LEGAL ASPECTS

OF INFORMED CONSENT
IN INDONESIA

By : Anna Haroen Atmodirono

Member of Bioetics Unit, Medical school, Airlangga University
Lecturer on Medical Law
Hospital Legal Counsellor

INTRODUCTION
The regulation on informed consent has
been issued in Indonesia since 1989
under Regulation of Minister of Health No.
585

The contents of regulation are:

General regulation.
Consent.
Information.
The Person who are valid to consent.
Responsibility.
Legal sanctions.
Other regulations.
Closing regulation.

The implimentation of regulation was

issued by General Director of Medical
Service, Departement of Health, under the
Letter of Decree on April, 21, 1999 and
serves as guidelines

The content of the guide line are :

I.

Introduction.
1.
2.
3.
4.

General regulation.
The principle of regulation.
The purpose of regulation.
Definition of informed consent.

II.

Informed consent
1.
2.
3.
4.
5.
6.
7.

The rules of informed consent & refusal consent.

The obligation of doctor to obtain consent.
The validity of informed consent implementation.
Content of information.
Obligation to explain information.
Methods of explaining information.
The party who has right to consent.

8. The procedure to consent.

9. Risky medical treatment.
10. Extention of medical treatment.
11. The implementation of certain medical
treatment.
12. Exception of informed consent.
13. Closing regulation.

Regulation on informed consentis also

mentioned in pargraph 2 article 45 of the
law of Medical Practice for doctors &
dentists that went into effect on October,
6, 2005.

DEFINITION
OF INFORMED CONSENT
According to both regulation and the law,
informed consent is a consent that is given
by the patient or his close relative or some
body who has authority to act in his behalf
after adequate information of the purpose
procedures that has been explained.

The consent given may either be implied or

express. Consent must be given by the
patient freely, rationally and voluntary.

IMPLIED & EXPRESS CONSENT

1.

Implied consent
May be implied
by a patients conduct
Voluntary
Example : injection

2. Express Consent
a.

Oral Consent
For the mayority of minor examination
Thetapeutic procedure
In the presence of third party as witness
from the part of institution

b. Written consent
For all risky & a major diagnostic
procedure,general anaesthetics &
surgical operation
Provided by institution
Consent is legally valid if they put their
signature or thumb print obn the form
But his thumb may not be held by
onyone

INFORMATION FOR CONSENT

The consent given to a purposed procedure
must be an informed consent with
understanding.
Make an informed decision.
Relevation of risk, is always a compromise.

Acording to the law of Medical Practice

(paragraph 2 article 45 )
a. The diagnose & the methods of treatment.
b. The purpose of the treatment.
c. The alternative of other treatment & risk
involved.
d. The risk & the complications that might
occur.
e. The prognoses of the treatment.

Addition ..
The information included the advantages
and disadvantages of the purpose
treatment.
The information is given to patient orally.

III.Extension Of Operation
- Is legally valid if consent is obtain from
patient, except to savethe patients live
- The physician has a right to extend an
operation beyond that authorizedby the
patient (condition instuiting a thread to
the patients life)
- The right is limited to emergencies calling
for immediate action.

Addition .
When operation in over, the physician
must explain to the patient or his close
relative what he has done.

THE PERSON WHO ARE VALID TO CONSENT

1. Consious, mentally sound adult (21

years old or married), give consent
themselves.
2. < 21 years old, unmarried

Father / mother
Brother / sister

3. < 21 years old, unmarried, has no

parents / his parent is unable to present
Foster Father / foster mother
Brother / sister
Employer

4. The patient is under trusteeship

Legally appointed guardian
Legally apointed trustee

5. The order of adult

Husband / wife
Father / mother
Children
Brother / sister

6. The patient is unsound mind and incompetent

to understanding the nature
Father / mother
Legally appointed guardian
Brother / sister

EXCEPTION OF THE RULES

There are two kinds of incidents where
informed consent is not necessary :
If a person is injured & unconscious , and
requires prompt attention to safe his life & no
one else present to consent for him.
If the treatment is inline with the program of
the government for welfare of the nation.

LEGAL SANCTION
A physician who treats / operates upon a
patient without obtaining consent from
patient ( oral / written) commit an assault
& battery for which he may be procecuted
criminaly, held civilly & administratif
sanction.