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The Regulation of Human Genomics Research 

The Regulation of Human Genomics Research
Chapter:
The Regulation of Human Genomics Research
Author(s):

Jane Kaye

DOI:
10.1093/med/9780199896028.003.0018
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date: 30 October 2020

Like any other biomedical research, genomic research is closely monitored and managed governed with accepted principles of research governance. Research ethics committees and oversight mechanisms for medical research on human beings have become the accepted norm in most countries. The regulation of genomic research, like other sub-sets of biomedical research, is subject to the same regulatory controls that apply to medical research in general. Most authorities (UK, USA and Europe) follow regulation of bio-medical research on human beings, separated from other regulatory functions, such the approval of medicines and medical devices, in order to discuss the ways in which these more general requirements apply to genomic research. Investigators are advised to consult some of the specialist bodies that have been established as expert advisory bodies for genomics.

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