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    Tutorial 3.2 Blok Dental Research: Rini Sulistyowati-J2A019009 - SGD 2

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    This document discusses ethical issues in research. It covers the following key points in 3 or fewer sentences: 1) Ethical principles in research include respecting participant autonomy, promoting justice, ensuring beneficence, and avoiding harm. The process of obtaining ethical clearance involves applying to an ethics committee with a research protocol. Informed consent involves providing participants with information, ensuring their understanding, and allowing their choice to participate voluntarily. 2) Relevant principles according to WHO are respect for persons, beneficence, and justice. A research protocol includes the study title, objectives, methods, ethics considerations, references, and investigator team. Informed consent is a process that ensures information is communicated and the participant is capable of consent

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    Tutorial 3.2 Blok Dental Research: Rini Sulistyowati-J2A019009 - SGD 2

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    rosa
    23 views22 pages
    This document discusses ethical issues in research. It covers the following key points in 3 or fewer sentences: 1) Ethical principles in research include respecting participant autonomy, promoting justice, ensuring beneficence, and avoiding harm. The process of obtaining ethical clearance involves applying to an ethics committee with a research protocol. Informed consent involves providing participants with information, ensuring their understanding, and allowing their choice to participate voluntarily. 2) Relevant principles according to WHO are respect for persons, beneficence, and justice. A research protocol includes the study title, objectives, methods, ethics considerations, references, and investigator team. Informed consent is a process that ensures information is communicated and the participant is capable of consent

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    This document discusses ethical issues in research. It covers the following key points in 3 or fewer sentences: 1) Ethical principles in research include respecting participant autonomy, promoting justice, ensuring beneficence, and avoiding harm. The process of obtaining ethical clearance involves applying to an ethics committee with a research protocol. Informed consent involves providing participants with information, ensuring their understanding, and allowing their choice to participate voluntarily. 2) Relevant principles according to WHO are respect for persons, beneficence, and justice. A research protocol includes the study title, objectives, methods, ethics considerations, references, and investigator team. Informed consent is a process that ensures information is communicated and the participant is capable of consent

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    23 views22 pages

    Tutorial 3.2 Blok Dental Research: Rini Sulistyowati-J2A019009 - SGD 2

    Uploaded by

    rosa
    This document discusses ethical issues in research. It covers the following key points in 3 or fewer sentences: 1) Ethical principles in research include respecting participant autonomy, promoting justice, ensuring beneficence, and avoiding harm. The process of obtaining ethical clearance involves applying to an ethics committee with a research protocol. Informed consent involves providing participants with information, ensuring their understanding, and allowing their choice to participate voluntarily. 2) Relevant principles according to WHO are respect for persons, beneficence, and justice. A research protocol includes the study title, objectives, methods, ethics considerations, references, and investigator team. Informed consent is a process that ensures information is communicated and the participant is capable of consent

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    of 22

    TUTORIAL 3.

    2
    BLOK DENTAL
    RESEARCH
    RINI SULISTYOWATI- J2A019009- SGD 2
    SKENARIO 3: Ethical Issue In Research
    http://bit.ly/Skenario2Metopen
    This Video Will Describe About Ethic Issue In Research

    Kata Kunci/ Keywords : Ethical principles, ethical clearance, informed consent


    LEARNING OBJECTIVE
    1. Apa saja prinsip- prinsip etika penelitian?
    2. Apa saja prinsip- prinsip etika penelitian menurut WHO?
    3. Bagaimana proses pembuatan protokol penelitian ethical clearance?
    4. Bagaimana proses pembuatan informed consent suatu tindakan (syarat)?
    5. Apa hadits/ Ayat Al- Qur’an yang relevan dengan skenario?
    PRINSIP- PRINSIP ETIKA
    PENELITIAN
    Sumber 1

    Berdasarkan deontology approach:


    • Menghargai otonomi partisipan (respect to autonomy)
    • Mengutamakan keadilan (promotion of justice)
    • Memastikan kemanfaatan (ensuring beneficience)
    • Memastikan tidak terjadi kecelakaan (ensuring maleficence)

    Heryana, Ade. 2020. Etika Penelitian. Prodi Kesehatan Masyarakat Universitas Esa Unggul . Hal 3-7
    Sumber 2

    These principles are based on human rights that need to be protected


    in research:
    • Principle of respect for persons → Individu bersifat otonom
    • Principle of beneficence
    • Principle of justice

    Brink, Hilla et al. 2018. Fundamentals of Research Methodology for Healthcare Professionals. 4th Edition. Juta and Company (Pty) Ltd. Pages 29- 31
    Sumber 3

    Principles of ethics for research involving human subjects:


    • Respect for persons
    • Beneficence and non-malificence
    • Justice

    Sulaiman et al. 2008. Guidelines for Ethical Conduct of Research Involving Human Subjects . Sudan Currency Printing Press. Pages 11-12
    Sumber 4

    Sesuai dengan Guideline Internasional CIOMS tahun 2016, baik


    Penelitian Epidemiologi (tahun 1991) maupun Penelitian Individu
    Manusia (tahun 2002), secara universal telah disepakati bahwa semua
    penelitian kesehatan yang mengikutsertakan manusia sebagai subjek
    penelitian wajib didasarkan pada prinsip etik:
    • Menghormati harkat dan martabat manusia (respect for persons)
    • Berbuat baik (beneficence) dan tidak merugikan (non maleficence)
    • Keadilan (justice)

