Consent Form

Chapter 5

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Introduction:

• Consent refers to the provision of approval or agreement, particularly and especially after thoughtful consideration and understanding.

• Consent signifies a possible defense (justification) against civil or criminal liability be the doctor.

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Consent Form:

The consent form is the single most important document, created in the presence of the patient, which removes obstacles to effective communication concerning choice.

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The key to effective communication is :

Engaging with the patient Empathizing with her needs.

Educating her as to the available options. Enlisting her approval for the appropriate choice.

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Only after engagement, empathy, and education is it appropriate for a clinician to ask for the approval of the patient. It will always be appropriate to record the decision. It will sometimes be appropriate for the patient to append her signature to an appropriate form. Vaild consent must be taken from the patient.

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Legal problems occur in certain conditions as follows:

Continuation of pregnancy after the procedure. Excessive or continued bleeding due to incomplete

evacuation. Injury to the organs either to the uterus or to the

other organs. Failure to diagnosis ectopic pregnancy while

perfoming maternal exam.

 

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Type of Consent:

1) Medical consent:• Consent is one of the critical issues in the area of

medical treatment.

• The earliest expression of this fundamental principle, based on autonomy, is found in the Nuremberg Code of 1947.

• The Nuremberg Code was adopted immediately after World War 2 in response to medical and experimental murders committed by the German Nazi regime.

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Medical Consent

• The code makes it mandatory to obtain voluntary and informed consent of human subjects.

• Similarly, the Declaration of Helsinki adopted by the World Medical Association in 1964 emphasizes the importance of obtaining freely given informed consent for medical research.

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Medical Consent

• Medical Council of India (MCI) has laid down guidelines that are issued as regulations in which consent is required to be taken in writing before performing an operation.

• The MCI guidelines are applicable to operations and not cover to the extent other treatments or procedures.

• These are covered under Implied and expressed consent

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o Consent is perhaps the only principle that runs through all aspects of health care provisions today.

o It also represents the legal and ethical expression of the basic right to have one's autonomy and self-determination.

o If a medical practitioner attempts to treat a person without valid consent, then he will be liable under both tort and criminal law.

o Patient must give valid consent to medical treatment; and it is his prerogative to refuse treatment even if the said treatment will save his or her life.

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LAW AND MEDICAL CONSENT:

The rights (autonomy) of the patient have deeply eroded the old model of doctor-patient relationship. "Doctors are no more Gods".

There have been significant changes in the doctor patient relationship with the advancement of technology in day-to-day practice.

More and more patients are becoming aware of their rights and are keen to make free choice and decision on their treatment.

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Law And Medical Consent:

This helps them to choose the treatment of their choice from the options available and to select a physician of their choice.

Informed consent was practically non-existent till the time COPRA (Consumer Protection Act) came into existence.

This is seen as more of a legal requirement than an ethical moral obligation on part of the doctor towards his patient.

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Law And Medical Consent:

The patient has now the ability to select or dismiss their doctor and to choose the treatment of their choice from the options available.

Important aspect of several Medical Consumer litigations is improper consent.

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2) Informed Consent:

• It is defined as voluntary acceptance after full understanding, by a competent patient, of a plan for medical care after physician adequately discloses the proposed plan, its risks and benefits, and alternative approaches.

• The decision-making capacity is free from coercion or manipulation by the patient/doctor

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Informed consent:

Components of Informed consent:

Informed consent must contain four vital components: Mental capacity of the patient to enter into a

contract (This also includes his ability to understand information given).

Complete Information to be provided by doctor. Voluntary acceptance of the procedure by the

patient Should be person and the procedure specific

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Consent And Medical Ethics:

The Hippocratic Oath prevalent for centuries has granted doctor the right to decide in the best interest of the Patient.

But the same has been conflicted with the trend of twentieth century right of "freedom to control health as well as avoiding non-consensual medical treatment."

