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Principles of medical law and ethics

Last updated: August 23, 2021

Summarytoggle arrow icon

Best medical practice is founded upon legal and ethical principles that guide the choices physicians and health care providers make when caring for patients or performing research. The core ethical principles of medicine are autonomy, beneficence, nonmaleficence, and justice. For a patient to be considered able to make choices about their health care, they must demonstrate mental capacity and competence; when these are lacking, the patient may have a surrogate make choices in their place. Unemancipated minors are unable to make medical decisions on their own and so must have a parent or caretaker act make decisions for them. The patient has the right to full disclosure about their health, medical status, medical records, and involvement in research protocols. End-of-life issues include medical aid-in-dying, organ donation, and the pronunciation of death. The physician is legally and ethically obligated to keep patients' medical information confidential, and may only break this confidentiality in particular settings. Social factors that may need to be considered include driving restrictions, elder abuse, and torture. Patients must be briefed on all of their treatment options, including potential risks and benefits, prior to treatment or medical intervention. Conflicts of interest occur when an external factor (e.g., payment from a pharmaceutical company) influences the physician's ability to make an objective medical decision. Medical research must be conducted according to ethical principles as well, and there is a specific set of guidelines for research on vulnerable populations (e.g., pregnant women, children, prisoners).

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.

Decision-making capacity [4]

  • Definition: the psychological and/or legal ability to process information, make decisions, communicate a choice, and understand the consequences of a decision
  • Components: The patient must have all of the following to demonstrate decision-making capacity.
    • Choice: the patient's ability to clearly and consistently communicate their choice of treatment
      • E.g., patients with severe stroke or advanced dementia may not be able to construct comprehensible sentences
      • Choice can be assessed by asking the patient what treatment they have decided to receive and then asking them to restate their choice later in their hospital stay.
    • Understanding
      • The patient's ability to comprehend the information provided by the physician, including therapeutic options and alternatives
      • Understanding can be assessed by asking the patient, “Please describe to me in your own words your understanding of what your physician told you regarding the status of your health, your treatment options, and the risks and benefits of treatment.”
    • Appreciation
      • The patient's ability to recognize and evaluate the facts that are relevant to their situation
      • Appreciation can be assessed by asking the patient, “What do you understand about what is good or bad about your health at this moment?” or, “Do you believe that you require some form of medical treatment?”
    • Reasoning
      • The patient's ability to describe the thought process behind the decisions they make about their own care
      • Reasoning can be assessed by asking the patient, “How did you decide to accept or refuse treatment?”
  • Caveats
    • Capacity is assessed and determined by the treating physician.
    • The patient must be ≥ 18 years of age or legally emancipated to have capacity (see “Medical decision-making in pediatrics” below).
    • The patient's decision must not be secondary to manifestations of a mood disorder or change in mental status (e.g., intoxication).
    • An individual's decision to refuse treatment may be disregarded if that decision endangers others (e.g., refusing treatment for active tuberculosis infection)
    • If a patient with capacity makes a decision, it cannot be reversed if the patient becomes incapacitated.
    • Intellectual disability (e.g., trisomy 21) or low literacy level does not exclude an individual from having capacity.
    • A pregnant individual has the right to refuse certain treatments even if their decision poses a risk to the unborn fetus (e.g., refusal of cesarean section).
      • This principle upholds the right to patient autonomy.
      • For pregnant patients with severe mental health disorders, a psychiatric professional should be integrated into the care team to make sure the core ethical principles and decision-making capacity are upheld. [5]

Medical decision-making in pediatrics

  • Pediatric definitions [6]
    • 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
  • General [7]
    • 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 [8]
      • 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.

