• Clinical science

Principles of medical law and ethics

Abstract

Physicians frequently encounter ethical dilemmas in all aspects of patient care. The resolution of these dilemmas should always be achieved with a focus on maximizing benefits for, respecting the preferences of, and minimizing harm and suffering to the patient. Patients should be briefed on all of their treatment options, including potential risks and benefits, prior to treatment. Competent patients, or in some cases, their surrogates, have the right to withdraw consent for any intervention, at any time, for any reason. A physician is ethically and legally obliged to keep a patient's medical information confidential except in isolated cases, in which the patient is at risk of harm to self or others.

Medical ethics

Core ethical principles

Medical ethics is founded on a set of core principles.

  • Autonomy
    • Respect patients as individuals (e.g., respecting their privacy by maintaining confidentiality and being truthful about their medical care).
    • Provide the information and opportunity for patients to make their own decisions regarding their care (e.g., informed consent).
    • Honor and respect patients' decisions regarding their choice to accept or decline care.
      • In addition to having the right to refuse a diagnostic or therapeutic intervention, patients also have the right to refuse to receive information
  • Beneficence
    • Act in the best interest of the patient and advocate for the patient.
    • May conflict with autonomy
  • Nonmaleficence
    • Avoid causing injury or suffering to patients
    • May conflict with beneficence
  • Justice
    • Treat patients fairly and equitably.
    • Equity is not the same as equality.

Obligation to treat

  • A physician is legally obliged to treat patients in a medical emergency in which failing to provide treatment would immediately endanger the patient's life.
  • Physicians are not obliged to treat a patient and may end a doctor-patient relationship if they wish, as long as the patient or their surrogate decision maker is notified and has the ability (e.g., time, money) to establish care with another physician; . The physician is also obligated to facilitate the transfer of care.
  • Freedom to treat: Freedom to treat describes a legal legitimization, in which each person (independent of educational level) is permitted to perform medical treatments. Since the Freedom to Treat Act was abolished in 1939, only physicians and certain authorized persons (e.g., natural health professional) are allowed to treat patients.

Decision-making capacity and legal competence

Decision-making capacity

  • Definition: the psychological and/or legally capability to process information, make decisions, and understand the consequences of the same with regard to health care
  • Typically determined by the attending physician
  • In order to have capacity, a patient must have:
    • Understanding: the patient's ability to understand the meaning of information provided by the physician
    • Appreciation: the patient's ability to determine how facts are relevant to their situation
    • Reasoning: the patient's ability to use the information provided by the physician to make decisions regarding their care
    • The ability to express a choice: the patient should have the ability to clearly communicate their choice of treatment

Legal competence

  • Definition: legal assessment of a patient's ability to make decisions
  • Assessed by a court of law (physicians do not have the legal power to pronounce patients legally incompetent)
  • Questions of legal competence arise in the presence of reduced mental capacity (e.g., severe mental illness, intoxication, impulsive/constantly changing decisions, or decisions that are inconsistent with the patient's values)

Shared decision-making

  • A model in which patients and physicians decide on the best treatment option together
  • Empowers patient, as it is based on the patient's personal values, cultural beliefs, and preferences
  • Results in better health outcomes and increases patient satisfaction

