Camb Q Healthc Ethics. 2021 Jan;30(1):146-160. doi: 10.1017/S0963180120000614.
Although the concept of biobanking is not new, the open and evolving nature of biobanks has created profound ethical, legal, and social implications, including issues around informed consent, community engagement, secondary uses of materials over time, ownership of materials, data sharing, and privacy. Complexities also emerge because of increasing international collaborations and differing national positions. In addition, the degrees and topics of concern vary as legislative, ethical, and social frameworks differ across developed and developing countries. Implementing national laws in an internationally consistent manner is also problematic. However, these concerns should not cause countries, especially developing countries, to lag behind as this novel wave of research gains momentum, particularly while several biobank initiatives are already underway in the developing world. As the law has always struggled to keep up with the fast-evolving scientific arena, this article seeks to identify the ethico-legal frameworks in place in the United Kingdom, Australia, Uganda, and South Africa, for human biobank research, in an attempt to compare and contextualize the approaches to human biobanking in specific developed and developing countries.
虽然生物库的概念并不新鲜,但生物库的开放性和不断发展的性质带来了深刻的伦理、法律和社会影响,包括知情同意、社区参与、材料的后续使用、材料的所有权、数据共享和隐私等问题。由于国际合作的增加和各国立场的不同,复杂性也随之出现。此外,由于立法、伦理和社会框架在发达国家和发展中国家存在差异,关注的程度和主题也有所不同。以国际一致的方式实施国家法律也是一个问题。然而,这些担忧不应该导致各国(尤其是发展中国家)落后,因为这一新的研究浪潮正在兴起,尤其是在发展中国家已经开展了几项生物库倡议的情况下。由于法律总是难以跟上快速发展的科学领域,本文试图确定英国、澳大利亚、乌干达和南非在人类生物库研究方面的伦理法律框架,以试图比较和理解特定发达国家和发展中国家的人类生物库方法。