Importance of consent in medical practice and legal provisions in India. Includes history, types of consent, informed consent, exceptions to consent.

1. Consent in Medical
Practice
Dr Ashutosh B Potdar,
Professor,
Forensic Medicine

2. Consent
• Agreement, compliance or permission given
voluntarily without compulsion
• In medical practice it refers to the willingness of a
person to subject himself for examination,
investigation and treatment

3. Consent
•Autonomy - the Nuremberg Code
of 1947
•Declaration of Helsinki 1964 -
informed consent for medical
research
•Sec. 13 of the Indian Contract Act,
1872: two or more persons are
said to consent when they agree
upon the same thing in the same
sense

4. X Doctors are Gods
X Patternalism

5. Present day
• Significant changes in the doctor-
patient relationship with the
advancement of technology
• Patients are becoming aware of their
rights
• Make free choice and decision on their
treatment
• Select a physician of their choice

6. •COPRA (Consumer Protection Act)
•Legal requirement than an ethical moral
obligation on part of the doctor
•Important aspect of several Medical Consumer
litigations is improper consent

7. Types of Consent

8. Consent
Implied Expressed
Verbal
Written
(Consent form)

9. Implied consent
•Patient presents himself at the doctor's
clinic or outpatient,
•Implied that he is agreeable to be
examined
•Only for procedures like inspection,
palpation, percussion and auscultation

10. Expressed Consent
•Specifically stated by the patient in distinct and explicit
language
Oral/verbal consent
•Relatively minor examinations or therapeutic
procedures
•In presence of disinterested party, like nurse
•E.g. Rectal and vaginal examinations
•Withdrawal of blood for diagnostic purposes

11. Written consent
•All major diagnostic procedures
• General anaesthesia
• Operations
•Participation in
Medical research

13. Doctrine of Informed Consent
Understanding by the patient of:
i. Condition or nature of illness
ii. Purpose and nature of procedure or treatment
proposed
iii. Risks and benefits of treatment or procedure
iv. Risks and benefits of alternative treatment(s) or
procedure(s)

14. Doctrine of Informed Consent
v. Prospect of success or failure - Prognosis
vi. Prognosis in the absence of intervention
vii. Acceptance or refusal (informed refusal) of the said
procedure or intervention
Vernacular Language

15. Consenting Ages for Treatment
•Age of consent for medical
examination and treatment :
• legally accepted as ≥12 years
•Child < 12 years of age, or a patient
of unsound mind:
• Guardian or person in whose custody
he/she is, can give consent

16. Consenting Ages for Treatment
•Invasive and diagnostic
procedures, general
anaesthesia and surgical
operations
•Age of consent is ≥ 18 years

17. Rules of Consent
•Free, voluntary, clear, intelligent, informed, direct and
personal
•Explain the object of examination to the patient
•Patient should be informed - findings - included in the
medical report
•Right to refuse to submit to examination and that the
result may go against him

18. Rules of Consent
• Insane or intoxicated person: unable to understand the nature
and consequences, consent is invalid (Sec. 90 IPC).
• Sec. 92 IPC: deals with cases of emergency, states that any
harm caused to a person in good faith, even without the
person's consent, is not an offence

19. Rules of Consent
• Consent of spouse is not
necessary for treatment
of other
• Contraceptive
sterilization and Artificial
insemination, consent of
both husband and wife is
must

20. Rules of Consent
•Civil cases: examination not done without the consent
of the person
•Criminal cases: the victim cannot be examined without
consent
•Under Sec. 53 (1) CrPC, an accused can be examined by
a doctor by using reasonable force, if requested by a
police office

21. Rules of Consent
• Organ donation: the will
of the deceased is
enough
• Prenatal diagnostic
procedures: Informed
written consent of
pregnant woman

22. Rules of Consent
•Pathological autopsy: consent of next of kin of the
deceased
•Medico-legal autopsy: does not require any consent
from the relatives of the deceased

23. Loco parentis (Latin, ‘in place of a parent’)
•Emergency involving children: parents or
guardians are not available
•Consent of the person-in-charge of the child,
e.g. a school teacher at picnic

24. Consent is Invalid if
•Not an informed consent
•Given for committing a crime or an illegal act, such
as criminal abortion
•Obtained by misrepresentation or fraud
•No legal capacity to give it,
e.g. a minor or an insane person

25. Exceptions to informed consent
•Emergencies (Sec. 92 IPC)
• 17 year old boy severely injured as he jumped from moving train
• Suffered crushed elbow joint
• Anesthetized immediately and 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
• Boy and his parent suit - against the surgeons
• Surgeon not held guilty

26. Exceptions to informed consent
•Therapeutic privilege:
• Doctor can withhold information from patient
• If the disclosure would pose serious psychological threat to the
patient (e.g. malignancy or unavoidable total results)
• Disclose full information to a competent relative of the patient

27. Exceptions to informed consent
•Therapeutic waiver:
• Competent person who is aware of being entitled to informed consent
may give up his right by waiving it

28. Exceptions to informed consent
•Medico-legal postmortems (Sec. 174 CrPC)
•Examination of an arrested accused [Sec. 53 (1) CrPC]
•Treatment of patient suffering from ‘notifiable diseases’
for greater community interest
•Psychiatric examination or treatment by court order
•Prisoners (new entrants)

29. Case Scenario
• Sarita is an unmarried 17 years old girl. She comes
unaccompanied to the Obstetrics OPD with h/o amenorrhea
• Pregnancy test is positive and doctor informs her that she is
10 weeks pregnant
• On questioning, she reveals that her relationship with a boy
from neighbourhood led to pregnancy but he refuses to
marry her as she belongs to different community

30. Case Scenario
• Sarita requests the doctor to perform termination of
pregnancy
• She is afraid of parents as they may harm her or send her
away
• She can not give a valid or legal consent as she is only 17
years

31. Consent to be Valid…
• Free, voluntary, without undue influence
• Given by a competent person
• Is informed
-nature of illness
-prognosis
-options available and risks involved
• Guardian ( proxy consent) in the case of the mentally retarded,
minors