Asst. Prof., Dept. of Medical EthicsKing Fahad Medical City – Faculty of MedicineKing Saud Bin Abdul-Aziz University for Health Sciences

Dr. Ghaiath M. A. Hussein

Saudi Commission for Health SpecialtiesProfessionalism and Ethics Education for Residents (PEER)

Ethical, Legal & Fiqhi Issues

Consent to Treatment

Outline What is an informed consent to treatment? What is the elf basis to consent? What makes the consent an ethically valid one? Types of Consent When it is needed? When could it be waived? How to take an informed consent? What if the patient is not able to give consent? Documentation of Consent Special Issues about Consent

CASE Mrs. Cope, the 42-year-old woman with insulin-dependent

diabetes, is brought by her husband to the emergency department. She is stuporous, with severe diabetic ketoacidosis and pneumonia.

Physicians prescribe insulin and fluids for the ketoacidosis and antibiotics for the pneumonia.

Although Mrs. Cope was generally somnolent, she awoke while the IV was being inserted and stated loudly: "Leave me alone. No needles and no hospital. I'm OK."

Her husband urged the medical team to disregard the patient's statements, saying, "She is not herself."

What is an informed onsent? Informed consent is the process by which a fully informed

patient can participate in choices about his/her health care.

Informed consent is a consent obtained freely, without threats or improper inducements, after appropriate disclosure to the patient of adequate and understandable information in a form and language understood by the patient.

Why to Take Consent? Ethically: it reflects the ethical principle of respect of

autonomy.

Legally: It expresses the right of people to make informed decisions about health treatment.

Fiqhi: In Shariah, every adult has his/her competence (Zimma) to take permissible (Mobah) decisions related to his/her life, unless there are genuine causes to assume the opposite.

When is Consent Needed?

Consent would include any procedure undertaken

for the purpose of treatment :

1. Diagnosis

2. Anesthesia

3. Fluid infusion

4. Blood transfusion

5. Any operation

6. Any form of medical/ surgical treatment

What is the Treatment that Needs Consent? Anything that is done for a therapeutic, preventive, palliative,

diagnostic, cosmetic, or

Other health related purpose by any health practitioner (doctor, nurse, physiotherapist, etc.), and

Includes a course of treatment or plan of treatment.

Conditions for a Consent to be Valid?Capacity

Understand

Appreciate

Remember

Communicate

Disclosure

Relevant information

Understandable

Voluntariness

Free from undue influence

No coercion

Conditions for a Consent to be Valid?• "Disclosure" refers to the provision of relevant information by

the clinician and its comprehension by the patient.

• "Capacity" refers to the patient's ability to understand the relevant information and to appreciate those consequences of his or her decision that might reasonably be foreseen.

• "Voluntariness" refers to the patient's right to come to a decision freely, without force, coercion or manipulation.

• It must not be obtained through misrepresentation or fraud

1- Capacity

Presumption of CapacityA patient is presumed to be capable unless a health practitioner (e.g., doctor, nurse, physiotherapist) has reasonable grounds to believe the patient is incapable to consent to the specific treatment they are proposing.

Give examples of “reasonable grounds ” to doubt’s a patient’s capacity?

Conditions to CapacityA person is capable under the if:

1. They are able to UNDERSTAND The condition from which the treatment is proposed. The nature of the proposed treatment. The risk and benefits of the proposed treatment. The alternatives of the treatment presented by the health

practitioner including the alternative of not having the treatment.

a

Conditions to Capacity Cont…A person is capable under the if:

As per the Health Care Consent Act of Canada

2. They are able to APPRECIATE the reasonably foreseeable consequences of a decision or lack of decision by:

Acknowledge how the recommended treatment may affect them. Assessing how the proposed treatment and alternatives, including the alternative of not having the treatment, could affect their quality of life. Their choice of treatment, is not substantially based on delusional belief. Findings from the capacity assessment should be documented in the progress notes as the time of each consent process.

CASE Mrs. Cope, the 42-year-old woman with insulin-dependent

diabetes, is brought by her husband to the emergency department. She is stuporous, with severe diabetic ketoacidosis and pneumonia.

Physicians prescribe insulin and fluids for the ketoacidosis and antibiotics for the pneumonia.

Although Mrs. Cope was generally somnolent, she awoke while the IV was being inserted and stated loudly: "Leave me alone. No needles and no hospital. I'm OK."

Her husband urged the medical team to disregard the patient's statements, saying, "She is not herself."

DISCUSSION Mrs. Cope has an acute crisis (ketoacidosis and pneumonia) superimposed

on a chronic disease (Type I Diabetes) and she demonstrates progressive stupor during a two-day period.

At this time, she clearly lacks decisional capacity, although she could make decisions two days prior to the onset of her illness, and she could possibly make her own decisions again when she recovers from the ketoacidosis, probably within the next 24 hours.

Discussion Cont. At this moment, it would be unethical to be guided by the

demands of a stuporous individual who lacks decision-making capacity. The cause of her mental incapacity is known and is reversible.

Physicians and surrogate concur on the patient's incapacity and are agreed on the course of treatment in accordance with the patient's best interest. The physicians would be correct to be guided by the wishes of the patient's surrogate, her husband, and to treat Mrs. Cope over her objections.