Surrogate decision-making

  • When a patient lacks decision-making capacity or competence, another person must make treatment decisions for them.
  • The surrogate decision-maker may be appointed by patients (e.g., medical power of attorney), legally appointed (e.g., court-ordered guardian), or next of kin (if no oral advance directive exists).
    • The exact hierarchy of decision-making varies from state to state. However, it generally follows the following order:
      1. A mentally competent patient capable of expressing his/her own decision
      2. Advance healthcare directive
        • Durable medical power of attorney: a document through which an individual designates a surrogate health care decision-maker in the event that he/she lacks decision-making capacity or competence
        • Living will
          • Should the durable medical POA and the living will be in conflict, the POA can override the living will only if such a decision is in line with the patient's most recently expressed wishes.
      3. Next of kin
        1. Spouse
        2. Adult child
        3. Parent
        4. Adult sibling
        5. In about half of states: “close friend”
      4. Ethics committee or legal consult
        • When no surrogate is available or there is ongoing dispute (i.e., between equal priority surrogates) regarding who takes precedence as surrogate
        • When there is ongoing disagreement (i.e., between equal priority surrogates) about treatment decisions that cannot be resolved
        • When a physician determines that a surrogate's decision may go against the patient's best interests or preferred decision
        • When a physician determines that a surrogate's decision is made to benefit a third party, rather than in the patient's best interests
  • Regardless of who the surrogate is, it is paramount that decisions be made based on what patients themselves would have wanted.
    • The decision-maker should not let their own preferences influence decision-making.
    • A patient may have expressed their wishes via:
      • Oral advance directive: an incapacitated patient's prior oral statements regarding their preferences
      • Living will (written advance directive): a legal document in which patients describe their wishes regarding their healthcare (e.g., to maintain, withhold, or withdraw life-sustaining care), should they become incapacitated
    • If the patient's wish cannot be determined and there is a disagreement regarding the course of action:
      1. It is prudent to convene a meeting between the disagreeing parties in order to facilitate a conversation about what the patient would have desired.
      2. If the patient's most recent wish still cannot be determined, the wishes of the appropriate surrogate decision maker should ultimately be followed.

LED TO REASON: Lead in , Explore , Diagnosis , Treatment , Options , Results , Eventualities , Sound mind , Open questions , Notes

Patient with decision-making capacity and competence (even, e.g., psychiatric patients) have the right to provide or withdraw informed consent at any time (even during a procedure)!
References:[1][2]

Disclosure

Full disclosure

  • Patients have the right to full medical disclosure
  • A family does not have the right to ask a physician to withhold information from a patient with decision-making capacity and competence without good reason
  • Exceptions:
    • If the patient requests that the physician withholds information
    • Therapeutic privilege: a physician determines that full disclosure would cause severe harm to the patient's severe psychological harm (e.g., following an unfavorable prognosis)

Medical errors

  • Regardless of the outcome of a treatment, a physician must inform the patient immediately if an error has occurred and disclose the nature of that error.
    • There are several elements of an optimal error disclosure
      • Clearly admit an error has occured
      • State the course of events leading to and during the error, avoiding jargon
      • Explain the consequences of the error, both immediate and long term (if necessary)
      • Describe corrective steps and future preventative steps
      • Express personal regret and apology
      • Allow ample time for questions and continued dialogue
  • If a physician believes that a colleague has committed an error in a patient's care, the physician should urge their colleague to report this error to the patient.
  • If the colleague refuses, the physician should report this error via their hospital's or clinic's standard protocol.
  • If the cause of an error is not immediately known, the physician should inform the patient and maintain contact while investigations are being carried out.

Research disclosure

  • Clinical trials are critical to medical innovation. However, human testing should be designed in such a way as to minimize suffering and maximize potential benefit.
  • The primary target of clinical trials is to determine whether a medical treatment or device is safe or beneficial, not patient treatment
  • Patients must receive full disclosure prior to enrollment in a clinical trial
    • All aspects of the experimental protocol (i.e., the purpose of the study, the study design)
    • Any potential conflicts of interest
    • Any foreseeable hazards to the patient
    • The likelihood of direct benefit to the patient
    • All alternative treatment options
    • medical strategy, treatment, or device is safe
    • The differences between physician responsibility in the role of researcher and in that of attending physician
      • A physician-researcher is primarily concerned with clinical data and medical innovation
      • A treating physician is primarily concerned with the treatment and best interests of the patient
  • An informed consent form, approved by the responsible research institutional review board, must be completed by the patient prior to initiation of treatment
  • Patients participating in clinical research have the right to withdraw from a clinical trial at any time, for any reason (as with any form of informed consent)

Under the Health Insurance Portability and Accountability Act (HIPAA), patients have a legal right to obtain copies of their medical records within a specified timeframe!References:[1]

End-of-life issues

End-of-life care

  • There is a number of ethical dilemmas may arise in context of end-of-life care.
  • The physician's role in ethical dilemmas is to facilitate communication (e.g., family meetings) and to reiterate the importance of focusing on what patients themselves would have preferred.