Legal competence [9]

  • Definition: the legal assessment of a patient's ability to freely make conscious decisions (including those regarding their care) [10]
  • General
    • Assessed by a court of law; (with input from the patient's family and physicians as needed): Physicians do not have the power to pronounce individuals legally incompetent. [4]
    • If an individual is determined legally incompetent, the court will assign a guardian to make decisions on their behalf. [11]
      • 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)

Shared decision-making [12]

  • Definition: a model in which patients and physicians decide on the best treatment option together
  • General
    • Empowers the patient, as it is based on the patient's personal values, cultural beliefs, and preferences
    • Aimed at producing better health outcomes and increasing patient satisfaction
    • Is a key component of the patient-centered approach in patient-physician communication
  • Three-step model for shared decision-making [13]
    • Choice talk: an introductory discussion in which the patient is informed that there are choices available and that they will be able to participate in determining their treatment
    • Option talk: a description of all the available options, including the pros and cons of each option
      • The discussion may include the use of decision aids (e.g., videos, brochures)
      • Should be concluded by checking the patient's understanding of all the options
    • Decision talk: A discussion in which the patient either decides on their preferred treatment or defers the decision. When the patient is ready to make the decision, their understanding of the treatment should be checked again, and the decision talk should be repeated.

Surrogate decision-making [14]

  • Definition: a model in which another person makes treatment decisions for the patient because they lack decision-making capacity and/or competence
  • General
    • Advance directives (ADs) or surrogates are only used if the patient has lost the ability to make their own decisions. [15]
    • ADs 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: The 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 AD exists). [16][17]
    1. A mentally competent patient capable of making their own decisions
    2. Advance healthcare 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 healthcare (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 incapacitated patient's prior oral statements regarding their preferences
    3. Next of kin
      • Spouse
      • Adult child
      • Parent
      • Adult sibling
      • A close friend (in approx. 50% of U.S. 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 ADs may pose problems of interpretation, because oral statements are not as specific or easy to confirm as written statements. The validity of an oral AD increases when 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).

Overview [18]

  • Definition: the process of briefing a patient (or surrogate) about their medical condition and treatment options, then obtaining consent to pursue a selected course of treatment
  • Necessary components of informed consent [19]
    • Voluntariness: The patient must not be forced into a decision.
    • Capacity: The patient (or surrogate) must demonstrate decision-making capacity before they can consent to treatment.
    • Comprehension: The patient must understand the ramifications of the proposed intervention.
    • Disclosure: Relevant medical information regarding the intervention must be discussed with the patient.
  • Timing: The patient must be informed far enough in advance of the procedure that they have adequate time to make a thoroughly considered decision.
  • Patient briefing: The patient should be educated about the benefits, risks, alternatives, and indications of treatment as well as the nature of their illness.
    • Known complications, including estimated risks of death and morbidity
    • Types and risks of anesthesia, if relevant
    • Alternative treatments
    • The diagnosis and natural course of the disease without any treatment
  • Unexpected findings during surgery [20]
    • 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.
  • Expressing a decision
    • The patient with decision-making capacity is free to provide or revoke their decision at any time and without the need for a written document.
    • The decision must be free from any coercive pressure.
    • The patient (or their surrogate) must clearly communicate their decision.

Use your BRAIN: Benefits, Risks, Alternatives, Indications, Nature (to brief patients about informed consent).

Obtaining patient consent is crucial because without it, any medical procedure can represent an attempt to initiate harmful or offensive contact with the patient.

Language and use of an interpreter [21][22]

  • 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 accidentally consenting to unwanted procedures, misunderstanding their diagnosis, and poorly complying 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 medical setting.

Exceptions to standard informed consent [22]

  • 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.

Parental consent for minors [23]

