Technoscience and Regulation Research Unit, Faculty of Medicine, Dalhousie University, Halifax, Canada.
OMICS. 2010 Jun;14(3):327-32. doi: 10.1089/omi.2010.0022.
Standardization is critical to scientists and regulators to ensure the quality and interoperability of research processes, as well as the safety and efficacy of the attendant research products. This is perhaps most evident in the case of "omics science," which is enabled by a host of diverse high-throughput technologies such as genomics, proteomics, and metabolomics. But standards are of interest to (and shaped by) others far beyond the immediate realm of individual scientists, laboratories, scientific consortia, or governments that develop, apply, and regulate them. Indeed, scientific standards have consequences for the social, ethical, and legal environment in which innovative technologies are regulated, and thereby command the attention of policy makers and citizens. This article argues that standardization of omics science is both technical and social. A critical synthesis of the social science literature indicates that: (1) standardization requires a degree of flexibility to be practical at the level of scientific practice in disparate sites; (2) the manner in which standards are created, and by whom, will impact their perceived legitimacy and therefore their potential to be used; and (3) the process of standardization itself is important to establishing the legitimacy of an area of scientific research.
标准化对于科学家和监管机构来说至关重要,可确保研究过程的质量和互操作性,以及相关研究产品的安全性和有效性。在“组学科学”中,这一点最为明显,它得益于许多不同的高通量技术,如基因组学、蛋白质组学和代谢组学。但是,标准不仅受到(并受到)开发、应用和监管它们的个别科学家、实验室、科学联盟或政府等直接领域之外的许多人的关注。事实上,科学标准会对创新技术受到监管的社会、伦理和法律环境产生影响,因此引起政策制定者和公民的关注。本文认为,组学科学的标准化既是技术性的,也是社会性的。对社会科学文献的批判性综合表明:(1) 标准化需要一定程度的灵活性,才能在不同地点的科学实践层面上具有实际意义;(2) 标准的创建方式和创建者将影响其被认为的合法性,从而影响其被使用的可能性;(3) 标准化本身的过程对于确立科学研究领域的合法性非常重要。