2. Ethical and Legal Issues in Canadian Medicine

Question 1

Ethics addresses what? (2)

Answer 1

1. principles and values that help define what is morally permissible or not
2. rights, duties, and obligations of individuals and groups

Question 2

The practice of medicine assumes there is one code of professional ethics for all doctors and that they will be held ___ by that code and its implications

Answer 2

The practice of medicine assumes there is one code of professional ethics for all doctors and that they will be held accountable by that code and its implications

Question 3

The doctor-patient relationship is formed on what? (1)

Answer 3

on trust, which is recognized in the concept of fiduciary duty/ responsibility of physician towards patient

Question 4

Describe: Fiduciary duty (2)

Answer 4

• is a legal duty to act in another party’s interest.
• Profit from the fiduciary relationship must be strictly accounted for with any improper profit (monetary or otherwise) resulting in sanctions against the physician and potentially compensation to the patient, even if no harm has befallen the patient

Question 5

Name: The Four Principles Approach to Medical Ethics (4)

Answer 5

• Autonomy
• Beneficence
• Non-Maleficence
• Justice

Question 6

Describe this principle approach to medical ethics: Autonomy (2)

Answer 6

• Recognizes an individual’s right and ability to decide for themselves according to their beliefs and values
• May not be applicable in situations where informed consent and choice are not possible or may not be appropriate

Question 7

Describe this principle approach to medical ethics: Beneficence (4)

Answer 7

• Patient values-based best interests standard that combines doing good, avoiding harm, considering the patient’s values, beliefs, and preferences, so far as these are known
• Autonomy should be integrated with the physician’s conception of a patient’s medically-defined best interests
• Aim is to minimize harmful outcomes and maximize beneficial ones
• Paramount in situations where consent/choice is not possible or may not be appropriate

Question 8

Describe this principle approach to medical ethics: Non-maleficience (2)

Answer 8

• Obligation to avoid causing harm; primum non nocere (“First, do no harm”)
• Limit condition of the Beneficence principle

Question 10

Describe this principle approach to medical ethics: Justice (4)

Answer 10

• Fair distribution of benefits and harms within a community, regardless of geography or income
• Concept of fairness: Is the patient receiving what they deserve – their fair share? Are they treated the same as equally situated patients? (equity) How does one set of treatment decisions impact others? (equality)
• Equality and equity are different notions of justice. Equality is distribution of resources to all irrespective of needs, and equity is distribution of resources based on unique needs. Both concepts raise different considerations
• Basic human rights, such as freedom from persecution and the right to have one’s interests considered and respected

Question 11

Differentiate: Autonomy vs. Competence vs. Capacity

Answer 11

• Autonomy: the right that patients have to make decisions according to their beliefs and preferences
• Competence: the ability to make a specific decision for oneself as determined legally by the courts
• Capacity: the ability to make a specific decision for oneself as determined by clinicians

Question 12

Who developed a Code of Ethics that acts as a common ethical framework for Canadian physicians?

Answer 12

CMA

Question 13

Describe the Code of Ethics (4)

Answer 13

• prepared by physicians for physicians and applies to physicians, residents, and medical students
• based on the fundamental ethical principles of medicine
• sources include the Hippocratic Oath, developments in human rights, recent bioethical discussion
• CMA policy statements address specific ethical issues not mentioned by the code (e.g. abortion, transplantation, and euthanasia)

Question 14

Describe: The CMA Code of Ethics and Professionalism (2)

Answer 14

• is a quasi-legal standard for physicians
• if the law sets a minimal moral standard for doctors, the Code augments these standards

Question 15

Describe Overview of Confidentiality (8)

Answer 15

• when determining legal and ethical issues surrounding patient information, start from the point that all information given by the patient is both confidential (meaning it cannot be disclosed to others) and privileged (meaning it cannot be used in court), then determine whether exceptions to this exist
• the legal and ethical basis for maintaining confidentiality is that a full and open exchange of information between patient and physician is central to a therapeutic relationship
• privacy is the right of patients (which they may forego), while confidentiality is the duty of doctors (which they must respect barring patient consent or the requirements of the law)
• if inappropriately breached by a doctor, physician can be sanctioned by the hospital, court, or regulatory authority
• based on the ethical principle of patient autonomy, patients have the right to the following:
  
  • control of their own information
  • the expectation that information concerning them will receive proper protection from unauthorized access by others
• confidentiality may be ethically and legally breached in certain circumstances (e.g. the threat of harm to others)
  
  • while physician-patient privilege exists, it is less strong than solicitor-client privilege. Physicians can tell patients that they will only disclose their information where it is mandated by law and that these exceptions are generally quite narrow. Physicians should avoid promising absolute confidentiality or privilege, as it cannot be guaranteed
• physicians should seek advice from their local health authority or the CMPA before disclosing HIV status of a patient to someone else
  
  • many jurisdictions make mandatory not only the reporting of serious communicable diseases (e.g. HIV), but also the reporting of those who harbour the agent of the communicable disease
  • physicians failing to abide by such regulations could be subject to professional or civil actions
• legal duty to maintain patient confidentiality is imposed by provincial health information legislation and precedent-setting cases in the common law

Question 16

Legal Aspects of Confidentiality

Advice should always be sought from who when in doubt? (2)

Answer 16

provincial licensing authorities and/or legal counsel

Question 17

Name: Reasons to Breach Confidentiality (5)

Answer 17

• Child abuse
• Fitness to drive
• Communicable disease
• Coroner report
• Duty to inform/warn

Question 18

Legislation has defined specific instances where public interest overrides the patient’s right to confidentiality; varies by province, but may include what? (6)

Answer 18

1. suspected child abuse or neglect – report to local child welfare authorities (e.g. Children’s Aid Society)
2. fitness to drive a vehicle or fly an airplane – report to provincial Ministry of Transportation
3. communicable diseases – report to local public health authority
4. improper conduct of other physicians or health professionals – report to College or regulatory body of the health professional (sexual impropriety by physicians is required reporting in some provinces)
5. vital statistics must be reported; reporting varies by province (e.g. in Ontario, births are required to be reported within 30 d to Office of Registrar General or local municipality; death certificates must be completed by a MD then forwarded to municipal authorities)
6. reporting to coroners

physicians who fail to report in these situations are subject to prosecution and penalty, and may be liable if a third party has been harmed

Question 19

Describe: Duty to Protect/Warn (5)

Answer 19

• the physician has a duty to protect the public from a known dangerous patient; this may involve taking appropriate clinical action (e.g. involuntary detainment of violent patients for clinical assessment), informing the police, or warning the potential victim(s) if a patient expresses an intent to harm
• first established by a Supreme Court of California decision in 1976 (Taraso**ff v. Regents of the University of California)
• Canadian courts have not expressly imposed a mandatory duty to report, however, the CMA Code of Ethics and some provincial/territorial regulatory authorities may oblige physicians to report (mandatory reporting rather than permissive)
• concerns of breaching confidentiality should not prevent the MD from exercising the duty to protect; however, the disclosed information should not exceed that required to protect others
• applies in a situation where:
  
  1. there is an imminent risk
  2. to an identifiable person or group
  3. of serious bodily harm or death

Question 20

Describe: Ontario’s Medical Expert Panel on Duty to Warn (2)

Answer 20

1998;158(11):1473-1479

• There should be a duty to inform when a patient reveals that they intend to do serious harm to another person(s) and it is more likely than not that the threat will be carried out
• Where a threat is directed at a person or group and there is a specific plan that is concrete and capable of commission and the method for carrying it out is available to the threatener, the physician should immediately notify the police and, in appropriate circumstances, the potential victim. The report should include the threat, the situation, the physician’s opinion, and the information upon which it is based

Question 21

Disclosure of health records can be compelled by who? (3)

Answer 21

• a court order
• warrant
• or subpoena

Question 22

Describe: Privacy of Medical Records (3)