  • Overview
    • Minors are considered legally incompetent to make medical decisions.
    • Parental consent is generally required before a minor receives medical care.
    • Although not legally mandatory, it is preferable for the physician to gain the minor's approval for medical care.
    • It is legally required for parents or guardians to provide documented consent before their child participates in pediatric research, and minors should be encouraged to give assent. [24]
  • Exceptions when parental consent is not required
    • The hospitalization or treatment is emergent and life-saving (e.g., trauma, suicidal ideation, blood transfusion for hemorrhage). [25]
    • The minor is legally emancipated.
    • Care regarding sex (e.g., contraception, STIs, pregnancy care except for abortion in most states) [26][27]
    • Addiction care (e.g., health services to treat drug and/or alcohol dependency) [26][28]
    • Even in these situations, the minor should be encouraged to discuss their issues with their parents.
  • Refusal to consent [29]
    • Parents or legal guardians may refuse treatment of a minor for a variety of reasons (e.g., treatment side effects).
      • This refusal is only reasonable if that decision does not pose a risk of serious harm to the minor.
      • In all cases, the physician should attempt to address the underlying reasons for refusal (e.g., religious beliefs, misunderstanding of the procedure, fear of potential side effects).
    • Parents are legally allowed to refuse vaccinations. [30]
      • In rare cases, it can be appropriate to overrule a parental decision to decline immunization (e.g., in a child with a contaminated puncture wound and signs of life-threatening tetanus infection). [31]
      • Efforts should be made to understand the parents' refusal to vaccinate their children, and, where possible, to help parents understand the advantages of vaccinating.
    • A parent cannot refuse an emergency life-saving intervention for a minor for any reason (e.g., religious refusal). [25]
    • Legal intervention (e.g., court order) may be necessary to mandate treatment for a nonemergent but fatal medical condition. [32]

Full disclosure [33]

  • 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. [34]
  • 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 discovered to have multiple sclerosis who is having a concurrent major depressive episode with suicidal ideation due to divorce).

Medical errors

  • Medical errors result from the improper choice of medical care methods or failure to correctly perform the proper method
  • The physician must inform the patient about any errors that occur in their management.
  • It is unethical to blame other physicians for medical errors or to downplay errors to patients.
  • For more information, see “Medical error” in the article "Quality and safety.”

Research disclosure [35]

  • The primary aim of a clinical trial is not patient treatment, but rather to determine whether a medical treatment or device is safe and/or beneficial.
  • Individuals participating in a clinical trial have the right to withdraw at any time and are not obliged to explain the reason behind their decision. [36]
    • For interventional studies, it is recommended that the researcher clarifies with the subject whether they wish to withdraw completely from the trial or only from the primary interventional component.
      • If an individual wishes to withdraw only from the interventional component of the study (e.g., administration of a drug), they may continue participating in other research activities (interviews, blood tests, etc.) after their consent is being reobtained.
    • The withdrawal should be documented.
    • If the study is not subject to FDA review and the subject requests that the already collected data be destroyed, the investigator may honor the subject's requests depending on the protocol set up by the institutional review board.
    • Data collected for research conducted under FDA regulations cannot be destroyed or omitted from analysis.
  • Patients must receive full disclosure prior to enrollment in a clinical trial, including:
    • An informed consent form, approved by the responsible research institutional review board
    • All aspects of the experimental protocol (i.e., the study design and purpose of the study)
    • Any potential conflicts of interest
    • Any foreseeable hazards to the patient
    • The likelihood of direct benefit to the patient
    • All alternative treatment options
    • Medicine, treatment, and device safety information

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).
  • Healthcare 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 [37]

  • 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).
  • The patient poses a threat to themselves (e.g., suicidal intent).
  • Elder 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) [38]

  • The HIPAA was created 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 [39][40]

  • 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 healthcare 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 [41]

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

Electronic information safety

  • All healthcare 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 anti-virus protection. [42]

Overview

  • A number of ethically challenging scenarios may arise in the context of end-of-life care.
  • At the end of life (as throughout it), the core ethical principles of medicine should be upheld and the physician should act in the best interest of the patient.
  • Proper knowledge of the legal and ethical aspects of end-of-life care allows the physician to practice efficient and evidence-based medicine while respecting the patient's wishes.
  • In disputes over end-of-life issues, the physician plays a key role in facilitating communication and emphasizing the importance of focusing on what patients themselves would have preferred.

