Jurisprudence - Lecture 2 - Notes

Informed Consent: Core Principles

  • Informed consent means patients have the right to control their bodies and health care; practitioners do not have the right to assess or treat a patient without the patient’s consent.

  • Consent must be specific to the procedure or treatment; a blanket or broad consent covering everything will not stand in court.

  • Written consent is important, especially for the initial intake and for explicit treatments or sensitive areas; verbal follow-ups are acceptable but should be documented.

  • Implied consent exists in practice (e.g., patient shows up for an appointment and participates), but it should be supported by clear verbal confirmation and documented evidence. Always verify patient understanding.

  • It is possible for a patient to withdraw consent at any time during treatment; you must stop the treatment and discuss alternatives or other options.

  • Misrepresentation or over-promising outcomes (e.g., claims of cures) is unethical and potentially unlawful; communicate evidence-based possibilities only.

  • Informed consent is not only about risks and benefits; it includes the nature of the procedure, who is performing it, alternatives, and consequences of not proceeding.

  • The process is dynamic and ongoing across visits; you should reiterate consent with any significant change in treatment or new risks.

  • Documentation should reflect both subjective (patient-reported) and objective (clinical findings) information that informs the consent.

  • Consent applies to communication about the patient with others (e.g., substitute decision makers) and to the patient’s health information privacy.

  • Laws and professional norms distinguish governance (being governed by a college/health ministry) from being controlled by the government in daily practice; practitioners are ultimately responsible for appropriate consent.

The Consent Process: Stages and Practical Steps

  • Stage 1: Pre-visit intake (online forms or in-person) to gather personal and health information; include confidentiality statements and cancellation policies.

  • Stage 2: Initial consult and intake; discuss what information will be collected and how it will be used; obtain consent to collect personal and health information before delving into health issues.

  • Stage 3: Pre-treatment consent; during the consult, explain the proposed treatment (e.g., acupuncture), risks, potential side effects, and alternatives; confirm understanding and obtain consent to proceed with the treatment.

  • Stage 4: Treatment consent during the visit; for each treatment, obtain consent specific to that procedure (e.g., needling, electroacupuncture, cupping, moxa, etc.); document verbal confirmation in the chart if written consent is not feasible that visit.

  • Stage 5: Consent for sensitive areas; for treatments involving sensitive regions (e.g., chest, abdomen, breasts, groin, upper inner thigh, buttocks), use separate written consent and clearly explain why these areas are targeted and the risks involved.

  • Stage 6: Post-treatment and follow-up consent; with each follow-up, verify there are no new risks or changes; document verbal consent and any changes in the treatment plan.

  • Stage 7: Consent to communicate with substitutes; obtain consent to share information with substitute decision makers when applicable; ensure there is documentation of who is authorized to make decisions for the patient.

Written vs Verbal vs Implied Consent

  • Written consent (initial and for specific procedures) provides clear evidence of what was explained and agreed to; includes the nature of the procedure, risks, alternatives, and consequences of not performing the procedure.

  • Verbal consent can be used for follow-up visits or when adding a new procedure; it should be documented in the chart with details of what was explained and what was agreed to.

  • Implied consent occurs when a patient’s actions imply agreement (e.g., continuing with a treatment after being informed); however, best practice is to obtain explicit consent, especially for higher-risk procedures or sensitive areas.

Blanket vs Procedure-Specific Consent

  • Do not use a blanket consent form that covers every possible procedure; consent must be specific to each treatment step and to each procedure (e.g., needles vs electroacupuncture vs cupping).

  • If a new procedure is added (e.g., switching from acupuncture to electroacupuncture), obtain a new written consent for that specific procedure.

  • For sensitive areas, obtain a separate written consent that clearly outlines the location, technique, benefits, risks, and why the area is being addressed.

Initial Intake vs Treatment Consent: The Documentation Flow

  • Initial intake consent covers the collection of personal information, contact details, demographic information, and basic health information; it establishes permission to gather data and use it for clinical care and billing, with notices about confidentiality. Example: Consent to collect, use, and disclose personal health information (PHI).

  • Treatment consent is procedure-specific and occurs after the initial intake; it covers the actual treatment (e.g., acupuncture with needles, cupping, moxa, etc.), potential risks, alternatives, and consequences of not proceeding.

  • When using electronic systems (e.g., Jane app), electronic signatures are acceptable for the initial intake; subsequent treatment-specific consent can be verbal with a chart note or a separate written form.

  • If a practitioner is licensed in multiple modalities (e.g., naturopathic and acupuncture), consider separate consents for each professional hat if required by the college; this avoids confusion about scope and liability.

