CONSENT

Dr. Rijen Shrestha, 3rd year Resident (Forensic Medicine)28th november 2011

Consent

• Definition:Free and voluntary agreement, approval or permission for compliance to perform some act. Consent is valid only if it is given after knowing the nature and consequences of the consent and those of the act for which consent is given.

Situations requiring Consent in medical practice:

1. Examination of the patient for the purpose of diagnosis, investigation and subsequent treatment.

2. Examination of the living person for medico-legal purposes.

3. Any major/minor operative procedures

4. Abortion, organ transplantation, blood donation/ infusion

5. Pathological autopsy

• Legal provision for consent in medical practice;

MULUKI AIN Ilaj Garneko Mahal Art. 2

• For any operative procedures consent from patient or from guardian should be taken before procedure. If nobody is available in case of minor or mentally unsound patient or if patient is unconsciousness, procedure can be started without consent for the benefit of patient’s health.

From whom consent is obtained?– Conscious, mentally sound adults (above the age

of 16 years)

– Procedures involving marital relation, the wishes of the spouse are necessary

– Below the age of 16 years consent should be obtained from the parent or guardian except in case of emergency.

Consent is invalid in case of – Mentally unsound person

– Minors (below the age of 16 years)

– Consent obtained by force, fear or fraud

– Consent for unethical and illegal procedures.

– Jehovah’s witness

– Loco-Parentis

• Types of Consent:

A.Implied Consent

B.Expressed Consent1. Oral2. Written

C.Informed Expressed Consent

Implied consent • Consent which is implied either by words or by behavior of the

patient or by circumstances under which treatment is given.

• For example, it is common for a patient to arrange an appointment with a physician, to keep the appointment, to volunteer a history, to answer questions relating to the history and to submit without objection to physical examination. In these circumstances consent for the examination is clearly implied.

• To avoid misunderstanding, however, it may be prudent to state to the patient an intention to examine the breasts, genitals or rectum.

• In many cases, the extent to which consent was implied may later become a matter of disagreement.

• Physicians should be reasonably confident the actions of the patient imply permission for the examinations, investigations and treatments proposed. When there is doubt, it is preferable the consent be expressed, either orally or in writing.

Expressed consent

• Expressed consent may be in oral or written form. It should be obtained when the treatment is likely to be more than mildly painful, when it carries appreciable risk, or when it will result in ablation of a bodily function.

• Although orally expressed consent may be acceptable in many circumstances, frequently there is need for written confirmation. Patients can change their minds or may not recall what they authorized; after the procedure or treatment has been carried out, they may attempt to take the position it had not been agreed to or was not acceptable or justified.

• Consent may be confirmed and validated adequately by means of a suitable notation by the treating physician in the patient's record.

• Expressed consent in written form should be obtained for surgical operations and invasive investigative procedures. It is prudent to obtain written consent also whenever analgesic, narcotic or anaesthetic agents will significantly affect the patient's level of consciousness during the treatment.

INFORMED CONSENT

Informed consent is the usual way in which patient preferences are expressed

practical application of respect of patient’s autonomy

When a patient consults a physician for a suspected medical problem, the physician makes a diagnosis and recommends treatment

He explains those steps to the patient, giving reasons for the recommended treatment, the options of alternate treatments and the benefits and risks of all options

The patient understands the information, assess the treatment choices and expresses a preference for one of the options proposed by the physician

This is the essence of the Informed Consent

Constitutes a central feature of an encounter characterized by mutual participation, good communication, mutual respect and shared decision making

Requires a dialogue between the physician and patient leading to an agreement about the course of medical care

Establishes a reciprocal relationship between physician and patients

After initial consent to treatment has occurred, an ongoing dialogue between patient and physician concerning the patient’s continuing medical needs reinforces the original consent

A properly negotiated Informed Consent benefits both physicians and patients. A therapeutic alliance is forged in which the physician’s work is facilitated because the patient has realistic expectations about results of the treatment and is prepared for possible complications and more likely to be a willing collaborator in the treatment

Many studies reveal that physicians often fail to observe the practice and the spirit of informed consent

Informed Consent: Standard And Disclosure

Q: How should the adequacy of disclosure of information by a physician be determined?

