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 healthcare team membersinvolved in the “circle of care.” However, the

patient may withdraw consent for thissharing of information and may put parts of the chart in a

“lockhox”

physicians have a professional obligation to facilitate timely transmission of the patient'

s medical

record to third parties(with the patient'

s consent),such asfor 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 regulationsregarding 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: https://www.cpso.on.ca /Physicians/Policies-Guidance/Policies/

Protecting-Personal-Health-Information

Reasons to Breach Confidentiality

. Child abuse

• Fitnesstodrive

. Communicable disease

• Coroner report

• Duty to inform/warn

Lock Boxes

The term “lock boxes"applies to

situations where the patient has

expressly restricted their physician

from disclosing specific aspects of

their health information toothers, 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 physiciansfrom disclosing

personal health information permitted/

required by the law

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ELOM11 Ethical, Legal,and Organizational Medicine Toronto Notes 2023

• 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 healthcare providers

that are not part of a patient'

s circle of care accessing medical records inappropriately (e.g. out of

curiosity or for profit). All staff should be aware that most EMRslog which healthcare providers

view records and automatically flag files for further review in certain cases (e.g.same surname,

VIP patients, or audit of access to records)

CPSO Policy Consent

Obtaining valid consent before carrying

out medical,therapeutic,and diagnostic

procedures has long been recognized

as an elementary step in fulfilling the

physician'

s obligations to the patient

Consent and Capacity

Ethical Principles Underlying Consent and Capacity

• consent is the autonomous authorization of a medical intervention by a patient

• usually the principle of respect for patient autonomy must be balanced with the principle of

beneficence, since a physician need not offer an intervention that does not serve some benefit based on

their clinical judgment

• informed consent is a process, not a transaction or a signature on a page

• informed refusal is equivalent in principle and approach

• if a patient is deemed incapable of consenting to a proposed medical intervention, then it isthe 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 and taking into account the patient'

s values,

beliefs, and preferences, including any relevant cultural and/or religious considerations and the

patient’

sinterpretation of those considerations

• more recently expressed wishes take priority over remote ones

• patient wishes may be expressed verbally or in written form

• patients found incapable of making a specific decision should still be involved in the decision-making

process as much as possible. If a patient found incapable expresses a willingness to pursue the

proposed treatment/intervention, then thisis known as assent (rather than ‘consent,’which requires

capacity)

• agreement or disagreement with medical advice does not determine findings of capacity/incapacity

• however, patients opting for care that puts them at risk ofserious harm that most people would want

to avoid should have their capacity carefully assessed. Steer clear from the tendency to define what

reasonable person standards may be. If appropriate, look to discern patterns of justification offered

by patients and their individual values and beliefs, which may be influenced by social context,such as

culture and/or religion

• laws pertaining to consent and capacity may vary by province/territory and readers are encouraged to

consult provincial/territorial guidelines

PSO Policy on Capacity

Capacity is an essential component

of valid consent and obtaining valid

consent is a policy of the CMA and other

professional bodies

4 Basic Elements of Consent

• Voluntary

• Capable

• Specific

• Informed

Professional Considerations

Geriatric Patient

• Identify their goals of care and

resuscitation options (CPR or DNR)

(Note:we should aim to have goals

of care discussions with all patients,

regardless of age)

• Check for documentation of advance

care planning (commonly referred

to as‘advance directives'

) and PQA

where applicable

Paediatric Patient

• Identify the primary decision-maker,

if applicable (parents, guardian,

wards-ofstate.emancipated)

• Regarding capacity assessment

(see Poediotric Aspects of Capacity,

ELOM14)

• Be aware of custody issues, if

applicable

Terminally III or Palliative Patient

. Consider the SPIKES approach to

breaking bad news (see ELOM15)

• Identify the patient’s goals of

care (i.e. disease vs.symptom

management)?

• Identify whether an advance care

plan exists(See Palliative Medicine.

PM5)

• Determine the patient'sSDM

according to the SDM hierarchy. If the

patient has a POA then obtain a copy

of the document

• Check for documentation of

resuscitation options (CPR or DNR)

Incapable Patient

• Note:Capacity istreatment-specific

and time-specific.An incapable

patient is only incapable for the

specific treatment at the specific time

• If not already present, perform a

formal capacity assessment and

thoroughly document

• Identify if the patient has an SDM or

who has their POA and locate it. if

applicable

• Check the patient’s chartfor any

Mental Health Forms(e.g. Form1)

or any forms they may have on their

person (e.g.Form 42)

Four Basic Requirements of Valid Consent

1.Voluntary

consent must be given free of coercion or pressure (e.g. from family members who might exert

‘undue influence,'

from members of the clinical team)

• the physician must not deliberately mislead the patient about the proposed treatment

the physician must engage in self-reflection prior to entering the conversation regarding their

position of power and privilege as well as take measures to mitigate the power differential within

the relationship

2.Capable

the patient must be able to understand and appreciate the nature

well as of the proposed treatment or decision

and effect of their condition as

3.Specific

• the consent provided isspecific to the procedure being proposed and to the provider who

will carry out the procedure (e.g. the patient must be informed ifstudents will be involved in

providing the treatment)

-1. Informed

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

disclose common adverse events and all serious risks (e.g. death), even if remote

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

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)

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EL0M12 Ethical, Legal, and Organizational Medicine Toronto Notes 2023

Is this a No

"treatment"

?

