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"Skripsi ini mengkaji pengaturan informed consent di Indonesia terhadap manusia yang menjadi subjek eksperimen medis, perlindungan hukum atas risiko dan dampak yang ditimbulkan pada manusia sebagai subjek eksperimen medis, dan aturan pelaksanaan eksperimen medis pada Indonesian Medical Education and Research Institute (IMERI) Fakultas Kedokteran Universitas Indonesia. Menggunakan metode yuridis-normatif, dengan tipe penelitian deskriptif, data penelitian dikumpulkan melalui data sekunder yang terdiri dari bahan hukum, dan data primer melalui wawancara mendalam dengan IMERI FK UI. Simpulan penelitian ini adalah: pengaturan informed consent di Indonesia terhadap manusia yang menjadi subjek eksperimen medis terdapat pada Undang-Undang Nomor 36 Tahun 2009 tentang Kesehatan, Peraturan Pemerijntah Nomor 39 Tahun 1995 tentang Penelitian dan Pengembangan Kesehatan, Keputusan Menteri Kesehatan Nomor 1333/Menkes/SK/X/2002 tentang Persetujuan Penelitian Kesehatan terhadap Manusia, dan Peraturan Menteri Kesehatan No 657 tahun 2009 tentang Pengiriman dan Penggunaan Spesimen Klinik, Materi Biologik dan Muatan Informasi. Bentuk perlindungan hukum atas risiko dan dampak yang ditimbulkan pada manusia yang menjadi subjek eksperimen medis adalah bentuk perlindungan hukum perdata, pidana, dan administrasi. Adapun aturan pelaksanaan eksperimen pada IMERI FK UI merujuk pada konvensi internasional, peraturan perundang-undangan nasional, etika penelitian kesehatan, prosedur good clinical practice, serta Joint Commission International, dan Human Research Subject Program. Penelitian ini menyarankan, gagasan general informed consent dapat ditindaklanjuti oleh para pihak terkait

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This thesis examines the regulation of informed consent in Indonesia for humans who are subject to medical experiments, legal protection of risks and impacts caused to humans as subjects of medical experiments, and the rules of conducting medical experiments at the Indonesian Medical Education and Research Institute (IMERI) Faculty of Medicine, University of Indonesia (FK UI). Using juridical-normative methods, with descriptive research type, research data was collected through secondary data consisting of legal material, and primary data through in-depth interviews with IMERI FK UI. The conclusions of this study are: the regulation of informed consent in Indonesia for humans who are subjected to medical experiments is contained in Law Number 36 of 2009 concerning Health, Government Regulation Number 39 of 1995 concerning Health Research and Development, Minister of Health Decree Number 1333 / Menkes / SK / X / 2002 concerning the Approval of Health Research on Humans, and Minister of Health Regulation No. 657 of 2009 concerning the Delivery and Use of Clinical Specimens, Biological Materials and Information Contents. The form of legal protection for risks and impacts caused by humans who are the subject of medical experiments is a form of legal protection for civil, criminal and administrative matters. The rules of conducting experiments on the IMERI FK UI refer to international conventions, national legislation, health research ethics, good clinical practice procedures, as well as the International Joint Commission, and the Human Research Subject Program. This research suggests, the idea of general informed consent can be followed up by related parties"

