title: Standardization and omics science: technical and social dimensions are inseparable and demand symmetrical study.
abstract: 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.
authors.affiliation: Technoscience and Regulation Research Unit, Faculty of Medicine, Dalhousie University, Halifax, Canada.
authors.forename: Christina
authors.initials: C
authors.lastname: Holmes
authors.forename: Fiona
authors.initials: F
authors.lastname: McDonald
authors.forename: Mavis
authors.initials: M
authors.lastname: Jones
authors.forename: Vural
authors.initials: V
authors.lastname: Ozdemir
authors.forename: Janice E
authors.initials: JE
authors.lastname: Graham
mesh_terms: D003142:Communication; D023281:Genomics; D006801:Humans; D040901:Proteomics; D012015:Reference Standards; D012106:Research; D012942:Social Sciences
references.citation: CMAJ. 2001 Sep 18;165(6):783-5
references.pmid: 11584569
references.citation: OMICS. 2008 Jun;12(2):109-13
references.pmid: 18564915
references.citation: OMICS. 2006 Summer;10(2):94-9
references.pmid: 16901212
references.citation: JAMA. 2001 Jul 4;286(1):89-91
references.pmid: 11434832
references.citation: Brief Funct Genomic Proteomic. 2009 Mar;8(2):126-35
references.pmid: 19109305
references.citation: N Engl J Med. 2005 Sep 8;353(10):1060-5
references.pmid: 16148294
references.citation: OMICS. 2009 Dec;13(6):451
references.pmid: 20001859
references.citation: OMICS. 2006 Summer;10(2):172-8
references.pmid: 16901223
references.citation: OMICS. 2008 Jun;12(2):101-8
references.pmid: 18564914
references.citation: OMICS. 2006 Summer;10(2):231-7
references.pmid: 16901231
references.citation: OMICS. 2006 Summer;10(2):138-44
references.pmid: 16901218
references.citation: Neuroepidemiology. 1996;15(5):246-56
references.pmid: 8878077
references.citation: Genet Med. 2007 Oct;9(10):665-74
references.pmid: 18073579
references.citation: OMICS. 2008 Jun;12(2):99
references.pmid: 18479203
references.citation: OMICS. 2008 Jun;12(2):137-41
references.pmid: 18416670
references.citation: Bull World Health Organ. 2006 Aug;84(8):597-602
references.pmid: 16917645
references.citation: OMICS. 2009 Feb;13(1):43-61
references.pmid: 19290811
references.citation: OMICS. 2006 Summer;10(2):145-51
references.pmid: 16901219
references.citation: OMICS. 2006 Summer;10(2):152-7
references.pmid: 16901220
references.citation: OMICS. 2008 Jun;12(2):157-60
references.pmid: 18564916
references.citation: OMICS. 2006 Summer;10(2):158-63
references.pmid: 16901221
references.citation: OMICS. 2006 Summer;10(2):114-8
references.pmid: 16901215