Answer 22

• privacy of health information is protected by professional codes of ethics, provincial and federal legislation, the Canadian Charter of Rights and Freedoms, and the physician’s fiduciary duty
• the federal government created the PIPEDA in 2000 which established principles for the collection, use, and disclosure of information that is part of commercial activity (e.g. physician practices, pharmacies, private labs)
• PIPEDA has been superseded by provincial legislation in many provinces, such as the Ontario Personal Health Information Protection Act, which applies more specifically to health information

Question 23

Describe: Duties of Physicians with Regard to the Privacy of Health Information (8)

Answer 23

• inform patients of information-handling practices through various means (e.g. posting notices, brochures and pamphlets, and/or through discussions with patients)
• obtain the patient’s expressed consent to disclose information to third parties
  
  • under Ontario privacy legislation, the patient’s expressed consent need not be obtained to share information between health care team members involved in the “circle of care.” However, the patient may withdraw consent for this sharing of information and may put parts of the chart in a “lock box”
    
    • physicians have a professional obligation to facilitate timely transmission of the patient’s medical record to third parties (with the patient’s consent), such as for insurance claims. Failure to do so has resulted in sanctions by regulatory bodies
    • while patients have a right of access to their medical records, physicians can charge a “reasonable fee” commensurate with the time and material used in providing copies/access
• provide the patient with access to their entire medical record; exceptions include instances where there is potential for serious harm to the patient or a third party
• provide secure storage of information and implement measures to limit access to patient records
• ensure proper destruction of information that is no longer necessary
• regarding taking pictures or videos of patients, findings, or procedures, in addition to patient consent and privacy laws, trespassing laws apply in some provinces
• CPSO published policy is designed to help Ontario physicians understand legal and professional obligations set out under the Regulated Health Professions Act, 1991, the Medicine Act, 1991, and the Personal Health Information Protection Act, 2004. This includes regulations regarding express or implied consent, incapacity, lock boxes, disclosure under exceptional circumstances, mandatory reporting, ministry audits, subpoenas, court orders and police, as well as electronic records and voice messaging communications: http://www.cpso.on.ca/Policies-Publications/Policy/Confidentiality-of-Personal- Health-Information
• it is the physician’s responsibility to ensure appropriate security provisions with respect to electronic records and communications
  
  • with the advent of digital records, there have been increasing issues with access of healthcare providers that are not part of the patient’s circle of care accessing medical records inappropriately (e.g. curiousity or for profit). All staff should be aware that most EMRs log which healthcare providers view records and automatically flag files for further review in certain cases (e.g. same surname, VIP patients, audit of access to records)

Question 24

Describe: Lock Boxes (2)

Answer 24

• The term “lock boxes” applies to situations where the patient has expressly restricted their physician from disclosing specific aspects of their health information to others, even those involved in the patient’s circle of care.
• Note that the Personal Health Information Protection Act (PHIPA) provisions denote that patients may not prevent physicians from disclosing personal health information permitted/ required by the law

Question 25

Describe: Ethical Principles Underlying Consent and Capacity (10)

Answer 25

* consent is the autonomous authorization of a medical intervention by a patient * usually the principle of respect for patient autonomy must be balanced by the principle of beneficence * where a patient cannot make an autonomous decision (i.e. incapable), it is the duty of the SDM (or the physician in an emergency) to act on the patient’s known prior wishes or, failing that, to act in the patient’s best interests * there is a duty to discover, if possible, what the patient would have wanted when capable * central to determining best interests is understanding the patient’s values, beliefs, and patient’s interpretation of cultural or religious background * more recently expressed wishes take priority over remote ones * patient wishes may be verbal or written * patients found incapable to make a specific decision should still be involved in that decision as much as possible; this is known as assent * agreement or disagreement with medical advice does not determine findings of capacity/incapacity * however, patients opting for care that puts them at risk of serious harm that most people would want to avoid should have their capacity carefully assessed. Steer clear from tendency to define what reasonable person standard may be. If appropriate, look to discern patterns of justification offered by patient and how they interpret their values, beliefs and culture/religion

Question 26

Describe: CPSO Policy Consent (1)

Answer 26

Obtaining valid consent before carrying out medical, therapeutic, and diagnostic procedures has long been recognized as an elementary step in fulfilling the doctor’s obligations to the patient

Question 27

Name four Basic Requirements of Valid Consent

Answer 27

* Voluntary * Capable * Specific * Informed

Question 28

Describe this requirement of Valid Consent: Voluntary (2)

Answer 28

* consent must be given free of coercion or pressure (e.g. from parents or other family members who might exert ‘undue influence’) * the physician must not deliberately mislead the patient about the proposed treatment

Question 29

Describe this requirement of Valid Consent: Capable (1)

Answer 29

the patient must be able to understand and appreciate the nature and effect of their condition as well as of the proposed treatment or decision

Question 30

Describe this requirement of Valid Consent: Specific (1)

Answer 30

* the consent provided is specific to the procedure being proposed and to the provider who will carry out the procedure (e.g. the patient must be informed if students will be involved in providing the treatment)

Question 31

Describe this requirement of Valid Consent: Informed (9)

Answer 31

sufficient information and time must be provided to allow the patient to make choices in accordance with their wishes, including: * the nature of the treatment or investigation proposed and its expected effects * all significant risks and special or unusual risks * alternative treatments or investigations and their anticipated effects and significant risks * the consequences of declining treatment * answers to any questions the patient may have * the reasonable person test – the physician must provide all information that would be needed “by a reasonable person in the patient’s position” to be able to make a decision * disclose common adverse events and all serious risks (e.g. death), even if remote * it is the physician’s responsibility to make reasonable attempts to ensure that the patient understands the information, including overcoming language barriers, or communication challenges * physicians have a duty to inform the patient of all legitimate therapeutic options and must not withhold information based on conscientious objections (e.g. not discussing the option of emergency contraception)

Question 32

In regards to valid consent, describe Professional Considerations for: Elderly Patient (2)

Answer 32

* Identify their goals of care and resuscitation options (CPR or DNR), if applicable * Check for documentation of advance directives and power of attorney where applicable

Question 33

In regards to valid consent, describe Professional Considerations for: Pediatric Patient (3)

Answer 33

* Identify the primary decision-maker (parents, guardian, wards-of-state, emancipated) * Regarding capacity assessment see *Pediatric* *Aspects of Capacity*, ELOM11 * Be wary of custody issues if applicable

Question 34

In regards to valid consent, describe Professional Considerations for: Terminally Ill or Palliative Patient (4)

Answer 34

* Consider the SPIKES approach to breaking bad news * What are patient's goals of care (i.e. disease vs. symptom management)? * Identify advance directives, power of attorney POA, or substitute decision-maker SDM, if applicable * Check for documentation of resuscitation options (CPR or DNR) and likelihood of success

Question 35

In regards to valid consent, describe Professional Considerations for: Incapable Patient (3)

Answer 35

* If not already present, perform a formal capacity assessment and thoroughly document * Identify if the patient has an substitute decision-maker (SDM) or who has their power of attorney (POA) * Check the patient’s chart for any Mental Health Forms (e.g. Form 1) or any forms they may have on their person (e.g. Form 42)

Question 36

Name: Criteria For Administration of Treatment for an Incapable Patient in Emergency Situations (2)

Answer 36

* Patient is experiencing extreme suffering * Patient is at risk of sustaining serious bodily harm if treatment is not administered promptly (loss of life or limb)

Question 37

Describe: Ontario consent flowchart (Figure)

Answer 37

Question 38

Consent of the patient must be obtained before any medical intervention is provided; consent can be how? (4)

Answer 38

* verbal or written, although written is usually preferred * a signed consent form is only evidence of consent – it does not replace the process for obtaining valid consent * most important component is what the patient understands and appreciates, not what the signed consent form states * implied (e.g. a patient holding out their arm for an immunization) or expressed