"Informed consent merupakan salah satu unsur terpenting yang harus dipenuhi sebelum dilakukannya tindakan medis. Oleh karena itu, pemahaman mengenai informed consent sangat diperlukan baik pada pihak yang memberikan pelayanan kesehatan (health providers) dan pihak yang menerima pelayanan kesehatan (health receivers). Namun terdapat kondisi yang tidak memungkinkan untuk dilaksanakannya informed consent, yakni dalam keadaan gawat darurat. Skripsi ini fokus pada kondisi-kondisi gawat darurat medis yang diatur dalam undang-undang yang mengecualikan pelaksanaan informed consent serta penerapan pengecualian ini terhadap gugatan perbuatan melawan hukum terhadap dokter yang tidak melaksanakan informed consent karena kondisi pasien yang tidak dapat menunggu untuk dilaksanakannya informed consent. Terkait kondisi gawat darurat, pada peraturan perundang-undangan di Indonesia telah terdapat pengaturan mengenai pelayanan kegawatdaruratan, namun masih terdapat kerancuan terkait indikator mengenai keadaan darurat. Penelitian dilakukan dengan metode yuridis-normatif dengan tipe deskriptif, data bersumber penelitian adalah data sekunder berupa bahan hukum dan data primer yakni melalui wawancara. Berdasarkan penelitian yang dilakukan oleh penulis, Informed Consent dalam tatanan perundang-undangan diatur dalam beberapa peraturan, antara lain Undang-Undang Republik Indonesia Nomor 36 Tahun 2014 Tentang Tenaga Kesehatan dan Peraturan Menteri Kesehatan Republik Indonesia Nomor 290/ MENKES/III/PER/III/ 2008 tentang Persetujuan Tindakan Kedokteran. Jika dikaitkan dengan hukum perikatan, informed consent timbul berdasarkan transaksi terapeutik yakni perikatan usaha (inspanningsverbintenis) antara dokter dan pasien. Pengecualian terhadap informed Consent didasari kewajiban dokter untuk mengusahakan upaya secara maksimal dalam demi kesehatan pasien termasuk dalam kondisi gawat darurat. Kondisi gawat darurat ini juga telah diatur dalam PERMENKES 47/2018 dimana suatu kondisi merupakan kondisi gawat darurat apabila memenuhi kriteria gawat darurat.

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Informed consent is one of the most important elements that must be fulfilled before taking medical action. Therefore, an understanding of informed consent is needed both for those who provide health services (health providers) and those who receive health services (health receivers). However, there are conditions that make it impossible to carry out informed consent, namely in an emergency.This thesis focuses on medical emergency conditions regulated by law which exclude the implementation of informed consent as well as the application of this exception to lawsuits against doctors who do not carry out informed consent because of the patient's condition who cannot wait for informed consent to be carried out. Emergency conditions in Indonesian laws and regulations are regulated through arrangements regarding emergency services, but there is still confusion regarding indicators regarding emergencies. The research was conducted using a juridical-normative method with a descriptive type, the data sourced from the research were secondary data in the form of legal materials and primary data, namely through interviews. Based on research conducted by the author, Informed Consent in statutory arrangements is regulated in several regulations, including the Law of the Republic of Indonesia Number 36 of 2014 concerning Health Workers and Regulation of the Minister of Health of the Republic of Indonesia Number 290/MENKES/III/PER/III/ 2008 concerning Approval of Medical Actions. Based on the law of obligations, informed consent arises based on therapeutic transactions, namely business engagements (inspanningsverbintenis) between doctors and patients. Exceptions to informed consent are based on the doctor's obligation to make maximum efforts for the sake of patient health, including in emergency situations. This emergency condition has also been regulated in PERMENKES 47/2018 where a condition is an emergency condition if it meets the criteria for an emergency."

"Skripsi ini membahas mengenai Informed consent dalam tindakan medis yang merupakan program pemerintah. Terdapat pengecualian informed consent dalam keadaan khusus yaitu persetujuan tindakan kedokteran tidak perlu bagi tindakan medis yang dilaksanakan sesuai dengan program pemerintah. Tujuan dari penulisan skripsi ini adalah untuk menganalisis penerapan informed consent pada tindakan imunisasi yang mana merupakan salah satu program pemerintah di bidang kesehatan. Penelitian untuk penulisan skripsi ini adalah penelitian yang menggunakan pendekatan yuridis-normatif dengan menggunakan data sekunder dan dengan teknik pengumpulan data yang bersifat kualitatif. Persetujuan dapat berbentuk secara tertulis dan lisan. Dalam imunisasi, persetujuan yang diberikan oleh orang tua merupakan persetujuan yang diberikan secara tersirat dan dipersamakan dengan persetujuan lisan. Pemerintah perlu membuat suatu peraturan lebih lanjut mengenai frasa dari tidak diperlukannya persetujuan tindakan kedokteran dalam tindakan medis yang dilakukan sesuai dengan program pemerintah.This thesis discusses Informed consent in medical treatment which is a government program. There is an exception for informed consent in special circumstances, namely approval of medical treatment is not necessary for medical actions carried out in accordance with government programs. The purpose of writing this thesis is to analyze the application of informed consent to immunization action which is one of the government programs in the health sector. The research for writing this thesis is a research that uses a juridical-normative approach by using secondary data and with qualitative data collection techniques. Consent can be in written and oral form. In immunization, the consent given by parents is an implied consent and is equated with verbal consent. The government needs to make a further regulation regarding the phrase that there is no need for approval of medical treatment in medical actions carried out in accordance with government programs."

