INFORMED CONSENT

2. INTRODUCTION
 Legal and moral imperitives for informed consent are
based on ethical principle of respect for patient
autonomy i.e.
-ability to choose without controlling interference by
others and without personal limitations which prevent
meaningful choices

3. COMPONENTS
 Name and purpose of diagnostic test or procedure
 Most significant risks of test / procedure
 Benefits of intervention,including chances of success if
pertinent
 Probable outcome of intervention/refusal of proposed
plan
 Possible alternatives and procedure
 Patient must be free from concerns

4. DEFINITION
 Consent requires an active communication between
doctor and patient where in the physician educates the
patient explaining the nature and purpose of the
proposed procedure or therapy,along with the
attendant risks and benefits
 In the indian context , informed consent was non
existent till consumer protection act was made
applicable to medical profession

5. DOCUMENTATION OF CONSENT
 Hand written notes
-Is the best evidence of discussion and consent
-Time consumed in the process however, is unacceptable
 Separate anaesthesia consent from required with
common risks detailed is not very reliable
 Reliance on surgical consent is not very reliable

6. ETHICAL ASPECTS OF CONSENT
 Ethical obligation to respect patients autonomy
 Obligation to respect patients right to be involved in
discussions which affect them
 Patient must be supplied adequate information to
make a balanced decision free from corecin
 Need to respect autonomy may conflict with other
obligations like principles of beneficience (doing
good)
 For eg:pt may decline life saving therapy and this may
have to be respected

7. LEGAL ASPECTS OF CONSENT
 Touching a pt without consent may lead to chain of battery
or assault
 Treating doctor is responsible for ensuring that patient has
consent for treatment
 Consent is valid if given voluntarily by appropriately
informed patient who has a capacity to exercise a choice
 Pt without capacity to consent, may be treated without
consent ,if its in their best interest/consent is taken from
guardian
 Pain, illness, premedication does not necessarily render a a
patient incompetent to consent

8. INFORMED REFUSAL
 Informed consent is meaningless if patient cannot also
refuse medical treatment
 For example
 Request to withdraw life support and care in ICU
 Do not resuscitate(DNR) orders in operation theatre
 Jehovahs witness patients who refuse blood
transfusion
 Patient refusing preoperative testing like HIV and
pregnancy test

9. DISCLOSURE
 Informed consent requires honest disclosure of
medical information to patient
 Therapeutic priveledge cited if stress of discussing risk
can harm patient psychologically/physically
 Physician ,ust discuss therapy,its alternatices and no
therapy
 He should also disclose the common and serious risks

10. Two standards of disclosure:
Reasonable person standard: physician must disclose any
information which a reasonable person would want to
know
Subject to standard:
Some patient may have special need to special information
When the need is obvious ,information must be disclosed
For example, violinist has specific need to know about the
nerve damage from axillary nerve block

11. OUTCOME
 Patient will have sufficient knowledge to make an
educated decision whether or not to undergo the
proposed therapeutic intervention
 Physicians have ethical obligation to avoid exploiting
their influence on patients and to coerce or
manipulate than into decision by
threats/misinterpreting information