    KEMENKES RI. 2017. Pedoman dan Standar Etik Penelitian dan Pengembangan Kesehatan Nasional. Hal 73- 75
    ETHICAL CLEARANCE
    Proses pembuatan protokol penelitian ethical clearance
    How to get ethical clearance?
    Projects including
    humans

    In national,
    In one state or experimental or
    institution external participant
    design

    Apply to the state or


    institutional ethics Apply to the NHREC
    committee

    Sulaiman et al. 2008. Guidelines for Ethical Conduct of Research Involving Human Subjects . Sudan Currency Printing Press. Page33
    Sulaiman et al. 2008. Guidelines for Ethical Conduct of Research Involving Human Subjects . Sudan Currency Printing Press. Page 34
    PROTOKOL PENELITIAN
     Judul penelitian  Jadwal penelitian
     Identitas pengusul penelitian  Rekapitulasi biaya (rincian rencana
     Daftar isi anggaran)
     Ringkasan penelitian  Biodata ketua pelaksana dan peneliti
     Pendahuluan  Persetujuan atasan yang berwenang
     Metode penelitian  Kesediaan anggota tim peneliti
     Etik penelitian
     Daftar kepustakaan
     Lampiran
     Susunan tim peneliti

    KEMENKES RI. 2013. Panduan Umum Penyusunan Proposal, Protokol dan Laporan Akhir Penelitian. Badan Penelitian dan Pengembangan Kesehatan
    INFORMED CONSENT
    Proses pembuatan informed consent suatu tindakan (syarat)
    APA ITU INFORMED CONSENT?
    • CIOMS telah mendefinisikan informed consent sebagai persetujuan untuk
    berpartisipasi dalam studi atau percobaan yang diberikan oleh individu yang
    kompeten.
    Information aspect

    Capability
    Risk and benefit
    analysis aspect

    Communication
    aspect

    Heryana, Ade. 2020. Etika Penelitian. Prodi Kesehatan Masyarakat Universitas Esa Unggul . Hal 3-4
    Sulaiman et al. 2008. Guidelines for Ethical Conduct of Research Involving Human Subjects . Sudan Currency Printing Press. Page 43
    • Informed Consent merupakan masalah kunci dalam penelitian yang
    mengikutsertakan manusia sebagai subjek penelitian, karena berisi
    pernyataan kesediaan subjek penelitian untuk diambil datanya dan
    ikut serta dalam penelitian.
    • Aspek utama informed consent adalah “information, comprehension,
    dan volunterness”.

    KEMENKES RI. 2017. Pedoman dan Standar Etik Penelitian dan Pengembangan Kesehatan Nasional. Hal 75- 76
    ASPEK UTAMA DALAM INFORMED
    CONSENT
    • Information
    • Understanding
    • Choice

    Brink, Hilla et al. 2018. Fundamentals of Research Methodology for Healthcare Professionals. 4th Edition. Juta and Company (Pty) Ltd. Pages 31- 39
    ASPEK KEMANFAATAN INFORMED
    CONSENT
    • Penghormatan pada subjek penelitian
    • Melindungi subjek penelitian
    • Melindungi peneliti
    • Kerahasiaan informasi

    KEMENKES RI. 2017. Pedoman dan Standar Etik Penelitian dan Pengembangan Kesehatan Nasional. Hal 75- 76
    Brink, Hilla et al. 2018. Fundamentals of Research Methodology for Healthcare Professionals. 4th Edition. Juta and Company (Pty) Ltd. Pages 31- 39
    PROSES
    • Informed consent adalah proses komunikatif dua arah yang dimulai ketika kontak
    awal dibuat dengan calon peserta dan berakhir ketika persetujuan diberikan dan
    didokumentasikan, tetapi dapat ditinjau kembali nanti selama pelaksanaan
    penelitian.
    • Setiap individu harus diberikan waktu sebanyak yang diperlukan untuk mencapai
    suatu keputusan, termasuk waktu untuk berkonsultasi dengan anggota keluarga
    atau orang lain. Waktu dan sumber daya yang memadai harus disediakan untuk
    prosedur persetujuan

    1. Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). 2016. International Ethical Guidelines for
    Health-related Research Involving Humans. 4th Edition. Geneva.
    2. Sulaiman et al. 2008. Guidelines for Ethical Conduct of Research Involving Human Subjects . Sudan Currency Printing Press. Page 48
    DALIL
    Hadits/ Ayat Al- Qur’an yang relevan dengan skenario
    “Wahai orang-orang yang beriman! Jadilah kamu sebagai penegak keadilan karena Allah,
    (ketika) menjadi saksi dengan adil. Dan janganlah kebencianmu terhadap suatu kaum
    mendorong kamu untuk berlaku tidak adil. Berlaku adillah. Karena (adil) itu lebih dekat
    kepada takwa. Dan bertakwalah kepada Allah! Sungguh, Allah Maha Teliti terhadap apa
    yang kamu kerjakan”

    - Q.S. Al- Maidah (5): 8 -


    TERIMA KASIH

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