2. CONSENT
Consent means voluntary agreement , compliance, or
permission.
Consent refers to the provision of approval or agreement,
particularly and especially after thoughtful consideration
and understanding.
As per jurisprudence prior provision of consent signifies a
possible defense (justification) against civil or criminal
liability by the doctor.
Practitioners who use this defense claim that they should
not be held liable for a tort or a crime, as the consequence
in question occurred with the prior consent and permission
of the patient without realizing whether it is a commission
or an omission and the extent of negligence.
3. 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 II in response to medical and
experimental atrocities committed by the German
Nazi regime .
The code makes it mandatory to obtain voluntary and
informed consent of human subjects.
4. 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.
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.
5. MEDICAL CONSENT
Consent is perhaps the only principle that runs through
all aspects of health care provisions today.
It also represents the legal and ethical expression of the
basic right to have ones autonomy and self-
determination.
If a medical practitioner attempts to treat a person
without valid consent, then he will be liable under both
tort and criminal law.
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.
6. 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.
This helps them to choose the treatment of their
choice from the options available and to select a
physician of their choice.
7. 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.
The patient has now the ability to select or
dismiss their doctors and to choose the treatment
of their choice from the options available.
Important aspect of several Medical Consumer
litigations is improper consent.
8. CONSENT AND MEDICAL PRACTICE
There exists a duty to obtain prior consent (with
respect to living patients) for the purpose of
diagnosis, treatment, organ transplant, research
purposes, disclosure of medical records, and teaching
and medico-legal purposes.
With respect to the dead with regard to pathological
autopsy, organ transplant (for legal heirs), and for
disclosure of medical record, it is important that
prior informed consent of the patient, or relative is
obtained after death.
9. CONSENT AND MEDICAL ETHICS
The Hippocratic Oath prevalent for centuries has
granted doctors 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.
•Informed consent, truth telling,
•End-of-life decisions,
•Advance directives (substitute decision making for
incompetent patients)
•Emergency consent
11. 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.
COMPONENTS
Informed consent must contain four vital components:-
1. Mental capacity of the patient to enter into a contract (This also
includes his ability to understand information given)
2. Complete Information to be provided by doctor
3. Voluntary acceptance of the procedure by the patient
4. Should be person and the procedure specific
12. 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.
13. ELIGIBILITY FOR CONSENT
Age.
Soundness of mind.
Ability to understand.
Remember the information given.
Ability to deliberate and decide the treatment
choices.
Believes that the information applies to the said
patient and specific purpose.
14. 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.
Oral
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.
Written
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.
15. IMPLIED CONSENT
Implied consent may be implied by patients
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.
16. TACIT CONSENT
Tacit consent means implied consent understood
without being stated.
Usually the way a patient present him self for
treatment imply consent.
17. 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 patients
interest.
19. 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,
2 or 3 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.
20. CONSENT PROFORMA
I _____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 _____(anaesthesia) 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
21. WHO CAN GIVE CONSENT
Simple medical examination the minimum age of
consent is 12 years.
For consenting to have any major diagnostic or
therapeutic procedure or surgery the age is above
18 years (I.P.C. Sections 87-93).
The patient should be mentally sound and he/she
should not be under any fear or threat or any false
conception.
The patient should not be intoxicated or sedated.
Incomplete information about the patient’s
diagnosis, therapeutic plan etc. is a commission
than misconception of omission.
22. CONSENT REQUIRED
Some body else other than the “patient” wants him to be medically
examined and a medical certificate to be issued (employers,).
Consent of the concerned person must be obtained otherwise the doctor
runs the risk of liability to pay damages.
Such as:-
a. Issuing certificate involving complicated process of examination
or infertility in women.
b. When the process is likely to affect the physical or mental well
being of the patient e.g financial loss.
c. Damage to reputation, social status (STD, HIV etc.).
d. 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.
23. EXCEPTIONS TO THE INFORMED CONSENT
Doctrine of Therapeutic Procedure:
• Certain procedural details (especially invasive tests or complicated
surgery) may be difficult to explain to the patient.
• Often patients themselves do not want to know about it.
• It is better to explain to the family members.
Doctrine of Emergency:
•Under section 92 of Indian Penal Code (IPC) treating without consent of
patient is permissible if patient is unconscious, mentally ill or gravely sick
and no attendant with the patient.
•It is implied that the procedure /surgery is done to save the life or limb of
the patient.
•If possible, surrogate/proxy consent should be taken.
Doctrine of Loco Parents:
•In children in an emergency, when parents / guardians are not available,
consent can be obtained from the person bringing the child (school teacher)
24. EXCEPTIONS TO THE INFORMED CONSENT
Incompetence:
Incompetent patients such as delirious, unconscious, senile,
psychotic nature etc are unable to make rational decision.
In these cases they can be treated without informed consent
involving the “Emergency” doctrine.
Therapeutic privilege:
If doctor suspects that passing full information could have
detrimental effect on the health of the patient than he need not
follow “Doctrine of Full Disclosure”
And can be excused of obtaining consent from the patient.
However, to take the privilege of the doctrine, he should disclose
full information to the competent relative of the patient.
