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"This book is the first major work that addresses a core question in biomedical research. The acceptable level of risks is regulated by the requirement of proportionality in biomedical research law.This investigation addresses research on healthy volunteers, children, vulnerable subjects, and includes placebo controlled clinical trials. It represents a major contribution towards clarifying the most central, but also the most controversial and complex issue in biomedical research law and bioethics. "

"This book provides a comprehensive examination of the complex issues surrounding the regulation of the medical profession. It offers up-to-date information on the current legislative framework and institutional arrangements surrounding the regulation in the United Kingdom. Well organized and written in an accessible way, it offers an insight into key sociological theories surrounding medical regulation. It gives a historically situated analysis of the contemporary relationship between medicine, the state and the public, and an overview of relevant social scientific research. Readers will gain insight into possible future directions for medical governance. "

"This book enables those who are involved in genomics research, whether as researcher, participant or policy maker, to understand the ethical issues currently developing in this field and to participate actively in these important debates. A clear account is given of how science and technology are outstripping the capacity of previous ethical regulations to cope with current issues, together with practical illustrations of possible ways forward. Key ethical ideas are presented, drawing on the history of research regulation and on an account of the particular challenges arising in the field of genomics. The book uses a grounded, practical approach to explaining ethical concepts and issues which is geared to enhancing interdisciplinary dialogue. Its broad approach to ethical issues includes relevant considerations from social psychology and there is a particular emphasis on understanding the problems of ethical regulations and practice in the institutional and social context of research. "

"Skripsi ini membahas mengenai tata cara dan analisis hukum terhadap pengelolaan atas adanya kelebihan embrio yang dihasilkan dalam program bayi tabung serta tanggung jawab hukum RSPAD Gatot Soebroto beserta tenaga kesehatannya mengenai hal tersebut. Bentuk penelitian skripsi ini adalah yuridis-normatif dengan metode kualitatif. Hasil penelitian ini menyimpulkan bahwa pengelolaan kelebihan embrio dalam program bayi tabung di Indonesia dapat dilakukan dengan cara menyimpan atau memusnahkannya, dalam hal ini, RSPAD Gatot Soebroto telah melakukannya sesuai dengan peraturan perundang-undangan. Hasil penelitian ini menyarankan bahwa dalam pelaksanaan penyimpanan embrio beku hendaknya dilakukan perpanjangan setiap kurang dari satu tahun, dan melakukan sosialisasi mengenai cara memperbarui data dan status penyimpanan sisa embrio beku.

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This thesis discusses about the procedure and the legal analysis of the management of the excess embryos produced in the test-tube baby program and the law liability of RSPAD Gatot Soebroto and its medical personnel about it. The form of this thesis research is juridical-normative with qualitative method. The results of this study suggest that the management of the excess embryos in the test-tube baby program in Indonesia can be done by store or destroy it, in this case, RSPAD Gatot Soebroto has done it according to the regulations. The results of this study suggest that the implementation of frozen embryos storage should be extended every less than one year, and conduct socialization on how to update the data and storage status of the remaining frozen embryos."

"Skripsi ini membahas mengenai legalitas pelaksanaan operasi pergantian kelamin di Indonesia yang ditinjau berdasarkan hukum kesehatan dan Kode Etik Kedokteran, serta kaitannya dengan tanggung jawab hukum tim dokter terhadap pelaksanaan operasi penggantian kelamin tersebut. Pembahasan dilakukan melalui studi kasus pada penetapan pengadilan Nomor 17/Pdt.P/2015/PN.Kbm sebagai acuan untuk mengetahui bahwa penetapan yang dikeluarkan hakim terhadap pergantian kelamin seseorang apakah telah sah atau tidak. Tipe penelitian ini adalah deskriptif dengan bentuk penelitian yuridisnormatif. Hasil penelitian ini menyimpulkan bahwa pelaksanaan operasi pergantian kelamin di Indonesia adalah sah (legal) selama individu menderita Disorder of Sexual Developmet (DSD), maka pelaksanaan operasi pergantian kelamin Apriandika dalam penetapan pengadilan Nomor 17/Pdt.P/2015/PN.Kbm. menjadi berjenis kelamin perempuan adalah sah secara hukum karena Apriandika menderita DSD, kemudian mengenai pertanggungjawaban tim dokter telah terlaksana secara disiplin profesi, dan tidak diperlukannya tanggung jawab hukum karena tidak ada kesalahan/kelalaian/pelanggaran yang terjadi terhadap Apriandika, sehingga penetapan pergantian kelamin Apriandika adalah sah, walaupun Hakim dalam pertimbangan hukumnya perlu untuk mengelaborasi dari sisi Undang-Undang lainnya selain dari Undang-Undang Administrasi Kependudukan. Untuk saran dari hasil penelitian ini diperlukan adanya pengaturan yang jelas mengenai tahapan, kategori pasien, dan pengecualian untuk operasi pergantian kelamin di Indonesia, dan untuk peraturan yang sudah ada diperlukan adanya pembaharuan.