Question 39

Describe withdrawal of consent (3)

Answer 39

* consent is an ongoing process and can be withdrawn or changed after it is given, unless stopping a procedure would put the patient at risk of serious harm * if consent has been withdrawn during a procedure, the MD must stop treatment unless stopping the procedure would threaten the patient’s life * in obtaining consent to continue the procedure, the physician need only re-explain the procedure and risks if there has been a material change in circumstances since obtaining consent originally. If there has been no material change in circumstances, simple assent to continue is sufficient (*Ciarlariello* *v.* *Schachter*)

Question 40

What act covers consent to treatment, admission to a facility, and personal assistance services (e.g. home care)? (1)

Answer 40

Health Care Consent Act of Ontario (1996)

Question 41

The Supreme Court of Canada expects physicians to disclose the risks that a “reasonable” person would want to know. In practice, this means what? (2)

Answer 41

* means disclosing minor risks that are common * as well as serious risks that happen infrequently, especially those risks that are particularly relevant to a particular patient (e.g. hearing loss for a musician)

Question 42

Name Major Exceptions to Consent (3)

Answer 42

* Emergencies * Public and Mental Health Legislation * Communicable diseases

Question 43

Describe this exception to consent: Emergencies (5)

Answer 43

* treatment can be provided without consent where a patient is experiencing severe suffering, or where a delay in treatment would lead to serious harm or death and consent cannot be obtained from the patient or their substitute decision-maker SDM * emergency treatment should not violate a prior expressed wish of the patient (e.g. a signed Jehovah’s Witness card) * if patient is incapable, MD must document reasons for incapacity and why situation is emergent * patients have a right to challenge a finding of incapacity as it removes their decision-making ability * if a SDM is not available, MD can treat without consent until the SDM is available or the situation is no longer emergent

Question 44

Describe this exception to consent: Mental health Lesgislation (3)

Answer 44

* mental health legislation allows for: * the detention of patients without their consent * psychiatric outpatients may be required to adhere to a care plan in accordance with Community Treatment Orders * Public Health legislation allows medical officers of health to detain, examine, and treat patients without their consent (e.g. a patient with TB refusing to take medication) to prevent transmission of communicable diseases

Question 45

Describe this exception to consent: Special Situations (2)

Answer 45

* public health emergencies (e.g. an epidemic or communicable disease treatment) * warrant for information by police

Question 46

Describe: * Treatment without consent * Treatment with poor or invalid consent

Answer 46

* Treatment without consent = battery, including if NO consent or if WRONG procedure * Treatment with poor or invalid consent = negligence

Question 47

Describe: Consequences of Failure to Obtain Valid Consent (3)

Answer 47

* treatment without consent is battery (an offense in tort), even if the treatment is life-saving (excluding situations outlined in *Exceptions* *to Consent*) * treatment of a patient on the basis of poorly informed consent may constitute negligence, also an offense in tort * the onus of proof that valid consent was not obtained rests with the plaintiff (usually the patient)

Question 48

Capacity is the ability to what? (2)

Answer 48

* Understand information relevant to a treatment decision * appreciate the reasonably foreseeable consequences of a decision or lack of a decision

Question 49

Describe: Overview of Capacity (6)

Answer 49

* capacity is specific for each decision (e.g. a person may be capable to consent to having a chest x-ray, but not for a bronchoscopy) * capacity can change over time (e.g. temporary incapacity secondary to delirium) * most Canadian jurisdictions distinguish capacity to make healthcare decisions from capacity to make financial decisions; a patient may be deemed capable of one, but not the other * a person is presumed capable unless there is good evidence to the contrary * capable patients are entitled to make their own decisions * capable patients can refuse treatment even if it leads to serious harm or death; however, decisions that put patients at risk of serious harm or death require careful scrutiny

Question 50

Describe: College of Physicians and Surgeons of Ontario (CPSO) Policy on Capacity (1)

Answer 50

Capacity is an essential component of valid consent, and obtaining valid consent is a policy of the Canadian Medical Association (CMA) and other professional bodies

Question 51

Describe: Assessment of Capacity (7)

Answer 51

* capacity assessments must be conducted by the clinician providing treatment and, if appropriate, in consultation with other healthcare professionals (e.g. another physician, a mental health nurse) * clinical capacity assessment may include: * specific capacity assessment (i.e. capacity specific to the decision at hand): 1. effective disclosure of information and evaluation of patient’s reason for decision 2. understanding of: * their condition * the nature of the proposed treatment * alternatives to the treatment * the consequences of accepting and rejecting the treatment * the risks and benefits of the various options 3. for the appreciation needed for decision-making capacity, a person must: * acknowledge the symptoms that affect them * be able to assess how the various options would affect them * be able to reach a decision, and make a choice, not based primarily upon delusional belief * general impressions * input from psychiatrists, neurologists, etc. for any underlying mental health or neurological condition that may affect insight or decision-making * employ “Aid to Capacity Evaluation” or any other capacity assessment tool/guideline * a decision of incapacity may warrant further assessment by psychiatrist(s), legal review boards (e.g. in Ontario, the Consent and Capacity Review Board), or the courts * if found incapable by the Consent and Capacity Review Board, patient must receive notice of their ability to pursue judicial review (and essentially appeal the determination)

Question 52

Describe consent for Treatment of the Incapable Patient in a Non-Emergent Situation (2)

Answer 52

* obtain informed consent from substitute decision-maker * an incapable patient can only be detained against their will to receive treatment if they meet criteria for certification under the *Mental* *Health* *Act* (see _Psychiatry_, PS53); in such a situation: * document assessment in chart * notify patient of assessment using appropriate Mental Health Form(s) (Form 42 in Ontario) * notify Rights Advisor

Question 53

Most provinces have legislated hierarchies for substitute decision-makers. Describe the hierarchy in Ontario (9)

Answer 53

* Legally appointed guardian * Appointed attorney for personal care, if a power of attorney confers authority for treatment consent (see Powers of Attorney) * Representative appointed by the Consent and Capacity Board * Spouse or common law partner * Child (age 16 or older) or parent (unless the parent has only a right of access) * Parent with only a right of access * Sibling * Other relative(s) * Public guardian and trustee

Question 54

Substitute decision-maker must follow the following principles when giving informed consent (4)

Answer 54

* act in accordance with wishes previously expressed by the patient while capable * if wishes unknown, act in the patient’s best interest, taking the following into account: 1. values and beliefs held by the patient while capable 2. whether well-being is likely to improve with vs. without treatment 3. whether the expected benefit outweighs the risk of harm 4. whether a less intrusive treatment would be as beneficial as the one proposed

Question 55

Can the the final decision of the SDM be challenged by the MD? (1)

Answer 55

the final decision of the SDM may and should be challenged by the MD if the MD believes the SDM is not abiding by the above principles

Question 56

Describe: Instructional Advance Directives (5)

Answer 56

* allow patients to exert control over their care once they are no longer capable * the patient sets out their decisions about future health care, including who they would allow to make treatment decisions on their behalf and what types of interventions they would want * takes effect once the patient is incapable with respect to treatment decisions * in Ontario, a person can appoint a power of attorney for personal care to carry out their advance directives * the legal threshold to appoint a Power of Attorney for personal care is intentionally set lower than the legal threshold for capacity to consent to many complex medical treatments. This allows a patient that lacks treatment capacity to appoint a person of their choosing to make the decision for them * patients should be encouraged to review these documents with their family and physicians and to reevaluate them often to ensure they are current with their wishes

Question 57

Name: Other Types of Capacity Not Covered by the Health Care Consent Act (HCCA) (5)