25. DOCTRINE OF FULL DISCLOSURE
The Doctor is legally bound to pass on every detail
regarding the disease condition, nature of the proposed
treatment, any alternative treatment, and prognosis with
possible risks and benefits of the procedure to the patient.
Mental capacity, physical condition as well as age of the
patient should be considered while delivering this
information and likely after effect or else the same
information can be passed on to any other authorized
person.
This therapeutic privilege of a doctor is an exception to
professional secrecy.
26. CONSENT NOT REQUIRED
i. Medico-legal cases bought by police consent is implied under sec
53 of criminal procedure code. Hence can be examined
ii. Consent is not required in medical examination and issue of
certificate for insurance policies .
iii. Cases where it is issued in the interest of the community.
iv) A person suffering from disease under “notified” category( to notify
the authorities only)
v) Prisoners ( new entrants)
vi) Examination under Court Order
vii) Request by a police officer under Cr.P.C. Section 53(1)-To avoid
insufficient legal interpretations, Informed Consent (IC )should be
understood in terms of autonomy .
-A continuous interaction between the patient and the given physician
is considered as an essential pre requisite for the realisation of the
standards of IC
27. DIFFICULTY IN OBTAINING CONSENT
The difficulties in getting informed consent
include:
a. Incompetence and mental incapacity of the
patient.
b. Unusual (socio, religious) beliefs of patient.
c. Extent of truthful disclosure.
d. Incompleteness of information disclosed.
e. Advance directives by terminally ill patients or
those who anticipate grave illness.
f. Durability of power of attorney for health care,
when holder gives the consent and decisions in
advance.
28. INFORMED REFUSAL
It states that the doctor must inform the patient about the risks
of refusing a particular operation, test, medication, or other
medical intervention.
Concept of informed refusal is inherient in informed consent.
It assumes importance only when the patient does not consent
to treatment despite being informed of risks of refusal.
To be legally valid, such informed refusal must be reduced to
writing with signature of patient, doctor and witness.
29. Case studies:- Truman V Thomas –
In 1970 Mrs Truman died of cervical cancer at the
age of 30 years. Her family physician Dr Thomas
had seen her frequently between 1964 and 1969 and
had advised her Pap smear but they refused for the
same and Dr Thomas failed to inform her risk
involved in refusing Pap smear. Her two children
sued Dr.Thomas. Court held that merely advising
treatment is not enough, patient must be told about
risk of refusal.
This the first known case of informed refusal
30. INDIAN LEGAL PROVISION
Section 53(1) Cr PC:
In criminal cases when examination of an arrested person can lead to
vital evidence related with the commission of crime, he can be
examined by the doctor without his consent and even using force, if
the application for examination is from a person not below the rank
of sub Inspector.
Section 54 Cr PC:
An arrested person can also request to be examined by a doctor to
detect any evidence which he feels is good for him.
Section 87 IPC:
A person above 18 yrs of age can give consent to suffer any harm if
the act is not intended and not known to cause death or grievous
hurt.
Section 89 IPC:
A child under 12 yrs of age or a person of unsound mind cannot give
consent to suffer any harm for an act which may cause grievous hurt
or death even if done in good faith , but the consent has to be
obtained from the guardian of the child or insane person.
31. Section 90 IPC: Consent given by an insane person or given under
fear of injury, death etc. or due to misconception of a fact is invalid.
Section 92 IPC: Any harm caused to a person in good faith even
without the person’s consent is not an offence if the circumstances
were such that it was impossible to obtain consent of the person or
his lawful guardian at that material time for that thing to be done for
the benefit of the person.
However the act should not extend to intentionally causing hurt other
than for preventing death, grievous hurt or curing of disease or
infirmity.
Section 93 IPC: Any communication made in good faith for benefit
of patient is not an offence, if it causes harm to that person to whom
it is made.
32. CASE STUDIES
Moss vs Rishworth (1920)
An 11 year old girl taken to surgeon for removal
of tonsils & adenoids by her 2 adult sisters---
There was no emergency---Doctor perform
operation without contacting parents----Girl died
under anesthetic---Doctor was held responsible.
33. Jackovach vs Yocum (1931)
17 year old boy severely injured as he jumped
from moving train --- suffered crushed elbow
joint --- had to be anesthetized immediately----
while under anesthesia, suegeons determined that
his arm to be amputated ---- informed consent
could not be obtained because boy was under
anesthesia and his parent could not be contacted
because of emergency -----boy and his parent suit
against the surgeons----surgeon not held guilty.
34. Wells vs McGehee (1949)
11 year old child died when physician
administered chloroform before setting her
broken wrist----- consent of mother could not be
taken ----- it was held that doctor was justified in
proceeding without parental consent as
emergency existed.
35. REFERENCES
Modi JP.Modi’s Medical Jurisprudence and
Toxicology, 25th edn, edited by Justice K
Kannan, Lexis Nexis:59-61
K S N Reddy. Essentials of Forensic
Medicine and Toxicology, 34th Edn:48-52
Anil Aggarwal. Textbook of FORENSIC
MEDICINE and TOXICOLOGY, 1st edi
reprint 2017:47-50
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