive HIV status to their children.
    • The WHO and AMA recommend full disclosure of a child's HIV status before the age of 12 years. ^[76][78]
    • Health care providers should offer to help parents develop a plan for disclosing a positive HIV status to a child.
    • Disclosure increases understanding of the condition, which, in turn, improves drug adherence, coping with the condition, and awareness of risk management with regard to oneself and others.
    • Full disclosure after the age of 12 is associated with increased rates of anxiety, depression, and social exclusion.

Overview of common reportable diseases

Older adult abuse ^[80]

• Definition: any form of physical, sexual, psychological, financial mistreatment or neglect of an elderly person (> 60 years of age) at the hands of a caregiver or someone the individual trusts
• General
  • Physicians are legally and ethically obligated to report suspected elder abuse.
  • See “Older adult abuse” for more details.

Child abuse ^[81]

• Definition: any act (or failure to act) that produces an imminent risk of serious harm to an individual < 18 years old
• General
  • The precise legal definition of child abuse varies state-by-state.
  • Physicians are legally and ethically obliged to report suspected child abuse.
  • In most US states, child care providers, social service providers, and educators are also required to report suspected child maltreatment.
  • Which authority (e.g., child protective services, local police department) the report should be made to varies between jurisdictions.
  • See also “Child maltreatment” for risk factors and clinical manifestations.

Child protective services (CPS)

• A government agency responsible for protecting children who have experienced abuse and/or neglect. In the United States, child protective services are organized at state level.
• Once a report has been filed, CPS reviews the claims and determines whether a formal investigation is warranted. This involves speaking to anyone potentially involved in the case, including the child, family, and caregivers.
• Measures taken by CPS if an investigation concludes that intervention is necessary:
  • Once the safety and risk assessment is done, CPS develops plans, provides services (e.g., parenting education), sets goals, and identifies possible resources (e.g., mental health services, income support services, child care support)
  • Family preservation is paramount if the child can remain safely at home, to which end CPS may provide family preservation and support services (typically for about 1 year; for a maximum of 18 months).
  • A foster placement is arranged if CPS determines that a child cannot remain at home.
    • Family reunification and preservation should be the ultimate goal for children placed in foster care. Up to 18 months of family preservation and support services may be provided to families in which CPS determines that reunification is a realistic prospect.
    • Children who cannot be returned to a safe home must be placed in foster care that provides a familial structure.

Foster care

• A temporary service provided by the state that organizes the placement of children who cannot live with their families in the care of relatives, foster families, residential care facilities, designated group facilities, emergency shelters, or supervised independent living until a permanent living arrangement can be found.
• The first choice for temporary and, subsequently, permanent placement is usually kinship care.
• The next preferred arrangement is adoption by foster parents or by someone close to the child.
• Permanent and, in some cases, temporary caregivers become legal guardians with the corresponding rights and responsibilities (e.g., providing consent for minors; see “Parental consent for minors” in “Informed consent,” above for details).

Domestic violence ^[82]

• Definition
  • Any form of actual or threatened physical or emotional harm committed by one member of a household against another, frequently used as an extension power by the perpetrator against the person experiencing the violence
  • Intimate partner violence (IPV): any form of physical, emotional, or sexual violence that is carried out by a cohabitating or noncohabitating intimate partner against the other ^[83]

• General
  • Physicians may not report domestic violence without patient consent.
  • When a physician suspects domestic violence, they should speak privately with the patient, inquire further, and offer assistance.
  • If the patient refuses assistance, the physician should reiterate that they support the patient and are available to provide aid at any time.
  • See “Intimate partner violence” for more details.

Driving restriction ^[84]

• General
  • The physician may be required to report patients who are considered unsafe to drive to the licensing authority (e.g., Department of Motor Vehicles). ^[85]
  • Before reporting, the physician should share their concerns with the patient and encourage further treatment (e.g., occupational therapy, substance rehabilitation).
  • The physician should always suggest another means of transportation.
• Common conditions that may impair driving ^[86]
  • Severe visual defects
  • Dementia
  • Epilepsy
    • Frequent, poorly-controlled seizures
    • Recent history of seizures
  • Cardiac arrhythmias
  • Substance dependency

Medical malpractice

For more information about different types of errors leading to negligence, see “Medical error” in the article “Quality and safety.”