Answer 57

* Testamentary (ability to make a will) * Fitness (ability to stand trial) * Financial (ability to manage property – Form 21 of the *Mental Health Act*) * Personal (ability to care for oneself on a daily basis) * Substitute consent for a procedure whose primary purpose is research, sterilization for non-therapeutic purposes, or removal of organs or tissue for transplantation (does not apply to those already declared dead)

Question 58

Who has fiduciary duties for the dependent person? (2)

Answer 58

all Guardians and Attorneys have fiduciary duties for the dependent person

Question 59

Define: Power of Attorney for Personal Care (1)

Answer 59

* a legal document in which one person gives another the authority to make personal care decisions (health care, nutrition, shelter, clothing, hygiene, and safety) on their behalf if they become mentally incapable

Question 60

Define: Guardian of the Person (1)

Answer 60

* someone who is appointed by the Court to make decisions on behalf of an incapable person in some or all areas of personal care, in the absence of a POA for personal care

Question 61

Define: Continuing Power of Attorney for Property (1)

Answer 61

* legal document in which a person gives another the legal authority to make decisions about their finances if they become unable to make those decisions

Question 62

Define: Guardian of Property (1)

Answer 62

* someone who is appointed by the Public Guardian and Trustee or the Courts to look after an incapable person’s property or finances

Question 63

Define: Public Guardian and Trustee (1)

Answer 63

* acts as a substitute decision-maker of last resort on behalf of mentally incapable people who do not have another individual to act on their behalf

Question 64

Describe: Pediatric Aspects of Capacity Covered (7)

Answer 64

* no age of consent in all provinces and territories except Québec; consent depends on patient’s decision-making capacity * Québec has a specific age of consent, but common law and case law deem underage legal minors capable, allowing these individuals to make their own choices * infants and children are assumed to lack mature decision-making capacity for consent but they should still be involved (i.e. be provided with information appropriate to their comprehension level) * adolescents are usually treated as adults * preferably, assent should still be obtained from patient, even if not capable of giving consent * in the event that the physician believes the SDM is not acting in the child’s best interests, an appeal must be made to the local child welfare authorities * under normal circumstances, parents have right of access to the child’s medical record

Question 65

True or False ## Footnote There is no age of consent in Ontario Capacity is assessed on an individual basis

Answer 65

True

Question 66

Describe Ethical Basis of negligence (2)

Answer 66

* the doctor-patient relationship is formed on trust, which is recognized in the concept of fiduciary duty/ responsibility of physician towards patient * negligence or malpractice is a form of failure on the part of the physician in fulfilling their fiduciary duty in providing appropriate care and leading to harm of the patient (and/or abuse of patient’s trust)

Question 67

Describe Legal Basis of negligence (4)

Answer 67

* physicians are legally liable to their patients for causing harm (tort) through a failure to meet the standard of care applicable under the circumstances * standard/duty of care is defined as one that would reasonably be expected under similar circumstances of an ordinary, prudent physician of the same training, experience, specialization, and standing * liability arises from physician’s common law duty of care to their patients in the doctor/patient relationship (or, in Québec, from the Civil Code provisions regarding general civil liability) * action(s) in negligence (or civil liability) against a physician must be launched by a patient within a specific prescribed period required by the respective province in which the

Question 68

Errors of care are compatible with non-negligent care when? (1)

Answer 68

if they are ones that a reasonably cautious and skilled MD could make (i.e. mistakes can be made due to ‘honest error’)

Question 69

Name: Four Basic Elements for Action Against a Physician to Succeed in Negligence

Answer 69

1. A duty of care owed to the patient (i.e. doctor/patient relationship must be established) 2. A breach of the duty of care 3. Some harm or injury to the patient 4. The harm or injury must have been caused by the breach of the duty of care

Question 70

Describe ethical basis of Truth-Telling (3)

Answer 70

* helps to promote and maintain a trusting physician-patient relationship * patients have a right to be told important information that physicians have regarding their care * enables patients to make informed decisions about health care and their lives

Question 71

Describe legal basis of Truth-Telling (3)

Answer 71

* required for valid patient consent (see *Consent* *and* *Capacity*, ELOM7) * goal is to disclose information that a reasonable person in the patient’s position would need in order to make an informed decision (“standard of disclosure”) * withholding information can be a breach of fiduciary duty and duty of care * obtaining consent on the basis of misleading information can be seen as negligent

Question 72

Describe: Evidence about Truth-Telling (6)

Answer 72

* it is a patient’s right to have the option of knowing what is wrong with them * most patients want to know what is wrong with them * although many patients want to protect family members from bad news, they themselves would want to be informed in the same situation * truth-telling improves adherence and health outcomes * informed patients are more satisfied with their care and most often take the news better than expected * negative consequences of truth-telling can include decreased emotional well-being, anxiety, worry, social stigmatization, and loss of insurability

Question 73

Describe: CPSO Policy on Truth-Telling (1)

Answer 73

* Physicians should provide patients with whatever information that will, from the patient’s perspective, have a bearing on medical decision-making and communicate that information in a way that is comprehensible to the patient

Question 74

Give Examples of Warning of Impending Bad News (2)

Answer 74

* “I have something difficult to tell you…” “This may come as a shock to you, but the tests indicate…” * “There is no easy way for me to tell you this, so I will tell you straight away that you have a serious problem…”

Question 75

# Define: Adverse Event (1)

Answer 75

An unintended injury or complication from health care management resulting in disability, death, or prolonged hospital stay

Question 76

Describe: Medical Error (7)

Answer 76

* medical error may be defined as ‘preventable adverse events (AEs)’ caused by the patient’s medical care and not the patient’s underlying illness; some errors may be identified before they harm the patient, so not all error is truly ‘adverse’ * many jurisdictions and professional associations expect and require physicians to disclose medical error; that is, any event that harms or threatens to harm patients must be disclosed to the patient or the patient’s family and reported to the appropriate health authorities * physicians must disclose to patients the occurrence of AEs or errors caused by medical management, but should not suggest that they resulted from negligence because: * negligence is a legal determination * error is not equal to negligence * disclosure allows the injured patient to seek appropriate corrective treatment promptly * physicians should avoid simple attributions as to cause and sole responsibility of others or oneself * physicians should offer apologies or empathic expressions of regret (e.g. “I wish things had turned out differently”) as these build trust and are not admissions of guilt or liability * Apology Acts across Canada protect apologies, both as expressions of regret and admissions of responsibility, from being used as evidence of liability and negligence

Question 77

Describe Breaking Bad News (3)

Answer 77

* ‘bad news’ may be any information that reveals conditions or illnesses threatening the patient’s sense of well-being * poorly done disclosure may be as harmful as non-disclosure * caution patients in advance of serious tests and disclose possible bad findings * give time for patient to reflect prior to receiving such news * give warnings of impending bad news by reviewing prior discussions * provide time for the patient and questions * adequate supports and strategies should always be provided following disclosure of difficult news * **SPIKES** protocol was developed to facilitate “breaking bad news”

Question 78

Describe: **SPIKES** protocol (6)

Answer 78

* **S**ETTING and LISTENING SKILL * Patient **P**ERCEPTIONS of condition and seriousness * **I**NVITATION from patient to receive information * **K**NOWLEDGE - provide medical facts * Explore **E**MOTIONS and **E**MPATHIZE * **S**TRATEGY and SUMMARY

Question 79

Name: Arguments Against Truth-Telling (3)

Answer 79

* may go against certain cultural norms and expectations * may lead to patient harm, but only in extreme, rare situations * medical uncertainty may result in the disclosure of uncertain or inaccurate information

Question 80

Name: Exceptions to Truth-Telling (4)

Answer 80

* a patient may waive their right to know the truth about their situation (i.e. decline information that would normally be disclosed) when: * the patient clearly declines to be informed * a strong cultural component exists that should be respected and acknowledged * the patient may wish others to be informed and make the medical decisions for them * the more weight for the consequences for the patient from non-disclosure, the more carefully one must consider the right to ignorance * ‘emergencies’: an urgent need to treat may legitimately delay full disclosure; the presumption is that most people would want such treatment and the appropriate SDM cannot be found * ‘therapeutic privilege’