"Current developments in EU internal security policy, such as increased information sharing (which includes the exchange of personal data between European law enforcement agencies and judicial actors in the area of freedom, security and justice (Europol, Eurojust, Frontex and OLAF)) and the access of EU agencies, in particular Europol and Eurojust, to data stored in European information systems such as the SIS (II), VIS, CIS or Eurodac raise interesting questions regarding the balance between the rights of individuals and security interests. This book deals with the complexity of the relations between these actors and offers for the first time a comprehensive overview of the structures for information exchange in the area of freedom, security and justice and their compliance with data protection rules in this field."

"ABSTRAKSkripsi ini membahas mengenai pertanggungjawaban perdata dokter mengenai tindakan medis tanpa informed consent. Tujuan penulisan skripsi ini adalah untuk memperoleh pemahaman mengenai bagaimana sebenarnya hak dan kewajiban dokter dan pasien dalam hal terjadi suatu tindakan medis tanpa informed consent.Penelitian untuk penulisan skripsi ini adalah penelitian kepustakaan dengan pengolahan data secara kualitatif serta bersifat deskriptif. Penelitian ini menemukan bahwa di antara pasien dan dokter terdapat hubungan hukum perdata berupa perikatan. Dalam hal salah satu pihak merasa dirugikan maka yang bersangkutan dapat menuntut dengan dasar gugatan wanprestasi atau perbuatan melawan hukum. Penelitian ini juga menemukan bahwa dokter memiliki kewajiban untuk melaksanakan informed consent sebelum melakukan tindakan medis. Namun demikian, dokter dapat mengesampingkan kewajiban ini dalam keadaan tertentu, misalnya pada pasien gawat darurat.

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This thesis talks about physician?s civil liability on medical treatment without informed consent. The purpose of this thesis is to get an understanding about responsibilities and rights of physicians and patient when there is a medical treatment without informed consent.

The research for this thesis writing is a literature research with qualitative data processing and descriptive design. This research found that between physicians and his patient is a civil legal relationship that is obligation. If a party thinks that they have been harmed, they can sue the other party with breach of contract or tort. The research also found that physicians have an obligation to do an informed consent before doing a medical action. But, physician can override that obligation in some circumstances, such as medical emergency."

"Legal aspects of informed consent in medical treatment in Indonesia."

"Legal aspects of informed consent in medical treatment in Indonesia."

"Skripsi ini membahas mengenai peran informed consent pada perjanjian medis dalam Hukum Perjanjian. Dalam skripsi ini akan dibahas mengenai definisi informed consent, perjanjian medis dan keberlakuannya sesuai dengan Hukum perjanjian yang berlaku di Indonesia. Tujuan penulisan karya tulis ini adalah agar setiap orang dapat paham bahwa saat pasien datang ke dokter untuk berobat, pasien tersebut telah melakukan perjanjian medis dengan dokter. Penelitian ini adalah penelitian kualitatif dengan desain eksplanatoris. Hasil dari penelitian ini menyarankan agar penyampaian informasi keadaan kesehatan pasien disampaikan dokter dengan jelas dan komunikasi pihak pasien dan dokter harus terjalin baik. pihak pasien harus sadar bahwa perjanjian medis adalah perjanjian melakukan usaha bukan perjanjian hasil.This thesis is to take up the role of informed consent of medical contract in law of agreement. As the matter subjects are both definitions of informed consent as well medical contract and the enforceability corresponding to Law of Agreement in Indonesia. The purpose of this paper is that everyone can understand that when patients come to doctor for treatment, the patient has made a medical agreement with a doctor. Also, writer did research on the application of informed consent of medical contract in internist practice. During the research, method used is qualitative with explanatory design. As the outcome is advice on delivering vivid information from doctor to patient and good communication between both parties. Patient must realize that medical contract is NOT a result contract, but an attempt contract."