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. (shrink)

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 and dozens of minority groups who are collectively called “Formosan,” an appellation for indigenous peoples in Taiwan. Formosans can be divided into Pingpu and Gaoshan 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. (shrink)