2. 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.
3. Situations requiring Consent in medical practice:
3. Examination of the patient for the purpose of
diagnosis, investigation and subsequent treatment.
4. Examination of the living person for medico-legal
purposes.
5. Any major/minor operative procedures
6. Abortion, organ transplantation, blood donation/
infusion
7. Pathological autopsy
4. • 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.
5. 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.
6. 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
7. • Types of Consent:
A.Implied Consent
C.Expressed Consent
1. Oral
2. Written
E.Informed Expressed Consent
8. 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.
9. • 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.
10. 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.
11. • 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.
13. 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
14. 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
15. 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
16. 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
17. 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
18. 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
19. Many studies reveal that physicians often
fail to observe the practice and the spirit
of informed consent
20. 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?
21. [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
22. 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
23. 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
24. 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
25. i. a professional opinion about alternative
modalities of treatment open to the
patient
ii. a recommendation that is based on the
physician best clinical judgement
26. In carrying this information, physicians
should:
i. Speak in the patients’ language of
preference
ii. Avoid technical terms
iii. Attempt to translate statistical data
into everyday probabilities
27. (con’t)
ii. Enquire whether patients understand
the information
iii. Invite questions
iv. Interpret other information that
patient has to ascertain its relevance
28. 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
29. 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
30. 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
31. 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.
32. Difficulties With Informed Consent
Problems physicians may face
i. Use of technical language
ii. Uncertainties intrinsic to all medical
information
iii. Worried about harming or alarming
the patient
iv. Hurried and pressed by multiple duties
33. Problems patients may face:
ii. Limited knowledge
iii. May be inattentive or distracted
iv. Overcome by fear and anxiety
v. Selective hearing because of denial,
fear, or preoccupation with illness
34. 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
35. 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
36. 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
37. 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
38. 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
39. 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.
40. • 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