Life support to end-of-life issues

Orders and legal considerations in end-of-life care

  • Do not resuscitate orders (DNR orders) [43]
  • Withdrawal of care [44]
    • Patients with decision-making capacity (or their surrogate) have the right to refuse any form of treatment at any time, even if doing so would result in the patient's death.
    • There is no ethical distinction between withholding care and withdrawing care at a later time.
    • The physician should make an effort to understand the reasons behind the patient's decision for refusing treatment.
    • Patients who opt to withdraw from treatment and have limited life expectancy may be approved for hospice care.
  • Futile treatment [45][46]
    • Medical treatment or intervention for a terminally ill patient that is deemed nonbeneficial by the healthcare team or family
      • The concept of medical futility is vague and there are many interpretations of the practice; there is no universally accepted definition.
      • Some believe that futility only applies to end-of-life care, while others apply the term to any medical intervention that appears to lack a significant medical benefit.
    • The physician is not ethically obligated to provide treatment if it is considered medically futile.
    • Treatment can be considered medically inappropriate or futile if:
      • There is no evidence for the effectiveness of treatment.
      • The intervention has previously failed.
      • Last-line therapy is failing.
      • Treatment will not fulfill the goals of care.
  • Persistent vegetative state (PVS): The decision to maintain a patient in PVS depends on their advance directive or surrogate decision-maker and should be made with the patient's best interests in mind. [47]

Standardized forms for end-of-life care directives [48][49]

  • Individuals with life-limiting conditions, multiple chronic conditions, or conditions that cause frailty can begin planning end-of-life care with their health care providers.
  • Standardized advance directive forms such as the Medical Orders for Life-Sustaining Treatment and the Physician Orders for Life-Sustaining Treatment forms allow for documentation of the patient's preferences regarding end-of-life medical care, including the following:
  • The advance directive form can be completed and signed either by the patient or, if the patient lacks capacity, a surrogate.
  • The form is completed after a series of conversations between the patient and health care providers about the patient's medical condition, prognosis, and values and personal goals for end-of-life care.
  • In contrast to a living will or healthcare proxy, which act only if the patient loses decision-making capacity, advance care directive forms apply independent of the decision-making capacity of the patient at the time of application.

Medical aid in dying

  • Physician-assisted dying [50][51]
    • Physician provision of medication, intervention, or information to a patient to enable or accelerate their death
    • Illegal in most states
    • The U.S. Supreme Court has ruled three times that the laws of physician-assisted death are to be decided on a state-by-state basis.
  • Euthanasia
    • Active and intentional termination of a patient's life, usually by sedative or paralytic, performed by the physician at the explicit request of the patient
    • Requires the full process of informed consent before initiation
    • Currently illegal in the U.S.
  • Terminal sedation [52]
    • The administration of sedative medication to a terminally ill patient to relieve intractable end-of-life pain
    • Legal and distinct from euthanasia
    • The intent must be to relieve pain rather than bring about death, even though doing so may hasten the dying process.
    • Not an appropriate means of addressing suffering that is primarily existential (e.g., death anxiety). [53]
    • Relies on the principle of double effect
      • An ethical principle that legitimizes an act of good intent despite causing serious harm
      • An act may be justified when the positive effects outweigh the negative ones (e.g., administering large amounts of opioids to relieve pain despite causing respiratory depression).

Organ and tissue donation [54]

  • Identification of a potential organ donor
    • An individual may declare themselves an organ and tissue donor (e.g., in a living will or driver's license) in the event of their death.
    • The decision to become a donor can be revoked at any time.
    • Patients without ADs who are critically ill without hope for recovery (e.g., mechanically ventilated with neurologic death) may also be considered for organ donation.
      • The decision to withdraw life-sustaining care must be made independently from the discussion of organ donation.
      • Hospitals that receive payment from Medicare must discuss organ donation with the family of the deceased.
    • Organ donation considerations after death
      • If a deceased individual is a potential donor candidate and had not refused to donate organs or tissue (e.g., in a living will), the proper organ donation organization/team should be notified immediately.
      • Some things that the organization must consider:
        • Has an organ donation plan already been established?
        • If no such plans were made, did the deceased individual volunteer to be an organ donor (e.g., in a living will or driver's license)?
        • If no such instructions are available, an approach to discuss the family's wishes for potential donors should be carefully planned and carried out by the organ donation organization. Such discussions should be: [55]
          • Collaborative and compassionate
          • Informative concerning the value of a donation
          • Supportive of determining the best long-term decision that respects the wishes of the potential donor
  • Deceased donors
    • Individuals (e.g., in a living will) or their families (in the absence of a will) may specify which organs may be donated.
    • Hospitals must decline organ donations from deceased individuals with the following conditions: [54][56]
      • HIV
      • Poor organ function or prolonged organ ischemia
      • Untreated fungal, bacterial, or viral sepsis
      • Age > 80 years old
      • BMI > 50 kg/m2
      • Weight < 5 kg
  • Living donors
    • Nonvital organs and tissues (e.g., kidney or bone marrow) can be acquired from living donors.
    • Prior to donation, donors must give full informed consent.
    • Donors may select the recipient of their donation.
    • Donors may not be paid for their donation, but can be reimbursed for associated costs (e.g., travel, food, lost wages).
    • A donor may engage in an “organ swap.”