Consent Contents: Core Components (for each consent form)

  • The nature of the assessment or treatment: what will be done, what it involves, and what the patient should expect.

  • Who is performing it: the practitioner's name and professional designation.

  • The reasons for the procedure: rationale and expected goals.

  • Material risks and side effects: what could realistically happen, including rare but serious risks.

  • Alternatives: other options, including non-treatment and referral to other professionals when appropriate.

  • Consequences of not having the procedure: what may occur if treatment is declined or delayed.

  • Questions and understanding: opportunity for questions and confirmation that the patient understands.

  • Specifics about sensory experiences: depth, sensation, and any potential discomfort during the procedure; patient preferences (e.g., “you want me to tell you when it will hurt” or “you’d rather I distract you”).

  • Clinician’s duty to educate: explain findings (e.g., tongue/pulse) and how they relate to symptoms; involve patient in learning about their health care.

  • Documentation of capacity: verify patient understanding, assess capacity if there are concerns, and document the decision-making process.

Risks and Side Effects: Examples and Context

  • Acupuncture risks: puncturing the lung (pneumothorax) is a potential but very small risk, especially with needles near the chest/back; emphasis on lay terms to avoid unnecessary fear while ensuring awareness.

  • Chest and back points: higher-risk areas; explain risk and signs to watch for post-treatment.

  • Bruising from cupping: not dangerous but visible; advise on timing if the patient has an event the next day.

  • Bleeding from needle insertion: generally minor; discuss any known bleeding tendencies or medications that affect bleeding.

  • Facial acupuncture: potential for minor bleeding; discuss likelihood and healing expectations.

  • Electroacupuncture: specific contraindications (e.g., pacemakers, implants, epilepsy); ensure patient is aware of risks and clarifications.

  • Sensitive areas: points around upper inner thigh, buttocks, chest wall, breast area; always obtain explicit consent for these areas and explain rationale and risks.

  • Risks vs benefits: not all treatments have the same risk profile; tailor the discussion to the patient’s condition and comorbidities; always present in plain language.

  • Layered risk communication: separate risks by modality (e.g., moxa, cupping) and scenario (home event, upcoming wedding, etc.).

Alternatives and Consequences of Not Treating

  • Alternatives to acupuncture or other therapies include acupressure, cupping, moxibustion, herbal medicine, or watchful waiting.

  • Referral to other health professionals when necessary (e.g., gastroenterologist, MRI for shoulder issues, GP for blood work).

  • If there is evidence suggesting a more serious underlying condition, advise the patient to seek medical evaluation; you may write a referral letter to the patient’s family doctor.

  • Even when not recommended, provide the patient with reasonable options and ensure they understand potential consequences of not proceeding.

Special Areas: Consent for Sensitive Areas

  • Sensitive areas require explicit consent and separate documentation (e.g., chest and breast areas, abdomen near reproductive organs, groin, buttocks).

  • Clarify that no point will be used in a sensitive area without patient consent; discuss alternatives that achieve the same therapeutic goal when possible.

  • When addressing sensitive points (e.g., REN 1, DU channels), explain the rationale and ensure patient comfort and autonomy; respect refusals and adjust the treatment plan accordingly.

  • Language and clarity matter: avoid ambiguous phrases; give concrete examples of what you plan to do and why.

Capacity and Substitute Decision Makers: Key Concepts

  • Capacity assessment: assume capacity unless there is evidence to the contrary; if the patient cannot understand or appreciate consequences, you should pause treatment and reassess, possibly referring to their physician.

  • Do not treat without appropriate consent; if capacity is in doubt, involve substitute decision makers and document who can decide on behalf of the patient.

  • Substitute decision maker hierarchy (Ontario context):

    • 1) power of attorney for personal care (POA-PC)

    • 2) spouse or partner (including common-law, same-sex, or living with them as a partner)

    • 3) a child of the patient

    • 4) a parent of the patient who does not have custody

    • 5) a sibling

    • 6) other relatives

    • 7) public guardian or trustee

  • Court involvement: guardianship or appointment by the Consent and Capacity Board can determine who may substitute decision-maker in complex cases.

  • Documentation: collect substitute decision-maker information and ensure signatures are on file; do not rely on informal understandings alone.

  • Capacity in vulnerable situations: cases involving dementia, stroke, or other conditions require careful assessment, safe treatment planning, and possibly involvement of a social worker or health-care team allied professionals.

Language Barriers and Translation

  • Use translators when necessary; family members may translate, but you should obtain consent to share information with them and ensure translations are accurate.

  • Forms should be available in English and French; for other languages, consider bilingual copies or certified translation; ensure patient signs both language versions if needed.

