Maruyama Eiji
Kobe University School of Law.
Nihon Rinsho. 2009 Jun;67(6):1209-13.
Whole-genome research projects, especially those involving whole-genome sequencing, tend to raise intractable ethical and legal challenges. In this kind of research, genetic and genomic data obtained by typing or sequencing are usually put in open or limited access scientific databases on the Internet to promote studies by many researchers. Once data become available on the Internet, it will be virtually meaningless to withdraw the information, effectively nullifying participants' right to revoke consent. Although the author favors the governance system that will assure research subjects of the right to withdraw their participation, considering these characteristics of whole-genome research, he finds those recommendations offered in Caulfield T, et al: Research ethics recommendations for whole-genome research: Consensus statement. PLoS Biol 6(3): e73(2008), especially to the effect that the consent process should include information about data security and the governance structure and, in particular, the mechanism for considering future research protocols, well reasoned and acceptable.
全基因组研究项目，尤其是那些涉及全基因组测序的项目，往往会引发棘手的伦理和法律挑战。在这类研究中，通过分型或测序获得的遗传和基因组数据通常会被存入互联网上开放或访问受限的科学数据库，以促进众多研究人员开展研究。一旦数据在互联网上可用，撤回这些信息实际上将毫无意义，这实际上使参与者撤销同意的权利失效。尽管作者赞成能够确保研究对象有权撤回其参与的治理体系，但考虑到全基因组研究的这些特点，他认为考尔菲德等人在《全基因组研究的研究伦理建议：共识声明》（《公共科学图书馆·生物学》6(3): e73[2008]）中提出的那些建议，尤其是关于同意过程应包括数据安全和治理结构方面的信息，特别是考虑未来研究方案的机制，是经过充分论证且可接受的。