Question 81

Describe: Therapeutic privilege (3)

Answer 81

* withholding of information by the clinician in the belief that disclosure of the information would itself lead to severe anxiety, psychological distress, or physical harm to the patient * clinicians should avoid invoking therapeutic privilege due to its paternalistic overtones; it is a defence of non-disclosure that is rarely accepted anymore * it is often not the truth that is unpalatable; it is how it is conveyed that can harm the patient

Question 82

Describe: Managing Controversial and Ethical Issues in Practice (5)

Answer 82

* discuss in a non-judgmental manner * ensure patients have full access to relevant and necessary information * identify if certain options lie outside the physician's moral boundaries and refer to another physician if appropriate * consult with appropriate ethics committees or boards * protect freedom of moral choice for students or trainees

Question 83

Describe: Overview of the Maternal-Fetal Relationship (2)

Answer 83

* in general, maternal and fetal interests align * in some situations, a conflict between maternal autonomy and the best interests of the fetus may arise

Question 84

Describe fetus legal rights (1)

Answer 84

The fetus does not have legal rights until it is born alive and with complete delivery from the body of the woman

Question 85

Name: Ethical Issues and Arguments of Reproductive Technologies (2)

Answer 85

* principle of reproductive freedom: women have the right to make their own reproductive choices * coercion of a woman to accept efforts to promote fetal well-being is an unacceptable infringement of her personal autonomy

Question 86

The law protects a woman’s right to life, liberty, and security of person, and does not recognize fetal rights; key aspects of the mother’s rights include what? (4)

Answer 86

* the law protects a woman’s right to life, liberty, and security of person, and does not recognize fetal rights; key aspects of the mother’s rights include: * if a woman is competent and refuses medical advice, her decision must be respected even if the fetus will suffer * the fetus does not have legal rights until it is born alive and with complete delivery from the body of the woman * a pregnant woman that is addicted to teratogenic substances cannot be detained and treated to protect the fetus (*Winnipeg* *Child* *and* *Family* *Services (Northwest Area) v. G. (D.F.), [1997] 3 S.C.R.* *925*) * a fetus is not a “human being” within the meaning of the Criminal Code of Canada, thus medical negligence during delivery resulting in the death of a fetus that has not been born alive does not constitute criminal negligence causing death (manslaughter) and cannot attract criminal penalties (*R v Sullivan*)

Question 87

Describe: Neonate as Member of Society (4)

Answer 87

Paediatr Child Health 2012;17(8):443-444 * Once outside the mother’s body, the neonate becomes a member of society with all the rights and protections other vulnerable persons receive. * Non-treatment of a neonate born alive is only acceptable if \<22 wk GA * 23-25 wk GA: treatment should be a consensual decision between physician and parents * 25 wk GA and more: neonate should receive full treatment unless major anomalies or conditions incompatible with life are present

Question 88

*Name: Royal Commission on New Reproductive Technologies* (1993) recommendations (5)

Answer 88

1. medical treatment must never be imposed upon a competent pregnant woman against her wishes 2. no law should be used to confine a pregnant woman in the interest of her fetus 3. the conduct of a pregnant woman in relation to her fetus should not be criminalized 4. child welfare should never be used to control a woman’s behaviour during pregnancy 5. civil liability should never be imposed upon a woman for harm done to her fetus during pregnancy

Question 89

Name: Examples involving the use of established guidelines for Maternal-Fetal Relationship (2)

Answer 89

* a woman is permitted to refuse HIV testing during pregnancy, even if vertical transmission to fetus results, however, once the baby is born, breastfeeding and even theoretical transmission of HIV may attract criminal liability (this area of law is unsettled) * a woman is permitted to refuse Caesarean section in labour that is not progressing, despite evidence of fetal distress

Question 90

Name examples of Advanced Reproductive Therapies (3)

Answer 90

* non-coital insemination * hormonal ovarian stimulation * in vitro fertilization IVF

Question 91

Name topics with ethical concerns in Advanced Reproductive Therapies (7)

Answer 91

* donor anonymity vs. child-centred reproduction (i.e. knowledge about genetic medical history) * preimplantation genetic testing for diagnosis before pregnancy * use of new techniques without patients appreciating their experimental nature * embryo status – the Supreme Court of Canada maintains that fetuses are “unique” but not persons under law; this view would likely apply to embryos as well * private vs. public funding of advanced reproductive technologies ART * social factors limiting access to advanced reproductive technologies ART (e.g. same-sex couples) * the ‘commercialization’ of reproduction

Question 92

Ppluripotent stem cells can currently be derived from what? (2)

Answer 92

human embryonic and fetal tissue

Question 93

Name potential uses of stem cells in research (5)

Answer 93

* studying human development and factors that direct cell specialization * evaluating drugs for efficacy and safety in human models * cell therapy: using stem cells grown in vitro to repair or replace * degenerated/destroyed/malignant tissues (e.g. Parkinson’s disease) * genetic treatment aimed at altering somatic cells (e.g. myocardial or immunological cells) is acceptable and ongoing

Question 94

Describe: Advanced Reproductive Technologies: Ethically Appropriate Actions (4)

Answer 94

* Educate patients and address contributors to infertility (e.g. stress, alcohol, medications, etc.) * Investigate and treat underlying health problems causing infertility * Wait at least 1 yr before initiating treatment with ART (exceptions – advanced age or specific indicators of infertility) * Educate and prepare patients for potential negative outcomes of ART

Question 95

Payment of gamete donors is currently legal/illegal in Canada.

Answer 95

illegal

Question 96

The advanced reproductive technologies Act is currently not being enforced. Why? (1)

Answer 96

as it does not clarify whether ART falls under the jurisdiction of the federal or provincial government

Question 97

Describe: Semen Regulations of the Food and Drug Act, 1996 (1)

Answer 97

No one under age 18 can donate sperm or eggs, except for the purpose of creating a child that the donor plans to raise himself/ herself (e.g. young patients receiving radiation therapy for cancer that may cause infertility)

Question 98

Describe: Assisted Human Reproduction Act, 2004 (1)

Answer 98

Surrogate mothers cannot be paid or offered compensation beyond a reimbursement of their expenses

Question 99

Define: CMA definition of induced abortion (1)

Answer 99

* the active termination of a pregnancy before fetal viability (fetus \>500 g or \>20 wk GA)

Question 100

Describe: CMA policy on induced abortion (9)

Answer 100

1. induced abortion should not be used as an alternative to contraception 2. counselling on contraception must be readily available 3. full and immediate counselling services must be provided in the event of unwanted pregnancy 4. there should be no delay in the provision of abortion services 5. no patient should be compelled to have a pregnancy terminated 6. physicians should not be compelled to participate in abortion – if morally opposed, the physician should inform the patient so she may consult another physician 7. no discrimination should be directed towards either physicians who do not perform or assist at induced abortions or physicians who do 8. induced abortion should be uniformly available to all women in Canada and health care insurance should cover all the costs (note: the upper limit of GA for which coverage is provided varies between provinces) 9. elective termination of pregnancy after fetal viability may be indicated under exceptional circumstances

Question 101

Describe Ethical and Legal Concerns and Arguments of Induced Abortion (3)

Answer 101

* in Canada, there is no criminal prohibition regarding abortion * it is a woman’s medical decision to be made in consultation with whom she wishes; there is no mandatory role for spouse/family * 2nd and even 3rd trimester abortions are not illegal in Canada, but are usually only carried out when there are serious risks to the woman’s health, or if the fetus has died in utero or has major malformations (e.g. anencephaly). Medical termination of pregnancy (MTP) for social reasons are now conducted in select medical centres in Canada