2- Disclosure

Disclosure Patient must receive information on the:

Nature and the process of the intervention Nature of the treatment The diagnosis and the prognosis Expected benefits of the treatment Material risks of the treatment Material and possible undesirableside effects Alternative course of action Possibilities, benefits and risks of alternative interventions Likely consequences of not having the treatment

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Tips to DisclosureIn carrying this information physician should:

Avoid technical terms Attempt to translate statistical data into everyday probabilities Enquire whether patient understand the information Interpret other information that patient has to ascertain its relevance Use language appropriate to the patient's level of understanding in a language of their influency

Pause and observe patients for their reactions Invite questions from the patient and check for understanding

Comprehension Invite the patient to share fears, concerns, hopes and expectations Watch for patients' emotional response: verbal and non-verbal Show empathy and compassion Summarize the imparted information Provide contact information (and other resources) Explanation should be given clearly and simple questions asked to assess understanding Written instructions or printed materials should be provided CD or video given if necessary

3- Voluntariness

Voluntariness:Refers to a participant’s right to make treatment decisions free of any undue

influence.

Influences include:

Physical restraint or sedation Coercion involves the use of explicit or implicit threat to ensure that the

treatment is accepted Manipulation involves the deliberate distortion or omission of information in

an attempt to induce the patient to accept a treatment Undue financial payment Undue influence (Emotional?) Fear of injury Misconception of fact

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Documentation of Consent

Documentation of ConsentA consent may be expressed or implied

Example: A patient may imply consent to have a lacerated arm sutured as proposed by the physician, by holding out the arm, but the consent must be documented in the progress note by the health practitioner obtaining it, e.g., Mr. Smith agreed to sutures.

The rule is that consent to treatment should be written andreported in the patient’s record, except when this is not possible.

Consent in Special Conditions (Incompetent Patients)

Who May not be Able to Consent?

Emergency Children (& adolescents?) Alcohol or substance abuse Mentally disabled Others?

Consent and Refusal of Treatment for Incompetent Adults and Children

Consent for children Competent children can consent to treatment but cannot

refuse treatment. The consent of one parent is sufficient if the other one disagrees. Parental choice takes precedence over the child's choice.

Life-saving treatment of minors is given even if parents refuse. Parental choice is final in therapeutic or non-therapeutic research on children.

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Consent and Refusal of Treatment for Incompetent Adults and Children Cont.Consent for children Cont.

Assent: A child’s affirmative agreement to participate (without meeting all of the full consent elements)

The mere failure to object, absent affirmative agreement, should not be construed as assent.

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Mental PatientsMental patients cannot consent to treatment, research, or sterilization because of their intellectual incompetence. They are admitted, detained and treated voluntarily or involuntarily for their own benefit, in emergencies, for purposes of assessment if they are a danger to themselves, or on a court order. Suicidal patients tend to refuse treatment because they want to die.

Consent and Refusal of Treatment for Incompetent Adults and Children

The unconsciousFor patients in coma proxy consent by family members can be resorted to. If no family members are available, the physician does what he as a professional thinks is in the best interest of the patient.

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Consent and Refusal of Treatment for Incompetent Adults and Children

ObstetricsLabor and delivery are emergencies that require immediate decisions but the woman may not be competent and proxies are used. Forced medical intervention and caesarean section may be ordered in the fetal interest. Birth plans can be treated as an advance directive.

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Consent and Refusal of Treatment for Incompetent Adults and Children

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General Challenges to Patient-Physician Communication

Time constraints Language differences Mismatch of agendas Lack of teamwork Discomfort with strong emotions Quality of physician training Resistance to change habits

Buckman (1984), Ford et al (1994), Buss (1998)

Watch the Differences on How we Make Decisions

The Patient The Health Care Professional

Values and priorities Culture Religious beliefs Desire for information and control personality and coping style Roles: spouse, parent, child, provider Degrees of dependence upon and trust in the professional

Education

knowledge

experience

communication style

values and priorities

demographic profile ( e.g. gender, age )

Difficulties With Informed Consent

Many studies reveal that physicians consistently fail toconduct ethically and legally satisfactory consentnegotiation.

Physicians may be having the following problems1. Use of technical language2. Uncertainties intrinsic to all medical information3. Worried about harming or alarming the patient4. Hurried and pressed by multiple duties

الطبي لإلذن الضابطة الشرعية القواعد• ) كان ) إن السيما الحق مبدأ للتص�رفات المنظمة المبادئ من إن

) من ) وكل ، اإلذن بمبدأ الصلة شديد وهو ملكهم، في أو للعباد ( ) اإلذن ) و الله حق الشارع إلى يرجع أن إما واإلذن الحق،

) ( ) المالك( ) إذن و العبد حق اإلنسان إلى أو الشرعيأن • بموجبه الطبيب يتعهد والمريض الطبيب بين عقد الطبي اإلذن

. الطب أهل عند عليها المتعارف األصول المريضوفق يعالجالعقد • يتم بل والقبول، اإليجاب وجود العقد لص�حة يشترط وال

يجوز ال ولهذا له، نفسه وتسليم الطبيب إلى المريض مجيء بمجرد. حاالت في إال إذنه بغير المريض جسد في يتصرف أن للطبيب

خص�وصية • ع�لى اعتداء ألنه الحرمة، أصل على يبقى ذ�لك ع�دا وماغير من ونحوه الفحص عن تنتج قد التي الفساد لذريعة وسدا الغير،

إذ�ن.

Take home message Informed consent is a process of communication between a clinician and a Patient/Patient Representative.

It is not simply a matter of obtaining a patient's signature on a consent form.

References

Presentation by : Prof. Omar Kasule

Dr. Datuk Dr. Ahmad Tajudin Jaafar

Health Care Consent and Advance Care Planning - Getting it Right, by: Judith Wahl, B.A., LL.B. & Barrister and Solicitor - Advocacy Centre for the Elderly

Consent and assent in the adolescent and young adult with cancer by: Conrad Fernandez MD, FRCPC