Taiwan is an island country situated in the northwest Pacific, close to the southeast of China. The land area is about 36,000 square kilometers. The population of Taiwan is about 23 million, and it consists of the majority Han ethnic groups (it can be further divided into Ho-ló, Hakka, and Mainlander) and dozens of minority groups who are collectively called “Formosan,” an appellation for indigenous peoples in Taiwan. Formosans can be divided into Pingpu (plain-land indigenous peoples) and Gaoshan (mountain indigenous peoples) by their living area. In recent years, marriages between Taiwanese, Mainland Chinese, and Southeast Asians have increased significantly. Because of the genetic background of the Taiwanese people, it was thought to be highly beneficial for Taiwan to establish a biobank specifically designed for the Taiwanese population, as it would enable large-scale cohort studies to be carried out for common diseases occurring in Taiwan.
There has been little, if any, discussion of the issue as of now b. There has been discussion among researchers, but little discussion among policy makers c. There has been discussion among both researchers and policy makers d. I am not sure -or other answer 1.1 In Australia, genomic research would require ethics approval like any other human research. DTP research would also attract the general requirements for approving human research, including minimizing risk and ensuring consent (Chapter 2.1-2.3 National Statement). In addition, there are specific requirements for Genomic Research in the National Statement in Chapter 3.3. Any proposed DTP genomic research would need to comply with the specific requirements of Chapter 3.3 to be satisfactorily addressed for ethical approval. 1.2 The National Health and Medical Research Council has the issue of Direct to Customer Genetic Testing under consideration and has published three relevant information documents. 1 1.3 The Commonwealth Australia Government, Department of Health has issued guidance for the Provision of Direct-to-Consumer Genetic Tests: Guiding Principles for Providers. 2 The Australian Genomics Health Alliance (AGHA) published a news page on Understanding Direct-to-Consumer Genetic Testing, with information on clinical-grade testing. 3 2. Assume that a researcher in your country wants to conduct DTP genomic research with participants in your country and that such research is subject to IRB/REC review. Please describe the conditions for IRB/ REC approval, if it could be approved at all.
In the United States, final amendments to the Federal Policy for the Protection of Human Subjects (“the Common Rule”) were published on January 19, 2017, and they will take effect on January 21, 2019. One of the most widely discussed provisions is that for the first time, federal regulations governing research with humans authorize the use of broad consent for future, unspecified research on individually identifiable biospecimens and associated data. Many questions have been raised about broad consent, including what effect it will have on research and whether it adequately protects the interests of research participants. There are lessons to be learned for the U.S. and other countries by looking to countries that already have experience with broad consent for biobank collection and with the storage and subsequent use of the biospecimens and data. This article describes how broad consent works in five countries—Canada (in Quebec), Israel, Nigeria, Taiwan, and the United Kingdom—and with different types of biobanks: national biobanks, federated biobanks, and regional biobanks. Evaluating the provisions and challenges of the broad consent approaches in these countries can inform policies for this increasingly used approach to biobank regulation.
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