Templates and College Resources

  • The college website provides consent templates and standard forms:

    • Consent to collect, use, and disclose personal health information (PHI)

    • Consent to treatment (for acupuncture, with or without needles, and for sensitive areas)

    • Consent forms for sensitive areas

    • Templates for intake forms, patient information forms, and treatment-specific consents

  • You can customize templates for your practice; ensure they reflect your clinical workflow and jurisdictional requirements.

  • Templates can help standardize the process and reduce risk of missing critical components, but you should tailor them to each patient and each procedure.

Addressing Misrepresentation, Fair Communication, and Ethics

  • Do not claim cures or guaranteed outcomes; communicate the evidence base and potential outcomes honestly.

  • Provide clear, factual information about risks, benefits, alternatives, and the consequences of not undergoing treatment.

  • Avoid pressuring patients; encourage questions and allow time to review information.

  • If a patient asks about a treatment outside your scope or competency (e.g., high-dose herbal regimens or unproven supplements), refer them to a qualified provider and document the referral and rationale.

  • When discussing supplements, understand your competency and potential interactions with medications; refer to a physician or nutrition expert as needed.

  • Document all communications and decisions; maintain a clear record of what was explained, understood, and agreed to by the patient.

Practical Scenarios, Questions, and Takeaways

  • Vitamin A megadoses example: if a practitioner recommends megadoses of vitamin A and claims dramatic cognitive improvement without detailing dosage, duration, risks, and alternatives, this constitutes misrepresentation and lack of essential consent components. Key missing elements include:

    • Specific nature of the recommendation and how it will be used (dosage, duration, administration)

    • Clear discussion of risks and potential liver damage with high-dose vitamin A

    • Viable alternatives (e.g., vitamin D, dietary changes, protein intake, exercise)

  • The importance of dosage, duration, timing, and monitoring when recommending supplements or herbs; avoid making absolute claims about efficacy without evidence.

  • Capacity and substitute decision makers in practice: the need to verify who can consent on behalf of an incapacitated patient, and to document who should be contacted if the primary decision maker is unavailable.

  • For cases involving language barriers or special populations, ensure translation support and culturally appropriate consent processes; keep documentation in the appropriate language with English/French copies if required.

  • In clinical practice, consider a staged approach to consent: initial intake consent to collect information; subsequent procedure-specific consents; separate consent for sensitive areas; and ongoing confirmation at follow-up visits.

Quick Reference: Practical Checklists

  • Before any treatment: verify patient’s capacity; obtain written consent for the initial intake (PHI collection) and a separate consent for the treatment.

  • For each procedure: document the nature, steps, involved practitioner, risks, alternatives, and consequences of not proceeding; obtain explicit consent.

  • For sensitive areas: secure separate written consent with explicit acknowledgement of the area and the risks.

  • Discuss alternatives and coordinate with other health professionals if needed; do not rely on a single modality when alternatives may be appropriate.

  • If capacity is questionable: pause treatment, involve substitute decision maker, or refer to the patient’s physician; document all steps.

  • After each treatment: confirm that consent remains valid; document verbal confirmation and any changes in plan.

  • Maintain language clarity: use lay terms; confirm patient understanding; allow questions.

  • Protect PHI: ensure consent to collect/use/disclose PHI is on file; specify who has access to the information.

  • Be prepared to justify ethical decisions to the regulatory college; keep thorough documentation and seek guidance when in doubt.

Bottom-Line Principles to Remember for Exams and Practice

  • Consent must be informed, voluntary, specific to each procedure, and well-documented.

  • Initial intake and subsequent treatment consents are distinct; separate consents are required for new procedures and sensitive areas.

  • Capacity matters: do not proceed without appropriate consent from a capable patient or a legally authorized substitute decision maker; document who can decide and how.

  • Always present risks, alternatives, and consequences of not proceeding; do not overstate benefits or promise cures.

  • Use plain language, teach-back style (ask patients to repeat back key points), and document the patient’s understanding and questions.

  • Know the college resources and templates for consent forms; customize to your practice while maintaining compliance.

Example Scenario Prompts for Study or Quiz Practice

  • Identify missing consent elements in a hypothetical scenario where a practitioner recommends a high-dose supplement with vague language and no dosage or duration.

  • Determine the highest-ranked substitute decision maker in a scenario where the POA-PC is unavailable, the spouse is not present, and a capable adult child is available.

  • Explain how you would handle consent for a treatment involving chest needles with a risk of pneumothorax, including how you would communicate the risk in lay terms and document consent.

  • Outline steps to obtain consent when language barriers require a translator and the patient’s PHI must remain confidential.

  • Describe how you would document follow-up verbal consent after adjusting a treatment plan based on patient feedback.