Death

See the article “Death” for more information about definitions, signs, pronouncing, addressing loved ones, documentation, investigation, and autopsy.

  • Criteria: Death can be diagnosed if a patient meets the criteria for brain death or cardiopulmonary death.
  • Brain death
    • Irreversible, complete loss of function of the entire brain (including the brainstem), even if cardiopulmonary functions can be upheld by artificial life support
    • Two physicians are required to make the legal diagnosis of brain death.
    • See “Requirements for the diagnosis of brain death” for more information.
  • Cardiopulmonary death: the absence of a spontaneous heartbeat in an asystolic patient
  • Ethical issues concerning brain death [57]
    • If a patient has been declared to have brain death, no consent is needed to withdraw life-sustaining therapy.
    • The patient's family should be informed that the patient is being assessed for brain death as soon as the evaluation has started.
    • The patient's family should be given a reasonable amount of time to visit the patient and accept the diagnosis before discontinuation of life-sustaining treatment. [58]
    • If the patient's family disagree with a diagnosis of brain death:
      • Discuss the family members' concerns with them; express empathy and respect for their position and provide additional information to eliminate any misunderstandings regarding the diagnosis. [59]
      • Involving a hospital ethical committee may be helpful in resolving disagreements. [57]
      • If the disagreement stems from religious or cultural beliefs, consider involving chaplains and/or local cultural leaders in the discussion. [59]

Notification of diseases

  • General [60]
    • 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 [61][62]
      • 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. [63]
      • The physician's right to disclose a patient's HIV status is dependent on the state in which they practice.
Overview of common reportable diseases
Pathogen/disease
Sexually transmitted diseases
Diseases affecting unvaccinated patients
Zoonotic diseases
Water/foodborne diseases
Tick borne diseases
Mosquito borne diseases
Potential biological weapons
Other

Elder abuse [65]

  • Definition: any form of physical, psychological, or financial mistreatment of an elderly person
  • General
    • Frequently perpetrated by someone with a longitudinal relationship and responsibility for the patient (e.g., a caregiver or relative)
    • Physicians are legally and ethically obligated to report suspected elder abuse.
  • Clinical manifestations of abuse

Child abuse [66]

Domestic violence [67]

  • Definition
    • Any form of actual or threatened physical or emotional harm frequently used by one person in a household to maintain power over another
    • Intimate partner violence: physical, psychological, emotional, or sexual violence that is carried out by a cohabitating or noncohabitating partner [68]
  • General
    • Physicians are not legally permitted to report domestic violence without patient consent.
    • When a physician suspects domestic violence, they should speak privately with the affected patient, inquire further, and offer assistance.
    • In cases where the patient refuses assistance, the physician should reiterate that they support the patient and are available to provide aid at any time.
    • See “Abuse” in “Ethically challenging situations,” below.

Driving restriction [69]

  • 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). [70]
    • 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 [71]

Prisoner execution [72]

  • There is debate over whether physicians should be involved in prisoner executions.
  • Most medical resources agree it is not ethical for physicians to participate in any executions.
  • Some proponents of physician involvement in prisoner execution argue that physicians should be involved to make sure the procedure occurs without additional unnecessary harm to the prisoner.

Physician-patient romantic relationships [73]

  • 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).
  • 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. [74]

Torture [75]

  • Physicians should oppose and refuse to participate in torture.
  • Physicians must not be present if torture is used or threatened.
  • Physicians may treat prisoners undergoing torture, but may not evaluate a prisoner's health so that torture may begin.