Question 102

Describe: The Tri-Council Policy Statement (10)

Answer 102

1. Genetic treatment aimed at altering germ cells is prohibited in Canada and elsewhere 2. Embryo research is permitted up to 14 d post-fertilization 3. Embryos created for reproductive purposes that are no longer required may be used 4. Gamete providers must give free and informed consent for research use 5. No commercial transactions in the creation and use of the embryos are permitted 6. Creation of embryos solely for research purposes is prohibited 7. 8. Human cloning is strictly prohibited 8. Risks of coercion must be minimized (i.e. the fertility treatment team may not be pressured to generate more embryos than necessary) 9. One may only discuss the option of using fetal tissue for research after free and informed choice to have a therapeutic abortion has been made by the patient 10. Physicians responsible for fertility treatment may not be part of a stem cell research team

Question 103

Name uses of Prenatal/Antenatal Genetic Testing (4)

Answer 103

1. to confirm a clinical diagnosis 2. to detect genetic predisposition to a disease 3. allows preventative steps to be taken and helps patient prepare for the future 4. gives parents the option to terminate a pregnancy or begin early treatment

Question 104

In Prenatal/Antenatal Genetic Testing, ethical dilemmas arise because of the sensitive nature of genetic information; important considerations of genetic testing include what? (5)

Answer 104

* the individual and familial implications * its pertinence to future disease * its ability to identify disorders for which there are no effective treatments or preventive steps * its ability to identify the sex of the fetus * ethical issues and arguments regarding the use of prenatal/antenatal genetic testing include: * obtaining informed consent is difficult due to the complexity of genetic information * doctor’s duty to maintain confidentiality vs. duty to warn family members * risk of social discrimination (e.g. insurance) and psychological harm

Question 106

Name legal aspects of Induced Abortion (4)

Answer 106

* no current specific legislation exists * testing requires informed consent * no standard of care exists for clinical genetics, but physicians are legally obligated to inform patients that prenatal testing exists and is available * a physician may be able to breach confidentiality in order to warn family members about a condition if harm can possibly be prevented via treatment or prevention. In general, the patient’s consent is required, unless the harm to be avoided is sufficiently serious to rise to the level of imminent risk of serious bodily harm or death (i.e. not a chronic condition, but an acute life-threatening condition)

Question 107

In Genetic Testing, name Ethically Appropriate Actions (2)

Answer 107

* thorough discussion and realistic planning with patient before testing is done * genetic counselling for delivery of complex information

Question 108

Describe: Overview of Palliative and End-of-Life Care (5)

Answer 108

* focus of care is comfort and respect for person nearing death and maximizing quality of life for patient, family, and loved ones * palliative care is an approach that improves the quality of life of patients facing life-threatening illness, through the prevention and relief of suffering, including treating pain, physical, psychosocial, and spiritual concerns * appropriate for any patient at any stage of a serious or life-limiting illness * may occur in a hospital, hospice, in the community, or at home * often involves an interdisciplinary team of caregivers * addresses the medical, psychosocial, and spiritual dimensions of care

Question 109

Describe: Euthanasia (1)

Answer 109

knowingly and intentionally performing an act, with or without consent, that is explicitly intended to end another person’s life where that person has an incurable illness

Question 110

Describe: medical-assistance in dying (2)

Answer 110

* the administering or prescribing for self-administration, by a medical practitioner or nurse practitioner, of a substance, at the request of a person, that causes their death * palliative sedation * withdrawing or withholding life sustaining interventions (e.g. artificial ventilation or nutrition) that are keeping the patient alive but no longer wanted or indicated

Question 111

Describe: Palliative sedation (2)

Answer 111

* the use of sedative medications for patients that are terminally ill to relieve suffering and manage symptoms. * Though the intent is not to hasten death, this may be a foreseeable consequence

Question 112

Describe the difference between palliative care and euthanasia (2)

Answer 112

* Palliative care is an approach designed to improve symptoms and quality of life for the duration of a person's life, but unlike Medical Assistance in Dying, it does not aim directly at or intend to end the person’s life. * Many palliative care physicians are incorporating Medical-Assistance in Dying (MAID) into their practice, though some may conscientiously object

Question 113

Name: Common Ethical Arguments/Opinions of Euthanasia and Medical-Assistance in Dying (MAID) (7)

Answer 113

* criminally prohibiting assistance in death, forces some who will eventually become too unwell to end their own lives at an earlier time and forces others to endure intolerable suffering. * patient has the right to make autonomous choices about the time and manner of their own death * belief that there is no ethical difference between the acts of euthanasia/assisted suicide and forgoing life- sustaining treatments * belief that these acts benefit terminally ill patients by relieving suffering * patient autonomy has limits * death should be the consequence of the morally justified withdrawal of life-sustaining treatments only in cases where there is a fatal underlying condition, and it is the condition (not the withdrawal of treatment) that causes death * an argument presented in the Carter case (see below) suggested permitting MAID will detract support for palliative care, since with proper palliative care, the number of requests for MAID would decrease. This argument was rejected in *Carter v. Canada*, as making people suffer to potentially improve care for others is not acceptable

Question 114

Describe legal aspect: Common Ethical Arguments/Opinions of Euthanasia and Medical-Assistance in Dying (MAID) (2)

Answer 114

* in the *Carter v. Canada* decision of February 2015, the criminal prohibition on assistance in suicide was ruled unconstitutional to the extent that they prohibit physician-assisted death for a competent adult person who (1) clearly consents to the termination of life and (2) has a grievous and irremediable medical condition that causes enduring suffering that is intolerable to the individual in the circumstances of his or her condition * Bill C-14 (June 17, 2016) legalized MAID by amending the Criminal Code to create exemptions permitting medical practitioners to provide MAID, specified the eligibility criteria, safeguards, and required documentation and authorization from the Minister of Health, as well as new offences for failure to comply with the new regulations. http://www.parl.ca/DocumentViewer/en/42-1/bill/C-14/ royal-assent * as the Bill C-14 criteria are narrower than the Carter decision, there are ongoing constitutional challenges to the MAID framework as it currently stands

Question 115

Describe: Bill C-14 Criteria for MAID (4)

Answer 115

* patient is eligible for publicly-funded health services in Canada * at least 18 yr of age, and has capacity for clear and freely given consent * grievous and irremediable medical condition: in an advanced state of irreversible decline in capability * suffering intolerable to the patient, not relieved under conditions they consider acceptable natural death is reasonably foreseeable

Question 116

Describe Euthanasia and Medical-Assistance in Dying (MAID) (7)

Answer 116

1. eligibility criteria satisfied 2. patient signs and dates a written request for MAID 3. two independent witness sign the written request. Witnesses must be 18 years of age, understand the nature of MAID, and must not a) benefit (financially or otherwise) from the death, b) be an owner or operator of the healthcare facility where the patient is receiving care, c) be directly involved in the provision of health or personal care of the patient 4. HCP must inform the patient that they can withdraw their consent at any time 5. two independent assessors (MD or NP) must provide written confirmation that eligibility criteria are met 6. 10 clear days must elapse between the request and the day on which MAID is provided, unless both healthcare providers agree that a shorter period is appropriate due to the patient’s imminent death or loss of capacity 7. throughout the 10 d period and immediately before providing MAID, the HCP must give the individual an opportunity to withdraw the request and ensure that the patient gives express consent to receive MAID * contravention of this process is an offence punishable by up to five years in prison

Question 117

Name: Acceptable Use of Palliative and End-of-Life Care (5)