Use

common law

Yes

Isthe patient

capable to

make this

decision?

Discuss

involvement

ofSDM

Is this No No *

an

emergency?

Does patient

dispute the

finding of

incapacity

Review

Board

Yes Yes

No

Yes

Is tho SUM

capable to

make this

decision?

Is thoro

a SUM

available?

Doos tho

SOM

consent?

Yes Yes No Do not

treat

>

No No

Treat as omorgoncy following any known

prior capable wishes(c.g. Jehovah's

Witness card)

Doesthe

patient

consent?

No Do not

treat

If there is no SDM for the incapable patient, the doctor can

apply to the CCB to appoint a patient representative

I

If tho doctor has good reason to think tho SDM is making

Inappropriate decisionsfor the incapable patient, an

application can be made to tho CCB to roview tho SDM's

decisions and appoint a new patient representative

Yes

[ Treat ]

CCB = consent and capacity board;SDM = substitute decision-maker

Figure 2. Ontario consent flowchart

Adapted byHebert P Irom Sunnybrook Health Sciences CentreConsent Guidelines

Obtaining Legal Consent

•consent of the patient must be obtained before any medical intervention is provided; consent can be;

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

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, and the patient is not informed of and/

or capable of considering these harms

if consent has been withdrawn during a procedure, the physician muststop treatment unless

stopping the procedure would threaten the patient’

slife

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 circumstancessince obtaining consent originally.

If there has been no material change in circumstances,simple assent to continue is sufficient

CCiarlariello v. Schacliler)

•HCCA of Ontario (1996) covers consent to treatment, admission to a facility, and personal assistance

services(e.g. home care)

Exceptions to Consent

1. Emergencies

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 SDM

emergency treatment should not violate a prior expressed wish of the patient (e.g. a signed

(ehovah s Witness card)

if patient is incapable, the physician must document reasonsfor 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, the physician can treat without consent until the SDM is available or the

situation is no longer emergent

LJ

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EL0M13 Ethical, Legal, and Organizational Medicine Toronto Notes 2023

2.Legislation

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 T'

B refusing to take medication) to prevent transmission

of communicable diseases

3.Special Situations

public health emergencies (e.g. an epidemic or communicable disease treatment)

warrant for information by police

Consequences of Failure to Obtain Valid Consent

•treatment without consent is battery (a claim in tort, meaning a civil legal matter, as opposed to a

criminal legal matter), 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 a claim

in tort

•the onus of proof that valid consent was not obtained rests with the plaintiff (usually the patient)

Overview of Capacity

•capacity is the ability to:

understand information relevant to a treatment decision

appreciate the reasonably foreseeable consequences of a decision or lack of a decision

•capacity isspecific for each decision (e.g. a person may be capable to consent to having a CXK, 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 ofserious harm or death require carefulscrutiny

Assessment of Capacity

•the person undergoing the assessment of capacity must be informed that they will be assessed

• capacity assessments must be conducted by the clinician providing treatment and, if appropriate,

in consultation with other healthcare professionals (e.g. another physician or interprofessional

healthcare provider)

• 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.understandingof:

the condition

the nature of the proposed treatment

alternativesto 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 symptomsthat 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 (CCB)),or the courts; the patient has the right to a

hearing before the CCB

• 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)

Treatment of the Incapable Patient in a Non-Emergent Situation

• obtain informed consent from SDM

• 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, PS62);in such a situation:

document assessment in chart

• notify patient of assessment using appropriate Mental Health form(s) under the Mental Health

Act (Form 42 or Form 30 in Ontario)

notify'Rights Advisor

Capacity Assessment Criteria in

Ontario

Test for understanding:can the patient

recitewhat you have disclosed to them

in their own words?

Test for appreciation:are their beliefs

responsive to evidence?

Refer to: JAMA The Rational Clinical

Examination “Does This Patient Have

Medical Decision- Making Capacity?"

Aid to Capacity Evaluation

J Gen Intern Med 1999:14(1); 2 7-34

• Ability to understand the medical

problem

• Ability to understand the proposed

treatment

. Ability to understand the alternatives

fif any) to the proposed treatment

• Ability to understand the option of

refusing treatment or of it being

withheld or withdrawn

. Ability to appreciate the reasonably

foreseeable consequences of

accepting the proposed treatment

- Ability to appreciate the reasonably

foreseeable consequences of

refusing the proposed treatment

• Ability to make a decision that is not

substantially based on delusions or

depression

n \

i.J

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