Informed Consent

Dr Sontang Simamora MMedEd

Informed Consent
Form Templates
(language used throughout form should be at the level of a local student of class 6th/8th)
Notes to Researchers:
Please note that these are templates developed by the WHO ERC to assist the Principal Investigator
in the design of their informed consent forms (ICF). It is important that Principal Investigators adapt
their own ICFs to the outline and requirements of their particular study. The logo of the Institution
must be used on the ICF and not the WHO logo.
The informed consent form consists of two parts: the information sheet and the consent certificate.
Do not be concerned by the length of these templates. They are long only because they contain
guidance and explanations which are for you and which you will not include in the informed
consent forms that you develop and provide to participants in your research.
These templates include examples of key questions that may be asked at the end of each section,
that could ensure the understanding of the information being provided, especially if the research
study is complex. These are just examples, and suggestions, and the investigators will have to
modify the questions depending upon their study.




KBK
L O
Blok
Masalah
Penyakit Pokok
Bahasan
Kompetensi
UU Kesehatan
Setiap orang berhak memperoleh informasi
tentang data kesehatan dirinya termasuk
tindakan dan pengobatan yang telah maupun
yang akan diterimanya dari tenaga kesehatan.

1. Penggunaan bahasa yang baik, benar, dan mudah
dimengerti
2. Prinsip komunikasi dalam pelayanan kesehatan
a. Metode komunikasi oral dan tertulis yang efektif
b. Metode untuk memberikan situasi yang
nyaman dan kondusif dalam berkomunikasi efektif
c. Metode untuk mendorong pasien agar memberikan
informasi dengan sukarela
d. Metode melakukan anamnesis secara sistematis
e. Metode untuk mengidentifikasi tujuan pasien
berkonsultasi
f. Melingkupi biopsikososiokultural spiritual


Area Kompetensi 3: Komunikasi Efektif

Area Kompetensi 3: Komunikasi Efektif
3. Berbagai elemen komunikasi efektif
a. Komunikasi intrapersonal, interpersonal dan komunikasi masa
b. Gaya dalam berkomunikasi
c. Bahasa tubuh, kontak mata, cara berbicara, tempo berbicara, tone suara, kata-
kata yang digunakan atau dihindari
d. Keterampilan untuk mendengarkan aktif
e. Teknik fasilitasi pada situasi yang sulit, misalnya pasien marah, sedih, takut,atau
kondisi khusus
f. Teknik negosiasi, persuasi, dan motivasi

4. Komunikasi lintasbudaya dan keberagaman
Perilaku yang tidak merendahkan atau menyalahkan pasien, bersikap sabar, dan
sensitif terhadap budaya

5. Kaidah penulisan dan laporan ilmiah
6. Komunikasi dalam public speaking

2 kata
Informed consent is a process for getting
permission before conducting a healthcare
intervention on a person
Informed consent : AMA 1998

Informed Consent: Its Not About the
Form
surgery, anesthesia, and other invasive or
complex medical or radiologic procedures.


Pemeriksaan non invasive,
Obat risiko rendah
Test umu : urin rutin dll
Layanan
Pateint centre
Patient
dokter
Nurse
lainnya
Who : informed consent
Doctors
Surgeons
Nurses
Health Educators
Pharmacists
Administrative staff
Technicians/Specialists
Risk Managers
General Legal Counsels/Attorneys
Interpreters
Translators
Patient Advocates Quality/Accreditation Managers

How To Improve Your Informed
Consent:
Policies, processes, and forms?

What are the highest priorities?
How should we make improvements?
Who can help in this process?
How should we measure our progress?

Persiapan
Verbal dan non verbal
Lihat kompetensi area 3
Kolaborasi dengan kolega
dll


Boleh baca
Informed consent is an ethical conceptthat all patients should
understand and agree to the potential consequences of their care
that has become codified in the law and in daily practice at every
medical institution.
One of the earliest legal precedents in this area was established in
1914 when a physician removed a tumor from the abdomen of a
patient who had consented to only a diagnostic procedure
(Schloendorff vs. Society of New York Hospital).
The judge in this case ruled that the physician was liable for battery
because he violated an individuals fundamental right to decide
what is being done with his or her body.
[Edwards 1998, Wescott 2005] The first case actually defining the
elements of informed consent occurred in the late 1950s and
involved a question of potential negligence and whether a patient
was given sufficient information to make a decision.