Physician-aided death

  • Physician-assisted suicide
    • When a physician supplies a patient with the means to end their own life (e.g., a physician provides a patient with a lethal dose of morphine that the patient then self-injects)
    • Illegal in most states
  • Euthanasia
    • The active termination of a terminally ill patient's life by a physician to end suffering. (e.g., a physician injects a lethal dose of morphine).
    • Euthansia is illegal in the United States.
  • Terminal sedation
    • It is legal to adjust medical therapy accordingly to provide relief from pain and suffering in a patient with terminal illness, despite hastening the patient's dying process (e.g., increasing doses of morphine in a patient with metastatic cancer)
    • Legal and distinct from euthanasia in so far as the intent must be to relieve pain rather than bring about death, even though it may hasten the dying process.
    • Not an appropriate means of addressing primarily existential suffering, e.g., death anxiety.
    • Principle of double effect: An ethical principle that legitimizes an act of good intent despite causing serious harm (e.g. self defense homicide or terminal sedation).

Do not resuscitate orders (DNR orders)

Withdrawal of care

  • Patients with capacity (or their surrogate decision-makers) have the right to refuse any form of treatment at any time, even if that would result in that patient's death.
  • Physicians should make an effort to understand the reasons behind the patient's decision for refusing treatment.
  • There is no ethical difference between withholding care and withdrawing care at a later time

Futile treatment

  • A physician is not ethically obligated to provide treatment if it is considered futile (inappropriate treatment), even if requested by the patient or surrogate.
  • Treatment can be considered futile if:
    • There is no evidence for the effectiveness of treatment
    • If the intervention has previously failed
    • If last-line therapy is failing
    • If treatment will not fulfill the goals of care
  • A physicians should discuss their concerns regarding a treatment and determine a plan to address all goals of care that would be more appropriate.
  • When patients, their family, and the treatment team are unable to reach an agreement on a treatment plan despite extensive discussion, an ethics committee should be consulted.

Organ and tissue donation

  • Deceased donors
    • Patients may declare themselves organ and tissue donors prior to death (e.g., in a living will or driver's license)
    • Hospitals that receive payment from Medicare must discuss organ donation with the family of the deceased
    • Patients (e.g., in a living will) or their families may specify which organs may be donated after death
    • Hospitals must decline organs that are considered unsuitable:
  • Living donors
    • Nonvital organs and tissues can be acquired from living donors (e.g., liver or bone marrow)
    • Prior to donation, donors must give full informed consent
    • Donors have the right to withdraw from donation at any time
    • Donors may select the recipient of their donation
    • Donors may not be paid for their donation, but can be reimbursed for associated costs (travel, food, lost wages, etc.)
    • A donor may engage in an “organ swap”

Death

  • Criteria: Death can be diagnosed if a patient meets criteria for brain death or cardiopulmonary death. Only one of these conditions is required, although they may coexist.
  • Brain death
  • Cardiopulmonary death: the absence of a spontaneous heartbeat in an asystolic patient.

A hypothermic patient must be warmed to normal body temperature before death can be diagnosed!

References:[1][3][4]

Confidentiality

  • A physician is ethically and legally obliged to keep a patient's medical information (including information disclosed by the patient to the doctor) confidential, with the following exceptions:
    • The patient directly requests the physician to share information with another party (e.g., a family member or for insurance purposes)
      • The Health Insurance Portability and Accountability Act requires verbal or written consent 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
    • The patient has a notifiable disease
      • In this case, a physician is legally permitted to notify only a public health official. Depending on the disease, the patient should be encouraged to inform any third parties that may have been infected (e.g., sexual partners). The physician does not, however, have the right to inform third parties without the patient's consent.
    • The patient poses a danger to others (e.g., impaired driver, homicidal)
      • Physicians should protect the intended victim of homicide by any reasonable means (e.g., notify the police)
    • The patient poses a threat to himself or herself
    • Elder abuse and child maltreatment
    • The patient has suffered penetrating trauma from assault (e.g., a gunshot wound, stab wound)
    • The patient is a minor and care does not involve sexual or addiction medicine (see informed consent in minors)
  • Confidential information should only be shared with other health care workers if they are immediately involved in the patient's care.
  • Any other requests by health care workers to share information should be denied
  • Avoid discussing patient information in public areas.