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This thesis discusses the legality of the implementation of sex reassignment operations in Indonesia which are reviewed based on Health Law and the Medical Ehics Code as well as the relation to the legal teams responsibility for carrying out the sex reassignment operations. The discussion is determined through 17/PDT.P/2015/PN.KBM as the number ofcase study of the court determination in which as a reference, also to know that the classification issued by a judge on a persons sex change is valid or not, with the additional interviews to the surgeons, forensics and psychiatrists, this research therefore, is descriptive research with juridical-normative formed. The result of this study concluded which the implementation of sex change operations in Indonesia is legal as long as individuals suffer from Disorder of Sexual Development (DSD), then the implementation of Apriandikas sex change operationin the determination of court number 17/Pdt.P/2015/PN.Kbm. beingfemale is legal due to the status of Apriandikas who suffers from DSD, in regards of relation to the accountability of the team of doctors which has been carried out in a professional discipline, in addition that there is no need for legal responsibility which there are ultimately noerrors/omissions/violations which occur against Apriandika, thus the determination of Apriandikas sex change is essentially valid even though the judge in his consideration should need to elaborate extensively on the other side of the Lawwhich also regulates sex reassignment operationsother than the Population Administration Act. Therefore, for other suggestions from the results of this study, it is necessary to have clear arrangements regarding the stages, categories, exceptionsof sex change operations in Indonesia, and for existing regulations there is a need for renewal. As a result, this advice is more directed to the Minister of Health."

"ABSTRAKSkripsi ini membahas mengenai kompetensi serta kewenangan bidan serta meninjau tanggung jawab hukum bidan yang melakukan tindakan aborsi. Metode penelitian yang dipergunakan dalam skripsi ini jika ditinjau dari bentuknya merupakan penelitian yuridis-normatif denganmenggunakan metode deskriptif-analitis. Dapat disimpulkan bahwa kompetensi dan kewenangan bidan dalam berprofesi meliputi keluarga berencana, persalinan baik sebelum masa kehamilan, pada masa kehamilan, pada saat kehamilan dan setelah masa kehamilan serta Bidan juga memiliki wewenang dalam memberikan pelayanan kesehatan kepada anak. Sehingga dalam hal ini bidan tidak memiliki kompetensi dan kewenangan dalam menangani persalinan tidak normal atau melakukan aborsi. Tanggung jawab hukum Bidan dapat dilihat dari tanggung jawab Bidan yang dilanggar, sehingga kemudian Bidan karena kesalahannya dapat dikenakan hukuman pidana. Penulis juga memiliki saran bahwa pengaturan mengenai dewan pengawas perlu diperbaiki dan ditambah serta perlunya penambahan pengetahuanhukum bagi para tenaga kesehatan di seluruh Indonesia

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ABSTRACTThis thesis discusses the competence and authority of midwives and reviews the legal responsibilities of midwives who carry out abortion. The research method used in this thesis if viewed from its form is juridical-normative research using descriptive-analytical methods. It can be concluded that the competence and authority of midwives in their profession includes family planning, childbirth both before pregnancy, during pregnancy, during pregnancy and after pregnancy, and midwives also have the authority to provide health services to children. So that in this case the midwife does not have the competence and authority to handle abnormal labor or have an abortion. The legal responsibility of the Midwife can be seen from the responsibilities of the Midwife who is violated, so that later the Midwife due to his mistake can be subject to criminal punishment. The author also has suggestions that arrangements regarding the supervisory board need to be improved and added and the need for additional legal knowledge for health workers throughout Indonesia."