Penelitian adalah suatu kegiatan yang dilakukan sesuai dengan kaidah dan metode ilmiah secara sistematis untuk memperoleh keterangan, data, dan informasi yang berkaitan dengan pemahaman dan pembuktian benar atau salahnya asumsi dan/atau hipotesis di bidang ilmu pengetahuan dan teknologi serta menyiapkan kesimpulan ilmiah untuk tujuan tersebut. tujuan kemajuan ilmu pengetahuan dan teknologi. Fasilitas kesehatan adalah tempat yang digunakan untuk melaksanakan upaya pelayanan kesehatan yang bersifat promotif, preventif, kuratif, dan/atau rehabilitatif, termasuk laboratorium kesehatan. Lembaga penelitian dan pengembangan adalah lembaga yang melaksanakan kegiatan penelitian dan/atau pengembangan di bidang kesehatan, yang dapat berupa organisasi mandiri atau bagian dari organisasi pemerintah, pemerintah daerah, lembaga pendidikan, universitas, rumah sakit, badan usaha, lembaga penunjang, dan organisasi kemasyarakatan.
Spesimen klinis adalah bahan yang berasal dari dan/atau diambil dari tubuh manusia untuk tujuan diagnostik, penelitian, pengembangan, pendidikan, dan/atau analisis lainnya, termasuk penyakit baru, re-emerging, dan menular yang berpotensi menjadi pandemi. Bahan Biologi adalah bahan hayati yang terkandung dalam sampel klinik, sampel hewan, tumbuhan, isolat virus, bakteri, jamur, dan mikroorganisme lainnya, parasit, vektor, dan sumber alam lainnya yang merupakan bagian dan/atau turunan serta produk dari bagian dan/atau bahan tersebut. atau turunannya, termasuk yang mengandung materi dan informasi urutan genetik seperti urutan nukleotida pada molekul RNA dan/atau cDNA. Perjanjian transfer material (MTA) adalah perjanjian pengalihan suatu sampel klinis dan/atau bahan biologis atau kandungan informasinya antara dua penyedia atau lembaga atau negara, dimana pihak pertama adalah pengirim/penyedia/pengangkut/negara asal dan pihak kedua adalah negara penerima/pengguna/pemroses/penerima.
Kepala Badan Penelitian dan Pengembangan Kesehatan dibantu Tim Peninjau Perjanjian Transfer Material mengkaji usulan pengiriman spesimen beserta lampirannya; Apabila disetujui, Perjanjian Pengalihan Material akan ditandatangani oleh Kepala Badan Penelitian dan Pengembangan atas nama Menteri. identitas penyelenggara dan penyelenggara pihak pengirim, pihak penerima, pihak pengguna dan pembawa sampel klinis, bahan biologi dan/atau kandungan informasi pada institusinya;
Penyedia pelayanan kesehatan, lembaga penelitian dan pengembangan dan/atau lembaga lain yang bergerak di bidang penyimpanan, pengolahan, konversi, pengelolaan, penyediaan, penelitian dan pengembangan sampel klinis, bahan biologi dan/atau kandungan informasi harus mempunyai staf, sarana dan prasarana, standar prosedur operasional yang memenuhi persyaratan dan mempunyai aturan internal (berdasarkan undang-undang) yang ditetapkan untuk itu.
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Penentuan siapa yang akan menerima vaksin dan obat-obatan sesuai ketentuan yang berlaku dan penanganan kejadian tindak lanjut pasca imunisasi g.Pemeriksaan ulang terhadap spesimen klinis dan/atau bahan biologi, pembatalan atau pengukuhan keputusan yang diambil oleh Tim Peninjau Perjanjian Transfer Bahan;
BAB IV
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BAB V KEPEMILIKAN
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BAB VII
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BAB VIII
BAB IX
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Dengan ditetapkannya Peraturan ini, maka Keputusan Menteri Kesehatan Nomor 732/Menkes/SK/VII/2008 tentang Petunjuk Pengiriman Sampel Untuk Keperluan Penelitian dan Pengembangan Kesehatan, dinyatakan tidak berlaku.
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- DEFINITIONS
- OWNERSHIP OF MATERIALS
- THE RESEARCH PLAN/ PROTOCOL
- INTELLECTUAL PROPERTY RIGHTS
- RETURN OF MATERIALS AND MODIFICATIONS
- PUBLICATION
- CONFIDENTIALITY
- INDEMNITY
- ARBITRATION
- NOTICE 1 Address
- GOVERNING LAWS
Modifications: Substances created by the Recipient that contain and/or include and/or originate from the Materials and/or use of the Materials. The Second Party acknowledges that the rights, title and interest in the Materials are the property of the First Party and the First Party shall retain ownership of the Materials. The role and responsibilities of the scientists will be further described in the Research Plan/Protocol.
The Second Party agreed to return to the first Party any and all unused Materials, Modifications and all data, records and results derived from the Materials and Research Plan/Protocol within two (2) weeks after the study was completed. The First Party may at any time and at its discretion request in writing the Second Party to return any and all unused Materials, Modifications and all data, records and results obtained from the Materials and Research Plan/Protocol, and the Second Party agreed to fulfill the request within one (1) week of the written request. The inclusion of the First Party in the Outputs, as author or co-author, will be described in detail in the Research Plan/Protocol.
In the event of any subsequent dissemination authorized by the First Party, the Second Party has agreed to recognize the First Party and its scientists as academically and scientifically appropriate, based on international guidelines regarding the provision of the Materials or other direct contributions. to the research. The First Party agrees that it will recognize the publications of the Second Party, as academically and scientifically appropriate, in its publications, which may refer to the results of the Research Plan/Protocol. Such information includes, without limitation, any specific, technical, trade or business information of the First Party.
The first party and the second party shall respectively have the right to appoint one (1) arbitrator, and if a party fails to appoint its arbitrator within fourteen (14) days after the appointment of the first arbitrator, such arbitrator shall be appointed by the ICC . If the two (2) arbitrators fail to appoint the third arbitrator within fourteen (14) days of the appointment of the second arbitrator, that third arbitrator shall be appointed by the ICC. The role and responsibilities of both parties' scientists will be described in the research plan/protocol.
The Second Party has agreed to return any and all unused Materials, Modifications and all data, records and results derived from the Materials, Modifications and Research Plan/Protocol to the first Party within two (2) weeks after the study has been completed. In addition, the First Party may at any time and in its sole discretion request the Second Party in writing to return any and all unused materials, modifications and all data, records and results obtained from the materials and research plan/protocol. , and the Second Party agreed to fulfill the request within one (1) week of the written request. The use of any data, results or concepts, hereinafter called Outputs, derived from the use of the material and modifications in presentations, abstracts, publications (both peer-reviewed and non-peer-reviewed), grants, or other means of dissemination by the Second Party or Scientific, will require express written consent by the First Party.
The inclusion of the First Party in the Outputs, as author or co-author, will be described in detail in the Research Plan/Protocol. The First Party agrees that it will recognize the Second Party's publications, as academically and scientifically appropriate, in its publications, which may refer to the results of the Research Plan.