References:[3]

Societal factors

Notification of diseases

Elder abuse and child abuse

  • Elder abuse/neglect
    • Any form of physical, psychological, or financial mistreatment of an elderly person (exact age varies by jurisdiction). Signs of this include:
    • Always perpetrated by someone with a longitudinal relationship and responsibility for the patient (e.g., a caregiver or relative)
    • Physicians are legally (and ethically) obliged to report suspected elder abuse
  • Child maltreatment
    • The precise legal definition of child abuse and neglect varies by state, but broadly can be defined as any act (or failure to act) that produces an imminent risk of serious harm to an individual < 18 years old
    • Physicians are legally (and ethically) obliged to report suspected child abuse

Domestic violence

  • Refers to any form of actual or threatened physical or emotional harm within a household, frequently used to by one person to maintain power over another.
  • Usually occurs between partners in a relationship, in which case it is more accurately called intimate partner violence
  • When a physician suspects domestic violence, they should privately speak with the affected patient, inquire further, and offer assistance.
  • Physicians are not legally permitted to report domestic violence without patient consent (unless the patient is incompetent e.g., mentally disabled, elderly, or a minor)
  • In cases where the patient refuses aid, a physician should reiterate their support of the patient and the availability of aid at any time.

Driving restriction

  • Physicians are sometimes required to report patients who are considered unsafe to drive (e.g., uncontrolled epilepsy is one of the most common reasons) to the licensing authority.
  • A physician should always suggest another means of transportation
  • Generally, only patients at a high risk of having a seizure while driving should be restricted

Prisoner execution

  • It is not ethical for physicians to participate in any executions, regardless of state laws that enforce the death penalty.

Torture

  • A physician should act in the best interest of their patient, and provide all possible support to aid the patient and facilitate removal from harm, including:
    • Refusing to participate in torture
    • Ensuring the patient's safety

Abortion and stillbirth laws

  • 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 and unexplained stillbirth
  • Abortion
    • Abortion laws vary greatly between US states
    • Most states only permit a licensed physician to perform abortions:
    • Most states allow physicians to refuse performing 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 parent's of minors undergoing an abortion procedure are notified and/or informed to provide consent

Age of criminal responsibility

  • The age of criminal responsibility is established by state law
  • It describes the age at which individuals are able to perceive the consequences of their actions
  • Most states use common law, which states that from age 7 to age 14 children can be held responsible, but cannot be presumed to bear responsibility

References:[1][5][6][7][8][9]

Malpractice

  • A civil suit because of negligence is due to substandard care by a physician
  • Medical negligence leads to patient harm
  • Concern over medical malpractice lawsuits has resulted in increasing practice of defensive medicine:
    • Testing and treatment that is not medically necessary, but is performed by the physician to avoid legal liability
    • Defensive medicine is unethical and should be avoided, because it increases risk of patient harm without significant benefit (e.g., radiation exposure from an unnecessary CT scan)
    • Instead, physicians should communicate openly with patients regarding the risks and benefits of tests or treatments that they believe are medically unnecessary

References:[10][11][12]

Physician licensing and disciplinary action

Medical license

  • According to the Medical Licensure Act, a medical license is the authorization for healthcare professionals to practice medicine.
  • The issue and withdrawal of a medical license is done by the responsible administrative authority of each state (federal state law).

Disciplinary action

  • Any health professional deemed to be unethical, incompetent, or corrupt should undergo disciplinary action
  • The aim is to protect patients and to ensure the effectivity of a safe and ethical health care system
  • The responsibility to report these cases falls on individual health professionals and medical associations
  • Medical associations also have the responsibility to:
    • Initiate disciplinary action, regardless of criminal or civil proceedings related to the case
    • Impose a penalty (i.e., expulsion from membership)

References:[1]

Informed consent

Definition

  • The process of briefing a patient (or a surrogate decision-maker) about their medical condition and treatment options, then obtaining consent to pursue a selected course of treatment.
  • Patients (or their surrogate) must demonstrate decision-making capacity and competence before they can consent to, or refuse surgery (e.g., if patients make decisions contrary to sound medical reasoning such as refusing blood transfusions out of religious conviction).