Abortion and stillbirth laws [76]

  • Stillbirth: An autopsy of the fetus and placenta should be performed (with permission from the parents if the parent is a minor) after a confirmed unexplained stillbirth.
  • Abortion
    • Abortion laws vary greatly state-by-state.
    • 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.
    • 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.
    • Patient counseling prior to abortion procedures is mandatory in some states.
    • Most states require that parents of minors undergoing an abortion procedure are notified and/or sufficiently informed to provide consent.

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 healthcare provider or performance of a medical task with unreasonable lack of skill. [77]
  • 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 [78]
    • 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 [79]
    • 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 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 [82]
  • Potential signs of impairment [83]
    • 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 [84]
    • 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.

Overview [85]

  • 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 [86][87]
    • 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 [86]
    • Gifts from patients that are small and do not have substantial monetary value (e.g., home-cooked meals, flowers, knitted quilts). [88]
      • 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.
    • 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.

  • The physician may refer a patient to another physician or diagnostic or therapeutic service if they consider the referral beneficial to the patient. [89]
  • 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). There are a number of exceptions to this law. [92]
  • 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. [93]

Overview [94]

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 [94]

  • Permitted research: only clinical trials or research studies that fulfill the following requirements
    • Preclinical studies involving pregnant animals and clinical studies involving nonpregnant individuals have been conducted.
    • Adequate data regarding the potential risks to pregnant individuals and fetuses are 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 should 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 of benefit to the fetus, paternal consent should also be obtained unless the father is unavailable, temporarily incapacitated, or the pregnancy resulted from rape or incest.

Neonates [94]

  • Permitted research: only clinical trials with the purpose of obtaining crucial biomedical knowledge that cannot be obtained by other means or that has the potential to provide direct benefit to the neonate without posing any 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.
      • The research poses no additional risk to the neonate.
    • Legally effective informed consent must be obtained from the parents, guardians, or legally authorized representatives.

Children [94]

  • 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 should 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.
    • It is necessary to obtain informed consent from the parents as well as assent from the child.

Prisoners [94]

  • Permitted research: clinical trials or behavioral research that investigate health issues directly related to the prison population
  • Requirements
    • The risks associated with the research should 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 prisoner or a prisoner representative.
    • None of the nonprisoner members of the IRB should have any affiliation with the prison.
    • Any potential advantages offered to the prisoners through participation in the research may not be so great that they affect the prisoner's ability to weigh the risks of participation against the benefits.
  • 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 [95]
  • Regulations [95]
    • 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.
  • Culture is a set of behaviors and beliefs shared by a group of people bound by a certain factor (e.g., religion, country of origin). [96]
  • A patient's cultural background may influence their values about health, which can impact their health care preferences and decisions and may conflict with standard clinical practice and/or physician values. [57][96]
  • Physicians should respect the cultural values of their patients and tailor the clinical approach accordingly. [97]
  • A direct conversation with the patient about their cultural background can help to improve mutual understanding. [96][97]
    • An interpreter should be involved if there is a language barrier between a physician and a patient (see “General concepts of patient counseling” in “Patient communication and counseling” for more information about the use of interpreters).
    • If needed, social workers, chaplains, or team members with the same cultural background may be involved in the conversation.
    • A decision made by a capable patient may not be discarded even if it is influenced by their cultural background.

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. [98]

  • 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.

Autonomy

  • An adult patient refuses treatment based on religious beliefs.
    • Explain the treatment options and available alternatives.
    • Make sure that the patient understands the consequences.
    • Respect the patient's choice.
  • A patient wants to try alternative medicine.
    • Identify the underlying reason.
    • Do not negate or devalue the patient's decision.
    • Evaluate for possible drug interactions, adverse effects, and safety.
    • Allow treatment integration if it poses no risk of harm to the patient.

