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 SKDI

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Masalah

PenyakitPokok 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 dimengerti2. Prinsip komunikasi dalam pelayanan kesehatan

a. Metode komunikasi oral dan tertulis yang efektifb. Metode untuk memberikan situasi yang nyaman dan kondusif dalam berkomunikasi efektifc. Metode untuk mendorong pasien agar memberikan informasi dengan sukarelad. Metode melakukan anamnesis secara sistematise. Metode untuk mengidentifikasi tujuan pasien berkonsultasi

f. Melingkupi biopsikososiokultural spiritual

Area Kompetensi 3: Komunikasi Efektif

Area Kompetensi 3: Komunikasi Efektif

3. Berbagai elemen komunikasi efektifa. Komunikasi intrapersonal, interpersonal dan komunikasi masa b. Gaya dalam berkomunikasic. Bahasa tubuh, kontak mata, cara berbicara, tempo berbicara, tone suara, kata-kata yang digunakan atau dihindarid. Keterampilan untuk mendengarkan aktife. Teknik fasilitasi pada situasi yang sulit, misalnya pasien marah, sedih, takut,atau kondisi khususf. 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 ilmiah6. Komunikasi dalam public speaking

2 kata

informed consent

information consentSegala sesuatu tentang pasien

Pemeriksaandiagnosa

Respons

• Informed consent is a process for getting permission before conducting a healthcare intervention on a person

Informed consent : AMA 1998

• process communication

patientphysician

medical intervention

“Informed Consent: It’s 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

written consent

oral consent

Layanan

• Pateint centre

Patient

dokter

Nursedietisen

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

What needs to be improved?

• Persiapan– Verbal dan non verbal– Lihat kompetensi area 3

• Kolaborasi dengan kolega• dll

Boleh baca• Informed consent is an ethical concept—that 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 “individual’s 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.