Language

  • Discuss health care decisions with patients in terms they can relate to
  • Communicate in a language that the patient understands

Timepoint of patient briefing

  • The patient must be informed in time (with a sufficient interval) prior to an elective medical procedure

Extent of patient briefing

A patient should be educated about their diagnosis, treatment options, and the risks and benefits of those options before treatment.

  • Diagnosis and natural course of the disease without any treatment
  • Nature of the proposed medical or surgical treatment
    • Benefits
    • Known complications, estimated risks of death and morbidity
  • Types and risks of anesthesia, if necessary
  • Alternative treatments
  • Informing the patient about the possibility of intraoperative findings that may require more intervention than originally planned.
  • Medical safety advisory: The physician is obliged to brief the patient about the measures necessary for assuring treatment success (e.g., physical rest after surgery).

Expressing a decision

  • After patients reviews the standardized information sheet, they are briefed by the physician over the course of the planned intervention and all relevant risks and complications.
  • Once patients (or their surrogate decision-maker) have been briefed, they must be provided with adequate time to digest that information.
  • The patient (or their surrogate decision-maker) must then clearly communicate their decision

Exceptions to standard informed consent

  • The following measures are generally performed without (or against) the patient's consent, although a thorough attempt to persuade the patient to comply voluntarily is preferred:
    • Life-threatening emergencies (e.g., an unconscious trauma patient without a surrogate decision-maker present)
      • The physician can be individually accountable for unequivocally necessary measures in an acute emergency.
      • If the patient is unconscious, the patient's presumed will is determined, with a particular gravity assigned to the advance directive.
    • A patient lacking decision-making capacity, but whose surrogate decision-maker has authorized intervention
    • A patient lacking decision-making capacity, for whom no surrogate decision-maker is available, and treatment is in the best interest of the patient
    • Examination, treatment, or quarantine to prevent epidemics
    • If the patient's decision to refuse treatment poses a safety risk to their own well-being and/or the welfare of others (e.g., in the event of severe psychosis, patient with active TB)
      • A legal form must be completed by a physician that allows temporary commitment (usually for a few days at most)
      • Informed consent of the patient or surrogate is required if hospitalization is required beyond the stabilization period

Informed consent in minors

  • A minor is any person < 18 years old in most states. Exceptions include:
    • Mississippi: < 21 years
    • Nebraska and Alabama: < 19 years
  • Parental consent is required before a minor receives medical care, with a few exceptions:
    • The hospitalization or treatment is emergent and life-saving (e.g., trauma, suicidal ideation)
    • The minor is legally emancipated
    • The minor is seeking care regarding sex (contraception, pregnancy care, or STIs) or addiction care
    • If the parents of the patient are themselves minors, the grandparents may give consent for their grandchildren.
    • Even in these situations, the minor should be encouraged to discuss their issues with their parents.
  • If parents refuse consent to treatment of a child for a non-emergent but fatal medical condition (e.g., bacterial meningitis, malignancy), the physician should first discuss this decision with the parents, then seek a court order mandating treatment if parents continue to refuse.
  • A parent cannot refuse an emergently life-saving intervention for a minor (e.g., blood transfusion for hemorrhage), not even for religious reasons

Informed consent during pregnancy

  • A pregnant woman has the right to refuse health care even if her decision poses a risk to the unborn fetus.