Answer 117

* the use of palliative sedation with opioids in end-of-life care, knowing that death may occur as an unintended consequence (principle of double effect) is distinguished from euthanasia and assisted suicide where death is the primary intent * the appropriate withdrawal of life-support is distinguished from euthanasia and assisted suicide as it is seen as allowing the underlying disease to take its ‘natural course’, but this distinction may be more theoretical than real * consent for withdrawal of life-support must be sought from the capable patient, or in case of incapable patient the SDMs, as per the *Health* *Care* *Consent* *Act* and *Substitute* *Decisions* *Act*, and as re-affirmed by the ruling in *Cuthbertson* *v.* *Rasouli* in 2013, as palliative care would be instituted and consent for that would require SDM consent * refusals of care by the patient that may lead to death as well as requests for a hastened death, ought to be carefully explored by the physician to rule out any ‘reversible factors’ (e.g. poor palliation, depression, poverty, ill-education, isolation) that may be hindering authentic choice * Government of Canada – Services and Information for End-of-Life Care: https://[www.canada.ca/en/](http://www.canada.ca/en/) health-canada/topics/end-life-care.html * options and decision making at end of life: palliative care, do not resuscitate orders, refusal or withdrawal of treatment, refusal of food and drink, palliative sedation, MAID * decisions at end of life: informed and capacity for consent, substitute decision maker, advanced care planning (written plan, will, or medical directive) often established through a family meeting

Question 118

Describe: Physician Responsibilities Regarding Death (6)

Answer 118

* physicians are required by law to complete a medical certificate of death unless the coroner needs notification; failure to report death is a criminal offence * *Coroner’s* *Act*, 1990 (specific to Ontario, similar in other provinces) requires physicians to notify a coroner or police officer if death occurs: * coroner investigates these deaths, as well as deaths that occur in psychiatric institutions, jails, foster homes, nursing homes, hospitals to which a person was transferred from a facility, institution or home, etc. * in consultation with forensic pathologists and other specialists, the coroner establishes: * the identity of the deceased * where and when the death occurred * the medical cause of death * the means of death (i.e. natural, accidental, suicide, homicide, or undetermined) * coroners do not make decisions regarding criminality or legal responsibility * while the Supreme Court of Canada noted that nothing in the *Carter v. Canada* decision compelled a physician to participate in MAID, the College of Physicians and Surgeons of Ontario mandatory referral policy, which has been upheld by the courts, requires physicians in Ontario to provide an effective referral if the physician conscientiously objects to MAID * the impact of MAID on religious institutions’ obligation towards patients is not yet clear

Question 119

*Coroner’s* *Act*, 1990 (specific to Ontario, similar in other provinces) requires physicians to notify a coroner or police officer if death occurs how? (7)

Answer 119

* due to violence, negligence, misconduct, misadventure, or malpractice * during pregnancy or is attributable to pregnancy * suddenly and unexpectedly * from disease which was not treated by a legally qualified medical practitioner * from any cause other than disease * under suspicious circumstances * death from MAID

Question 120

Describe: CanMEDS Competencies (2)

Answer 120

* a framework of professional competencies established by the Medical Council of Canada (MCC) as objectives for the MCC Qualifying Exam * further information on Medical Council of Canada objectives can be found at [www.mcc.ca](http://www.mcc.ca/)

Question 121

Describe: CPSO Policy - Ending the Physician-Patient Relationship (1)

Answer 121

Discontinuing services that are needed is an act of professional misconduct unless done by patient request, alternative services are arranged, or adequate notice has been given

Question 122

Physicians’ conduct and competence are legally regulated to do what? (1)

Answer 122

protect patients and society via mandatory membership to provincial governing bodies (e.g. the CPSO)

Question 123

Physicians are legally required to maintain a license with the appropriate authority, and are thus legally bound to do what? (1)

Answer 123

outlined policies on matters of conduct within their medical practice

Question 124

The ultimate constraint on MD behaviour with regards to unprofessionalism is what? (5)

Answer 124

is ‘conduct unbecoming a physician’, such as * inappropriate behaviour with colleagues * conflicts of interest * untruthfulness * unethical billing practices * and sexual impropriety with patients

Question 125

Name: Common Policies on Physician Conduct (4)

Answer 125

* physicians must ensure that patients have access to continuous on-call coverage and are never abandoned * physicians are required to comply with the law, which include human rights laws. A failure to accommodate a disability in violation of human rights legislation, can result in the regulatory body sanctioning the physician in addition to any penalties assigned by the human rights tribunal * sexual conduct with patients, even when consented to by the patient, is a serious matter that can lead to accusations of battery by the patient and provincial governing body. Important notes on this topic include: * inappropriate sexual conduct includes intercourse, undue touching, references to sexual matters, sexual jokes, and physician presence when capable patients undress or dress * in specified situations, physicians may have a personal relationship with a patient provided a year has passed since the last therapeutic contact * physicians are permanently prohibited from personal relationships with patients whom they saw for psychotherapy * in Ontario, physicians must report any colleagues of whom they have information regarding sexual impropriety (as per CPSO Code of Ethics) * physicians must maintain adequate records for each patient, which include: * demonstration that care has been continuous and comprehensive * minimal standards for record-keeping, including readability, diagnosis, differential diagnosis, appropriate tests and referrals, and a coherent patient record, including drugs, a cumulative patient profile, and all aspects of charting that are required for safe patient care (full standards available at www.cpso.on.ca). Another physician should be able to take over the safe care of the patient based on the record * records stored for 10 years in most jurisdictions * although the medical record is the property of the physician or an institution, the patient or the patient’s delegate must be: * allowed full access to information in the medical record * patient or delegate must obtain access within a reasonable period of time * usually upon written request by the patient or patient's delegate * physician can charge a reasonable fee for this service * in the hospital, physicians must ensure their own competence, respect hospital by-laws and regulations, practice only within the limits of granted privileges, cooperate with other hospital personnel, and maintain adequate hospital records

Question 126

Describe: Research Ethics (4)

Answer 126

* involves the systematic analysis of ethical dilemmas arising during research involving human subjects to ensure that: * study participants are protected * clinical research is conducted to serve the interests of the participants and/or society as a whole * major ethical dilemmas arise when a physician’s obligation to the patient comes into conflict with other obligations and incentives * any exceptions to disclosure for therapeutic consent do not apply in an experimental situation * important ethical principles to consider when conducting research on human subjects are laid out in the *Declaration of Helsinki, the Belmont Report*, and the *Tri-Council Policy Statement: Ethical Conduct on Research Involving Human Subjects*

Question 127

Name guiding principles of ethical research (3)

Answer 127

* Respect for persons: informed consent * Beneficence: harm vs. benefit * Justice: avoid exploitation/unjustified exclusion

Question 128

Describe: Informed Consent for Research (5)

Answer 128

* Purpose of study * Sum of funding * Name and probability of harm and benefits * Nature of physician’s participation including compensation * Proposals for research must be submitted to a research ethics board

Question 129

Randomization is allowed even if there is an efficacious standard if. For example when? (1)

Answer 129

for example, there are drawbacks to it (such as it doesn’t work for all, has side effects, and is not tolerated). In such cases, there must be a good safety net established to make sure subjects in the placebo arm do not deteriorate (i.e. there must be a safety monitoring plan for such studies)

Question 130

Name: Ethical Principles for Research Involving Human Subjects (9)

Answer 130

* Patient’s participation in research should not put them at a known or probable disadvantage with respect to medical care (i.e. cannot deny participants in research ‘known effective care’, such as randomizing patients with depression to a placebo arm with no treatment) * Participant’s voluntary and informed choice is usually required, except in special circumstances (i.e. chart reviews without patient contact, or emergency situations for which there is no accepted or helpful standard of care and the proposed intervention is not likely to cause more harm than such patients already face) * Access to the treatment that is considered standard (i.e. placebo-controlled trials are generally acceptable where patients still receive the standard of care, or, if not, are informed about the placebo arm and what that entails) * Must employ a scientifically valid design to answer the research question (ensured via peer review, expert opinion) * Must demonstrate sufficient value to justify any risk posed to participants * Must be conducted honestly (i.e. carried out as stated in the approved protocol) * Findings must be reported promptly and accurately without exaggeration, to allow practicing clinicians to draw reasonable conclusions * Patients must not be enticed into risky research by financial incentives and investigators must not trade the interests of patients for disproportionate recompense by a sponsor; both participants and investigators are due fair recompense for their time and efforts * Any significant interventional trial ought to have a data safety monitoring board that is independent of the sponsor and can ensure safety of the ongoing trial