• Definition: Negligent conduct on the part of a health care provider or performance of a medical task with unreasonable lack of skill. ^[87]
• Elements of malpractice
  • The physician-patient relationship has been established.
  • This obligation to provide care has been neglected.
  • There is damage to the patient.
  • The medical negligence is directly responsible for the damage to the patient.
• Reporting malpractice ^[88]
  • Physicians are ethically obliged to report any violations resulting from their colleagues' incompetence, negligence, and/or unethical conduct.
  • Contact the hospital authorities at the first instance; if the consequences of the malpractice pose a threat to patients' health, contact the state licensing board.
• Defensive medicine: testing and treatment that is not medically necessary but is performed by the physician to avoid legal liability ^[89]
  • Is unethical and should be avoided because it increases risk of patient harm and does not add significant benefits (e.g., an unnecessary CT scan causes radiation exposure)
  • Physicians should openly communicate with patients about the risks and benefits of tests or treatments that they believe are not medically necessary.

The 4 D's of malpractice: Duty (obligation to deliver proper medical care to the patient), Dereliction of duty, Damage to the patient, Direct cause of damage.

Physician misconduct

• Physician misconduct is any physician behavior that goes against the ethical principles of medical practice. ^[90]
• Physician misconduct can occur outside the established physician-patient relationships and thus does not always constitute malpractice.
• Examples of misconduct ^[90]
  • Bullying
  • Inappropriate comments towards colleagues or patients
  • Sexual harassment of colleagues or patients
  • Billing fraud
  • Inadequate record keeping (e.g., intentional falsification of medical records)
  • Accepting expensive gifts from patients or industry
• Colleagues who suspect a physician of misconduct should report their concerns to the state medical board and, if the misconduct implies any legal liability, to the proper federal authorities. ^[91]

Physician impairment

• Definition: the inability of a physician to provide adequate medical care due to mental health disorder, substance-related disorder, or physical condition that limits the use of motor, cognitive, or perceptive skills ^[92]
• Potential signs of impairment ^[93]
  • Disruptive behavior (e.g., increased conflicts with colleagues or patients, irritability, anxiety, aggression)
  • Physical signs of substance use disorder (e.g., needle marks, alcohol smell)
  • Nonadherence with working schedule (e.g., being late or absent at work for no reason) or sudden changes in schedule (e.g., unusually early or late appointments)
  • Decreased quality of care (e.g., increased rate of medical errors, incorrect charting)
  • Personal life problems (e.g., divorce, withdrawal from family, debts)
• Physician Health Program: a program that is supervised by a state medical board and is aimed to prevent, detect, and manage disorders that cause impairment in physicians ^[94]
  • Colleagues of a physician should contact the PHP if they suspect impairment.
  • The PHP performs a thorough assessment of the potentially impaired physician and arranges management if impairment is confirmed.
  • If an impaired physician accepts the treatment voluntarily, the PHP is not obliged to notify the state medical board about the physician's condition.
  • If the physician refuses treatment, the PHP will report the physician's condition to the state medical board, which may lead to an involuntary referral for treatment and disciplinary actions.
  • After treatment, the PHP monitors the physician with regular assessments and/or laboratory tests for 1–5 years depending on the condition underlying the impairment.

Physician-patient romantic relationships ^[95]

• Romantic relationships with current patients are always unethical and inappropriate.
  • A romantic physician-patient relationship compromises the objectivity of the physician's decisions in regard to the care of that patient.
  • Such relationships make patients more vulnerable to exploitation.
• Romantic relationships with former patients are also inappropriate if:
  • Less than one year has passed since the end of the patient-physician relationship.
  • The physician has a position of influence or influence from their previous experience with the former patient (e.g., knowledge of trauma expressed during therapy).
  • The former relationship was a patient-psychiatrist relationship
• Should a physician feel that their actions may be perceived as sexual and/or lead to a romantic relationship with a current patient, the physician should take active measures to avoid unnecessary contact with the patient.
  • Use direct, close-ended questions.
  • Conduct interviews with a chaperone present.
• Romantic relationships with patient-accompanying third parties (e.g., their children, friends, surrogates) may also be inappropriate in case the third party plays a considerable role in physician-patient interaction and may be emotionally dependent on the physician. ^[96]

Overview ^[97]