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

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

LED TO REASON: Lead in , Explore , Diagnosis , Treatment , Options , Results , Eventualities , Sound mind , Open questions , Notes

References:[1]

Conflicts of interest

  • A conflict of interest occurs when a physician's objectivity regarding their primary interest (e.g., patient welfare) is potentially affected by a secondary interest (e.g., personal financial gain).
  • In order to minimize risk of conflicts of interest and associated patient harm, a physician should:
    • not accept gifts of material value from the medical industry
    • not publish or present data controlled by medical industry
    • not publish or present data that was written by an unidentified or improperly acknowledged author
    • not meet with representatives from medical companies except by documented appointment and without personal incentive (e.g., free meal or compensation)
    • not accept free drug samples, except in small amounts for treatment of patients who are unable to afford treatment otherwise
  • Patients may offer gifts to a physician for a variety of reasons. and in order to maintain a positive patient-physician relationship, physicians should:
    • not accept gifts of disproportionate or inappropriately high value relative to the patient's means
    • not accept gifts that they would be uncomfortable disclosing to colleagues
    • make it clear that gifts will not affect the patient's current or future care
    • decline any gift that may incur hardship on the patient or their family
    • consider suggesting a charitable donation in lieu of a gift

A physician must disclose all conflicts of interest to all affected parties and refer affected patients to an unbiased colleague whenever possible.

References:[1][13]

Examples of ethically challenging situations

Autonomy

  • An adult patient refuses treatment based on religious belief:
    • Explain the treatment option and other available alternatives
    • Make sure that the patient understands the consequences
    • Respect patient's choice
  • Patient wants to try alternative medicine
    • Identify the underlying reason behind the decision
    • Do not negate or devalue patient's idea (will affect patient-physician relationship)
    • Evaluate for drug interaction, adverse effect, safety; allow treatment integration if it is safe

Abuse

  • Patient discloses abuse by close partner
    • Evaluate safety and the presence of emergency plan
    • Show empathy and willingness to provide continuous support
    • Counsel and evaluate for comorbid pychological issues
    • Perform thorough documentation as the victim might want to take legal measures
    • Do not force the patient to leave the partner
  • A pediatric patient has injury inconsistent with caregiver's report
    • Physicians are obliged by law to report cases of child abuse
    • Inform authorities and keep the child in a safe place

Confidentiality

  • Family members request information about patient's health condition: do not discuss issues with relatives without the consent of the patient
  • Family members request the physician to withhold information about the diagnosis of the patient (e.g., patient is diagnosed with lung cancer)
    • Understand why the family members want to withhold this information (helps to build an empathetic relationship, addresses fear and anxiety)
    • Evaluate the extent of information the patient wants to receive
    • Deliver information based on the patient's preference
  • Patient with HIV refuses to inform his/her partner
    • Counsel the patient to disclose the information to individuals at risk
    • If the patient refuses, inform the health department for tracing at risk individuals
    • At risk individuals can be informed by the physician or the health department
    • There is no legal consequence for breaching confidentiality

Competence and decision making

  • Parents refuse life saving treatment for their child
    • Emergency treatment: go ahead and treat
    • Non-emergency essential treatment: get court order
  • A 16-year-old pregnant teenager wants to have an abortion
    • Many states require parental consent for an abortion in minors
  • A 15-yearl-old teenager wants to keep her baby against her parent's will
    • The patient has the right to decide about her baby's fate (adoption or keeping the baby)
    • Provide practical information about all options
    • Support the patient irrespective of her decision
  • A 14-year-old girl request for contraceptive
    • Advise on safe sex practices and prescribe contraceptive
    • No need to notify parents to get a consent
  • Patient is suicidal or homicidal
    • Considered to have impaired judgement
    • Assess the threat (organized plan, access to weapons)
    • Admit pateint voluntarily; admit involuntarily if patient refuses
    • In homicide threats: inform authorities and threatened individual

Malpractice

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

Miscellaneous cases

  • Angry patient (e.g., waiting at the office for a long time): apologize, acknowledge anger, refrain from justifying or explaining the delay.
  • Patient desires 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.
  • Patient has poor adherence or difficulty of taking medications
    • Identify the underlying causes of non-adherence.
    • Take a non-judgemental stance and use motivational interviewing if possible.
    • Evaluate willingness to change.
    • Describe treatment plan in easily understandable language, give written instructions, use teach-back method, and involve other relatives with the permission of the patient.
    • Do not refer the patient to another physician.

References:[14][15]