Kayte Spector-Bagdady1. 1. Center for Bioethics & Social Sciences in Medicine, Program in Research Ethics, University of Michigan, Ann Arbor. Electronic address: kaytesb@med.umich.edu.
Abstract
PURPOSE: 23andMe is back on the market as the first direct-to-consumer genetic testing company that "includes reports that meet Food and Drug Administration (FDA) standards…." But, whereas its front-end product is selling individual genetic tests online, its back-end business model is amassing one of the largest privately owned genetic databases in the world. What is the effect, however, of the private control of bio/databases on genetic epidemiology and public health research? METHODS: The recent federal government notices of proposed rulemaking for: (1) revisions to regulations governing human subjects research and (2) whether certain direct-to-consumer genetic tests should require premarket FDA review, were reviewed and related to the 23andMe product, business model, and consumer agreements. RESULTS: FDA regulatory action so far has focused on the return of consumer test reports but it should also consider the broader misuse of data and information not otherwise protected by human subjects research regulations. CONCLUSIONS: As the federal government revises its decades-old human subjects research structure, the Executive Office of the President (EOP) should consider a cohesive approach to regulating private genetic bio/databanks. This strategy should allow the FDA and other agencies to play a role in expanding current regulatory coverage.
PURPOSE: 23andMe is back on the market as the first direct-to-consumer genetic testing company that "includes reports that meet Food and Drug Administration (FDA) standards…." But, whereas its front-end product is selling individual genetic tests online, its back-end business model is amassing one of the largest privately owned genetic databases in the world. What is the effect, however, of the private control of bio/databases on genetic epidemiology and public health research? METHODS: The recent federal government notices of proposed rulemaking for: (1) revisions to regulations governing human subjects research and (2) whether certain direct-to-consumer genetic tests should require premarket FDA review, were reviewed and related to the 23andMe product, business model, and consumer agreements. RESULTS: FDA regulatory action so far has focused on the return of consumer test reports but it should also consider the broader misuse of data and information not otherwise protected by human subjects research regulations. CONCLUSIONS: As the federal government revises its decades-old human subjects research structure, the Executive Office of the President (EOP) should consider a cohesive approach to regulating private genetic bio/databanks. This strategy should allow the FDA and other agencies to play a role in expanding current regulatory coverage.
Authors: George Davey Smith; Shah Ebrahim; Sarah Lewis; Anna L Hansell; Lyle J Palmer; Paul R Burton Journal: Lancet Date: 2005 Oct 22-28 Impact factor: 79.321
Authors: Kayte Spector-Bagdady; Raymond G De Vries; Michele G Gornick; Andrew G Shuman; Sharon Kardia; Jodyn Platt Journal: Health Aff (Millwood) Date: 2018-08 Impact factor: 6.301