INFORMED

CONSENT
BENTENG PENCEGAH TUNTUTAN
PASIEN
HERKUTANTO
 Herkutanto
Ketua Komite Nasional Keselamatan Pasien Rumah
Sakit, Kementerian Kesehatan RI
Ketua Konsil Kedokteran, Konsil Kedokteran
Indonesia
Pendidikan dibidang Kedokteran
Pendidikan dibidang Hukum
 Doktor (S3), Dokter, Spesialis • Sarjana Hukum (SH) Universitas
Forensik - Universitas Indonesia Indonesia, Fakultas Hukum
 Grad. Dip. Forens.Med. - • Master of Laws (LL.M) La Trobe
Monash University, Australia University, Australia School of
Law
PENGANTAR
 Intervensi hukum terhadap dunia kedokteran
dirasakan semakin intens
 Jenis intervensi dan prosedur tindakan medis
dan risikonya semakin banyak
 Persepsi terhadap informed consent masih
sangat beragam
ALASAN UTAMA MELAKUKAN
REGULASI

(Schellekens, W : Patient Safety Conference,

European Union Presidency Luxembourg, 4 – 5 April 2005)
risk D
E
D
risk E
risk
F
F E
E INCIDENT
N
N
risk risk risk
C C
E ACCIDENT
risk E
S S

HERKUTANTO,
5
PERSI, 2015
 INCIDENT
Clinical Privileges Tindakan Medis

Clinical Privileges Tindakan Medis

Clinical Privileges Tindakan Medis

Clinical Privileges Tindakan Medis

ACCIDENT
TUJUAN DISKUSI
 Menyamakani persepsi tentang informed
consent
 Mendiskusikan implementasi informed

consent dalam berbagai situasi klinis dan

konsekuensi hukumnya
SISTIMATIKA PAPARAN
1. Konsep Akuntabilitas Profesi dan
Tanggungjawab hukum Tenaga
Kesehatan dalam rumah sakit
2. Regulasi tentang Informed Consent
3. Konsep informed consent dan
implementasinya dalam rumah sakit
KONSEP TANGGUNGJAWAB
HUKUM

1
BENTUK KLAIM TERHADAP TENAGA MEDIS

 DISIPLIN PROFESI
 Majelis Kehormatan Disiplin Kedokteran Indonesia
(MKDKI)
 Peringatan – Suspensi STR

 HUKUM PERDATA
 Pengacara – Ganti Rugi

 HUKUM PIDANA
 Polisi – Jaksa – Sanksi Pidana
Herkutanto, Dinas Kesehatan DKI 2013
STATEMENT ON MEDICAL MALPRACTICE
44th World Medical Assembly, Marbella, Spain, September 1992

 A distinction must be made between medical

malpractice and an untoward result occurring in
the medical treatment that is not the fault of the
physician
 An injury occurring in the course of medical
treatment which could not be foreseen ….. is an
untoward result
 In an untoward result, physician should not bear
What is foreseeable – is what the defendant will pay for
any liability
I.Kennedy, A.Grubb, Principles of Medical Law, Oxford Univ.Press, London, 1998, p.415
 RISK
?
UNWANTED RESULT IN
MEDICINE

NEGLIGENCE
12
?
2/21/2017Herkutanto, 2001
 LIABILITY IN MEDICINE

DAMAGE

RISK NEGLIGENCE
Consent No Consent
obtained obtained

Not liable liable

13 21/02/2017
Herkutanto, 2001
 MEDICAL MISHAPS
FORESEEN
UNFORESEEN

Prevention Prevention
not performed performed

liable Not liable

14 2/21/2017Herkutanto, 2001
 AKUNTABILITAS PROFESI
DAN KESELAMATAN PASIEN

POTENTIAL
COMPENSATED
EVENTS

RISK
CMPA, Medical Liability System in Canada: toward the right balance, 2005
 COMMON GOOD - ACCOUNTABILITY

 If the risk is known ...... Prevent it

.....

 If it is broken .................. Fix it .......