• Definition: A conflict of interest (COI) occurs when a physician's objectivity regarding their primary interest (i.e., patient welfare) is potentially affected by a secondary interest (e.g., personal financial gain).
• Minimizing COIs ^[98][99]
  • Physicians should always disclose COIs to patients, employing institutions, and when presenting medical results (e.g., at a medical conference or in a peer-reviewed journal).
  • Gifts of significant value from the medical industry should be declined.
    • Gifts may only be accepted if they directly benefit patients and do not have substantial monetary value (e.g., pens, notepads, medical textbooks).
    • Cash should never be accepted.
    • Gifts that have “strings attached” should not be accepted (e.g., a gift that affects the physician's prescribing practices).
  • Physicians should not allow pharmaceutical industry-funded advertisements in their practice.
  • Industry subsidies for physician travel, lodging, or personal expenses should be declined.
• Acceptable gifts and donations ^[98]
  • Gifts from patients that are small and do not have substantial monetary value (e.g., home-cooked meals, flowers, knitted quilts) ; ^[100]
    • The gift should not influence the patient's care.
    • Gifts that may represent a financial sacrifice for the patient should be declined.
    • No amount of direct cash exchange (e.g., checks, deposits) is acceptable.
    • The physician may suggest that the patient donate to a charitable organization in lieu of a personal gift.
    • When declining gifts, physicians should stress that the physician-patient relationship remains intact.
  • Medical industry honoraria to attend medical education conferences
  • Industry-funded simple meals or social events
  • Remuneration for medical consultation for a pharmaceutical or medical device company
  • Industry-funded scholarships for travel to academic conferences by medical students or residents.

The physician must disclose all COIs to all affected parties and, in the event of a COI, refer patients to an unbiased colleague whenever possible.

Conscientious refusal

• Definition: Conscientious refusal is the denial of indicated medical care because it poses a conflict with the personal, religious, or moral beliefs of the provider (e.g., abortion, birth control).
• Health care provider responsibilities
  • Timely referral to a different provider who offers the required care
  • In case of emergency, when a referral is not possible, or if the patient's physical or mental health is at risk, provision of necessary care regardless of moral conflict
  • Provide patients with accurate and unbiased information and resources to facilitate informed decision-making.
  • Notify patients about moral conflicts related to the provision of standard care (e.g., abortion, contraceptives, sterilization).
• Abortion services and reproductive medicine
  • Individuals should be referred within an appropriate time frame to a provider who offers the required medical care.
  • Resource-poor areas
    • Denying safe and legal access to reproductive services in low-income communities promotes inequality
    • Providers who object to providing care on moral grounds should only practice in areas where other providers are available and/or where referrals can be made.
• Key considerations
  • Patient well-being and access to ethical medical care are the foremost priorities.
  • Conditions in which conscientious refusal is unethical:
    • When it imposes religious or moral beliefs on patients
    • When it has a negative effect on patient well-being
    • When it is based on scientific misinformation
    • When it reinforces racial or socioeconomic inequalities

• The physician may refer a patient to another physician or diagnostic or therapeutic service if they consider the referral beneficial to the patient. ^[101]
  • The referral may involve nonphysician health care providers.
  • It is never ethical to refer a patient to illegal medical treatment.
  • Referrals to complementary and alternative medicine providers may be ethical if the use of such practices is grounded in scientific knowledge (e.g., chiropractic interventions or acupuncture for lower back pain). ^{[101][102][103]}
• Stark law prohibits the physician from self-referrals (i.e. referring patients to entities with which the physician or one of their immediate family members has a financial relationship). ^[104]
• Physicians who perform self-referrals should ensure that the referral is indeed required, disclose all the potential COIs to the patient, and provide them with information about alternative care providers. ^[105]

Physicians increasingly use social media and other internet resources for learning, networking, interacting with patients, and disseminating health care related knowledge. The following considerations can help ensure that their online presence aligns with professional ethics. ^[106]

• Identifiable patient information should not be posted online (unless documented consent has been obtained from the patient).
• Appropriate boundaries should be maintained when communicating with patients online.
• Proper personal conduct should be maintained (e.g., in comments on social media posts), even in the context unrelated to medicine.
• If a colleague posts professionally inappropriate content online, the colleague should be alerted to the fact that their behavior is inappropriate and be encouraged to remove the content and avoid inappropriate posts in the future. If personal communication fails to resolve the issue, appropriate authorities (e.g., state licensing board) should be notified.
• Physicians should follow cybersecurity measures to ensure that their personal information is safeguarded.

• One-Minute Telegram 65-2022-3/3: Misunderstanding of medical jargon in the general population

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