Clinical ethics teaches physicians, a wide range of specific ethical issues.o Informed consent, truth telling,o End-of-life decisions,o Advance directives (Substitute decision making for

incompetent patients)o Emergency consent

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Contents Of The Consent:

Condition (Disease) of the patient Purpose and Nature of intervention Consequences of such intervention Any Alternatives available Risks involved Prognosis in the absence of intervention The immediate and future cost The knowledge regarding the intervention should be

in an understandable language and format so that decision in the form of authorization by patient can be made.

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3) Expressed consent:

• It may be oral or in writing.

• Though both these categories of consents are of equal value, written consent can be considered as superior because of its evidential value.

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→ Oral expressed consent:

• Oral consent should be taken in the presence of uninterested third party.

• Mainly in cases where intimate examination of female is required.

• Tests necessitating removal of body fluids, radiological examination can be done after securing oral consent.

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→ Written expressed consent:

• It is advisable to take written consent in the presence of disinterested third party (this third party is only to attest the signature of the patient).

• Consent should be taken in the patients own language.

• Written consent is mandatory in every invasive diagnostic/ therapeutic procedures or any medico legal examination.

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4) Implied consent:

Implied consent may be implied by patient's conduct.

So it is basically the conduct of the patient when he comes to the doctor for examination / treatment.

Doctor should remember that this is only for routine examination as well as treatment.

This does not extend to the performance of intimate examination or diagnostic procedures.

If there is slightest chance of any complication express consent should be taken.

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5) Surrogate Consent:

This consent is given by family members for minors or dead.

Generally, courts have held that consent of family members with the written approval of 2 physicians sufficiently protects a patient's interest.

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6) Advance Consent:

It is the consent given by patient in advance before death.

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7) Proxy Consent:

It indicates consent given by an authorized person before or after death. If an unconscious patient brought by police from road and operation essential to save life 2or3 doctors to give consent by signing on consent form, preferably along with police.

Informed consent obtained after explaining all possible risks and side effects is superior to all other forms of consent and legally defensive.

CONSENT PROFORMAI_____ S/D/W of _____ aged __ Address_____ under the treatment of Dr _____ do hereby give consent to the performance of _____(procedure/treatment) and to the administration of _____ (anesthesia) upon myself / upon ____ aged __ who is related to me as ___.The nature and purpose has been explained to me by Dr____.I declare that I am more than 18 years of age.I have been informed that there are inherent risks involved in the treatment.No assurance has been given to me regarding the success of the treatment.I have given this consent voluntarily out of my free will without any pressure.Place:Date & Time: SIGNATURE I hereby declare that I have explained in detail regarding the case to the patient and answered all his queries to his satisfaction in a language that he could understand.Place:Date & Time:Signature of the Doctor

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Who can give consent?

o Simple medical examination the minimum age of consent is 12 years.

o For consenting to have any major diagnostic or therapeutic procedure or surgery the age is above 18 years (I.P.C. Section 87-93).

o The patient should be mentally sound and he / she should not be under any fear or threat or any false conception.

o The patient should not be intoxicated or sedated.

o Incomplete information about the patient's diagnoses, therapeutic plan etc. is a commission than misconception of commission.

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Consent Required:I. Somebody else other than the "Patient" wants him

to be medically examined and a medical certificate to be issued (employers,).

II. Consent of the concerned person must be obtained otherwise the doctor runs the risk of liability to pay damages. Such as

Issuing certificate involving complicated process of examination or infertility in women.

When the process is likely to affect the physical or mental well-being of the patient e.g financial loss.

Damage to reputation, social status (STD, HIV etc.).

Procedures violating rights of spouse is in cases such as Sterilization, artificial insemination.

Even after the consent is taken the examination should be done in presence of third person (nurse, female attendant) while examining a female patient.

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Difficulty in obtaining consent:

The difficulties in getting informed consent includes:

1. Incompetence and mental incapacity of the patient,

2. Unusual (socio, religious) beliefs of patient.

3. Extent of truthful disclosure,

4. Incompleteness of information disclosed

5. Advance directives by terminally ill patients or those who anticipate grave illness.

6. Durability of power of attorney for health care, when holder gives the consent and decisions in advance

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