Question 131

Describe: CMA and CPSO Guidelines for Ethically Appropriate Physician-Industry Relations (5)

Answer 131

* The primary goal should be the advancement of the health of Canadians * Relationships should be guided by the CMA Code of Ethics * The physician’s primary obligation is to the patient * Physicians should avoid any self-interest in their prescribing and referral practices * Physicians should always maintain professional autonomy, independence, and commitment to the scientific method

Question 132

Describe: Physician-Industry Relations (5)

Answer 132

* health care delivery in Canada involves collaboration between physicians and the pharmaceutical and health supply industries in the areas of research, education, and clinical evaluation packages (i.e. product samples) * however, unlike physicians, pharmaceutical and health supply industries do not have a fiduciary duty to patients and are profit-driven * for example, the dissemination of free product samples by pharmaceutical companies is associated with increased patient preference for new drugs that are often more expensive, thus incurring a greater long-term cost for patients and the healthcare system * new pharmaceutical products are not always more effective than previous standard of care and may have less robust safety evidence by virtue of being new drugs * physicians must ensure that their participation in such collaborative efforts is in keeping with their duties to their patients and society; however, physicians often struggle to properly identify situations in which a conflict of interest is present * even seemingly innocuous gifts or other interactions (pens with pharmaceutical logo, research honoraria, meals, speaker fees, etc.) can subconsciously influence physician practices and beliefs in favour of promoted products, resulting in the prescription of medications for reasons other than their efficacy and safety profile * gifts or free products from the pharmaceutical industry are usually inappropriate: * sponsorship for travel and fees for conference attendance may be accepted only where the physician is a conference presenter and not just in attendance * physicians receiving such sponsorship must disclose this at presentations and/or in written articles

Question 133

Define: Ressource allocation (1)

Answer 133

the distribution of goods and services to programs and people

Question 134

What must physicians do in regards to resource allocations (2)

Answer 134

* physicians have the duty to inform patients about therapeutic options even if they are not available * physicians must make health care resources available to patients in a manner which is fair and equitable, without bias or discrimination * need and benefit are morally relevant criteria for resource allocation * gender, sexual orientation, religion, level of education, or age **alone** are morally irrelevant criteria. Must be weighed against need and benefit to justify equitable allocation of resources

Question 135

Name ethical dilemmas that arise when deciding how best to allocate resources (4)

Answer 135

* fair chances vs. best outcome: favouring best outcome vs. giving all patients fair access to limited resources (e.g. transplant list prioritization) * priorities problem: how much priority should the sickest patients receive? * aggregation problem: modest benefits to many vs. significant benefits to few * democracy problem: when to rely on a fair democratic process to arrive at a decision

Question 136

Describe Guidelines for Appropriately Allocating Resources (7)

Answer 136

* protect and promote the welfare and best interests of their patients * choose interventions known to be beneficial on the basis of evidence of effectiveness * seek the tests or treatments that will accomplish the diagnostic or therapeutic goal for the least cost * advocate for one’s patients, but avoid manipulating the system to gain unfair advantage for them * resolve conflicting claims for scarce resources justly, on the basis of morally relevant criteria such as need and benefit, using fair and publicly defensible procedures * inform patients of the impact of cost constraints on care, but in a sensitive way * seek resolution of unacceptable shortages at the level of hospital management or government

Question 137

Describe: Patients Refusing Treatment (3)

Answer 137

* in accordance with the principle of autonomy, it is generally acceptable for competent patients to refuse medical interventions for themselves or others, although exceptions may occur * the onus of justifying reasons for refusal or agreement is higher on SDMs than on capable patients * if parents or SDMs make decisions that are clearly not in the “best interests” of an incapable child, physicians may have ethical grounds for administering treatment, depending on the acuity of the clinical situation * in high-acuity scenarios (e.g. refusing blood transfusion based on religious grounds for a child in hemorrhagic shock), physicians have a stronger obligation to act in the child’s best interests * in lower acuity scenarios (e.g. refusing childhood immunization in a developed nation) there is a stronger obligation to respect the autonomy of the decision-makers * in 2014, a child was found not to be “a child in need of protection” when her mother refused chemotherapy and pursued traditional Indigenous healing. While this decision purported to establish a new constitutional right to Indigenous healing, the decision was amended such that “the best interests of the child are paramount." These statements could be interpreted in contradiction with each other, so it is unclear what the current status of the law is. See *Hamilton* *Health* *Sciences* *Centre* *v.* *DH* for more information

Question 138

Describe: Physicians Refusing to ProvideTreatment (1)

Answer 138

* physicians may refuse to provide treatment or discontinue relationships with patients, but must ensure these patients can access services elsewhere by way of referring the patient to a willing practitioner (e.g. a pediatrician who refuses to treat an unvaccinated child should refer the family to another practice)

Question 139

Name: Recommendations for Working with Families Who Refuse Childhood Immunization (6)

Answer 139

1. Provide clear information about the risks and benefits of immunization and the diseases targeted. 2. Inform parents when their beliefs are unsupported by evidence. 3. Physicians can discontinue professional services but must comply with legal and ethical requirements. Parents are entitled to refuse treatment that a physician recommends; not every disagreement should result in discharge from practice. 4. Vaccine education for Complementary and Alternative Medicine providers. 5. Public education campaigns regarding immunization. 6. No-fault compensation for vaccine- related injury.

Question 140

Indigenous peoples collectively refers to who? (6)

Answer 140

* original inhabitants of Canada and their descendants: First Nations, Inuit, and Métis peoples defined in the *Canadian* *Constitution* *Act*, 1982 * First Nations traditional territory encompasses all of geographic Canada and constitutes many distinct communities and languages * Inuit refers to original inhabitants of arctic regions including Labrador, northern Quebec, Nunavut, and Northwest Territories * Métis are Indigenous people of both First Nations and European heritage * Canada’s *Indian* *Act*, 1876, defined who is considered a “status Indian” and thus eligible for programs and services by federal and provincial agencies. Non-Status First Nations, are Indigenous people who are not a “Registered Indian” with the federal government * while used by the federal government and for legal proceedings, the terms “status/non-status Indian” are paternalistic and offensive * the *Daniels* *Decision*, 2016, the Federal Court of Canada, deemed Métis and non-status First Nations peoples be considered “Indians” under *Canadian* *Constitution* *Act* but no reparations in fiduciary duty or duty to consult have been made

Question 141

Describe: Indigenous Health Policy in Canada (5)

Answer 141

* is made up of a complicated “patchwork” of policies, legislation and agreements between federal, provincial, municipal, and Indigenous governments which is in a constant state of flux; reviewed by the National Collaborating Centre for Indigenous Health (NCCIH): [http://www.nccah-ccnsa.ca/en/publications.aspx?sortcode=2.8.10&publication=28](http://www.nccah-ccnsa.ca/en/publications.aspx?sortcode=2.8.10&publication=28) * while some Indigenous health services are adequate, gaps and ambiguities created by complicated policy and jurisdictions have created barriers to health equity * for on-reserve First Nations and Inuit, the federal government finances and administers health services through the First Nations and Inuit Health Branch (FNIHB) * the *Indian* *Health* *Policy*, 1979, and *Health* *Transfer* *Policy*, 1989, transferred control to individual communities to negotiate with the FNIHB varying levels of health care responsibility to the community or council level * treaties and Self Government Agreements can define areas of jurisdiction for federal, provincial/ territorial, and First Nations governments