Abuse

  • A patient discloses abuse by a close partner.
    • Evaluate safety and the presence of an emergency plan for the victim.
    • Show empathy and willingness to provide continuous support.
    • Counsel and evaluate for psychological comorbidities.
    • Perform thorough documentation of abuse (the patient may want to take legal measures against their abuser).
    • Do not force the patient to leave their partner.
  • A pediatric patient has an injury inconsistent with the caregiver's report.
    • Physicians are obliged by law to report cases of child abuse.
    • Inform the authorities and keep the child in a safe place.

Confidentiality

  • Family members request information about the patient's health condition: Do not discuss issues with relatives without the consent of the patient.
  • Family members request that the physician withhold diagnostic information from a patient.
    • Explore why the family members want to withhold this information.
    • Evaluate the extent of the information that the patient wants to receive.
    • Deliver the patient information according to their preferences.
    • According to therapeutic privilege, the physician may withhold information from the patient if disclosure increases their likelihood of causing self-harm.
  • A patient with HIV refuses to inform their partner.
    • Encourage the patient to disclose the information to individuals they may have transmitted HIV to.
    • All cases of HIV must be reported to the local and state health departments.
    • If the patient refuses to inform their partner, the use of confidential partner notification procedures via the health department is encouraged.
    • For a more in-depth explanation of the legal nuances surrounding this issue, see “HIV” in “notification of diseases,” above.

Competence and decision making

  • Parents refuse life-saving treatment for their child.
    • Emergency treatment: Provide life-saving treatment.
    • Nonemergency essential treatment: Get a court order.
  • A pregnant 16-year-old wants to have an abortion. [99]
    • Many states require parental consent for abortion in minors.
    • If there are no medical risks associated with the pregnancy, the physician should respect the legally accepted decision for or against abortion in any case of maternal age or fetal condition.
  • A 15-year-old wants to keep her baby against her parents' will.
    • Pregnant individuals have the right to decide to carry their infants to term, and to chose to keep the baby or put it up for adoption.
    • Provide practical information about all options.
    • Accept and support the patient's decision.
    • Encourage good communication between the patient and her parents to evaluate the options and arrive at an agreement.
  • A 14-year-old girl requests contraceptives.
    • Offer advice on safe sex practices and prescribe contraceptives.
    • There is no need to notify parents to get consent.
  • A patient's family insists on maintaining life support indefinitely despite evidence of brain death because the patient still moves when touched.
    • Carefully explain to the family that brain death is equivalent to death and it excludes any chance of recovery.
    • Clarify that the movements are only an involuntary result of spinal arc reflex.
    • Refer the case to the ethics committee regarding futile treatment and withdrawal of life-sustaining therapy.
  • A father and 13-year-old son are found unconscious with internal bleeding after a car accident; the father is found to have a religious preferences card, which states that he declines blood transfusions because of religious beliefs.
  • A patient asks for a nonemergency treatment or procedure that is in opposition to the physician's personal or religious beliefs.
    • Impartially inform the patient about all the options, in order to help them make an informed decision.
    • Respectfully explain that you do not perform the requested intervention.
    • It is mandatory to facilitate the transfer of care to another qualified physician.
  • A patient is suicidal or homicidal.
    • The patient is considered to have impaired decision-making.
    • Assess the threat (organized plan, access to weapons).
    • Admit the patient voluntarily; admit involuntarily if the patient refuses.
    • If the patient produces homicidal threats, inform authorities and the threatened individual (Tarasoff decision).
  • A patient with terminal disease asks for assistance in ending their own life.
    • Physician-assisted death is not supported by the majority of U.S. states.
    • Appropriate analgesics can be prescribed regardless of their eventual effect in shortening the patient's life.

Malpractice

  • A patient receives wrong treatment/test: Inform the patient, even if no harm has been inflicted, and apologize.

Emotional support

  • A patient complains that she feels “ugly” after a mastectomy.
    • Support the patient in identifying and breaking down the reasons why she feels this way.
    • Avoid comments that give false comfort (e.g., “You look good anyway”).
  • A 6-year-old child experiences the death of a sibling and feels responsible.
    • Describe with simple and honest words what happened, avoiding euphemisms and clichés.
    • Offer reassurance, explaining to the child with clear and logical arguments that they cannot be responsible in any way.
    • Help the child to label feelings and fears, and normalize them.
    • Encourage healthy coping behaviors (e.g., making time for playing, creating a special way to remember their sibling).