A: 3 approaches

[PHYSICIAN centered]

Ask what a reasonable and prudent physician would tell a patient?

[PATIENT centered]

What information would a reasonable patient need to know to make an rational decision?

[SUBJECTIVE or PATIENT SPECIFIC]

Whether the information provided is specifically tailored to particular patients need for information and understanding

The trend is now going towards [SUBJECTIVE or PATIENT SPECIFIC]

The reasonable - patient centered standard may be ethically sufficient, but the subjective standard is ethically ideal

Scope Of Disclosure

Many studies show that patients desire information from their physicians

In recent years, candid disclosure even of ‘bad news’ has become the norm

Disclosure should include

i. the patient’s current medical status, including the likely course if no treatment is provided

ii. the interventions that might improve prognosis including risks and benefits of procedures and estimation of probabilities and uncertainties associated with these procedures

iii. a professional opinion about alternative modalities of treatment open to the patient

iv. a recommendation that is based on the physician best clinical judgement

In carrying this information, physicians should:

i. Speak in the patients’ language of preference

ii. Avoid technical termsiii. Attempt to translate statistical data

into everyday probabilities

(con’t)

iv. Enquire whether patients understand the information

v. Invite questions

vi. Interpret other information that patient has to ascertain its relevance

It is ethically appropriate to disclose levels of experience and it is obligatory to do so in situations where the procedure is serious and elective

The moral and legal obligations of disclosure vary with the situation, they become more stringent as the treatment situation moves from emergency through elective to experimental

COMPREHENSION

The comprehension of the patient is as important as the provision of the information

The physician has an ethical obligation to make reasonable efforts to ensure comprehension

Explanation should be given clearly and simply and questions asked to assess understanding

Written instructions or printed materials should be provided

Use of CD or video given if necessary

Documentation of Consent

The process of Informed Consent concludes with the patient’s consent (or refusal). This consent is documented in a signed ‘consent form’ that is entered in the patients medical records.

Difficulties With Informed Consent

Problems physicians may face

i. Use of technical language

iii. Uncertainties intrinsic to all medical information

iv. Worried about harming or alarming the patient

v. Hurried and pressed by multiple duties

Problems patients may face:

i. Limited knowledgeii. May be inattentive or distractediii. Overcome by fear and anxietyiv. Selective hearing because of denial,

fear, or preoccupation with illness

Decisional Capacity

Consent to treatment is complicated not only by the difficulty of disclosure but also by the fact that some patients lack the mental capacity to understand or to make choices

In law, the term ‘competence’ or ‘incompetence’ are used to indicate whether persons have the legal authority to make personal choices

Only a judge, can rule whether a person is legally incompetent and to appoint a guardian

In medical care, persons who are legally competent may have their mental capacities compromised by illness, anxiety, pain or hospitalization

This is referring to the capacity or incapacity to make decisions

Determining the decisional capacity of a patient is an essential part of a informed consent process

Determining Decisional Capacity

Decisional Capacity refers to the specific acts of comprehending, evaluating and choosing among realistic options

Determining decisional capacity is a clinical judgment

This is done through engaging the patient in conversation, to observe the patient’s behavior and to talk to 3rd parties e.g. family, friends

Conclusion

• Consent is the choice of the patient which also gives him the right to refuse.

• Consent can be given only by a mentally sound adult who knows the consequences of the giving the consent as well as the consequences of the consenting to the procedure in question.

• Consent should include not only the procedure the patient is consenting to but also the alternative modalities as well as the common well-known consequences of procedure in question

IF in doubt, take a written informed consent