MANAGE IT .....
REGULASI INFORMED
CONSENT

2
REGULASI INFORMED CONSENT DI
INDONESIA
 UU No. 29/2004 tentang Praktik Kedokteran
 UU No. 44/2009 tentang Rumah Sakit
 UU No. 36/2009 tentang Kesehatan
 PERATURAN MENTERI KESEHATAN
REPUBLIK INDONESIA NOMOR
290/MENKES/PER/III/2008 TENTANG
PERSETUJUAN TINDAKAN KEDOKTERAN
UU No. 29/2004 tentang Praktik
Kedokteran
UU No. 29/2004 tentang Praktik
Kedokteran
 Penjelasan Pasal 45 ayat (1)
UU No. 29/2004 tentang Praktik
Kedokteran
 Tertulis
UU No. 29/2004 tentang Praktik
Kedokteran
 Pasal 32 Tentang Hak Pasien RS
UU No. 44/2009 tentang Rumah Sakit
UU No. 36/2009 tentang Kesehatan

 Persetujuan pengakhiran kehamilan,

Subyek Penelitian, Donor Transplantasi
Organ, Bedah Mayat Klinis
KONSEP INFORMED
CONSENT

3
KONSEP PEDULI RISIKO DALAM KULTUR INDONESIA

• Peduli mencegah Risiko (yang akan menimpa pasien)

– DUTY OF DUE CARE (against the Risk to Patients)
• Kenihilan konsep “RISIKO”
Masyakarat KOMUNAL
• Kenihilan konsep “KEPEDULIAN” Masyarakat HIERARKHIS

Apa akibatnya bagi Praktisi Medis ...?

 HAZARD vs RISK vs. COMPLICATIONS
1. A hazard is something that can cause harm, e.g. electricity, chemicals, working
up a ladder, noise, a keyboard, a bully at work, stress, etc. [... tindakan medik ...??]
2. Complications are things that happen as a result of a disease or a treatment
that you prefer didn't happen [stroke from hypertension, or bleeding following
surgery]
 A complication may be described as an adverse event caused by pre-existing
factors that were outside the doctor’s control. Patients are not the same in health,
habits, immunity or healing power, and have varying susceptibility to complications
3. A risk is the chance, high or low, that any hazard will actually cause
somebody harm.
 Risk factors are things that make it more likely that you will develop a disease or
condition. They may be things you can't do anything about, like gender, family
history, or race, or things you can control, like smoking and diet.

2/21/2017
 RISK ARISE FROM let the patient RISK ARISE FROM
MEDICAL PROCEDURES CHOOSE THE RISK THE DISSEASE

INFORMATION
FROM PHYSICIAN

? INFORMED OPINION

INFORMED DECIS ION

?
CONSENT TO REFUSE
THE MEDICAL PROCEDURES THE MEDICAL PROCEDURES
(accept risk arising from medical procedure ) (accept risk arising from the
dissease)
INFORMED CONSENT (What is it ... and
what is it not)

Informed Consent is Informed Consent is

NOT
 NOT just a FORM ...
 It is a PROCEDURE
(Formulier) (Protocol)
 NOT a WAIVER  It is aWAIFER

against malpractice against Risk

 NOT AN Liabilities
AGREEMENT  PATIENT

between Dr vs CONSENT to
ELEMEN ESENSIAL DALAM
INFORMED CONSENT
1. Persetujuan atau Penolakan diberikan untuk tindakan kedokteran
yang dinyatakan secara spesifik tindakan tersebut (The Consent
must be for what will be actually performed)
2. Persetujuan atau Penolakan Tindakan Kedokteran diberikan atas
pengambilan keputusan yang bebas / sukarela (Voluntary)
3. pengambilan keputusan Persetujuan dan Penolakan Tindakan
Kedokteran diberikan setelah diberikan informasi yang cukup
(adekuat) tentang perlunya tindakan kedokteran dilakukan, alternatif
dan risikonya.
4. Persetujuan atau Penolakan diberikan oleh pasien yang mampu
mengambil putusan secara sehat, atau yang berhak secara hukum
IMPLEMENTASI INFORMED
CONSENT
 Menyusun Kebijakan tentang Informed Consent
 Implementasi informed consent dalam situasi spesifik
 Bukti2 informed consent, penggunaan meterai, dll

 Monitoring dan Evaluasi Pelaksaaan Informed

Consent
 Kerjasama dengan Komite Medik
KESIMPULAN
 Informed consent telah diatur secara tegas
dan rinci dalam peraturan perundang-
undangan
 Informed consent memproteksi tenaga
kesehatan dan RS atas risiko yang telah
disetujui pasien
 Berbagai mispersepsi tentang Informed
consent perlu diluruskan
Herkutanto 2009