Miscellaneous cases

  • Angry patient (e.g., waiting at the office for a long time): Apologize, acknowledge anger, refrain from justifying or explaining the delay.
  • A patient complains about the treatment received from another physician.
    • Suggest that the patient contacts that physician directly to speak about their concerns.
    • If the issue regards a member of your staff, let the patient know you will address the issue with the staff member personally.
  • A patient requests an unnecessary intervention (e.g., diagnostic or therapeutic procedure, unnecessary medication).
    • Find out why the patient wants the intervention and address any underlying concerns.
    • Avoid performing unnecessary medical or surgical interventions.
    • Do not refuse to see the patient or refer the patient to another physician.
  • A patient has poor adherence to or difficulty taking medications.
    • Identify the underlying causes of nonadherence.
    • Take a nonjudgmental stance and use motivational interviewing if possible.
    • Evaluate the patient's willingness to change.
    • Describe the treatment plan in easily understandable language, give written instructions, use the teach-back method, and involve close friends and relatives (with the permission of the patient).
    • Do not refer the patient to another physician.
  • A pharmaceutical company offers a physician a sponsorship to advertise a new drug.
    • Physicians should decline the offer of any gifts that can potentially create a COI.
    • The AMA Code of Ethics identifies the following as acceptable gifts that do not create a COI: [86]
      • Gifts directly entailing a benefit to patients
      • Gifts with no substantial value
      • Scholarships or other special funds for the medical education of students, residents, or fellows
      • Grants that identify beneficiaries based on independent qualification criteria
      • For more information, see “Conflicts of Interest,” above.
  • A physician is impaired in the work environment (e.g., due to substance use).
  • A patient shows attraction to a physician.
    • Romantic relationships between patients and physicians are never appropriate.
    • Ask specific, close-ended questions.
    • Use a chaperone if needed.
    • Consider transitioning care to another physician.
  • A patient asks a medical student to disclose treatment, diagnostic, or prognostic information. [100]
    • Medical students usually lack the experience and knowledge to disclose complex diagnostic, treatment, or prognostic information.
    • Hence, they should ensure the following:
      • Act in the best interest of the patient at all times.
      • Maintain honesty (if the information is available, explain why disclosure has been postponed).
      • Inform the patient that complex treatment plans or diagnostic information will be disclosed by senior members of the team.
      • Disclosure should take place in an appropriate environment and at a suitable time to ensure that the patient's privacy and emotional needs are met.
  • A patient needs medical therapy that is not covered by their insurance.
    • Always guarantee the necessary care regardless of its costs.
    • Evaluate all the therapeutic options with the patient, including those not covered by their insurance.
  • Parents refuse to vaccinate their child. [30]
    • Respect the parents' decision and address their concerns regarding vaccination.
    • Provide the parents with reliable information regarding the risks and benefits of vaccination, and attempt to address/adjust misconceptions to ensure that an informed decision can be made.
    • Revisit the topic in subsequent visits.
  • Self-treatment and treatment of relatives [101][102]
    • Physicians should generally avoid treating or prescribing drugs for themselves or their immediate relatives. Exceptions:
      • Emergency cases when no other qualified physicians are available
      • Minor events (e.g., a bloody nose, small minor burn)
    • Rationale:
      • A physician's personal feelings may affect their professional judgment and result in inadequate or improper care.
      • Treatment of a close relative may interfere with the patient's autonomy.
  • A patient requests that a physician intervene in a conflict with one of their family members. [103]
    • Encourage the patient to voice their concern directly to the family member.
    • Avoid a triangulated relationship: A triangulated relationship occurs when two individuals that are in conflict both try to align with a third individual for support and/or mediation.
    • If both the family members are the physician's patients and one of the family members has difficulty voicing their concern to the other, the physician can:
      • Offer a space for communication between the two individuals during a family consult (family interview).
      • Refer the patients to a family therapist.
    • In the case of suspected abuse or neglect, the physician should intervene on the patient's behalf. (See elder abuse, child maltreatment, and domestic violence.)
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